Document ID: FDA-2011-D-0597-0055
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Oversight of Clinical
Investigations: A Risk-Based Approach To Monitoring
Posted Date: 2015-07-14T04:00Z

[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 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, 
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