[Federal Register Volume 88, Number 224 (Wednesday, November 22, 2023)]
[Notices]
[Pages 81421-81422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25816]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4996]


Advancing Drug Development for the Prevention of Spontaneous 
Preterm Birth; 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 the following public meeting entitled ``Advancing Drug 
Development for the Prevention of Spontaneous Preterm Birth.'' The 
meeting will be convened by Duke University's Robert J. Margolis, MD, 
Center for Health Policy (Duke-Margolis) and supported by a cooperative 
agreement with FDA. The meeting is intended to gather industry, family, 
clinician, researcher, ethicist, professional society, and other 
stakeholder input on the impact of preterm birth on families and on 
society, as well as on the ethical, regulatory, and clinical trial 
considerations surrounding the drug development for the prevention of 
spontaneous preterm birth.

DATES: The public meeting will be held on January 23 and 24, 2024, from 
1 p.m. to 4:30 p.m. Eastern Time each day. See the SUPPLEMENTARY 
INFORMATION section for registration information.

ADDRESSES: The public meeting will be held virtually via Zoom.

FOR FURTHER INFORMATION CONTACT: Luke Durocher, Duke-Margolis Center 
for Health Policy, [email protected], 202-621-2800; or Christina 
Chang, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-2078.

SUPPLEMENTARY INFORMATION:

I. Background Information

    In the United States in 2021, 1 in every 10 infants was born 
prematurely (before 37 weeks of pregnancy). Infants born too early have 
higher rates of death and disability, resulting in a significant public 
health concern. The exact mechanisms and risk factors associated with 
spontaneous preterm birth are not fully understood, resulting in a 
dearth of interventions demonstrated to be effective and safe.
    FDA endorses an informed and balanced approach to gathering data 
supporting the safe and effective use of drugs and biological products 
for the prevention of spontaneous preterm birth. Currently, there is a 
significant medical need for such therapies, as there are no FDA 
approved therapies for reducing the risk of neonatal morbidity/
mortality resulting from spontaneous preterm birth. Input from this 
meeting will help provide guidance on the development of therapies for 
the prevention of spontaneous preterm birth.

II. Topics for Discussion at the Public Meeting

    The meeting will allow participants (including clinicians, 
patients, family, researchers, ethicists, professional societies, and 
other stakeholders) to provide input on key topics, including:

 The current understanding of spontaneous preterm birth, 
including the epidemiology of the condition, etiologies, and 
pathophysiology
 Ethical and regulatory considerations and challenges 
associated with the development of therapeutics for the prevention of 
spontaneous preterm birth
 Impact of preterm birth on families and society
 Assessing efficacy and safety in clinical programs for 
therapeutics for spontaneous preterm birth prevention
 Dose-finding and clinical trial design considerations

    For more information on the meeting topics and discussion 
questions, visit https://duke.is/g/gde6. Duke-Margolis will publish a 
discussion guide outlining background information and current thinking 
on the topic areas to this website approximately 2 weeks before the 
meeting date. FDA will also post the agenda and other meeting materials 
to this website approximately 5 business days before the meeting.
    The format of the public meeting will consist of a series of 
presentations, panel discussions, and open discussion.

III. Participating in the Public Meeting

    Registration: To register for the virtual public meeting, please 
visit the following website: https://duke.is/g/gde6. Please provide 
complete contact information for each attendee, including name, title, 
affiliation, address, email, and telephone.
    Registration is free. Persons interested in attending this virtual 
public meeting must register. Early registration is recommended. 
Registrants will receive confirmation once they have been accepted. If 
you need special accommodations due to a disability, please contact 
Luke Durocher, Duke-Margolis Center for Health Policy, at 
[email protected] or at 202-621-2800.
    Streaming Webcast of the Public Meeting: This virtual public 
meeting will be webcast via Zoom and the archived video footage will be 
available at the event website. The link for registration is the same 
as above: https://duke.is/g/gde6. Registered webcast participants will 
be sent technical system requirements in advance of the event. It is 
recommended that you review these technical system requirements prior 
to joining the streaming webcast of the public meeting. Although FDA 
has verified the website addresses in this document, please note that 
websites are subject to change over time.

[[Page 81422]]

    Transcripts: Please be advised that transcripts of the public 
meeting will not be available.

    Dated: November 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-25816 Filed 11-21-23; 8:45 am]
BILLING CODE 4164-01-P