0608 SS Part A 2018 Ext

United States Food and Drug Administration
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 Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we) regulations.
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) also 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. Accordingly, we have promulgated regulations at 21 CFR Part
111 establishing minimum current good manufacturing practice requirements for the
manufacture, packaging, labeling, or holding of dietary supplements.
Subpart E of 21 CFR Part 111 (21 CFR 111.55-111.95) covers certain quality control
specifications including component identity testing. Section 111.75(a)(1) provides for petitions
to request an exemption from certain testing requirements under the regulation. According to
§ 111.75(a)(1)(ii), manufacturers may request an exemption when a dietary ingredient is
obtained from one or more suppliers as 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.
Part 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 flexibility in the CGMP requirements.
Part 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.
We therefore request extension of OMB approval for the information collection provisions found
in under 21 CFR 111.75 and discussed in this supporting statement.
2. Purpose and Use of the Information Collection
The information is used to show whether 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. Respondents to the information
collection are individuals or firms who manufacture, package, label, or hold a dietary
supplement. 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. Having received one petition over the
past three years by electronic mail, we estimate 100% of respondents would utilize electronic
means to satisfy the information collection.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. While OMB Control No. 0910-0606
(Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding
Operations for Dietary Supplements) otherwise covers recordkeeping requirements under 21
CFR Part 111, this collection of information exclusively covers petitions covered under Subpart
E. Upon our next renewal of OMB Control No. 0910-0606 we will consider whether it is
appropriate to consolidate the collections.
5. Impact on Small Businesses or Other Small Entities
We estimate a substantial proportion (75%) of respondents are small businesses, however we do
not believe the information collection imposes undue burden on small entities. At the same time,
we assist small businesses in complying with our regulations through the availability of Regional
Small Business Representatives and administrative and scientific staffs within the agency. We
also provide a Small Business Guide on our website at http://www.fda.gov/oc/industry/.

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6. Consequences of Collecting the Information Less Frequently
Respondents to the collection may petition for an exemption from 100 percent identity testing of
dietary ingredients occasionally as needed. Absent the petition process underlying the
information collection, FDA would have difficulty meeting its public health safety objectives.
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), we published a 60 day notice for public comment in the
Federal Register of April 9, 2018 (83 FR 15159). One comment was received suggesting that
“microbial cultures and probiotics should not be required to go through such a process to ensure
exemption from the Agency’s 100 percent identity testing requirement,” but did not suggest a
revision to the estimated burden. We appreciate this comment, however, we believe that the
current requirements impose minimal information collection while simultaneously ensuring the
safety of dietary supplements.
Additionally, in December 2017, FDA received its first petition under the information collection,
which is currently pending agency review. Because of overlap in processing the petition and
publication submission deadlines, our 60-day and 30-day Federal Register notices communicated
that we had not yet received a submission under the information collection. However, we
believe we have accounted for the associated burden and therefore retain our current estimate.
Should we receive additional petitions under the information collection, we will adjust our
estimate accordingly prior to any future extension request.
9. Explanation of Any Payment or Gift to Respondents
No gifts or respondents are provided to respondents to the information collection.
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.

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12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
We estimate the burden of this collection of information as follows:
Table 1.-Estimated Annual Reporting Burden1
21 CFR Section; Activity

No. of
Respondents

111.75(a)(1)(ii); Determining
whether specifications are met

1

1

No. of
Responses per
Respondent
1

Total
Annual
Responses
1

Average
Burden per
Response
8

Total
Hours
8

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

Since OMB’s last review and approval of the information collection, we have received one
petition. We therefore retain the currently approved estimated burden which assumes no more
than one petition will be submitted annually. We further assume it takes respondents 8 hours to
prepare the factual and legal information necessary to support a petition for exemption and to
prepare the petition, for a total of 8 burden hours annually. These figures are based on our
experience with the information collection.
12b. Annualized Cost Burden Estimate
Gathering the information discussed here and providing it to the agency may be done by
a professional employee. Using 2018 OPM salary data, we assume an hourly wage
commensurate to a GS-11/Step-1 Federal employee in the Washington/Baltimore locality of
$32.60. Doubling this wage to account for overhead costs, we estimate an average hourly cost to
respondents of $65.20/hour. The overall estimated cost incurred by respondents, therefore, is
$521.60 (8 burden hours x $65.20/hr = $521.60).
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
Review of petitions under 21 CFR Part 111.75 is conducted by employees at least at the GS-13/5
level. Using OPM salary data we therefore assume an hourly cost for the review and evaluation
of petitions of $52.66 per hour in the Washington-Baltimore locality for the year 2018. To
account for overhead, we have increased this cost by 100%, for a total estimated cost to the
Federal government of $4,212.80 ($105.32/hour x 40 hours = $4,212.80).
15. Explanation for Program Changes or Adjustments
We retain the currently approved burden estimate for the information collection. As noted
previously under Question 8 above, there was an overlap in processing a petition and publication

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submission deadlines required for our 60-day and 30-day Federal Register notices. As a result,
our notices communicated that we had not yet received a submission. While we have now
received the first petition under the information collection, we believe we have accurately
accounted for the associated burden.
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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