
[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66744-66745]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26549]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1319]


Draft Guidance for Industry on Pulmonary Tuberculosis: Developing 
Drugs for Treatment; 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availability of a draft guidance for industry entitled ``Pulmonary 
Tuberculosis: Developing Drugs for Treatment.'' The purpose of the 
draft guidance is to assist sponsors in the development of 
antimycobacterial drugs for the treatment of pulmonary tuberculosis. 
This guidance applies to the development of a single investigational 
drug as well as development of two or more unmarketed investigational 
drugs for use in combination.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 4, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Eileen Navarro, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6126, Silver Spring, MD 20993-0002, 301-
796-1300; or 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 ``Pulmonary Tuberculosis: Developing Drugs for Treatment.'' 
The purpose of this draft guidance is to assist sponsors in the 
development of antimycobacterial drugs for the treatment of pulmonary 
tuberculosis.
    Tuberculosis remains endemic in the United States and is epidemic 
in many parts of the world. Current treatment for tuberculosis involves 
administration of multiple-drug regimens for a minimum of 6 months. The 
development of new drugs for treatment of pulmonary tuberculosis 
remains an important public health goal. Some of the public health 
challenges to be addressed in the treatment of tuberculosis include: 
(1) The administration of new drug regimens for shorter periods of 
time; (2) new drugs that do not have drug-drug interactions with the 
drugs used to treat human immunodeficiency virus/acquired 
immunodeficiency syndrome; and (3) new drugs that are active in the 
treatment of patients with drug-resistant tuberculosis. This draft 
guidance addresses these issues in the context of clinical trial 
designs for new drugs. The draft guidance addresses the complexities of 
the superiority clinical trial design, where an investigational drug is 
found to be superior on a clinical endpoint while ensuring that all 
patients in trials receive appropriately active treatment regimens. The 
draft guidance includes a discussion of noninferiority clinical trial 
designs, with justification for a noninferiority margin in the setting 
of treatment-shortening regimens. The draft guidance also discusses 
clinical trials designed to include patients with drug-resistant 
tuberculosis.
    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 ``Pulmonary 
Tuberculosis: Developing Drugs for Treatment.'' 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 draft 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, respectively.

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.


[[Page 66745]]


    Dated: October 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26549 Filed 11-5-13; 8:45 am]
BILLING CODE 4160-01-P


