[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66744-66745]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry on Pulmonary Tuberculosis: Developing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availability of a draft guidance for industry entitled ``Pulmonary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draft guidance is to assist sponsors in the development of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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 4, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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]
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