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    Start Preamble Federal Transit Administration phenergan with codeine buy (FTA), DOT. Notice of funding opportunity. The Coronavirus Disease 2019 (COVID-19) public health emergency Start Printed Page 63654has had a significant phenergan with codeine buy impact on transit operations. During a series of FTA listening sessions held over the last three months, transit agencies asked FTA to support research to identify solutions to address the operational challenges that they are facing as a result of COVID-19. In response, FTA makes available through this Notice of Funding Opportunity (NOFO) funding to support research demonstration grants to public transit agencies to develop, deploy, and demonstrate innovative solutions that improve the operational efficiency of transit agencies, as well as enhance the mobility of transit users affected by the COVID-19 public health emergency.

    Demonstration grants under this NOFO are authorized under FTA's Public phenergan with codeine buy Transportation Innovation Program (49 U.S.C. 5312). Eligible projects will demonstrate innovative solutions to improve the operational efficiencies of transit systems and enhance mobility for their communities in four major areas. (1) Vehicle, phenergan with codeine buy facility, equipment and infrastructure cleaning and disinfection. (2) exposure mitigation measures.

    (3) innovative mobility such as contactless payments. And (4) measures that strengthen public confidence in phenergan with codeine buy transit services. The total funding available for awards under this NOFO is $10,000,000. FTA may supplement phenergan with codeine buy this amount if additional funding becomes available. Applicants must submit completed proposals for funding opportunity FTA-2020-015-TRI through the GRANTS.GOV “APPLY” function by 11:59 p.m.

    Eastern Time on November 2, 2020. Prospective applicants should register as soon as possible on the GRANTS.GOV website phenergan with codeine buy to ensure they can complete the application process before the submission deadline. Application instructions are available on FTA's website at http://transit.dot.gov/​howtoapply and in the “FIND” module of GRANTS.GOV. FTA will not accept mail and fax submissions. Start Further Info Please send any phenergan with codeine buy questions on this notice to Jamel El-Hamri email.

    Jamel.El-Hamri@dot.gov phone. 2020-366-8985. A Telecommunication phenergan with codeine buy Device for the Deaf (TDD) is available for individuals who are deaf or hard of hearing at 1-800-877-8339. End Further Info End Preamble Start Supplemental Information Table of Contents A. Program Description B.

    Federal Award Information C phenergan with codeine buy. Eligibility Information D. Application and phenergan with codeine buy Submission Information E. Application Review Information F. Federal Award Administration Information G.

    Federal Awarding Agency Contact Information A phenergan with codeine buy. Program Description The Public Transportation COVID-19 Research Demonstration Grant Program is funded through the Public Transportation Innovation Program (49 U.S.C. 5312), with the goal to develop, deploy, and demonstrate innovative solutions that improve the operational efficiency of transit agencies, as well as enhance the mobility of transit users affected by the COVID-19 public health emergency. Eligible projects will propose to develop and deploy innovative solutions phenergan with codeine buy in four major areas. (1) Vehicle, facility, equipment and infrastructure cleaning and disinfection.

    (2) exposure mitigation measures. (3) innovative mobility phenergan with codeine buy such as contactless payments. And (4) measures that strengthen public confidence in transit. As required phenergan with codeine buy by 49 U.S.C. 5312(e)(4), projects funded under this NOFO must participate in an evaluation by an independent outside entity that will conduct a comprehensive evaluation of the success or failure of the projects funded under this subsection and any plan for broad-based implementation of the innovation promoted by successful projects.

    B. Federal Award Information FTA makes available $10,000,000 in fiscal year (FY) 2020 funds under the Public phenergan with codeine buy Transportation Innovation Program (49 U.S.C. 5312) to finance the Public Transportation COVID-19 Research Demonstration Grant Program. FTA may supplement the total funds available if additional funding becomes available at the time project selections are made. FTA will phenergan with codeine buy grant pre-award authority starting on the date of the project award announcement for selected projects and should be completed within 24 months from the date of award.

    Funds are available only for eligible expenses incurred after the announcement of project selections. C. Eligibility Information (1) Eligible Applicants Eligible applicants include State and local governmental authorities, direct recipients phenergan with codeine buy of Urbanized Area (49 U.S.C. 5307) and Rural Area (49 U.S.C. 5311) formula funds, and Indian tribes.

    Eligible applicants are limited to FTA grantees or subrecipients who would be the primary beneficiaries of the innovative products and services that are developed—typically public transit agencies phenergan with codeine buy. Except for projects proposed by Indian tribes, proposals for projects in rural (non-urbanized) areas must be submitted as part of a consolidated State proposal. States and other eligible applicants phenergan with codeine buy also may submit consolidated proposals for projects in urbanized areas. The submission of the Statewide application will not preclude the submission and consideration of any application from other eligible recipients in an urbanized area in a State. Proposals may contain projects to be implemented by the recipient or its subrecipients.

    Eligible subrecipients phenergan with codeine buy include public agencies, private nonprofit organizations, and private providers engaged in public transportation. Eligible applicants may submit consolidated proposals for projects. (2) Cost Sharing or Matching The maximum Federal share of project costs is 100 percent. FTA may give additional consideration to applicants that propose a local share and may view these applicants phenergan with codeine buy as more competitive. The applicant must document the source(s) of the local match, if any, in the grant application.

    For any applicants proposing match, eligible local match sources include the following. Cash from non-Government sources other phenergan with codeine buy than revenues from providing public transportation services. Revenues derived from the sale of advertising and concessions. Revenues generated from value capture financing mechanisms. Funds from an phenergan with codeine buy undistributed cash surplus.

    Replacement or depreciation cash fund or reserve. New capital phenergan with codeine buy. Or in-kind contributions. (3) Eligible Projects Eligible projects will propose innovative solutions to improve operational efficiencies of transit agencies and enhance the mobility of transit users, through projects that demonstrate innovative solutions for. Vehicle, facility, equipment phenergan with codeine buy and infrastructure cleaning and disinfection.

    Exposure mitigation measures such a real-time notification of rail and bus passenger loads. New multi-modal payment innovative mobility systems such as contactless payments. And measures that phenergan with codeine buy strengthen public confidence in transit. Each applicant may only submit one proposal.Start Printed Page 63655 D. Application and Submission Information (1) Address and Form of Application Submission Applications must be submitted through GRANTS.GOV.

    Applicants can find general information for submitting applications through GRANTS.GOV at www.fta.dot.gov/​howtoapply, along with specific instructions for the forms and phenergan with codeine buy attachments required for submission. Mail and fax submissions will not be accepted. (2) Content and Form of Application Submission a. Proposal Submission A complete proposal submission consists of at least two phenergan with codeine buy forms. 1.

    The SF-424 Mandatory Form phenergan with codeine buy (downloadable from GRANTS.GOV) and 2. The supplemental form for the FY 2020 COVID-19 Demonstration Program (downloadable from GRANTS.GOV), which is available on FTA's website at (placeholder for FTA COVID-19 Demonstration Program). The application must include responses to all sections of the SF-424 mandatory form and the supplemental form unless a section is indicated as optional. FTA will use the information on the supplemental form to determine applicant and project eligibility for the program and to evaluate the proposal against the phenergan with codeine buy selection criteria described in part E of this notice. FTA will accept only one supplemental form per SF-424 submission.

    FTA encourages applicants to consider submitting a single supplemental form that includes multiple activities to be evaluated as a consolidated proposal. Applicants may attach additional supporting information to the SF-424 submission, including but not limited to letters of support, project budgets, or phenergan with codeine buy excerpts from relevant planning documents. Supporting documentation must be described and referenced by file name in the appropriate response section of the supplemental form, or it may not be reviewed. Information such as applicant name, Federal amount requested, local match amount, description of areas served, etc., may be requested in varying degrees of detail on both the SF-424 form and supplemental form. Applicants must fill in all fields phenergan with codeine buy unless stated otherwise on the forms.

    If applicants copy information into the supplemental form from another source, they should verify that the supplemental form has fully captured pasted text and that it has not truncated the text due to character limits built into the form. Applicants should use both the phenergan with codeine buy “Check Package for Errors” and the “Validate Form” validation buttons on both forms to check all required fields. Applicants should also ensure that the Federal and local amounts specified are consistent. Addressing the deteriorating conditions and disproportionately high fatality rates on our rural transportation infrastructure is of critical interest to the Department, as rural transportation networks face unique challenges in safety, infrastructure condition, and passenger and freight usage. Consistent with the R.O.U.T.E.S phenergan with codeine buy.

    Initiative, the Department encourages applicants to consider how the project will address the challenges faced by rural areas. B. Application Content The SF-424 Mandatory phenergan with codeine buy Form and the supplemental form will prompt applicants for the required information, including. I. Applicant Name ii.

    Dun and phenergan with codeine buy Bradstreet (D&B) Data Universal Numbering System (DUNS) number iii. Key contact information (contact name, address, email address, and phone number) iv. Congressional district(s) where project will take place v. Project Information (title, phenergan with codeine buy executive summary, and type) vi. A detailed description of the need for the project vii.

    A detailed description of how the project will support the phenergan with codeine buy Program objectives viii. Evidence that the applicant can provide the local cost shares ix. A description of the technical, legal, and financial capacity of the applicant x. A detailed phenergan with codeine buy project budget xi. Details on the local matching funds xii.

    A detailed project timeline xiii. Whether the project impacts an Opportunity Zone (3) Unique Entity Identifier and System for phenergan with codeine buy Award Management (SAM) Each applicant is required to. (1) Be registered in SAM before submitting an application. (2) provide a valid unique entity identifier in its application. And (3) continue to maintain an active phenergan with codeine buy SAM registration with current information at all times during which the applicant has an active Federal award or an application or plan under consideration by FTA.

    These requirements do not apply if the applicant. (1) Is excepted from the requirements under 2 CFR 25.110(b) or (c). Or (2) has an exception approved by FTA under 2 CFR phenergan with codeine buy 25.110(d). FTA may not make an award until the applicant has complied with all applicable unique entity identifier and SAM requirements. If an applicant has not fully complied with the phenergan with codeine buy requirements by the time FTA is ready to make an award, FTA may determine that the applicant is not qualified to receive an award and use that determination as a basis for making a Federal award to another applicant.

    All applicants must provide a unique entity identifier provided by SAM. Registration in SAM may take as little as 3-5 business days, but there can be unexpected steps or delays. For example, the applicant may need to phenergan with codeine buy obtain an Employer Identification Number. FTA recommends allowing ample time, up to several weeks, to complete all steps. For additional information on obtaining a unique entity identifier, please visit www.sam.gov.

    (4) Submission Dates and Times Project proposals must phenergan with codeine buy be submitted electronically through GRANTS.GOV by 11:59 p.m. Eastern on November 2, 2020. Mail and fax submissions will not be accepted. FTA urges applicants to submit applications at least 72 hours prior to the due date to allow time to correct any problems that may have caused either GRANTS.GOV or phenergan with codeine buy FTA systems to reject the submission. Proposals submitted after the deadline will only be considered under extraordinary circumstances not within the applicant's control.

    Deadlines will not be extended due phenergan with codeine buy to scheduled website maintenance. GRANTS.GOV scheduled maintenance and outage times are announced on the GRANTS.GOV website. Within 48 hours after submitting an electronic application, the applicant should receive two email messages from GRANTS.GOV. (1) Confirmation of successful phenergan with codeine buy transmission to GRANTS.GOV. And (2) confirmation of successful validation by GRANTS.GOV.

    If the applicant does not receive confirmation of successful validation or receives a notice of failed validation or incomplete materials, the applicant must address the reason for the failed validation, as described in the email notice, and resubmit before the submission deadline. If making a resubmission for any reason, applicants must include all original attachments regardless of which attachments were updated and check the box on the supplemental form phenergan with codeine buy indicating this is a resubmission. Applicants are encouraged to begin the process of registration on the GRANTS.GOV site well in advance of the submission deadline. Registration is Start Printed Page 63656a multi-step process, which may take several weeks to complete before an application can be submitted. Registered applicants may still be required to update their registration before submitting an application phenergan with codeine buy.

    Registration in SAM is renewed annually and persons making submissions on behalf of the Authorized Organization Representative (AOR) must be authorized in GRANTS.GOV by the AOR to make submissions. (5) Funding Restrictions Funds may be used for post-award expenditures only. Funds under this NOFO cannot be used to reimburse projects for otherwise eligible phenergan with codeine buy expenses incurred prior to the date of project award announcements. (6) Other Submission Requirements FTA encourages applicants to identify scaled funding options in case insufficient funding is available to fund a project at the full requested amount. If an applicant indicates that a project is scalable, the applicant must provide an appropriate minimum funding amount that will fund an eligible project that achieves the objectives of the phenergan with codeine buy program and meets all relevant program requirements.

    The applicant must provide a clear explanation of how a reduced award would affect the project budget and scope. FTA may award a lesser amount whether or not the applicant provides a scalable option. E. Application Review Information (1) Project Evaluation Criteria Addressing the deteriorating conditions and disproportionately high fatality rates on our rural transportation infrastructure is of critical interest to the Department, as rural transportation networks face unique challenges in safety, infrastructure condition, and passenger and freight usage. Consistent with the R.O.U.T.E.S.

    Initiative, the Department will consider how the project will address the challenges faced by rural areas. In addition, the Department will review and consider applications for funding pursuant to this Notice in accordance with the President's September 2, 2020 memorandum, entitled Memorandum on Reviewing Funding to State and Local Government Recipients of Federal Funds that Are Permitting Anarchy, Violence, and Destruction in American Cities, consistent with guidance from the Office of Management and Budget and the Attorney General and with all applicable laws. FTA will evaluate proposals submitted according to the following criteria. (a) Project Innovation and Impact. (b) Project Approach.

    (c) National Applicability. (d) Commercialization and/or Knowledge Transfer. And (e) Technical, Legal and Financial Capacity. FTA encourages each applicant to demonstrate how a project supports all criteria with the most relevant information the applicant can provide, regardless of whether such information has been specifically requested or identified in this notice. A.

    Project Innovation and Impact i. Effectiveness of the project in achieving and demonstrating the specific objectives of this program. Ii. Demonstration of benefits in addressing the needs of the transit agency and industry and impacts to infrastructure, equipment, transit workforce, and riders. Iii.

    Degree of improvement over current and existing technologies, designs, and/or practices applicable to the transit industry. B. Project Approach i. Quality of the project approach such as existing partnerships, collaboration strategies and level of commitment of the project partners. Ii.

    Proposal is realistic in its approach to fulfill the milestones/deliverables, schedule and goals. C. National Applicability i. Degree to which the project could be replicated by other transit agencies regionally or nationally. Ii.

    Ability to evaluate technologies, designs and/or practices in a wide variety of conditions and locales. Iii. Degree to which the technology, designs and/or practices can be replicated by other transportation modes. D. Commercialization and/or Knowledge Transfer i.

    Demonstrates a realistic plan for moving the results of the project into the transit marketplace (patents, conferences, articles in trade magazines, webinar, site visits, etc.). Ii. How the project team plans to work with the industry on improving best practices, guidance and/or standards, if applicable. Iii. Demonstrate a clear understanding and robust approach to data collection, access and management.

    E. Technical, Legal and Financial Capacity Capacity of the applicant and any partners to successfully execute the project effort. There should be no outstanding legal, technical, or financial issues with the applicant that would make this a high-risk project. (2) Review and Selection Process An FTA technical evaluation committee will evaluate proposals based on the published project evaluation criteria. Members of the technical evaluation committee will rate the applications and may seek clarification about any statement in an application.

    The FTA Administrator will determine the final selection and amount of funding for each project after consideration of the findings of the technical evaluation committee. Geographic diversity, diversity of the project type, the amount of local match to be provided, and the applicant's receipt and management of other Federal transit funds may be considered in FTA's award decisions. Prior fare payment innovation efforts may receive priority consideration. The FTA Administrator will consider the following key DOT objectives. A.

    Utilizing alternative funding sources and innovative financing models to attract non-Federal sources of investment. B. Whether the project is located in or supports public transportation service in a qualified opportunity zone designated pursuant to 26.U.S.C. 1400Z-1. And c.

    The extent to which the project addresses challenges specific to the provision of rural public transportation. (3) FAPIIS Review Prior to making a grant award, FTA is required to review and consider any information about the applicant that is in the Federal Awardee Performance and Integrity Information System (FAPIIS) accessible through SAM. An applicant may review and comment on information about itself that a Federal awarding agency previously entered. FTA will consider any comments by the applicant, in addition to the other information in FAPIIS, in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR 200.205 Federal Awarding Agency Review of Risk Posed by Applicants. F.

    Federal Award Administration Information (1) Federal Award Notices FTA will announce the final project selections on the FTA website. Project recipients should contact their FTA Regional Office for additional information regarding allocations for Start Printed Page 63657projects. At the time project selections are announced, FTA will extend pre-award authority for the selected projects. There is no blanket pre-award authority for these projects before announcement. There is no minimum or maximum grant award amount, but FTA intends to fund as many meritorious projects as possible.

    FTA only will consider proposals from eligible recipients for eligible activities. Due to funding limitations, projects selected for funding may receive less than the amount originally requested. In those cases, applicants must be able to demonstrate that the proposed projects are still viable and can be completed with the amount awarded. (2) Administrative and National Policy Requirements a. Pre-Award Authority FTA will issue specific guidance to recipients regarding pre-award authority at the time of selection.

    FTA does not provide pre-award authority for competitive funds until projects are selected, and there are Federal requirements that must be met before costs are incurred. For more information about FTA's policy on pre-award authority, see the FY 2020 Apportionments Notice published on June 3, 2020, at https://www.govinfo.gov/​content/​pkg/​FR-2020-06-03/​pdf/​2020-11946.pdf. b. Grant Requirements Selected applicants will submit a grant application through FTA's electronic grant management system and adhere to the customary FTA grant requirements for research project (insert Circular name). All competitive grants, regardless of award amount, will be subject to the Congressional notification and release process.

    FTA emphasizes that third-party procurement applies to all funding awards, as described in FTA Circular 4220.1F, “Third Party Contracting Guidance.” However, FTA may approve applications that include a specifically identified partnering organization(s) (2 CFR 200.302(f)). When included, the application, budget, and budget narrative should provide a clear understanding of how the selection of these organizations is critical for the project and give sufficient detail about the costs involved. C. Planning FTA encourages applicants to engage the appropriate State Departments of Transportation, Regional Transportation Planning Organizations, or Metropolitan Planning Organizations in areas to be served by the project funds available under this program. D.

    Standard Assurances The applicant assures that it will comply with all applicable Federal statutes, regulations, executive orders, FTA circulars, and other Federal administrative requirements in carrying out any project supported by the FTA grant. The applicant acknowledges that it is under a continuing obligation to comply with the terms and conditions of the grant agreement issued for its project with FTA. The applicant understands that Federal laws, regulations, policies, and administrative practices might be modified from time to time and may affect the implementation of the project. The applicant agrees that the most recent Federal requirements will apply to the project unless FTA issues a written determination otherwise. The applicant must submit the Certifications and Assurances before receiving a grant if it does not have current certifications on file.

    E. Free Speech and Religious Liberty In connection with any program or activity conducted with or benefiting from funds awarded under this notice, recipients of funds must comply with all applicable requirements of Federal law, including, without limitation, the Constitution of the United States. Statutory, regulatory, and public policy requirements, including without limitation, those protecting free speech, religious liberty, public welfare, the environment, and prohibiting discrimination. The conditions of performance, non-discrimination requirements, and other assurances made applicable to the award of funds in accordance with regulations of the Department of Transportation. And applicable Federal financial assistance and contracting principles promulgated by the Office of Management and Budget.

    In complying with these requirements, recipients must ensure that no concession agreements are denied or other contracting decisions made on the basis of speech or other activities protected by the First Amendment. If the Department determines that a recipient has failed to comply with applicable Federal requirements, the Department may terminate the award of funds and disallow previously incurred costs, requiring the recipient to reimburse any expended award funds. (3) Reporting The post-award reporting requirements include submission of the Federal Financial Report (FFR) and Milestone Progress Report in TrAMS. An evaluation of the grant will occur at various points in the demonstration process and at the end of the project. In addition, FTA is responsible for producing an Annual Report to Congress that compiles evaluation of selected projects, including an evaluation of the performance measures identified by the applicants.

    All applicants must develop an evaluation plan to measure the success or failure of their projects and describe any plans for broad-based implementation of successful projects. FTA may request data and reports to support the evaluation and Annual Report. A. Independent Evaluation To achieve a comprehensive understanding of the impacts and implications of each proposed COVID-19 Research Demonstration Program, projects funded under this announcement will require the recipient to conduct a third party independent evaluation of their project. Recipients will be required to contract with a third party independent evaluator to assist in developing an evaluation plan, and collecting, storing and managing data required to fulfill the evaluation requirement.

    No more than 10 percent of the Federal share of the project may be used to hire the third-party independent evaluator and the inclusion of a third-party independent evaluation should be described in the grant application. If the project duration is more than two years, an interim evaluation report would need to be submitted to FTA, otherwise the evaluation report should be included as part of the final project report. B. COVID-19 Research Demonstration Grant Program Evaluation Projects funded under this announcement will be required to establish a set of performance metrics set by the third-party independent evaluator and shared with FTA. G.

    Federal Awarding Agency Contacts Information For questions about applying, please contact Jamel El-Hamri email. Jamel.El-Hamri@dot.gov phone. 202-366-8985. A TDD is available at 1-800-877-8339 (TDDFIRS). To ensure that applicants receive accurate information about eligibility or the program, applicants are encouraged to contact FTA directly with questions, rather than through intermediaries or third parties.Start Printed Page 63658 FTA staff also may conduct briefings on the competitive grants selection and award process upon request.

    Start Signature K. Jane Williams, Deputy Administrator. End Signature End Supplemental Information [FR Doc. 2020-22316 Filed 10-7-20. 8:45 am]BILLING CODE 4910-57-PStart Preamble Office of the Secretary, Department of Health and Human Services.

    Notice. The Department of Health and Human Services (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the Assistant Secretary for Health (OASH) announces the draft Viral Hepatitis National Strategic Plan. A Roadmap to Elimination (2021-2025) (Hepatitis Plan) available for public comment. The draft Hepatitis Plan may be reviewed at www.hhs.gov/​hepatitis. All comments must be received by 5:00 p.m.

    ET on October 8, 2020 to ensure consideration. All comments must be submitted electronically to HepatitisPlanComments@hhs.gov. Start Further Info Carol Jimenez, OIDP, Carol.Jimenez@hhs.gov. 202-401-5131. End Further Info End Preamble Start Supplemental Information Viral hepatitis is a significant public health threat that puts people who are infected at increased risk for serious disease and death.

    In the United States, new hepatitis A and hepatitis C infections have increased dramatically in recent years, little progress has been made on preventing hepatitis B infections, and, as of 2016, an estimated 3.3 million people were chronically infected with hepatitis B and hepatitis C.1-3 Collectively, viral hepatitis costs people, health systems, states, and the federal government billions of dollars each year 4 5 and contributes to substantial health disparities, stigma, and discrimination. Reversing the rates of viral hepatitis, preventing new infections, and improving care and treatment require a strategic and coordinated approach by federal partners in collaboration with state and local health departments, tribal communities, community-based organizations, and other nonfederal partners and stakeholders. To spur action to reduce new viral hepatitis infections and their adverse public health impact, OASH through OIDP, in collaboration with federal partners throughout HHS and other departments, led and coordinated development of the Hepatitis Plan. Opportunities for public input were provided, and public comments received were reviewed and analyzed and helped inform the components of the Hepatitis Plan. The Hepatitis Plan focuses on hepatitis A, hepatitis B, and hepatitis C—the hepatitis viruses that most significantly affect the health of the nation.

    It is an elimination plan, with the overarching goal of eliminating viral hepatitis as a public health threat in the United States by 2030. The Hepatitis Plan is intended to serve as a roadmap for all stakeholders at all levels to eliminate hepatitis in this nation. The Hepatitis Plan presents a strategic framework for integrating and leveraging synergistic policies, programs, and resources. It sets forth a vision and five goals for the nation, with objectives and strategies for each goal. The objectives and strategies offered in this plan are interrelated and may be used to make progress toward more than one goal.

    The Hepatitis Plan identifies disproportionately impacted populations based on national hepatitis incidence, prevalence, and mortality data, to help federal and other stakeholders focus their efforts to realize the greatest impact. The Hepatitis Plan also includes indicators to measure progress and quantitative targets for each indicator. Although it is a 5-year plan, it sets 10-year quantitative targets for each indicator—reflecting the reality that it will take more than 5 years to eliminate viral hepatitis as a public health threat. The order in which the goals, objectives, strategies, and indicators are presented is not associated with any prioritization. The following are the Hepatitis Plan's vision and goals.

    Vision. The United States will be a place where new viral hepatitis infections are prevented, every person knows their status, and every person with viral hepatitis has high-quality health care and treatment and lives free from stigma and discrimination. This vision includes all people, regardless of age, sex, gender identity, sexual orientation, race, ethnicity, geographic location, or socioeconomic circumstance. Goals. 1.

    Prevent New Viral Hepatitis Infections 2. Improve Viral Hepatitis—Related Health Outcomes of People with Viral Hepatitis 3. Reduce Viral Hepatitis—Related Disparities and Health Inequities 4. Improve Viral Hepatitis Surveillance and Data Usage 5. Achieve Integrated, Coordinated Efforts That Address the Viral Hepatitis Epidemics among All Partners and Stakeholders A roadmap for stakeholders at all levels and sectors, the Hepatitis Plan envisions a whole-of-nation response to preventing and controlling viral hepatitis in the United States.

    The Hepatitis Plan assumes the active participation of state, local, and tribal health departments and organizations, health plans and health care providers, schools and other academic institutions, community- and faith-based organizations, scientists, researchers, and the public in this effort. The priority populations, indicators, and quantitative targets, especially the methods used to determine them, are intended to help focus efforts and limited resources to realize the most impact. Stakeholders are encouraged to focus on activities that resonate the most with the needs of the populations they serve and services they provide, and, using the Hepatitis Plan as a framework, develop their own plans to eliminate viral hepatitis and improve the health of their communities, states, tribal nations, and the nation. Information Needs The draft Hepatitis Plan may be reviewed at. Www.hhs.gov/​hepatitis.

    OIDP seeks to obtain feedback from external stakeholders on the following. 1. Do the draft plan's goals, objectives, and strategies appropriately address the viral hepatitis epidemics?. 2. Are there any critical gaps in the Hepatitis Plan's goals, objectives, and strategies?.

    If so, please specify the gaps. 3. Do any of the Hepatitis Plan's goals, objectives and strategies cause concern?. If so, please specify the goal, objective or strategy, and describe the concern regarding it. Each commenter is limited to a maximum of seven pages.

    Start Authority 77 FR 15761 (March 16, 2012). End Authority Start Signature Dated. September 22, 2020. B. Kaye Hayes, Acting Director, Office of Infectious Disease and HIV/AIDS Policy.

    End Signature Footnotes 1. Centers for Disease Control and Prevention. Viral Hepatitis Surveillance—Start Printed Page 60814United States, 2018. U.S. Department of Health and Human Services.

    2020. Accessed August 9, 2020. Https://www.cdc.gov/​hepatitis/​statistics/​2018surveillance/​index.htm. 2. Hofmeister MG, Rosenthal EM, Barker LK, et al.

    Estimating prevalence of hepatitis C virus infection in the United States, 2013-2016. Hepatology. 2019 Mar;69(3):1020-1031. Doi. 10.1002/hep.30297.

    3. LeFevre ML. Screening for hepatitis B virus infection in nonpregnant adolescents and adults. US Preventive Services Task Force recommendation statement. Annals Internal Med.

    2014;161(1):58-66. 4. Morey RJ, Collier MG, Nelson NP. The financial burden of public health responses to hepatitis A cases among food handlers, 2012-2014. Public Health Rep.

    2017;132(4):443-447. Doi:10.1177/0033354917710947. 5. Wittenborn J, Brady J, Dougherty M, Rein D. Potential epidemiologic, economic, and budgetary impacts of current rates of hepatitis C treatment in Medicare and non-Medicare populations.

    Hepatol Commun. 2017;1(2):99-109. Doi:10.1002/hep4.1031. End Supplemental Information [FR Doc. 2020-21288 Filed 9-25-20.

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    Latest Pregnancy cheap phenergan pills News FRIDAY, Oct. 16, 2020 (HealthDay News) -- A series of studies show that preterm births have decreased during lockdowns to control the coronavirus pandemic, and researchers are trying to determine why.A large study from the Netherlands found that preterm births fell 15-23% after March 9, when the government started urging people to follow cheap phenergan pills more social distancing measures and to stay home if they had symptoms or possible exposures to the virus. Within the next week, schools and workplaces began to close down, The New York Times reported.The study was published Oct.

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    The Amazing Journey from Egg to Embryo See SlideshowLatest Coronavirus News By Robin Foster and E.J. MundellHealthDay ReportersFRIDAY, cheap phenergan pills Oct. 16, 2020 (HealthDay News)The number of new U.S.

    Coronavirus cases topped 60,000 on Thursday, a tally not reported since early August, as health experts worried the coming winter might push the toll even higher.The latest numbers have also sent the country's total COVID-19 case count past 8 million, the The New cheap phenergan pills York Times reported.The surge is nationwide, with cases multiplying across the country. Forty-four states and the District of Columbia have higher caseloads now than in mid-September, and the new coronavirus is spreading across rural communities in the Midwest, the Upper Midwest and the Great Plains, the Washington Post reported.On Thursday, Wisconsin set a record with more than 4,000 new cases reported, the newspaper said. Illinois also reported more than 4,000 cases on Thursday, breaking records that were set in cheap phenergan pills April and May.

    Ohio set a new high, as did Indiana, New Mexico, North Dakota, Montana and Colorado, the Post reported."We know that this is going to get worse before it gets better," Wisconsin Department of Health Services secretary-designee Andrea Palm said during a briefing Thursday, the Post reported. "Stay home cheap phenergan pills. Wear a mask.

    Stay six feet cheap phenergan pills apart. Wash your hands frequently."Some hospitals in the Upper Midwest and Great Plains have become jammed with patients and are running low on ICU beds, the Post reported. Montana reported a record 301 hospitalized COVID-19 patients Thursday, with 98 percent of cheap phenergan pills the inpatient beds occupied the day before in Yellowstone County.In just the past week, at least 20 states have set record seven-day averages for infections, and a dozen have hit record hospitalization rates, according to health department data analyzed by the Post.The reopening of many schools and colleges did not fuel a major spike in cases right away, as some experts had feared, but the numbers have steadily gone upward since, the newspaper reported.The jump in cases and hospitalizations has been followed by a more modest rise in COVID-19 deaths, most likely due to better patient care from now-seasoned medical workers.

    The widespread use of powerful steroids and other treatments has lowered mortality rates among people who are severely ill, the Post reported.Still, experts caution that most Americans remain vulnerable to COVID infection and the virus will likely spread more easily as colder weather sends more people indoors, where they might be exposed to larger amounts of the virus in poorly ventilated spaces."Inevitably, we're moving into a phase where there's going to need to be restrictions again," David Rubin, director of PolicyLab at Children's Hospital of Philadelphia, told the Post.Second COVID vaccine trial pausedA second coronavirus vaccine trial has been paused after an unexplained illness surfaced in one of the trial's volunteers.Johnson &. Johnson, which only began a phase 3 trial of its vaccine last month, did not offer any more details on the illness and did not say whether the sick participant cheap phenergan pills had received the vaccine or a placebo. The trial pause was first reported by the health news website STAT.While Johnson &.

    Johnson was behind several of its competitors in the vaccine race, cheap phenergan pills its candidate has an advantage in that it doesn't need to be frozen and it could be given in one dose instead of two, the Times reported. The J&J vaccine is also the focus of the largest COVID-19 vaccine trial, with a goal of enrolling 60,000 volunteers."Adverse events -- illnesses, accidents, etc. -- even those cheap phenergan pills that are serious, are an expected part of any clinical study, especially large studies," the company said in a statement.

    "We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information.""It's actually a good thing that these companies are pausing these trials when these things come up," Dr. Phyllis Tien, cheap phenergan pills an infectious disease physician at the University of California, San Francisco, a vaccine trial site for both Johnson &. Johnson and AstraZeneca, told the Times.

    "We just need to let the sponsor and the safety board do their review and let cheap phenergan pills us know their findings."Johnson &. Johnson is not the first company to pause a coronavirus vaccine trial. Two participants in AstraZeneca's trial became seriously ill after getting its vaccine cheap phenergan pills.

    That trial has been halted and has not yet resumed in the United States.Two companies working on antibody cocktailsRegeneron Pharmaceuticals Inc. Said last week that it cheap phenergan pills is seeking emergency approval from the U.S. Food and Drug Administration for an experimental antibody cocktail given to Trump shortly after he was diagnosed with COVID-19.Hours before the company made the announcement, Trump proclaimed in a video released by the White House that the drug had an "unbelievable" effect on his recovery from coronavirus infection, the Post reported.

    While there is no hard evidence yet proving the drug's effectiveness in humans, it has shown promise in treating mild cases of the new coronavirus, the Post reported.Regeneron said in its statement that it could initially produce doses of the cheap phenergan pills antibody cocktail for 50,000 patients, and then ramp production up to doses for 300,000 patients in the next few months if granted emergency authorization.The U.S. Government first inked a contract with Regeneron back in July, and has promised to distribute initial doses of the treatment at no cost if it is approved, the Post reported. Regeneron isn't the only company developing an antibody cocktail to battle COVID-19 cheap phenergan pills infection.

    Eli Lilly and Co. Has also announced that it is seeking emergency use authorization from the FDA for a similar cocktail cheap phenergan pills. But on Tuesday, the company announced it has paused a trial of its antibody cocktail for safety concerns and did not divulge any further details about the reason for the pause, the Post reported.COVID continues to spread around the globeBy Friday, the U.S.

    Coronavirus case count passed 8 million while the death toll passed 217,500, according to a Times tally.According to the same tally, the top five states in cheap phenergan pills coronavirus cases as of Friday were. California with over 870,000. Texas with cheap phenergan pills more than 853,500.

    Florida with nearly 745,000. New York with cheap phenergan pills over 484,000. And Illinois with more than 336,000.Curbing the spread of the coronavirus in the rest of the world remains challenging.Several European countries are experiencing case surges as they struggle with a second wave of coronavirus infections and hospital beds begin to fill up, the Post reported.In England, Prime Minister Boris Johnson has instituted a three-tier lockdown in a bid to slow a startling spike in coronavirus cases across the country.

    In the past three weeks, new coronavirus cases have quadrupled and there are now more COVID-19 patients hospitalized than before the government imposed a lockdown back in March, the Post reported.Addressing the nation this week, Johnson warned Britons that the country's rise in cases was "flashing like dashboard warnings in a passenger jet."Things are no better in India, where the coronavirus case count has passed 7.3 cheap phenergan pills million, a Johns Hopkins tally showed.More than 112,000 coronavirus patients have died in India, according to the Hopkins tally, but when measured as a proportion of the population, the country has had far fewer deaths than many others. Doctors say this reflects India's younger and leaner population.Still, the country's public health system is severely strained, and some sick patients cannot find hospital beds, the Times said. Only the United States has more coronavirus cases.Meanwhile, Brazil passed 5.1 million cases and had over 152,000 deaths as of Friday, the Hopkins tally showed.Cases are also cheap phenergan pills spiking in Russia.

    The country's coronavirus case count has passed 1.3 million. As of Friday, the reported death toll in Russia was over 23,500, the Hopkins tally showed.Worldwide, the number of reported infections passed 38.9 million on Friday, with nearly cheap phenergan pills 1.1 million deaths, according to the Hopkins tally.Copyright © 2020 HealthDay. All rights reserved.

    References cheap phenergan pills SOURCES. The New York Times. Washington Post.

    Associated Press. Oct. 7, 2020, statement, Regeneron Pharmaceuticals Inc..

    Latest Pregnancy News FRIDAY, phenergan with codeine buy Oct. 16, 2020 (HealthDay News) -- A series of studies show that preterm births have decreased during lockdowns to control the coronavirus pandemic, and researchers are trying to determine why.A large study from the Netherlands found that preterm births fell 15-23% after March 9, when the government started urging people phenergan with codeine buy to follow more social distancing measures and to stay home if they had symptoms or possible exposures to the virus. Within the next week, schools and workplaces began to close down, The New York Times reported.The study was published Oct. 13 in The Lancet Public Health medical journal.Two phenergan with codeine buy studies from Ireland and Denmark found that declines in preterm births in the spring during lockdowns, and there are anecdotal reports from doctors worldwide about decreases in preterm births, The Times reported.Some experts suggest that better hygiene, cleaner air and reduced stress on mothers during lockdowns may be factors in falling preterm birth rates.Copyright © 2019 HealthDay.

    All rights reserved. SLIDESHOW phenergan with codeine buy Conception. The Amazing Journey from Egg to Embryo See SlideshowLatest Coronavirus News By Robin Foster and E.J. MundellHealthDay ReportersFRIDAY, phenergan with codeine buy Oct.

    16, 2020 (HealthDay News)The number of new U.S. Coronavirus cases topped 60,000 on Thursday, a tally not reported since early August, as health phenergan with codeine buy experts worried the coming winter might push the toll even higher.The latest numbers have also sent the country's total COVID-19 case count past 8 million, the The New York Times reported.The surge is nationwide, with cases multiplying across the country. Forty-four states and the District of Columbia have higher caseloads now than in mid-September, and the new coronavirus is spreading across rural communities in the Midwest, the Upper Midwest and the Great Plains, the Washington Post reported.On Thursday, Wisconsin set a record with more than 4,000 new cases reported, the newspaper said. Illinois also reported more than 4,000 cases on Thursday, breaking records that were set phenergan with codeine buy in April and May.

    Ohio set a new high, as did Indiana, New Mexico, North Dakota, Montana and Colorado, the Post reported."We know that this is going to get worse before it gets better," Wisconsin Department of Health Services secretary-designee Andrea Palm said during a briefing Thursday, the Post reported. "Stay home phenergan with codeine buy. Wear a mask. Stay six feet apart phenergan with codeine buy.

    Wash your hands frequently."Some hospitals in the Upper Midwest and Great Plains have become jammed with patients and are running low on ICU beds, the Post reported. Montana reported a record 301 hospitalized COVID-19 patients Thursday, with 98 percent of the inpatient beds occupied the day before in Yellowstone County.In just the past week, at phenergan with codeine buy least 20 states have set record seven-day averages for infections, and a dozen have hit record hospitalization rates, according to health department data analyzed by the Post.The reopening of many schools and colleges did not fuel a major spike in cases right away, as some experts had feared, but the numbers have steadily gone upward since, the newspaper reported.The jump in cases and hospitalizations has been followed by a more modest rise in COVID-19 deaths, most likely due to better patient care from now-seasoned medical workers. The widespread use of powerful steroids and other treatments has lowered mortality rates among people who are severely ill, the Post reported.Still, experts caution that most Americans remain vulnerable to COVID infection and the virus will likely spread more easily as colder weather sends more people indoors, where they might be exposed to larger amounts of the virus in poorly ventilated spaces."Inevitably, we're moving into a phase where there's going to need to be restrictions again," David Rubin, director of PolicyLab at Children's Hospital of Philadelphia, told the Post.Second COVID vaccine trial pausedA second coronavirus vaccine trial has been paused after an unexplained illness surfaced in one of the trial's volunteers.Johnson &. Johnson, which only began a phase 3 trial of its vaccine last month, did not offer phenergan with codeine buy any more details on the illness and did not say whether the sick participant had received the vaccine or a placebo.

    The trial pause was first reported by the health news website STAT.While Johnson &. Johnson was behind several of its competitors in the vaccine race, its candidate has an advantage in that it doesn't need to be frozen and it could be given phenergan with codeine buy in one dose instead of two, the Times reported. The J&J vaccine is also the focus of the largest COVID-19 vaccine trial, with a goal of enrolling 60,000 volunteers."Adverse events -- illnesses, accidents, etc. -- even those that are serious, are an expected part of any phenergan with codeine buy clinical study, especially large studies," the company said in a statement.

    "We're also learning more about this participant's illness, and it's important to have all the facts before we share additional information.""It's actually a good thing that these companies are pausing these trials when these things come up," Dr. Phyllis Tien, an infectious disease physician at the University of California, San Francisco, a vaccine trial site for phenergan with codeine buy both Johnson &. Johnson and AstraZeneca, told the Times. "We just need to let the sponsor and the safety board phenergan with codeine buy do their review and let us know their findings."Johnson &.

    Johnson is not the first company to pause a coronavirus vaccine trial. Two participants in AstraZeneca's trial became seriously phenergan with codeine buy ill after getting its vaccine. That trial has been halted and has not yet resumed in the United States.Two companies working on antibody cocktailsRegeneron Pharmaceuticals Inc. Said last phenergan with codeine buy week that it is seeking emergency approval from the U.S.

    Food and Drug Administration for an experimental antibody cocktail given to Trump shortly after he was diagnosed with COVID-19.Hours before the company made the announcement, Trump proclaimed in a video released by the White House that the drug had an "unbelievable" effect on his recovery from coronavirus infection, the Post reported. While there is no hard evidence yet proving the drug's effectiveness in humans, it has shown promise in treating mild cases of the new coronavirus, the Post reported.Regeneron said in its statement that it could initially produce doses of the antibody cocktail for 50,000 patients, and then ramp production phenergan with codeine buy up to doses for 300,000 patients in the next few months if granted emergency authorization.The U.S. Government first inked a contract with Regeneron back in July, and has promised to distribute initial doses of the treatment at no cost if it is approved, the Post reported. Regeneron isn't the only company phenergan with codeine buy developing an antibody cocktail to battle COVID-19 infection.

    Eli Lilly and Co. Has also announced that it is seeking emergency use authorization from the FDA phenergan with codeine buy for a similar cocktail. But on Tuesday, the company announced it has paused a trial of its antibody cocktail for safety concerns and did not divulge any further details about the reason for the pause, the Post reported.COVID continues to spread around the globeBy Friday, the U.S. Coronavirus case count phenergan with codeine buy passed 8 million while the death toll passed 217,500, according to a Times tally.According to the same tally, the top five states in coronavirus cases as of Friday were.

    California with over 870,000. Texas with phenergan with codeine buy more than 853,500. Florida with nearly 745,000. New York with over phenergan with codeine buy 484,000.

    And Illinois with more than 336,000.Curbing the spread of the coronavirus in the rest of the world remains challenging.Several European countries are experiencing case surges as they struggle with a second wave of coronavirus infections and hospital beds begin to fill up, the Post reported.In England, Prime Minister Boris Johnson has instituted a three-tier lockdown in a bid to slow a startling spike in coronavirus cases across the country. In the past three weeks, new coronavirus cases have quadrupled and there are now more COVID-19 patients hospitalized than before the government imposed a lockdown back in March, the Post reported.Addressing the nation this week, Johnson warned Britons that the country's rise in cases was "flashing like dashboard warnings in a passenger jet."Things are no better phenergan with codeine buy in India, where the coronavirus case count has passed 7.3 million, a Johns Hopkins tally showed.More than 112,000 coronavirus patients have died in India, according to the Hopkins tally, but when measured as a proportion of the population, the country has had far fewer deaths than many others. Doctors say this reflects India's younger and leaner population.Still, the country's public health system is severely strained, and some sick patients cannot find hospital beds, the Times said. Only the United States has more coronavirus cases.Meanwhile, Brazil passed 5.1 million cases and had over 152,000 deaths as of Friday, the Hopkins tally phenergan with codeine buy showed.Cases are also spiking in Russia.

    The country's coronavirus case count has passed 1.3 million. As of Friday, the reported death toll in Russia was over 23,500, the Hopkins tally showed.Worldwide, phenergan with codeine buy the number of reported infections passed 38.9 million on Friday, with nearly 1.1 million deaths, according to the Hopkins tally.Copyright © 2020 HealthDay. All rights reserved. References SOURCES phenergan with codeine buy.

    The New York Times. Washington Post. Associated Press. Oct.

    7, 2020, statement, Regeneron Pharmaceuticals Inc..

    What should I tell my health care provider before I take Phenergan?

    They need to know if you have any of these conditions:

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    What’s happened? cpt code for phenergan. We have received reports of fraudulent telephone calls from an individual cpt code for phenergan or organisation claiming to be a representative of the Australian Digital Health Agency. It has been reported that the caller says they are calling from the “digital health agency” to enrol people to get a “health record”.What do I need to do?. If you receive a call from someone offering to enrol you for a “health record”, do not provide any personal information, hang up the call and report it to scamwatch.gov.au.The Australian Digital Health Agency will not telephone you with an offer cpt code for phenergan to enrol you for a My Health Record.

    For more information on how cpt code for phenergan to register for a My Health Record, visit myhealthrecord.gov.au.If you have shared your Medicare number with an unknown caller, report this to Services Australia who will place your details on a watch list to monitor for any compromise or misuse of your Medicare record. Email [email protected] or phone 1800 941 126. How could cpt code for phenergan this affect me?. The caller cpt code for phenergan is requesting personal information which could be used to steal your identity or commit financial fraud.

    Reports indicate that the caller is requesting the following personal information:• Medicare number• Date of birth• Email address• Mobile telephone number• Credit card detailsIdentity theft (also known as identity fraud) occurs when one person uses another individual’s personal information without their consent, usually for personal gain or to conduct further crimes.Where can I get more information?. If you have shared personal information and believe you may be at risk, you can contact IDCARE, a not for cpt code for phenergan profit organisation that provides assistance and support to victims of identity theft and other cybercrime. Visit idcare.org or telephone 1800 595 160.The Office of the Australian Information Commissioner provides information about identity fraud including what to do if your identity has been stolen.For additional information about scams, visit scamwatch.gov.au – you can also subscribe to a free alert service to receive updates about the latest scams.The Australian Cyber Security Centre also provides advice for individuals, a free alert service to help you understand the latest online threats and the ability to report online crimes via the ReportCyber page..

    What’s happened? phenergan with codeine buy. We have phenergan with codeine buy received reports of fraudulent telephone calls from an individual or organisation claiming to be a representative of the Australian Digital Health Agency. It has been reported that the caller says they are calling from the “digital health agency” to enrol people to get a “health record”.What do I need to do?. If you receive a call from someone offering to enrol you for a “health record”, do not provide any personal information, hang up the call and report it to scamwatch.gov.au.The Australian phenergan with codeine buy Digital Health Agency will not telephone you with an offer to enrol you for a My Health Record.

    For more information on how to register for a My Health Record, visit myhealthrecord.gov.au.If you have shared your Medicare number with an unknown caller, report this to Services Australia who will place your details on a phenergan with codeine buy watch list to monitor for any compromise or misuse of your Medicare record. Email [email protected] or phone 1800 941 126. How could this phenergan with codeine buy affect me?. The caller is requesting personal information which could be used to steal your identity or commit financial phenergan with codeine buy fraud.

    Reports indicate that the caller is requesting the following personal information:• Medicare number• Date of birth• Email address• Mobile telephone number• Credit card detailsIdentity theft (also known as identity fraud) occurs when one person uses another individual’s personal information without their consent, usually for personal gain or to conduct further crimes.Where can I get more information?. If you have shared personal phenergan with codeine buy information and believe you may be at risk, you can contact IDCARE, a not for profit organisation that provides assistance and support to victims of identity theft and other cybercrime. Visit idcare.org or telephone 1800 595 160.The Office of the Australian Information Commissioner provides information about identity fraud including what to do if your identity has been stolen.For additional information about scams, visit scamwatch.gov.au – you can also subscribe to a free alert service to receive updates about the latest scams.The Australian Cyber Security Centre also provides advice for individuals, a free alert service to help you understand the latest online threats and the ability to report online crimes via the ReportCyber page..

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    Researchers at the University of Maryland School of Medicine (UMSOM) have conducted a study phenergan vc plain that has determined the role that a critical protein plays in the development of hair cells. These hair cells are vital for hearing phenergan vc plain. Some of these cells amplify sounds that come into the ear, and others transform sound waves into electrical signals that travel to the brain. Ronna Hertzano, MD, PhD, Associate Professor in the Department of Otorhinolaryngology Head and Neck Surgery at UMSOM and Maggie Matern, PhD, a postdoctoral fellow at Stanford University, demonstrated that the protein, called GFI1, may be critical for determining whether an embryonic hair cell matures into a functional adult hair cell or becomes a different cell that functions more like a nerve cell or neuron.The study was published in the journal Development, and was conducted by physician-scientists and researchers at the UMSOM Department of Otorhinolaryngology Head and Neck Surgery and the UMSOM Institute for Genome Sciences (IGS), in collaboration with researchers at the Sackler School of Medicine at Tel Aviv phenergan vc plain University in Israel.Hearing relies on the proper functioning of specialized cells within the inner ear called hair cells. When the hair cells do not develop properly or are damaged by environmental stresses like loud noise, it results in a loss of hearing function.In the United States, the prevalence of hearing loss doubles with every 10-year increase in age, affecting about half of all adults in their 70s and about 80 percent of those who are over age 85.

    Researchers have been focusing on describing the developmental steps that lead to a functional hair cell, phenergan vc plain in order to potentially generate new hair cells when old ones are damaged.Hair cells in the inner earTo conduct her latest study, Dr. Hertzano and her team utilized cutting-edge methods to study gene expression in the hair cells of genetically modified newborn mice that did not produce GFI1. They demonstrated that, in the absence of this vital protein, embryonic hair cells failed to progress phenergan vc plain in their development to become fully functional adult cells. In fact, the genes expressed by these cells indicated that they were likely to develop into neuron-like cells."Our findings explain why GFI1 is critical to enable embryonic cells to progress into functioning adult hair cells," said Dr. Hertzano.

    "These data also explain the importance of GFI1 in experimental protocols to regenerate hair cells from stem cells. These regenerative methods have the potential of being used for patients who have experienced hearing loss due to age or environmental factors like exposure to loud noise."Dr. Hertzano first became interested in GFI1 while completing her M.D., Ph.D. At Tel Aviv University. As part of her dissertation, she discovered that the hearing loss resulting from mutations in another protein called POU4F3 appeared to largely result from a loss of GFI1 in the hair cells.

    Since then, she has been conducting studies to discover the role of GFI1 and other proteins in hearing. Other research groups in the field are now testing these proteins to determine whether they can be used as a "cocktail" to regenerate lost hair cells and restore hearing."Hearing research has been going through a Renaissance period, not only from advances in genomics and methodology, but also thanks to its uniquely collaborative nature among researchers," said Dr. Herzano.The new study was funded by the National Institute on Deafness and Other Communication Disorders (NIDCD) which is part of the National Institutes of Health (NIH). It was also funded by the Binational Scientific Foundation (BSF)."This is an exciting new finding that underscores the importance of basic research to lay the foundation for future clinical innovations," said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z.

    And Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. "Identifying the complex pathways that lead to normal hearing could prove to be the key for reversing hearing loss in millions of Americans." Story Source. Materials provided by University of Maryland School of Medicine. Note.

    Content may be edited for style and length.Researchers at Indiana University School of Medicine are learning more about how a person's genes play a role in the possibility they'll suffer from alcoholic cirrhosis with the discovery of a gene that could make the disease less likely.Alcoholic cirrhosis can happen after years of drinking too much alcohol. According to the researchers, discovering more about this illness couldn't come at a more important time."Based on U.S. Data, alcohol-associated liver disease is on the rise in terms of the prevalence and incidents and it is happening more often in younger patients," said Suthat Liangpunsakul, MD, professor of medicine, dean's scholar in medical research for the Department of Medicine Division of Gastroenterology and Hepatology, and one of the principal investigators of the study. "There's a real public health problem involving the consumption of alcohol and people starting to drink at a younger age."The team describes their findings in a new paper published in Hepatology. The GenomALC Consortium was funded by the National Institutes on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institute of Health (NIH).

    This genome-wide association study began several years ago and is one of the largest studies related to alcoholic cirrhosis ever performed. DNA samples were taken from over 1,700 patients from sites in the United States, several countries in Europe and Australia and sent to IU School of Medicine where the team performed the DNA isolation for genome analysis. The patients were divided into two groups -- one made up of heavy drinkers that never had a history of alcohol-induced liver injury or liver disease and a second group of heavy drinkers who did have alcoholic cirrhosis."Our key finding is a gene called Fas Associated Factor Family Member 2, or FAF2," said Tae-Hwi Schwantes-An, PhD, assistant research professor of medical and molecular genetics and the lead author of the study. "There's this convergence of findings now that are pointing to the genes involved in lipid droplet organization pathway, and that seems to be one of the biological reasonings of why certain people get liver disease and why certain people do not."The researchers are anticipating to study this gene more closely and looking at its relationship to other, previously-discovered genes that can make a person more likely to develop alcoholic cirrhosis."We know for a fact those genes are linked together in a biological process, so the logical next step is to study how the changes in these genes alter the function of that process, whether it's less efficient in one group of people, or maybe it's inhibited in some way," Schwantes-An said. "We don't know exactly what the biological underpinning of that is, but now we have a pretty well-defined target where we can look at these variants and see how they relate to alcoholic cirrhosis."As their research continues, the team hopes to eventually find a way to identify this genetic factor in patients with the goal of helping them prevent alcoholic cirrhosis in the future or developing targeted therapies that can help individuals in a more personalized way.

    Story Source. Materials provided by Indiana University School of Medicine. Original written by Christina Griffiths. Note. Content may be edited for style and length.Penn Medicine researchers have found that middle-aged individuals -- those born in the late 1960s and the 1970s -- may be in a perpetual state of H3N2 influenza virus susceptibility because their antibodies bind to H3N2 viruses but fail to prevent infections, according to a new study led by Scott Hensley, PhD, an associate professor of Microbiology at the Perelman School of Medicine at the University of Pennsylvania.

    The paper was published today in Nature Communications."We found that different aged individuals have different H3N2 flu virus antibody specificities," Hensley said. "Our studies show that early childhood infections can leave lifelong immunological imprints that affect how individuals respond to antigenically distinct viral strains later in life."Most humans are infected with influenza viruses by three to four years of age, and these initial childhood infections can elicit strong, long lasting memory immune responses. H3N2 influenza viruses began circulating in humans in 1968 and have evolved substantially over the past 51 years. Therefore, an individual's birth year largely predicts which specific type of H3N2 virus they first encountered in childhood.Researchers completed a serological survey -- a blood test that measures antibody levels -- using serum samples collected in the summer months prior to the 2017-2018 season from 140 children (ages one to 17) and 212 adults (ages 18 to 90). They first measured the differences in antibody reactivity to various strains of H3N2, and then measured for neutralizing and non-neutralizing antibodies.

    Neutralizing antibodies can prevent viral infections, whereas non-neutralizing antibodies can only help after an infection takes place. Samples from children aged three to ten years old had the highest levels of neutralizing antibodies against contemporary H3N2 viruses, while most middle-aged samples had antibodies that could bind to these viruses but these antibodies could not prevent viral infections.Hensley said his team's findings are consistent with a concept known as "original antigenic sin" (OAS), originally proposed by Tom Francis, Jr. In 1960. "Most individuals born in the late 1960s and 1970s were immunologically imprinted with H3N2 viruses that are very different compared to contemporary H3N2 viruses. Upon infection with recent H3N2 viruses, these individuals tend to produce antibodies against regions that are conserved with older H3N2 strains and these types of antibodies typically do not prevent viral infections."According to the research team, it is possible that the presence of high levels of non-neutralizing antibodies in middle-aged adults has contributed to the continued persistence of H3N2 viruses in the human population.

    Their findings might also relate to the unusual age distribution of H3N2 infections during the 2017-2018 season, in which H3N2 activity in middle-aged and older adults peaked earlier compared to children and young adults.The researchers say that it will be important to continually complete large serological surveys in different aged individuals, including donors from populations with different vaccination rates. A better understanding of immunity within the population and within individuals will likely lead to improved models that are better able to predict the evolutionary trajectories of different influenza virus strains."Large serological studies can shed light on why the effectiveness of flu vaccines varies in individuals with different immune histories, while also identifying barriers that need to be overcome in order to design better vaccines that are able to elicit protective responses in all age groups," said Sigrid Gouma, PhD, a postdoctoral researcher of Microbiology and first author on the paper.Other Penn authors include Madison Weirick and Megan E. Gumina. Additional authors include Angela Branche, David J. Topham, Emily T.

    Martin, Arnold S. Monto, and Sarah Cobey.This work was supported by the National Institute of Allergy and Infectious Diseases (1R01AI113047, S.E.H.. 1R01AI108686, S.E.H.. 1R01AI097150, A.S.M.. CEIRS HHSN272201400005C, S.E.H., S.C., E.T.M., A.S.M.

    A.B., D.J.T.) and Center for Disease Control (U01IP000474, A.S.M.). Scott E. Hensley holds an Investigators in the Pathogenesis of Infectious Disease Awards from the Burroughs Wellcome Fund.Males and females share the vast majority of their genomes. Only a sprinkling of genes, located on the so-called X and Y sex chromosomes, differ between the sexes. Nevertheless, the activities of our genes -- their expression in cells and tissues -- generate profound distinctions between males and females.Not only do the sexes differ in outward appearance, their differentially expressed genes strongly affect the risk, incidence, prevalence, severity and age-of-onset of many diseases, including cancer, autoimmune disorders, cardiovascular disease and neurological afflictions.Researchers have observed sex-associated differences in gene expression across a range of tissues including liver, heart, and brain.

    Nevertheless, such tissue-specific sex differences remain poorly understood. Most traits that display variance between males and females appear to result from differences in the expression of autosomal genes common to both sexes, rather than through expression of sex chromosome genes or sex hormones.A better understanding of these sex-associated disparities in the behavior of our genes could lead to improved diagnoses and treatments for a range of human illnesses.In a new paper in the PERSPECTIVES section of the journal Science, Melissa Wilson reviews current research into patterns of sex differences in gene expression across the genome, and highlights sampling biases in the human populations included in such studies."One of the most striking things about this comprehensive study of sex differences," Wilson said, "is that while aggregate differences span the genome and contribute to biases in human health, each individual gene varies tremendously between people."Wilson is a researcher in the Biodesign Center for Mechanisms in Evolution, the Center for Evolution and Medicine, and ASU's School of Life Sciences. advertisement A decade ago, an ambitious undertaking, known as the Genotype-Tissue Expression (GTEx) consortium began to investigate the effects DNA variation on gene expression across the range of human tissues. Recent findings, appearing in the Science issue under review, indicate that sex-linked disparities in gene expression are far more pervasive than once assumed, with more than a third of all genes displaying sex-biased expression in at least one tissue. (The new research highlighted in Wilson's PERSPECTIVES piece describes gene regulatory differences between the sexes in every tissue under study.)Sex-linked differences in gene expression are shared across mammals, though their relative roles in disease susceptibility remain speculative.

    Natural selection likely guided the development of many of these attributes. For example, the rise of placental mammals some 90 million years ago may have led to differences in immune function between males and females.Such sex-based distinctions arising in the distant past have left their imprint on current mammals, including humans, expressed in higher rates of autoimmune disorders in females and increased cancer rates in males.Despite their critical importance for understanding disease prevalence and severity, sex differences in gene expression have only recently received serious attention in the research community. Wilson and others suggest that much historical genetic research, using primarily white male subjects in mid-life, have yielded an incomplete picture.Such studies often fail to account for sex differences in the design and analysis of experiments, rendering a distorted view of sex-based disease variance, often leading to one-size-fits-all approaches to diagnosis and treatment. The authors therefore advise researchers to be more careful about generalizations based on existing databases of genetic information, including GTEx.A more holistic approach is emerging, as researchers investigate the full panoply of effects related to male and female gene expression across a broader range of human variation. Story Source.

    Materials provided by Arizona State University. Original written by Richard Harth. Note. Content may be edited for style and length.Researchers at Yale have identified a possible treatment for Duchenne muscular dystrophy (DMD), a rare genetic disease for which there is currently no cure or treatment, by targeting an enzyme that had been considered "undruggable." The finding appears in the Aug. 25 edition of Science Signaling.DMD is the most common form of muscular dystrophy, a disease that leads to progressive weakness and eventual loss of the skeletal and heart muscles.

    It occurs in 16 of 100,000 male births in the U.S. People with the disease exhibit clumsiness and weakness in early childhood and typically need wheelchairs by the time they reach their teens. The average life expectancy is 26.While earlier research had revealed the crucial role played by an enzyme called MKP5 in the development of DMD, making it a promising target for possible treatment, scientists for decades had been unable to disrupt this family of enzymes, known as protein tyrosine phosphatases, at the enzymes' "active" site where chemical reactions occur.In the new study, Anton Bennett, the Dorys McConnell Duberg Professor of Pharmacology and professor of comparative medicine, and his team screened over 162,000 compounds. They identified one molecular compound that blocked the enzyme's activity by binding to a previously undiscovered allosteric site -- a spot near the enzyme's active site."There have been many attempts to design inhibitors for this family of enzymes, but those compounds have failed to produce the right properties," Bennett said. "Until now, the family of enzymes has been considered 'undruggable.'"By targeting the allosteric site of MKP5 instead, he said, "We discovered an excellent starting point for drug development that circumvented the earlier problems."The researchers tested their compound in muscle cells and found that it successfully inhibited MKP5 activity, suggesting a promising new therapeutic strategy for treating DMD.The research was supported by a National Institutes of Health grant through the National Institute of Arthritis and Musculoskeletal and Skin Diseases, as well as by the Blavatnik Fund for Innovation at Yale, which annually presents awards to support the most promising life science discoveries from Yale faculty.Bennett said that the Blavatnik funding, which is administered by the Yale Office of Cooperative Research, was critical in moving the research forward.

    "It resulted in a license with a major pharmaceutical company," he said, "and we hope they will rapidly move forward with the development of the new treatment."The finding has implications well beyond muscular dystrophy, he added. The researchers have demonstrated that the MKP5 enzyme is broadly implicated in fibrosis, or the buildup of scar tissue, a condition that contributes to nearly one-third of natural deaths worldwide."Fibrosis is involved in the end-stage death of many tissues, including liver, lung, and muscle," Bennett said. "We believe this enzyme could be a target more broadly for fibrotic tissue disease."The research team from Yale included Naftali Kaminski, the Boehringer-Ingelheim Professor of Internal Medicine and chief of pulmonary, critical care and sleep medicine. Jonathan Ellman, the Eugene Higgins Professor of Chemistry and professor of pharmacology. Karen Anderson, professor of pharmacology and of molecular biophysics and biochemistry.

    Elias Lolis, professor of pharmacology. Zachary Gannam, a graduate student in pharmacology. Kisuk Min, a postdoctoral fellow. Shanelle Shillingford, a graduate student in chemistry. Lei Zhang, a research associate in pharmacology.

    And the Yale Center for Molecular Discovery. Story Source. Materials provided by Yale University. Original written by Brita Belli. Note.

    Content may be edited for style and length..

    Researchers at the University of Maryland School of Medicine (UMSOM) have conducted a phenergan with codeine buy study that has determined the role that a critical protein plays in the development of hair cells. These hair cells are vital for phenergan with codeine buy hearing. Some of these cells amplify sounds that come into the ear, and others transform sound waves into electrical signals that travel to the brain. Ronna Hertzano, MD, PhD, Associate Professor in the Department of Otorhinolaryngology Head and Neck Surgery at UMSOM and Maggie Matern, PhD, a postdoctoral fellow at Stanford University, demonstrated that the protein, called GFI1, may be critical for determining whether an embryonic hair cell matures into a functional adult hair cell or becomes a different cell that functions more like a nerve cell or neuron.The study was published in the journal Development, and was conducted by physician-scientists and researchers at the UMSOM Department of Otorhinolaryngology Head and Neck Surgery and the UMSOM Institute for Genome Sciences (IGS), in collaboration with researchers at the Sackler School of Medicine at Tel Aviv University in Israel.Hearing relies on the proper functioning of specialized cells within the inner ear called hair phenergan with codeine buy cells. When the hair cells do not develop properly or are damaged by environmental stresses like loud noise, it results in a loss of hearing function.In the United States, the prevalence of hearing loss doubles with every 10-year increase in age, affecting about half of all adults in their 70s and about 80 percent of those who are over age 85.

    Researchers have been focusing on describing the developmental steps that lead to a functional hair cell, in order to potentially generate new hair cells when phenergan with codeine buy old ones are damaged.Hair cells in the inner earTo conduct her latest study, Dr. Hertzano and her team utilized cutting-edge methods to study gene expression in the hair cells of genetically modified newborn mice that did not produce GFI1. They demonstrated that, in the absence of this vital protein, embryonic hair cells failed to phenergan with codeine buy progress in their development to become fully functional adult cells. In fact, the genes expressed by these cells indicated that they were likely to develop into neuron-like cells."Our findings explain why GFI1 is critical to enable embryonic cells to progress into functioning adult hair cells," said Dr. Hertzano.

    "These data also explain the importance of GFI1 in experimental protocols to regenerate hair cells from stem cells. These regenerative methods have the potential of being used for patients who have experienced hearing loss due to age or environmental factors like exposure to loud noise."Dr. Hertzano first became interested in GFI1 while completing her M.D., Ph.D. At Tel Aviv University. As part of her dissertation, she discovered that the hearing loss resulting from mutations in another protein called POU4F3 appeared to largely result from a loss of GFI1 in the hair cells.

    Since then, she has been conducting studies to discover the role of GFI1 and other proteins in hearing. Other research groups in the field are now testing these proteins to determine whether they can be used as a "cocktail" to regenerate lost hair cells and restore hearing."Hearing research has been going through a Renaissance period, not only from advances in genomics and methodology, but also thanks to its uniquely collaborative nature among researchers," said Dr. Herzano.The new study was funded by the National Institute on Deafness and Other Communication Disorders (NIDCD) which is part of the National Institutes of Health (NIH). It was also funded by the Binational Scientific Foundation (BSF)."This is an exciting new finding that underscores the importance of basic research to lay the foundation for future clinical innovations," said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z.

    And Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. "Identifying the complex pathways that lead to normal hearing could prove to be the key for reversing hearing loss in millions of Americans." Story Source. Materials provided by University of Maryland School of Medicine. Note.

    Content may be edited for style and length.Researchers at Indiana University School of Medicine are learning more about how a person's genes play a role in the possibility they'll suffer from alcoholic cirrhosis with the discovery of a gene that could make the disease less likely.Alcoholic cirrhosis can happen after years of drinking too much alcohol. According to the researchers, discovering more about this illness couldn't come at a more important time."Based on U.S. Data, alcohol-associated liver disease is on the rise in terms of the prevalence and incidents and it is happening more often in younger patients," said Suthat Liangpunsakul, MD, professor of medicine, dean's scholar in medical research for the Department of Medicine Division of Gastroenterology and Hepatology, and one of the principal investigators of the study. "There's a real public health problem involving the consumption of alcohol and people starting to drink at a younger age."The team describes their findings in a new paper published in Hepatology. The GenomALC Consortium was funded by the National Institutes on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institute of Health (NIH).

    This genome-wide association study began several years ago and is one of the largest studies related to alcoholic cirrhosis ever performed. DNA samples were taken from over 1,700 patients from sites in the United States, several countries in Europe and Australia and sent to IU School of Medicine where the team performed the DNA isolation for genome analysis. The patients were divided into two groups -- one made up of heavy drinkers that never had a history of alcohol-induced liver injury or liver disease and a second group of heavy drinkers who did have alcoholic cirrhosis."Our key finding is a gene called Fas Associated Factor Family Member 2, or FAF2," said Tae-Hwi Schwantes-An, PhD, assistant research professor of medical and molecular genetics and the lead author of the study. "There's this convergence of findings now that are pointing to the genes involved in lipid droplet organization pathway, and that seems to be one of the biological reasonings of why certain people get liver disease and why certain people do not."The researchers are anticipating to study this gene more closely and looking at its relationship to other, previously-discovered genes that can make a person more likely to develop alcoholic cirrhosis."We know for a fact those genes are linked together in a biological process, so the logical next step is to study how the changes in these genes alter the function of that process, whether it's less efficient in one group of people, or maybe it's inhibited in some way," Schwantes-An said. "We don't know exactly what the biological underpinning of that is, but now we have a pretty well-defined target where we can look at these variants and see how they relate to alcoholic cirrhosis."As their research continues, the team hopes to eventually find a way to identify this genetic factor in patients with the goal of helping them prevent alcoholic cirrhosis in the future or developing targeted therapies that can help individuals in a more personalized way.

    Story Source. Materials provided by Indiana University School of Medicine. Original written by Christina Griffiths. Note. Content may be edited for style and length.Penn Medicine researchers have found that middle-aged individuals -- those born in the late 1960s and the 1970s -- may be in a perpetual state of H3N2 influenza virus susceptibility because their antibodies bind to H3N2 viruses but fail to prevent infections, according to a new study led by Scott Hensley, PhD, an associate professor of Microbiology at the Perelman School of Medicine at the University of Pennsylvania.

    The paper was published today in Nature Communications."We found that different aged individuals have different H3N2 flu virus antibody specificities," Hensley said. "Our studies show that early childhood infections can leave lifelong immunological imprints that affect how individuals respond to antigenically distinct viral strains later in life."Most humans are infected with influenza viruses by three to four years of age, and these initial childhood infections can elicit strong, long lasting memory immune responses. H3N2 influenza viruses began circulating in humans in 1968 and have evolved substantially over the past 51 years. Therefore, an individual's birth year largely predicts which specific type of H3N2 virus they first encountered in childhood.Researchers completed a serological survey -- a blood test that measures antibody levels -- using serum samples collected in the summer months prior to the 2017-2018 season from 140 children (ages one to 17) and 212 adults (ages 18 to 90). They first measured the differences in antibody reactivity to various strains of H3N2, and then measured for neutralizing and non-neutralizing antibodies.

    Neutralizing antibodies can prevent viral infections, whereas non-neutralizing antibodies can only help after an infection takes place. Samples from children aged three to ten years old had the highest levels of neutralizing antibodies against contemporary H3N2 viruses, while most middle-aged samples had antibodies that could bind to these viruses but these antibodies could not prevent viral infections.Hensley said his team's findings are consistent with a concept known as "original antigenic sin" (OAS), originally proposed by Tom Francis, Jr. In 1960. "Most individuals born in the late 1960s and 1970s were immunologically imprinted with H3N2 viruses that are very different compared to contemporary H3N2 viruses. Upon infection with recent H3N2 viruses, these individuals tend to produce antibodies against regions that are conserved with older H3N2 strains and these types of antibodies typically do not prevent viral infections."According to the research team, it is possible that the presence of high levels of non-neutralizing antibodies in middle-aged adults has contributed to the continued persistence of H3N2 viruses in the human population.

    Their findings might also relate to the unusual age distribution of H3N2 infections during the 2017-2018 season, in which H3N2 activity in middle-aged and older adults peaked earlier compared to children and young adults.The researchers say that it will be important to continually complete large serological surveys in different aged individuals, including donors from populations with different vaccination rates. A better understanding of immunity within the population and within individuals will likely lead to improved models that are better able to predict the evolutionary trajectories of different influenza virus strains."Large serological studies can shed light on why the effectiveness of flu vaccines varies in individuals with different immune histories, while also identifying barriers that need to be overcome in order to design better vaccines that are able to elicit protective responses in all age groups," said Sigrid Gouma, PhD, a postdoctoral researcher of Microbiology and first author on the paper.Other Penn authors include Madison Weirick and Megan E. Gumina. Additional authors include Angela Branche, David J. Topham, Emily T.

    Martin, Arnold S. Monto, and Sarah Cobey.This work was supported by the National Institute of Allergy and Infectious Diseases (1R01AI113047, S.E.H.. 1R01AI108686, S.E.H.. 1R01AI097150, A.S.M.. CEIRS HHSN272201400005C, S.E.H., S.C., E.T.M., A.S.M.

    A.B., D.J.T.) and Center for Disease Control (U01IP000474, A.S.M.). Scott E. Hensley holds an Investigators in the Pathogenesis of Infectious Disease Awards from the Burroughs Wellcome Fund.Males and females share the vast majority of their genomes. Only a sprinkling of genes, located on the so-called X and Y sex chromosomes, differ between the sexes. Nevertheless, the activities of our genes -- their expression in cells and tissues -- generate profound distinctions between males and females.Not only do the sexes differ in outward appearance, their differentially expressed genes strongly affect the risk, incidence, prevalence, severity and age-of-onset of many diseases, including cancer, autoimmune disorders, cardiovascular disease and neurological afflictions.Researchers have observed sex-associated differences in gene expression across a range of tissues including liver, heart, and brain.

    Nevertheless, such tissue-specific sex differences remain poorly understood. Most traits that display variance between males and females appear to result from differences in the expression of autosomal genes common to both sexes, rather than through expression of sex chromosome genes or sex hormones.A better understanding of these sex-associated disparities in the behavior of our genes could lead to improved diagnoses and treatments for a range of human illnesses.In a new paper in the PERSPECTIVES section of the journal Science, Melissa Wilson reviews current research into patterns of sex differences in gene expression across the genome, and highlights sampling biases in the human populations included in such studies."One of the most striking things about this comprehensive study of sex differences," Wilson said, "is that while aggregate differences span the genome and contribute to biases in human health, each individual gene varies tremendously between people."Wilson is a researcher in the Biodesign Center for Mechanisms in Evolution, the Center for Evolution and Medicine, and ASU's School of Life Sciences. advertisement A decade ago, an ambitious undertaking, known as the Genotype-Tissue Expression (GTEx) consortium began to investigate the effects DNA variation on gene expression across the range of human tissues. Recent findings, appearing in the Science issue under review, indicate that sex-linked disparities in gene expression are far more pervasive than once assumed, with more than a third of all genes displaying sex-biased expression in at least one tissue. (The new research highlighted in Wilson's PERSPECTIVES piece describes gene regulatory differences between the sexes in every tissue under study.)Sex-linked differences in gene expression are shared across mammals, though their relative roles in disease susceptibility remain speculative.

    Natural selection likely guided the development of many of these attributes. For example, the rise of placental mammals some 90 million years ago may have led to differences in immune function between males and females.Such sex-based distinctions arising in the distant past have left their imprint on current mammals, including humans, expressed in higher rates of autoimmune disorders in females and increased cancer rates in males.Despite their critical importance for understanding disease prevalence and severity, sex differences in gene expression have only recently received serious attention in the research community. Wilson and others suggest that much historical genetic research, using primarily white male subjects in mid-life, have yielded an incomplete picture.Such studies often fail to account for sex differences in the design and analysis of experiments, rendering a distorted view of sex-based disease variance, often leading to one-size-fits-all approaches to diagnosis and treatment. The authors therefore advise researchers to be more careful about generalizations based on existing databases of genetic information, including GTEx.A more holistic approach is emerging, as researchers investigate the full panoply of effects related to male and female gene expression across a broader range of human variation. Story Source.

    Materials provided by Arizona State University. Original written by Richard Harth. Note. Content may be edited for style and length.Researchers at Yale have identified a possible treatment for Duchenne muscular dystrophy (DMD), a rare genetic disease for which there is currently no cure or treatment, by targeting an enzyme that had been considered "undruggable." The finding appears in the Aug. 25 edition of Science Signaling.DMD is the most common form of muscular dystrophy, a disease that leads to progressive weakness and eventual loss of the skeletal and heart muscles.

    It occurs in 16 of 100,000 male births in the U.S. People with the disease exhibit clumsiness and weakness in early childhood and typically need wheelchairs by the time they reach their teens. The average life expectancy is 26.While earlier research had revealed the crucial role played by an enzyme called MKP5 in the development of DMD, making it a promising target for possible treatment, scientists for decades had been unable to disrupt this family of enzymes, known as protein tyrosine phosphatases, at the enzymes' "active" site where chemical reactions occur.In the new study, Anton Bennett, the Dorys McConnell Duberg Professor of Pharmacology and professor of comparative medicine, and his team screened over 162,000 compounds. They identified one molecular compound that blocked the enzyme's activity by binding to a previously undiscovered allosteric site -- a spot near the enzyme's active site."There have been many attempts to design inhibitors for this family of enzymes, but those compounds have failed to produce the right properties," Bennett said. "Until now, the family of enzymes has been considered 'undruggable.'"By targeting the allosteric site of MKP5 instead, he said, "We discovered an excellent starting point for drug development that circumvented the earlier problems."The researchers tested their compound in muscle cells and found that it successfully inhibited MKP5 activity, suggesting a promising new therapeutic strategy for treating DMD.The research was supported by a National Institutes of Health grant through the National Institute of Arthritis and Musculoskeletal and Skin Diseases, as well as by the Blavatnik Fund for Innovation at Yale, which annually presents awards to support the most promising life science discoveries from Yale faculty.Bennett said that the Blavatnik funding, which is administered by the Yale Office of Cooperative Research, was critical in moving the research forward.

    "It resulted in a license with a major pharmaceutical company," he said, "and we hope they will rapidly move forward with the development of the new treatment."The finding has implications well beyond muscular dystrophy, he added. The researchers have demonstrated that the MKP5 enzyme is broadly implicated in fibrosis, or the buildup of scar tissue, a condition that contributes to nearly one-third of natural deaths worldwide."Fibrosis is involved in the end-stage death of many tissues, including liver, lung, and muscle," Bennett said. "We believe this enzyme could be a target more broadly for fibrotic tissue disease."The research team from Yale included Naftali Kaminski, the Boehringer-Ingelheim Professor of Internal Medicine and chief of pulmonary, critical care and sleep medicine. Jonathan Ellman, the Eugene Higgins Professor of Chemistry and professor of pharmacology. Karen Anderson, professor of pharmacology and of molecular biophysics and biochemistry.

    Elias Lolis, professor of pharmacology. Zachary Gannam, a graduate student in pharmacology. Kisuk Min, a postdoctoral fellow. Shanelle Shillingford, a graduate student in chemistry. Lei Zhang, a research associate in pharmacology.

    And the Yale Center for Molecular Discovery. Story Source. Materials provided by Yale University. Original written by Brita Belli. Note.

    Content may be edited for style and length..

    Phenergan dosage for sleep baby

    Date published phenergan dosage for sleep baby. August 26, 2020On this page BackgroundCOVID-19 is an infectious disease caused by the SARS-CoV-2 coronavirus. The World Health Organization declared a global pandemic in March 2020, and the Minister phenergan dosage for sleep baby of Health signed the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 on March 18, 2020. The Interim Order (IO) allows us to quickly address large-scale public health emergencies.This IO allows for faster authorization of Class I-IV medical devices for COVID-19.This document presents the criteria for safety and effectiveness that apply to test swabs used for COVID-19 sampling.

    It also provides guidance on how to meet these criteria in an application under the IO pathway. Diagnostic testing is a key phenergan dosage for sleep baby element in both. identifying cases of infection preventing the spread of the coronavirus A test swab may be used to collect a sample for either Polymerase Chain Reaction (PCR) laboratory testing or point-of-care testing. Point-of-care testing can be done directly in a hospital or doctor’s office.

    Once the sample has been taken, the swab is either placed in a preserving liquid and sent to a laboratory for testing, phenergan dosage for sleep baby or placed directly in a testing device (point-of-care).Swabs may be packaged in a variety of virus transport media (VTM). Specifications for individual VTMs are beyond the scope of this document. Swabs play a role in the accuracy of COVID-19 diagnostic testing. For example, phenergan dosage for sleep baby false negatives can occur in PCR tests if.

    the swab material inhibits the test reaction or the swab design doesn’t provide enough surface area to obtain a sufficient sample Test swabs that are not safe and effective may cause or lead to harm. For example. A swab that breaks during sample collection can cause physical injury a non-sterile swab that produces an incorrect test result can lead to harmHealth Canada has published a guidance document to support the preparation of applications submitted under phenergan dosage for sleep baby the IO. It should be read in conjunction with this document.

    We are processing applications as quickly as possible. To avoid delays, please ensure you have completed your application properly.Medical Devices Regulations (MDR) classification In the Canadian regulatory phenergan dosage for sleep baby framework, Class I devices present the lowest potential risk and Class IV the highest. Swabs are classified according to their labelling and intended use. For example, if a swab is labelled for nasopharyngeal (NP) or oropharyngeal (OP) use only, it will be classified as a Class I medical device according to Classification Rule 2(2) of the MDR.

    If a swab is not exclusively for use in oral or nasal cavities, or its use is phenergan dosage for sleep baby not explicitly stated, it will be classified as a Class II device by Rule 2(1). These swabs belong to a higher risk class because their use in other body orifices for the collection of tissue samples (for example, to test for chlamydia or ureaplasma) is associated with greater risk. Rule 2 Subject to subrules (2) to phenergan dosage for sleep baby (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II. A device described in subrule (1) that is intended to be placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum is classified as Class I.Regulatory pathways for COVID-19 devicesManufacturers of Class I swabs may seek authorization to import and sell their products under either.

    A Medical Device Establishment Licence (MDEL) MDEL is an establishment oversight framework that is not product-specific and not designed to assess safety and effectiveness an IO authorization information on safety and effectiveness are required as part of the application Health Canada is encouraging a sub-group of swab manufacturers to use the IO authorization pathway for Class I swabs, especially if they are. New to the manufacturing of swabs and manufacturing in phenergan dosage for sleep baby Canada (such as a company that has re-tooled to manufacture), or using a new manufacturing process or design for swabs (such as 3D printing or honeycomb design)IO applications for swabs should include the following information.Device description The device description should include. A picture and/or engineering drawing identification of all materials used in the production of the swab the intended use(s) (for example, NP swabs)Quality manufacturingManufacturers must either. demonstrate compliance with Quality Manufacturing Systems (for example, ISO 13485 certificate) applicable to the swab, or provide a clear description of the planned quality manufacturing systems that are consistent with similar existing manufacturing systemsDesign verificationProvide swab design verification (bench testing) data in a summary report.

    It should phenergan dosage for sleep baby show that the essential minimum design characteristics are met. These data should be based on test samples representative of finished swabs that have undergone sterilization prior to bench testing.Dimensions Swabs should have minimum length specifications and minimum and maximum head diameter specifications in order to be safe and effective. Minimum length specification for example, adult NP swabs require ≥14 cm to reach the posterior nasopharynx minimum and maximum head diameter specification for example, adult NP swabs require 1–4 mm to pass into the mid-inferior portion of the inferior turbinate and maneuver well FlexibilitySwab flexibility is assessed through. Durability for example, tolerate 20 rough repeated insertions into a 4 mm inner diameter clear plastic tube curved back on itself with a curve radius of 3 cm bendability for example, bend tip and neck 90º without breaking ability to maintain initial form phenergan dosage for sleep baby for example, restore to initial form following 45º bending Manufacturers may describe the test performed, the number of samples, and a summary of the results.Strength/Breakpoint (failure) To limit the potential for patient harm, the minimum breakpoint distance should be approximately 8 to 9 cm from the nasopharynx.

    However, no breaks or fractures should occur following reasonable manipulation. Applicants should submit a rationale for the design of the breakpoint distance from the swab tip. It should demonstrate that the breakpoint length can be accommodated by phenergan dosage for sleep baby commercially available swab/media tubes.Surface propertiesThe swab surface should be free of. processing aids (such as disinfectants) foreign materials degreasers mold release agents For injection molded swabs, no burrs, flashing, or sharp edges should be present.

    Design validationProvide swab validation (performance) data in a summary report that demonstrates that the swab. can acquire samples comparable to a commercially available swab control, and will not inhibit the PCR reactionThese data should be based on test samples representative of finished swabs phenergan dosage for sleep baby that have undergone sterilization prior to testing.Comparable sample acquisition to a control, and PCR compatibilityThe manufacturer should demonstrate test swab cycle threshold (Ct) recovery values (RT-PCR) that are statistically comparable to those obtained from a commercially available swab control using SARS-CoV-2 (or a scientifically justified surrogate).Pass/Fail criteria. Values ≥ 2Cts indicate significantly less efficient ribonucleic acid collection and/or elution.Clinical feasibility/suitability simulationManufacturers should submit either. A clinical test report or previous clinical data Clinical test reportThe clinical test report should describe the use of the proposed finished swab (sterilized) in a sufficient number of individuals by trained healthcare professionals in a minimum of 30 patients that have phenergan dosage for sleep baby tested positive for SARS-CoV-2, or a scientifically justified surrogate virus.

    Include comparisons of the proposed swab against a flocked swab commercially available in Canada with respect to. flexibility fit ability to navigate to the nasopharynx (or other areas specified in the indications) ability to collect a specimen/respiratory epithelial cells for example, using the RNase P housekeeping gene test results agreement for example, ≥ 90% positive % agreement using a composite control (positive % agreement calculation that includes all positive findings from control and test swabs) Clinical testing considerations A scientifically justified surrogate virus may be used if COVID-positive patients are not available. Positive % agreement phenergan dosage for sleep baby should not be determined using high Ct samples. One-half (1/2) to two-thirds (2/3) of COVID-positive samples should have a high viral loads (Cts <.

    30). Report agreement phenergan dosage for sleep baby between control and test swabs in terms of quantitative (Ct) and qualitative (+/- test) values with appropriate descriptive statistics. Include patient symptomatology for samples. For example, days from symptom onset, known vs.

    Suspected COVID status phenergan dosage for sleep baby. Use of different VTM/universal transport media (V/UTM) across COVID-positive samples may contribute to Ct variability. Ensure consistency by using the same media/tubes for each specimen within a clinical evaluation. Validate the chosen V/UTM media/tubes to show they will not interfere with the phenergan dosage for sleep baby PCR test results.

    For example, allowing 7 days of swab positive specimen incubation with the chosen media/vial is considered a worst-case transportation scenario to evaluate maximal leaching/interaction potential). Use a single PCR test platform throughout each clinical evaluation. The platform should phenergan dosage for sleep baby have been previously authorized by HC or another jurisdiction. Location (for example, left vs right nostril) and order of sampling (for example, control vs.

    Test swab) can affect specimen quality and results variability. Location and swab sampling order should be randomized.For additional information on collecting, handling, and testing COVID-19 specimens, please refer to the Centers for Disease Control and Prevention (CDC) Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19.Previous clinical dataPreviously obtained phenergan dosage for sleep baby clinical data may be submitted in lieu of clinical testing. Those data should demonstrate the safe and effective use of a swab of identical design and materials in human subjects. The proposed swab should phenergan dosage for sleep baby be compared against a flocked swab commercially available in Canada with respect to.

    flexibility fit ability to navigate to the nasopharynx (or other areas specified in the indications) ability to collect a specimen/respiratory epithelial cells for example, using the RNase P housekeeping gene test results agreement for example, ≥ 90% positive % agreement) using a composite control (positive % agreement calculation that includes all positive findings from control and test swabs) Sterility Provide sterilization validation data in a summary report. It should demonstrate that the chosen sterilization method will achieve a minimum Sterility Assurance Level (SAL) of 10-6 for the proposed swab, using an appropriate biological indicator (BI) organism (see below). If the swab will be phenergan dosage for sleep baby sterilized using an ethylene oxide (EtO) method, you should demonstrate that EtO and ethylene chlorohydrin (ECH) residuals meet the tolerable contact limits (TCL) specified in ISO 10993-7. Commonly used swab materials, compatible sterilization methods, and appropriate biological indicators are described below.

    Sterilization Method Swab Materials EtO(for example, ISO 11135) Gamma Irradiation(ISO 11137) Polystyrene handle, polyester bicomponent fiber tipFootnote * X(for example, Puritan 25-3316-H/U) Not applicable Polystyrene handle, nylon flocked fiber tipFootnote * X(for example, Copan 503CS01) X(for example, BD 220252) Footnote * The CDC provides guidance on the types of swabs that should be used for optimal specimen collection for PCR testing. They include swabs that are made of polyester (for example, Dacron), rayon, or nylon-flocked phenergan dosage for sleep baby. Cotton-tipped or calcium alginate swabs are not acceptable because residues present in those materials inhibit the PCR reaction. Return to footnote * referrer Appropriate BIIf ionizing radiation will be used to sterilize the swab.

    Bacillus pumilus spores are recommended for doses of phenergan dosage for sleep baby 25 kGy Bacillus cereus or Bacillus sphaericus spores are recommended for doses of >. 25 kGy (World Health Organization, The International Pharmacopoeia, 9th Ed., 2019) Sterilization Process Spore (Indicator Organism) Steam Geobacillus stearothermophilus(formerly Bacillus stearothermophilus) Dry Heat Bacillus atrophaeus (formerly Bacillus subtilis var. Niger) Ethlylene Oxide Bacillus atrophaeus (formerly Bacillus subtilis var. Niger) Hydrogen Peroxide Geobacillus stearothermophilus(formerly Bacillus stearothermophilus) phenergan dosage for sleep baby Source.

    US Food and Drug Administration, "Biological Indicator (BI) Premarket Notification [510(k)] Submissions," October 2007. [Online].Packaging validation Provide packaging validation data in a summary report. It should demonstrate that the swab packaging system will maintain a phenergan dosage for sleep baby sterile environment across the labelled shelf life (for example, ASTM F1980). without leakage (for example, ASTM D3078-02) with adequate seal strength (for example, ASTM F88/EN 868-5)Test packaging samples should be representative of finished swab packages that have undergone sterilization prior to testing.Biocompatibility Provide biocompatibility data in a summary report.

    It should demonstrate compliance with biocompatibility tests recommended for devices in limited contact (≤24 hrs) with mucosal membranes, as per ISO 10993-1. These include phenergan dosage for sleep baby. cytotoxicity sensitization irritation/intracutaneous reactivityThese data should be based on test samples representative of finished swabs that have undergone sterilization prior to testing.LabellingSwabs should be individually packaged and labelled. The application must include the swab label, which phenergan dosage for sleep baby must include.

    The name and model number of the device the term ‘sterile’, along with the sterilization method (EtO = ethylene oxide. R = gamma irradiation), if the swab is intended to be sold in a sterile condition the name and address of the manufacturer manufacturing and expiry datesIf swabs are not sterile but must be sterilized at the user facility, then the sterilization parameters and method should be clearly described in accompanying instructions for use documentation.Post-market requirementsAs stated in Section 12 of the IO, within 10 days of becoming aware of an incident in Canada, all IO authorization holders must. report the incident specify the nature of the incident specify the circumstances surrounding the incidentOn this page About face shields Personal protective equipment (PPE) can help prevent potential exposure to infectious disease phenergan dosage for sleep baby. They are considered medical devices in Canada and therefore must follow the requirements outlined in the Medical Devices Regulations.

    Medical devices are classified into 4 groups (Class I, II, III and IV) based on their risk to health and safety. Class I devices, such as gauze bandages, pose the lowest potential risk, while Class phenergan dosage for sleep baby IV devices, such as pacemakers, pose the greatest potential risk. In Canada, face shields are Class I medical devices. A face shield has a transparent window or visor that shields the face and associated mucous membranes (eyes, nose and mouth).

    It protects the wearer against exposure from phenergan dosage for sleep baby splashes and sprays of body fluids. Face shields are made of shatterproof plastic, fit over the face and are held in place by head straps or caps. They may be made of polycarbonate, propionate, acetate, polyvinyl chloride, or polyethylene terephthalate. They are usually worn with other PPE, such phenergan dosage for sleep baby as a medical mask, respirator or eyewear.

    Health Canada strongly advises against the use of plastic bags as an alternative to face shields. Standards and requirements for face shields Organizations that are manufacturing face shields are advised to consult some or all of the following standards throughout the design and testing stages. ANSI/ISEA Z.87.1 (2015), American National Standard for Occupational and Educational Personal Eye and Face Protection Devices CSA Z94.3 (2020), Eye and Face Protectors CSA Z94.3.1 (2016), Guideline for Selection, Use, and Care of Eye and Face Protectors BS EN 166 (2002), Personal Eye Protection phenergan dosage for sleep baby. Specifications.

    Minimum specifications must be incorporated into the design and verification stages to ensure safe and effective face shields. Provide adequate coverage (CSA Z94.3 Sections phenergan dosage for sleep baby 0.2.1/10.2.2/10.3/10.4). The size of the face shield is important because it must protect the face and front part of the head. This includes the eyes, forehead, cheeks, nose, mouth, and chin.

    Protection may also need to extend to the front of the neck in situations with flying particles and sprays phenergan dosage for sleep baby of hazardous liquids. Fit snugly to afford a good seal to the forehead area and to prevent slippage of the device Footnote 1. Be made of optically clear, distortion-free, lightweight materials (CSA Z94.3.1-16 and phenergan dosage for sleep baby Footnote 1). Be free of visible defects or flaws that would impede vision (ANSI Z87.1 Section 9.4).

    Be comfortable and easy to assemble, use and remove by health care professionals. Provide adequate space between the wearer’s face and the inner surface of phenergan dosage for sleep baby the visor to allow for the use of ancillary equipment (for example, medical mask, respirator, eyewear) Footnote 1. The characteristics and performance requirements of face shields must not be altered when attaching shields to other protective equipment, such as hats or caps. Display anti-fog characteristics on inside and outside of shield (CSA Z94.3.1-16).

    For face shields that are not fog resistant, anti-fog phenergan dosage for sleep baby spray must be provided. Provide user-contacting materials that have adequate material biocompatibility (skin sensitivity and cytotoxic testing) (ISO 10993-5, 10). Other items to take note of include. Face shields used for protection in hospital settings do not phenergan dosage for sleep baby have to be impact- or flame- resistant.

    If the device is specifically designed to withstand impact from sharp or fast projectiles, it must comply with set-out standards (ANSI Z87.1, sections 9.2 and 9.3, CSA Z94.3, section 10.1). For reuse, manufacturers must provide validated cleaning instructions. Sterilization procedures must not compromise the shield phenergan dosage for sleep baby in any way, such as deformation or cracking. Regulatory authorization Most PPE, including face shields, are Class I medical devices if they are manufactured, sold or represented for use for reducing the risk of or preventing the user from infection.

    This includes COVID-19. Face shields phenergan dosage for sleep baby may be authorized for sale or import into Canada through the following regulatory pathways. Pathway 1. Interim order authorization to import and sell medical devices related to COVID-19.

    Pathway 2 phenergan dosage for sleep baby. Expedited review and issuance of Medical Device Establishment Licences (MDEL) related to COVID-19. MDEL holders that import phenergan dosage for sleep baby and sell face shields should take measures to ensure they are safe and effective. Pathway 3.

    Exceptional importation and sale of certain non-compliant medical devices related to COVID-19. Note that a sale generally requires the transfer of ownership of a device from one party to another and does not necessitate any transfer of phenergan dosage for sleep baby money. Applicants should carefully review the pathways and select the most appropriate authorization route for their product. For more information, see Personal protective equipment (COVID-19).

    How to phenergan dosage for sleep baby get authorization. If you intend to manufacture 3D print face shields in response to the COVID-19 crisis, see. 3D printing and other manufacturing of personal protective equipment in response to COVID-19 Feedback If you have any questions or comments about this notice, contact the Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.ca R. J.

    Roberge, "Face shields for infection control. A review," Journal of Occupational and Environmental Hygiene, pp. 235-242, 2016. Related links FootnotesFootnote 1 R.

    J. Roberge, "Face shields for infection control. A review," Journal of Occupational and Environmental Hygiene, pp. 235-242, 2016.Return to footnote 1 referrer.

    Date published phenergan with codeine buy. August 26, 2020On this page BackgroundCOVID-19 is an infectious disease caused by the SARS-CoV-2 coronavirus. The World phenergan with codeine buy Health Organization declared a global pandemic in March 2020, and the Minister of Health signed the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 on March 18, 2020.

    The Interim Order (IO) allows us to quickly address large-scale public health emergencies.This IO allows for faster authorization of Class I-IV medical devices for COVID-19.This document presents the criteria for safety and effectiveness that apply to test swabs used for COVID-19 sampling. It also provides guidance on how to meet these criteria in an application under the IO pathway. Diagnostic testing phenergan with codeine buy is a key element in both.

    identifying cases of infection preventing the spread of the coronavirus A test swab may be used to collect a sample for either Polymerase Chain Reaction (PCR) laboratory testing or point-of-care testing. Point-of-care testing can be done directly in a hospital or doctor’s office. Once the sample has been taken, phenergan with codeine buy the swab is either placed in a preserving liquid and sent to a laboratory for testing, or placed directly in a testing device (point-of-care).Swabs may be packaged in a variety of virus transport media (VTM).

    Specifications for individual VTMs are beyond the scope of this document. Swabs play a role in the accuracy of COVID-19 diagnostic testing. For example, false negatives can occur phenergan with codeine buy in PCR tests if.

    the swab material inhibits the test reaction or the swab design doesn’t provide enough surface area to obtain a sufficient sample Test swabs that are not safe and effective may cause or lead to harm. For example. A swab that breaks during sample collection can cause physical injury a non-sterile swab that produces an incorrect test result can lead to harmHealth Canada has published a guidance document to support the preparation of applications submitted phenergan with codeine buy under the IO.

    It should be read in conjunction with this document. We are processing applications as quickly as possible. To avoid delays, please ensure you have completed your application properly.Medical Devices Regulations phenergan with codeine buy (MDR) classification In the Canadian regulatory framework, Class I devices present the lowest potential risk and Class IV the highest.

    Swabs are classified according to their labelling and intended use. For example, if a swab is labelled for nasopharyngeal (NP) or oropharyngeal (OP) use only, it will be classified as a Class I medical device according to Classification Rule 2(2) of the MDR. If a swab is not exclusively for use in oral or nasal cavities, or its use is not explicitly phenergan with codeine buy stated, it will be classified as a Class II device by Rule 2(1).

    These swabs belong to a higher risk class because their use in other body orifices for the collection of tissue samples (for example, to test for chlamydia or ureaplasma) is associated with greater risk. Rule 2 Subject to phenergan with codeine buy subrules (2) to (4), all invasive devices that penetrate the body through a body orifice or that come into contact with the surface of the eye are classified as Class II. A device described in subrule (1) that is intended to be placed in the oral or nasal cavities as far as the pharynx or in the ear canal up to the ear drum is classified as Class I.Regulatory pathways for COVID-19 devicesManufacturers of Class I swabs may seek authorization to import and sell their products under either.

    A Medical Device Establishment Licence (MDEL) MDEL is an establishment oversight framework that is not product-specific and not designed to assess safety and effectiveness an IO authorization information on safety and effectiveness are required as part of the application Health Canada is encouraging a sub-group of swab manufacturers to use the IO authorization pathway for Class I swabs, especially if they are. New to the manufacturing of swabs and manufacturing in Canada (such as a company that has re-tooled to manufacture), or using phenergan with codeine buy a new manufacturing process or design for swabs (such as 3D printing or honeycomb design)IO applications for swabs should include the following information.Device description The device description should include. A picture and/or engineering drawing identification of all materials used in the production of the swab the intended use(s) (for example, NP swabs)Quality manufacturingManufacturers must either.

    demonstrate compliance with Quality Manufacturing Systems (for example, ISO 13485 certificate) applicable to the swab, or provide a clear description of the planned quality manufacturing systems that are consistent with similar existing manufacturing systemsDesign verificationProvide swab design verification (bench testing) data in a summary report. It should show that the essential minimum design characteristics are phenergan with codeine buy met. These data should be based on test samples representative of finished swabs that have undergone sterilization prior to bench testing.Dimensions Swabs should have minimum length specifications and minimum and maximum head diameter specifications in order to be safe and effective.

    Minimum length specification for example, adult NP swabs require ≥14 cm to reach the posterior nasopharynx minimum and maximum head diameter specification for example, adult NP swabs require 1–4 mm to pass into the mid-inferior portion of the inferior turbinate and maneuver well FlexibilitySwab flexibility is assessed through. Durability for example, tolerate 20 rough repeated insertions into a 4 mm inner diameter clear plastic tube curved back on itself with a curve radius of 3 cm phenergan with codeine buy bendability for example, bend tip and neck 90º without breaking ability to maintain initial form for example, restore to initial form following 45º bending Manufacturers may describe the test performed, the number of samples, and a summary of the results.Strength/Breakpoint (failure) To limit the potential for patient harm, the minimum breakpoint distance should be approximately 8 to 9 cm from the nasopharynx. However, no breaks or fractures should occur following reasonable manipulation.

    Applicants should submit a rationale for the design of the breakpoint distance from the swab tip. It should demonstrate that the breakpoint length can be accommodated by commercially available swab/media tubes.Surface propertiesThe phenergan with codeine buy swab surface should be free of. processing aids (such as disinfectants) foreign materials degreasers mold release agents For injection molded swabs, no burrs, flashing, or sharp edges should be present.

    Design validationProvide swab validation (performance) data in a summary report that demonstrates that the swab. can acquire samples comparable to a commercially available swab control, and will not inhibit the PCR reactionThese data should be based on test samples phenergan with codeine buy representative of finished swabs that have undergone sterilization prior to testing.Comparable sample acquisition to a control, and PCR compatibilityThe manufacturer should demonstrate test swab cycle threshold (Ct) recovery values (RT-PCR) that are statistically comparable to those obtained from a commercially available swab control using SARS-CoV-2 (or a scientifically justified surrogate).Pass/Fail criteria. Values ≥ 2Cts indicate significantly less efficient ribonucleic acid collection and/or elution.Clinical feasibility/suitability simulationManufacturers should submit either.

    A clinical test report or previous clinical data Clinical test reportThe clinical test report should describe the use of the proposed finished swab (sterilized) in a sufficient number of individuals by trained healthcare professionals in a minimum of 30 patients that have tested positive phenergan with codeine buy for SARS-CoV-2, or a scientifically justified surrogate virus. Include comparisons of the proposed swab against a flocked swab commercially available in Canada with respect to. flexibility fit ability to navigate to the nasopharynx (or other areas specified in the indications) ability to collect a specimen/respiratory epithelial cells for example, using the RNase P housekeeping gene test results agreement for example, ≥ 90% positive % agreement using a composite control (positive % agreement calculation that includes all positive findings from control and test swabs) Clinical testing considerations A scientifically justified surrogate virus may be used if COVID-positive patients are not available.

    Positive % agreement should not be determined using high phenergan with codeine buy Ct samples. One-half (1/2) to two-thirds (2/3) of COVID-positive samples should have a high viral loads (Cts <. 30).

    Report agreement between control and test swabs phenergan with codeine buy in terms of quantitative (Ct) and qualitative (+/- test) values with appropriate descriptive statistics. Include patient symptomatology for samples. For example, days from symptom onset, known vs.

    Suspected COVID phenergan with codeine buy status. Use of different VTM/universal transport media (V/UTM) across COVID-positive samples may contribute to Ct variability. Ensure consistency by using the same media/tubes for each specimen within a clinical evaluation.

    Validate the chosen V/UTM media/tubes to show they will not interfere phenergan with codeine buy with the PCR test results. For example, allowing 7 days of swab positive specimen incubation with the chosen media/vial is considered a worst-case transportation scenario to evaluate maximal leaching/interaction potential). Use a single PCR test platform throughout each clinical evaluation.

    The platform should have phenergan with codeine buy been previously authorized by HC or another jurisdiction. Location (for example, left vs right nostril) and order of sampling (for example, control vs. Test swab) can affect specimen quality and results variability.

    Location and swab sampling order should be randomized.For additional information on collecting, handling, and testing COVID-19 specimens, phenergan with codeine buy please refer to the Centers for Disease Control and Prevention (CDC) Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for COVID-19.Previous clinical dataPreviously obtained clinical data may be submitted in lieu of clinical testing. Those data should demonstrate the safe and effective use of a swab of identical design and materials in human subjects. The proposed phenergan with codeine buy swab should be compared against a flocked swab commercially available in Canada with respect to.

    flexibility fit ability to navigate to the nasopharynx (or other areas specified in the indications) ability to collect a specimen/respiratory epithelial cells for example, using the RNase P housekeeping gene test results agreement for example, ≥ 90% positive % agreement) using a composite control (positive % agreement calculation that includes all positive findings from control and test swabs) Sterility Provide sterilization validation data in a summary report. It should demonstrate that the chosen sterilization method will achieve a minimum Sterility Assurance Level (SAL) of 10-6 for the proposed swab, using an appropriate biological indicator (BI) organism (see below). If the swab will be sterilized using an ethylene oxide (EtO) method, you should demonstrate that EtO and ethylene chlorohydrin (ECH) residuals meet phenergan with codeine buy the tolerable contact limits (TCL) specified in ISO 10993-7.

    Commonly used swab materials, compatible sterilization methods, and appropriate biological indicators are described below. Sterilization Method Swab Materials EtO(for example, ISO 11135) Gamma Irradiation(ISO 11137) Polystyrene handle, polyester bicomponent fiber tipFootnote * X(for example, Puritan 25-3316-H/U) Not applicable Polystyrene handle, nylon flocked fiber tipFootnote * X(for example, Copan 503CS01) X(for example, BD 220252) Footnote * The CDC provides guidance on the types of swabs that should be used for optimal specimen collection for PCR testing. They include swabs that are phenergan with codeine buy made of polyester (for example, Dacron), rayon, or nylon-flocked.

    Cotton-tipped or calcium alginate swabs are not acceptable because residues present in those materials inhibit the PCR reaction. Return to footnote * referrer Appropriate BIIf ionizing radiation will be used to sterilize the swab. Bacillus pumilus spores are phenergan with codeine buy recommended for doses of 25 kGy Bacillus cereus or Bacillus sphaericus spores are recommended for doses of >.

    25 kGy (World Health Organization, The International Pharmacopoeia, 9th Ed., 2019) Sterilization Process Spore (Indicator Organism) Steam Geobacillus stearothermophilus(formerly Bacillus stearothermophilus) Dry Heat Bacillus atrophaeus (formerly Bacillus subtilis var. Niger) Ethlylene Oxide Bacillus atrophaeus (formerly Bacillus subtilis var. Niger) Hydrogen Peroxide Geobacillus stearothermophilus(formerly Bacillus stearothermophilus) Source phenergan with codeine buy.

    US Food and Drug Administration, "Biological Indicator (BI) Premarket Notification [510(k)] Submissions," October 2007. [Online].Packaging validation Provide packaging validation data in a summary report. It should demonstrate phenergan with codeine buy that the swab packaging system will maintain a sterile environment across the labelled shelf life (for example, ASTM F1980).

    without leakage (for example, ASTM D3078-02) with adequate seal strength (for example, ASTM F88/EN 868-5)Test packaging samples should be representative of finished swab packages that have undergone sterilization prior to testing.Biocompatibility Provide biocompatibility data in a summary report. It should demonstrate compliance with biocompatibility tests recommended for devices in limited contact (≤24 hrs) with mucosal membranes, as per ISO 10993-1. These include phenergan with codeine buy.

    cytotoxicity sensitization irritation/intracutaneous reactivityThese data should be based on test samples representative of finished swabs that have undergone sterilization prior to testing.LabellingSwabs should be individually packaged and labelled. The application must include the swab label, which must phenergan with codeine buy include. The name and model number of the device the term ‘sterile’, along with the sterilization method (EtO = ethylene oxide.

    R = gamma irradiation), if the swab is intended to be sold in a sterile condition the name and address of the manufacturer manufacturing and expiry datesIf swabs are not sterile but must be sterilized at the user facility, then the sterilization parameters and method should be clearly described in accompanying instructions for use documentation.Post-market requirementsAs stated in Section 12 of the IO, within 10 days of becoming aware of an incident in Canada, all IO authorization holders must. report the incident specify the nature of the incident specify the circumstances surrounding the incidentOn this page About face shields Personal protective equipment (PPE) can help prevent potential exposure to infectious phenergan with codeine buy disease. They are considered medical devices in Canada and therefore must follow the requirements outlined in the Medical Devices Regulations.

    Medical devices are classified into 4 groups (Class I, II, III and IV) based on their risk to health and safety. Class I devices, such as gauze bandages, pose the lowest potential risk, while Class IV devices, such as pacemakers, pose the phenergan with codeine buy greatest potential risk. In Canada, face shields are Class I medical devices.

    A face shield has a transparent window or visor that shields the face and associated mucous membranes (eyes, nose and mouth). It protects the wearer phenergan with codeine buy against exposure from splashes and sprays of body fluids. Face shields are made of shatterproof plastic, fit over the face and are held in place by head straps or caps.

    They may be made of polycarbonate, propionate, acetate, polyvinyl chloride, or polyethylene terephthalate. They are usually worn with other PPE, such as a medical mask, respirator or phenergan with codeine buy eyewear. Health Canada strongly advises against the use of plastic bags as an alternative to face shields.

    Standards and requirements for face shields Organizations that are manufacturing face shields are advised to consult some or all of the following standards throughout the design and testing stages. ANSI/ISEA Z.87.1 (2015), American National Standard for Occupational and Educational Personal Eye and phenergan with codeine buy Face Protection Devices CSA Z94.3 (2020), Eye and Face Protectors CSA Z94.3.1 (2016), Guideline for Selection, Use, and Care of Eye and Face Protectors BS EN 166 (2002), Personal Eye Protection. Specifications.

    Minimum specifications must be incorporated into the design and verification stages to ensure safe and effective face shields. Provide adequate coverage (CSA Z94.3 Sections phenergan with codeine buy 0.2.1/10.2.2/10.3/10.4). The size of the face shield is important because it must protect the face and front part of the head.

    This includes the eyes, forehead, cheeks, nose, mouth, and chin. Protection may also need to extend to the front of the neck in situations with flying phenergan with codeine buy particles and sprays of hazardous liquids. Fit snugly to afford a good seal to the forehead area and to prevent slippage of the device Footnote 1.

    Be made of optically clear, distortion-free, lightweight materials (CSA Z94.3.1-16 and phenergan with codeine buy Footnote 1). Be free of visible defects or flaws that would impede vision (ANSI Z87.1 Section 9.4). Be comfortable and easy to assemble, use and remove by health care professionals.

    Provide adequate space between the wearer’s face and the inner surface of the visor to allow for the use of ancillary equipment (for example, medical mask, respirator, eyewear) Footnote phenergan with codeine buy 1. The characteristics and performance requirements of face shields must not be altered when attaching shields to other protective equipment, such as hats or caps. Display anti-fog characteristics on inside and outside of shield (CSA Z94.3.1-16).

    For face shields that are not fog phenergan with codeine buy resistant, anti-fog spray must be provided. Provide user-contacting materials that have adequate material biocompatibility (skin sensitivity and cytotoxic testing) (ISO 10993-5, 10). Other items to take note of include.

    Face shields used for protection in hospital settings do not have to phenergan with codeine buy be impact- or flame- resistant. If the device is specifically designed to withstand impact from sharp or fast projectiles, it must comply with set-out standards (ANSI Z87.1, sections 9.2 and 9.3, CSA Z94.3, section 10.1). For reuse, manufacturers must provide validated cleaning instructions.

    Sterilization procedures must not compromise the phenergan with codeine buy shield in any way, such as deformation or cracking. Regulatory authorization Most PPE, including face shields, are Class I medical devices if they are manufactured, sold or represented for use for reducing the risk of or preventing the user from infection. This includes COVID-19.

    Face shields may be authorized for phenergan with codeine buy sale or import into Canada through the following regulatory pathways. Pathway 1. Interim order authorization to import and sell medical devices related to COVID-19.

    Pathway 2 phenergan with codeine buy. Expedited review and issuance of Medical Device Establishment Licences (MDEL) related to COVID-19. MDEL holders phenergan with codeine buy that import and sell face shields should take measures to ensure they are safe and effective.

    Pathway 3. Exceptional importation and sale of certain non-compliant medical devices related to COVID-19. Note that a sale generally requires the transfer of ownership of a device from one party to another phenergan with codeine buy and does not necessitate any transfer of money.

    Applicants should carefully review the pathways and select the most appropriate authorization route for their product. For more information, see Personal protective equipment (COVID-19). How to get authorization phenergan with codeine buy.

    If you intend to manufacture 3D print face shields in response to the COVID-19 crisis, see. 3D printing and other manufacturing of personal protective equipment in response to COVID-19 Feedback If you have any questions or comments about this notice, contact the Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.ca R. J.

    Roberge, "Face shields for infection control. A review," Journal of Occupational and Environmental Hygiene, pp. 235-242, 2016.

    Related links FootnotesFootnote 1 R. J. Roberge, "Face shields for infection control.

    A review," Journal of Occupational and Environmental Hygiene, pp. 235-242, 2016.Return to footnote 1 referrer.

    Generic phenergan online

    In the rush of the COVID-19 vaccine “race,” it’s easy to forget one important generic phenergan online detail. There might be several winners. It’s too generic phenergan online early to tell which or how many candidates will make it to market, which means some of the administrative protocols or requirements are unknown, too.

    €œAs results start to become clear, we will then have that kind of a situation where we’ll have more certainty about what's going on and how that will impact vaccination policy,” says Saad Omer, epidemiologist and director of the Yale Institute for Global Health. In other words, it's only after the first vaccine (or vaccines) receive approval that heath officials and policymakers can nail down logistics of how to get people vaccinated. Plus, no matter how good the initial vaccine options are, it may take generic phenergan online additional options to help nationwide vaccination campaigns run smoother and faster.What Later Options Could OfferFor starters, slower-to-market vaccines could have higher efficacy rates.

    Again, it’s still not clear if this will be the case. And if this scenario does pan out, it doesn’t generic phenergan online mean that the first vaccine will be ineffective. The FDA has set an expectation that any COVID-19 vaccine would block the disease or reduce illness severity in at least 50 percent of people who get it.

    Maybe the first option available will blow past the minimum expectation, Omer says. But if it doesn’t, then there’s still value in pursuing vaccines that are more likely to generic phenergan online convey immunity to their recipients. There’s also a future scenario in which the first vaccine works well in younger people, but drops in efficacy for the elderly, says William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center.

    Aging immune generic phenergan online systems can struggle to develop strong responses to vaccines, and seniors might need modified formulas to up the odds that they will be protected from getting ill. For a COVID-19 vaccine, whether or not older people would need a different vaccine is still unknown, Omer emphasizes — there hasn’t been enough data yet from the various vaccines in development to determine whether they convey equal odds of immunity across all age groups. But the possibility means there could be room for formulas that work better for that portion of the population.

    Enhanced options for the elderly already exist generic phenergan online for some viruses. A seasonal flu vaccine approved only for people over 65 has four times the virus-like component, for example. Manufacturers can also add molecules called adjuvants as a way to improve likelihood of vaccination generic phenergan online success.

    €œAdjuvants can stimulate an immune system to function as if it were younger,” says Schaffner. Already, labs are researching adjuvants that, when added to a vaccine, kick off the best immune response possible, regardless of age.Several leading COVID-19 vaccine candidates might also require people to get two doses. People receive several injections for a generic phenergan online single preventative treatment all the time.

    The HPV vaccine, for example, requires two or three shots depending on your age. But as vaccination efforts roll out, generic phenergan online single-dose options are easier on the supply chain — that’s one syringe per person, not two — and let people arrange time for a medical visit just once.There’s also the question of how different COVID-19 vaccines might reach people. A couple frontrunners in development need to be kept at super cold temperatures — we’re talking -4 degrees Fahrenheit for the Moderna candidate and -94 F for the two vaccines from a BioNTech and Pfizer collaboration.

    Medical centers are used to keeping vaccines cold. But current CDC recommendations for optimal freezer temperatures only go as low as -58 F, which means many clinics likely aren't set up to store these generic phenergan online vaccines.Manufacturers and shipping companies are working hard to assemble enough deep freezers for distribution needs, which should be doable for the entire U.S. €œIt’s not a rocket science-level technology,” Omer says.

    €œIt’s expensive, but it can be done.” An extreme cold requirement could become a larger issue in nations with a less-developed power infrastructure, so in those places, a less-deep-freeze-dependent vaccine could eliminate major barriers to vaccination programs.Of generic phenergan online course, one of the largest challenges to vaccinating people against COVID-19 is each individual’s willingness to participate. And right now, the federal education plan on the pandemic and COVID-19 vaccines specifically amounts to the CDC website, says Omer. €œWe don't have a national vaccine communication strategy,” he says, “and that blows my mind.” Without a concerted education effort, it could be challenging to convince people to go get their injection — let alone remind them if they’ll need to go back for a second..

    In the rush of the COVID-19 phenergan with codeine buy vaccine “race,” it’s easy to forget one important detail. There might be several winners. It’s too early phenergan with codeine buy to tell which or how many candidates will make it to market, which means some of the administrative protocols or requirements are unknown, too. €œAs results start to become clear, we will then have that kind of a situation where we’ll have more certainty about what's going on and how that will impact vaccination policy,” says Saad Omer, epidemiologist and director of the Yale Institute for Global Health.

    In other words, it's only after the first vaccine (or vaccines) receive approval that heath officials and policymakers can nail down logistics of how to get people vaccinated. Plus, no matter how good the initial vaccine options are, it may take additional options to help nationwide vaccination campaigns run smoother and faster.What Later Options Could OfferFor starters, slower-to-market vaccines could have higher efficacy phenergan with codeine buy rates. Again, it’s still not clear if this will be the case. And if phenergan with codeine buy this scenario does pan out, it doesn’t mean that the first vaccine will be ineffective.

    The FDA has set an expectation that any COVID-19 vaccine would block the disease or reduce illness severity in at least 50 percent of people who get it. Maybe the first option available will blow past the minimum expectation, Omer says. But if it doesn’t, then there’s still value in pursuing vaccines that are more likely to convey phenergan with codeine buy immunity to their recipients. There’s also a future scenario in which the first vaccine works well in younger people, but drops in efficacy for the elderly, says William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center.

    Aging immune systems can phenergan with codeine buy struggle to develop strong responses to vaccines, and seniors might need modified formulas to up the odds that they will be protected from getting ill. For a COVID-19 vaccine, whether or not older people would need a different vaccine is still unknown, Omer emphasizes — there hasn’t been enough data yet from the various vaccines in development to determine whether they convey equal odds of immunity across all age groups. But the possibility means there could be room for formulas that work better for that portion of the population. Enhanced options phenergan with codeine buy for the elderly already exist for some viruses.

    A seasonal flu vaccine approved only for people over 65 has four times the virus-like component, for example. Manufacturers can also add molecules called adjuvants as a way to improve phenergan with codeine buy likelihood of vaccination success. €œAdjuvants can stimulate an immune system to function as if it were younger,” says Schaffner. Already, labs are researching adjuvants that, when added to a vaccine, kick off the best immune response possible, regardless of age.Several leading COVID-19 vaccine candidates might also require people to get two doses.

    People receive several injections for a single preventative phenergan with codeine buy treatment all the time. The HPV vaccine, for example, requires two or three shots depending on your age. But as vaccination efforts roll out, single-dose options are easier on the supply phenergan with codeine buy chain — that’s one syringe per person, not two — and let people arrange time for a medical visit just once.There’s also the question of how different COVID-19 vaccines might reach people. A couple frontrunners in development need to be kept at super cold temperatures — we’re talking -4 degrees Fahrenheit for the Moderna candidate and -94 F for the two vaccines from a BioNTech and Pfizer collaboration.

    Medical centers are used to keeping vaccines cold. But current CDC recommendations for optimal freezer temperatures only go phenergan with codeine buy as low as -58 F, which means many clinics likely aren't set up to store these vaccines.Manufacturers and shipping companies are working hard to assemble enough deep freezers for distribution needs, which should be doable for the entire U.S. €œIt’s not a rocket science-level technology,” Omer says. €œIt’s expensive, but it can be done.” An extreme cold requirement could become a larger issue phenergan with codeine buy in nations with a less-developed power infrastructure, so in those places, a less-deep-freeze-dependent vaccine could eliminate major barriers to vaccination programs.Of course, one of the largest challenges to vaccinating people against COVID-19 is each individual’s willingness to participate.

    And right now, the federal education plan on the pandemic and COVID-19 vaccines specifically amounts to the CDC website, says Omer. €œWe don't have a national vaccine communication strategy,” he says, “and that blows my mind.” Without a concerted education effort, it could be challenging to convince people to go get their injection — let alone remind them if they’ll need to go back for a second..

    Phenergan for allergic reaction

    Sport is predicated on the phenergan for allergic reaction idea of victors emerging from a level playing field. All ethically informed evaluate practices are like this. They require an equality of respect, consideration, phenergan for allergic reaction and opportunity, while trying to achieve substantively unequal outcomes. For instance.

    Limited resources mean that physicians must treat some patients and not others, while still treating them with equal respect. Examiners must phenergan for allergic reaction pass some students and not others, while still giving their work equal consideration. Employers may only be able to hire one applicant, while still being required to treat all applicants fairly, and so on. The 800 m is meant to be one of phenergan for allergic reaction these practices.

    A level and equidistance running track from which one victor is intended to emerge. The case of Caster Semenya raises challenging questions about what makes level-playing-fields level, questions that extend beyond any given playing field.In the Feature Article for this issue Loland provides us with new and engaging reasons to support of the Court of Arbitration for Sport (CAS) decision in the Casta Semenya case. The impact phenergan for allergic reaction of the CAS decision requires Casta Semenya to supress her naturally occurring testosterone if she is to compete in an international athletics events. The Semenya case is described by Loland as creating a ‘dilemma of rights’.i The dilemma lies in the choice between ‘the right of Semenya to compete in sport according to her legal sex and gender identity’ and ‘the right of other athletes within the average female testosterone range to compete under fair conditions’ (see footnote i).No one denies the importance of Semenya’s right.

    As Carpenter phenergan for allergic reaction explains, ‘even where inconvenient, sex assigned at birth should always be respected unless an individual seeks otherwise’.2 Loland’s conclusions, Carpenter argues, ‘support a convenience-based approach to classification of sex where choices about the status of people with intersex variations are made by others according to their interests at that time’ (see footnote ii). Carpenter then further explains how the CAS decision is representative of ‘systemic forms of discrimination and human rights violations’ and provides no assistance in ‘how we make the world more hospitable and more accepting of difference’ (see footnote ii).What is therefore at issue is the existence of the second right. Let me explain how Loland constructs it. The background principle is the principle of fair equality of opportunity, which requires that ‘individuals with similar endowments and phenergan for allergic reaction talents and similar ambitions should be given similar opportunities and roughly equivalent prospects for competitive success’(see footnote i).

    This principle reflects, according to Loland, a deeper deontological right of respect and fair treatment. As we can appreciate, when it comes to the principle of fair equality of opportunity, a lot turns on what counts as ‘similar’ (or sufficiently different) endowments and talents and what counts as ‘similar’ (or sufficiently different) opportunities and prospects for success.For Loland, ‘dynamic inequalities’ concern differences in capabilities (such as strength, speed, and endurance, and in technical and tactical skills) that can be ‘cultivated by hard work and effort’ (see footnote i). These are capabilities that are ‘relevant’ and therefore permit a range differences between otherwise ‘similar’ athletes phenergan for allergic reaction. €˜Stable inequalities’ are characterises (such as in age, sex, body size, and disability/ability) are ‘not-relevant’ and therefore require classification to ensure that ‘similar’ athletes are given ‘roughly equivalent prospects for success’.

    It follows for Loland that athletes with ‘46 XY DSD conditions (and not for individuals with normal phenergan for allergic reaction female XX chromosones), with testosterone levels above five nanomoles per litre blood (nmol/L), and who experience a ‘material androgenizing effect’’ benefit from a stable inequality (see footnote i). Hence, the ‘other athletes within the average female testosterone range’ therefore have a right not to compete under conditions of stable inequality. The solution, according to Knox and Anderson, lies in more nuance classifications. Commenting in (qualified) support of Loland, they suggest that ‘classification according to sex alone is no longer adequate’.3 Instead, ‘all athletes would be categorised, making phenergan for allergic reaction classification the norm’ (see footnote iii).However, as we have just seen, Loland’s distinction between stable and dynamic inequalities depends on their ‘relevance’, and ‘relevance’ is a term that does not travel alone.

    Something is relevant (or irrelevant) only in relation to the value, purpose, or aim, of some practice. One interpretation (which I take Loland to be saying) is that strength, speed, and endurance (and so phenergan for allergic reaction on) are ‘relevant’ to ‘performance outcomes’. This can be misleading. Both dynamic and stable inequalities are relevant to (ie, can have an impact on) an athletic performance.

    Is a question of whether we ought to phenergan for allergic reaction permit them to have an impact. The temptation is then to say that dynamic inequalities are relevant (and stable inequalities are irrelevant) where the aim is ‘respect and fair treatment’. But here the snake begins to eat its tail (the principle of fair treatment requires sufficiently similar prospects for success >similar prospects for success require only dynamic inequalities>dynamic inequalities are capabilities that are permitted by the principle of fair treatment).In order to determine questions of relevance, we need to identify the value, purpose, or aim, of the social practice in question. If the aim of an athletic event is to have a victor emerge from a completely level playing field, then, as Chambers notes, socioeconomic inequalities are a larger affront to fair treatment than athletes with 46 XY DSD conditions.4 phenergan for allergic reaction If the aim is to have a victor emerge from completely level hormonal playing field then ‘a man with low testosterone levels is unfairly disadvantaged against a man whose natural levels are higher, and so men’s competitions are unfair’ (see footnote iv).

    Or, at least very high testosterone males should be on hormone suppressants in order to give the ‘average’ competitor a ‘roughly equivalent prospect for competitive success’.The problem is that we are not interested in the average competitor. We are interested in the phenergan for allergic reaction exceptional among us. Unless, it is for light relief. In every Olympiad there is the observation that, in every Olympic event, one average person should be included in the competition for the spectators’ reference.

    The humour lies in the absurd scenarios that would follow, whether it be the 100 m sprint, high jump, or synchronised swimming phenergan for allergic reaction. Great chasms of natural ability would be laid bare, the results of a lifetime of training and dedication would be even clearer to see, and the last place result would be entirely predictable. But note phenergan for allergic reaction how these are different attributes. While we may admire Olympians, it is unclear whether it is because of their God-given ability, their grit and determination, or their role in the unpredictable theatre of sport.

    If sport is a worthwhile social practice, we need to start spelling out its worth. Without doing so, we are unable to identify what capabilities are ‘relevant’ or ‘irrelevant’ to its phenergan for allergic reaction aims, purpose or value. And until we can explain why one naturally occurring capability is ‘irrelevant’ to the aims, purposes, or values, of sport, while the remainder of them are relevant, I can only identify one right in play in the Semenya case.IntroductionSince the start of the COVID-19 pandemic, many medical systems have needed to divert routine services in order to support the large number of patients with acute COVID-19 disease. For example, in the National Health Service (NHS) almost all elective surgery has been postponed1 and outpatient clinics have been cancelled or conducted phenergan for allergic reaction on-line treatment regimens for many forms of cancer have changed2.

    This diversion inevitably reduces availability of routine treatments for non-COVID-19-related illness. Even urgent treatments have needed to be modified. Patients with acute surgical emergencies such as appendicitis still present for care, cancers continue to phenergan for allergic reaction be discovered in patients, and may require urgent management. Health systems are focused on making sure that these urgent needs are met.

    However, to achieve this goal, many patients are offered treatments that deviate from standard, non-pandemic management.Deviations from standard management are required for multiple factors such as:Limited resources (staff and equipment reallocated).Risk of nosocomial acquired infection in high-risk patients.Increased risk for medical staff to deliver treatments due to aerosolisation1.Treatments requiring intensive care therapy that is in limited availability.Operative procedures that are long and difficult or that are technically challenging if conducted in personal protective equipment. The outcomes from such procedures may be worse than in normal circumstances.Treatments that phenergan for allergic reaction render patients more susceptible to COVID-19 disease, for example chemotherapy.There are many instances of compromise, but some examples that we are aware of include open appendectomy rather than laparoscopy to reduce risk of aerosolisation3 and offering a percutaneousCoronary intervention (PCI) rather than coronary artery bypass grafting (CABG) for coronary artery disease, to reduce need for intensive care. Surgery for cancers ordinarily operated on urgently maybe deferred for up to 3 months4 and surgery might be conducted under local anaesthesia that would typically have merited a general anaesthetic (both to reduce the aerosol risk of General anaesthesia, and because of relative lack of anaesthetists).The current emergency offers a unique difficulty. A significant number of treatments with proven benefit might be phenergan for allergic reaction unavailable to patients while those alternatives that are available are not usually considered best practice and might be actually inferior.

    In usual circumstances, where two treatment options for a particular problem are considered appropriate, the decision of which option to pursue would often depend on the personal preference of the patient.But during the pandemic what is ethically and legally required of the doctor or medical professional informing patients about treatment and seeking their consent?. In particular, do health professionals need to make patients aware of the usual forms of treatment that they are not being offered in the current setting?. We consider two theoretical case examples:Case 1Jenny2 is a model in her mid-20s who presents phenergan for allergic reaction to hospital at the peak of the COVID-19 pandemic with acute appendicitis. Her surgeon, Miss Schmidt, approaches Jenny to obtain consent for an open appendectomy.

    Miss Schmidt explains the risks of the operative procedure, and the alternative of phenergan for allergic reaction conservative management (with intravenous antibiotics). Jenny consents to the procedure. However, she develops a postoperative wound infection and an unsightly scar. She does some research and discovers that a laparoscopic procedure would ordinarily phenergan for allergic reaction have been performed and would have had a lower chance of wound infection.

    She sues Miss Schmidt and the hospital trust where she was treated.Case 2June2s a retired teacher in her early 70s who has well-controlled diabetes and hypertension. She is active and runs a local food bank. Immediately prior to the pandemic lockdown in the UK June had an episode of severe chest pain and investigations revealed that she has had a non-ST elevation myocardial infarction phenergan for allergic reaction. The cardiothoracic surgical team recommends that June undergo a PCI although normally her pattern of coronary artery disease would be treated by CABG.

    When the cardiologist explains that surgery would be normally offered in this situation, and is theoretically superior to PCI, June’s husband becomes angry phenergan for allergic reaction and demands that June is listed for surgery.In favour of non-disclosureIt might appear at first glance that doctors should obviously inform Jenny and June about the usual standard of care. After all, consent cannot be informed if crucial information is lacking. However, one reason that this may be called into question is that it is not immediately clear how it benefits a patient to be informed about alternatives that are not actually available?. In usual circumstances, doctors are not obliged to inform phenergan for allergic reaction patients about treatments that are performed overseas but not in the UK.

    In the UK, for example, there is a rigorous process for assessment of new treatments (not including experimental therapies). Some treatments that are available in other jurisdictions have not been phenergan for allergic reaction deemed by the National Institute for Health and Care Excellence (NICE) to be sufficiently beneficial and cost-effective to be offered by the NHS. It is hard to imagine that a health professional would be found negligent for not discussing with a patient a treatment that NICE has explicitly rejected. The same might apply for novel therapies that are currently unfunded pending formal evaluation by NICE.Of course, the difference is that the treatments we are discussing have been proven (or are believed) to be beneficial and would normally be provided.

    The Montgomery Ruling of 2015 in the UK established that patients must be informed of material risks of treatment and reasonable alternatives to phenergan for allergic reaction treatment. The Bayley –v- George Eliot Hospital NHS Trust5case established that those reasonable alternative treatments must be ‘appropriate treatment’ not just a ‘possible treatment’6. In the current crisis, many previously standard treatments are no longer appropriate phenergan for allergic reaction given the restrictions outlined. In other circumstances they are appropriate.

    During a pandemic they are no longer appropriate, even if they become appropriate again at some unknown time in the future.In both ethical and legal terms, it is widely accepted that, for consent to be valid, if must be given voluntarily by a person who has capacity to consent and who understands the nature and risks of the treatment. A failure phenergan for allergic reaction to obtain valid consent, or performing interventions in the absence of consent, could result in criminal proceedings for assault. Failing to provide adequate information in the consent process could support a claim of negligence. Ethically, adequate information about treatments is essential for the patient to enable them to weigh up options and decide which treatments they wish to undertake.

    However, information about unavailable treatments arguably does not help the patient make an informed decision because phenergan for allergic reaction it does not give them information that is relevant to consenting or to refusal of treatment that is actually available. If Miss Schmidt had given Jenny information about the relative benefits of laparoscopic appendectomy, that could not have helped Jenny’s decision to proceed with surgery. Her available choices phenergan for allergic reaction were open appendectomy or no surgery. Moreover, as the case of June highlights, providing information about alternatives may lead them to desire or even demand those alternative options.

    This could cause distress both to the patient and the health professional (who is unable to acquiesce).Consideration might also be paid to the effect on patients of disclosure. How would it affect a patient with newly diagnosed cancer to tell them that an alternative, perhaps better therapy, might be routinely available in usual circumstances but is not available phenergan for allergic reaction now?. There is provision in the Montgomery Ruling, in rare circumstances, for therapeutic exception. That is, if information phenergan for allergic reaction is significantly detrimental to the health of a patient it might be omitted.

    We could imagine a version of the case where Jenny was so intensely anxious about the proposed surgery that her surgeon comes to a sincere belief that discussion of the laparoscopic alternative would be extremely distressing or might even lead her to refuse surgery. In most cases, though, it would be hard to be sure that the risks of disclosing alternative (non-available) treatments would be so great that non-disclosure would be justified.In favour of disclosureIn the UK, professional guidance issued by the GMC (General Medical Council) requires doctors to take a personalised approach to information sharing about treatments by sharing ‘with patients the information they want or need in order to make decisions’. The Montgomery judgement of 20157 broadly endorsed the position phenergan for allergic reaction of the GMC, requiring patients to be told about any material risks and reasonable alternatives relevant to the decision at hand. The Supreme Court clarifies that materiality here should be judged by reference to a new two-limbed test founded on the notions of the ‘reasonable person in the patient’s position’ and the ‘particular patient’.

    One practical test might be for the clinician to ask themselves whether patients in general, or this particular patient might wish to know about alternative forms of treatment that would usually be offered.The GMC has recently produced pandemic-specific guidance8 on consent and decision-making, but this guidance is focused on managing consent in COVID-19-related interventions. While the GMC takes the view that its consent guidelines continue to apply as far as is practical, it also notes that the patient is enabled to consider the ‘reasonable alternatives’, and that the doctor is ‘open and honest with patients about the decision-making process and the criteria for setting priorities in individual cases’.In some situations, there phenergan for allergic reaction might be the option of delaying treatment until later. When other surgical procedures are possible. In that setting, it would be important to ensure that phenergan for allergic reaction the patient is aware of those future options (including the risks of delay).

    For example, if Jenny had symptomatic gallstones, her surgeons might be offering an open cholecystectomy now or the possibility of a laparoscopic surgery at some later point. Understanding the full options open to her now and in the future may have considerable influence on Jenny’s decision. Likewise, if June is aware that she is not being offered phenergan for allergic reaction standard treatment she may wish to delay treatment of her atherosclerosis until a later date. Of course, such a delay might lead to greater harm overall.

    However, it would be ethically permissible to delay treatment if that was the patient’s informed choice (just as it would be permissible for the patient to refuse treatment altogether).In phenergan for allergic reaction the appendicitis case, Jenny does not have the option for delaying her treatment, but the choice for June is more complicated, between immediate PCI which is a second-best treatment versus waiting for standard therapy. Immediate surgery also raises a risk of acquiring nosocomial COVID-19 infection and June is in an age group and has comorbidities that put her at risk of severe COVID-19 disease. Waiting for surgery leaves June at risk of sudden death. For an active phenergan for allergic reaction and otherwise well patient with coronary disease like June, PCI procedure is not as good a treatment as CABG and June might legitimately wish to take her chances and wait for the standard treatment.

    The decision to operate or wait is a balance of risks that only June is fully able to make. Patients in phenergan for allergic reaction this scenario will take different approaches. Patients will need different amounts of information to form their decisions, many patients will need as much information as is available including information about procedures not currently available to make up their mind.June’s husband insists that she should receive the best treatment, and that she should therefore be listed for CABG. Although this treatment would appear to be in June’s best interests, and would respect her autonomy, those ethical considerations are potentially outweighed by distributive justice.

    The COVID-19 phenergan for allergic reaction pandemic of 2020 is being characterised by limitations. Liberties curtailed and choices restricted, this is justified by a need to protect healthcare systems from demand exceeding availability. While resource allocation is always a relevant ethical concern in publicly funded healthcare systems, it is a dominant concern in a setting where there is a high demand for medical care and scare resources.It is well established that competent adult patients can consent to or refuse medical treatment but they cannot demand that health professionals provide treatments that are contrary to their professional judgement or (even more importantly) would consume scarce healthcare resources. In June’s case, agreeing to perform CABG at a time when large numbers of patients are critically ill with COVID-19 might mean that another patient is denied access to phenergan for allergic reaction intensive care (and even dies as a result).

    Of course, it may be that there are actually available beds in intensive care, and June’s operation would not directly lead to denial of treatment for another patient. However, that does not automatically mean that surgery must phenergan for allergic reaction proceed. The hospital may have been justified in making a decision to suspend some forms of cardiac surgery. That could be on the basis of the need to use the dedicated space, staff and equipment of the cardiothoracic critical care unit for patients with COVID-19.

    Even if all that physical phenergan for allergic reaction space is not currently occupied if may not be feasible or practical to try to simultaneously accommodate some non-COVID-19 patients. (There would be a risk that June would contract COVID-19 postoperatively and end up considerably worse off than she would have been if she had instead received PCI.) Moreover, it seems problematic for individual patients to be able to circumvent policies about allocation of resources purely on the basis that they stand to be disadvantaged by the policy.Perhaps the most significant benefit of disclosure of non-options is transparency and honesty. We suggest that the main reason why Miss Schmidt ought to have included discussion of the laparoscopic alternative is so that Jenny understands the reasoning behind the phenergan for allergic reaction decision. If Miss Schmidt had explained to Jenny that in the current circumstances laparoscopic surgery has been stopped, that might have helped her to appreciate that she was being offered the best available management.

    It might have enabled a frank discussion about the challenges faced by health professionals in the context of the pandemic and the inevitable need for compromise. It may have avoided awkward discussions later after Jenny developed her phenergan for allergic reaction complication.Transparent disclosure should not mean that patients can demand treatment. But it might mean that patients could appeal against a particular policy if they feel that it has been reached unfairly, or applied unfairly. For example, if June became aware that some patients were still being offered CABG, she might (or might not) be justified in appealing against the decision not to offer it to her.

    Obviously such an appeal would only be possible if the patient were aware of the phenergan for allergic reaction alternatives that they were being denied.For patients faced by decisions such as that faced by June, balancing risks of either option is highly personal. Individuals need to weigh up these decisions for them and require all of the information available to do so. Some information is phenergan for allergic reaction readily available, for example, the rate of infection for Jenny and the risk of death without treatment for June. But other risks are unknown, such as the risk of acquiring nosocomial infection with COVID-19.

    Doctors might feel discomfort talking about unquantifiable risks, but we argue that it is important that the patient has all available information to weigh up options for them, including information that is unknown.ConclusionIn a pandemic, as in other times, doctors should ensure that they offer appropriate medical treatment, based on the needs of an individual. They should aim to provide available treatment that is beneficial and should not offer treatment that is unavailable phenergan for allergic reaction or contrary to the patient best interests. It is ethical. Indeed it is vital within a public healthcare system, to consider distributive justice phenergan for allergic reaction in the allocation of treatment.

    Where treatment is scarce, it may not be possible or appropriate to offer to patients some treatments that would be beneficial and desired by them.Informed consent needs to be individualised. Doctors are obliged to tailor their information to the needs of an individual. We suggest that in the current climate this should include, for most patients, a nuanced open discussion about alternative treatments that phenergan for allergic reaction would have been available to them in usual circumstances. That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing.

    However, transparency and honesty will usually be the best policy..

    Sport is predicated on the idea of victors emerging from a level phenergan with codeine buy playing field. All ethically informed evaluate practices are like this. They require an equality of phenergan with codeine buy respect, consideration, and opportunity, while trying to achieve substantively unequal outcomes.

    For instance. Limited resources mean that physicians must treat some patients and not others, while still treating them with equal respect. Examiners must pass some students and not phenergan with codeine buy others, while still giving their work equal consideration.

    Employers may only be able to hire one applicant, while still being required to treat all applicants fairly, and so on. The 800 m is meant phenergan with codeine buy to be one of these practices. A level and equidistance running track from which one victor is intended to emerge.

    The case of Caster Semenya raises challenging questions about what makes level-playing-fields level, questions that extend beyond any given playing field.In the Feature Article for this issue Loland provides us with new and engaging reasons to support of the Court of Arbitration for Sport (CAS) decision in the Casta Semenya case. The impact of the CAS decision requires Casta Semenya to supress her naturally occurring testosterone phenergan with codeine buy if she is to compete in an international athletics events. The Semenya case is described by Loland as creating a ‘dilemma of rights’.i The dilemma lies in the choice between ‘the right of Semenya to compete in sport according to her legal sex and gender identity’ and ‘the right of other athletes within the average female testosterone range to compete under fair conditions’ (see footnote i).No one denies the importance of Semenya’s right.

    As Carpenter explains, ‘even where inconvenient, sex assigned at birth should always be respected unless an individual seeks otherwise’.2 Loland’s conclusions, Carpenter argues, ‘support a convenience-based approach to classification of sex where choices about the status of people with intersex variations are made by others according to their interests at that time’ (see phenergan with codeine buy footnote ii). Carpenter then further explains how the CAS decision is representative of ‘systemic forms of discrimination and human rights violations’ and provides no assistance in ‘how we make the world more hospitable and more accepting of difference’ (see footnote ii).What is therefore at issue is the existence of the second right. Let me explain how Loland constructs it.

    The background principle is the principle of fair equality of opportunity, which requires that ‘individuals with similar endowments and talents and similar ambitions should be phenergan with codeine buy given similar opportunities and roughly equivalent prospects for competitive success’(see footnote i). This principle reflects, according to Loland, a deeper deontological right of respect and fair treatment. As we can appreciate, when it comes to the principle of fair equality of opportunity, a lot turns on what counts as ‘similar’ (or sufficiently different) endowments and talents and what counts as ‘similar’ (or sufficiently different) opportunities and prospects for success.For Loland, ‘dynamic inequalities’ concern differences in capabilities (such as strength, speed, and endurance, and in technical and tactical skills) that can be ‘cultivated by hard work and effort’ (see footnote i).

    These are capabilities that are ‘relevant’ and therefore permit a range differences between otherwise phenergan with codeine buy ‘similar’ athletes. €˜Stable inequalities’ are characterises (such as in age, sex, body size, and disability/ability) are ‘not-relevant’ and therefore require classification to ensure that ‘similar’ athletes are given ‘roughly equivalent prospects for success’. It follows for Loland that athletes with ‘46 XY DSD conditions (and not for individuals with normal female XX chromosones), with testosterone levels above five nanomoles per litre blood (nmol/L), and who experience a ‘material androgenizing effect’’ benefit from a stable inequality (see footnote i) phenergan with codeine buy.

    Hence, the ‘other athletes within the average female testosterone range’ therefore have a right not to compete under conditions of stable inequality. The solution, according to Knox and Anderson, lies in more nuance classifications. Commenting in (qualified) support of Loland, they suggest that ‘classification according to sex alone is no longer adequate’.3 Instead, ‘all athletes would be categorised, making classification the norm’ (see footnote iii).However, as we have just seen, Loland’s distinction between stable and dynamic inequalities depends on their ‘relevance’, and ‘relevance’ is a term that does phenergan with codeine buy not travel alone.

    Something is relevant (or irrelevant) only in relation to the value, purpose, or aim, of some practice. One interpretation (which I take Loland to be saying) is that strength, speed, and endurance (and so on) are ‘relevant’ to ‘performance outcomes’ phenergan with codeine buy. This can be misleading.

    Both dynamic and stable inequalities are relevant to (ie, can have an impact on) an athletic performance. Is a question of whether we ought to permit phenergan with codeine buy them to have an impact. The temptation is then to say that dynamic inequalities are relevant (and stable inequalities are irrelevant) where the aim is ‘respect and fair treatment’.

    But here the snake begins to eat its tail (the principle of fair treatment requires sufficiently similar prospects for success >similar prospects for success require only dynamic inequalities>dynamic inequalities are capabilities that are permitted by the principle of fair treatment).In order to determine questions of relevance, we need to identify the value, purpose, or aim, of the social practice in question. If the aim of an athletic event is to have a victor emerge from a completely level playing field, then, as Chambers notes, socioeconomic inequalities are a larger affront to fair treatment than athletes with 46 XY DSD conditions.4 If the aim is to have a victor emerge from completely level hormonal playing field then ‘a man with low testosterone levels is unfairly disadvantaged against a man whose natural levels are higher, and so men’s competitions are unfair’ phenergan with codeine buy (see footnote iv). Or, at least very high testosterone males should be on hormone suppressants in order to give the ‘average’ competitor a ‘roughly equivalent prospect for competitive success’.The problem is that we are not interested in the average competitor.

    We are phenergan with codeine buy interested in the exceptional among us. Unless, it is for light relief. In every Olympiad there is the observation that, in every Olympic event, one average person should be included in the competition for the spectators’ reference.

    The humour lies in the absurd scenarios that phenergan with codeine buy would follow, whether it be the 100 m sprint, high jump, or synchronised swimming. Great chasms of natural ability would be laid bare, the results of a lifetime of training and dedication would be even clearer to see, and the last place result would be entirely predictable. But note how these are different phenergan with codeine buy attributes.

    While we may admire Olympians, it is unclear whether it is because of their God-given ability, their grit and determination, or their role in the unpredictable theatre of sport. If sport is a worthwhile social practice, we need to start spelling out its worth. Without doing so, we are unable to identify what capabilities are phenergan with codeine buy ‘relevant’ or ‘irrelevant’ to its aims, purpose or value.

    And until we can explain why one naturally occurring capability is ‘irrelevant’ to the aims, purposes, or values, of sport, while the remainder of them are relevant, I can only identify one right in play in the Semenya case.IntroductionSince the start of the COVID-19 pandemic, many medical systems have needed to divert routine services in order to support the large number of patients with acute COVID-19 disease. For example, in the phenergan with codeine buy National Health Service (NHS) almost all elective surgery has been postponed1 and outpatient clinics have been cancelled or conducted on-line treatment regimens for many forms of cancer have changed2. This diversion inevitably reduces availability of routine treatments for non-COVID-19-related illness.

    Even urgent treatments have needed to be modified. Patients with acute surgical emergencies such as appendicitis still present for care, cancers continue to be discovered phenergan with codeine buy in patients, and may require urgent management. Health systems are focused on making sure that these urgent needs are met.

    However, to achieve this goal, many patients are offered treatments that deviate from standard, non-pandemic management.Deviations from standard management are required for multiple factors such as:Limited resources (staff and equipment reallocated).Risk of nosocomial acquired infection in high-risk patients.Increased risk for medical staff to deliver treatments due to aerosolisation1.Treatments requiring intensive care therapy that is in limited availability.Operative procedures that are long and difficult or that are technically challenging if conducted in personal protective equipment. The outcomes from such procedures may be worse than in normal circumstances.Treatments that render patients more susceptible to COVID-19 disease, for example chemotherapy.There are many instances of compromise, but some examples that we are aware of include open appendectomy rather than laparoscopy to reduce risk of aerosolisation3 and offering a percutaneousCoronary intervention (PCI) rather than coronary artery bypass grafting (CABG) for coronary artery disease, to reduce phenergan with codeine buy need for intensive care. Surgery for cancers ordinarily operated on urgently maybe deferred for up to 3 months4 and surgery might be conducted under local anaesthesia that would typically have merited a general anaesthetic (both to reduce the aerosol risk of General anaesthesia, and because of relative lack of anaesthetists).The current emergency offers a unique difficulty.

    A significant phenergan with codeine buy number of treatments with proven benefit might be unavailable to patients while those alternatives that are available are not usually considered best practice and might be actually inferior. In usual circumstances, where two treatment options for a particular problem are considered appropriate, the decision of which option to pursue would often depend on the personal preference of the patient.But during the pandemic what is ethically and legally required of the doctor or medical professional informing patients about treatment and seeking their consent?. In particular, do health professionals need to make patients aware of the usual forms of treatment that they are not being offered in the current setting?.

    We consider two theoretical case examples:Case 1Jenny2 is a phenergan with codeine buy model in her mid-20s who presents to hospital at the peak of the COVID-19 pandemic with acute appendicitis. Her surgeon, Miss Schmidt, approaches Jenny to obtain consent for an open appendectomy. Miss Schmidt explains the risks of the operative phenergan with codeine buy procedure, and the alternative of conservative management (with intravenous antibiotics).

    Jenny consents to the procedure. However, she develops a postoperative wound infection and an unsightly scar. She does some research and discovers that a laparoscopic procedure would ordinarily have been performed and would have phenergan with codeine buy had a lower chance of wound infection.

    She sues Miss Schmidt and the hospital trust where she was treated.Case 2June2s a retired teacher in her early 70s who has well-controlled diabetes and hypertension. She is active and runs a local food bank. Immediately prior to the pandemic lockdown in the UK June had an episode of severe chest pain and investigations revealed phenergan with codeine buy that she has had a non-ST elevation myocardial infarction.

    The cardiothoracic surgical team recommends that June undergo a PCI although normally her pattern of coronary artery disease would be treated by CABG. When the cardiologist explains that surgery would be normally offered in this situation, and is theoretically superior to phenergan with codeine buy PCI, June’s husband becomes angry and demands that June is listed for surgery.In favour of non-disclosureIt might appear at first glance that doctors should obviously inform Jenny and June about the usual standard of care. After all, consent cannot be informed if crucial information is lacking.

    However, one reason that this may be called into question is that it is not immediately clear how it benefits a patient to be informed about alternatives that are not actually available?. In usual circumstances, doctors are not obliged to inform patients about phenergan with codeine buy treatments that are performed overseas but not in the UK. In the UK, for example, there is a rigorous process for assessment of new treatments (not including experimental therapies).

    Some treatments that are available in other jurisdictions have not been deemed by the National Institute for Health and Care Excellence (NICE) to phenergan with codeine buy be sufficiently beneficial and cost-effective to be offered by the NHS. It is hard to imagine that a health professional would be found negligent for not discussing with a patient a treatment that NICE has explicitly rejected. The same might apply for novel therapies that are currently unfunded pending formal evaluation by NICE.Of course, the difference is that the treatments we are discussing have been proven (or are believed) to be beneficial and would normally be provided.

    The Montgomery phenergan with codeine buy Ruling of 2015 in the UK established that patients must be informed of material risks of treatment and reasonable alternatives to treatment. The Bayley –v- George Eliot Hospital NHS Trust5case established that those reasonable alternative treatments must be ‘appropriate treatment’ not just a ‘possible treatment’6. In the current crisis, many previously standard treatments are no longer appropriate given the restrictions phenergan with codeine buy outlined.

    In other circumstances they are appropriate. During a pandemic they are no longer appropriate, even if they become appropriate again at some unknown time in the future.In both ethical and legal terms, it is widely accepted that, for consent to be valid, if must be given voluntarily by a person who has capacity to consent and who understands the nature and risks of the treatment. A failure to obtain valid consent, or performing interventions in the absence of phenergan with codeine buy consent, could result in criminal proceedings for assault.

    Failing to provide adequate information in the consent process could support a claim of negligence. Ethically, adequate information about treatments is essential for the patient to enable them to weigh up options and decide which treatments they wish to undertake. However, information about unavailable treatments arguably does not help the patient make an informed decision because it does phenergan with codeine buy not give them information that is relevant to consenting or to refusal of treatment that is actually available.

    If Miss Schmidt had given Jenny information about the relative benefits of laparoscopic appendectomy, that could not have helped Jenny’s decision to proceed with surgery. Her available choices were open appendectomy phenergan with codeine buy or no surgery. Moreover, as the case of June highlights, providing information about alternatives may lead them to desire or even demand those alternative options.

    This could cause distress both to the patient and the health professional (who is unable to acquiesce).Consideration might also be paid to the effect on patients of disclosure. How would it affect a patient with newly diagnosed cancer to tell them that an alternative, perhaps better phenergan with codeine buy therapy, might be routinely available in usual circumstances but is not available now?. There is provision in the Montgomery Ruling, in rare circumstances, for therapeutic exception.

    That is, phenergan with codeine buy if information is significantly detrimental to the health of a patient it might be omitted. We could imagine a version of the case where Jenny was so intensely anxious about the proposed surgery that her surgeon comes to a sincere belief that discussion of the laparoscopic alternative would be extremely distressing or might even lead her to refuse surgery. In most cases, though, it would be hard to be sure that the risks of disclosing alternative (non-available) treatments would be so great that non-disclosure would be justified.In favour of disclosureIn the UK, professional guidance issued by the GMC (General Medical Council) requires doctors to take a personalised approach to information sharing about treatments by sharing ‘with patients the information they want or need in order to make decisions’.

    The Montgomery judgement of 20157 broadly endorsed the position of the GMC, requiring patients to be told about any material risks and reasonable alternatives relevant to the phenergan with codeine buy decision at hand. The Supreme Court clarifies that materiality here should be judged by reference to a new two-limbed test founded on the notions of the ‘reasonable person in the patient’s position’ and the ‘particular patient’. One practical test might be for the clinician to ask themselves whether patients in general, or this particular patient might wish to know about alternative forms of treatment that would usually be offered.The GMC has recently produced pandemic-specific guidance8 on consent and decision-making, but this guidance is focused on managing consent in COVID-19-related interventions.

    While the GMC takes the view that its consent guidelines continue to apply as far as is practical, it also notes that the patient is enabled to consider the ‘reasonable alternatives’, and that the doctor phenergan with codeine buy is ‘open and honest with patients about the decision-making process and the criteria for setting priorities in individual cases’.In some situations, there might be the option of delaying treatment until later. When other surgical procedures are possible. In that phenergan with codeine buy setting, it would be important to ensure that the patient is aware of those future options (including the risks of delay).

    For example, if Jenny had symptomatic gallstones, her surgeons might be offering an open cholecystectomy now or the possibility of a laparoscopic surgery at some later point. Understanding the full options open to her now and in the future may have considerable influence on Jenny’s decision. Likewise, if phenergan with codeine buy June is aware that she is not being offered standard treatment she may wish to delay treatment of her atherosclerosis until a later date.

    Of course, such a delay might lead to greater harm overall. However, it would be ethically permissible to delay treatment if that was the patient’s informed choice (just as it would be phenergan with codeine buy permissible for the patient to refuse treatment altogether).In the appendicitis case, Jenny does not have the option for delaying her treatment, but the choice for June is more complicated, between immediate PCI which is a second-best treatment versus waiting for standard therapy. Immediate surgery also raises a risk of acquiring nosocomial COVID-19 infection and June is in an age group and has comorbidities that put her at risk of severe COVID-19 disease.

    Waiting for surgery leaves June at risk of sudden death. For an active and otherwise well patient with coronary disease like June, PCI procedure is not as good a treatment as CABG and June might legitimately wish to take phenergan with codeine buy her chances and wait for the standard treatment. The decision to operate or wait is a balance of risks that only June is fully able to make.

    Patients in this scenario phenergan with codeine buy will take different approaches. Patients will need different amounts of information to form their decisions, many patients will need as much information as is available including information about procedures not currently available to make up their mind.June’s husband insists that she should receive the best treatment, and that she should therefore be listed for CABG. Although this treatment would appear to be in June’s best interests, and would respect her autonomy, those ethical considerations are potentially outweighed by distributive justice.

    The COVID-19 pandemic of 2020 phenergan with codeine buy is being characterised by limitations. Liberties curtailed and choices restricted, this is justified by a need to protect healthcare systems from demand exceeding availability. While resource allocation is always a relevant ethical concern in publicly funded healthcare systems, it is a dominant concern in a setting where there is a high demand for medical care and scare resources.It is well established that competent adult patients can consent to or refuse medical treatment but they cannot demand that health professionals provide treatments that are contrary to their professional judgement or (even more importantly) would consume scarce healthcare resources.

    In June’s case, agreeing to perform CABG at a time when large phenergan with codeine buy numbers of patients are critically ill with COVID-19 might mean that another patient is denied access to intensive care (and even dies as a result). Of course, it may be that there are actually available beds in intensive care, and June’s operation would not directly lead to denial of treatment for another patient. However, that does phenergan with codeine buy not automatically mean that surgery must proceed.

    The hospital may have been justified in making a decision to suspend some forms of cardiac surgery. That could be on the basis of the need to use the dedicated space, staff and equipment of the cardiothoracic critical care unit for patients with COVID-19. Even if all that physical space is not currently occupied if may not be feasible or practical to try to simultaneously accommodate some non-COVID-19 phenergan with codeine buy patients.

    (There would be a risk that June would contract COVID-19 postoperatively and end up considerably worse off than she would have been if she had instead received PCI.) Moreover, it seems problematic for individual patients to be able to circumvent policies about allocation of resources purely on the basis that they stand to be disadvantaged by the policy.Perhaps the most significant benefit of disclosure of non-options is transparency and honesty. We suggest that the main reason why Miss Schmidt ought to have included phenergan with codeine buy discussion of the laparoscopic alternative is so that Jenny understands the reasoning behind the decision. If Miss Schmidt had explained to Jenny that in the current circumstances laparoscopic surgery has been stopped, that might have helped her to appreciate that she was being offered the best available management.

    It might have enabled a frank discussion about the challenges faced by health professionals in the context of the pandemic and the inevitable need for compromise. It may have avoided awkward discussions later after phenergan with codeine buy Jenny developed her complication.Transparent disclosure should not mean that patients can demand treatment. But it might mean that patients could appeal against a particular policy if they feel that it has been reached unfairly, or applied unfairly.

    For example, if June became aware that some patients were still being offered CABG, she might (or might not) be justified in appealing against the decision not to offer it to her. Obviously such phenergan with codeine buy an appeal would only be possible if the patient were aware of the alternatives that they were being denied.For patients faced by decisions such as that faced by June, balancing risks of either option is highly personal. Individuals need to weigh up these decisions for them and require all of the information available to do so.

    Some information is phenergan with codeine buy readily available, for example, the rate of infection for Jenny and the risk of death without treatment for June. But other risks are unknown, such as the risk of acquiring nosocomial infection with COVID-19. Doctors might feel discomfort talking about unquantifiable risks, but we argue that it is important that the patient has all available information to weigh up options for them, including information that is unknown.ConclusionIn a pandemic, as in other times, doctors should ensure that they offer appropriate medical treatment, based on the needs of an individual.

    They should aim to provide available treatment that phenergan with codeine buy is beneficial and should not offer treatment that is unavailable or contrary to the patient best interests. It is ethical. Indeed it phenergan with codeine buy is vital within a public healthcare system, to consider distributive justice in the allocation of treatment.

    Where treatment is scarce, it may not be possible or appropriate to offer to patients some treatments that would be beneficial and desired by them.Informed consent needs to be individualised. Doctors are obliged to tailor their information to the needs of an individual. We suggest that in the current climate this should include, for most patients, a phenergan with codeine buy nuanced open discussion about alternative treatments that would have been available to them in usual circumstances.

    That will sometimes be a difficult conversation, and require clinicians to be frank about limited resources and necessary rationing. However, transparency and honesty will usually be the best policy..

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