Document ID: FDA-2012-N-0454-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application, etc.
Posted Date: 2012-05-15T04:00Z

[Federal Register Volume 77, Number 94 (Tuesday, May 15, 2012)]
[Notices]
[Pages 28604-28605]
From the Federal Register Online via the Government Printing 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, 
juanmanuel.vilela@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, 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