Testicular Toxicity: Evaluation During Drug Development; Draft Guidance for Industry; Availability, 42501-42502 [2015-17557]

Download as PDF 42501 Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices comments should be received within 30 days of this notice. Proposed Project National Disease Surveillance Program III—CDC Support for Case Investigation, Contact Tracing, and Case Reports—New—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description The international outbreak of Ebola virus disease (EVD) in West Africa began March 10, 2014. The initial cases were from southern Guinea, near its rural border with Liberia and Sierra Leone. Highly mobile populations contributed to increasing waves of person-to-person transmission of EVD that occurred in multiple countries in West Africa. The CDC activated its Emergency Operations Center on July 9, information collection request to initiate multiple urgently needed information collections in West Africa, at U.S. ports of entry, and within STL jurisdictions. These information collections allowed the agency to accomplish its primary mission on many fronts to quickly prevent public harm, illness, and death from the uncontrolled spread of EVD. This new collection of information is designed to allow CDC to conduct active disease surveillance in support of and at the request of STL authorities among respondents that may include the general public, workers, and STL authorities. This should cut down on the need for multiple steps in emergency requests that were experienced in the first year of the 2014 Ebola virus response. There are no costs to the respondents other than their time. The total annualized burden requested is 14,702 hours. 2014 to help coordinate technical assistance and control activities with international partners and to deploy teams of public health experts to the affected countries. The operations turned to the United States (U.S.) when the first imported case of EVD was diagnosed in Texas on September 30, 2014. In response, on October 11, 2014, the CDC Quarantine Stations and the Department of Homeland Security Customs and Border Patrol mobilized to screen, detect, and refer arriving travelers who were potential persons at risk for EVD to appropriate state, territorial, and local (STL) authorities. The CDC also increased its commitment to support STL public health authorities to combat and control the spread of EVD within their jurisdictions. Thus in 2014, the CDC requested and received an expedited emergency review and approval from OMB of an 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 ...................................... Laboratory Personnel ...................................... Environmental Services Personnel ................. Environmental Services Personnel ................. State, Territorial, and Local Public Health Authorities and Their Delegates. Total ......................................................... srobinson on DSK5SPTVN1PROD with NOTICES Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. 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 ......................................................................... ........................ ........................ ........................ 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 http:// 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 http://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 http:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or http:// 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]


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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: 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 http://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 http://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 http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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