FDA Pushes Paperwork for Lab Standards Review
Published Date: 11/24/2025
Notice
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!
Analyzed Economic Effects
4 provisions identified: 0 benefits, 4 costs, 0 mixed.
Large reporting burden for CLIA waiver applications
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 should include in waiver applications.
Extensive recordkeeping for CLIA waivers
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
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 comments by December 24, 2025.
Small time cost for CLIA categorization requests
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.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-06478 — Determination of Regulatory Review Period for Purposes of Patent Extension; VYLOY
The FDA has officially set the review period for VYLOY, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind VYLOY, giving them a chance to extend their patent protection and potentially boost profits. If anyone thinks the dates are wrong or wants to challenge the company’s review speed, they must act by June 2 or September 30, 2026.
2026-06481 — Determination of Regulatory Review Period for Purposes of Patent Extension; HYMPAVZI
The FDA has set the official review period for HYMPAVZI, a new human biological product, so its patent holder can apply for extra patent time. This affects the company behind HYMPAVZI and anyone interested in patent extensions. If you think the dates are wrong or want to challenge the company’s diligence, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.
2026-06480 — Determination of Regulatory Review Period for Purposes of Patent Extension; EMRELIS
The FDA has officially set the review period for EMRELIS, a medicine patent, so the patent owner can apply for extra protection time. If anyone thinks the dates are wrong, they have until June 2, 2026, to speak up. Also, people can challenge whether the patent owner was diligent during the review by September 30, 2026. This affects patent holders and could impact how long they keep exclusive rights to their product.
2026-06479 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENFLONSIA
The FDA has set the official review period for ENFLONSIA, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind ENFLONSIA and anyone interested in patent rules. If you think the dates are wrong or want to challenge the company’s review speed, you have until June 2 or September 30, 2026, to speak up—potentially impacting patent length and market exclusivity.
2026-06477 — Determination of Regulatory Review Period for Purposes of Patent Extension; ENCELTO
The FDA has officially set the review period for ENCELTO, a medicine patent, so the company can apply to extend its patent protection. This affects the drug maker by potentially giving them more time to exclusively sell ENCELTO, which can mean more money. If anyone thinks the dates are wrong or the company wasn’t diligent, they have until June 2 or September 30, 2026, to speak up.
2026-06483 — Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER
The FDA has officially set the review period for INJECTAFER, a drug patent up for extension. This means the company can apply to extend their patent protection, potentially keeping their exclusive rights longer and impacting competition and pricing. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by June 2 or September 30, 2026.
Previous / Next Documents
Previous: 2025-20773 — Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
The FDA wants your thoughts on how they collect info about making special human drugs under sections 503A and 503B. This affects pharmacies and drug makers who customize medicines for patients. Comments are open until January 23, 2026, so speak up now—this could shape paperwork and processes, but no new fees are mentioned.
Next: 2025-20775 — Agency Information Collection Extension
The Energy Information Administration (EIA) wants to keep collecting coal data for three more years without changing the forms. This affects coal producers, power plants, and anyone involved in coal markets by continuing surveys on coal production, stocks, and prices. You can send your thoughts by January 23, 2026, and there’s no new cost or paperwork added—just a smooth extension!
Take It Personal
Get Your Personalized Policy View
Start a Free Government Policy Watch to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in