[Federal Register Volume 80, Number 45 (Monday, March 9, 2015)]
[Notices]
[Pages 12491-12493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05357]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1152]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an

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opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information and to allow 60 days for public comment in response to the 
notice. This notice invites comments on the information collection 
provisions of our existing regulations governing petitions to request 
an exemption from 100 percent identity testing of dietary ingredients.

DATES: Submit either electronic or written comments on the collection 
of information by May 8, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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--21 CFR 111.75(a)(1)(ii) (OMB Control Number 0910-0608)--
(Extension)

    The Dietary Supplement Health and Education Act (DSHEA) (Pub. L. 
103-417) added section 402(g) of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that the 
Secretary of Health and Human Services (the Secretary) 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 
us the authority to issue regulations for the efficient enforcement of 
the FD&C Act.
    Part 111 (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 
our 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. Under Sec.  111.75(a)(1)(ii), manufacturers may 
request an exemption from the requirements set forth in Sec.  
111.75(a)(1)(i) when the dietary ingredient is obtained from one or 
more suppliers identified in the petition. The regulation clarifies 
that we are 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 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 added to Sec.  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 Sec.  10.30 (21 CFR 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. 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 our response to a petition submitted under Sec.  
111.75(a)(1)(ii) as a record under Sec.  111.95 (21 CFR 111.95). The 
collection of information in Sec.  111.95 has been approved under OMB 
control number 0910-0606.
    Description of Respondents: The respondents to this collection of 
information are firms in the dietary supplement industry, including 
dietary supplement manufacturers, packagers and re-packagers, holders, 
labelers and re-labelers, distributors, warehouses, exporters, 
importers, large businesses, and small businesses.
    We estimate the burden of this collection of information as 
follows:

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                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                          Number of                      Average
 21 CFR Section; CGMP requirements for     Number of    responses per   Total annual   burden per    Total hours
          dietary supplements             respondents     respondent      responses     response
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111.75(a)(1)(ii).......................            1                1             1             8             8
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    In the last 3 years, we have 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 it will take a requestor about 8 hours 
to prepare the factual and legal information necessary to support a 
petition for exemption and to prepare the petition. Although we have 
not received any new petitions to request an exemption from 100 percent 
identity testing of dietary ingredients in the last 3 years, we believe 
that OMB approval of 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.

    Dated: March 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05357 Filed 3-6-15; 8:45 am]
 BILLING CODE 4164-01-P