Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Practices and Procedures; Formal Hearings
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This law outlines the procedures for the Food and Drug Administration (FDA) to collect information from the public regarding administrative practices and formal hearings. It mandates a public comment period under the Paperwork Reduction Act, allowing stakeholders to provide feedback on the potential impacts and effectiveness of the proposed information collection. The FDA seeks to enhance clarity, utility, and minimize the burden on individuals participating in these processes.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Introduces a public comment period for information collection under the Paperwork Reduction Act.
- Clarifies the procedures for formal hearings and administrative practices.
- Establishes guidelines for submitting confidential information.
Obligations
What this law requires
Submit comments on the proposed information collection by June 8, 2026 at 11:59 p.m. Eastern Time via https://www.regulations.gov or by mail/hand delivery/courier to Dockets Management Staff
Include Docket No. FDA-2026-N-2431 in all comment submissions regarding Administrative Practices and Procedures; Formal Hearings
Ensure comments do not include confidential information such as medical information, Social Security numbers, or confidential business information unless submitted as written/paper submissions marked confidential
Submit confidential comments as written/paper submissions only, providing two copies with one clearly marked 'THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION' and the second copy with confidential information redacted
Mail/hand deliver/courier written/paper submissions to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852