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FDA Seeks Public Comment on Temporary Marketing Permit Application Reporting Requirements

The Food and Drug Administration is opening a 60-day public comment window on its information collection requirements for temporary marketing permit applications, as mandated by the Paperwork Reduction Act.

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The Food and Drug Administration (FDA) has published a notice in the Federal Register announcing an opportunity for public comment on the proposed collection of information related to temporary marketing permit applications. The notice covers a proposed extension of an existing information collection, and is being conducted pursuant to the Paperwork Reduction Act of 1995 (PRA), which requires federal agencies to publish such notices and allow time for public response.

Under the PRA, federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information — including proposed extensions of existing collections — and to allow 60 days for public comment in response. FDA's notice specifically solicits comments on reporting requirements contained in existing FDA regulations governing temporary marketing permit applications.

Comments may be submitted in either electronic or written form. The deadline for submission is November 20, 2026.

What to watch

  • November 20, 2026 — Deadline for submission of electronic or written comments on the proposed information collection related to temporary marketing permit applications.

Related

Sources

4 cited

Every hard fact above is grounded in and cited to a primary source record.

  1. The Food and Drug Administration is announcing an opportunity for public comment on the proposed collection of certain information by the Agency.

    federalregister.gov

  2. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice.

    federalregister.gov

  3. The notice solicits comments on reporting requirements contained in existing FDA regulations governing temporary marketing permit applications.

    federalregister.gov

  4. Either electronic or written comments on the collection of information must be submitted by November 20, 2026.

    federalregister.gov

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