Notice: Draft Guidance for Industry on End-of-Phase 2A Meetings; 
Availability

Federal Register: September 26, 2008 (Volume 73, Number 188)               
                  Page 55851-55852

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availability of a draft guidance for industry entitled ``End-of-Phase 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 This draft guidance provides information on end-of-phase 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 This draft guidance is 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

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draft guidance before it begins work on the final version of the 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

[[Page 55852]]

written or electronic comments on the draft guidance by November 25, 
2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 Submit written comments on the draft guidance to the 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 
See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Robert Powell, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, rm. 4526, Silver Spring, MD 20993-0002, 301-
796-1589

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``End-of-Phase 2A Meetings.'' This draft 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 end-of-phase 2A meetings (see section XI.A.4 at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/pdufa4/pdufa4goals.html). 
This draft guidance is 
intended to facilitate early meetings (referred to as end-of-phase 2A 
meetings or EOP2A meetings) between FDA and sponsors who seek 
interaction or guidance related to the use of quantitative drug 
development methods (i.e., exposure-response, pharmacokinetic/
pharmacodynamic (PK/PD) modeling, drug-disease modeling, genomic 
analysis) to inform drug development and regulatory decisions. The 
draft guidance provides recommendations to IND sponsors on the 
following topics:
     Objectives of an EOP2A meeting,
     Possible topics for discussion at EOP2A meetings,
     Useful information for an EOP2A meeting package, and
     Timing of EOP2A meetings.
    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 end-of-phase 
2A meetings. 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

III. Paperwork Reduction Act of 1995

    This draft 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm 
or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

    Dated: September 22, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22669 Filed 9-25-08; 8:45 am]

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