Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

ICR 201108-0910-005

OMB: 0910-0629

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0629 201108-0910-005
Historical Active 200712-0910-011
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
Extension without change of a currently approved collection   No
Approved with change 02/27/2012
Retrieve Notice of Action (NOA) 08/10/2011
  Inventory as of this Action Requested Previously Approved
02/28/2015 36 Months From Approved 02/29/2012
1 0 1
1 0 1
0 0 0

The guidance document provides information concerning cooperative manufacturing arrangements applicable to biological products subject to licensure under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262). The guidance document addresses several different types of cooperative manufacturing arrangements (i.e., short supply arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and contract manufacturing arrangements). The guidance document describes certain reporting and recordkeeping responsibilities associated with these arrangements, including the following: (1) Notification of all important proposed changes to production and facilities; (2) notification of results of tests and investigations regarding or possibly impacting the product; (3) notification of products manufactured in a contract facility; and (4) standard operating procedures.

US Code: 42 USC 262 Name of Law: PHS Act

Not associated with rulemaking

  76 FR 14405 03/16/2011
76 FR 48166 08/08/2011

IC Title Form No. Form Name
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 1 1 0 0 0 0
Annual Time Burden (Hours) 1 1 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Johnny Vilela 301 796-3792 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
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    (ii) Use of information;
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