Health and Human Services Department, Food and Drug Administration
In accordance with the memorandum of January 20, 2025, from the President, entitled "Regulatory Freeze Pending Review," the effective date of the final rule, entitled "Nonprescription Drug Product With an Additional Condition for Nonprescription Use," (ACNU) was delayed until March 21, 2025. Additional time is needed for review; therefore, the delay is extended for an additional 60 days.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Parts 201 and 314 [Docket No. FDA-2021-N-0862] RIN 0910-AH62 ( printed page 13553) AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; delay of effective date. SUMMARY: In accordance with the memorandum of January 20, 2025, from the President, entitled “Regulatory Freeze Pending Review,” the effective date of the final rule, entitled “Nonprescription Drug Product With an Additional Condition for Nonprescription Use,” (ACNU) was delayed until March 21, 2025. Additional time is needed for review; therefore, the delay is extended for an additional 60 days. DATES: As of March 21, 2025, the effective date for the final rule published December 26, 2024, ( 89 FR 105288 ), is further delayed to a new effective date of May 27, 2025. FOR FURTHER INFORMATION CONTACT: Myla Dellupac, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Silver Spring, MD 20993-0002, 301-837-7461. SUPPLEMENTARY INFORMATION: I. Electronic Access and Filing A copy of the notice of proposed rulemaking ( 87 FR 38313 , June 28, 2022), all comments received, the final rule ( 89 FR 105288 , December 26, 2024), and all background material may be viewed online at http://www.regulations.gov using the docket number listed above. A copy of this document will be placed in the docket. Electronic retrieval help and guidelines are available on the website. It i…
Other Federal Register documents from the same docket.
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Extension of Comment Period
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
Citation: 90 FR 13553
