Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals

Forms and Documents

Document Name	Status
0139 SS 2011.doc Supporting Statement A	2011-09-23

IC Document Collections

IC ID	Document Title	Status
37604	Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals	Modified

ICR Details

OMB Control No: 0910-0139	ICR Reference No: 201109-0910-005
Status: Historical Active	Previous ICR Reference No: 200809-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals
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: 04/09/2012
	Date Received in OIRA: 09/29/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved. The agency is reminded that the type of burden (recordkeeping, reporting, third-party disclosure) should be properly entered in the ROCIS system.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2015	36 Months From Approved	04/30/2012
Responses	1,248,727	0	1,174,427
Time Burden (Hours)	848,625	0	798,132
Cost Burden (Dollars)	0	0	0

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Abstract: The CGMP regulations help ensure that drug products meet the statutory requirements for safety and have their purported or represented identity, strength, quality, and purity characteristics. The information collection requirements in the CGMP regulations are necessary to establish accountability in the manufacturing and processing of drug products, provide for meaningful FDA inspections, and enable manufacturers to improve the quality of drug products over time. The CGBP recordkeeping requirements also serve as crucial information if it is necessary to recall a drug product.

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Authorizing Statute(s): US Code: 21 USC 301 Name of Law: FFDCA
  

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:
	76 FR 31342	05/31/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 60052	09/28/2011
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
Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals

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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	1,248,727	1,174,427	0	0	74,300	0
Annual Time Burden (Hours)	848,625	798,132	0	0	50,493	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: $45,280,000

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: 09/29/2011

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