Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring, 15620-15621 [2019-07523]
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Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Notices
524 of the FD&C Act, Congress intended
to stimulate new drug development for
drugs to treat certain tropical diseases
for which there are no or few available
treatments by offering additional
incentives for obtaining FDA approval
for pharmaceutical treatments for these
diseases. Under section 524 of the FD&C
Act, a sponsor of a human drug
application for a qualified tropical
disease may be eligible for a voucher
that can be used to obtain a priority
review for any application submitted
under section 505(b)(1) of the FD&C Act
(21 U.S.C. 355(b)(1)) or section 351 of
the Public Health Service Act (the PHS
Act).
Accordingly, we have developed the
guidance document entitled, ‘‘Guidance
for Industry (GFI): Tropical Disease
Priority Review Vouchers.’’ The
guidance explains how FDA will
implement the provisions of section 524
include new information collection
established by section 611 of the FDA
Reauthorization Act of 2017 (FDARA).
As amended, section 524 of the FD&C
Act requires the sponsor of a tropical
disease product application to include
an attestation regarding its eligibility for
a priority review voucher. The guidance
is available at https://www.fda.gov/
downloads/Drugs/Guidances/
UCM080599.pdf.
Description of Respondents: Sponsors
submitting applications under section
505(b)(1) of the FD&C Act or section 351
of the PHS Act.
In the Federal Register of November
7, 2018 (83 FR 55720), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of the
information collection as follows:
of the FD&C Act, how sponsors may use
priority review vouchers, and how
priority review vouchers may be
transferred to other sponsors. The
guidance also explains eligibility
criteria for tropical disease drug product
applications submitted under section
505(b)(1) of the FD&C Act and section
351 of the PHS Act, and provides
instructions to sponsors on how they
may:
• Request a priority review voucher;
and
• notify FDA of their intent to use a
priority review voucher, including the
date on which the sponsor intends to
submit the application.
The guidance also explains that
transfer of a priority review voucher
from one sponsor to another is
permitted and that each transfer should
be documented with a letter of transfer.
Finally, the guidance will be revised to
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Information collection activity
Total hours
Priority Review Voucher Request ........................................
Notifications of Intent to Use a Voucher ..............................
Letters Indicating the Transfer of a Voucher Letter ............
Acknowledging the Receipt of a Transferred Voucher ........
Attestation of Eligibility .........................................................
5
5
2
2
5
1
1
1
1
1
5
5
2
2
5
8
8
8
8
2
40
40
16
16
10
Total ..............................................................................
........................
........................
........................
........................
122
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We have increased our burden
estimate since last approval to account
for attestations added by FDARA;
however, all other information
collection elements remain unchanged.
Dated: April 10, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–07464 Filed 4–15–19; 8:45 am]
BILLING CODE 4164–01–P
SUMMARY:
The Food and Drug
Administration (FDA, Agency, or we) 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.
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
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.
DATES:
Fax written comments on the
collection of information by May 16,
2019.
Oversight of Clinical Investigations: A
Risk-Based Approach to Monitoring—
21 CFR Parts 312 and 812
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 0910–0733. Also
include the FDA docket number found
in brackets in the heading of this
document.
OMB Control Number 0910–0733—
Extension
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0597]
khammond on DSKBBV9HB2PROD with NOTICES
Average
burden per
response
Total annual
responses
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Oversight of
Clinical Investigations: A Risk-Based
Approach to Monitoring
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
16:32 Apr 15, 2019
Jkt 247001
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
This information collection supports
reporting and recordkeeping found in
Agency guidance. Under parts 312 and
812 (21 CFR parts 312 and 812),
sponsors are required to provide
appropriate oversight of their clinical
investigations to ensure adequate
protection of the rights, welfare, and
safety of human subjects and to ensure
the quality and integrity of the resulting
data submitted to FDA. As part of this
oversight, sponsors of clinical
investigations are required to monitor
the conduct and progress of their
clinical investigations. The regulations
do not specify how sponsors are to
E:\FR\FM\16APN1.SGM
16APN1
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Notices
conduct monitoring of clinical
investigations and are, therefore,
compatible with a range of approaches
to monitoring.
Accordingly, we developed the
guidance document entitled ‘‘Guidance
for Industry—Oversight of Clinical
Investigations: A Risk-Based Approach
to Monitoring’’ (available at: https://
www.fda.gov/ucm/groups/fdagovpublic/@fdagov-drugs-gen/documents/
document/ucm269919.pdf). The
guidance is intended to assist sponsors
of clinical investigations in developing
strategies for risk-based monitoring and
plans for clinical investigations of
human drug and biological products,
medical devices, and combinations
thereof. The guidance describes
strategies for monitoring activities
performed by sponsors or by contract
research organizations (CROs) that focus
on the conduct, oversight, and reporting
of findings of an investigation by
clinical investigators. The guidance also
recommends strategies that reflect a
risk-based approach to monitoring that
focuses on critical study parameters and
relies on a combination of monitoring
activities to oversee a study effectively.
Finally, the guidance specifically
encourages greater reliance on
centralized monitoring methods where
appropriate.
Information collections for reports
and records associated with clinical
investigations under parts 312 and 812
are currently approved under OMB
control numbers 0910–0014 and 0910–
0078, respectively. These reporting and
recordkeeping provisions cover general
elements. The guidance discusses other
elements sponsors and investigators
should consider and include in
developing a monitoring plan. As
explained in the guidance,
documentation of monitoring should
include sufficient detail to allow
15621
verification that the monitoring plan
was followed. The plan should provide
adequate information to those involved
with monitoring to effectively carry out
their duties. All sponsor and CRO
personnel who may be involved with
monitoring (including those who review
appropriate action, determine
appropriate action, or both) regarding
potential issues identified through
monitoring should review the
monitoring plan.
In the Federal Register of November
30, 2018 (83 FR 61646), we published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was
received; however, it was not responsive
to any of the four information collection
topics solicited in the notice.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Documentation included in comprehensive monitoring plan ...........................
88
1.5
132
4
528
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection, we have made no
adjustments to our burden estimate. We
estimate 88 sponsors will develop 132
comprehensive monitoring plans in
accordance with the guidance. We
believe the associated burden for each
plan is approximately 4 hours and
includes the time necessary to develop,
and amend as appropriate, the
monitoring plan.
Dated: April 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–07523 Filed 4–15–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKBBV9HB2PROD with NOTICES
[Docket No. FDA–2018–N–4839]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Registering With the
Center for Veterinary Medicine’s
Electronic Submission System
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
16:32 Apr 15, 2019
Jkt 247001
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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,
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 information
collection provisions of the Center for
Veterinary Medicine (CVM) Guidance
for Industry (GFI) #108 entitled
‘‘Registering with CVM’s Electronic
Submission System.’’
DATES: Submit either electronic or
written comments on the collection of
information by June 17, 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 June 17, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
SUMMARY:
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
at the end of June 17, 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
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
E:\FR\FM\16APN1.SGM
16APN1
]]>Agencies
[Federal Register Volume 84, Number 73 (Tuesday, April 16, 2019)]
[Notices]
[Pages 15620-15621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07523]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0597]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Oversight of Clinical
Investigations: A Risk-Based Approach to Monitoring
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 May 16,
2019.
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 0910-0733.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[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.
Oversight of Clinical Investigations: A Risk-Based Approach to
Monitoring--21 CFR Parts 312 and 812
OMB Control Number 0910-0733--Extension
This information collection supports reporting and recordkeeping
found in Agency guidance. Under parts 312 and 812 (21 CFR parts 312 and
812), sponsors are required to provide appropriate oversight of their
clinical investigations to ensure adequate protection of the rights,
welfare, and safety of human subjects and to ensure the quality and
integrity of the resulting data submitted to FDA. As part of this
oversight, sponsors of clinical investigations are required to monitor
the conduct and progress of their clinical investigations. The
regulations do not specify how sponsors are to
[[Page 15621]]
conduct monitoring of clinical investigations and are, therefore,
compatible with a range of approaches to monitoring.
Accordingly, we developed the guidance document entitled ``Guidance
for Industry--Oversight of Clinical Investigations: A Risk-Based
Approach to Monitoring'' (available at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm269919.pdf). The
guidance is intended to assist sponsors of clinical investigations in
developing strategies for risk-based monitoring and plans for clinical
investigations of human drug and biological products, medical devices,
and combinations thereof. The guidance describes strategies for
monitoring activities performed by sponsors or by contract research
organizations (CROs) that focus on the conduct, oversight, and
reporting of findings of an investigation by clinical investigators.
The guidance also recommends strategies that reflect a risk-based
approach to monitoring that focuses on critical study parameters and
relies on a combination of monitoring activities to oversee a study
effectively. Finally, the guidance specifically encourages greater
reliance on centralized monitoring methods where appropriate.
Information collections for reports and records associated with
clinical investigations under parts 312 and 812 are currently approved
under OMB control numbers 0910-0014 and 0910-0078, respectively. These
reporting and recordkeeping provisions cover general elements. The
guidance discusses other elements sponsors and investigators should
consider and include in developing a monitoring plan. As explained in
the guidance, documentation of monitoring should include sufficient
detail to allow verification that the monitoring plan was followed. The
plan should provide adequate information to those involved with
monitoring to effectively carry out their duties. All sponsor and CRO
personnel who may be involved with monitoring (including those who
review appropriate action, determine appropriate action, or both)
regarding potential issues identified through monitoring should review
the monitoring plan.
In the Federal Register of November 30, 2018 (83 FR 61646), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received; however, it was
not responsive to any of the four information collection topics
solicited in the notice.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of records Total annual Average burden per
Activity recordkeepers per recordkeeper records recordkeeping Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Documentation included in comprehensive monitoring 88 1.5 132 4 528
plan...............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection, we have made no
adjustments to our burden estimate. We estimate 88 sponsors will
develop 132 comprehensive monitoring plans in accordance with the
guidance. We believe the associated burden for each plan is
approximately 4 hours and includes the time necessary to develop, and
amend as appropriate, the monitoring plan.
Dated: April 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07523 Filed 4-15-19; 8:45 am]
BILLING CODE 4164-01-P
