
[Federal Register Volume 79, Number 195 (Wednesday, October 8, 2014)]
[Notices]
[Pages 60852-60853]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23970]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1439]


Critical Path Innovation Meetings; Draft Guidance for Industry; 
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availability of a draft guidance for industry entitled ``Critical Path 
Innovation Meetings.'' This draft guidance describes a Critical Path 
Innovation Meeting (CPIM), a means by which FDA's Center for Drug 
Evaluation and Research (CDER) and investigators

[[Page 60853]]

from industry, academia, government, and patient advocacy groups can 
communicate to improve efficiency and success in drug development. The 
goals of the CPIM are to discuss a methodology or technology proposed 
by the meeting requester and for CDER to provide general advice on how 
this methodology or technology might enhance drug development. The 
discussions and background information submitted through the CPIM are 
nonbinding on both FDA and CPIM requesters.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by December 8, 2014.

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. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Alicia Stuart, Office of Translational 
Sciences, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 21, Rm. 4547, Silver 
Spring, MD 20993-0002, 301-796-3852.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Critical Path Innovation Meetings.'' The draft guidance 
describes the purpose and scope of a CPIM and how to request such a 
meeting. A CPIM provides the opportunity to discuss a methodology or 
technology proposed by the meeting requester and for CDER to provide 
general advice on how the methodology or technology might enhance drug 
development. During a CPIM, CDER will identify some of the larger gaps 
in existing knowledge that requesters might consider addressing in the 
course of their work. The discussions and background information 
submitted through the CPIM are nonbinding on both FDA and CPIM 
requesters. The CPIM initiative meets Prescription Drug User Fee Act 
(PDUFA) V Reauthorization Goal IX.A, ``Enhancing Regulatory Science and 
Expediting Drug Development'' by ``Promoting Innovation Through 
Enhanced Communication Between FDA and Sponsors During Drug 
Development.''
    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 CPIMs. 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 draft 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 collection of information in 21 CFR part 312 
(investigational new drug applications) has been approved under OMB 
control number 0910-0014. The collection of information in 21 CFR part 
314 (new drug applications) has been approved under OMB control number 
0910-0001. The collection of information resulting from formal meetings 
between interested persons and FDA has been approved under OMB control 
number 0910-0429.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments 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, and will 
be posted to the docket at http://www.regulations.gov.

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: October 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23970 Filed 10-7-14; 8:45 am]
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