Notice2023-16544
Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies; Public Meeting
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 3, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled "Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies." This public meeting will satisfy the mandate of the Food and Drug Omnibus Reform Act of 2022 (FDORA) to convene a public meeting on clinical study flexibilities initiated in response to the COVID-19 pandemic. The public meeting will be convened and supported by a cooperative agreement between FDA and the Clinical Trials Transformation Initiative (CTTI) to bring the clinical research community together to discuss a variety of topics related to mitigating disruptions of clinical studies of medical products during disasters and public health emergencies (PHEs). The meeting format will include presentations and panel discussions.
Full Text
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<title>Federal Register, Volume 88 Issue 148 (Thursday, August 3, 2023)</title>
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[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51323-51324]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-16544]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0001]
Mitigating Clinical Study Disruptions During Disasters and Public
Health Emergencies; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public meeting entitled ``Mitigating Clinical Study
Disruptions During Disasters and Public Health Emergencies.'' This
public meeting will satisfy the mandate of the Food and Drug Omnibus
Reform Act of 2022 (FDORA) to convene a public meeting on clinical
study flexibilities initiated in response to the COVID-19 pandemic. The
public meeting will be convened and supported by a cooperative
agreement between FDA and the Clinical Trials Transformation Initiative
(CTTI) to bring the clinical research community together to discuss a
variety of topics related to mitigating disruptions of clinical studies
of medical products during disasters and public health emergencies
(PHEs). The meeting format will include presentations and panel
discussions.
DATES: The public meeting will be held virtually on October 18 and 19,
2023, from 10 a.m. to 1:30 p.m. Eastern Time. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: The public meeting will be held virtually using the Zoom
platform. The link for the public meeting will be sent to registrants
upon registration.
FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993, 240-402-8926,
<a href="/cdn-cgi/l/email-protection#4d092c396309222c230d2b292c6325253e632a223b"><span class="__cf_email__" data-cfemail="b5f1d4c19bf1dad4dbf5d3d1d49bddddc69bd2dac3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
This public meeting satisfies FDA's mandate under section 3605 of
FDORA to convene a public meeting, not later than 180 days after the
date when the COVID-19 emergency period ends, to discuss the
recommendations provided by FDA during the COVID-19 emergency period to
mitigate disruption of clinical studies. Among other things, the public
meeting will include discussion about strategies for mitigating
disruptions of clinical studies of medical products during disasters
and PHEs.
II. Topics for Discussion at the Public Meeting
Topics for discussion during this meeting include:
1. The recommendations provided by FDA during the COVID-19 emergency
period to mitigate disruption of clinical studies, including
recommendations detailed in the guidance for industry, investigators,
and institutional review boards entitled ``Conduct of Clinical Trials
of Medical Products During the COVID-19 Public Health Emergency \1\''
(March 2020, updated August 2021)
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\1\ Available at: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency</a>.
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2. The actions sponsors took to utilize such recommendations and the
[[Page 51324]]
frequency at which such recommendations were utilized
3. The characteristics of the sponsors, studies, and patient
populations impacted by such recommendations
4. Consideration of how recommendations intended to mitigate disruption
of clinical studies during the COVID-19 emergency period, including any
recommendations to consider decentralized clinical studies when
appropriate, may have affected access to clinical studies for certain
patient populations, especially underrepresented racial and ethnic
minorities
5. Recommendations for incorporating certain clinical study disruption
mitigation recommendations into current or additional guidance to
improve clinical study access and enrollment of diverse patient
populations
6. Strategies for advanced planning to mitigate disruption of clinical
studies during future disasters and PHEs
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website: duke.zoom.us/meeting/register/tJAvcO-oqD4vE9Ov1Vv-
A3SoItVhL7Rhg66T. Please provide complete contact information for each
attendee, including name, title, affiliation, address, email, and
telephone.
Registration is free, and persons interested in attending this
public meeting must register to receive a link to the meeting.
Registrants will receive a confirmation email after they register.
If you need special accommodations due to a disability, please
contact <a href="/cdn-cgi/l/email-protection#bfeccad2d2dacd91eccbdecdd3d6d1d8ffdbcad4da91dadbca"><span class="__cf_email__" data-cfemail="90c3e5fdfdf5e2bec3e4f1e2fcf9fef7d0f4e5fbf5bef5f4e5">[email protected]</span></a> no later than October 4, 2023. Please
note, closed captioning will be available automatically.
Dated: July 31, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-16544 Filed 8-2-23; 8:45 am]
BILLING CODE 4164-01-P
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