Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

Forms and Documents

Document	Type	Status	Availability
0606 part 111 SSA 2020 REV consolidating 0608.pdf	Supporting Statement A	Uploaded 2020-04-26	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
181126	Records Regarding Product Complaints		Removed
181125	Records for Returned Dietary Supplements		Removed
181124	Records of Product Distribution and Procedures for Holding and Distributing Operations		Removed
181123	Records of the Written Procedures for Packaging and Labeling Operations		Removed
181122	Records of the Written Procedures Established for Manufacturing Operations		Removed
181121	Records That Quality Control Personnel Must Make and Keep for Laboratory Operations		Removed
181120	Requirements for What the Batch Record Must Include		Removed
181119	Records for What the Master Manufacturing Record Must Include		Removed
181118	Records That Quality Control Personnel Must Make and Keep		Removed
181117	Records of Production and Process Control Systems		Removed
181116	Records of Equipment and Utensils Calibration and Sanitation Practices		Removed
181115	Dietary Supplements CGMP; Reporting		Modified
181114	Dietary Supplements CGMP; Recordkeeping		Modified

ICR Details

OMB Control No: 0910-0606	ICR Reference No: 202004-0910-003
Status: Active	Previous ICR Reference No: 201703-0910-016
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
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: 05/29/2020
	Date Received in OIRA: 04/27/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2023	36 Months From Approved	05/31/2020
Responses	719,041	0	719,040
Time Burden (Hours)	929,148	0	929,140
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection provides for documenting procedures and maintaining records pertaining to the production of dietary supplements. Products that do not meet CGMP requirements may be deemed to be in violation of the Federal Food, Drug, and Cosmetic Act. The information collection also covers regulations pertaining to exemptions from testing requirements applicable to these products and how petitions should be filed with FDA.

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Authorizing Statute(s): US Code: 21 USC 342(g) Name of Law: FFDCA
  

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 66678	12/05/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 18998	04/03/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Records for What the Master Manufacturing Record Must Include
Dietary Supplements CGMP; Recordkeeping
Dietary Supplements CGMP; Reporting
Records of Production and Process Control Systems
Requirements for What the Batch Record Must Include
Records That Quality Control Personnel Must Make and Keep for Laboratory Operations
Records of the Written Procedures Established for Manufacturing Operations
Records of the Written Procedures for Packaging and Labeling Operations
Records of Product Distribution and Procedures for Holding and Distributing Operations
Records for Returned Dietary Supplements
Records Regarding Product Complaints
Records of Equipment and Utensils Calibration and Sanitation Practices
Records That Quality Control Personnel Must Make and Keep

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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	719,041	719,040	0	0	1	0
Annual Time Burden (Hours)	929,148	929,140	0	0	8	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: We have made no changes to our estimate of the information collection based on our most recent review. However, in consolidating burden from OMB control number 0910-0608, the information collection reflects an increase of 8 hours and one response annually applicable to petitions under 21 CFR 111.75. We have also consolidated previously itemized elements found at Question 12 of this supporting statement into a single, cumulative estimate we attribute to the recordkeeping requirements found in 21 CFR part 111.

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Annual Cost to Federal Government: $49,190

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: 04/27/2020

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