[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