A Risk-Based Approach To Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Availability, 22038-22040 [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.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘A RiskBased Approach to Monitoring of
Clinical Investigations—Questions and
Answers.’’ This guidance provides
information on risk-based approaches to
SUMMARY:
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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finalizes the draft guidance entitled ‘‘A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.
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Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Notices
• 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-201509-18/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.
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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,
mona.shing@fda.hhs.gov; 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, CDRHClinicalEvidence@
fda.hhs.gov; 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,
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 guidance for industry entitled ‘‘A
Risk-Based Approach to Monitoring of
Clinical Investigations—Questions and
Answers.’’ Sponsors of clinical
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22039
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
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Federal Register / Vol. 88, No. 70 / Wednesday, April 12, 2023 / Notices
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/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, 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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0721]
Center for Devices and Radiological
Health Radiation Sterilization Master
File Pilot Program
AGENCY:
Food and Drug Administration,
HHS.
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Jkt 259001
ACTION:
Notice.
The Food and Drug
Administration’s (FDA, Agency, or we)
Center for Devices and Radiological
Health (CDRH or Center) is announcing
its Radiation Sterilization Master File
Pilot Program (‘‘Radiation Pilot
Program’’). The Radiation Pilot Program
is voluntary and intends to allow
companies that terminally sterilize
single-use medical devices
(‘‘sterilization providers’’) using gamma
radiation or ethylene oxide (EO) to
submit Master File(s) when making
certain changes to sterilization sites,
methods, or processes under the specific
conditions outlined in this notice.
Under this voluntary pilot program,
manufacturers of class III devices
subject to premarket approval (‘‘PMA
holders’’) who have been granted a right
of reference by a sterilization provider
may, upon notification from FDA that a
manufacturer may do so, include
references to Master File(s) accepted
into the Radiation Pilot Program in
postapproval reports describing the
particular changes noted above affecting
the sterilization sites, methods, or
processes of their class III devices, in
lieu of submitting premarket approval
application (PMA) supplements for such
changes. By helping industry advance
alternatives for gamma radiation and EO
sterilization of medical devices, the
Radiation Pilot Program seeks to help
ensure patient access to safe medical
devices and, through evaluation of data
from pilot participants, provide insights
into future regulatory approaches that
may help address potential device
shortages related to sterilization site,
method, or process shifts and facilitate
supply chain resiliency.
DATES: FDA is seeking participation in
the voluntary Radiation Pilot Program
beginning April 12, 2023. See the
‘‘Participation’’ section for eligibility
criteria for participation in the
Radiation Pilot Program and the
‘‘Procedures’’ section for instructions on
how to submit a Master File for
consideration for inclusion into the
Radiation Pilot Program. Up to nine
eligible participants may be selected for
the Radiation Pilot Program.
FOR FURTHER INFORMATION CONTACT:
Clarence W. Murray, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4536, Silver Spring
MD 20993, 301–796–0270,
Clarence.Murray@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Radiation-based sterilization is widely
used to sterilize medical devices and
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thereby keep them safe for patient use.
Established sources of radiation that
may be used to generate radiation for
medical device sterilization in
accordance with FDA-recognized
international consensus standards
include gamma radiation, x-rays, and
electron beams. Of these three types of
radiation-based sterilization, gamma
radiation is the most frequently used
radiation source for medical device
sterilization and, more broadly, is the
second most frequently used
sterilization method by sterilization
providers,1 accounting for
approximately 40 to 45 percent of sterile
medical devices (Ref. 1). The most
frequently used sterilization method is
ethylene oxide (EO), which is used to
sterilize approximately 50 percent of
sterile medical devices (Ref. 2).
Before sterile medical devices subject
to PMA requirements are approved for
marketing, FDA reviews the submitted
PMA to determine if the sterility
information is adequate (e.g., in
accordance with internationally agreed
upon voluntary consensus standards
that FDA recognizes). If a medical
device manufacturer changes the
sterilization method (i.e., changes the
type of sterilization modality used),
process, or facility identified in its
original PMA submission for sterilizing
its devices, the manufacturer generally
needs to submit a PMA supplement so
the Agency can review these changes
(Ref. 3).
However, FDA recognizes the need to
facilitate more timely changes to
alternative sterilization methods,
processes, or sites among sterilization
providers who use gamma radiation or
EO to support sterilization supply chain
resiliency.2 In the case of gamma
radiation, the radiation used for medical
device sterilization is generated using
radioactive cobalt (Co60) as a source
material, and there may be potential
supply chain constraints for Co60
relative to the level of demand for
radiation sterilization (Ref. 4). FDA also
is aware of ongoing supply chain
considerations for EO sterilization of
medical devices as well as concerns
about the effects of EO exposure and
environmental emissions. In 2019, FDA
1 In this notice, ‘‘method’’ or ‘‘modality’’
generally refers to the type of sterilization and
‘‘processes’’ generally refers to steps within that
method to achieve a sterile device.
2 Further, FDA more generally seeks to improve
and strengthen the device supply chain through
other broader initiatives, such as the planned
Resilient Supply Chain and Shortages Prevention
Program (RSCSPP). See FDA’s Budget, Medical
Device Supply Chain and Shortages Prevention
Program, https://www.fda.gov/news-events/fdavoices/fdas-budget-medical-device-supply-chainand-shortages-prevention-program.
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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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]
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