83 FR 40771 - Agency Information Collection Activities; Proposed Collection; 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 159 (August 16, 2018)

Page Range		40771-40772
FR Document		2018-17715

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed information collection involving surveys and interviews of sponsors of commercial investigational new drugs (INDs) to obtain feedback about communication practices with FDA review staff.

Federal Register, Volume 83 Issue 159 (Thursday, August 16, 2018)

[Federal Register Volume 83, Number 159 (Thursday, August 16, 2018)]
[Notices]
[Pages 40771-40772]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on a proposed information collection involving 
surveys and interviews of sponsors of commercial investigational new 
drugs (INDs) to obtain feedback about communication practices with FDA 
review staff.

DATES: Submit either electronic or written comments on the collection 
of information by October 15, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before October 15, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of October 15, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-2970 for ``Surveys and Interviews with Investigational New 
Drug (IND) Sponsors to Assess Current Communication Practices with FDA 
Review Staff under the Sixth Authorization of the Prescription Drug 
User Fee Act (PDUFA VI).'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

[[Page 40772]]


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

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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

OMB Control Number 0910--NEW

    In Fiscal Year (FY) 2017, FDA published guidance on communications 
between FDA review staff and drug sponsors during the IND phase of drug 
development. As part 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.
    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.
    Thus, 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
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\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: August 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17715 Filed 8-15-18; 8:45 am]
 BILLING CODE 4164-01-P

40772 Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices

FOR FURTHER INFORMATION CONTACT: Ila the quality, utility, and clarity of the assessment, formal meetings are Type
S. Mizrachi, Office of Operations, Food information to be collected; and (4) A, B, B (End of Phase), and C meetings
and Drug Administration, Three White ways to minimize the burden of the during the IND phase of drug
Flint North, 10 a.m.–12 p.m., 11601 collection of information on development.
Landsdown St., North Bethesda, MD respondents, including through the use • For each active commercial IND in
20852, 301–796–7726, PRAStaff@ of automated collection techniques, the assessment, conduct an interview
fda.hhs.gov. when appropriate, and other forms of with the sponsor to obtain broader
SUPPLEMENTARY INFORMATION: Under the information technology. feedback about all communications with
PRA (44 U.S.C. 3501–3520), Federal Surveys and Interviews With FDA review staff during the study
Agencies must obtain approval from the Investigational New Drug (IND) period, including telephone and email
Office of Management and Budget Sponsors To Assess Current interactions in addition to meetings.
(OMB) for each collection of Communication Practices With FDA The purpose of this information
information they conduct or sponsor. Review Staff Under the Sixth collection is to understand active
‘‘Collection of information’’ is defined Authorization of the Prescription Drug commercial IND sponsor perspectives
in 44 U.S.C. 3502(3) and 5 CFR User Fee Act (PDUFA VI) on communication during drug
1320.3(c) and includes Agency requests development with a focus on what is
or requirements that members of the OMB Control Number 0910—NEW
working well, ongoing challenges and
public submit reports, keep records, or In Fiscal Year (FY) 2017, FDA pain points, lessons learned, and
provide information to a third party. published guidance on communications opportunities for improvement. The
Section 3506(c)(2)(A) of the PRA (44 between FDA review staff and drug contractor will develop anonymized
U.S.C. 3506(c)(2)(A)) requires Federal sponsors during the IND phase of drug aggregated summaries of survey and
Agencies to provide a 60-day notice in development. As part PDUFA VI, FDA interview responses, analyze this
the Federal Register concerning each committed to a third-party assessment information to identify common themes,
proposed collection of information of current IND-phase communication consider these results along with IND
before submitting the collection to OMB practices, which should reflect this data and feedback from FDA review
for approval. To comply with this guidance. The contractor for the staff to develop a set of findings and
requirement, FDA is publishing notice assessment of IND communication recommendations, and prepare a report
of the proposed collection of practices is Eastern Research Group, Inc. to be published on FDA’s website. The
information set forth in this document. (ERG). contractor will keep information
With respect to the following Therefore, in accordance with the collected private; ERG will not disclose
collection of information, FDA invites PDUFA VI Commitment Letter, FDA personally identifying information to
comments on these topics: (1) Whether proposes to have ERG conduct surveys FDA or any other party.
the proposed collection of information and interviews with sponsors of up to
is necessary for the proper performance 150 active commercial INDs as follows: The number of commercial INDs with
of FDA’s functions, including whether • For each formal meeting between activity is approximately 4,000 per year.
the information will have practical FDA review staff and active commercial ERG will interview 1 to 3 sponsor
utility; (2) the accuracy of FDA’s IND sponsors during the assessment representatives at a time for up to 150
estimate of the burden of the proposed period, send a survey to the sponsor to INDs during the annual assessment
collection of information, including the solicit specific feedback about period.
validity of the methodology and communication practices employed for Thus, FDA estimates the burden of
assumptions used; (3) ways to enhance that meeting. For the purpose of this this collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Type of respondent responses per Total hours
respondents responses per response
respondent

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 collections for similar types of PDUFA- DEPARTMENT OF HEALTH AND
IND sponsor a maximum of 10 minutes related assessments. HUMAN SERVICES
to complete a survey. Up to 150 Dated: August 13, 2018.
respondents will take part in the survey, Food and Drug Administration
Leslie Kux,
yielding a maximum burden of 25.5
Associate Commissioner for Policy.
hours. FDA estimates that it will take [Docket No. FDA–2018–N–2945]
[FR Doc. 2018–17715 Filed 8–15–18; 8:45 am]
each IND sponsor up to 90 minutes to
sradovich on DSK3GMQ082PROD with NOTICES

respond to requests for interviews and BILLING CODE 4164–01–P Vaccines and Related Biological
participate in interviews. Up to 450 Products Advisory Committee; Notice
respondents will take part in interviews, of Meeting
yielding a maximum burden of 675 AGENCY: Food and Drug Administration,
hours. FDA’s burden estimates are based HHS.
on experience with information ACTION: Notice.

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Document Created: 2018-08-16 01:02:27
Document Modified: 2018-08-16 01:02:27

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by October 15, 2018.
Contact		Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]
FR Citation		83 FR 40771

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 159 (August 16, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration