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, 56349-56350 [2018-24608]
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Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices
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Staff (see ADDRESSES).
Dated: November 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24656 Filed 11–9–18; 8:45 am]
BILLING CODE 4164–01–P
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.
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.
SUMMARY:
Fax written comments on the
collection of information by December
13, 2018.
DATES:
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 oira_
submission@omb.eop.gov. 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.
ADDRESSES:
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, PRAStaff@
fda.hhs.gov.
amozie on DSK3GDR082PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:34 Nov 09, 2018
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Frm 00076
Fmt 4703
Sfmt 4703
56349
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
E:\FR\FM\13NON1.SGM
13NON1
56350
Federal Register / Vol. 83, No. 219 / Tuesday, November 13, 2018 / Notices
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
respondents
Type of respondent
Total annual
responses
Average burden
per response
Total hours
IND sponsors: Surveys ................................................
IND sponsors: Interviews ............................................
150
450
1
1
150
450
0.17 (10 minutes) ..
1.5 ..........................
25.50
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 PDUFArelated 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4042]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Establishing and
Maintaining Lists of U.S.
Manufacturers/Processors With
Interest in Exporting Center for Food
Safety and Applied Nutrition-Regulated
Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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,
SUMMARY:
amozie on DSK3GDR082PROD with NOTICES1
Number of
responses per
respondent
VerDate Sep<11>2014
17:34 Nov 09, 2018
Jkt 247001
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the collection of
information that FDA uses to establish
and maintain lists of U.S. manufacturers
and processors with an interest in
exporting products regulated by the
Center for Food Safety and Applied
Nutrition (CFSAN) to countries that
require such lists to be maintained. The
notice also solicits comments on
changes to the electronic registry that
will allow manufacturers and processors
of CFSAN-regulated products to
electronically request inclusion on the
export lists.
DATES: Submit either electronic or
written comments on the collection of
information by January 14, 2019.
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 January 14,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 14, 2019.
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
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
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–4042 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Establishing and Maintaining Lists of
Manufacturers/Processors With Interest
in Exporting CFSAN-regulated
Products.’’ 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
E:\FR\FM\13NON1.SGM
13NON1
]]>Agencies
[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
