Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics

Forms and Documents

Document Name	Status
Response to OMB SEPT 2008.doc Supplementary Document	2008-09-09
Coop guidance 42 USC 262.htm Supplementary Document	2007-11-07
Coop guidance ss 10-9-07.doc Supporting Statement A	2007-11-07

IC Document Collections

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183136	Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Other-Guidance document	New

ICR Details

OMB Control No: 0910-0629	ICR Reference No: 200712-0910-011
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Draft Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/09/2008
	Date Received in OIRA: 12/20/2007
Terms of Clearance: This information collection request is approved consistent with FDA's agreed-upon revisions in its 9/9/2008 memo.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2011	36 Months From Approved
Responses	1	0	0
Time Burden (Hours)	1	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The guidance document referred to in the title of this submission 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 such as short supply arrangements, divided manufacturing arrangements, shared manufacturing arrangements, and contract manufacturing arrangements. The guidance document describes the various reporting and recordkeeping requirements as well as the responsibilities, on the part of the licensed manufacturer(s), contract manufacturer(s), and final product manufacturer(s) associated with each different type of cooperative manufacturing arrangement.

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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:
	72 FR 40157	07/23/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 65034	11/19/2007
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Draft 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	0	0	1	0	0
Annual Time Burden (Hours)	1	0	0	1	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: There is no burden associated with this information collection as FDA believes that it is usual and customary to the respondents. We are estimating one burden hour for the purposes of entering this ICR in ICRAS and ROCIS.

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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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 12/20/2007

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