Federal Register #FDA-1998-P-0083

Federal Health Initiatives: Firefighter Cancer Registry, Rural Opioid Response Data Collection, and FDA Drug Product Enforcement

This summary covers several federal health initiatives and regulatory actions: - The National Institute for Occupational Safety and Health (NIOSH), part of the CDC, seeks a three-year renewal to enroll at least 33,333 U.S. firefighters annually in the National Firefighter Registry for Cancer, aiming for a total of 200,000 enrollees. - The registry collects health and occupational data to monitor cancer incidence and risk factors among firefighters. - Enrollment includes completion of informed consent, user profile, enrollment questionnaire, and records request forms. - The Health Resources and Services Administration (HRSA) plans to collect performance data for the Rural Communities Opioid Response Program (RCORP), supporting substance use disorder prevention, treatment, and recovery in rural areas. - Data collection covers multiple RCORP grant initiatives, including Northern Border Rural Workforce, Pathways, and Overdose Response programs. - The Food and Drug Administration (FDA) announces the withdrawal of hearing requests for estrogen-androgen fixed-combination drug products (e.g., Syntest D.S. and Syntest H.S. Tablets), finding them ineffective for their labeled use and prohibiting their shipment without approved applications. - No specific OEMs or commercial vendors are named in these initiatives; the focus is on federal program administration and regulatory enforcement. - Notable requirements include large-scale voluntary enrollment of firefighters, comprehensive data collection for rural opioid response, and regulatory compliance for drug manufacturers. - Key federal locations involved include CDC/NIOSH, FDA offices in Silver Spring and Rockville, HRSA, and the Office of Management and Budget.

Description

The Food and Drug Administration (FDA) announces the withdrawal of all outstanding hearing requests for estrogen-androgen fixed-combination drug products under Docket FDA-1998-P-0083 (DESI 7661). The FDA finds that these products have not been shown to be effective for their labeled use, specifically for moderate to severe vasomotor symptoms associated with menopause in patients not improved by estrogen alone. Shipment in interstate commerce of any such product not subject to an approved new drug application (NDA) or abbreviated new drug application (ANDA) is unlawful as of the effective date of this notice, June 26, 2026. The notice also details the history of the drug efficacy study implementation and the regulatory actions taken regarding these products.

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