Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Second Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-1998-P-0083 (formerly 76N-0377); DESI 7661] AGENCY: Food and Drug Administration, Health and Human Services (HHS). ACTION: Notice; second extension of effective date. SUMMARY: The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice published in the Federal Register on ( printed page 55349) May 27, 2026, entitled “Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661” ( 91 FR 31462 ) (the “May 2026 Notice”), as previously extended by the notice published in the Federal Register on June 26, 2026 ( 91 FR 38717 ) (the “June 2026 Notice”), by an additional 41 days. The effective date of the May 2026 Notice, which was previously extended to September 24, 2026, is hereby further extended to November 4, 2026. This further extension is necessary to allow FDA sufficient time to consider issues raised by interested parties. DATES: The effective date of the May 27, 2026, notice ( 91 FR 31462 ), as previously extended, is further extended to November 4, 2026. ADDRESSES: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in b…