Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability, 66744-66745 [2013-26549]

Download as PDF 66744 Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Notices requirements of the applicable statutes and regulations. II. 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. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. Dated: October 31, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–26570 Filed 11–5–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1319] Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Pulmonary Tuberculosis: Developing Drugs for Treatment.’’ The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:25 Nov 05, 2013 Jkt 232001 either electronic or written comments on the draft guidance by February 4, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201,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 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 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 treatmentshortening 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/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. E:\FR\FM\06NON1.SGM 06NON1 Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Notices Dated: October 30, 2013. Leslie Kux, Assistant Commissioner for Policy. recommendations 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: Kris ´ Andre, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240–276–8866. SUPPLEMENTARY INFORMATION: [FR Doc. 2013–26549 Filed 11–5–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide productspecific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. 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 comments on these draft and revised draft guidances before it begins work on the final versions of the guidances, submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by January 6, 2014. ADDRESSES: Submit written requests for single copies of the individual BE guidances 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 selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance recommendations. Submit electronic comments on the draft product-specific BE mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:25 Nov 05, 2013 Jkt 232001 I. Background In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make productspecific BE recommendations available to the public on FDA’s Web site at http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. Under that process, draft recommendations are posted on FDA’s Web site and announced periodically in the Federal Register. The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register. FDA considers any comments received and either publishes final recommendations or publishes revised draft recommendations for comment. Recommendations were last announced in the Federal Register on June 20, 2013 (78 FR 37230). This notice announces draft product-specific recommendations, either new or revised, that are being posted on FDA’s Web site concurrently with publication of this notice. 66745 TABLE 1—NEW DRAFT PRODUCT-SPECIFIC BE RECOMMENDATIONS FOR DRUG PRODUCTS—Continued M ............ N ............ P ............ Mesna. Methenamine hippurate. Methocarbamol. Nicotine (multiple reference listed drugs). Nicotine polacrilex (multiple reference listed drugs). Phentermine hydrochloride. Prednisone. III. Drug Products for Which Revised Draft Product-Specific BE Recommendations Are Available FDA is announcing revised draft product-specific BE recommendations for drug products containing the following active ingredients: TABLE 2—REVISED DRAFT PRODUCTSPECIFIC BE RECOMMENDATIONS FOR DRUG PRODUCTS A ............ B ............ C ............ D ............ L ............. O ............ R ............ T ............. Acitretin. Amphetamine aspartate; Amphetamine sulfate; Dextroamphetamine saccharate; Dextroamphetamine sulfate. Bumetanide. Bupropion hydrobromide. Bupropion hydrochloride (multiple reference listed drugs and dosage forms). Cefixime. Celecoxib. Colesevelam hydrochloride. Doxorubicin hydrochloride. Drospirenone; Ethinyl estradiol. Lanthanum carbonate. Lenalidomide. Oxybutynin chloride. Rivastigmine. Tacrolimus (multiple strengths). Testosterone (multiple reference listed drugs and dosage forms). For a complete history of previously published Federal Register notices related to product-specific BE recommendations, please go to http:// II. Drug Products for Which New Draft www.regulations.gov and enter Docket Product-Specific BE Recommendations No. FDA–2007–D–0369. Are Available These draft and revised draft FDA is announcing new draft guidances are being issued consistent product-specific BE recommendations with FDA’s good guidance practices for drug products containing the regulation (21 CFR 10.115). These following active ingredients: guidances represent the Agency’s TABLE 1—NEW DRAFT PRODUCT-SPE- current thinking on product-specific design of BE studies to support ANDAs. CIFIC BE RECOMMENDATIONS FOR They do not create or confer any rights DRUG PRODUCTS for or on any person and do not operate to bind FDA or the public. An B ............ Bedaquiline fumarate. alternative approach may be used if Bupropion hydrochloride. such approach satisfies the C ............ Clobazam. E ............ Etodolac (multiple reference listed requirements of the applicable statutes and regulations. drugs and dosage forms). PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\06NON1.SGM 06NON1

Agencies

[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]


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

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.

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

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