# 2025-20774: FDA Pushes Paperwork for Lab Standards Review

2025-20774, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-11-24, effective Submit written comments on the collection of information by December 24, 2025. (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-20774
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-20774
- Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 52960
- Published: 2025-11-24
- Effective: Submit written comments on the collection of information by December 24, 2025.
- Comments close: 2025-12-24
- Significant: no
- Touches household money: no
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## In one line

FDA Pushes Paperwork for Lab Standards Review

## Summary

The FDA is asking for public feedback on how it collects info about lab tests to keep them safe and reliable. This affects labs that test human samples and helps decide how tricky each test is. Comments are open until December 24, 2025, with no new costs expected—just smoother rules!

## 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

- Small time cost for CLIA categorization requests: cost, low. If you request CLIA categorization from FDA, the agency estimates 430 total responses with an average burden of 1 hour per response (total 430 hours) and $2,150 in operating and maintenance costs. FDA reports 86 respondents making 5 requests each on average.
- Large reporting burden for CLIA waiver applications: cost, high. If you submit a CLIA waiver application, FDA estimates each submission carries an average burden of 1,200 hours; FDA expects 20 submissions for a total of 24,000 hours and $540,000 in operating and maintenance costs. The guidance lists specific documentation and study results that manufacturers sho…
- Extensive recordkeeping for CLIA waivers: cost, high. For CLIA waiver recordkeeping, FDA estimates 20 recordkeepers with an average burden of 2,800 hours per recordkeeper, totaling 56,000 hours. FDA lists this recordkeeping burden as part of implementing CLIA waiver guidance.
- Overall paperwork burden and cost increase: cost, medium. FDA estimates the total burden for this information collection is 80,430 hours (24,430 reporting + 56,000 recordkeeping) and reports an overall increase of 28,030 hours and a corresponding increase of $190,150 in operating and maintenance costs. The OMB control number is 0910-0607 and FDA sought co…

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## Sources
- [2025-20774 on federalregister.gov](https://www.federalregister.gov/documents/2025/11/24/2025-20774/agency-information-collection-activities-submission-for-office-of-management-and-budget-review)
- [2025-20774 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-11-24/pdf/2025-20774.pdf)

## Related
- [Previous: 2025-20773, Agency Information Collection Activities; Proposed Collection; Comment Request;…](https://policyrisk.com/federal-register/2025-20773)
- [Next: 2025-20775, Agency Information Collection Extension](https://policyrisk.com/federal-register/2025-20775)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-20774 (as of 2026-06-08).