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

The original Federal Register Notice announcing the December 2020 Advisory Commission on Childhood Vaccines (ACCV) meeting indicated that this meeting would be held on December 3, 2020, and December 4, 2020. This meeting is not being conducted over two days, and instead will only take place on December 3, 2020.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a material threat medical countermeasure (MCM) priority review voucher for fiscal year (FY) 2021. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to determine and collect material threat MCM priority review user fees for certain applications for review of human drug products when those applications use a material threat MCM priority review voucher. These vouchers are awarded to the sponsors of material threat MCM applications that meet all the requirements of this program and upon FDA approval of such applications. The amount of the fee for using a material threat MCM priority review voucher is determined each FY based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the material threat MCM priority review fee rate for FY 2021 and outlines the payment procedures for such fees.

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2021. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to determine and collect rare pediatric disease priority review user fees for certain applications for review of human drug or biological products when those applications use a rare pediatric disease priority review voucher. These vouchers are awarded to sponsors of rare pediatric disease product applications that meet all the requirements of this program and are submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. The amount of the fee for using a rare pediatric disease priority review voucher is determined each FY, based on the difference between the average cost incurred by FDA to review a human drug application designated as priority review in the previous FY, and the average cost incurred in the review of an application that is not subject to priority review in the previous FY. This notice establishes the rare pediatric disease priority review fee rate for FY 2021 and outlines the payment procedures for such fees.

The Food and Drug Administration (FDA or we) is requesting information pertaining to the labeling of foods comprised of or containing cultured seafood cells. Foods comprised of or containing cultured seafood cells are being developed and may soon enter the marketplace. Therefore, we intend to use information and data resulting from this notice to determine what type(s) of action, if any, we should take to ensure that these foods are labeled properly.

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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects, as required by 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.

This notice will serve to announce that the U.S. Department of Health and Human Services (HHS) is seeking nominations of non-federal public (public) individuals who represent diverse scientific disciplines and views and are interested in being considered for appointment to the Tick-Borne Disease Working Group (TBDWG). Resumes or curricula vitae from qualified individuals who wish to be considered for appointment as a member of the TBDWG are currently being accepted.

As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a virtual meeting. The meeting will be open to the public. For this meeting, the TBDWG will review chapters and the template for the 2020 report to the HHS Secretary and Congress. The 2020 report will address ongoing tick- borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, and interventions for individuals with tick-borne diseases; advances made pursuant to such research; federal activities related to tick-borne diseases; and gaps in tick-borne disease research

The Food and Drug Administration (FDA) is announcing the revocations of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Autobio Diagnostics Co. Ltd. (``Autobio'') for the Anti-SARS-CoV-2 Rapid Test (``Autobio's Test'') and to Manufacturers and Other Stakeholders (``Stakeholders'') for certain in vitro diagnostic SARS-CoV-2 Antibody Tests. FDA revoked Autobio's Authorization on August 6, 2020, and the Stakeholders' Authorization on July 21, 2020, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

The Food and Drug Administration (FDA) is postponing the meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee scheduled from October 7, 2020, to a later date to be determined. The meeting was announced in the Federal Register of August 20, 2020. A future meeting date will be announced in the Federal Register.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through April 1, 2022.

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 information collection associated with Orphan Drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and implementing regulations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment.'' This draft guidance provides recommendations to sponsors regarding the development of drugs and biologics (referred to as drugs in this document) for the adjuvant treatment of muscle-invasive bladder cancer. The draft guidance includes recommendations regarding eligibility criteria, choice of comparator, follow up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results. This draft guidance is intended to facilitate the development of drugs for the adjuvant treatment of bladder cancer.

Statement of Organizations, Functions, and Delegations of Authority. The Administration for Children and Families (ACF) is restructuring the Office on Trafficking in Persons (OTIP) within the Office of the Assistant Secretary for Children and Families, ACF, into three divisionsPrevention, Protection, and Research and Policythat report to the OTIP Director.

HRSA has decided not to provide funding for HRSA-20-083 Quality Improvement Solutions for Sustained Epidemic Control Project, supported by the President's Emergency Plan for AIDS Relief (PEPFAR).