Recent Department of Health and Human Services regulations affecting small businesses
Page 3 of 14 • Last updated April 30, 2026
197 Department of Health and Human Services regulations have been published in the past 30 days, covering rule changes, notices, and final actions affecting small businesses.
- Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory StudiesApril 30, 2026
FDA seeks 60 days of public comment on information collection requirements for Good Laboratory Practice standards in nonclinical laboratory studies.
- Medical Devices; Radiology Devices; Classification of the Radiation Therapy Marking DeviceApril 30, 2026
The FDA classifies radiation therapy marking devices as class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
- Agency Information Collection Activities: Proposed Collection; Comment RequestApril 30, 2026
CMS seeks public comment for 60 days on proposed information collection activities under the Paperwork Reduction Act, inviting feedback on burden estimates and collection methodology.
- Advisory Committee; Pharmacy Compounding Advisory Committee; RenewalApril 30, 2026
FDA renews the Pharmacy Compounding Advisory Committee for an additional two years, extending its charter through April 25, 2028.
- Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement SystemApril 30, 2026
FDA classifies brain temperature measurement systems as Class II medical devices with special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.
- Medical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval CatheterApril 30, 2026
FDA classifies the laser-powered inferior vena cava filter retrieval catheter as a Class II medical device, requiring special controls to ensure safety and effectiveness for cardiovascular applications.
- Determination FENOGLIDE (Fenofibrate) Tablets, 40 Milligrams and 120 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or EffectivenessApril 30, 2026
The FDA determined that FENOGLIDE (fenofibrate) tablets at 40 mg and 120 mg strengths were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions.
- Determination That OZEMPIC (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or EffectivenessApril 30, 2026
FDA determines that OZEMPIC semaglutide 2mg/1.5mL solution was not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions.
- Submission for OMB Review; 30-Day Comment Request Application and Impact of Clinical Research Training on Healthcare Professionals in Academia and Clinical Research (Office of the Director)April 30, 2026
National Institutes of Health submits application to OMB for approval of information collection on clinical research training impact; 30-day public comment period open.
- ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a HearingApril 30, 2026
The FDA proposes to withdraw approval of ChemoCentryx's TAVNEOS (avacopan) capsule based on lack of substantial evidence of effectiveness and untrue material statements in the application, with opportunity for hearing.
- Proposed Collection; 60-Day Comment Request; NIH Office of Intramural Training & Education-Application, Registration, and Alumni Systems Office of the DirectorApril 30, 2026
NIH Office of Intramural Training & Education seeks public comment on proposed data collection for application, registration, and alumni systems; comment period closes 60 days from publication.
- Center for Scientific Review; Notice of Closed MeetingsApril 30, 2026
Center for Scientific Review will hold closed meetings to review grant applications and personnel matters on specified dates in accordance with federal sunshine laws.
- Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Ryan White HIV/AIDS Program: Expenditures Reports, OMB No. 0915-0390-RevisionApril 29, 2026
HRSA's Ryan White HIV/AIDS Program expenditure reports collection (OMB No. 0915-0390) is under OMB review with a 30-day public comment period before approval.
- Submission for Office of Management and Budget Review; Next Generation of Enhanced Employment Strategies ProjectApril 29, 2026
Administration for Children and Families seeks one-year extension for NextGen Project's second follow-up survey data collection; OMB approval number 0970-0545 expires April 30, 2026.
- Statement of Delegation of AuthorityApril 29, 2026 • Impact: none
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