[Federal Register Volume 74, Number 35 (Tuesday, February 24, 2009)]
[Notices]
[Pages 8262-8264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3916]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0209] (formerly Docket No. 2007D-0491)


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.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995. Elsewhere in this issue of the Federal 
Register, FDA is announcing that a proposed collection of information 
regarding labeling requirements for nonprescription human drugs 
marketed without an approved application has been submitted to OMB for 
review.

DATES: Fax written comments on the collection of information by March 
26, 2009.

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: 202-395-6974, or e-mailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title, ``Dietary Supplement Labeling Requirements and Recommendations 
under the Dietary Supplement and Nonprescription Drug Consumer 
Protection Act.'' Also include the FDA docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of 
Information Management (HFA-710), Food and Drug

[[Page 8263]]

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3794.

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

    On December 22, 2006, the President signed into law the Dietary 
Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) 
(Public Law 109-462, 120 Stat. 3469). This law amends the Federal Food, 
Drug, and Cosmetic Act (the act) with respect to serious adverse event 
reporting for dietary supplements and nonprescription drugs marketed 
without an approved application. The law also amended the 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 January 2, 2008 (73 FR 197), FDA 
announced the availability of a draft guidance document entitled 
``Questions and Answers Regarding the Labeling of Dietary Supplements 
as Required by the Dietary Supplement and Nonprescription Drug Consumer 
Protection Act. '' In the Federal Register of December 11, 2008 (73 FR 
75438), FDA announced the availability of a revised version of the same 
draft guidance document . The guidance document contains questions and 
answers relating to the labeling requirements in section 403(y) of the 
act and provides guidance to industry on the following topics: (1) The 
meaning of ``domestic address'' for purposes of the labeling 
requirements of section 403(y) of the act; (2) FDA's recommendation for 
the use of an introductory statement before the domestic address or 
telephone number that is required to appear on the product label under 
section 403(y) of the act; and (3) FDA's intent regarding enforcing the 
labeling requirements of section 403(y) of the act.
    In the Federal Register of January 2, 2008 (73 FR 197), FDA 
published a notice of availability for the original draft guidance that 
also gave notice of the proposed collections of information in the 
draft guidance, included an analysis and burden estimate for these 
proposed collections of information, and provided 60 days for public 
comment under the Paperwork Reduction Act of 1995 (PRA). FDA did not 
revise the PRA burden analysis and estimate when it issued the revised 
draft guidance in December 2008 because the revisions did not affect 
them.
    Several comments suggested that FDA underestimated the number of 
dietary supplement labels that would have to be revised. Two comments 
noted that in the past FDA had estimated the number of distinct dietary 
supplement labels at 29,514, and another comment noted that in the past 
FDA had estimated the number of distinct dietary supplement labels at 
75,000. Several other comments suggested that the number of dietary 
supplements sold in the United States was between 50,000 and 60,000 
products based on information from the Office of Dietary Supplements at 
the National Institutes of Health (NIH). All the aforementioned 
comments suggested that the costs associated with re-labeling the 
dietary supplements represented a significant burden to the industry. 
Based on these comments, FDA has revised its estimate of the number of 
labels that would have to be redesigned to include the complete 
domestic address or domestic telephone number of the responsible person 
for each dietary supplement stockkeeping unit (SKU).
    FDA used A.C. Nielsen Sales Scanner Data from 2004 to improve its 
estimate of the number of dietary supplement SKUs. The 2004 A.C. 
Nielsen scanner data are more recent and more complete than the data 
FDA used to derive the estimate used in the 60-day notice. FDA also 
adjusted the Nielsen scanner data estimate to account for methods of 
sale not covered by the Nielsen scanner data, such as non-participating 
retailers and internet sales. Based on the adjusted Nielsen scanner 
data, FDA estimates that the number of dietary supplement SKUs for 
which sales of the products are greater than zero is 55,600. This 
number of SKUs is similar to the number of dietary supplement products 
that was suggested by several comments and the number estimated by the 
Office of Dietary Supplements at NIH.
    FDA did not receive any comments regarding the number of firms that 
would be responsible for re-labeling the dietary supplement products. 
Therefore, we retain our estimate that there are about 1,460 dietary 
supplement firms that must comply with the labeling requirements of 
section 403(y) of the act. Assuming the 55,600 SKUs are split equally 
among the firms, then each firm would be responsible for updating about 
38 SKUs. FDA also did not receive any comments regarding how many of 
the dietary supplement SKUs would have to undergo a label change to 
include the complete domestic address or domestic phone number of the 
responsible person as required by the DSNDCPA. Thus, as in the 60-day 
notice, FDA is assuming conservatively that all labels will need to be 
redesigned.
    Several comments noted that the overall process of changing a label 
requires a significant amount of time to implement; however, FDA did 
not receive any estimates of the actual time it would take to assess 
the current layout of each label and redesign it. FDA also did not 
receive any estimates of how many firms would choose to include an 
explanatory statement on the reason for the domestic address or 
telephone number appearing on the label of the dietary supplement 
product, though several comments speculated that all or nearly all 
firms would be likely to include an explanatory statement. Because we 
did not receive any comments on the burden associated with each of 
these tasks, we retain our original estimates. We assume conservatively 
that all firms will include an explanatory statement on the label, and 
we estimate that the redesign of each label to include the domestic 
address or telephone number and the explanatory statement will take a 
total of 8 hours (4 hours for each change).
    FDA estimates the burden of this collection of information as 
follows:

Hour Burden Estimate

[[Page 8264]]



                                Table 1.--Estimated One-Time Reporting Burden \1\
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                      No. of       Annual Frequency per     Total annual        Hours Per
                   Respondents           Response            Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Domestic                    1,460               38.0822             55,600                  4            222,400
 address or
 telephone
 number
 labeling
 requirement
 (21 U.S.C.
 343(y))
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FDA                         1,460               38.0822             55,600                  4            222,400
 recommendatio
 n for label
 statement
 explaining
 purpose of
 domestic
 address or
 telephone
 number
----------------------------------------------------------------------------------------------------------------
Total                                                                                                    444,800
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or maintenance and operating costs associated with this collection of
  information.


    Dated: February 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3916 Filed 2-23-09; 8:45 am]
BILLING CODE 4160-01-S