Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry: Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring, 58998-58999 [2012-23545]
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Federal Register / Vol. 77, No. 186 / Tuesday, September 25, 2012 / Notices
sequences in their devices, and
incorporate the result of these analyses
into their quality management system,
as required by 21 CFR 820.100(a)(1).
These analyses will be evaluated against
the device design validation and risk
analysis required by 21 CFR 820.30(g),
to determine if any design changes may
be necessary.
FDA estimates that 10 respondents
will be affected annually. Each
respondent will collect this information
twice per year; each response is
estimated to take 15 hours. This results
in a total data collection burden of 300
hours. The guidance also refers to
previously approved information
collections found in FDA regulations.
The collections of information in 21
CFR 801 have been approved under
OMB control number 0910–0485; 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 820 have been approved under
OMB control number 0910–0073.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
FD&C Act section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
513(g) ...................................................................................
10
2
20
15
1 There
Availability.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, Ila.Mizrachi@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.
[FR Doc. 2012–23544 Filed 9–24–12; 8:45 am]
BILLING CODE 4160–01–P
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Comment Request; Draft Guidance for
Industry: Oversight of Clinical
Investigations: A Risk-Based
Approach to Monitoring
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.
DATES: Fax written comments on the
collection of information by October 25,
2012.
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
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–New and
title ‘‘Draft Guidance for Industry on
Oversight of Clinical Investigations: A
Risk-Based Approach to Monitoring;
SUMMARY:
emcdonald on DSK67QTVN1PROD with NOTICES
300
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
AGENCY:
Total hours
VerDate Mar<15>2010
14:15 Sep 24, 2012
Jkt 226001
Draft Guidance for Industry: Oversight
of Clinical Investigations: A Risk-Based
Approach to Monitoring—(OMB
Control Number 0910–New)
Description of Respondents:
Respondents to this collection of
information are sponsors that monitor
clinical investigations.
Burden Estimate: The draft guidance
is intended to assist sponsors of clinical
investigations in developing risk-based
monitoring strategies and plans for
investigational studies of medical
products, including human drug and
biological products, medical devices,
and combinations thereof. The guidance
is intended to make clear that sponsors
can use a variety of approaches to fulfill
their responsibilities related to
monitoring investigator conduct and the
progress of investigational new drug
(IND) or investigational device
exemption (IDE) studies. The guidance
describes strategies for monitoring
activities performed by a sponsor, or
contract research organizations (CROs),
that focus on the conduct, oversight,
and reporting of findings of an
investigation by clinical investigators.
The guidance 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
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
study effectively. The guidance
specifically encourages greater reliance
on centralized monitoring methods,
where appropriate.
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 the quality
and integrity of the resulting data
submitted to FDA.1 As part of this
oversight, sponsors of clinical
investigations are required to monitor
the conduct and progress of their
clinical investigations.2 3 The
regulations are not specific about 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).
However, the collections of
information associated with this draft
guidance that are not currently
approved under OMB control numbers
0910–0014 or 0910–0078 are as follows:
Development of Comprehensive
Monitoring Plan: Section IV.D of the
draft guidance recommends that
sponsors develop a prospective, detailed
monitoring plan that describes the
monitoring methods, responsibilities,
1 Part 312 (21 CFR part 312), subpart D, generally
(Responsibilities of Sponsors and Investigators) and
part 812 (21 CFR part 812), subpart C, generally
(Responsibilities of Sponsors).
2 Section 312.50 requires a sponsor to, among
other things, ensure ‘‘proper monitoring of the
investigation(s)’’ and ‘‘that the investigation(s) is
conducted in accordance with the general
investigational plan and protocols contained in the
IND.’’
3 Also see §§ 312.53(d), 312.56(a), 812.40, and
812.43(d).
E:\FR\FM\25SEN1.SGM
25SEN1
Federal Register / Vol. 77, No. 186 / Tuesday, September 25, 2012 / Notices
and requirements for each clinical trial.
The plan should provide those involved
in monitoring with adequate
information to effectively carry out their
duties. All sponsor and CRO personnel
who may be involved with monitoring,
including those who review and/or
determine appropriate action regarding
potential issues identified through
monitoring, should review the
monitoring plan. The components of a
monitoring plan are described in the
draft 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 following burden
estimate provides the additional time
that a sponsor would expend in
developing a comprehensive monitoring
plan based on the recommendations in
the guidance. We estimate that
approximately 88 sponsors will develop
approximately 132 comprehensive
monitoring plans in accordance with the
draft guidance, and that the added
burden for each plan will be
approximately 4 hours to develop,
including the time needed for preparing
monitoring plan amendments when
appropriate (a total of 528 hours).
Voluntary Submission of Monitoring
Plans to FDA: Section IV.D of the draft
guidance permits sponsors to
voluntarily and prospectively submit
their monitoring plans to the
appropriate Center for Drug Evaluation
and Research (CDER) review division
and request input from the division’s
clinical trial oversight component
(sponsors of significant risk device
studies are already required under
§ 812.25(e) to submit and maintain
written procedures for monitoring). We
estimate that approximately 22 sponsors
will submit approximately 33
monitoring plans to CDER for feedback
and that each submission will take
approximately 2 hours to complete (a
total of 66 hours).
In the Federal Register of August 29,
2011 (76 FR 53683), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. The following is a
summary of the comments and FDA’s
response to the comments for the two
collections of information associated
with the draft guidance that are not
currently approved by OMB.
Development of Comprehensive
Monitoring Plan:
FDA received comments that the
guidance lacks specific information on
development and initialization of risk
assessment plans, appropriate
mitigation plans, and execution of
mitigation plans through the monitoring
plan. Addition of use of risk
management tools, along with potential
applications for using risk-based
monitoring strategies would help
facilitate implementation.
In response to the comments, FDA
included additional detail in the final
guidance in an effort to enhance the
quality, utility, and clarity of the
information collected. Specifically, FDA
included additional detail on the
development of a monitoring plan,
which focuses on the important and
likely risks, identified by the risk
58999
assessment, to critical data and
processes. In addition, FDA included
additional guidance on the steps
involved in performing a risk
assessment and references to tools and
methodologies that can be used to
perform a risk assessment. FDA clarified
that the guidance does not provide
comprehensive detail on how to
perform a risk assessment.
FDA received several comments that
the guidance should specify that it is
acceptable for monitoring plans to
reference existing standard operating
procedures (SOPs) or other documents.
The draft guidance specifies that a
monitoring plan may reference existing
policies and procedures in order to
minimize the burden of the collection of
information.
Voluntary Submission of Monitoring
Plans to FDA:
FDA received numerous comments
that the lack of specific details about
FDA review of the monitoring plans
early enough in the IND process could
delay startup of clinical trials. In
addition, numerous comments
requested a detailed process or
procedure.
Although the draft guidance stated
that CDER was considering establishing
processes through which sponsors could
voluntarily submit monitoring plans for
CDER feedback, CDER has concluded
that CDER does not have the resources
necessary to commit to such a review at
this time. CDER is exploring the
possibility of a pilot program in this
area in the future.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Draft guidance on monitoring clinical investigations
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
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–23545 Filed 9–24–12; 8:45 am]
emcdonald on DSK67QTVN1PROD with NOTICES
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0938]
Draft Guidance for Industry on
Abbreviated New Drug Applications:
Stability Testing of Drug Substances
and Products; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
VerDate Mar<15>2010
14:15 Sep 24, 2012
Jkt 226001
PO 00000
Notice.
Frm 00022
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘ANDAs: Stability
Testing of Drug Substances and
Products.’’ FDA is recommending that
generic drug manufacturers follow the
stability testing recommendations in the
International Conference on
Harmonisation (ICH) guidances
Q1A(R2) through Q1E. The use of these
ICH recommendations will standardize
FDA’s stability testing policies, which
will help make the abbreviated new
SUMMARY:
E:\FR\FM\25SEN1.SGM
25SEN1
]]>Agencies
[Federal Register Volume 77, Number 186 (Tuesday, September 25, 2012)]
[Notices]
[Pages 58998-58999]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23545]
-----------------------------------------------------------------------
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; Draft Guidance for
Industry: 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 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 October
25, 2012.
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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title ``Draft Guidance for Industry on Oversight of Clinical
Investigations: A Risk-Based Approach to Monitoring; Availability.''
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Food and Drug
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-7726, Ila.Mizrachi@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.
Draft Guidance for Industry: Oversight of Clinical Investigations: A
Risk-Based Approach to Monitoring--(OMB Control Number 0910-New)
Description of Respondents: Respondents to this collection of
information are sponsors that monitor clinical investigations.
Burden Estimate: The draft guidance is intended to assist sponsors
of clinical investigations in developing risk-based monitoring
strategies and plans for investigational studies of medical products,
including human drug and biological products, medical devices, and
combinations thereof. The guidance is intended to make clear that
sponsors can use a variety of approaches to fulfill their
responsibilities related to monitoring investigator conduct and the
progress of investigational new drug (IND) or investigational device
exemption (IDE) studies. The guidance describes strategies for
monitoring activities performed by a sponsor, or contract research
organizations (CROs), that focus on the conduct, oversight, and
reporting of findings of an investigation by clinical investigators.
The guidance 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.
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 the quality and integrity of
the resulting data submitted to FDA.\1\ As part of this oversight,
sponsors of clinical investigations are required to monitor the conduct
and progress of their clinical investigations.2 3 The
regulations are not specific about 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).
---------------------------------------------------------------------------
\1\ Part 312 (21 CFR part 312), subpart D, generally
(Responsibilities of Sponsors and Investigators) and part 812 (21
CFR part 812), subpart C, generally (Responsibilities of Sponsors).
\2\ Section 312.50 requires a sponsor to, among other things,
ensure ``proper monitoring of the investigation(s)'' and ``that the
investigation(s) is conducted in accordance with the general
investigational plan and protocols contained in the IND.''
\3\ Also see Sec. Sec. 312.53(d), 312.56(a), 812.40, and
812.43(d).
---------------------------------------------------------------------------
However, the collections of information associated with this draft
guidance that are not currently approved under OMB control numbers
0910-0014 or 0910-0078 are as follows:
Development of Comprehensive Monitoring Plan: Section IV.D of the
draft guidance recommends that sponsors develop a prospective, detailed
monitoring plan that describes the monitoring methods,
responsibilities,
[[Page 58999]]
and requirements for each clinical trial. The plan should provide those
involved in monitoring with adequate information to effectively carry
out their duties. All sponsor and CRO personnel who may be involved
with monitoring, including those who review and/or determine
appropriate action regarding potential issues identified through
monitoring, should review the monitoring plan. The components of a
monitoring plan are described in the draft 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
following burden estimate provides the additional time that a sponsor
would expend in developing a comprehensive monitoring plan based on the
recommendations in the guidance. We estimate that approximately 88
sponsors will develop approximately 132 comprehensive monitoring plans
in accordance with the draft guidance, and that the added burden for
each plan will be approximately 4 hours to develop, including the time
needed for preparing monitoring plan amendments when appropriate (a
total of 528 hours).
Voluntary Submission of Monitoring Plans to FDA: Section IV.D of
the draft guidance permits sponsors to voluntarily and prospectively
submit their monitoring plans to the appropriate Center for Drug
Evaluation and Research (CDER) review division and request input from
the division's clinical trial oversight component (sponsors of
significant risk device studies are already required under Sec.
812.25(e) to submit and maintain written procedures for monitoring). We
estimate that approximately 22 sponsors will submit approximately 33
monitoring plans to CDER for feedback and that each submission will
take approximately 2 hours to complete (a total of 66 hours).
In the Federal Register of August 29, 2011 (76 FR 53683), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. The following is a summary of the comments
and FDA's response to the comments for the two collections of
information associated with the draft guidance that are not currently
approved by OMB.
Development of Comprehensive Monitoring Plan:
FDA received comments that the guidance lacks specific information
on development and initialization of risk assessment plans, appropriate
mitigation plans, and execution of mitigation plans through the
monitoring plan. Addition of use of risk management tools, along with
potential applications for using risk-based monitoring strategies would
help facilitate implementation.
In response to the comments, FDA included additional detail in the
final guidance in an effort to enhance the quality, utility, and
clarity of the information collected. Specifically, FDA included
additional detail on the development of a monitoring plan, which
focuses on the important and likely risks, identified by the risk
assessment, to critical data and processes. In addition, FDA included
additional guidance on the steps involved in performing a risk
assessment and references to tools and methodologies that can be used
to perform a risk assessment. FDA clarified that the guidance does not
provide comprehensive detail on how to perform a risk assessment.
FDA received several comments that the guidance should specify that
it is acceptable for monitoring plans to reference existing standard
operating procedures (SOPs) or other documents.
The draft guidance specifies that a monitoring plan may reference
existing policies and procedures in order to minimize the burden of the
collection of information.
Voluntary Submission of Monitoring Plans to FDA:
FDA received numerous comments that the lack of specific details
about FDA review of the monitoring plans early enough in the IND
process could delay startup of clinical trials. In addition, numerous
comments requested a detailed process or procedure.
Although the draft guidance stated that CDER was considering
establishing processes through which sponsors could voluntarily submit
monitoring plans for CDER feedback, CDER has concluded that CDER does
not have the resources necessary to commit to such a review at this
time. CDER is exploring the possibility of a pilot program in this area
in the future.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Draft guidance on monitoring clinical investigations 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.
Dated: September 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-23545 Filed 9-24-12; 8:45 am]
BILLING CODE 4160-01-P
