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View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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
Retrieve Notice of Action (NOA)
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
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
31
IC Title
Form No.
Form Name
Automatic, Mechanical, and Electronic Equipment
Batch Production and Control Records
Changes in Master Production and Control Records or Other Records
Compliant Files
Component, Drug, Product Container, Closure, and Labeling Records
Components and Drug Product Containers or Closures
Computer or Related Systems
Consultants
Discrepancies in Drug Product Production and Control Records
Distribution Records
Equipment Cleaning and Maintenance
Equipment Cleaning and Use Log
Equipment Identification
Expiration Dating
Filters
Labeling and Packaging Facilities
Labeling and Packaging Material
Laboratory Animals
Laboratory Controls
Laboratory Records
Master Production and Control Records
New Start-up SOPs
Procedures for Notification of Regulatory Actions
Production and Process Controls
Production, Control, and Distribution Records
Returned Drug Products
SOP Maintenance
Stability Testing
Tamper Evident-Packaging
Tamper-Evident Packaging
Test Methodology
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:
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
Agency Contact:
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov
Common Form ICR:
No
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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