[Federal Register Volume 73, Number 188 (Friday, September 26, 2008)]
[Notices]
[Pages 55851-55852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-22669]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0514]
Draft Guidance for Industry on End-of-Phase 2A Meetings;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availability of a draft guidance for industry entitled ``End-of-Phase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 This draft guidance provides information on end-of-phase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 This draft guidance is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draft guidance before it begins work on the final version of the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written or electronic comments on the draft guidance by November 25,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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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 Submit written comments on the draft guidance to the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://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INFORMATION section for electronic access to the draft guidance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://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://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://www.fda.gov/cder/guidance/index.htm or 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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