0608 SS May 2015

Petition to Request an Exemption from 100 Percent Identity Testing of
Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing,
Packaging, Labeling, or Holding Operations for Dietary Supplements
OMB Control No. 0910-0608
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
The Dietary Supplement Health and Education Act (Public Law 103–417) added section 402(g) of
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 342(g)) which provides, in
part, that the Secretary of Health and Human Services may, by regulation, prescribe good
manufacturing practices for dietary supplements. Section 402(g)(1) of the FD&C 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 701(a) of the FD&C Act (21
U.S.C. 371(a)) gives FDA the authority to issue regulations necessary for the efficient enforcement
of the FD&C Act.
Part 111 of FDA regulations (21 CFR part 111) establishes the minimum Current Good
Manufacturing Practice (CGMP) necessary for activities related to manufacturing, packaging,
labeling, or holding dietary supplements to ensure the quality of the dietary supplement. Section
111.75(a)(1) of FDA regulations (21 CFR 111.75(a)(1)) establishes a procedure for a petition to
request an exemption from 100 percent identity testing of dietary ingredients. According to
§ 111.75(a)(1)(ii), manufacturers may request an exemption from the requirements set forth in
§ 111.75(a)(1)(i) when the dietary ingredient is obtained from one or more suppliers identified in
the petition. The regulation 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) reflects FDA’s 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, FDA recognizes 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, FDA added to § 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 21 CFR 10.30 and the agency grants such exemption. Such a procedure
would be consistent with FDA’s stated goal, as described in the CGMP final rule, of providing
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flexibility in the CGMP requirements. Section 111.75(a)(1)(ii) sets forth the information a
manufacturer is required to submit in such a petition. The regulation also contains a requirement to
ensure that the manufacturer keeps FDA’s response to a petition submitted under § 111.75(a)(1)(ii)
as a record under § 111.95. The collection of information in § 111.95 has been approved under
OMB Control No. 0910-0606.
We request OMB approval of the following information collection requirements:
21 CFR 111.75(a)(1)(ii) -- Reporting:
Sets forth the information a manufacturer is required to submit in a petition to request an exemption
from 100 percent identity testing of dietary ingredients.
2. Purpose and Use of the Information Collection
The information will be used to show that a particular manufacturer of dietary supplements has
successfully, or unsuccessfully, petitioned FDA for an exemption from 100 percent identity testing
for ingredients used in supplement manufacture.
Description of Respondents: The respondents to this collection of information are firms in the
dietary supplement industry, including dietary supplement manufacturers, packagers and repackagers, holders, labelers and re-labelers, distributors, warehouses, exporters, importers, large
businesses, and small businesses. Respondents are from the private sector (for-profit businesses).
3. Use of Improved Information Technology and Burden Reduction
The regulation does not specifically prescribe the use of automated, electronic, mechanical, or other
technological techniques or other forms of information technology as necessary for use by firms.
Companies are free to use whatever forms of information technology may best assist them in
preparing the petition and submitting it to the agency. In the last 3 years, FDA has not received any
new petitions to request an exemption from 100 percent identity testing of dietary ingredients;
therefore, the agency estimates that no petitions (0%) will be submitted electronically.
4. Efforts to Identify Duplication and Use of Similar Information
No duplication of Federal regulations concerning the process for petitioning for an exemption from
100 percent identity testing of dietary ingredients is likely because of the clear Congressional
authorization that FDA promulgate regulations pertaining to the manufacture of dietary supplements
as opposed to the jurisdiction of the U.S. Department of Agriculture (meats and poultry) and the
Federal Trade Commission (advertising).
5. Impact on Small Businesses or Other Small Entities
FDA estimates that a substantial proportion (75%) of firms affected by this regulation are small
businesses, and has kept their particular needs in mind throughout the development of these
regulations. Small businesses with fewer than 20 employees were given an additional 2 years to
comply with the 2007 final rule. Small businesses with 20 to 499 employees were given an
additional year to comply with the final rule. FDA aids small businesses in complying with its
requirements through the agency’s Regional Small Business Representatives and through the
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administrative and scientific staffs within the agency. FDA has provided a Small Business Guide
on the agency’s website at http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
A firm would submit a petition for an exemption from 100 percent identity testing of dietary
ingredients occasionally, as needed. If the petition process being considered here was not
conducted, the agency would have difficulty meeting its stated goal, as described in the CGMP final
rule, of providing flexibility in the CGMP requirements.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
the Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in the
Federal Register of November 14, 2013 (78 FR 68453) and again on March 9, 2015 (80 FR 12491).
While the agency received few comments, none were responsive to the information collection
topics solicited and were therefore not addressed.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payment or gift to respondents.
10. Assurance of Confidentiality Provided to Respondents
Information submitted to FDA in a petition for an exemption from 100 percent identity testing of
dietary ingredients may contain trade secret and commercial confidential information. Confidential
commercial information is protected from disclosure under the Freedom of Information Act (FOIA)
under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), by section 301(j) of the FD&C Act, and by
part 20 of the agency’s regulations (21 CFR part 20).
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
Description of Respondents: The respondents to this collection of information are firms in the
dietary supplement industry, including dietary supplement manufacturers, packagers and repackagers, holders, labelers and re-labelers, distributors, warehouses, exporters, importers, large
businesses, and small businesses. Respondents are from the private sector (for-profit businesses).
12 a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
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Table 1.-Estimated Annual Reporting Burden1
21 CFR Section

111.75(a)(1)(ii)
1

Number of
Respondents

1

No. of
Responses
per
Respondent
1

Total
Annual
Responses

Average
Burden per
Response

1

8

Total
Hours

8

There are no capital costs or operating and maintenance costs associated with this collection of information.

In the last 3 years, FDA has not received any new petitions to request an exemption from 100
percent identity testing of dietary ingredients; therefore, the agency estimates that one or fewer
petitions will be submitted annually. Based on our experience with petition processes, we estimate
that the assembly of information in support of the petition required by § 111.75(a)(1)(ii) will take
about 8 hours. Although FDA has not received any new petitions to request an exemption from 100
percent identity testing of dietary ingredients in the last 3 years, it believes that these information
collection provisions should be extended to provide for the potential future need of a firm in the
dietary supplement industry to petition for an exemption from 100 percent identity testing of dietary
ingredients.
12 b. Annualized Cost Burden Estimate
Gathering the information discussed here and providing it to the agency may be done by a
professional employee. FDA estimates that the average hourly wage for this employee would be
equivalent to a GS-11/Step-1 level in the locality pay area of Washington-Baltimore in 2014,
approximately $30.23/hour. Doubling this wage to account for overhead costs, FDA estimates the
average hourly cost to respondents to be $60.46/hour. The overall estimated cost incurred by the
respondents is $483.68 (8 burden hours x $60.46/hr = $483.68).
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
Costs
There are no capital, start-up, or operating, or maintenance costs associated with this collection.
14. Annualized Cost to the Federal Government
At the agency, professional employees would review the petition. The review would require
approximately forty hours. FDA estimates the hourly cost for review and evaluation of petitions to
be $48.83 per hour, the GS-13/Step-5 rate for the Washington-Baltimore locality pay area for the
year 2014. To account for overhead, this cost is increased by 100 percent, making the total cost
$97.66 per hour. Thus, FDA estimates the cost to the Federal Government for the review of
submissions to be $3,906.40 ($97.66/hour x 40 hours = $3,906.40).
15. Explanation for Program Changes or Adjustments
The hour burden is unchanged.

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16. Plans for Tabulation and Publication and Project Time Schedule
The results of this information collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the information
collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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