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Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability

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Information about this document as published in the Federal Register.

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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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Pulmonary Tuberculosis: Developing Drugs for Treatment.” The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 4, 2014.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Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201,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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

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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.

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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FDA is announcing the availability of a draft guidance for industry entitled “Pulmonary Tuberculosis: Developing Drugs for Treatment.”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.

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Dated: October 30, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2013-26549 Filed 11-5-13; 8:45 am]

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