[Federal Register Volume 74, Number 181 (Monday, September 21, 2009)]
[Notices]
[Page 48080]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-22623]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0514]


Guidance for Industry on End-of-Phase 2A Meetings; 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 guidance for industry entitled ``End-of-Phase 2A 
Meetings.'' This guidance provides information on end-of-phase 2A 
(EOP2A) meetings for sponsors of investigational new drug applications 
(INDs). The purpose of an EOP2A meeting is to facilitate interaction 
between FDA and sponsors who seek guidance related to clinical trial 
design employing clinical trial simulation and quantitative modeling of 
prior knowledge (e.g., drug, disease, placebo), designing trials for 
better dose response estimation and dose selection, and other related 
issues. This guidance is intended to further FDA initiatives directed 
at identifying opportunities to facilitate the development of 
innovative medical products and improve the quality of drug 
applications through early meetings with sponsors.

DATES:  Submit written or electronic comments on agency guidances at 
any time.

ADDRESSES:  Submit written requests for single copies of this 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 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 guidance document.

FOR FURTHER INFORMATION CONTACT:  Jogarao Gobburu, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 3186, Silver Spring, MD 20993-0002, 301-
796-2460.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``End-of-Phase 2A Meetings.'' This guidance will meet one of 
the performance goals agreed to under the September 27, 2007, 
reauthorization of the Prescription Drug User Fee Act (PDUFA IV). Under 
section XI of the PDUFA IV Performance Goals, Expediting Drug 
Development, FDA agreed to publish by the end of fiscal year 2008 a 
draft guidance on EOP2A meetings and to complete the final guidance 
within 1 year of the close of the public comment period (see http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm 
at section XI.A).
    FDA has a long-standing interest in defining dose or exposure-
response relationships for the effectiveness and safety of new drugs. 
Accurate dose-response information is important for understanding how 
patients should take drugs to maximize desirable effects and minimize 
undesirable effects. Dose selection for phase 2 and phase 3 studies is 
a challenge in many drug development programs and poor choice may lead 
to trial failure. Improving early dose selection may increase the 
likelihood of future trial success. FDA recognizes trial planning may 
be improved by clinical trial simulations that employ quantitative 
models of drug exposure-response, placebo effect, and disease 
progression. This guidance on EOP2A meetings is intended to encourage 
the best use of this science to facilitate the exploration of trial 
design alternatives to increase the likelihood for successful trials.
    In the Federal Register of September 26, 2008 (73 FR 55851), FDA 
announced the availability of a draft guidance of the same title. In 
response to public comments on the draft version, the guidance has been 
revised to clarify the following topics: (1) The type of information 
that should be submitted with the meeting request and the background 
package and (2) the role of the Office of New Drugs in preparing for 
and conducting EOP2A meetings.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on the roles of model-based drug development 
together with early interaction between FDA and industry to improve 
late phase clinical trial success. 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. 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.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 the guidance on 
``Formal Meetings with Sponsors and Applicants for PDUFA Products'' 
have been approved under OMB control numbers 0910-0014 and 0910-0429, 
respectively.

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 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-22623 Filed 9-18-09; 8:45 am]
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