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).
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
2026-11530 — Employment and Training Services for Noncustodial Parents in the Child Support Program; Rescission
The government plans to cancel a recent rule that let child support agencies offer job training to noncustodial parents using federal funds. This change affects agencies and parents involved in the child support program and could shift how support services are funded and delivered. Comments on this proposal are open until August 10, 2026, so folks have time to weigh in before it’s final.
2026-11140 — Federal Independent Dispute Resolution Operations
Starting soon, health plans and insurers must share clearer info when they pay or deny surprise medical bills. They’ll use special codes to explain these decisions, especially when dealing with folks they don’t have contracts with. This helps patients and providers understand bills better and speeds up fixing disputes, with no extra costs for most people.
2026-10890 — Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model
Starting July 1, 2026, Medicare is updating the Increasing Organ Transplant Access (IOTA) Model to help kidney transplant hospitals do even better at getting more people transplanted and improving care quality. These changes affect hospitals involved in kidney transplants and aim to make the process smoother and more effective, with new payment rules that reward success. This update is part of a 6-year plan running through 2031 to save more lives and boost patient experience.
2026-10292 — Medicaid Program; Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments
This proposed rule changes how states can pay Medicaid managed care plans and certain doctors to make sure payments are fair, efficient, and encourage enough providers to offer quality care. It affects states, Medicaid managed care organizations, and targeted Medicaid practitioners, aiming to keep payments balanced and services available. Comments on these changes are open until July 21, 2026, so stakeholders have time to weigh in before it’s finalized.
2026-10050 — Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program
Starting in 2027, health insurance plans on federal and state marketplaces will see new rules to make coverage fairer and easier to use. These changes affect insurance companies, agents, and people buying plans, including new fees, penalties, and better protections for those with hardships. Expect updates on plan quality, dental coverage limits, and longer-term catastrophic plans, all aiming to keep your health coverage solid and affordable.
2026-09383 — Restoring Flexibility To Support Head Start Program Access
The government wants to give Head Start programs more freedom by removing some strict rules about staff wages and benefits. This change aims to save over $2 billion and help programs serve more kids better. If you want to share your thoughts, make sure to comment by June 11, 2026!
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!