Department of Health and Human Services November 30, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry.'' The draft guidance, when finalized, will explain FDA's current thinking on a number of issues related to the labeling of food allergens, including requirements in the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act). The draft guidance is a revision of a currently issued guidance, entitled ``Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4).'' This draft guidance is not final nor is it in effect at this time. In addition, the FDA is announcing availability of a final guidance entitled ``Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Final Guidance for Industry.'' This final guidance includes the questions and answers from the currently issued guidance that remain substantively unchanged.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #276 entitled ``Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.'' This draft guidance is intended for sponsors and potential sponsors who may be interested in pursuing approval of investigational new animal drugs for the prevention of heartworm disease in dogs. The draft guidance provides recommendations for the effectiveness evaluation of drugs indicated for the prevention of heartworm disease caused by Dirofilaria immitis in dogs. These recommendations should be read in conjunction with related Agency Veterinary International Conference on Harmonization (VICH) guidance documents and are intended to provide additional detail to elements of study design and interpretation under the recommendations laid out in the VICH guidances.

The Health Resources and Services Administration implements section 340B of the Public Health Service (PHS) Act, which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' This notice of proposed rulemaking (NPRM) proposes to revise the current 340B administrative dispute resolution (ADR) final rule (Dec. 14, 2020) with a new process and solicits comment on the proposal.