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[Federal Register Volume 90, Number 2 (Friday, January 3, 2025)]
[Notices]
[Pages 322-324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31312]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-5784]

Interested Parties Meeting: Implementation of the Best 
Pharmaceuticals for Children Act and Pediatric Research Equity Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration's (FDA, Agency, or we) Office 
of Pediatric Therapeutics, the Center for Drug Evaluation and Research, 
and the Center for Biologics Evaluation and Research are announcing a 
public meeting entitled ``Interested Parties Meeting:

[[Page 323]]

Implementation of the Best Pharmaceuticals for Children Act and 
Pediatric Research Equity Act.'' The purpose of the public meeting is 
to seek input from interested parties, including patient/parent/
caregiver groups, consumer groups, regulated industry, academia, and 
others. This input will enable FDA to obtain any recommendations or 
information relevant to the report to Congress that FDA is required to 
submit concerning pediatric drug and biologic development and labeling, 
as outlined in section 508 of the Food and Drug Administration Safety 
and Innovation Act (FDASIA).

DATES: The public meeting will be held on May 15, 2025, from 9 a.m. to 
4:30 p.m. Eastern Time. Regardless of attendance at the public meeting, 
you can submit electronic or written comments to the public docket. 
Either electronic or written comments on this public meeting must be 
submitted by June 13, 2025. See the SUPPLEMENTARY INFORMATION section 
for registration date and information.

ADDRESSES: The public meeting will be held in-person at the FDA White 
Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, 
the White Oak Great Room, Silver Spring, MD 20993-0002 and virtually 
using the Zoom platform. Entrance for the in-person public meeting 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to https://www.fda.gov/about-fda/visitor-information.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of June 13, 2025. 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-2024-N-5784 for ``Interested Parties Meeting: Implementation of 
the Best Pharmaceuticals for Children Act and Pediatric Research Equity 
Act.'' 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 and 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: Cindy Tworek, the Office of Pediatric 
Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993-0002, 301-796-9234, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, the President signed into law the Food and Drug 
Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144). 
Section 508 of FDASIA directs the Secretary of HHS to submit a report 
to Congress on the implementation of sections 505A and 505B of the 
Federal Food, Drug, and Cosmetic Act, which are commonly known as the 
Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research 
Equity Act (PREA), respectively.
    The first report was required to be submitted to Congress by July 
9, 2016, and subsequent reports are required every 5 years thereafter, 
with the next report due to be submitted in July 2026. FDASIA also 
requires FDA to obtain, at least 180 days prior to submission of the 
report, input from interested parties, including: patient groups 
(including pediatric patient groups), consumer groups, regulated 
industry, academia, and any other interested parties to obtain any 
recommendations or information relevant to the report including 
suggestions for modifications that would improve pediatric drug 
research and pediatric labeling of drugs and biological products. In 
addition, on August 18, 2017, the FDA Reauthorization Act of 2017 (Pub. 
L.

[[Page 324]]

115-52) was signed into law, which outlined additional requirements to 
be included in the report.

II. Topics for Discussion at the Public Meeting

    Some of the issues to be discussed at the meeting will include, but 
not be limited to:
     Hearing from patients/parents/caregivers and patient/
parent/caregiver groups, consumer groups, industry, academia, and other 
interested parties about the public health impact that the pediatric 
legislation may have had on them or their communities, including 
treatment advances for children resulting from the legislation, as well 
as areas of continued unmet medical need.
     Understanding the effects of the requirement of pediatric 
studies under PREA or the incentives under BPCA on drug/biologic 
development plans, including issues related to the balance of 
incentives and requirements and progress toward international alignment 
on pediatric drug development to the extent practicable.
     Understanding if there are any barriers or resource issues 
preventing undertaking or completing studies under PREA and BPCA, 
including issues related to clinical trial infrastructure and 
enrollment and ensuring pediatric clinical trial populations reflect 
the diversity of children most likely to use and benefit from the 
therapeutic treatments.
     Understanding successes and challenges with leveraging 
scientific advances in product development, including, but not limited 
to, use of pediatric extrapolation, adaptive trial designs, biomarkers 
as surrogates, and real-world data to facilitate more timely evidence-
generation for pediatric populations.

III. Participating in the Public Meeting

    Registration: For more information and to register for the public 
meeting, please visit: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/interested-parties-meeting-implementation-best-pharmaceuticals-children-act-and-pediatric-research. Please 
provide complete contact information for each attendee, including name, 
email address, and affiliation. Registration is free and based on space 
availability for in-person attendance, with priority given to early 
registrants. Persons interested in attending this public meeting in-
person must register by May 1, 2025, 11:59 p.m. Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. If time 
and space permit, onsite registration on the day of the public meeting 
will be provided beginning at 8 a.m. We will post a notice on the 
meeting web page if registration for in-person attendance closes before 
the day of the public meeting.
    If you need special accommodations due to a disability, please 
contact [email protected] no later than May 8, 2025, 11:59 p.m. Eastern 
Time.
    Requests for Oral Comment: During online registration you may 
indicate if you wish to present an oral comment during a public comment 
session, and which topic(s) you wish to address. We will do our best to 
accommodate requests to make oral comments. Individuals and 
organizations with common interests are urged to consolidate or 
coordinate their comments. All requests to make oral comments, for both 
virtual and in-person attendees, must be received by the close of in-
person registration on May 1, 2025, 11:59 p.m. Eastern Time. Following 
the close of registration, we will determine the amount of time 
allotted to each presenter and the approximate time that the oral 
comment session is to begin, and will notify participants making an 
oral comment by May 5, 2025, 11:59 p.m. Eastern Time. If making an oral 
comment, any presentation materials must be emailed to [email protected] 
(see FOR FURTHER INFORMATION CONTACT) no later than May 9, 2025, 11:59 
p.m. Eastern Time. No commercial or promotional material will be 
permitted to be presented or distributed at the public meeting.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. The link to view the virtual Zoom webinar will be sent 
to registered participants prior to the meeting. The meeting web page 
link is: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/interested-parties-meeting-implementation-best-pharmaceuticals-children-act-and-pediatric-research.
    Although FDA verified the website addresses in this document, 
please note that websites are subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public meeting is available, it will be accessible at https://www.regulations.gov, https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/interested-parties-meeting-implementation-best-pharmaceuticals-children-act-and-pediatric-research, or the 
Dockets Management Staff, Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday 
through Friday, 240-402-7500.
    Notice of this meeting is given pursuant to 21 CFR 10.65.

    Dated: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31312 Filed 1-2-25; 8:45 am]
BILLING CODE 4164-01-P
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