AGENCY:

Food and Drug Administration, Health and Human Services (HHS).

ACTION:

Notice; third 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 May 27, 2026, titled 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 August 27, 2026 (91 FR 55348), by an additional 6 months. The effective date of the May 2026 Notice, as previously extended to November 4, 2026, is hereby further extended to May 4, 2027. 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 May 4, 2027.

ADDRESSES:

For access to the docket to read background documents or the electronic and written/paper comments received, go to www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500 between 9 a.m. and 4 p.m., Monday through Friday. Publicly available submissions may be seen in the docket.

The most relevant background documents regarding this matter are available in the docket. However, additional background documents are available upon request (see FOR FURTHER INFORMATION CONTACT ).

FOR FURTHER INFORMATION CONTACT:

Amber McKinley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5172, Silver Spring, MD 20993-0002, 301-796-0061, Amber.McKinley@fda.hhs.gov.