[Federal Register Volume 83, Number 219 (Tuesday, November 13, 2018)]
[Notices]
[Pages 56349-56350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24608]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2970]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Surveys and 
Interviews With Investigational New Drug Sponsors To Assess Current 
Communication Practices With Food and Drug Administration Review Staff 
Under the Sixth Authorization of the Prescription Drug User Fee Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 13, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Surveys and Interviews with Investigational New Drug Sponsors 
to Assess Current Communication Practices with Food and Drug 
Administration Review Staff Under the Sixth Authorization of the 
Prescription Drug User Fee Act.'' Also include the FDA docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Surveys and Interviews With Investigational New Drug (IND) Sponsors To 
Assess Current Communication Practices With Food and Drug 
Administration Review Staff Under the Sixth Authorization of the 
Prescription Drug User Fee Act (PDUFA VI)

OMB Control Number 0910-NEW

    In Fiscal Year 2017, FDA published guidance on communications 
between FDA review staff and drug sponsors during the IND phase of drug 
development. As part of PDUFA VI, FDA committed to a third-party 
assessment of current IND-phase communication practices, which should 
reflect this guidance. The contractor for the assessment of IND 
communication practices is Eastern Research Group, Inc. (ERG).
    Therefore, in accordance with the PDUFA VI Commitment Letter, FDA 
proposes to have ERG conduct surveys and interviews with sponsors of up 
to 150 active commercial INDs as follows:
     For each formal meeting between FDA review staff and 
active commercial IND sponsors during the assessment period, send a 
survey to the sponsor to solicit specific feedback about communication 
practices employed for that meeting. For the purpose of this 
assessment, formal meetings are Type A, B, B (End of Phase), and C 
meetings during the IND phase of drug development.
     For each active commercial IND in the assessment, conduct 
an interview with the sponsor to obtain broader feedback about all 
communications with FDA review staff during the study period, including 
telephone and email interactions in addition to meetings.
    The purpose of this information collection is to understand active 
commercial IND sponsor perspectives on communication during drug 
development with a focus on what is working well, ongoing challenges 
and pain points, lessons learned, and opportunities for improvement. 
The contractor will develop anonymized aggregated summaries of survey 
and interview responses, analyze this information to identify common 
themes, consider these results along with IND data and feedback from 
FDA review staff to develop a set of findings and recommendations, and 
prepare a report to be published on FDA's website. The contractor will 
keep information collected private; ERG will not disclose personally 
identifying information to FDA or any other party.
    In the Federal Register of August 16, 2018 (83 FR 40771), FDA 
published a 60-day notice requesting public

[[Page 56350]]

comment on the proposed collection of information. No comments were 
received.
    The number of commercial INDs with activity is approximately 4,000 
per year. ERG will interview 1 to 3 sponsor representatives at a time 
for up to 150 INDs during the annual assessment period.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
              Type of respondent                  Number of     responses per   Total annual          Average burden  per response          Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
IND sponsors: Surveys........................             150               1             150  0.17 (10 minutes)........................           25.50
IND sponsors: Interviews.....................             450               1             450  1.5......................................             675
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................          700.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates that it will take each IND sponsor a maximum of 10 
minutes to complete a survey. Up to 150 respondents will take part in 
the survey, yielding a maximum burden of 25.5 hours. FDA estimates that 
it will take each IND sponsor up to 90 minutes to respond to requests 
for interviews and participate in interviews. Up to 450 respondents 
will take part in interviews, yielding a maximum burden of 675 hours. 
FDA's burden estimates are based on experience with information 
collections for similar types of PDUFA-related assessments.

    Dated: November 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24608 Filed 11-9-18; 8:45 am]
 BILLING CODE 4164-01-P


