HHS Seeks Feedback on Proposed Information Collection Rules
Published Date: 12/8/2025
Notice
Summary
The Department of Health and Human Services wants your thoughts on updated forms about research misconduct rules. If you work at or with research institutions, these changes affect how you report issues. You’ve got until January 7, 2026, to share your feedback—no cost, just your voice to help improve the process!
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Annual Research Misconduct Report
If your institution conducts Public Health Service (PHS)-supported research, you must submit the Annual Report on Possible Research Misconduct (form PHS-6349) once per year. The notice estimates 6,619 institutions will respond, each response takes about 10 minutes, and the total annual burden for this form is 1,103 hours.
New Universal Assurance Form
The Office of Research Integrity is discontinuing form PHS-6315 and replacing it with a new Research Integrity Assurance Establishment form (PHS-7091) that lets all institutions subject to 42 CFR part 93 establish an assurance with ORI regardless of sub-awardee status. PHS-7091 is to be submitted once when seeking an ORI assurance for the first time, and may also be submitted on a case-by-case basis at the conclusion of institutional research misconduct proceedings.
New Institutional Record Transmittal Form
ORI created a new Institutional Record Transmittal form (PHS-7092) to capture different types of information collected during institutional research misconduct proceedings. The notice estimates 230 institutions will use this form, with each response taking about 10 minutes and a total annual burden of 38 hours.
Updated Small Institution Statement
ORI will continue to use a Small Institution Statement as an addendum to forms PHS-6349 and PHS-7091 to assist small institutions, and that statement has been updated to reflect new regulatory language in the 2024 Final Rule (42 CFR part 93).
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
2026-16414, Adoption and Foster Care Analysis and Reporting System
This document withdraws a proposed rule that was published in the Federal Register on January 11, 2008. The proposed rule would have amended the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations at 45 CFR 1355.40 and the appendices to Part 1355 to modify the requirements for States to collect and report data to ACF on children in out-of-home care and in subsidized adoption or guardianship arrangements with the State. This document also withdraws the provision of the 2008 proposed rule that implemented the AFCARS penalty requirements of the Adoption Promotion Act of 2003 (Pub. L. 108-145).
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).
2026-14709, Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program; Correction
This correction fixes some typos and technical mistakes in the 2027 health insurance rules under the Affordable Care Act. It mainly affects people and organizations involved in health coverage plans by clarifying when the rules take effect and restoring some important regulation details. These fixes take effect on July 20, 2026, ensuring smoother and clearer health plan operations next year.
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.
2026-12069, Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflicts of Interest, and Related Provisions
This new rule makes sure the groups that check Medicare providers play fair and follow clear rules to avoid conflicts of interest. It updates how psychiatric hospitals are reviewed and tightens rules for providers who lost their Medicare status but want back in. These changes affect Medicare providers and accrediting groups, start June 16, 2027, and aim to keep care safe and trustworthy.
Previous / Next Documents
Previous: 2025-22152, Virginia-Waters of the Northern Neck Peninsula Vessel Sewage No-Discharge Zone; Tentative Affirmative Determination
Virginia wants to keep the waters around the Northern Neck Peninsula super clean by banning all boat sewage dumping in Richmond, Lancaster, Northumberland, and Westmoreland counties. They’ve asked the EPA to approve this no-dump zone because there are enough places for boats to safely get rid of their sewage. If approved, boaters will have to use these facilities starting soon, helping protect local waters without extra costs.
Next: 2025-22156, Light-Walled Rectangular Pipe and Tube From China, Mexico, South Korea, and Turkey; Notice of Commission Determination To Conduct Full Five-Year Reviews
The U.S. International Trade Commission is launching full five-year reviews to decide if special taxes on light-walled rectangular pipe and tube from China, Mexico, South Korea, and Turkey should stay or go. This affects companies importing these pipes and tubes, with a schedule coming soon that could impact prices and trade rules. The reviews started on November 24, 2025, so keep an eye out for updates!