[Federal Register Volume 79, Number 209 (Wednesday, October 29, 2014)]
[Notices]
[Page 64397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1575]


Best Practices for Communication Between the Food and Drug 
Administration and Investigational New Drug Sponsors During Drug 
Development; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket, request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
establishment of a docket to receive suggestions, recommendations, and 
comments from interested parties, including academic institutions, 
regulated industry, and other interested organizations on best 
practices for communication between FDA and investigational new drug 
application (IND) sponsors during drug development. These comments will 
help FDA identify and ultimately establish best practices to be 
included in a draft guidance for industry and review staff.

DATES: Submit either electronic or written comments by December 29, 
2014.

ADDRESSES: Submit electronic comments 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. Identify comments with the docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel E. Hartford, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6312, Silver Spring, MD 20993-0002, 301-
796-0331, email: [email protected]; or Stephen Ripley, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    One of FDA's performance commitments made as part of the fifth 
authorization of the Prescription Drug User Fee Act (PDUFA) under Title 
I of the Food and Drug Administration Safety and Innovation Act (Pub. 
L. 112-144), related to promoting innovation through enhanced 
communication between FDA and sponsors during drug (including 
biological product) development, is for FDA to publish draft guidance 
for industry and review staff describing best practices for 
communication between FDA and IND sponsors during drug development. (A 
copy of the PDUFA Reauthorization Performance Goals and Procedures; 
Fiscal Years 2013 Through 2017 is available on the FDA Web site at 
http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.)
    The guidance will describe FDA's philosophy regarding timely 
interactive communication with IND sponsors as a core activity and the 
scope of appropriate interactions between the review team and the 
sponsor, outline the types of advice that are appropriate for sponsors 
to seek from FDA in pursuing their drug development program, describe 
the general expectations for the timing of FDA response to IND sponsor 
inquiries of simple and clarifying questions or referral of more 
complex questions to the formal meeting process, and describe best 
practices and communication methods (including the value of person-to-
person scientific dialogue) to facilitate interactions between the FDA 
review team and the IND sponsor during drug development. We anticipate 
that the best practices will include expectations and agreement on 
appropriate methods (e.g., when teleconferencing or secure email may be 
the most appropriate means of communication) and frequency of such 
communications.

II. Establishment of a Docket and Request for Comments

    To help FDA identify and ultimately establish best practices to be 
included in a draft guidance, FDA is requesting public suggestions, 
recommendations, and comments for each aspect of the best practices 
mentioned above. FDA will consider all comments submitted. FDA 
generally will not respond directly to the person or organization 
submitting the comment.

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.

    Dated: October 22, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25641 Filed 10-28-14; 8:45 am]
BILLING CODE 4164-01-P