[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Notices]
[Pages 83097-83098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28069]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0001]


Scientific and Ethical Considerations for the Inclusion of 
Pregnant Women in Clinical Trials; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing a public meeting that will be convened by Duke University's 
Robert J. Margolis Center for Health Policy and supported by a 
cooperative agreement with FDA. The meeting, entitled ``Scientific and 
Ethical Considerations for the Inclusion of Pregnant Women in Clinical 
Trials,'' is intended to gather industry, patient, clinician, 
researcher, institutional review board, ethicist, professional society 
and other stakeholder input on the scientific and ethical issues that 
surround the inclusion of pregnant women in clinical trials for drug 
development.

DATES: The public meeting will be held on February 2, 2021, from 12 
p.m. to 4 p.m. Eastern Time and February 3, 2021, from 12 p.m. to 3 
p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public meeting will be a Zoom virtual meeting.

FOR FURTHER INFORMATION CONTACT: Jasmine Smith, Office of New Drugs, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
at ONDPublicMTGSupport@fda.hhs.gov or 301-796-0621; or Catherine 
Sewell, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5360, Silver 
Spring, MD 20993-0002, Fax: 301-796-9897.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA endorses an informed and balanced approach to gathering data 
informing the safe and effective use of drugs and biological products 
in pregnancy through judicious inclusion of pregnant women in clinical 
trials and careful attention to potential fetal risk. Input from this 
meeting will help provide information on the development of therapies 
for pregnancy-specific conditions and for general medical conditions 
that occur in women of childbearing age and who require treatment 
during pregnancy. This meeting supports the objectives of The Task 
Force on Research Specific to Pregnant Women and Lactating Women, which 
was established by section 2041 of the 21st Century Cures Act (Pub. L. 
114-255), to provide advice and guidance on activities related to 
identifying and addressing gaps in knowledge and research on safe and 
effective therapies for pregnant women and lactating women, including 
the development of such therapies and the collaboration on and 
coordination of such activities.\1\ Input from this meeting may also 
help further inform the finalization of FDA's draft guidance entitled 
``Pregnant Women: Scientific and Ethical Considerations for Inclusion 
in Clinical Trials'' (https://www.fda.gov/media/112195/download, also 
see 83 FR 15161 (April 9, 2018)).
---------------------------------------------------------------------------

    \1\ https://www.nichd.nih.gov/sites/default/files/2018-09/PRGLAC_Report.pdf.
---------------------------------------------------------------------------

II. Topics for Discussion at the Public Meeting

    The meeting will allow participants (including industry, 
clinicians, patients, researchers, institutional review boards, 
ethicists, professional societies and other stakeholders) to provide 
input on key topics, including:
     Key areas of unmet needs for therapeutic development or 
clinical data in obstetrics
     The regulatory, scientific, and ethical considerations and 
challenges in the enrollment of pregnant women in clinical research
    For more information on the meeting topics and discussion 
questions, visit https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials. FDA 
will publish a discussion guide outlining background information 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.

[[Page 83098]]

    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 public meeting, please visit the 
following website: https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials. Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Registration is free. Persons interested in attending this public 
meeting must register. Registrants will receive confirmation once they 
have been accepted. Registered participants will be sent technical 
system requirements in advance of the event. We recommend that you 
review these technical system requirements prior to joining the virtual 
public meeting. The meeting will be recorded, and the recording will be 
available after the meeting.
    There will be live closed captioning for the event. If you need 
other special accommodations due to a disability, by January 25, 2021, 
please contact Jasmine Smith, Office of New Drugs, Center for Drug 
Evaluation and Research, Food and Drug Administration, at 
ONDPublicMTGSupport@fda.hhs.gov or 301-796-0621; or Catherine Sewell, 
Center for Drug Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 22, Rm. 5360, Silver Spring, MD 20993-
0002, Fax: 301-796-9897.
    FDA has verified the website addresses in this document as of the 
date this document publishes in the Federal Register, but websites are 
subject to change over time.
    Transcripts: Please be advised that transcripts of the public 
meeting will be available by February 8, 2021, at the event page 
https://healthpolicy.duke.edu/events/scientific-and-ethical-considerations-inclusion-pregnant-women-clinical-trials.

    Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28069 Filed 12-18-20; 8:45 am]
BILLING CODE 4164-01-P


