HHS Acquisition Rules
Federal Register rules, proposed rules, and notices from Department of Health and Human Services (HHS) and its acquisition components — sorted newest first. HHS operating divisions (NIH, CDC, CMS, FDA) buy under one umbrella but with very different evaluation cultures. Watch NIH protest decisions for what evaluation language withstands challenge on R&D contracts.
Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations
Clinical laboratory testing technology has advanced significantly since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations were implemented in 1992. This request for information (RFI) seeks input from the public regarding various topics related to the CLIA regulations, including: breath testing; laboratory processes and procedures; emergency preparedness, biosafety and biosecurity, and cybersecurity; and specialty testing areas. Responses to this RFI may be used to help in
This proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to drugs and biological products paid under Pa
Designated Placement Requirements Under Titles IV-E and IV-B for LGBTQI+ Children; Rescission
This rule finalizes the removal of the requirements issued in the Designated Placement Requirements Under Titles IV-E and IV-B for LGBTQI+ Children final rule that was published on April 30, 2024 (hereafter referred to as the 2024 final rule). The 2024 final rule required title IV-E/IV-B agencies to ensure that a Designated Placement is available for all children who self-identify with an alternative sexual orientation or self-identify as something other than their sex in foster care who request
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and foreign drug establishments. This action, if finalized, will provide a pathway for a distributed manufacturing establishment that manufactures drugs at multiple different physical locations to register as a single drug manufacturing establishment and align drug establishment regist
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2026. The animal drug regulations are also being amended to improve their accuracy and readability.
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