Testicular Toxicity: Evaluation During Drug Development; Draft Guidance for Industry; Availability, 42501-42502 [2015-17557]
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Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
General Public—Case ....................................
Ebola Virus Disease Case Investigation
Form—United States.
Symptom Monitoring Form .............................
Ebola Virus Disease Person Under Investigation (PUI) Form.
Symptom Monitoring Form .............................
General Public—Case ....................................
General Public—Person Under Investigation
(PUI).
General Public—Person Under Investigation
(PUI).
General Public—Contact ................................
General Public—Contact ................................
Healthcare Workers ........................................
Healthcare Workers ........................................
Laboratory Personnel ......................................
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State, Territorial, and Local Public Health Authorities and Their Delegates.
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srobinson on DSK5SPTVN1PROD with NOTICES
Leroy A. Richardson,
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1
30/60
15
300
42
1
5/60
10/60
300
42
5/60
Ebola Virus Disease Contact Tracing Form—
United States.
Symptom Monitoring Form .............................
Ebola Virus Disease Tracking Form for
Healthcare Workers with Direct Patient
Contact.
Symptom Monitoring Form .............................
Ebola Tracking Form for Laboratory Personnel.
Symptom Monitoring Form .............................
Ebola Tracking Form for Environmental
Services Personnel.
Symptom Monitoring Form .............................
White House Evening Report ........................
105
1
10/60
105
600
42
15
5/60
10/60
600
600
57
15
5/60
10/60
600
600
57
15
5/60
10/60
600
15
57
42
5/60
10/60
.........................................................................
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–2306]
Testicular Toxicity: Evaluation During
Drug Development; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Sep<11>2014
20:59 Jul 16, 2015
Jkt 235001
Avg. burden
per response
(in hrs.)
15
[FR Doc. 2015–17554 Filed 7–16–15; 8:45 am]
BILLING CODE 4163–18–P
Number of
responses per
respondent
PO 00000
Notice.
Frm 00035
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Testicular Toxicity: Evaluation During
Drug Development.’’ The draft guidance
addresses nonclinical findings that may
raise concerns of a drug-related adverse
effect on the testes, clinical monitoring
of adverse testicular effects early in
clinical development, and the design
and conduct of a safety clinical trial
assessing drug-related testicular
toxicity. The draft guidance is intended
SUMMARY:
E:\FR\FM\17JYN1.SGM
17JYN1
42502
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.
VerDate Sep<11>2014
20:59 Jul 16, 2015
Jkt 235001
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
Frm 00036
Fmt 4703
Sfmt 4703
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:
E:\FR\FM\17JYN1.SGM
17JYN1
]]>Agencies
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42501-42502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17557]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-2306]
Testicular Toxicity: Evaluation During Drug Development; Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Testicular
Toxicity: Evaluation During Drug Development.'' The draft guidance
addresses nonclinical findings that may raise concerns of a drug-
related adverse effect on the testes, clinical monitoring of adverse
testicular effects early in clinical development, and the design and
conduct of a safety clinical trial assessing drug-related testicular
toxicity. The draft guidance is intended
[[Page 42502]]
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.
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 drug-related 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 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/GuidanceComplianceRegulatoryInformation/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
