Department of Health and Human Services 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ``Requesting FDA Feedback on Combination Products.'' The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics. These interactions can occur through application-based mechanisms, such as the pre-submission process used in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) and the formal meetings used in the Center for Drug Evaluation and Research (CDER) and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate.

The Food and Drug Administration (FDA) is announcing the renewal of the Pharmacy Compounding Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Pharmacy Compounding Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until April 25, 2022.

The Food and Drug Administration (FDA or Agency) is correcting a notice entitled ``Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability'' that appeared in the Federal Register of November 25, 2020. The document announced the availability for a guidance for industry. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section. This document corrects that error.

The Department of Health and Human Services (HHS), Office of Minority Health (OMH) is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Minority Health (hereafter referred to as the ``Committee or ACMH''). The Committee provides advice to the Deputy Assistant Secretary for Minority Health on the development of goals and specific program activities for improving the health and the quality of health care minorities receive and eliminating racial and ethnic health disparities consistent with the Public Health Service (PHS) Act.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. Consistent with FDA's regulations, this notice is being published with less than 15 days prior to the date of the meeting based on a determination that convening a meeting of the Vaccines and Related Biological Products Advisory Committee as soon as possible is warranted. This Federal Register notice could not be published 15 days prior to the date of the meeting due to a recent submission by Moderna, Inc., of a request for Emergency Use Authorization (EUA) for an investigational vaccine to prevent Coronavirus Disease 2019 (COVID-19) and the need for prompt discussion of such submission, given the COVID-19 pandemic.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the existing information collection project titled Paul Coverdell National Acute Stroke Program (PCNASP) reporting system, which was established to improve quality of care for acute stroke patients from onset of signs and symptoms through hospital care and rehabilitation and recovery.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the proposed information collection, Certification of Maintenance of Effort for Title III and Certification of Long Term Care Ombudsman Program Expenditures OMB #0985-0009.

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 HIV National Strategic Plan: A Roadmap to End the HIV Epidemic (2021-2025) (HIV Plan) available for public comment. The draft HIV Plan may be reviewed at www.hiv.gov.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our Living Systematic Review on Plant-Based Treatment for Chronic Pain, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of our infant formula regulations, including infant formula labeling, quality control procedures, notification requirements, and recordkeeping. The notice also invites comment on electronic Form FDA 3978 that allows manufacturers of infant formula to submit reports and notifications in a standardized format.

This document corrects technical and typographical errors that appeared in the final rule published in the September 29, 2020 Federal Register entitled ``Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures,'' which established the Radiation Oncology Model and the End-Stage Renal Disease Treatment Choices Model.

This final rule addresses any undue regulatory impact and burden of the physician self-referral law. This final rule is being issued in conjunction with the Centers for Medicare & Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care. This final rule establishes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It also establishes a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; establishes a new exception for donations of cybersecurity technology and related services; and amends the existing exception for electronic health records (EHR) items and services. This final rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This survey previously ran a 60-day FRN in 83 FR 66276 on 12/ 26/2018. As required under the PRA we are providing the public an opportunity to comment on any changes or updates applied to this IC since the 2018 publication. We are requesting an abbreviated public comment period for additional 30-days prior to publication of a 30-day FRN and submittal to OMB. Any changes to the survey from the initial 60-day FRN publication are incorporated into the revised version of the survey. This notice solicits comments on any revisions since the initial publication in 2018. This is a new information collection 0985-New Inventory of Adult Protective Services Practices and Service Innovations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.'' This draft guidance focuses on specific recommendations pertinent to gastric pH- dependent drug-drug interaction (DDI) assessment and describes the FDA's recommendations regarding when clinical DDI studies with acid- reducing agents (ARAs) are needed; design of the clinical studies; interpretation of study results; and communicating findings and options for managing pH-dependent DDIs in product labeling.

The Food and Drug Administration (FDA or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

This final rule adopts certain changes to the risk adjustment data validation error estimation methodology beginning with the 2019 benefit year for states where the Department of Health and Human Services (HHS) operates the risk adjustment program. This rule is finalizing changes to the HHS-RADV error estimation methodology, which is used to calculate adjusted risk scores and risk adjustment transfers, beginning with the 2019 benefit year of HHS-RADV. This rule also finalizes a change to the benefit year to which HHS-RADV adjustments to risk scores and risk adjustment transfers would be applied beginning with the 2020 benefit year of HHS-RADV. These policies seek to further the integrity of HHS-RADV, address stakeholder feedback, promote fairness, and improve the predictability of HHS-RADV adjustments.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) seeks approval to conduct semi-structured, qualitative interviews with Head Start staff (grantee administrators, managers/coordinators, center directors, teachers, staff), parents, affiliated community providers, and partner local education agency staff (administrators, elementary school principals, staff, and kindergarten teachers) at six sites. A comparative case study design will explore varying strategies and approaches to supporting children's transitions from Head Start to kindergarten.

The Administration for Children and Families (ACF), Office of Family Assistance (OFA), has had administrative responsibility for federal funding of programs that strengthen families through healthy marriage and relationship education and responsible fatherhood programming since 2006 through the Healthy Marriage (HM) and Responsible Fatherhood (RF) Grant Programs. ACF required the 2015 cohort of HMRF granteeswhich received 5-year grants in September 2015to collect and report performance measures about program operations, services, and clients served (OMB #0970-0460). A performance measures data collection system called nFORM (Information, Family Outcomes, Reporting, and Management) was implemented with the 2015 cohort to improve the efficiency of data collection and reporting and the quality of data. This system allows for streamlined and standardized submission of grantee performance data through regular progress reports and supports grantee-led and federal research projects. ACF will continue performance measure and other data collection activities for the HMRF grant program with a new cohort of grantees who received 5-year awards in September 2020. ACF is requesting comment on a new data collection to support these activities with the 2020 HMRF grantee cohort. ACF has made changes to the previous cohort's data collection instruments and performance reports for use in the new cohort. This new grantee cohort is expected to begin collecting performance measure data and reporting to ACF in April 2021.

In compliance with the requirement for opportunity for public comment on the proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services is proposing to collect data on the challenges and unique opportunities of administering human services programs in rural contexts. Case studies of 12 communities, in combination with analysis of administrative data and qualitative comparative analysis of the qualitative data, will provide ACF with a rich description of human services programs in rural contexts and provide ACF opportunities for strengthening human services programs' capacity to promote the economic and social wellbeing of individuals, families, and communities in rural contexts.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Michael L. Babich from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Babich was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Babich was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of September 2, 2020 (30 days after receipt of the notice), Mr. Babich had not responded. Mr. Babich's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #242 entitled ``In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products.'' The purpose of in-use stability testing is to establish a period of time during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured). This guidance reflects the Agency's current thinking on how to formulate in-use statements, as well as how to design and carry out in-use stability studies to support these in-use statements, for multiple-dose injectable drug products intended for use in animals. This current thinking pertains to both generic drug products and pioneer drug products regardless of whether the pioneer reference listed new animal drug (RLNAD) currently has an in-use statement on the labeling.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Ag Chem Resources, LLC, proposing that the food additive regulations be amended to provide for the safe use of tannic acid as a flavoring agent in animal feed.

The Immediate Office of the Secretary (IOS) is issuing this policy regarding redundant, overlapping, or inconsistent regulations.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new data collection, the Serious Medical Procedure Request (SMR) Form.

Through this Request for Information (RFI), the Sexual & Gender Minority Research Office (SGMRO) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH), invites feedback from stakeholders throughout the scientific research community, clinical practice communities, patient and family advocates, scientific or professional organizations, federal partners, internal NIH stakeholders, and other interested constituents on research opportunities related to the upcoming NIH Scientific Workshop on Violence and Related Health Outcomes in Sexual and Gender Minority (SGM) Communities. The overarching purpose of this workshop is to identify and prioritize key research opportunities to further our understanding of violence against SGM individuals.

The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act (PRA) of 1995.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are announcing the availability of a final guidance for industry and FDA staff entitled ``Qualification Process for Drug Development Tools.'' Under the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, a new section was added to the Federal Food, Drug, and Cosmetic Act (FD&C Act), which defined a three-stage qualification process for drug development tools (DDTs). This guidance meets the Cures Act's requirement to issue guidance on this qualification process. It elaborates on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other DDTs. This guidance finalizes the draft guidance of the same title issued on December 16, 2019.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Models of Care that Include Primary Care for Adult Survivors of Childhood Cancer, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The Administration for Children and Families (ACF) proposes to extend data collection under the existing overarching Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (OMB #0970-0401). There are no changes to the proposed types of information collection or uses of data, but ACF is requesting an increase to the estimated number of respondents.

As required by the Social Security Act, the Department is publishing the allotment percentage for each state under the Title IV-B Subpart 1, Stephanie Tubbs Jones Child Welfare Services Grant Program. The allotment percentages are one of the factors used in the computation of the Federal grants awarded under the Program.

The U.S. Department of Health and Human Services (HHS) seeks to gain a comprehensive understanding of the impact of changes adopted by health care systems and health care providers in response to the COVID-19 pandemic. Many healthcare systems and clinicians have rapidly reengineered their policies and programs to improve access, safety, quality, outcomes including mortality and morbidity, cost, and value for both COVID-19 and non-COVID-19 related medical conditions. HHS plans to identify and learn from effective innovative approaches and best practices implemented by non-HHS organizations in order to inform HHS priorities and programs.

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) requires mandatory formula grant applications, state plans, and performance progress reports from states and territories for the development and implementation of their State Personal Responsibility Education Program (PREP). The State PREP Funding Opportunity Announcement sets forth the application and state plan requirements for the receipt of the following documents from applicants and awardees: Application, State Plan, and Performance Progress Report. ACYF/FYSB are requesting a reinstatement with no changes to the previously approved information collections under OMB #0970-0380.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Temporary Assistance for Needy Families (TANF) Expenditure Report, Form ACF-196R (OMB #0970-0446, expiration 2/28/2021). ACF is reporting a change to remove certain guidance that was associated with an earlier ACF-196 report in order to devote the instructions to the singular ACF-196R report. In addition, ACF has clarified instructions where states have previously expressed confusion and has reorganized the format and chronology of section headers to better reflect the flow of the TANF reporting process.

This notice announces the national expansion of the Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transports to all states, but we are delaying the implementation of the expansion to all additional states due to the COVID-19 Public Health Emergency. The model will continue to operate in the states currently participating in the model under section 1115A of the Social Security Act (the Act), which includes Delaware, the District of Columbia, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia. CMS will continue to monitor the Public Health Emergency and will provide public notice before implementing the model in additional states.

The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ``Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls; Guidance for Industry and FDA staff.'' The guidance for industry and FDA staff describes how and when FDA intends to collect, compile, and publicize lists of retail consignees that may have received recalled foods. While FDA intends to focus on recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals (Class I recalls), FDA may also publicize retail consignee lists for other food recalls as described in the guidance. FDA's goal is to publicize retail consignee lists for these food recalls where providing this additional information will be of the most use to consumers to help them identify recalled food and to determine whether that food is in their possession as effectively and quickly as possible.

This notice announces a virtual Town Hall meeting for CMS to share updates on the Merit-based Incentive Payment System (MIPS) Value Pathway (MVP) policy considerations and for stakeholders to provide feedback on those MVP considerations for future implementation. Clinicians, professional organizations, third party vendors, stakeholders, and other interested parties are invited to this meeting to present their individual views on MVP design and implementation. The opinions and alternatives provided during this meeting will assist us as we evaluate our policies on essential components of the MVP framework, including, but not limited to, expanding reporting options to allow clinicians to form subgroups and report MVPs, MVP scoring policies, as well as other areas of MVP refinement. The meeting is open to the public, but registration is required, and attendance is limited. We encourage early registration to secure a spot.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Ecoflora SAS, proposing that the color additive regulations be amended to provide for the safe use of jagua (genipin-glycine) blue in various food categories at levels consistent with good manufacturing practice.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., proposing that the color additive regulations be amended to expand the safe use of calcium carbonate to include use in dietary supplement tablets and capsules.

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Evaluation of Venous Thromboembolism Prevention Practices in U.S. Hospitals. This proposed study is designed to support a framework for improving hospital venous thromboembolism (VTE) prevention practices through the evaluation of current VTE prevention practices in U.S. adult general medical and surgical hospitals.

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Social Security Administration (SSA), ``Determining Enrollment or Eligibility for Insurance Affordability Programs Under the Patient Protection and Affordable Care Act.''

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is inviting public comments on several proposed instruments. The instruments will be added to the following existing information collections: Services Provided to Unaccompanied Alien Children (OMB #0970-0553), Placement and Transfer of Unaccompanied Alien Children into ORR Care Provider Facilities (OMB #0970-0554), and Administration and Oversight of the Unaccompanied Alien Children Program (OMB #0970-0547).

In accordance with the Public Health Service Act and the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting to be held on Tuesday, December 1, 2020. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/ advisory-committees/heritable-disorders/.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on January 8, 2020. The document announced the withdrawal of approval of 19 new drug applications (NDAs) from multiple applicants, withdrawn as of February 7, 2020. The document indicated that FDA was withdrawing approval of NDA 202342, Esomeprazole Strontium Delayed-Release Capsules, Equivalent to (EQ) 20 milligrams (mg) base and EQ 40 mg base, after receiving a withdrawal request from R2 Pharma, LLC, 11550 North Meridian St., Suite 290, Carmel, IN 46032-5505 (R2 Pharma). Because of clerical errors in the Agency's processing of communications regarding this application, FDA has determined that NDA 202342 remains approved. Accordingly, FDA's approval of NDA 202342 remains in effect. There are no changes with respect to the other 18 NDA withdrawals announced in the January 8, 2020 Federal Register notice.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

NIOSH announces the availability of Skin Notation Profiles for Chlorodiphenyl (42% chlorine) (CAS: 53469-21-9), Cyclohexanol (CAS: 108-93-0), Cyclohexanone (CAS: 108-94-1), Cyclonite (CAS: 121-82-4), and Diethylenetriamine (CAS: 111-40-0).

The Office of the Assistant Secretary for Health (OASH) in the Department of Health and Human Services, in partnership with other federal agencies, seeks to gain a more comprehensive understanding from health systems, community based organizations, academic institutions, non-federal government agencies, innovators, entrepreneurs, non-profit organizations, and other relevant stakeholders regarding innovative solutions to chronic disease management leveraging novel technologies (e.g., artificial intelligence (AI), biosensors, apps, remote monitoring, 5G) to optimize compliance with evidence-based standards of care in disease states that cause significant morbidity and mortality in aging populations in underserved areas (e.g., low income, Medicaid- eligible, rural). OASH will review information collected in this request for information (RFI) to better inform federal government priorities and programs. We also seek to identify opportunities to strengthen the U.S. healthcare system, as a whole, through public- private partnerships in data sharing, comprehensive analytics including AI, and other potential mechanisms. OASH welcomes public feedback related to how these questions should be addressed and/or potential solutions. The set of questions is available in the SUPPLEMENTARY INFORMATION section below.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Electromagnetic Compatibility (EMC) of Medical Devices.'' FDA has developed this guidance document to describe relevant information that should be provided in a premarket submission (i.e., premarket approval application (PMA), humanitarian device exemption (HDE), premarket notification (510(k)) submission, investigational device exemption (IDE), and De Novo request) to support a claim of electromagnetic compatibility for electrically powered medical devices and medical devices with electrical or electronic functions. This draft guidance is not intended to change current policy, but to provide specific technical information to address the recommendations originally described in the guidance entitled ``Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices'' published July 11, 2016 (2016 EMC guidance). This draft guidance is not final nor is it in effect at this time.

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the proposed extension for the information collection requirements related to the NIDILRR Grantee Annual Performance Reporting (APR) and Final Report Forms.

The Health Information Technology Advisory Committee (HITAC) was established in accordance with the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2021. See list of public meetings below.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a virtual meeting. The meeting will be open to the public and public comment will be heard during the meeting.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.'' This guidance is intended to explain FDA implementation of the revised statutory provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) amended the statutory provisions relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom sensitive and identifiable information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled in a legal proceeding to disclose identifiable sensitive information about the research participant, created or compiled for the research. As amended, a CoC prohibits a researcher from disclosing such information unless a specified exception applies. This guidance finalizes the draft guidance of the same title issued on November 25, 2019.

On July 28, 2018 the Center for State, Tribal, Local, and Territorial Support (CSTLTS), Centers for Disease Control and Prevention (CDC), published a notice in the Federal Register announcing the Public Health Associate Program (PHAP) Alumni and Host Site Assessment. Written comments were to be received by September 28, 2020. The Docket Number that was included in the initial publication of this 60 Day Federal Register Notice was incorrect. CDC is announcing the reopening of the comment period.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #197 entitled ``Documenting Electronic Data Files and Statistical Analysis Programs.'' This guidance is intended to inform sponsors of recommendations for documenting electronic data files and statistical analyses submitted to the Center for Veterinary Medicine (CVM) to support new animal drug applications.

The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the Office of Intramural Research (OIR), Office of the Director (OD), National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.