Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

ICR 201412-0910-012

OMB: 0910-0629

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0629 201412-0910-012
Historical Active 201108-0910-005
Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
Extension without change of a currently approved collection   No
Approved without change 02/06/2015
Retrieve Notice of Action (NOA) 12/30/2014
  Inventory as of this Action Requested Previously Approved
02/28/2018 36 Months From Approved 02/28/2015
1 0 1
1 0 1
0 0 0

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. The notifications of the requested information provides the appropriate parties with the necessary information regarding any cooperative manufacturing arrangements. The SOPs ensure that the written procedures are followed.

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

Not associated with rulemaking

  79 FR 38318 07/07/2014
79 FR 75569 12/18/2014

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

Ila Mizrachi 301 796-7726 [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).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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