[Federal Register Volume 74, Number 191 (Monday, October 5, 2009)]
[Notices]
[Page 51161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23875]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0447]


Draft Guidance for Industry on Helicobacter pylori-Associated 
Duodenal Ulcer Disease in Adults: 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availability of a draft guidance for industry entitled ``Helicobacter 
pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs 
for Treatment.'' The purpose of this draft guidance is to assist 
sponsors in clinical drug development for the treatment of adults with 
duodenal ulcers caused by H. pylori for the reduction of duodenal ulcer 
recurrence. Specifically, this guidance addresses FDA's current 
thinking regarding the overall development program and clinical trial 
designs to support antimicrobial-containing H. pylori treatment 
regimens.

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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 January 4, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. Submit written comments on the draft guidance to the 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.regulations.gov. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT:  Joette M. Meyer, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6130, Silver Spring, MD 20993-0002, 301-
796-1600.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Helicobacter pylori-Associated Duodenal Ulcer Disease in 
Adults: Developing Drugs for Treatment.'' The purpose of this draft 
guidance is to assist sponsors in clinical antimicrobial drug 
development for the treatment of adults with duodenal ulcers caused by 
H. pylori for the reduction of duodenal ulcer recurrence. This 
guidance, when finalized, will supersede advice given in the draft 
guidance for industry entitled ``Evaluating Clinical Studies of 
Antimicrobials in the Division of Anti-Infective Drug Products,'' 
published in 1997, which contains section V, regarding indication 25 H. 
pylori.
    This draft guidance pertains to development of drugs for the 
treatment of adults with duodenal ulcers. It does not address treatment 
of children, or those with other conditions also associated with H. 
pylori, including gastric ulcers and non-ulcer dyspepsia.
    Currently approved regimens for the treatment of adults with 
duodenal ulcers consist of multiple drugs used in combination. We 
anticipate that drug development for new drugs or regimens will occur 
in one of three ways: (1) Substitution of a new drug for one component 
of an approved regimen, (2) addition of a new drug to an approved 
regimen, and (3) development of a new regimen not studied previously. 
The draft guidance provides information on the type of study design and 
supportive information that should be provided for each of these 
development paths. Information is also provided regarding 
microbiological procedures and use of diagnostic testing to determine 
subject evaluability.
    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 
drugs for the treatment of H. pylori-associated duodenal ulcer disease 
in adults. 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 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 parts 312 and 314 have 
been approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively.

III. 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.

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.

    Dated: September 29, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23875 Filed 10-2-09; 8:45 am]
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