Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients)

ICR 202309-0910-010

OMB: 0910-0139

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0139 202309-0910-010
Received in OIRA 202304-0910-008
HHS/FDA CDER
Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients)
No material or nonsubstantive change to a currently approved collection   No
Regular 09/28/2023
  Requested Previously Approved
06/30/2026 06/30/2026
1,939,820 1,939,819
1,286,787 1,286,757
0 0

This information collection supports FDA regulations for finished pharmaceuticals, as well as medical gas containers and closures and active pharmaceutical ingredients (APIs). 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. We are revising the collection to provide for pharmaceutical voluntary consensus standard recognition.

US Code: 21 USC 331; 374 Name of Law: Federal Food, Drug, and Cosmetic Act - Prohibited Acts; Factory Inspection
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  84 FR 4076 02/14/2019
87 FR 45114 07/27/2022
No

  Total Request 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 1,939,820 1,939,819 0 0 1 0
Annual Time Burden (Hours) 1,286,787 1,286,757 0 0 30 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
For efficiency of agency operations, we are requesting to consolidate the related information collection activity and account for burden we attribute to the recommendations found in the referenced guidance document in the information collection under OMB control no. 0910-0139. Accordingly, we have adjusted the estimated burden to reflect an additional 1 response and 30 hours annually to account for the burden.

$65,625,000
No
    No
    No
No
No
No
No
Amber Sanford 301 796-8867 amber.sanford@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.
09/28/2023


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