[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Pages 35687-35688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14487]
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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) 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
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 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 August 13, 2012.
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: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, [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.
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 DSNDCPA (Pub. L. 109-462, 120 Stat. 3469) 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), FDA
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 the Agency's interpretation of
the labeling requirements for section 403(y) of the FD&C Act and the
Agency's views on the information that should be included on the label.
The Agency believes that the guidance will enable persons to meet the
criteria for labeling that are established in section 403(y) of the
FD&C Act.
FDA estimates 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
Activity respondents per disclosures burden per Total hours
respondent \2\ disclosure
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Domestic address or phone number 1,460 3.8 5,560 0.5 2,780
labeling requirement (21 U.S.C.
343(y))........................
FDA recommendation for label 1,460 3.8 5,560 0.5 2,780
statement explaining purpose of
domestic address or phone
number.........................
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Total....................... .............. .............. .............. .............. 5,560
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Number has been rounded to the nearest tenth.
The labeling requirements of section 403(y) of the FD&C Act became
effective on December 22, 2007, although FDA exercised enforcement
discretion until September 30, 2010, to enable all firms to meet the
labeling requirements for dietary supplements. FDA estimates 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 by the
effective date. Thus, in succeeding years, the Agency estimates that
the burden hours associated with the labeling requirements of section
403(y) of the FD&C Act and the Agency's recommendations on the use of
an explanatory statement will apply only to new product labels. Based
on the A.C. Nielsen Sales Scanner Data, FDA estimated that the number
of dietary supplement SKUs for which sales of the products are greater
than zero is 55,600. Assuming that the flow of new products is 10
percent per year, then approximately 5,560 new dietary supplement
products will come on the market each year. FDA also estimates that
there are about 1,460 dietary supplement manufacturers, re-packagers,
re-labelers, and holders of dietary supplements. Assuming the
approximately 5,560 new products are split equally among the firms,
then each firm would prepare labels for close to four new products per
year (5,560 new products/1,460 firms is approximately 3.8 labels per
firm). Thus, the estimated total annual disclosures are 5,560 (1,460
firms x 3.8 labels per year = 5,560).
The Agency expects 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 on their product labels. Based
upon its knowledge of food and dietary supplement labeling, FDA
estimates that firms would require less than 0.5 hour per product to
comply with the requirement to include the domestic address or
telephone number pursuant to section 403(y) of the FD&C Act. The total
hour burden of this task is shown in row 1 of table 1.
FDA estimates that all firms will include an explanatory statement
on the label, which lets consumers know the purpose of the domestic
address or telephone number on the label of the dietary supplement
product. Based upon its knowledge of food and dietary supplement
labeling, FDA estimates that firms would require less than 0.5 hour per
product to comply with the Agency's recommendations on the use of an
explanatory statement. The total hour burden of this task is shown in
row 2 of table 1.
The total reporting hour burden is 5,560 hours, which equals the
burden for the required domestic address or telephone (2,780) plus the
burden for the explanatory statement before the domestic address or
telephone number (2,780).
Dated: June 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14487 Filed 6-13-12; 8:45 am]
BILLING CODE 4160-01-P