Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 12-19-14.docx Supporting Statement A	2014-12-29

IC Document Collections

IC ID	Document Title	Status
183136	Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0629	ICR Reference No: 201412-0910-012
Status: Historical Active	Previous ICR Reference No: 201108-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CBER
Title: Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/06/2015
	Date Received in OIRA: 12/30/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2018	36 Months From Approved	02/28/2015
Responses	1	0	1
Time Burden (Hours)	1	0	1
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 262 Name of Law: PHS Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 38318	07/07/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 75569	12/18/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

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

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 12/30/2014

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