[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, [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: (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