Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases

ICR 201804-0910-009

OMB: 0910-0139

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2018-04-16
IC Document Collections
IC ID
Document
Title
Status
37604
Modified
215482
Removed
215481
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215480
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215479
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215478
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215477
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215476
Removed
215475
Removed
215474
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215473
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215472
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215471
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215470
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215469
Removed
215468
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215467
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215466
Removed
215465
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215464
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215463
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215462
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215461
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215460
Removed
215459
Removed
215458
Removed
215457
Removed
215456
Removed
215455
Removed
215454
Removed
215453 Modified
ICR Details
0910-0139 201804-0910-009
Active 201502-0910-014
HHS/FDA CDER
Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases
Revision of a currently approved collection   No
Regular
Approved without change 06/25/2018
Retrieve Notice of Action (NOA) 04/16/2018
  Inventory as of this Action Requested Previously Approved
06/30/2021 36 Months From Approved 06/30/2018
1,620,586 0 1,301,095
1,051,808 0 882,203
0 0 0

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.

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
  
None

Not associated with rulemaking

  82 FR 58811 12/14/2017
83 FR 14861 04/06/2018
No

  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
No
No

$49,525,000
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
04/16/2018


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