United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2025_register executive 2025-04-23 article Notices D09002ee1d1ff7835 D09002ee1d1ff78b3 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the second year of the voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a refined prototype assessment protocol to evaluate quality management maturity (QMM). The Center of Drug Evaluation and Research (CDER) implemented this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with, and further refine as necessary, the prototype assessment protocol and process, to help enable consistent and meaningful assessment of participating establishments' quality management practices, and to provide useful feedback to participants. This notice announces CDER's intent to continue the voluntary QMM Prototype Assessment Protocol Evaluation Program, outlines the types of establishments CDER is seeking for participation, and describes the process for submitting a request to participate in the program. 90 FR 17069 https://www.govinfo.gov/app/details/FR-2025-04-23/2025-06968 2025-06968 fr23ap25-39 4164-01-P Docket No. FDA-2023-N-5706 https://www.govinfo.gov/app/details/FR-2025-04-23/2025-06968 https://www.govinfo.gov/content/pkg/FR-2025-04-23/html/2025-06968.htm https://www.govinfo.gov/content/pkg/FR-2025-04-23/pdf/2025-06968.pdf 3 p. 17069 17071 90 FR 17069 Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program; Federal Register Vol. 90, Issue NOTICE 2025-06968 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2023-N-5706 4164-01-P 2025-06968 Notice.

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for a limited number of drug manufacturing establishments to participate in the second year of the voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a refined prototype assessment protocol to evaluate quality management maturity (QMM). The Center of Drug Evaluation and Research (CDER) implemented this voluntary program for manufacturers of CDER-regulated drug products to gain additional experience with, and further refine as necessary, the prototype assessment protocol and process, to help enable consistent and meaningful assessment of participating establishments' quality management practices, and to provide useful feedback to participants. This notice announces CDER's intent to continue the voluntary QMM Prototype Assessment Protocol Evaluation Program, outlines the types of establishments CDER is seeking for participation, and describes the process for submitting a request to participate in the program.

CDER intends to accept requests to participate in the voluntary QMM Prototype Assessment Protocol Evaluation Program through June 9, 2025. See the "Participation" section of this document for instructions on submitting a request to participate and the selection process. For questions about the voluntary QMM Prototype Assessment Protocol Evaluation Program: Djamila Harouaka, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4160, Silver Spring, MD 20993- 0002, 240-402-0224, CDER-QMM@fda.hhs.gov. To submit a request to participate in the program: Conchetta Newton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4144, 240-402-6551, CDER-QMM@fda.hhs.gov. Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program, CDER-QMM@fda.hhs.gov https://doi.org/10.1208/s12248-022-00777-z https://www.fda.gov/media/171705/download https://www.federalregister.gov/d/2020-22976 https://www.federalregister.gov/d/2020-22977 Vol. 90, no. 77 Office of the Federal Register, National Archives and Records Administration 2025-04-23 continuing daily deposited born digital 237 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2025-04-23 P0b002ee1d1ff6459 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr23ap25 https://www.govinfo.gov/app/details/FR-2025-04-23 https://www.govinfo.gov/content/pkg/FR-2025-04-23/pdf/FR-2025-04-23.pdf https://www.govinfo.gov/content/pkg/FR-2025-04-23/xml/FR-2025-04-23.xml fdlp 16997 17224 DGPO 2025-04-23 2025-04-23 FR-2025-04-23 machine generated eng FR FR-2025-04-23 90 77