Best Practices for Communication Between the Food and Drug Administration and Investigational New Drug Sponsors During Drug Development; Request for Comments, 64397 [2014-25641]

Download as PDF Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices anticipate manufacturing these tobacco products and are estimated to take approximately 5 hours each to conduct a review of their records, draft and send a letter to FDA indicating that they do not have documents to submit. Total burden hours for this portion of the collection are expected to be 595 hours. ONDEnhancedComm@fda.hhs.gov; 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: Dated: October 23, 2014. Leslie Kux, Assistant Commissioner for Policy. 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communication between FDA and sponsors during drug (including biological product) development, is for FDA to publish draft guidance for industry and review staff describing best practices for communication between FDA and IND sponsors during drug development.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. [FR Doc. 2014–25638 Filed 10–28–14; 8:45 am] BILLING CODE 4164–01–P 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. Notice; establishment of docket, request for comments. ACTION: 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: mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:21 Oct 28, 2014 Jkt 235001 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 64397 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General Solicitation of Information and Recommendations for Revising OIG’s Non-Binding Criteria for Implementing Permissive Exclusion Authority Under Section 1128(b)(7) of the Social Security Act Office of Inspector General (OIG), HHS. ACTION: Notice; Extension of comment period. AGENCY: This document announces an extension of the public comment period for the OIG Federal Register notice published on July 11, 2014 (79 FR 40114). The notice solicited input from the public on revising the criteria used by OIG in implementing its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act. Due to a technical problem, the public may have been unable to submit comments at http://www.regulations.gov during the comment period. Accordingly, we are extending the comment period to ensure that the public has an opportunity to provide input. DATES: To ensure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on December 29, 2014. ADDRESSES: In commenting, please refer to file code OIG–1271–N. Because of staff and resource limitations, we cannot SUMMARY: E:\FR\FM\29OCN1.SGM 29OCN1

Agencies

[Federal Register Volume 79, Number 209 (Wednesday, October 29, 2014)]
[Notices]
[Page 64397]
From the Federal Register Online via the Government Printing 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.

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

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: ONDEnhancedComm@fda.hhs.gov; 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