Current Good Manufacturing Practices for Finished Pharmaceuticals

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 0139 3-2-15.doc Supporting Statement A	2015-03-02

IC Document Collections

IC ID	Document Title	Status
37604	SOP Maintenance	Modified
215482	Returned Drug Products	New
215481	Compliant Files	New
215480	Distribution Records	New
215479	Laboratory Records	New
215478	Discrepancies in Drug Product Production and Control Records	New
215477	Batch Production and Control Records	New
215476	Master Production and Control Records	New
215475	Component, Drug, Product Container, Closure, and Labeling Records	New
215474	Equipment Cleaning and Use Log	New
215473	Procedures for Notification of Regulatory Actions	New
215472	Production, Control, and Distribution Records	New
215471	Laboratory Animals	New
215470	Stability Testing	New
215469	Test Methodology	New
215468	Laboratory Controls	New
215467	Expiration Dating	New
215466	Tamper-Evident Packaging	New
215465	Tamper Evident-Packaging	New
215464	Labeling and Packaging Facilities	New
215463	Labeling and Packaging Material	New
215462	Equipment Identification	New
215461	Production and Process Controls	New
215460	Components and Drug Product Containers or Closures	New
215459	Filters	New
215458	Computer or Related Systems	New
215457	Automatic, Mechanical, and Electronic Equipment	New
215456	Changes in Master Production and Control Records or Other Records	New
215455	Equipment Cleaning and Maintenance	New
215454	Consultants	New
215453	New Start-up SOPs	New

ICR Details

OMB Control No: 0910-0139	ICR Reference No: 201502-0910-014
Status: Historical Active	Previous ICR Reference No: 201109-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Current Good Manufacturing Practices 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: 05/18/2015
	Date Received in OIRA: 03/06/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2018	36 Months From Approved	05/31/2015
Responses	1,301,095	0	1,248,727
Time Burden (Hours)	882,203	0	848,625
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 provide FDA with the necessary information to perform its duty to protect public health and safety. CGMP requirements 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 CGMP recordkeeping requirements also serve preventive and remedial purposes and provide crucial information if it is necessary to recall a drug product.

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Authorizing Statute(s): US Code: 21 USC 374 Name of Law: FD&C Act
   US Code: 21 USC 331(f) Name of Law: Federal Food, Drug, and Cosmetic 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 66724	11/10/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 10117	02/25/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 31

IC Title	Form No.	Form Name
Production, Control, and Distribution Records
Procedures for Notification of Regulatory Actions
Component, Drug, Product Container, Closure, and Labeling Records
Labeling and Packaging Facilities
Tamper Evident-Packaging
Tamper-Evident Packaging
Expiration Dating
Laboratory Controls
Test Methodology
Stability Testing
SOP Maintenance
New Start-up SOPs
Consultants
Equipment Cleaning and Maintenance
Changes in Master Production and Control Records or Other Records
Automatic, Mechanical, and Electronic Equipment
Laboratory Animals
Computer or Related Systems
Filters
Components and Drug Product Containers or Closures
Production and Process Controls
Equipment Identification
Labeling and Packaging Material
Master Production and Control Records
Batch Production and Control Records
Discrepancies in Drug Product Production and Control Records
Distribution Records
Compliant Files
Equipment Cleaning and Use Log
Laboratory Records
Returned Drug Products

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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	1,301,095	1,248,727	0	0	52,368	0
Annual Time Burden (Hours)	882,203	848,625	0	0	33,578	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: $77,825,000

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: 03/06/2015

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