
[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Pages 78745-78746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31695]


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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; Guidance for Industry on Oversight of 
Clinical Investigations: A Risk-Based Approach to Monitoring

AGENCY: Food and Drug Administration, HHS.

[[Page 78746]]


ACTION: Notice.

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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 January 
19, 2016.

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 0910-0733. 
Also include the FDA 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 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, 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.

Guidance for Industry: Oversight of Clinical Investigations: A Risk-
Based Approach to Monitoring, OMB Control Number 0910-0733

    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 is 
approved under OMB control number 0910-0733 is as follows:
    Development of Comprehensive Monitoring Plan: Section IV.D 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 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, the 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).
    In the Federal Register of July 14, 2015 (80 FR 41044), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one comment; however, it did 
not pertain to the information collection.
    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.


    Dated: December 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-31695 Filed 12-16-15; 8:45 am]
BILLING CODE 4164-01-P


