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, 40771-40772 [2018-17715]
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Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices
authority of exemption 4 of the Freedom
of Information Act (5 U.S.C. 552(b)(4)).
Exemption 4 protects from disclosure
trade secrets and privileged or
confidential commercial or financial
information.
Current actions: On May 18, 2018, the
Board published a notice in the Federal
Register (83 FR 23276) requesting
public comment for 60 days on the
extension, with revision, of the FR 2420.
The Board proposes to revise the FR
2420 by adding Selected Deposits (Part
D) and removing Selected Borrowings
from Non-Exempt Entities (Part AA).
Other minor edits in the reporting
instructions are proposed to improve
clarity. The first report for the proposed
revisions to FR 2420 would be as of
October 1, 2018. The comment period
for this notice expired on July 17, 2018.
The Board received one comment from
a government entity supporting the
continued collection of data on the FR
2420. The revisions will be
implemented as proposed.
Board of Governors of the Federal Reserve
System, August 13, 2018.
Ann Misback,
Secretary of the Board.
[FR Doc. 2018–17670 Filed 8–15–18; 8:45 am]
BILLING CODE 6210–01–P
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.
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
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:15 Aug 15, 2018
Jkt 244001
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
PO 00000
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Fmt 4703
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40771
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
E:\FR\FM\16AUN1.SGM
16AUN1
40772
Federal Register / Vol. 83, No. 159 / Thursday, August 16, 2018 / Notices
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, PRAStaff@
fda.hhs.gov.
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
FOR FURTHER INFORMATION CONTACT:
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
respondents
Type of respondent
Number of
responses per
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
sradovich on DSK3GMQ082PROD with NOTICES
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
VerDate Sep<11>2014
17:15 Aug 15, 2018
Jkt 244001
collections for similar types of PDUFArelated assessments.
Dated: August 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2945]
[FR Doc. 2018–17715 Filed 8–15–18; 8:45 am]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
BILLING CODE 4164–01–P
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AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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]]>Agencies
[Federal Register Volume 83, Number 159 (Thursday, August 16, 2018)]
[Notices]
[Pages 40771-40772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17715]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.gpo.gov/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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
