Source: https://www.federalregister.gov/documents/2007/07/23/E7-14149/agency-information-collection-activities-proposed-collection-comment-request-draft-guidance-for
Timestamp: 2017-09-21 22:17:02
Document Index: 594228863

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Federal Register :: Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
Submit written or electronic comments on the collection of information by September 21, 2007.
40157-40159 (3 pages)
Docket No. 1999D-2013 (formerly Docket No. 99D-2013)
https://www.federalregister.gov/d/E7-14149 https://www.federalregister.gov/d/E7-14149
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed collection of information concerning cooperative manufacturing arrangements for licensed biologics.
Submit electronic comments on the collection of information to: http://www.fda.gov/​dockets/​ecomments. Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Start Printed Page 40158Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.
Submit written requests for single copies of the draft guidance dated January 2007 to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The draft guidance may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. Persons with access to the Internet may obtain the draft guidance at either http://www.fda.gov/​cber/​guidelines.htm or http://www.fda.gov/​ohrms/​dockets/​default.htm.
For shared manufacturing arrangements, each manufacturer must submit a separate biologics license application describing the manufacturing facilities and operations applicable to the preparation of that manufacturer's biological substance or product (§ 601.2(a)) (21 CFR 601.2(a)). In this draft guidance, we expect the manufacturer that prepares (or is responsible for the preparation of) the product in final form for commercial distribution to assume primary responsibility for providing data demonstrating the safety, purity, and potency of the final product. We also expect the licensed finished product manufacturer to be primarily Start Printed Page 40159responsible for any postapproval obligations, such as postmarketing clinical trials, additional product stability studies, complaint handling, recalls, postmarket reporting of the dissemination of advertising and promotional labeling materials as required under § 601.12(f)(4) and adverse experience reporting. We recommend that the final product manufacturer establish a procedure with the other participating manufacturer(s) to obtain information in these areas.
This draft guidance also refers to previously approved collections of information found in FDA regulations at parts 201, 207, 211, 600, 601, 606, 607, 610, 660, 803, and 807 (21 CFR parts 201, 207, 211, 600, 601, 606, 607, 610, 660, 803, and 807). The collections of information in §§ 606.121, 606.122, and 610.40 have been approved under OMB Control No. 0910-0116; § 610.2 has been approved under OMB Control No. 0910-0206; §§ 600.12(e) and 600.80 have been approved under OMB Control No. 0910-0308; §§ 601.2(a), 601.12, 610.60, 610.61, 610.62, 610.67, 660.2(c), 660.28(a) and (b), 660.35(a), (c) through (g), and (i) through (m), 660.45, and 660.55(a) and (b) have been approved under OMB Control No. 0910-0338; §§ 803.20, 803.50, and 803.53 have been approved under OMB Control No. 0910-0437; and §§ 600.14 and 606.171 have been approved under OMB Control No. 0910-0458. The current good manufacturing practice regulations for finished pharmaceuticals (part 211) have been approved under OMB Control No. 0910-0139; the establishment registration regulations (parts 207, 607, and 807) have been approved under OMB Control Nos. 0910-0045, 0910-0052, and 0910-0387; and the labeling regulations (part 201) have been approved under OMB Control Nos. 0910-0340 and 0910-0370.
[FR Doc. E7-14149 Filed 7-20-07; 8:45 am]