[Federal Register Volume 79, Number 129 (Monday, July 7, 2014)]
[Notices]
[Pages 38319-38320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-15801]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0587]


Guidance for Industry on Neglected Tropical Diseases of the 
Developing World: Developing Drugs for Treatment or Prevention; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Neglected Tropical 
Diseases of the Developing World: Developing Drugs for Treatment or 
Prevention.'' The purpose of the guidance is to assist sponsors in the 
development of drugs for the treatment or prevention of neglected 
tropical diseases (NTDs). This guidance represents the FDA's current 
thinking regarding drug development for the treatment or prevention of 
NTDs, including clinical trial designs and internal review standards to 
support approval of drugs. This guidance finalizes the draft guidance 
issued August 24, 2011.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your

[[Page 38320]]

requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the 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: Joseph G. Toerner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Neglected Tropical Diseases of the Developing World: 
Developing Drugs for Treatment or Prevention.'' The purpose of this 
guidance is to assist sponsors in the development of drugs for the 
treatment or prevention of NTDs as defined in section 524(a)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(3)).
    NTDs are infectious diseases that are generally rare or absent in 
developed countries, but are often widespread in developing countries. 
The availability of new drugs that are safe and effective for treatment 
or prevention of NTDs could provide public health benefit for overall 
global health.
    This guidance addresses general issues in drug development and 
implementation of clinical trials for NTDs. FDA will review and comment 
on drug development plans and will review new drug applications or 
biologics license applications for new drugs for NTDs, regardless of 
where the clinical development program takes place. Specifically, the 
guidance provides a general overview of nonclinical development 
considerations, as well as clinical development considerations and 
regulatory paradigms. Other activities in the Center for Drug 
Evaluation and Research that pertain to NTDs are summarized in the 
guidance. Listings of guidance documents that are most relevant to drug 
development for NTDs are included in the guidance.
    This guidance finalizes the draft guidance issued August 24, 2011. 
Comments on the draft guidance were considered while finalizing this 
guidance. Specifically, changes from the draft guidance include 
descriptions of new regulatory designations (Qualified Infectious 
Disease Product; Breakthrough Therapy).
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on developing drugs for the treatment or 
prevention of neglected tropical diseases of the developing world. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that 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 and 21 CFR 
part 314 have been approved under OMB control numbers 0910-0014 and 
0910-0001.

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 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15801 Filed 7-3-14; 8:45 am]
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