FR: Health and Human Services Department

National Survey of Health Information Exchange Organizations (HIO) - 60-Day Comment Request

HHS ONC is requesting public comment on a revised information collection for the National Survey of Health Information Exchange Organizations (HIO). The survey (OMB No. 0955-0019) collects data on HIO capabilities including technical standards adoption, information blocking perceptions, TEFCA connectivity, public health data exchange, and organizational demographics. This 3-year approval request revises a survey previously approved in 2022 and 2024, removing low-relevance questions and updating wording to align with current policy priorities. Comments are due June 22, 2026.

SAMHSA Proposes PAIMI Program Performance Report Data Collection Under PRA

SAMHSA published a 60-Day Notice in the Federal Register seeking public comment on information collection activities for the Protection and Advocacy for Individuals with Mental Illness (PAIMI) Revised Annual Program Performance Report (PPR). The notice requests comments on whether the proposed data collection is necessary, accurate, and minimally burdensome. The OMB clearance for the current 2024-2025 PPR expires July 31, 2026, and SAMHSA is seeking approval for updates to the reporting requirements.

Importation of Prescription Drugs Comment Request

The FDA has published a notice in the Federal Register announcing an opportunity for public comment on a proposed information collection related to the importation of prescription drugs. Under the Paperwork Reduction Act, the Agency seeks public input on existing information collection requirements. The comment period closes on June 15, 2026.

VICH GL8(R1) Draft Guidance: Stability Testing for Medicated Premixes (Revision 1)

The FDA announced availability of draft guidance for industry GFI #91 (VICH GL8(R1)) on stability testing for medicated premixes for veterinary use. Developed through the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), this revision updates recommendations for stability testing of medicated premixes intended for oral administration following incorporation into animal feed. The draft is open for public comment until June 15, 2026.

Call for Nominations for Center for Indigenous Innovation and Health Tribal Advisory Committee

The HHS Office on Minority Health (OMH) is accepting nominations for primary and alternate delegates to serve on the Center for Indigenous Innovation and Health Tribal Advisory Committee (CIIH TAC). The CIIH TAC provides tribal leaders a forum to exchange views and provide feedback on activities addressing four priority areas: research, education, service, and policy development. Nomination letters must be submitted by May 18, 2026.

Advisory Council on Alzheimer's Research, Care, and Services Meeting

HHS announces a public meeting of the Advisory Council on Alzheimer's Research, Care, and Services scheduled for Monday, April 27, 2026, from 1:00 p.m. to 5:00 p.m. The meeting is open to the public for attendance and comment participation. This is a routine advisory council meeting announcement with no new compliance obligations.

CDC Proposes Data Collection Under Paperwork Reduction Act

CDC proposes a new data collection under the Paperwork Reduction Act and seeks public comments. The notice requests feedback on the proposed data collection, associated burden estimates, and collection methods. Comments are due June 15, 2026.

CDC Proposes Data Collection Under Paperwork Reduction Act

The CDC has published a notice proposing a new data collection under the Paperwork Reduction Act. The notice requests public comments on the proposed collection of information. The comment period closes 61 days from the date of publication.

CDC Agency Forms Undergo Paperwork Reduction Act Review

CDC published a notice announcing that certain agency forms are undergoing the Paperwork Reduction Act review process. The notice identifies forms under review by docket number 30Day-26-1335 and invites public comment on these information collections. Affected parties who submit information to CDC using these forms may wish to monitor the review for any changes to reporting requirements.

SAMHSA Information Collection OMB Review Request

SAMHSA, a division of HHS, has submitted an information collection request to OMB for review under the Paperwork Reduction Act. The notice announces a 30-day public comment period on proposed data collection activities related to substance abuse and mental health services programs. This is a standard administrative action to gather feedback on existing or modified information collection requirements.

HRSA AIDS Drug Assistance Program Data Report Extension Request

The Health Resources and Services Administration (HRSA) is seeking public comment on extending OMB Control No. 0915-0345 for the AIDS Drug Assistance Program (ADAP) Data Report. The comment period closes on May 13, 2026. This is an administrative information collection extension request for an existing data reporting mechanism used to monitor ADAP program activities.

Determination That BILTRICIDE (Praziquantel) 600mg Tablet Was Not Withdrawn From Sale

The FDA has issued a determination that BILTRICIDE (Praziquantel) oral tablet, 600 milligrams, was not withdrawn from sale for reasons of safety or effectiveness. This determination affects pharmaceutical manufacturers, healthcare providers, and patients who rely on this anti-parasitic medication. The notice confirms the drug remains available on the market and was not subject to removal due to regulatory safety concerns.

HRSA Extends Funding to University of Utah for Emergency Medical Services for Children Data Center

The Health Resources and Services Administration (HRSA) has issued a Notice extending funding to the University of Utah for the Emergency Medical Services for Children Data Center (EDC). The document, published in the Federal Register on April 13, 2026, is designated as Notice document number 2026-07035, appearing at citation 91 FR 18867.

Annual Survey of Refugees Information Collection Extension Request

The Administration for Children and Families (ACF) seeks OMB approval to extend the Annual Survey of Refugees (ASR) through 2027, maintaining the existing survey form for the 2025 and 2026 collection cycles. The ASR collects data from approximately 6,400 refugee households that entered the U.S. within the previous 5 fiscal years, supporting the Office of Refugee Resettlement's congressional reporting requirements under the Refugee Act of 1980.

LIHEAP Household Data Collection Report Reinstatement Request

HHS Administration for Children and Families proposes to reinstate the LIHEAP Household Report (OMB #0970-0060) with proposed changes to reduce reporting burden. States, DC, and Puerto Rico would submit household statistics by assistance type and funding source, while tribal grantees would submit simplified household counts. Comments are due June 8, 2026.

Procedures for Requests From Tribal Lead Agencies To Use CCDF Funds for Construction or Major Renovation

The Office of Child Care (OCC) under HHS proposes to extend and modify an existing information collection for Tribal Lead Agencies requesting Child Care and Development Fund (CCDF) funds for child care facility construction or renovation. The updated Program Instruction significantly streamlines requirements, reducing burden by 70% from 20 hours to 6 hours per response, cutting 19 pages and eliminating 5 requirements while maintaining statutory compliance under 42 U.S.C. 9858m(c)(6). Comments are due May 11, 2026.

Administrative Practices and Formal Hearings Information Collection

FDA issued a notice seeking public comment on an information collection request regarding administrative practices and formal hearings. The agency is requesting feedback on how it manages formal hearing procedures and administrative processes. Comments must be submitted by June 8, 2026.

Priority Review Voucher for LOARGYS Rare Pediatric Disease Product

FDA issued a priority review voucher to Aeglea BioTherapeutics for LOARGYS (pegzilarginase-nbln), a rare pediatric disease product designated for arginase deficiency. This voucher grants the holder priority FDA review for a future drug marketing application and is transferable. The document is a routine notice under the Rare Pediatric Disease Priority Review Voucher Program.

Rural Health Care Services Outreach Program Measures

HRSA is seeking public comments on proposed measures for the Rural Health Care Services Outreach Program under OMB No. 0906-0009-Revision. The notice requests input on information collection requirements affecting entities participating in rural health outreach. Comments must be submitted by June 8, 2026.

STRATTERA Not Withdrawn for Safety or Effectiveness

The FDA determined that STRATTERA (atomoxetine hydrochloride) capsules at all dosage strengths (5mg through 100mg) were not withdrawn from sale for reasons of safety or effectiveness. This determination allows generic drug manufacturers to reference this finding in abbreviated new drug applications (ANDAs) without providing separate safety and effectiveness data.

E2B(R3) Data Standards for Postmarketing Safety Reports

FDA issued a notice proposing updated E2B(R3) data standards for electronic submission of postmarketing individual case safety reports to the FDA Adverse Event Monitoring System. The notice introduces new regional data elements and establishes an implementation schedule. Comments are due by October 1, 2026 (180 days from publication).

Reducing Bureaucracy and Burden for Children, Youth, and Family Programs

The Administration for Children and Families (ACF) within HHS has published a proposed rule to reduce bureaucratic burden and administrative requirements for programs serving children, youth, and families. The rule aims to streamline regulations affecting child welfare, foster care, youth development, and family support programs. Public comments are being accepted through May 6, 2026.

ACIP Charter Renewal Notice

The CDC renewed the Advisory Committee on Immunization Practices (ACIP) charter through April 2028. This routine administrative notice confirms the committee's continued operation under its federal advisory committee mandate. No new policy requirements or compliance obligations are established.

Hazardous Waste Worker Training OMB Comment Request 42 CFR Part 65

NIH/NIEHS published a corrected notice reopening the 30-day public comment period for an information collection request regarding hazardous waste worker training under 42 CFR Part 65. The original notice was published on March 18, 2026. This correction notice extends the comment period for stakeholders to provide feedback on the proposed training requirements for workers handling hazardous waste.

Notice of Public Data Asset Release Under OPEN Government Data Act

The Centers for Medicare & Medicaid Services (CMS) published a Federal Register notice announcing the release of public data assets under the OPEN Government Data Act. This notice informs the public that CMS has made certain data assets available in compliance with federal open data requirements. The action applies to healthcare providers, researchers, and other stakeholders who utilize CMS public data.

TANF Work Participation Rate Calculation Changes

The HHS Children and Families Administration (ACF) has published a proposed rule to recalibrate the TANF work participation rate calculation, specifically modifying the caseload reduction credit methodology and prohibiting small checks in the calculation. The proposed changes would affect how states demonstrate compliance with federal work participation requirements under the Temporary Assistance for Needy Families program. Comments on the proposed rule are due by May 6, 2026.

HHS Reorganization Removing Office of Chief Information Officer

The Department of Health and Human Services published a notice announcing the reorganization of its administrative structure, specifically removing the Office of Chief Information Officer from the organizational chart. The change is effective upon publication date. This is an internal administrative restructuring that affects the agency's chain of command and information technology governance.

Priority Review Voucher Issuance for YUVIWEL Rare Pediatric Disease Product

The FDA announced the issuance of a priority review voucher to Ascendis Pharma Growth Disorders (A/S) for YUVIWEL (navepegritide), approved February 27, 2026. The drug is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This notice fulfills FDA's statutory requirement to publish awards of priority review vouchers under section 529 of the FD&C Act.

Determination That INAPSINE Droperidol Injection Was Not Withdrawn From Sale for Safety

The FDA determined that INAPSINE (droperidol) injection, 2.5 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to continue approving ANDAs (abbreviated new drug applications) that refer to this product, which is currently listed in the Orange Book's Discontinued Drug Product List. The drug was originally approved under NDA 016796 held by Akorn, Inc.

Petition to Remove Three Solvents from Color Additive Regulations

The FDA announced receipt of a color additive petition from the International Association of Color Manufacturers (IACM) requesting removal of three solvents from 21 CFR Part 73. The petition targets methylene chloride, trichloroethylene, and ethylene dichloride, citing permanent abandonment of these uses in color additive preparation. The FDA is seeking public comments through June 1, 2026.

Acceptable Market Name Change for Certain Rockfish Species

The FDA issued a notice requesting data and information to support an evidence-based determination on potential updates to the acceptable market name for 18 Sebastes rockfish species. This consultation invites stakeholders to submit comments and supporting data on the proposed market name change by May 1, 2026.

ONC Health IT Organization and Authority Structure Updates

HHS published a Federal Register Notice on April 1, 2026, reorganizing ONC (Office of the National Coordinator for Health Information Technology) by reversing the management title of Assistant Secretary for Technology Policy and restoring ONC as a singularly titled office. The roles of the HHS Chief Technology Officer, Chief AI Officer, and Chief Data Officer will no longer be part of ONC, and the organizational structure is consolidated into three offices.

National Blood Collection and Utilization Survey Information Collection

The CDC published a Federal Register notice extending the public comment period for the proposed National Blood Collection and Utilization Survey (NBCUS). The survey is a biennial data collection effort designed to produce national and regional estimates of blood collections, utilization, and safety. Comments on the proposed information collection are due 30 days from the April 1, 2026 publication date.

FDA Decision Denying Hearing Request on TRADIPITANT Approval Refusal

The FDA issued a decision denying Vanda Pharmaceuticals' request for a hearing regarding CDER's proposal to refuse approval of NDA 218489 for TRADIPITANT capsules (85 mg) for the treatment of gastroparesis symptoms. The decision upholds the complete response letter issued September 18, 2024, and the Notice of Opportunity for Hearing published January 16, 2025 (90 FR 4748).

Digital Health Technologies in Clinical Investigations - Request for Comments

FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have issued a Request for Information on the use of Digital Health Technologies (DHTs) in clinical investigations for drugs and biological products. The agency seeks stakeholder input on opportunities, challenges, and best practices before potential future regulatory activities. Comments are due June 1, 2026.

Information Collection Request Comment Notice

CMS published a Federal Register notice announcing a 60-day public comment period on a proposed information collection (CMS-10752) under the Paperwork Reduction Act. The collection relates to Medicare and Medicaid program information gathering. Comments must be received by June 1, 2026.

National Institute on Minority Health and Health Disparities; Notice of Partially Closed Meeting

The Department of Health and Human Services, through the National Institutes of Health, has issued a notice regarding a partially closed meeting of the National Institute on Minority Health and Health Disparities. The meeting is scheduled for May 19, 2026.

Center for Scientific Review; Notice of Closed Meetings

The National Institutes of Health, through the Center for Scientific Review, has issued a notice announcing upcoming closed meetings. These meetings are part of the review process for grant applications and are scheduled to occur on April 22, 2026.

Proposed TANF Pilot Evaluation Information Collection Activity

The Department of Health and Human Services (HHS) is proposing to collect data for a new Temporary Assistance for Needy Families (TANF) Pilot Evaluation. This initiative, authorized by the Fiscal Responsibility Act of 2023, aims to test new outcomes-based performance benchmarks in the TANF program. Public comments are being solicited on the proposed data collection instruments.

Proposed 30-Day Comment Request: Clinical Trials Reporting Program Database

The National Institutes of Health (NIH) is seeking public comment on a proposed extension for the Clinical Trials Reporting Program (CTRP) Database. This notice provides an additional 30-day comment period for the data collection project, which aims to consolidate reporting for NCI-supported clinical research.

TANF and MOE Annual Report Submission for OMB Review

The Administration for Children and Families (ACF) is requesting a 3-year extension for the Annual TANF and MOE Report (OMB #0970-0248). While no substantive changes are made to the form itself, the instructions have been updated, and burden estimates adjusted. This action supports GAO recommendations for enhanced oversight of TANF funds.

Agency Information Collection Activities: Submission for OMB Review; Comment Request

The Centers for Medicare & Medicaid Services (CMS) has submitted an agency information collection activity for review by the Office of Management and Budget (OMB). This notice requests public comment on the proposed collection.

HHS Adopts Standards for Health Care Claims Attachments and Electronic Signatures

The Department of Health and Human Services (HHS) has finalized standards for health care claims attachments transactions and electronic signatures. This rule aims to streamline administrative processes within the healthcare industry by adopting new standards for these transactions.

Center for Scientific Review Notice of Closed Meetings

The National Institutes of Health, through the Center for Scientific Review, has published a notice announcing upcoming closed meetings. These meetings are scheduled for April 16, 2026, and involve discussions that are not open to the public.

Center for Scientific Review Closed Meetings Notice

The National Institutes of Health published a notice regarding upcoming closed meetings for the Center for Scientific Review. These meetings are scheduled for April 15, 2026, and will involve discussions that are exempt from public disclosure under specific provisions of the Government in the Sunshine Act.

Health Workforce Connector Public Comment Request

The Health Resources and Services Administration has submitted a revision to the Health Workforce Connector information collection activity to the Office of Management and Budget (OMB) for review and approval. The public has 32 days to submit comments on this submission.

Center for Scientific Review Notice of Closed Meetings

The National Institutes of Health's Center for Scientific Review has announced upcoming closed meetings. These meetings are scheduled to occur on April 14, 2026. The purpose of these meetings is related to the review of grant applications.

NIH Director's Office Meeting Notice

The National Institutes of Health (NIH) has published a notice announcing an upcoming meeting of the Office of the Director. The notice provides details regarding the meeting, which is scheduled for April 13, 2026. This is an informational announcement regarding a government meeting.