
[Federal Register Volume 78, Number 13 (Friday, January 18, 2013)]
[Notices]
[Pages 4153-4154]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01031]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0032]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Labeling; Notification Procedures for Statements 
on Dietary Supplements

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. 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 
invites comments on the information collection provisions of the 
regulation requiring manufacturers, packers, and distributors of 
dietary supplements to notify us that they are marketing a dietary 
supplement product that bears on its label or in its labeling a 
statement provided for in the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act).

DATES: Submit either electronic or written comments on the collection 
of information by March 19, 2013.

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, domini.bean@fda.hhs.gov.

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, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility;

[[Page 4154]]

(2) the accuracy of our 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.

Food Labeling; Notification Procedures for Statements on Dietary 
Supplements--21 CFR 101.93 (OMB Control Number 0910-0331--Extension)

    Section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) requires 
that FDA be notified by manufacturers, packers, and distributors of 
dietary supplements that they are marketing a dietary supplement 
product that bears on its label or in its labeling a statement provided 
for in section 403(r)(6) of the FD&C Act. Section 403(r)(6) of the FD&C 
Act requires that FDA be notified, with a submission about such 
statements, no later than 30 days after the first marketing of the 
dietary supplement. Information that is required in the submission 
includes: (1) The name and address of the manufacturer, packer, or 
distributor of the dietary supplement product; (2) the text of the 
statement that is being made; (3) the name of the dietary ingredient or 
supplement that is the subject of the statement; (4) the name of the 
dietary supplement (including the brand name); and (5) a signature of a 
responsible individual who can certify the accuracy of the information 
presented, and who must certify that the information contained in the 
notice is complete and accurate, and that the notifying firm has 
substantiation that the statement is truthful and not misleading.
    The procedural regulation for this program is codified at Sec.  
101.93 (21 CFR 101.93). Section 101.93 provides submission procedures 
and identifies the information that must be included in order to meet 
the requirements of section 403 of the FD&C Act.
    Description of Respondents: Respondents to this collection of 
information include manufacturers, packers, or distributors of dietary 
supplements that bear section 403(r)(6) of the FD&C Act statements on 
their labels or labeling.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                           21 CFR Section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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101.93.............................................................           2,200                1            2,200             0.75            1,650
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We believe that there will be minimal burden on the industry to 
generate information to meet the requirements of section 403 of the 
FD&C Act in submitting information regarding section 403(r)(6) of the 
FD&C Act statements on labels or in labeling of dietary supplements. We 
are requesting only information that is immediately available to the 
manufacturer, packer, or distributor of the dietary supplement that 
bears such a statement on its label or in its labeling. We estimate 
that, each year, approximately 2,200 firms will submit the information 
required by section 403 of the FD&C Act. We estimate that a firm will 
require 0.75 hours to gather the information needed and prepare a 
submission, for a total of 1,650 hours (2,200 x 0.75). This estimate is 
based on the average number of notification submissions received by us 
in the preceding 3 years.

    Dated: January 14, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01031 Filed 1-17-13; 8:45 am]
BILLING CODE 4160-01-P


