Federal Register / Vol. 79, No. 209 / Wednesday, October 29, 2014 / Notices 64397 

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. 

Dated: October 23, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[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. 

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a draft guidance for industry and review 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 

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 

AGENCY: Office of Inspector General 

(OIG), HHS. 

ACTION: Notice; Extension of comment 

period. 

SUMMARY: 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 

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