[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]


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

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.

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

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]
BILLING CODE 4164-01-P