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

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
37604	Recordkeeping CGMP for Finished Pharmaceuticals	Unchanged
262288	Requests for Dispute Resolution (Tier One and Tier Two) Other-Agency Guidance	New
259864	Pharmaceutical Voluntary Consensus Standard Recognition Other-Agency Guidance	Unchanged
248022	Recordkeeping CGMP APIs	Unchanged
215453	Recordkeeping CGMP for Medical Gases, Containers, and Closures Other-Agency Guidance	Unchanged

ICR Details

OMB Control No: 0910-0139	ICR Reference No: 202309-0910-010
Status: Received in OIRA	Previous ICR Reference No: 202304-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Medical Gases and Active Pharmaceutical Ingredients)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/28/2023

	Requested	Previously Approved
Expiration Date	06/30/2026	06/30/2026
Responses	1,939,820	1,939,819
Time Burden (Hours)	1,286,787	1,286,757
Cost Burden (Dollars)	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 331; 374 Name of Law: Federal Food, Drug, and Cosmetic Act - Prohibited Acts; Factory Inspection
  

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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 4076	02/14/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 45114	07/27/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Pharmaceutical Voluntary Consensus Standard Recognition
Recordkeeping CGMP APIs
Recordkeeping CGMP for Finished Pharmaceuticals
Recordkeeping CGMP for Medical Gases, Containers, and Closures
Requests for Dispute Resolution (Tier One and Tier Two)

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ICR Summary of Burden

	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

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: 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.

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Annual Cost to Federal Government: $65,625,000

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? No

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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: 09/28/2023

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