80 FR 78745 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 242 (December 17, 2015)

Page Range		78745-78746
FR Document		2015-31695

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.

Federal Register, Volume 80 Issue 242 (Thursday, December 17, 2015)

[Federal Register Volume 80, Number 242 (Thursday, December 17, 2015)]
[Notices]
[Pages 78745-78746]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         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.


    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

Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices 78745

A. Proposed Reporting Burden Specifically, the sponsor should submit plans in accordance with the draft
Estimates for Developing and the list of anticipated serious adverse guidance and that the burden for each
Submitting a Safety Surveillance Plan events and previously recognized plan will be approximately 120 to 240
serious adverse reactions and guiding hours. This burden estimate includes
This draft guidance proposes the principles for periodic aggregate safety the time sponsors will need to prepare
following new collections of reviews.
information for reporting: safety surveillance plan amendments
Based on information available to when appropriate. The average burden
Developing and Submitting a Safety FDA, including burden estimates for per response is estimated as a range to
Surveillance Plan: The draft guidance collections of information approved account for respondents that will make
recommends that a sponsor develop a under OMB control numbers 0910–0014
changes to a pre-existing premarket
safety surveillance plan that describes [covers § 312.23 (21 CFR 312.23) (IND
safety system and those that will
processes and procedures for assessing content), portions of § 312.32 (IND
develop a new premarket safety system.
serious adverse events and other safety safety reports), and § 312.66 (21 CFR
information. The draft guidance 312.66) (investigator reporting to The average of this range (180 hours)
describes seven elements that should be institutional review board)] and 0910– was used to calculate the total hours
included in a safety surveillance plan 0733 (development of a comprehensive estimated in table 1 of this document (a
and recommends that the sponsor monitoring plan), we estimate that total of 19,980 hours).
submit a portion of the safety approximately 88 sponsors will develop FDA estimates the burden of this
surveillance plan to the IND. approximately 111 safety surveillance collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Safety assessment for IND safety reporting responses per burden per Total hours
respondents responses
respondent response

Develop and submit a safety surveillance plan ................... 88 1.26 111 180 19,980
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

B. Proposed Recordkeeping Burden The draft guidance recommends that records in accordance with the draft
Estimates for Maintaining a Safety a sponsor maintain the safety guidance and that the average burden
Surveillance Plan surveillance plan. per recordkeeping is 6 hours (a total of
This draft guidance proposes the Based on information available to 1,584 hours).
following new collections of FDA, we estimate that approximately 88 FDA estimates the burden of this
information for recordkeeping: sponsors will maintain approximately 3 collection of information as follows:

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Safety assessment for IND safety reporting records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

Maintain a safety surveillance plan ..................................... 88 3 264 6 1,584
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The draft guidance also refers to under OMB control number 0910–0014 Dated: December 11, 2015.
previously approved collections of (for example, reporting to FDA in an Leslie Kux,
information found in FDA regulations IND safety report any clinically Associate Commissioner for Policy.
that have been approved under the OMB important increase in the rate of [FR Doc. 2015–31690 Filed 12–16–15; 8:45 am]
control numbers that follow. occurrence of serious suspected adverse BILLING CODE 4164–01–P
• OMB control number 0910–0014 reactions over that listed in the protocol
covers § 312.23 (IND content), portions or the investigator brochure).
of § 312.32 (IND safety reports), and DEPARTMENT OF HEALTH AND
§ 312.66 (investigator reporting to III. Electronic Access HUMAN SERVICES
institutional review board).
• OMB control number 0910–0116 Persons with access to the Internet Food and Drug Administration
covers 21 CFR 606.170(b) (adverse may obtain the document at http://
reaction file). www.fda.gov/Drugs/
[Docket No. FDA–2011–D–0597]
• OMB control number 0910–0230 GuidanceCompliance
asabaliauskas on DSK5VPTVN1PROD with NOTICES

covers 21 CFR 310.305 and 314.80 RegulatoryInformation/Guidances/ Agency Information Collection
(postmarketing reporting of adverse default.htm, http://www.fda.gov/ Activities; Submission for Office of
drug experiences). BiologicsBloodVaccines/ Management and Budget Review;
• OMB control number 0910–0308 GuidanceCompliance Guidance for Industry on Oversight of
covers 21 CFR 600.80 (postmarketing RegulatoryInformation/Guidances/ Clinical Investigations: A Risk-Based
reporting of adverse experiences). default.htm, or http://www. Approach to Monitoring
• OMB control number 0910–0672
regulations.gov.
covers more recent provisions of AGENCY: Food and Drug Administration,
§ 312.32 that are not already approved HHS.

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78746 Federal Register / Vol. 80, No. 242 / Thursday, December 17, 2015 / Notices

ACTION: Notice. and combinations thereof. The guidance monitoring plan that describes the
describes strategies for monitoring monitoring methods, responsibilities,
SUMMARY: The Food and Drug activities performed by sponsors, or by and requirements for each clinical trial.
Administration (FDA) is announcing contract research organizations (CROs), The plan should provide adequate
that a proposed collection of that focus on the conduct, oversight, information to those involved with
information has been submitted to the and reporting of findings of an monitoring to effectively carry out their
Office of Management and Budget investigation by clinical investigators. duties. All sponsor and CRO personnel
(OMB) for review and clearance under The guidance also recommends who may be involved with monitoring
the Paperwork Reduction Act of 1995. strategies that reflect a risk-based (including those who review
DATES: Fax written comments on the approach to monitoring that focuses on appropriate action, determine
collection of information by January 19, critical study parameters and relies on appropriate action, or both) regarding
2016. a combination of monitoring activities potential issues identified through
ADDRESSES: To ensure that comments on to oversee a study effectively. The monitoring, should review the
the information collection are received, guidance specifically encourages greater monitoring plan. The components of a
OMB recommends that written reliance on centralized monitoring monitoring plan are described in the
comments be faxed to the Office of methods where appropriate. guidance, including monitoring plan
Information and Regulatory Affairs, Under parts 312 and 812 (21 CFR amendments (i.e., the review and
OMB, Attn: FDA Desk Officer, FAX: parts 312 and 812), sponsors are revision of monitoring plans and
202–395–7285, or emailed to oira_ required to provide appropriate processes for timely updates).
submission@omb.eop.gov. All oversight of their clinical investigations
comments should be identified with the FDA understands that sponsors
to ensure adequate protection of the currently develop monitoring plans;
OMB control number 0910–0733. Also rights, welfare, and safety of human
include the FDA docket number found however, not all monitoring plans
subjects and to ensure the quality and contain all the elements described in the
in brackets in the heading of this integrity of the resulting data submitted
document. guidance. Therefore, the burden
to FDA. As part of this oversight, estimate provides the additional time
FOR FURTHER INFORMATION CONTACT: FDA sponsors of clinical investigations are that a sponsor would expend in
PRA Staff, Office of Operations, Food required to monitor the conduct and developing a comprehensive monitoring
and Drug Administration, 8455 progress of their clinical investigations. plan based on the recommendations in
Colesville Rd., COLE–14526, Silver The regulations do not specify how the guidance. FDA estimates that
Spring, MD 20993–0002, PRAStaff@ sponsors are to conduct monitoring of approximately 88 sponsors will develop
fda.hhs.gov. clinical investigations and, therefore, approximately 132 comprehensive
SUPPLEMENTARY INFORMATION: In are compatible with a range of monitoring plans in accordance with the
compliance with 44 U.S.C. 3507, FDA approaches to monitoring. FDA guidance, and that the added burden for
has submitted the following proposed currently has OMB approval for the each plan will be approximately 4 hours
collection of information to OMB for information collection required under to develop, including the time needed to
review and clearance. part 812 (OMB control number 0910– prepare monitoring plan amendments
0078) and part 312, including certain when appropriate (a total of 528 hours).
Guidance for Industry: Oversight of provisions under subpart D (OMB
Clinical Investigations: A Risk-Based control number 0910–0014). In the Federal Register of July 14,
Approach to Monitoring, OMB Control The collection of information 2015 (80 FR 41044), FDA published a
Number 0910–0733 associated with this guidance that is 60-day notice requesting public
The guidance is intended to assist approved under OMB control number comment on the proposed collection of
sponsors of clinical investigations in 0910–0733 is as follows: information. FDA received one
developing strategies for risk-based Development of Comprehensive comment; however, it did not pertain to
monitoring and plans for clinical Monitoring Plan: Section IV.D of the the information collection.
investigations of human drug and guidance recommends that sponsors FDA estimates the burden of this
biological products, medical devices, develop a prospective, detailed collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent 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: December 10, 2015.
Leslie Kux,
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Associate Commissioner for Policy.
[FR Doc. 2015–31695 Filed 12–16–15; 8:45 am]
BILLING CODE 4164–01–P

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Document Created: 2018-03-02 09:18:02
Document Modified: 2018-03-02 09:18:02

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by January 19, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 78745

80 FR 78745 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 242 (December 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration