Document ID: FDA-2011-D-0597-0062
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Oversight of
Clinical Investigations: A Risk-Based Approach to Monitoring
Posted Date: 2019-04-16T04:00Z

[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]

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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; Comment Request; 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, 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\
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                                                           Number of       Number of records     Total annual     Average burden per
                      Activity                           recordkeepers     per recordkeeper         records          recordkeeping        Total hours
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Documentation included in comprehensive monitoring                   88                 1.5                 132                   4                 528
 plan...............................................
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\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