[Federal Register Volume 77, Number 94 (Tuesday, May 15, 2012)]
[Notices]
[Pages 28604-28605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-11688]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0454]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on 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
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 by the Agency. 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 guidance solicits comments on ``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.''
DATES: Submit either electronic or written comments on the collection
of information by July 16, 2012.
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: Juanmanuel Vilela,Office of
Information Management, Food and Drug Administration,1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-7651,
[email protected].
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, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's 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.
Guidance for Industry on 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--(OMB Control Number 0910-0640)--Extension
On December 22, 2006, the President signed into law the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (Pub. L.
109-462, 120 Stat. 3469). This law amends 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.
Section 502(x) of the FD&C 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. The guidance document contains
questions and answers relating to this 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 FD&C Act; (2) FDA's recommendation for the use of
an introductory statement before the domestic address or phone number
that is required to appear on the product label under section 502(x) of
the FD&C Act; and (3) FDA's intent regarding enforcing the labeling
requirements of section 502(x) of the FD&C Act. Separate guidance,
issued by the Center for Food Safety and Applied Nutrition on reporting
for dietary supplements, is announced elsewhere in the Federal
Register.
Title: Guidance for Industry on 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.
Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors whose name
(pursuant to section 502(b)(1) of the FD&C Act) appears on the label of
a nonprescription drug product marketed in the United States without an
approved application.
[[Page 28605]]
Burden Estimate: FDA is requesting public comment on the estimated
one-time reporting burden from these respondents, as required by 502(x)
of the FD&C Act and described in the guidance ``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.'' 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 One-Time Reporting Burden \1\
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Number of
Number of responses per Total Average burden Total hours
respondents respondent responses per response
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Domestic address or phone number labeling requirement (21 U.S.C. 200 500 100,000 4 400,000
502(x)) and recommendation to clarify its purpose.................
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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 draft 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, we estimate a one-time reporting burden for this information
collection of 400,000 hours.
Dated: May 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11688 Filed 5-14-12; 8:45 am]
BILLING CODE 4160-01-P