HHS regulations

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

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FDA publishes draft guidance (VICH GL8(R1)) for stability testing of medicated premixes intended for animal feed incorporation, developed through international harmonization standards.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

FDA draft guidance recommends next-generation sequencing methods for nonclinical safety assessment of investigational human genome editing products in gene therapy.

Center for Scientific Review holds closed meetings to review and evaluate grant applications and research proposals across multiple federal funding agencies.

HHS Office of Minority Health is accepting nominations for Tribal Advisory Committee delegates to advise on indigenous health innovation priorities and tribal consultation activities.

The Advisory Council on Alzheimer's Research, Care, and Services convenes for its second 2026 meeting to discuss federal agency updates, long-term care advancements, and faith-based partnership models for dementia support services.

HHS Administration for Children and Families will hold a Tribal Consultation meeting with tribal Head Start and Early Head Start program leaders to discuss funding allocations and service delivery improvements for American Indian and Alaska Native c…

FDA holds public meeting on expanding nonprescription drug access and requests stakeholder comments; no specific deadline or financial impact stated for small businesses.

FDA seeks public comments on financial transparency and efficiency of prescription drug, biosimilar, and generic drug user fee programs at a public meeting.

Center for Scientific Review will hold closed meetings to review and discuss grant applications and related matters; specific meeting dates and locations available upon request to the agency.

CDC seeks public comment on a proposed tuberculosis follow-up worksheet for newly arrived persons and U.S. status adjusters through the Paperwork Reduction Act process to improve national TB prevention programs.

Medicare and Medicaid insurers, including small group market QHP issuers on federally-facilitated exchanges, must implement electronic prior authorization for drugs and adopt HL7 FHIR standards for interoperability and data exchange to reduce patien…

Federal agency forms are undergoing Paperwork Reduction Act review to assess and potentially reduce information collection burdens on small businesses and other respondents.