Document ID: FDA-2007-D-0429-0025
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2015-07-17T04:00Z

[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42502-42503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17558]

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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; 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 notice solicits comments on certain labeling statements 
for nonprescription human drug products marketed without an approved 
application.

DATES: Submit either electronic or written comments on the collection 
of information by September 15, 2015.

ADDRESSES: Submit electronic comments on the collection of

[[Page 42503]]

information via the internet at http://www.regulations.gov. Submit 
written comments on the collection of information to the Dockets 
Management Branch (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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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: (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 0910-0641--Extension

    Section 502(x) of the FD&C Act (21 U.S.C. 352(x)), which was added 
by the Dietary Supplement and Nonprescription Drug Consumer Protection 
Act (Pub. L. 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 manufacturer, packer, and distributor 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.
    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.
    FDA estimates the burden of this collection of information as 
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
                              Activity                                  Number  of    disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures    per  disclosure
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Including a domestic address or phone number and a statement of its             300                3              900                4            3,600
 purpose on OTC drug labeling (21 U.S.C. 502(x))...................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: July 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17558 Filed 7-16-15; 8:45 am]
 BILLING CODE 4164-01-P