Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements

Forms and Documents

Document Name	Status
SS-0910-0608.doc Supporting Statement A	2010-09-29

IC Document Collections

IC ID	Document Title	Status
180790	Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements	Removed
180789	Reporting: Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements	Modified

ICR Details

OMB Control No: 0910-0608	ICR Reference No: 201009-0910-008
Status: Historical Active	Previous ICR Reference No: 200706-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP 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: 12/08/2010
	Date Received in OIRA: 09/30/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2013	36 Months From Approved	12/31/2010
Responses	1	0	972
Time Burden (Hours)	8	0	3,942
Cost Burden (Dollars)	0	0	0

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Abstract: On October 25,1994, the Dietary Supplement Health and Education Act (DSHEA)(Public Law 103-417) was signed into law. DHSEA, among other things, amended the Federal Food, Drug, and Cosmetic Act(the act) by adding section 402 (g) of the act (21 U.S.C. 342 (g) Section 402 (g)(2)of the act provides, in part, that the Secretary of Health and Human services (the secretary, may by regulation prescribe good manufacturing practices for dietary supplements. FDA published a final rule on June 25, 2007 (72 FR 34752) (the final rule) that established, in part 111 (21 CFR part 111) the minimum Current Good Manufacturing Practice (CGMP) necessary for activities related to manufactueing , packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. On June 25, 2007 (72 FR 34959 ), FDA also published an interin final rule 9 (the IFR ) establishing a procedure for a petition to request an exemption from 100 percent identity testing of dietary ingredients.

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Authorizing Statute(s): US Code: 21 USC 342 Name of Law: FFDCA
   US Code: 21 USC 371 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:
	75 FR 42095	07/20/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 60463	09/30/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Reporting: Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements
Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements

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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	1	972	0	-486	-485	0
Annual Time Burden (Hours)	8	3,942	0	-49	-3,885	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: As noted in the supporting statement, there was a program change (decrease) in the burden estimate of -49 hours due to agency discretion, i.e. the burden was consolidated under the OMB clearance 0910-0606.

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Annual Cost to Federal Government: $3,868

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: 09/30/2010

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