[Federal Register Volume 76, Number 164 (Wednesday, August 24, 2011)]
[Notices]
[Page 52958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21630]



[[Page 52958]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Neglected Tropical Diseases of the 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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Neglected 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 clinical development of drugs for the treatment or 
prevention of neglected diseases of the developing world. Specifically, 
this guidance addresses FDA's current thinking regarding the overall 
drug development program for the treatment or prevention of neglected 
tropical diseases (NTDs), including clinical trial designs and internal 
review standards to support approval of drugs.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 22, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 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 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: 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 draft guidance for industry 
entitled ``Neglected Tropical Diseases of the Developing World: 
Developing Drugs for Treatment or Prevention.'' This guidance addresses 
section 740 of the Agriculture, Rural Development, Food and Drug 
Administration and Related Agencies Appropriations Act, 2010 (Pub. L. 
111-80), dated October 21, 2009, that directed FDA to provide guidance 
in the form of general recommendations and regulatory considerations 
for drugs being developed for the treatment or prevention of NTDs. 
NTDs, as defined in section 524(a)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360n(a)(3)), are infectious diseases that 
generally are 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.
    The purpose of this draft guidance is to provide recommendations to 
sponsors and investigators who are involved in the development of drugs 
for the treatment or prevention of NTDs. This guidance is intended to 
clarify the regulatory requirements for drug approval in the United 
States as well as the internal review standards for drugs for NTDs. 
This guidance is directed at sponsors who lack general knowledge about 
drug development issues. Potential sponsors should understand that: (1) 
FDA will review and comment on clinical development programs for NTDs 
under an investigational new drug application submission, regardless of 
where the clinical development will take place; (2) FDA can approve a 
drug for treatment of an NTD not endemic in the United States; (3) the 
regulatory pathways and internal review standards for approval of drugs 
for NTDs are the same as for approval of drugs for diseases endemic in 
the United States; and (4) FDA is committed to exercising its 
regulatory authorities to facilitate access to therapies that can help 
reduce morbidity and mortality associated with NTDs.
    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 Agency's current thinking on this topic. 
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 have been 
approved under OMB control number 0910-0014.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed 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.

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: August 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21630 Filed 8-23-11; 8:45 am]
BILLING CODE 4160-01-P