[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Notices]
[Pages 22038-22040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07687]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0362]


A Risk-Based Approach To Monitoring of Clinical Investigations--
Questions and Answers; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``A Risk-
Based Approach to Monitoring of Clinical Investigations--Questions and 
Answers.'' This guidance provides information on risk-based approaches 
to monitoring investigational studies of human drug and biological 
products, medical devices, and combination products. The guidance 
contains recommendations on planning a monitoring approach, developing 
the content of a monitoring plan, and addressing and communicating 
monitoring results. This guidance expands on the guidance for industry 
entitled ``Oversight of Clinical Investigations--A Risk-Based Approach 
to Monitoring'' (August 2013) by providing additional information to 
facilitate sponsors' implementation of risk-based monitoring. This 
guidance finalizes the draft guidance entitled ``A Risk-Based Approach 
to Monitoring of Clinical Investigations: Questions and Answers,'' 
issued on March 15, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on April 12, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

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.

[[Page 22039]]

     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-2019-D-0362 for ``A Risk-Based Approach to Monitoring of Clinical 
Investigations--Questions and Answers.'' Received comments 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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; the 
Office of Policy, Guidance and Policy Development, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Room 5431, Silver Spring, MD 20993-0002; or 
the Office of Clinical Policy, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Mona Shing, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 3355, Silver Spring, MD 20993-0002, 301-796-0910, 
[email protected]; Diane Maloney, Center for Biologics Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; Martin 
Hamilton, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002, 301-796-5666, [email protected]; 
Sheila Brown, Office of Clinical Policy, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, Rm. 5109, Silver Spring, MD 20993, 
301-796-6563, [email protected]; or Hector Colon, Office of 
Regulatory Affairs/Office of Bioresearch Monitoring Operations, 12420 
Parklawn Dr., Rockville, MD 20857, 301-796-3899, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``A Risk-Based Approach to Monitoring of Clinical 
Investigations--Questions and Answers.'' Sponsors of clinical 
investigations involving human drugs, biological products, medical 
devices, and combination products are required to provide oversight of 
the conduct of their clinical investigations. Such oversight helps to 
ensure adequate protection of the rights, welfare, and safety of human 
subjects and the integrity of the data submitted to FDA. Therefore, FDA 
recommends that sponsors implement a system to manage risks to human 
subjects and data integrity throughout all stages of the clinical 
investigation process.
    This system to manage the quality of the investigation should help 
ensure data integrity while safeguarding the rights, safety, and 
welfare of trial participants by, for example, focusing on the design 
of efficient clinical trial protocols, tools for identifying and 
tracking potential risks, and procedures for data collection and 
processing. This system should include a risk-based approach to 
monitoring tailored to the potential risks for the specific clinical 
investigation. Clinical investigation monitoring is a quality control 
tool for determining whether investigation activities are being carried 
out as planned, so that, among other things, deficiencies can be 
identified and corrected. The types and intensity of monitoring 
activities should be proportionate to the risks to participants' 
rights, safety, and welfare and to data integrity inherent in the 
investigation. Effective implementation of risk-based monitoring of 
clinical investigations, including the prioritization of monitoring and 
other oversight activities directed at processes and procedures 
critical for human subject protection and maintaining data integrity, 
should help maximize the quality of a clinical investigation.
    This guidance finalizes the draft guidance entitled ``A Risk-Based 
Approach to Monitoring of Clinical Investigations: Questions and 
Answers,'' issued on March 15, 2019 (84 FR 9531). FDA considered 
comments received on the draft guidance as the guidance was being 
finalized and revised the guidance as appropriate in response to the 
comments. Additionally, editorial changes were made to improve clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``A Risk-Based Approach to Monitoring of 
Clinical Investigations--Questions and Answers.'' It does not establish 
any rights for any person and is not binding on FDA or the public. You 
can use an alternative approach if it satisfies the

[[Page 22040]]

requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 50 have been approved under OMB control 
number 0910-0130; the collections of information in 21 CFR part 312 
have been approved under OMB control number 0910-0014; the collections 
of information in 21 CFR part 812 have been approved under OMB control 
number 0910-0078; the collections of information in 21 CFR part 11 have 
been approved under OMB control number 0910-0303; and the collections 
of information in FDA's guidance for industry entitled ``Oversight of 
Clinical Investigations--A Risk-Based Approach to Monitoring'' have 
been approved under OMB control number 0910-0733.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, or https://www.regulations.gov.

    Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07687 Filed 4-11-23; 8:45 am]
BILLING CODE 4164-01-P