[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Questions and Answers; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``A Risk-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 The draft guidance provides information to sponsors on risk-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DATES: Submit either electronic or written comments on the draft
guidance by May 14, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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, [email protected]; 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,
[email protected]; 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,
[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 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