[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
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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
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Total 444,800
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\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