Department of Health and Human Services February 21, 2023 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), 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.

The Food and Drug Administration (FDA or Agency) has determined that ASACOL HD (Mesalamine) Delayed-Release Tablet, 800 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Product- Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.'' This draft guidance provides recommendations to industry on product-specific guidance (PSG) meetings between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application (ANDA) under the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, this draft guidance provides information on requesting and conducting PSG meetings with FDA (PSG teleconferences, pre-submission PSG meetings, and post- submission PSG meetings), as contemplated in the Generic Drug User Fee Amendments (GDUFA) Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter). This draft guidance is intended to provide procedures that will promote well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in accordance with the time frames set forth in the GDUFA III commitment letter.

The Food and Drug Administration (FDA, Agency, or we) 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 current good manufacturing practice (CGMP) for blood and blood components, including information collection recommendations found in Agency guidance related to reducing the risk of transfusion- transmitted infection (TTI).

The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of the compliance policy guide (CPG) Sec. 397.100 Accuracy Requirements for Indication of Temporal-Maximum Ultrasonic Power. The Agency is taking this action because the CPG identified in this notice contains policies that have been superseded by a subsequent FDA action.

The Office of the Assistant Secretary for Health published a document in the Federal Register of February 10, 2023, announcing a request for information on Promising Practices for Advancing Health Equity for Intersex Individuals. The document included incorrect information regarding the Addresses section and also Supplementary Information and also the collection for public comment.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $6,000,000 for Year 1 funding to the International Federation of Red Cross and Red Crescent Societies. The award will utilize IFRC's unique expertise, skills and access to countries and subnational consequential geographies that are inaccessible to CDC personnel, to continue polio eradication activities as well as to deliver measles and other life-saving vaccine preventable disease (VPD) interventions in priority countries. Funding amounts for years 2-5 will be set at continuation.