83 FR 61646 - Agency Information Collection Activities; Proposed Collection; Comment Request; Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 231 (November 30, 2018)

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 information collection associated with oversight of clinical investigations, a risk-based approach to monitoring.

[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61646-61648]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26032]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0597]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 or Agency) is announcing 
an opportunity for public

[[Page 61647]]

comment on the proposed collection of certain information by the 
Agency. Under the Paperwork Reduction Act of 1995 (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 information collection associated with oversight 
of clinical investigations, a risk-based approach to monitoring.

DATES: Submit either electronic or written comments on the collection 
of information by January 29, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 29, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 29, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-D-0597 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Oversight of Clinical 
Investigations: A Risk-Based Approach to Monitoring.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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.

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

[[Page 61648]]

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 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.'' 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.
    We estimate the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of      records per    Total Annual     burden per      Total hours
                                   recordkeepers   recordkeeper       Records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Documentation included in                     88             1.5             132               4             528
 comprehensive monitoring plan..
----------------------------------------------------------------------------------------------------------------
\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: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26032 Filed 11-29-18; 8:45 am]
 BILLING CODE 4164-01-P