Recent Department of Health and Human Services regulations affecting small businesses

Rural Communities Opioid Response Program-Behavioral Health Care Technical Assistance extends JBS International's one-year cooperative agreement from September 1, 2026, through August 31, 2027, to strengthen rural behavioral health and substance use…

The Agency for Healthcare Research and Quality invites nominations of qualified individuals to serve on the U.S. Preventive Services Task Force.

Center for Scientific Review will hold an amended meeting of the National Institutes of Health peer review committee on the specified date to address grant application assessments and related administrative matters.

National Heart, Lung, and Blood Institute open meeting notice provides information about scheduled public sessions for institute business and stakeholder input.

FDA adds constituents to the established list of harmful and potentially harmful substances in tobacco products and tobacco smoke under the Federal Food, Drug, and Cosmetic Act.

The FDA amends its Commissioner's National Priority Voucher Pilot Program public hearing notice to reflect changes in meeting dates, addresses, and contact information; original hearing was announced March 23, 2026.

FDA classifies digital therapy devices for amblyopia as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burdens for this ophthalmic category.

NIAID offers licensing of government-owned inventions from federally funded research to support commercialization by small businesses and companies.

FDA classifies Alzheimer's disease pathology assessment tests as Class II medical devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.

Centers for Medicare & Medicaid Services solicits public comment on proposed information collection activities under the Paperwork Reduction Act through the Federal Register.

HRSA's Information Collection Request for Health Center Program forms (OMB No. 0915-0285) is open for public comment for 30 days before OMB review and approval.

FDA classifies mandibular-movement-based sleep apnea testing devices as Class II medical devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden.

NIAID-owned government inventions are available for licensing to commercialize federally funded research and development, with foreign patent applications filed on selected inventions to extend market coverage.

CMS is seeking public comment on proposed information collection activities under the Paperwork Reduction Act; the 60-day comment period allows input on burden estimates and collection methodology.

FDA classifies the setmelanotide eligibility gene variant detection system as class II medical device with special controls to ensure safety and effectiveness for clinical chemistry and toxicology applications.