Health Science Administrator

0910-AI94 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments

The proposed rulemaking will revise the registration regulations at 21 CFR 207 to: (1) Clarify that the drug establishment registration and drug listing requirements are applicable to foreign drug manufacturing establishments that do not directly import or offer for import drugs into the United States, but are still involved in the manufacture of drugs that are imported or offered for import into the United States following the passage of section 2511 of the PREVENT Pandemics Act; and (2) establish drug establishment registration requirements specific to establishments engaging in distributed manufacturing.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No Deregulatory 21 CFR 207 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360b 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 379 21 U.S.C. 381 21 U.S.C. 393 42 U.S.C. 262 42 U.S.C. 264 42 U.S.C. 271 Statutory NPRM 12/29/2024 Section 2511 Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act). No NPRM 02/00/2026 Undetermined None No No Yes Ashley Boam Health Science Administrator 0910 Food and Drug Administration FDA 301 796-6341 ashley.boam@fda.hhs.gov Center for Drug Evaluation and Research, Building 51, Room 4192, 10903 New Hampshire Avenue, Silver Spring MD 20993