Source: https://www.federalregister.gov/documents/2014/07/07/2014-15810/agency-information-collection-activities-proposed-collection-comment-request-guidance-for-industry
Timestamp: 2017-10-17 19:25:28
Document Index: 487359638

Matched Legal Cases: ['§\u2009601', '§\u2009601', '§\u2009601', 'arts 201', 'arts 201', '§\u2009606', '§\u2009610', '§\u2009600', '§\u2009601', '§\u2009803', '§\u2009600', 'art 211', '§\u2009820', 'arts 207', 'arts 201']

Submit either electronic or written comments on the collection of information by September 5, 2014.
79 FR 38318
2014-15810
https://www.federalregister.gov/d/2014-15810 https://www.federalregister.gov/d/2014-15810
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed extension of the collection of information concerning cooperative manufacturing arrangements for licensed biologics.
For contract manufacturing arrangements, we recommend that the contract manufacturer should share with the license manufacturer all important proposed changes to production and facilities (including Start Printed Page 38319introduction of new products or at inspection). The license holder is responsible for reporting these changes to FDA (§ 601.12).
In the guidance, we remind the license manufacture that the license manufacturer assumes responsibility for compliance with the applicable product and establishment standards (21 CFR 600.3(t)). Therefore, if the license manufacturer enters into an agreement with a contract manufacturing facility, the license manufacturer must ensure that the facility complies with the applicable standards. An agreement between a license manufacturer and a contract manufacturing facility normally includes procedures to regularly assess the contract manufacturing facility's compliance. These procedures may include, but are not limited to, review of records and manufacturing deviations and defects, and periodic audits.
For shared manufacturing arrangements, each manufacturer must submit a separate biologics license application (BLA) describing the manufacturing facilities and operations applicable to the preparation of that manufacturer's biological substance or product (§ 601.2(a)). In the guidance, we state that 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 state that we expect the licensed finished product manufacturer to be primarily responsible 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.
The guidance also refers to previously approved collections of information found in FDA regulations at parts 201, 207, 211, 600, 601, 606, 607, 610, 660, 801, 803, and 807, 809, and 820 (21 CFR parts 201, 207, 211, 600, 601, 606, 607, 610, 660, 801, 803, 807, 809, and 820). The collections of information in §§ 606.121, 606.122, and 610.40 have been approved under OMB control number 0910-0116; § 610.2 has been approved under OMB control number 0910-0206; §§ 600.12(e) and 600.80 have been approved under OMB control number 0910-0308; §§ 601.2(a), 601.12, 610.60 through 610.65, 610.67, 660.2(c), 660.28(a) and (b), 660.35(a), (c) through (g), (i) through (m), 660.45, and 660.55(a) and (b) have been approved under OMB control number 0910-0338; §§ 803.20, 803.50, and 803.53 have been approved under OMB control number 0910-0437; and §§ 600.14 and 606.171 have been approved under OMB control number 0910-0458. The current good manufacturing practice regulations for finished pharmaceuticals (part 211) have been approved under OMB control number 0910-0139; §§ 820.181 and 820.184 have been approved under OMB control number 0910-0073; the establishment registration regulations (parts 207, 607, and 807) have been approved under OMB control numbers 0910-0045, 0910-0052, and 0910-0625; and the labeling regulations (parts 201, 801, and 809) have been approved under OMB control numbers 0910-0537, 0910-0572, and 0910-0485.
[FR Doc. 2014-15810 Filed 7-3-14; 8:45 am]