[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      disclosures    Total annual       Average
            Activity                respondents         per         disclosures     burden per      Total hours
                                                  respondent \2\                    disclosure
----------------------------------------------------------------------------------------------------------------
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.........................
                                 -------------------------------------------------------------------------------

[[Page 35688]]

 
    Total.......................  ..............  ..............  ..............  ..............          5,560
----------------------------------------------------------------------------------------------------------------
\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