Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Oversight of Clinical Investigations: A Risk-Based Approach To Monitoring, 41044-41046 [2015-17318]
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41044
Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices
Annual Responses: 861; Total Annual
Hours: 12,930. (For policy questions
regarding this collection contact Jaya
Ghildiyal at (301) 492–5149.)
Dated: July 9, 2015.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2015–17285 Filed 7–10–15; 11:15 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Annual Report on Households
Assisted by the Low Income Home
Energy Assistance Program (LIHEAP)
OMB No.: 0970–0060.
Description: This statistical report is
an annual activity required by statute
(42 U.S.C. 8629) and Federal regulations
(45 CFR 96.92) for the Low Income
Home Energy Assistance Program
(LIHEAP). Submission of the completed
report is one requirement for LIHEAP
grantees applying for Federal LIHEAP
block grant funds. States, the District of
Columbia, and the Commonwealth of
Puerto Rico are required to report
statistics for the previous Federal fiscal
year on the number and income levels
of LIHEAP applicants and assisted
households, as well as the number of
LIHEAP-assisted households with at
least one member who is elderly,
disabled, or a young child.
The statistical report requires States,
the District of Columbia, and the
Commonwealth of Puerto Rico to report
on assisted households having at least
one elderly person who is homebound;
an unduplicated count of assisted
households having at least one member
who is elderly, disabled, or a young
child; and an unduplicated count of
assisted households receiving one or
more types of LIHEAP assistance.
Insular areas receiving less than
$200,000 annually in LIHEAP funds and
Indian Tribal Grantees are required to
submit data only on the number of
households receiving heating, cooling,
energy crisis, or weatherization benefits.
The information is being collected for
the Department’s annual LIHEAP report
to Congress. The data also provides
information about the need for LIHEAP
funds. Finally, the data are used in the
calculation of LIHEAP performance
measures under the Government
Performance and Results Act of 1993.
The additional data elements will
improve the accuracy of measuring
LIHEAP targeting performance and
LIHEAP cost efficiency.
Respondents: State Governments,
Tribal Governments, Insular Areas, the
District of Columbia, and the
Commonwealth of Puerto Rico.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Assisted household Report-Long Form ...........................................................
Assisted Household Report-Short Form ..........................................................
Applicant Household Report ............................................................................
52
155
52
Desk Officer for the Administration for
Children and Families.
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade, SW., Washington, DC
20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Estimated Total Annual Burden
Hours: 2,131.
Robert Sargis,
Reports Clearance Officer.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project , Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Oversight of Clinical
Investigations: A Risk-Based
Approach To Monitoring
VerDate Sep<11>2014
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[FR Doc. 2015–17166 Filed 7–13–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0597]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
SUMMARY:
PO 00000
Frm 00054
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Number of
responses
per respondent
1
1
1
Average
burden hours
per response
25
1
13
Total burden
hours
1,300
155
676
Paperwork Reduction Act of 1995 (the
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 collection of information concerning
the development of comprehensive
monitoring plans in the guidance.
DATES: Submit either electronic or
written comments on the collection of
information by September 14, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
E:\FR\FM\14JYN1.SGM
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Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
Guidance for Industry on Oversight of
Clinical Investigations: A Risk-Based
Approach To Monitoring
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,
including each proposed extension of an
existing 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.
(OMB Control Number 0910–0733)—
Extension
SUPPLEMENTARY INFORMATION:
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. The
guidance specifically encourages greater
reliance on centralized monitoring
methods where appropriate.
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 conduct monitoring of
clinical investigations and, therefore,
are compatible with a range of
approaches to monitoring. FDA
currently has OMB approval for the
information collection required under
part 812 (OMB control number 0910–
0078) and part 312, including certain
provisions under subpart D (OMB
control number 0910–0014).
The collection of information
associated with this guidance that
approved under OMB control number
0910–0733 is as follows:
Development of Comprehensive
Monitoring Plan: Section IV.D
‘‘Monitoring Plan’’ of the guidance
recommends that sponsors develop a
prospective, detailed monitoring plan
that describes the monitoring methods,
responsibilities, and requirements for
each clinical trial. The plan should
provide adequate information to those
involved with monitoring to effectively
carry out their duties. All sponsor
personnel 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. The components of a
monitoring plan are described in the
guidance, including monitoring plan
amendments (i.e., the review and
revision of monitoring plans and
processes for timely updates).
FDA understands that sponsors
currently develop monitoring plans;
however, not all monitoring plans
contain all the elements described in the
guidance. Therefore, our burden
estimate provides the additional time
that a sponsor would expend in
developing a comprehensive monitoring
plan based on the recommendations in
the guidance. FDA estimates that
approximately 88 sponsors will develop
approximately 132 comprehensive
monitoring plans in accordance with the
guidance and that the added burden for
each plan will be approximately 4 hours
to develop, including the time needed to
prepare monitoring plan amendments
when appropriate (a total of 528 hours).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Development of Comprehensive Monitoring Plan ...............
88
1.5
132
4
528
asabaliauskas on DSK5VPTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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41046
Federal Register / Vol. 80, No. 134 / Tuesday, July 14, 2015 / Notices
Dated: July 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17318 Filed 7–13–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–2148]
Submission of Premarket Notifications
for Magnetic Resonance Diagnostic
Devices; Draft Guidance for Industry
and Food and Drug Administration
Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance entitled
‘‘Submission of Premarket Notifications
for Magnetic Resonance Diagnostic
Devices.’’ This draft guidance provides
a detailed description of the information
that should be included in a premarket
notification for a magnetic resonance
diagnostic device (MRDD). This draft
guidance is not final nor is it in effect
at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 13,
2015.
SUMMARY:
An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Guidance for the
Submission of Premarket Notifications
for Magnetic Resonance Diagnostic
Devices’’ to the Office of the Center
Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
19:09 Jul 13, 2015
Jkt 235001
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Jana
Delfino, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4236, Silver Spring,
MD 20993–0002, 301–796–6503; or
Sunder Rajan, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 62, Rm. 1113, Silver Spring,
MD 20993–0002, 301–796–4194.
SUPPLEMENTARY INFORMATION:
I. Background
The purpose of this document is to
provide a detailed description of the
information that should be included in
a premarket notification for an MRDD.
This document is an elaboration of the
general requirements contained in 21
CFR 807.87 and is intended to be used
in conjunction with general information
regarding the content and format of a
510(k) premarket notification. The
approach outlined in this guidance
document is intended to facilitate the
timely review and marketing clearance
of MRDDs.
This draft guidance is applicable to
MRDDs as defined in 21 CFR 892.1000.
An MRDD is intended for general
diagnostic use to present images that
reflect the spatial distribution and/or
magnetic resonance spectra that reflect
frequency and distribution of nuclei
exhibiting nuclear magnetic resonance.
Other physical parameters derived from
the images and/or spectra may also be
produced. The device includes
hydrogen-1 (proton) imaging, sodium-23
imaging, hydrogen-1 spectroscopy,
phosphorus-31 spectroscopy, and
chemical shift imaging (preserving
simultaneous frequency and spatial
information). MRDDs are class II
medical devices that require premarket
notification and an agency
determination of substantial
equivalence prior to marketing.
The principal components of current
MRDDs include the main magnet, shim
and gradient systems, radiofrequency
transmitter and receiver, transmit and
receive coils, power supplies, computer,
and software. This draft guidance
document is applicable to premarket
notifications for new magnetic
resonance imaging (MRI) and magnetic
resonance spectroscopy systems, new
components, and modifications to
systems and components that have a
significant impact on safety or
effectiveness of the magnetic resonance
PO 00000
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diagnostic device. The information in
this draft guidance document is also
applicable to the MRI system
components of dual-modality devices,
such as positron emission tomography/
MRI systems.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Submission of Premarket
Notifications for Magnetic Resonance
Diagnostic Devices.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Submission of Premarket
Notifications for Magnetic Resonance
Diagnostic Devices’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 340 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 807,
subpart E, have been approved under
OMB control number 0910–0120, and
the collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485.
V. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
E:\FR\FM\14JYN1.SGM
14JYN1
]]>Agencies
[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)]
[Notices]
[Pages 41044-41046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17318]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0597]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on 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) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 collection of information
concerning the development of comprehensive monitoring plans in the
guidance.
DATES: Submit either electronic or written comments on the collection
of information by September 14, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455
[[Page 41045]]
Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
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, including
each proposed extension of an existing 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.
Guidance for Industry on Oversight of Clinical Investigations: A Risk-
Based Approach To Monitoring
(OMB Control Number 0910-0733)--Extension
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. The guidance specifically encourages
greater reliance on centralized monitoring methods where appropriate.
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 conduct monitoring of clinical
investigations and, therefore, are compatible with a range of
approaches to monitoring. FDA currently has OMB approval for the
information collection required under part 812 (OMB control number
0910-0078) and part 312, including certain provisions under subpart D
(OMB control number 0910-0014).
The collection of information associated with this guidance that
approved under OMB control number 0910-0733 is as follows:
Development of Comprehensive Monitoring Plan: Section IV.D
``Monitoring Plan'' of the guidance recommends that sponsors develop a
prospective, detailed monitoring plan that describes the monitoring
methods, responsibilities, and requirements for each clinical trial.
The plan should provide adequate information to those involved with
monitoring to effectively carry out their duties. All sponsor personnel
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. The components of a monitoring plan are described
in the guidance, including monitoring plan amendments (i.e., the review
and revision of monitoring plans and processes for timely updates).
FDA understands that sponsors currently develop monitoring plans;
however, not all monitoring plans contain all the elements described in
the guidance. Therefore, our burden estimate provides the additional
time that a sponsor would expend in developing a comprehensive
monitoring plan based on the recommendations in the guidance. FDA
estimates that approximately 88 sponsors will develop approximately 132
comprehensive monitoring plans in accordance with the guidance and that
the added burden for each plan will be approximately 4 hours to
develop, including the time needed to prepare monitoring plan
amendments when appropriate (a total of 528 hours).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Development of 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.
[[Page 41046]]
Dated: July 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17318 Filed 7-13-15; 8:45 am]
BILLING CODE 4164-01-P
