[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 This guidance finalizes the draft guidance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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