Source: https://www.federalregister.gov/documents/2017/01/11/2017-00411/current-good-manufacturing-practice-requirements-for-combination-products-guidance-for-industry-and
Timestamp: 2017-08-19 17:23:42
Document Index: 287974059

Matched Legal Cases: ['art 4', 'art 4', 'art 4', 'arts 211', 'art 211', 'art 820', 'arts 606', 'art 610', 'art 680', 'art 1271']

Federal Register :: Current Good Manufacturing Practice Requirements for Combination Products; Guidance for Industry and Food and Drug Administration Staff; Availability
Submit either electronic or written comments on this guidance at any time.
82 FR 3336
3336-3338 (3 pages)
Docket No. FDA-2015-D-0198
2017-00411
FDA-2015-D-0198
https://www.federalregister.gov/d/2017-00411 https://www.federalregister.gov/d/2017-00411
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry and FDA staff entitled “Current Good Manufacturing Practice Requirements for Combination Products.” The guidance describes and explains the document on current good manufacturing practice (CGMP) requirements for combination products, which published in the Federal Register of January 22, 2013, and includes general considerations for CGMP compliance as well as analysis of hypothetical scenarios.
Start Printed Page 3337
Instructions: All submissions received must include the Docket No. FDA-2015-D-0198 for “Current Good Manufacturing Practice Requirements for Combination Products; Final Guidance for Industry and FDA Staff.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Submit written requests for single copies of the guidance document entitled “Current Good Manufacturing Practice Requirements for Combination Products” to the Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.
Melissa Burns or John Barlow Weiner, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002, 301-796-8930.
FDA is announcing the availability of a guidance for industry and FDA staff entitled “Current Good Manufacturing Practice Requirements for Combination Products.” The guidance provides background on combination products, including an overview of the document on CGMP requirements for combination products, which published in the Federal Register of January 22, 2013 (78 FR 4307), and the role of the lead center and other Agency components with respect to combination product CGMP issues. The guidance addresses general considerations for CGMP requirements for combination products and the purpose and content of specific CGMP provisions addressed in part 4 (21 CFR part 4). The guidance also contains hypothetical scenarios intended to clarify how to comply with certain CGMP requirements addressed in part 4 by presenting compliance considerations for specific types of combination products.
FDA carefully considered the comments received on the draft guidance, and, where possible, has incorporated into the final guidance additional detailed discussion of how the requirements apply and acceptable CGMP compliance approaches. FDA encourages combination product manufacturers to contact the lead Center for their combination product and/or the Office of Combination Products if they have questions on CGMP compliance or approaches they are considering for meeting CGMP requirements.
Persons with access to the Internet may obtain the document at http://www.fda.gov/​downloads/​RegulatoryInformation/​Guidances/​UCM429304.pdf.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). We note that the information collected under the underlying CGMP regulations for drugs, devices, and biological products, including current good tissue practices for human cells, tissues, and cellular and tissue-based products, found at parts 211, 820, 600 through 680, and 1271 (21 CFR parts Start Printed Page 3338211, 820, 600 through 680, and 1271), have already been approved and are in effect. The provisions of part 211 are approved under OMB control number 0910-0139. The provisions of part 820 are approved under OMB control number 0910-0073. The provisions of parts 606 and 640 are approved under OMB control number 0910-0116. The provisions of part 610 are approved under OMB control numbers 0910-0116 and 0910-0338 (also for part 680). The provisions of part 1271, subparts C and D, are approved under OMB control number 0910-0543.
[FR Doc. 2017-00411 Filed 1-10-17; 8:45 am]