Guidance for Industry on End-of-Phase 2A Meetings; Availability, 48080 [E9-22623]

Download as PDF 48080 Federal Register / Vol. 74, No. 181 / Monday, September 21, 2009 / Notices Dated: September 14, 2009. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E9–22646 Filed 9–18–09; 8:45 am] BILLING CODE 4163–18–P 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. mstockstill on DSKH9S0YB1PROD with NOTICES ACTION: Notice. 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 https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Jogarao Gobburu, Center for Drug VerDate Nov<24>2008 17:24 Sep 18, 2009 Jkt 217001 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 ‘‘Endof-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 https:// 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 doseresponse 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 modelbased drug development together with early interaction between FDA and industry to improve late phase clinical PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 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 https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: September 16, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–22623 Filed 9–18–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections E:\FR\FM\21SEN1.SGM 21SEN1

Agencies

[Federal Register Volume 74, Number 181 (Monday, September 21, 2009)]
[Notices]
[Page 48080]
From the Federal Register Online via the Government Printing 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.

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

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 https://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 https://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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: September 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-22623 Filed 9-18-09; 8:45 am]
BILLING CODE 4160-01-S
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