
[Federal Register Volume 88, Number 158 (Thursday, August 17, 2023)]
[Notices]
[Pages 56024-56025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17718]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3104]


Optimizing the Use of Postapproval Pregnancy Safety Studies; 
Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Optimizing the Use of Postapproval Pregnancy Safety 
Studies'' convened by the Duke-Margolis Center for Health Policy and 
supported by a cooperative agreement between FDA and Duke-Margolis. 
This workshop will include discussions of designs of postapproval 
pregnancy safety studies for drug and biological products regulated by 
the Center for Drug Evaluation and Research (CDER) and the Center for 
Biologics Evaluation and Research (CBER) and experiences with 
implementing these studies. The workshop also will include discussion 
of considerations for further development of a framework that describes 
how data from different types of postapproval pregnancy safety studies 
might optimally be used when it has been determined that this data 
should be collected.

DATES: The public workshop will be held in person and virtually on 
September 18, 2023, from 10 a.m. to 4 p.m., Eastern Daylight Time, and 
on September 19, 2023, from 10 a.m. to 2:30 p.m. Either electronic or 
written comments on this public workshop must be submitted by November 
30, 2023. See the SUPPLEMENTARY INFORMATION section for registration 
date and information.

ADDRESSES: The public workshop will be held in person at the National 
Press Club, 529 14th St. NW, Washington, DC 20045 and virtually using 
the Zoom Platform. The link for the public workshop will be sent to 
registrants upon registration for virtual attendance.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered for the subsequent workshop 
report describing the proposed framework, which will be published by 
October 2, 2024. The https://www.regulations.gov electronic filing 
system will accept comments until 11:59 p.m. Eastern Time on November 
30, 2023. Comments received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are received on or 
before that date.

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.
     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-2023-N-3104 for ``Optimizing the Use of Postapproval Pregnancy 
Safety Studies.'' Received comments, those filed in a timely manner 
(see ADDRESSES), 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. 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.

FOR FURTHER INFORMATION CONTACT: Commander Vicky Chan, Food and Drug 
Administration, CDER, 10903 New Hampshire Ave., Bldg. 22, Rm. 3404, 
Silver Spring, MD 20993, 301-796-1639, [email protected] or Anne 
Taylor, CBER, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911, 
[email protected].

SUPPLEMENTARY INFORMATION: 

[[Page 56025]]

I. Background

    In the United States, approximately 5.5 million pregnancies occur 
each year (Ref. 1). Half of individuals who are pregnant use at least 
one drug or biological product to treat chronic (e.g., diabetes, 
seizure disorders, or asthma), acute (e.g., infection) or serious 
medical conditions (Ref. 2). Typically at the time of initial market 
approval, there are limited to no human data on the safety of drug or 
biological products used during pregnancy. As a result, for most 
products, human pregnancy safety data are collected after a product is 
available on the market (i.e., postapproval).
    In May 2019, FDA published a draft Guidance for Industry entitled 
``Postapproval Pregnancy Safety Studies'' (available at https://www.fda.gov/media/124746/download), which discusses the strengths and 
limitations of postapproval study types including studies based on 
registry data and cohort studies using electronic health records or 
claims data. However, more research is needed to better understand the 
key considerations for determining the optimal postapproval study 
designs to obtain timely evidence to ensure the safe use of drug and 
biological products in pregnant individuals. The public workshop is a 
preliminary discussion with stakeholders to inform FDA's further 
development of a framework and also meets a performance goal under the 
FDA User Fee Reauthorization Act of 2022, in accordance with the 
Prescription Drug User Fee Act (PDUFA) Reauthorization Performance 
Goals and Procedures Fiscal Years 2023 Through 2027 letter (PDUFA VII 
Commitment Letter), which is available at https://www.fda.gov/media/151712/download. Specifically, the PDUFA VII Commitment Letter outlines 
the commitment of a public workshop to discuss postapproval pregnancy 
safety studies to facilitate determination of ideal study designs.

II. Topics for Discussion at the Public Workshop

    The public workshop will include the following topics for 
discussion:
    1. FDA's considerations for constructing a framework describing how 
data from different types of post-market pregnancy safety studies might 
optimally be used.
    2. Stakeholders' perspectives on opportunities to optimize 
postapproval pregnancy safety study types and designs.
    3. Design considerations and potential approaches to bridge 
knowledge gaps in developing the framework, including understanding how 
the Sentinel Initiative (i.e., Sentinel System and Biologics 
Effectiveness and Safety (BEST)) may address these gaps.
    4. Stakeholders' perspectives on considerations for FDA's proposed 
framework.
    Meeting updates, the agenda, and background materials (if any) will 
be made available at https://duke.is/nj5kg prior to the workshop.

III. Participating in the Public Workshop

    Registration: To register for this hybrid public workshop, please 
visit the following website: https://duke.is/nj5kg. Please provide 
complete contact information for each attendee, including attendance 
format (in-person or virtual), name, title, affiliation, and email. 
Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by 10 a.m. Eastern Daylight Time, September 18, 
2023. Early registration is recommended due to limited seating; 
therefore, FDA may limit the number of participants from each 
organization. Registrants will receive a confirmation email when they 
have been registered.
    If you need special accommodations due to a disability, please 
contact Luke Durocher, Duke-Margolis Center for Health Policy, 202-621-
2800, [email protected], no later than 5 p.m. Eastern Time, 
September 5, 2023.
    Requests for Oral Comments: During online registration, you may 
indicate if you wish to speak during a public comment session. We will 
do our best to accommodate requests to make public comments. 
Individuals and organizations with common interests are urged to 
consolidate or coordinate their comments and request a time for joint 
commentary. All requests to make oral comments must be received by 
11:59 p.m. Eastern Time on September 5, 2023. FDA will determine the 
amount of time allotted to each commenter and the approximate time each 
comment is to begin and will select and notify participants by 
September 11, 2023.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed by the Dockets Management Staff.

IV. References

    The following references marked with an asterisk (*) have been 
placed on display at the Dockets Management Staff (see ADDRESSES) and 
are available for viewing by interested persons between 9 a.m. and 4 
p.m., Monday through Friday; they are also available electronically at 
https://www.regulations.gov. References without asterisks are not on 
public display at https://www.regulations.gov because they have 
copyright restriction. Some may be available at the website address, if 
listed. References without asterisks are available for viewing only at 
the Dockets Management Staff. FDA has verified the website addresses, 
as of the date this document publishes in the Federal Register, but 
websites are subject to change over time.

*1. Centers for Disease Control and Prevention, National Center for 
Health Statistics. ``U.S. Pregnancy Rates Drop During Last Decade.'' 
Hyattsville (MD); 2023 April 12, Available from: https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2023/20230412.htm.
2. Mitchell, A.A, S.M. Gilboa, M.M. Werler, et al. ``Medication Use 
During Pregnancy, with Particular Focus on Prescription Drugs: 1976-
2008.'' American Journal of Obstetrics & Gynecology 2011;205:51.e1-
8.

    Dated: August 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17718 Filed 8-16-23; 8:45 am]
BILLING CODE 4164-01-P


