[Federal Register Volume 79, Number 229 (Friday, November 28, 2014)]
[Notices]
[Pages 70876-70878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28087]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

[[Page 70877]]


DATES: Fax written comments on the collection of information by 
December 29, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0608. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.
    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)--Reinstatement

    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 of our 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 our regulations establishes a procedure for a 
petition to request an exemption from 100 percent identity testing of 
dietary ingredients. In accordance with 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 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. 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.
    In the Federal Register of November 14, 2013 (78 FR 68453), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. While three comments were received, none 
were responsive to the four collection of information topics solicited 
in the notice and therefore are not discussed in this document. 
Additionally, although FDA was unable to publish a 30 day notice before 
the information collection expiration and is therefore requesting its 
reinstatement, the Agency has not conducted or sponsored any collection 
of information under OMB control number 0910-0608 in the interim 
period.
    We estimate the annual burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
     21 CFR Section; CGMP requirements for dietary supplements          Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per 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

[[Page 70878]]

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: November 21, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28087 Filed 11-26-14; 8:45 am]
BILLING CODE 4164-01-P