Federal Register #2026-09245

CDC Denial of Peripheral Neuropathy Petitions and FDA Stakeholder Meetings for ADUFA Reauthorization

This notice covers two distinct government actions: - The CDC's World Trade Center (WTC) Health Program denied petitions to add peripheral neuropathy to its list of covered health conditions. - Three petitions (032, 033, 068) were reviewed. - Scientific and medical literature, including epidemiologic studies, was evaluated. - The evidence was found insufficient to establish a causal link between 9/11 exposures and peripheral neuropathy. - No products or services are being procured or awarded as part of this action. - The FDA announced stakeholder consultation meetings for the reauthorization of the Animal Drug User Fee Act (ADUFA). - Meetings will involve veterinary professionals, patient and consumer advocacy groups, and scientific experts. - Sessions will be held in person and virtually, starting in the future and recurring at least every 4 months during negotiations. - Meetings will take place at the FDA Harvey W. Wiley Federal Building in College Park, MD. - No OEMs or commercial vendors are mentioned in either action. - No specific products or part numbers are requested. - Unique requirements include ongoing stakeholder engagement for ADUFA reauthorization, but no procurement of goods or services is involved.

Description

The Administrator of the World Trade Center (WTC) Health Program has denied three petitions (032, 033, and 068) requesting the addition of peripheral neuropathy to the List of WTC-Related Health Conditions. After reviewing scientific and medical literature, including studies provided by petitioners, the Administrator found insufficient evidence to support a causal association between 9/11 exposures and peripheral neuropathy. Consequently, the petitions are denied, and no further action such as proposing a rule or requesting advisory committee recommendations will be taken at this time. The decision was made effective May 11, 2026.

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