Department of Health and Human Services October 29, 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing the availability of revised fish advice entitled ``Advice About Eating Fish: For Those Who Might Become or Are Pregnant or Breastfeeding and Children Ages 1-11 Years.'' The revised advice updates advice that FDA and the U.S. Environmental Protection Agency (EPA) jointly issued in January 2017 and subsequently revised in July 2019. The advice is intended to help those who might become or are pregnant or breastfeeding, and parents and caregivers of children make informed choices about fish that are nutritious and safe to eat. We are revising the advice in accordance with a recent directive from Congress.

In compliance with the Paperwork Reduction Act of 1995 (PRA), 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 0917-0014, titled, ``IHS Loan Repayment Program (LRP).'' The IHS is requesting OMB to approve an extension for this collection, which expires on November 30, 2021. Notice regarding the information collection was last published in the Federal Register (86 FR 43257) on August 6, 2021, and allowed 60 days for public comment. The purpose of this notice is to announce the IHS' intent to submit this collection to OMB and to allow 30 days for public comment to be submitted directly to OMB.

The Food and Drug Administration (FDA) is announcing a virtual public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2023 through 2027. GDUFA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to assess and collect fees to support human generic drug activities. The current legislative authority for GDUFA expires at the end of September 2022. At that time, new legislation will be required for FDA to continue to assess and collect generic drug user fees for future fiscal years. The FD&C Act directs FDA, following negotiations with the regulated industry and periodic consultations with other stakeholders, to present recommendations for reauthorization of the GDUFA program to the relevant Congressional committees, publish the recommendations in the Federal Register, provide for a period of 30 days for the public to provide written comments on such recommendations, and hold a meeting at which the public may present its views on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary.