[Federal Register Volume 77, Number 163 (Wednesday, August 22, 2012)]
[Notices]
[Pages 50699-50701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20602]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0564]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the

[[Page 50700]]

Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 21, 2012.

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 0910-0642. 
Also include the FDA 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, 301-796-5733, [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.

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) (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.
    In the Federal Register of June 14, 2012 (77 FR 35687), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. The Agency received no comments in response 
to the notice.
    FDA estimates the burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    Number of                         Average
            Activity                Number of    disclosures per   Total annual     burden per      Total hours
                                   respondents    respondent \2\    disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
Domestic address or phone                 1,460              3.8           5,560             0.2           1,112
 number labeling requirement...
(21 U.S.C. 343(y)).............
FDA recommendation for label              1,460              3.8           5,560             0.2           1,112
 statement explaining purpose
 of domestic address or phone
 number........................
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............           2,224
----------------------------------------------------------------------------------------------------------------
\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 stock keeping units 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 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 0.2 hours 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 0.2 hour per 
product to comply with the Agency's recommendations on the use

[[Page 50701]]

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 2,224 hours, which equals the 
burden for the required domestic address or telephone (1,112 hours) 
plus the burden for the explanatory statement before the domestic 
address or telephone number (1,112 hours). This estimate is 3,336 hours 
lower than the 5,560 hours reported in the 60-day notice published June 
14, 2012, due to an Agency reassessment that 0.2 hours per disclosure 
more accurately reflects the burden. This reassessment is based on the 
Agency's expectation that firms, estimated to design four new labels 
per year, are familiar with the requirement to include the domestic 
address or telephone number in their product labels. It is also based 
on FDA's recommendations on the use of an explanatory statement and our 
expectation that the disclosed information (domestic address or 
telephone number and explanatory statement) would not change from 
product label to product label. Thus, FDA estimates that firms would 
not need a full hour per label, but rather, approximately 24 minutes 
per label to include this information.

    Dated: August 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20602 Filed 8-21-12; 8:45 am]
BILLING CODE 4160-01-P