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 2024_register executive 2024-01-25 article Notices D09002ee1c7938e6d D09002ee1c7938f4e 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 or Agency) is announcing an opportunity for a limited number of establishments to participate in a voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a prototype assessment protocol to evaluate quality management maturity (QMM). The Center for Drug Evaluation and Research (CDER) is implementing this voluntary program for manufacturers of CDER-regulated drug products to gain experience with the prototype assessment protocol and to evaluate whether use of the protocol, as designed, will enable a meaningful assessment of the establishment's quality management practices while providing useful feedback for the establishment. This notice outlines the types of establishments FDA is seeking for participation and the process for submitting a request to participate in the program. 89 FR 4950 https://www.govinfo.gov/app/details/FR-2024-01-25/2024-01423 2024-01423 fr25ja24-78 4164-01-P Docket No. FDA-2023-N-5706 https://www.govinfo.gov/app/details/FR-2024-01-25/2024-01423 https://www.govinfo.gov/content/pkg/FR-2024-01-25/html/2024-01423.htm https://www.govinfo.gov/content/pkg/FR-2024-01-25/pdf/2024-01423.pdf 3 p. 4950 4952 89 FR 4950 Voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program; Federal Register Vol. 89, Issue NOTICE 2024-01423 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2023-N-5706 4164-01-P 2024-01423 Notice.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for a limited number of establishments to participate in a voluntary Quality Management Maturity Prototype Assessment Protocol Evaluation Program involving the use of a prototype assessment protocol to evaluate quality management maturity (QMM). The Center for Drug Evaluation and Research (CDER) is implementing this voluntary program for manufacturers of CDER-regulated drug products to gain experience with the prototype assessment protocol and to evaluate whether use of the protocol, as designed, will enable a meaningful assessment of the establishment's quality management practices while providing useful feedback for the establishment. This notice outlines the types of establishments FDA is seeking for participation and the process for submitting a request to participate in the program.

FDA intends to accept requests to participate in the voluntary QMM Prototype Assessment Protocol Evaluation Program through March 25, 2024. 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. 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?attachment https://www.federalregister.gov/d/2020-22976 https://www.federalregister.gov/d/2020-22977 https://www.regulations.gov Vol. 89, no. 17 Office of the Federal Register, National Archives and Records Administration 2024-01-25 continuing daily deposited born digital 299 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2024-01-25 P0b002ee1c438eadd 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr25ja24 https://www.govinfo.gov/app/details/FR-2024-01-25 https://www.govinfo.gov/content/pkg/FR-2024-01-25/pdf/FR-2024-01-25.pdf https://www.govinfo.gov/content/pkg/FR-2024-01-25/xml/FR-2024-01-25.xml fdlp 4799 5086 DGPO 2024-01-25 2024-05-28 FR-2024-01-25 machine generated eng FR FR-2024-01-25 89 17