[Federal Register Volume 88, Number 148 (Thursday, August 3, 2023)]
[Notices]
[Pages 51323-51324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 
[email protected].

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: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency.
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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 [email protected] 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