[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Pages 51278-51280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20760]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0564]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Dietary Supplement Labeling Requirements and
Recommendations Under the Dietary Supplement and Nonprescription Drug
Consumer Protection Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
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
[[Page 51279]]
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. This notice
solicits comments on the information collection provisions of the
Dietary Supplement and Nonprescription Drug Consumer Protection Act
(the DSNDCPA) and the guidance document entitled, ``Guidance for
Industry: Questions and Answers Regarding the Labeling of Dietary
Supplements as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act.''
DATES: Submit either electronic or written comments on the collection
of information by October 23, 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, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
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.
Dietary Supplement Labeling Requirements and Recommendations Under the
Dietary Supplement and Nonprescription Drug Consumer Protection Act
OMB Control Number 0910-0642--Extension
In 2006, the Dietary Supplement and Nonprescription Drug Consumer
Protection Act (the DSNDCPA) amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) with respect to serious adverse event
reporting for dietary supplements and nonprescription drugs marketed
without an approved application. The DSNDCPA also amended the FD&C Act
to add section 403(y) (21 U.S.C. 343(y)), which requires the label of a
dietary supplement marketed in the United States to include a domestic
address or domestic telephone number through which the product's
manufacturer, packer, or distributor may receive a report of a serious
adverse event associated with the dietary supplement.
In the Federal Register of September 1, 2009 (74 FR 45221), we
announced the availability of a guidance document entitled ``Guidance
for Industry: Questions and Answers Regarding the Labeling of Dietary
Supplements as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act.'' The guidance document contains
questions and answers related to the labeling requirements in section
403(y) of the FD&C Act and provides guidance to industry on the use of
an explanatory statement before the domestic address or telephone
number. The guidance document provides our interpretation of the
labeling requirements for section 403(y) of the FD&C Act and our views
on the information that should be included on the label. We believe
that the guidance will enable persons to meet the criteria for labeling
that are established in section 403(y) of the FD&C Act.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Number of disclosures Total annual Average burden
Activity respondents per disclosures per disclosure Total hours
respondent
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Domestic address or phone number 1,700 3.27 5,560 0.2 1,112
labeling requirement (21 U.S.C. (12 minutes)
343(y))........................
FDA recommendation for label 1,700 3.27 5,560 0.2 1,112
statement explaining purpose of (12 minutes)
domestic address or phone
number.........................
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Total....................... .............. .............. .............. .............. 2,224
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The labeling requirements of section 403(y) of the FD&C Act became
effective on December 22, 2007, although we exercised enforcement
discretion until September 30, 2010, to enable all firms to meet the
labeling requirements for dietary supplements. At this time, therefore,
we expect that all labels required to include the domestic address or
telephone number pursuant to section 403(y) of the FD&C Act have been
revised accordingly. Thus our current burden estimate for this
information collection applies only to new product labels.
[[Page 51280]]
In row 1 of table 1 we estimate the total annual hourly burden
necessary to comply with the requirement under section 403(y) of the
FD&C Act to be 1,112 hours. Using historical A.C. Nielson Sales Scanner
Data, we estimate the number of dietary supplement stock keeping units
for which product sales are greater than zero to be 55,600. Assuming
that the flow of new products is 10 percent per year, then each year
approximately 5,560 new dietary supplement products are projected to
enter the market. Estimating that there are 1,700 dietary supplement
manufacturers, re-packagers, re-labelers, and holders of dietary
supplements subject to the information collection requirement (using
the figure 1,460 as provided in our final rule of June 25, 2007 (72 FR
34752), on the ``Current Good Manufacturing Practice in Manufacturing,
Packaging, Labeling, or Holding Operations for Dietary Supplements,''
and factoring for a 2 percent annual growth rate), we calculate an
annual disclosure burden of 3.27 disclosures (labels) per firm. Last,
we expect that firms prepare the required labeling for their products
in a manner that takes into account at one time all information
required to be disclosed and therefore believe that less than 0.2 hours
(12 minutes) per product label would be expended to fulfill this
requirement.
In row 2 of table 1 we estimate the total burden associated with
the recommendation to include an explanatory statement on dietary
supplement product labels letting consumers know the purpose of the
domestic address or telephone number to be 1,112 hours. Based upon our
knowledge of food and dietary supplement labeling, we estimate it would
require less than 0.2 hours (12 minutes) per product label to include
such a statement.
Dated: August 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20760 Filed 8-21-15; 8:45 am]
BILLING CODE 4164-01-P