FDA Seeks Comments on Paperwork Nobody Reads
Published Date: 7/6/2026
Notice
Summary
The FDA is asking for public feedback on how it collects information for formal hearings and administrative rules. This affects businesses and people who interact with the FDA, with no new costs but a chance to improve paperwork processes. Comments are due by August 5, 2026, so don’t miss your chance to weigh in!
Analyzed Economic Effects
5 provisions identified: 1 benefits, 4 costs, 0 mixed.
Citizen Petitions: 24 Hours Each
FDA estimates 330 citizen petitions or related petitions (including certain ANDAs, NDAs, and BLAs) at 24 hours per submission, totaling 7,920 annual burden hours for petition filers.
Total FDA Paperwork Burden: 9,440 Hours
The FDA estimates the annual paperwork burden for these administrative practices and formal hearings at 9,440 total hours and states the collection reflects an increase of 3,080 annual burden hours. The agency also says there are no capital costs or operating and maintenance costs for this information collection.
External Speaker Requests: 3,900 at 10 Minutes
FDA reports 3,900 external requests for FDA speakers annually, at an average burden of 0.17 hours (10 minutes) each, totaling 663 annual hours for requesters.
No Capital or Ongoing Monetary Costs
The FDA states there are no capital costs or operating and maintenance costs associated with this collection of information.
10.19 Waiver Requests: 1 Response, 1 Hour
FDA includes an estimate for Sec. 10.19 waiver/suspension/modification requests of 1 response annually at 1 hour of burden, noting that the agency has not received such requests but accounts for the possible burden.
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.
2026-20085, Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Improvement Program
The FDA is asking for public feedback by November 2, 2026, on its Voluntary Improvement Program (VIP), which helps medical device makers improve quality through third-party reviews. This program supports better products and safer devices without adding extra costs or deadlines for companies. It’s all about encouraging excellence and teamwork between the FDA, industry, and partners like the Medical Device Innovation Consortium.
Previous / Next Documents
Previous: 2026-13533, Agency Information Collection Activities; Proposed Collection; Comment Request; Biologics License Applications, Procedures and Requirements
The FDA wants your thoughts on how it collects info for biologics license applications—basically, the paperwork needed to approve new biological medicines. This affects companies making these medicines and anyone involved in the approval process. You’ve got until September 4, 2026, to share your comments, so don’t miss out on shaping the rules and possibly saving time and money!
Next: 2026-13535, Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify the NYSE Arca Options Fee Schedule Regarding Fees and Rebates Applicable to Manual Transactions
NYSE Arca is changing how it charges fees and gives rebates for manual options trades. Market Makers will see new fees on non-Penny stocks, and Floor Brokers will get a new rebate when their orders trade with Market Makers on the trading floor. These changes kicked in right away on June 22, 2026, affecting anyone who trades options manually on NYSE Arca.