80 FR 17051 - Critical Path Innovation Meetings; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 61 (March 31, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Critical Path Innovation Meetings.'' This guidance describes a Critical Path Innovation Meeting (CPIM), a means by which FDA's Center for Drug Evaluation and Research (CDER) and investigators 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.

[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17051-17052]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07272]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Critical Path Innovation Meetings; 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 guidance for industry entitled ``Critical Path 
Innovation Meetings.'' This guidance describes a Critical Path 
Innovation Meeting (CPIM), a means by which FDA's Center for Drug 
Evaluation and Research (CDER) and investigators 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: Submit either electronic or written 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

[[Page 17052]]

and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 
4th Floor, Silver Spring, MD 20993. 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 Barbieri 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 guidance for industry 
entitled ``Critical Path Innovation Meetings.'' The 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 guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Critical Path Innovation Meetings.'' It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This 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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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: March 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07272 Filed 3-30-15; 8:45 am]
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