[Federal Register Volume 74, Number 35 (Tuesday, February 24, 2009)]
[Notices]
[Pages 8264-8265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3917]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0429] (formerly Docket No. 2007D-0496)
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Labeling of
Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act: Questions and Answers
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 (the PRA). Elsewhere in this issue of
the Federal Register, FDA is announcing that a proposed collection of
information regarding dietary supplement labeling requirements and
recommendations has been submitted for OMB 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 title ``Labeling of
Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act: Questions and Answers.'' Also include the
FDA docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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.
Labeling of Nonprescription Human Drug Products Marketed Without an
Approved Application as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act: Questions and Answers
On December 22, 2006, the President signed into law the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (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.
Section 502(x) of the act (21 U.S.C. 352(x)), which was added by
Public Law 109-462, requires the label of a nonprescription drug
product marketed without an approved application in the United States
to include a domestic address or domestic telephone number through
which a responsible person may receive a report of a serious adverse
event associated with the product. In the Federal Register of January
2, 2008 (73 FR 196), FDA announced the availability of a draft guidance
document entitled ``Questions and Answers Regarding the Labeling of
Nonprescription Human Drug Products Marketed Without an Approved
Application as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act.'' In the Federal Register of December 11,
2008 (73 FR 75436), FDA published a notice of availability of a revised
version of the same draft guidance document. The guidance document
contains questions and answers relating to the labeling requirement and
provides guidance to industry on the following topics: (1) The meaning
of ``domestic address'' for purposes of the labeling requirements of
section 502(x) 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 502(x) of
the act; and (3) FDA's intent regarding enforcing the labeling
requirements of section 502(x) of the act.
Title: Labeling of Nonprescription Human Drug Products Marketed
Without an Approved Application as Required by the Dietary Supplement
and Nonprescription Drug Consumer Protection Act: Questions and
Answers.
Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors whose name
(under section 502(b)(1) of the act (21 U.S.C. 352(b)(1))) appears on
the label of a nonprescription drug product marketed in the United
States without an approved application.
Burden Estimate: FDA is requesting public comment on the estimated
one-time reporting burden from these respondents, as required by 502(x)
of the act and described in the guidance ``Labeling of Nonprescription
Human Drug Products Marketed Without an Approved Application as
Required by
[[Page 8265]]
the Dietary Supplement and Nonprescription Drug Consumer Protection
Act: Questions and Answers.'' The estimates for one-time reporting are
based on FDA's knowledge of nonprescription drug product labeling in
the United States, whether or not marketed under an approved
application.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden \1\
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No. of Frequency per Hours per
Respondents Response Total Responses Response Total Hours
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Domestic 200 500 100,000 4 400,000
address or
telephone
number
labeling
requirement
(21 U.S.C.
502(x)) and
recommendatio
n to clarify
its purpose
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\1\ There are no capital costs or maintenance and operating costs associated with this collection of
information.
As indicated in Table 1 of this document, we estimate that
approximately 200 manufacturers will revise approximately 100,000
labels to add a full domestic address and a domestic telephone number,
and should they choose to adopt the guidance's recommendation, to add a
statement identifying the purpose of the domestic address or telephone
number. FDA believes that designing the label change should not take
longer than 4 hours per label. Automated printing of the labels should
only require a few seconds per label. This estimate accounts for the
possibility that every manufacturer will make label revision, which is
unlikely. Because the majority of over-the-counter drug product labels
currently have a domestic telephone number that satisfies the
requirement, we believe many manufacturers will opt not to adopt the
guidance's recommendation to add a statement identifying the purpose of
the address or telephone number, significantly reducing the number of
total responses. However, assuming that all labels are revised,
estimate a one-time reporting burden for this information collection of
400,000 hours.
In the Federal Register of January 2, 2008 (73 FR 196), 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 those
proposed collections of information, and provided 60 days for public
comment under the 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.
FDA received one comment on the proposed collections of
information, stating that the time involved in revising labels would be
significantly longer than the typical timeframe to implement labeling
changes because the volume of labels required to be revised at one time
might exceed manufacturers' labeling revision capacity. Several
comments requested that FDA extend the date of its enforcement
discretion. In response to comments, in December 2008, FDA published a
notice of availability of the revised draft guidance for industry. The
revised draft guidance was identical to the first draft guidance, with
the exception that, in the revised draft guidance, FDA stated its
intention to exercise enforcement discretion until January 1, 2010. As
a result, any label revision made as a result of this guidance would
likely be made contemporaneously with other scheduled label revisions,
minimizing the burden to industry.
Dated: February 17, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-3917 Filed 2-23-09; 8:45 am]
BILLING CODE 4160-01-S