[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]
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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.
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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 http://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,
[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, 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\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Development of Comprehensive Monitoring Plan....................... 88 1.5 132 4 528
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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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