Department of Health and Human Services August 20, 2024 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Product- Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA." This 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 guidance provides information on requesting and conducting PSG meetings with FDA (i.e., pre-submission PSG teleconferences, post-submission 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 guidance provides 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. This guidance finalizes the draft guidance for industry of the same title issued on February 21, 2023.

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 (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 Ryan White HIV/AIDS Program (RWHAP) statute of the Public Health Service Act requires that RWHAP Parts A, B, and C recipients expend 75 percent of Parts A, B, and C grant funds on core medical services for individuals who are identified with HIV/AIDS and eligible for RWHAP services under the statute, after reserving statutorily permissible amounts for administrative and clinical quality management costs. The statute also grants the Secretary authority to waive this requirement if certain factors are met. HRSA is proposing to update Policy Notice 21-01, "Waiver of the Ryan White HIV/AIDS Program Core Medical Services Expenditure Requirement," pertaining to the associated data collection form to clarify applicants' proposed allocation of resources between core medical and support services.

The Food and Drug Administration (FDA, Agency, or we) has determined that PENNSAID (diclofenac sodium) Topical Solution 2%, 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.