# 2025-23859: FDA Reviews PET Drug Production Paperwork

2025-23859, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-12-29, effective 2026-01-28 (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-23859
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-23859
- Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 60726
- Published: 2025-12-29
- Effective: 2026-01-28
- Comments close: 2026-01-28
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Reviews PET Drug Production Paperwork

## Summary

The FDA is asking for public feedback on keeping rules that make sure PET drugs are made safely and correctly. This affects companies that produce these special medical drugs, helping keep patients safe without adding new costs. Comments are open until January 28, 2026, so now’s the time to speak up!

## Abstract

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

## Effects PRIA read

- CGMP applies to PET drug makers: cost, medium. If you operate a positron emission tomography (PET) drug production facility — academic, hospital, or commercial — you must follow the FDA's Current Good Manufacturing Practice (CGMP) rules in 21 CFR part 212. The rule covers personnel, quality assurance, facilities and equipment, control of compon…
- One-year record retention requirement: cost, low. You must keep all records required by 21 CFR part 212 at the PET drug production facility or another reasonably accessible location, ensure they are legible and protected from deterioration or loss, and make them readily available for FDA review and copying. All records and documentation must be re…
- Estimated annual recordkeeping burden: cost, high. FDA estimates the total annual recordkeeping burden for 21 CFR part 212 at 98,833 hours covering 197,665 records. The agency provides breakdowns: Academia/Small Firms & High-Risk Component Manufacture Records: 76 recordkeepers, ~62,644 total records, ~50,862 hours; Corporate Firm Records: 91 record…
- Sterility-failure disclosure burden: cost, low. For sterility testing failures under 21 CFR 212.70, FDA estimates 11 respondents will make 3 disclosures each (33 total disclosures) with an average burden of 2.5 hours per disclosure, totaling 83 hours annually.
- Increase in burden from new small facilities: cost, medium. FDA reports the estimated burden increased by 14,348 hours and 12,851 records compared to prior estimates, and attributes this adjustment to an increase in the estimate of the number of small firms due to new facilities.

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## Sources
- [2025-23859 on federalregister.gov](https://www.federalregister.gov/documents/2025/12/29/2025-23859/agency-information-collection-activities-submission-for-office-of-management-and-budget-review)
- [2025-23859 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-12-29/pdf/2025-23859.pdf)

## Related
- [Previous: 2025-23852, Over-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request…](https://policyrisk.com/federal-register/2025-23852)
- [Next: 2025-23862, Determination of Regulatory Review Period for Purposes of Patent Extension; ROM…](https://policyrisk.com/federal-register/2025-23862)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-23859 (as of 2026-06-08).