Recent Department of Health and Human Services regulations affecting small businesses

Federal agencies request public comment on proposed information collection activities that affect small businesses; submit feedback by the specified deadline to reduce regulatory burden.

Center for Scientific Review will hold closed meetings to review and discuss National Institutes of Health grant applications and proposals.

FDA determines REVIA (naltrexone hydrochloride) 50mg tablets were not withdrawn for safety or effectiveness reasons, allowing continued approval of generic versions meeting regulatory standards.

Centers for Medicare and Medicaid Services seeks public comment on generic information collections for Medicaid and CHIP state plan amendments, waivers, demonstrations, and reporting under expedited Paperwork Reduction Act clearance.

The FDA seeks public comment on information collection requirements for orphan drugs; the 60-day comment period begins with this Federal Register notice.

FDA determines the regulatory review period for UNLOXCYT patent extension eligibility under patent term extension law for human biological products.

FDA determines CHEWTADZY (tadalafil) chewable tablets were not withdrawn for safety or effectiveness reasons, enabling generic ANDA approvals for 5mg, 10mg, and 20mg formulations.

FDA requests 60-day public comment period on information collection requirements for its prescription drug importation regulation under the Paperwork Reduction Act.

FDA publishes draft guidance (VICH GL8(R1)) for stability testing of medicated premixes intended for animal feed incorporation, developed through international harmonization standards.

CMS is accepting public comments on proposed information collection activities subject to Paperwork Reduction Act requirements; submit feedback on burden estimates and collection necessity by the specified deadline.

This correction addresses a typographical error in the April 14, 2026 Federal Register notice regarding Medicare hospital inpatient and long-term care payment systems and quality program requirements for fiscal year 2027.

FDA approves MNEXSPIKE (COVID-19 Vaccine, mRNA) as a rare pediatric disease product eligible for priority review voucher redemption as of May 30, 2025.

FDA approves MRESVIA respiratory syncytial virus vaccine under a rare pediatric disease priority review voucher program on June 12, 2025.

FDA approves MRESVIA (Respiratory Syncytial Virus Vaccine) on May 31, 2024, redeeming a material threat medical countermeasure priority review voucher under the FD&C Act.

FDA approved AREXVY respiratory syncytial virus vaccine under the rare pediatric disease priority review voucher program on June 7, 2024, enabling the sponsor to redeem a voucher for expedited review of a future application.