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 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.

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.

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, christina.mccormick@nih.gov, 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 ( ryan.ranallo@nih.gov) 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.

[FR Doc. 2024-21928 Filed 9-24-24; 8:45 am]

BILLING CODE 4164-01-P