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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-20727, Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens
The FDA is officially classifying home test kits that detect non-viral germs causing sexually transmitted infections as Class II devices, meaning they have special safety rules but fewer hurdles than the strictest category. This change, effective October 9, 2026, helps make these tests safer and easier to get, benefiting patients and innovators alike. If you make or use these home test kits, this update means better access and clear safety standards without extra costs or delays.
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!