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OMB Control No: 0910-0608	ICR Reference No: 200706-0910-003
Status: Historical Active	Previous ICR Reference No:
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: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/25/2007
	Date Received in OIRA: 06/20/2007
Terms of Clearance: The information collection requirements associated with this Interim Final Rule are approved for 3 years. OMB understands that FDA has extended the comment period for the IFR to allow for additional public input. Although granted approval for 3 years, FDA will revise this ICR to reflect any changes made to the rule as a result of public comment, and or will revise to include any guidance documents associated with the petition process.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2010	36 Months From Approved
Responses	972	0	0
Time Burden (Hours)	3,942	0	0
Cost Burden (Dollars)	0	0	0

Abstract: Section 402(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 342 (g)) gives the Food and Drug Administration (FDA) explicit authority to issue a rule establishing Current Good Manufacturing Practice for dietary supplements. Section 402(g)(1) of the act states that a dietary supplement is adulterated if it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations. Section 402(g)(2) of the act authorizes FDA to, by regulation, prescribe good manufacturing practices for dietary supplements. Under section 701(a) of the act (21 U.S.C. 371), FDA may issue regulations necessary for the efficient enforcement of the act. Given the above legal authority FDA has decided to redesignate section 111.75(a)(1) of the dietary supplement final rule as section 111.75(a)(1)(i) and set forth a procedure for submission of a petition to FDA in a new section 111.75(a)(1)(ii), pursuant to which manufacturers may request an exemption from the requirements set forth in section 111.75(a)(1)(i) when the dietary ingredient is obtained from one or more suppliers identified in the petition. The codified provision set forth in this interim final rule clarifies that FDA is willing to consider, on a case-by-case basis, a manufacturers conclusion, supported by appropriate data and information in the petition submission, that it has developed a system that it would implement as a sound, consistent means of establishing, with no material diminution of assurance compared to the assurance provided by 100 percent identity testing, the identity of the dietary ingredient before use. Section 111.75(a)(1) of the CGMP final rule reflects our determination that manufacturers that test or examine 100 percent of the incoming dietary ingredients for identity can be assured of the identity of the ingredient. However, we recognize that it may be possible for a manufacturer to demonstrate, through various methods and processes in use over time for its particular operation, that a system of less than 100 percent identity testing would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing. To provide an opportunity for a manufacturer to make such a showing and reduce the frequency of identity testing of components that are dietary ingredients from 100 percent to some lower frequency, we decided to add to section 111.75(a)(1), an exemption from the requirement of 100 percent identity testing when a manufacturer petitions the agency for such an exemption to 100 percent identity testing under section 10.30 and the agency grants such exemption. Such a procedure would be consistent with our stated goal, as described in the CGMP final rule, of providing flexibility in the CGMP requirements. We also include a requirement to ensure that the manufacturer keeps the FDAs response to a petition submitted under section 111.75(a)(1)(ii) as a record under section 111.95.

Authorizing Statute(s): US Code: 21 USC 371 Name of Law: FFDCA
US Code: 21 USC 342 Name of Law: FFDCA

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AB88	Final or interim final rulemaking	72 FR 34752	06/25/2007

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	972	972
Annual Time Burden (Hours)	3,942	3,942
Annual Cost Burden (Dollars)	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: FDA has decided to redesignate section 111.75(a)(1) of the dietary supplement final rule as section 111.75(a)(1)(i) and set forth a procedure for submission of a petition to FDA in a new section 111.75(a)(1)(ii), pursuant to which manufacturers may request an exemption from the requirements set forth in section 111.75(a)(1)(i) when the dietary ingredient is obtained from one or more suppliers identified in the petition. The codified provision set forth in this interim final rule clarifies that FDA is willing to consider, on a case-by-case basis, a manufacturer's conclusion, supported by appropriate data and information in the petition submission, that it has developed a system that it would implement as a sound, consistent means of establishing, with no material diminution of assurance compared to the assurance provided by 100 percent identity testing, the identity of the dietary ingredient before use. Section 111.75(a)(1) of the CGMP final rule reflects our determination that manufacturers that test or examine 100 percent of the incoming dietary ingredients for identity can be assured of the identity of the ingredient. However, we recognize that it may be possible for a manufacturer to demonstrate, through various methods and processes in use over time for its particular operation, that a system of less than 100 percent identity testing would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing. To provide an opportunity for a manufacturer to make such a showing and reduce the frequency of identity testing of components that are dietary ingredients from 100 percent to some lower frequency, we decided to add to section 111.75(a)(1), an exemption from the requirement of 100 percent identity testing when a manufacturer petitions the agency for such an exemption to 100 percent identity testing under section 10.30 and the agency grants such exemption. Such a procedure would be consistent with our stated goal, as described in the CGMP final rule, of providing flexibility in the CGMP requirements. We also include a requirement to ensure that the manufacturer keeps the FDA's response to a petition submitted under section 111.75(a)(1)(ii) as a record under section 111.95.

Annual Cost to Federal Government: $2,665,960

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

Agency Contact: Saleda Perryman

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