Department of Health and Human Services February 17, 2022 – Federal Register Recent Federal Regulation Documents
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Device Good Manufacturing Practice Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Device Good Manufacturing Practice Advisory Committee. The committee reviews regulations proposed for promulgation regarding good manufacturing practices governing the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of devices, and makes recommendations to the Commissioner of Food and Drugs regarding the feasibility and reasonableness of those proposed regulations. The meeting will be open to the public.
Privacy Act; Implementation
The Department of Health and Human Services (HHS or Department) is issuing this final rule to make effective the exemptions that were previously proposed for a subset of records covered in a new Privacy Act system of records, No. 09-25-0165, NIH Loan Repayment Records, which is maintained by the National Institutes of Health (NIH). The system of records covers records used to manage and evaluate the Loan Repayment Programs (LRPs) at NIH. The exemptions are necessary to maintain the integrity of the NIH peer review and award processes by enabling NIH to protect the identities of reviewers.
Proposed Information Collection Activity; FFY 2022 CCDF Discretionary Funds Reallotment (0970-0510)
The Administration for Children and Families (ACF), Office of Child Care (OCC) plans to submit a generic information collection (GenIC) request under the following umbrella generic: Generic Clearance for Financial Reports used for ACF Mandatory Grant Programs (0970- 0510). This request includes a draft announcement with instructions to be completed by Child Care and Development Fund (CCDF) grant recipients that will be unable to obligate funds that will reach the end of their obligation period on September 30, 2022.
Proposed Collection; 60-Day Comment Request Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service (PHS) Funding Is Sought and Responsible Prospective Contractors (NIH/OD)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health, Office of Policy and Extramural Research Administration (OPERA), Office of Extramural Research (OER) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Request for Public Comment: 60-Day Information Collection: Indian Health Service Information Security Ticketing and Incident Reporting
In compliance with the Paperwork Reduction Act of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) invites the general public to take this opportunity to comment on the information collection Office of Management and Budget (OMB) Control Number 0917-0041, titled, Information Security Ticketing and Incident Reporting. The purpose of this notice is to allow 60 days for public comment. A copy of the draft supporting statement is available at www.regulations.gov (see Docket ID IHS_FRDOC_001).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Study of How Consumers Use Flavors To Make Inferences About Electronic Nicotine Delivery System Product Qualities and Intentions To Use (Phase 2)
The Food and Drug Administration (FDA, the Agency, 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 of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Class II Special Controls for Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests
The Food and Drug Administration (FDA, Agency, 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 of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Application Regulations
The Food and Drug Administration (FDA, Agency, 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 of 1995.
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Peripheral and Central Nervous System Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. COMIRNATY (COVID-19 Vaccine, mRNA) was approved on August 23, 2020, and a license was issued to BioNTech Manufacturing GmbH. FDA has determined that COMIRNATY (COVID-19 Vaccine, mRNA) meets the criteria for a material threat MCM priority review voucher, which has been issued to BioNTech Manufacturing GmbH.
Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a material threat medical countermeasure (MCM) product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act (Cures Act), authorizes FDA to award priority review vouchers to sponsors of approved material threat MCM product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that SPIKEVAX (COVID-19 Vaccine, mRNA), meets the criteria for a material threat priority review voucher, which has been issued to ModernaTX, Inc., the holder of the biologics license application.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
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