[Federal Register Volume 72, Number 109 (Thursday, June 7, 2007)]
[Notices]
[Page 31590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-11001]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0212]


Draft Guidance for Industry on Malaria: Developing Drug and 
Nonvaccine Biological Products for Treatment and Prophylaxis; 
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availability of a draft guidance for industry entitled ``Malaria: 
Developing Drug and Nonvaccine Biological Products for Treatment and 
Prophylaxis.'' This draft guidance addresses issues regarding the 
development of therapy for prophylaxis and treatment of malaria. 
Specific topics include recommendations for preclinical development, 
clinical trial study design, the use of microbiological testing during 
clinical trials, and statistical considerations.

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by September 5, 2007.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance to the Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Leonard Sacks, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6178, Silver Spring, MD 20993-0002, 301-
796-1600.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Malaria: Developing Drug and Nonvaccine Biological Products 
for Treatment and Prophylaxis.'' Malaria is a major global problem with 
the greatest burden of disease and mortality occurring in developing 
countries. Although cases of malaria are uncommon in the United States, 
antimalarial drugs have significant public health importance in the 
United States: Antimalarial prophylaxis is used extensively by U.S. 
travelers and by U.S. citizens residing in or deployed to endemic areas 
(e.g., military personnel).
    This guidance addresses the development of therapy for the 
prophylaxis and treatment of malaria. Overall aspects of a 
developmental program for antimalarial therapy are discussed. Specific 
topics include recommendations for preclinical development, clinical 
trial study design, the use of microbiological testing during clinical 
trials, and statistical considerations.
    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 developing 
drug and nonvaccine biological products for the treatment and 
prophylaxis of malaria. 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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/ohrms/dockets/default.htm or http://www.fda.gov/cder/guidance/index.htm.

    Dated: May 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11001 Filed 6-6-07; 8:45 am]
BILLING CODE 4160-01-S