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View Information Collection (IC) List
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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:
201804-0910-009
Status:
Historical Active
Previous ICR Reference No:
201502-0910-014
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
06/25/2018
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/16/2018
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2021
36 Months From Approved
06/30/2018
Responses
1,620,586
0
1,301,095
Time Burden (Hours)
1,051,808
0
882,203
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection supports FDA regulations for finished pharmaceuticals, as well as medical gas containers and closures. The regulations mandate recordkeeping responsibilities that ensure covered articles are produced in accordance with current good manufacturing practice (CGMP). Products not in compliance with CGMP may be deemed adulterated and subject to agency enforcement action.
Authorizing Statute(s):
US Code:
21 USC 331(f)
Name of Law: Federal Food, Drug, and Cosmetic Act
US Code:
21 USC 374
Name of Law: FD&C 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:
82 FR 58811
12/14/2017
30-day Notice:
Federal Register Citation:
Citation Date:
83 FR 14861
04/06/2018
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
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
Procedures for Notification of Regulatory Actions
Production and Process Controls
Production, Control, and Distribution Records
Recordkeeping CGMP for Finished Pharmaceuticals
Recordkeeping CGMP for Medical Gases, Containers, and Closures
Returned Drug Products
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
1,620,586
1,301,095
0
0
319,491
0
Annual Time Burden (Hours)
1,051,808
882,203
0
0
169,605
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:
$49,525,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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:
Domini Bean 301 796-5733 domini.bean@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:
04/16/2018
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