Recent Department of Health and Human Services regulations affecting small businesses

The FDA issues a final 10-year debarment order against Kimberly Schaff Kiehl, prohibiting her from importing or offering for import any drug into the United States based on felony convictions related to drug importation.

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.

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

CMS seeks public comment on generic Medicaid and CHIP information collection activities under expedited Paperwork Reduction Act review, with submissions accepted during the notice period.

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

CMS seeks public comment on Medicaid and CHIP information collection activities under the Paperwork Reduction Act generic clearance process (OMB control number 0938-1148) covering state plan amendments, waivers, demonstrations, and reporting.

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.

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.

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

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.

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.

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.

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.

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.

Office of Management and Budget solicits public comment on proposed federal information collection activities affecting small businesses; comment deadline is 60 days from publication.