Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements
ICR 200706-0910-003 · OMB 0910-0608 · Historical Active
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Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements
New collection (Request for a new OMB Control Number)
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
09/30/2010
36 Months From Approved
972
0
0
3,942
0
0
0
0
0
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.
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.
$2,665,960
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman
No
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:
(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;
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.
21 USC 371.htm
DS IFR Supporting Statement 5_07_07.doc
Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients: CGMP in Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements