80_FR_78987 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

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 Range78745-78746
FR Document2015-31695

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]


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

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
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by January 19, 2016.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation80 FR 78745 

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