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

Forms and Documents

Document Name	Status
0606 SS A 2017 Extension.pdf Supporting Statement A	2017-04-03

IC Document Collections

IC ID	Document Title	Status
181126	Records Regarding Product Complaints	Modified
181125	Records for Returned Dietary Supplements	Modified
181124	Records of Product Distribution and Procedures for Holding and Distributing Operations	Modified
181123	Records of the Written Procedures for Packaging and Labeling Operations	Modified
181122	Records of the Written Procedures Established for Manufacturing Operations	Modified
181121	Records That Quality Control Personnel Must Make and Keep for Laboratory Operations	Modified
181120	Requirements for What the Batch Record Must Include	Modified
181119	Records for What the Master Manufacturing Record Must Include	Modified
181118	Records That Quality Control Personnel Must Make and Keep	Modified
181117	Records of Production and Process Control Systems	Modified
181116	Records of Equipment and Utensils Calibration and Sanitation Practices	Modified
181115	Records of Physical Plant Sanitation Practices, Including Pest Control and Water Quality	Modified
181114	Records of Personnel Practices, Including Documentation of Training	Modified

ICR Details

OMB Control No: 0910-0606	ICR Reference No: 201703-0910-016
Status: Historical Active	Previous ICR Reference No: 201402-0910-005
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/25/2017
	Date Received in OIRA: 04/25/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2020	36 Months From Approved	05/31/2017
Responses	719,040	0	719,040
Time Burden (Hours)	929,140	0	929,140
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request seeks information regarding compliance and conformance with current good manufacturing practice (CGMP) regulations applicable to dietary supplements. Respondents are manufacturers engaged in the production of dietary supplements for which recordkeeping activities will be used to ensure quality control. Products that do not meet CGMP requirements may be deemed to be in violation of the Federal Food, Drug, and Cosmetic Act.

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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:
	81 FR 66967	09/29/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 18652	04/20/2017
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
Records of Personnel Practices, Including Documentation of Training
Records of Physical Plant Sanitation Practices, Including Pest Control and Water Quality
Records of Equipment and Utensils Calibration and Sanitation Practices
Records of Production and Process Control Systems
Records That Quality Control Personnel Must Make and Keep
Records for What the Master Manufacturing Record Must Include
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 Regarding Product Complaints
Records for Returned Dietary Supplements
Records of the Written Procedures for Packaging and Labeling Operations
Records of Product Distribution and Procedures for Holding and Distributing Operations

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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	719,040	719,040	0	0	0	0
Annual Time Burden (Hours)	929,140	929,140	0	0	0	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:

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Annual Cost to Federal Government: $45,420

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

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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: 04/25/2017

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