[Federal Register Volume 89, Number 186 (Wednesday, September 25, 2024)]
[Notices]
[Pages 78316-78318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-21928]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4392]
Live Biotherapeutic Products To Prevent Necrotizing Enterocolitis
in Very Low Birth Weight Infants; 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 or Agency), the Centers
for Disease Control and Prevention (CDC), the National Institutes of
Health (NIH), the National Institute of Allergy and Infectious Diseases
(NIAID), and the Eunice Kennedy Shriver National Institute of Child
Health and Human Development (NICHD) (collectively, we) are
[[Page 78317]]
announcing a public workshop entitled ``Live Biotherapeutic Products to
Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants.''
The purpose of the public workshop is to exchange information with the
medical and scientific community about the regulatory and scientific
issues associated with use of live biotherapeutic products to prevent
necrotizing enterocolitis (NEC) in very low birth weight (VLBW)
infants.
DATES: The public workshop will be held on October 25, 2024, from 9
a.m. to 4 p.m. Eastern Time. Either electronic or written comments on
this public workshop must be submitted by November 25, 2024. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop will be held at the NIH, National
Institute of Allergy and Infectious Diseases Building, 5601 Fishers
Lane, Rockville, MD 20892. Entrance for public workshop participants
(non-NIH employees) is through the NIAID Building front lobby entrance
where routine security check procedures will be performed. For parking
and security information, please refer to https://www.niaid.nih.gov/about/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 November 25, 2024. 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-4392 for ``Live Biotherapeutic Products to Prevent
Necrotizing Enterocolitis in Very Low Birth Weight Infants.'' 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: Ryan Ranallo, National Institute of
Allergy and Infectious Diseases, Division of Microbiology and
Infectious Diseases, National Institutes of Health, 5601 Fishers Lane,
Rockville, MD 20852, 240-479-1958, [email protected]; or Peter
Weina, Office of Vaccines Research and Review, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 202-740-8687.
SUPPLEMENTARY INFORMATION:
I. Background
Necrotizing enterocolitis (NEC) in very low birth weight infants
(VLBW) remains a significant public health problem. FDA has not
approved any products, including live biotherapeutic products, for the
prevention of NEC. Various products marketed as probiotics have been
used in efforts to prevent this serious and life-threatening outcome;
however, substantial evidence of effectiveness has not been
demonstrated and serious adverse outcomes, including death, have been
reported following use of probiotics in preterm infants.
II. Topics for Discussion at the Public Workshop
This public workshop is convened to: (1) advance a shared
understanding of the epidemiology of NEC; (2) review current feeding
practices; (3) discuss limitations of NEC case definitions; (4) review
dynamics of the microbiome and NEC pathogenesis; (5) discuss the state
of the evidence for probiotic use to prevent NEC; (6) review safety
signals with probiotics; (7) explore clinical trial considerations; and
(8) discuss challenges and opportunities in advancing development of
Live Biotherapeutic Products as safe and effective products for the
prevention of NEC in VLBW infants.
[[Page 78318]]
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website for registration information: https://cvent.me/9NerMP. Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone
number.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop in-person must register by October 11, 2024, 11:59 p.m.
Eastern Time. Early registration is recommended because in-person
seating is limited; therefore, we may limit the number of participants
from each organization.
If you need special accommodations due to a disability, please
contact Ms. Christina McCormick, [email protected], no later
than October 15, 2024.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session and
which topic(s) you wish to address. 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
presentations, and request time for a joint presentation, or submit
requests for designated representatives to participate in the public
comment session. Following the close of registration, we will determine
the amount of time allotted to each presenter and the approximate time
each oral presentation is to begin and will select and notify
participants by October 18, 2024. All requests to make oral
presentations must be received by the close of registration on October
11, 2024, at 11:59 p.m. Eastern Time. If selected for presentation, any
presentation materials must be emailed to Ryan Ranallo
([email protected]) no later than October 22, 2024. No commercial or
promotional material will be permitted to be presented or distributed
at the public workshop.
Streaming Webcast of the Public Workshop: This public workshop will
also be webcast on https://videocast.nih.gov/.
Although FDA verified the website addresses in this document,
please note that websites are subject to change over time.
Recording: Please be advised that as soon as possible after a
recording of the public workshop is available, it will be accessible at
https://videocast.nih.gov/PastEvents and available until October 25,
2025.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Dated: September 20, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-21928 Filed 9-24-24; 8:45 am]
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