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, 42502-42503 [2015-17558]
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Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
srobinson on DSK5SPTVN1PROD with NOTICES
to assist sponsors developing drugs to
identify nonclinical signals of testicular
toxicity and to evaluate the potential for
such toxicity in humans.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 15,
2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Eufrecina Deguia, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5348,
Silver Spring, MD 20993–0002, 301–
796–0881.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Testicular Toxicity: Evaluation During
Drug Development.’’ This draft guidance
is intended to help sponsors identify
nonclinical signals that raise concern
regarding the potential for human
testicular toxicity and to evaluate those
signals appropriately in human studies.
The draft guidance describes the
standard battery of nonclinical studies
that are used to assess the effects of
pharmaceuticals on the male
reproductive system. The draft guidance
discusses findings in nonclinical studies
that may increase the level of concern
for drug-related testicular toxicity.
Examples of nonclinical studies that
could be used to further evaluate initial
signals of testicular toxicity are also
described. The draft guidance then
provides a general approach on how to
weigh the relevance of nonclinical
findings, taking into account factors that
can confound the interpretation of these
findings.
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If a concerning nonclinical signal is
identified, the draft guidance presents
suggestions for clinical monitoring
when the drug is initially administered
to humans. These suggestions aim to
minimize the hazards to men while
making possible the collection of data
that will assist in evaluating the
potential toxicity of the drug in the
target population. These early studies,
however, are not intended to be a
definitive evaluation of the potential for
testicular toxicity of the drug. Rather,
they can provide clinical information
that, together with the nonclinical
information, will support a judgment as
to whether the testicular toxicity signal
warrants indepth evaluation in a
dedicated safety study.
If a reasonable basis for concern of
human testicular toxicity exists, a
dedicated clinical safety trial with a
primary objective of evaluating drugrelated testicular toxicity may be
warranted. The draft guidance provides
recommendations for the design of such
a trial, including conduct, endpoints,
and presentation of results. These are
general recommendations for the
purpose of defining the role of drugs in
testicular injury; however, the specific
details of an individual trial may vary
depending on the context of use of the
drug product.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the evaluation of testicular toxicity
during drug development. It does not
establish rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
PO 00000
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docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: July 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17557 Filed 7–16–15; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by September 15, 2015.
ADDRESSES: Submit electronic
comments on the collection of
DATES:
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42503
Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
information via the internet at https://
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.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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
SUPPLEMENTARY INFORMATION:
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
Activity
Number
of respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Including a domestic address or phone number and a
statement of its purpose on OTC drug labeling (21
U.S.C. 502(x)) ..................................................................
300
3
900
4
3,600
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]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0967]
BILLING CODE 4164–01–P
srobinson on DSK5SPTVN1PROD with NOTICES
Public Meeting on Patient-Focused
Drug Development for Huntington’s
and Parkinson’s Diseases
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing a public meeting and an
opportunity for public comment on
SUMMARY:
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Patient-Focused Drug Development for
Huntington’s disease and Parkinson’s
disease. Patient-Focused Drug
Development is part of FDA’s
performance commitments made as part
of the fifth authorization of the
Prescription Drug User Fee Act (PDUFA
V). The public meeting is intended to
allow FDA to obtain patient
perspectives on the impact of
Huntington’s disease and Parkinson’s
disease on daily life and patient views
on treatment approaches. Although
these are both neurological diseases,
since they are quite distinct, FDA will
structure this public meeting into two
distinct sessions. The morning session,
scheduled from 9 a.m. to 1 p.m., will be
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
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))...................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
