Document ID: FDA-2019-D-0362-0001
Agency: fda
Document Type: Notice
Title: A Risk-Based Approach To Monitoring of Clinical Investigations: Questions and Answers; Draft Guidance for Industry; Availability
Posted Date: 2019-03-15T04:00Z

[Federal Register Volume 84, Number 51 (Friday, March 15, 2019)]
[Notices]
[Pages 9531-9533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04814]

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

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Questions and Answers; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``A Risk-
Based Approach to Monitoring of Clinical Investigations: Questions and 
Answers.'' The draft guidance provides information to sponsors on risk-
based approaches to monitoring of investigational studies of human drug 
and biological products, medical devices, and combinations thereof. 
This guidance expands on the guidance for industry entitled ``Oversight 
of Clinical Investigations--A Risk-Based Approach to Monitoring'' 
(August 2013) (the RBM Guidance) by providing additional guidance to 
facilitate sponsors' implementation of risk-based monitoring.

DATES: Submit either electronic or written comments on the draft 
guidance by May 14, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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

[[Page 9532]]

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-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.
     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.gpo.gov/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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft 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 the Center Director, Guidance and Policy Development, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002; or the Office of Good Clinical Practice, 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Ansalan Stewart, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6312, Silver Spring, MD 20993-0002, 240-
402-6631, ansalan.stewart@fda.hhs.gov; Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7268, 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, 
CDRHClinicalEvidence@fda.hhs.gov; Sheila Brown, Office of Good Clinical 
Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 5109, Silver Spring, MD 20993, 301-796-6563, 
Sheila.Brown@fda.hhs.gov; or Hector Colon, Office of Regulatory 
Affairs/Office of Bioresearch Monitoring Operations, 12420 Parklawn 
Dr., Rockville, MD 20857, 301-796-3899, 
orabimoinspectionpoc@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``A Risk-Based Approach to Monitoring of Clinical 
Investigations: Questions and Answers.'' This document provides 
guidance to sponsors on risk-based approaches to monitoring 
investigational studies of human drug and biological products, medical 
devices, and combinations thereof. This guidance expands on the 
guidance for industry entitled ``Oversight of Clinical Investigations--
A Risk-Based Approach to Monitoring'' (the RBM guidance) \1\ by 
providing additional guidance to facilitate sponsors' implementation of 
risk-based monitoring.
---------------------------------------------------------------------------

    \1\ Available at: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm269919.pdf.
---------------------------------------------------------------------------

    FDA's experience since finalizing the RBM guidance in 2013 suggests 
that additional guidance would be beneficial regarding FDA's 
recommendations for planning a risk-based monitoring approach, 
developing the content of monitoring plans, and addressing and 
communicating monitoring results. The questions and answers in this 
draft guidance are intended to assist sponsors in planning and 
conducting risk-based monitoring.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on a risk-based 
approach to monitoring of clinical investigations. 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 
requirements of the applicable statutes and regulations. This

[[Page 9533]]

guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 50 have been approved under 
OMB control number 0910-0755; 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; and the collections of information in the 
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 draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov.

    Dated: March 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04814 Filed 3-14-19; 8:45 am]
 BILLING CODE 4164-01-P