Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 213972 for Sulopenem Etzadroxil/Probenecid Tablets, 64926-64928 [2024-17642]

Download as PDF 64926 Federal Register / Vol. 89, No. 153 / Thursday, August 8, 2024 / Notices the particular manufacturer has no unresolved enforcement actions pending before, or taken by, FDA. Consistent with this authority, interested persons may request human food and cosmetic export certificates electronically via the Export Certification Application and Tracking System (eCATS) or Certificate Application Process (CAP), components of the FDA Industry Systems, or by contacting FDA for assistance. Health certificates are the exception and are requested via email. To facilitate the application process, we have eliminated paper-based forms. All information is currently submitted electronically using Forms FDA 3613d, 3613e, and 3613k. The eCATS Module is Form 3613k, where 3613e is the Certificate of Free Sale (https://www.fda.gov/food/foodexport-certificates/online-applicationsexport-certificates-food). All ‘‘forms’’ are electronic and part of the eCATS or CAP portal accessed via https:// www.access.fda.gov. To view representations of the forms, instructions must be downloaded and are accessible through the following links: https://www.fda.gov/cosmetics/ cosmetics-exporters/onlineapplications-export-certificatescosmetics and https://www.fda.gov/ food/food-export-certificates/onlineapplications-export-certificates-food. While a burden associated with information collection activities for export certificates issued for other FDA regulated products is accounted for and approved under OMB control number 0910–0498, this collection specifically supports information collection activity attributable to export certificates issued for human food and cosmetic products. Also, because we have eliminated paper-based forms, respondents who require assistance with completing export certificate applications online may contact FDA directly by email (CFSANExportCertification@ fda.hhs.gov) or telephone (240–402– 2307). Instructions for requesting export certificates for cosmetics (Form FDA 3613d) are available online at https:// www.fda.gov/cosmetics/cosmeticsexporters/online-applications-exportcertificates-cosmetics and instructions for requesting export certificates for food (Forms FDA 3613e and Form 3613k) are available online at https:// www.fda.gov/food/food-exportcertificates/online-applications-exportcertificates-food. We are revising the information collection to include a web-based inquiry form, Form FDA 5077, entitled ‘‘U.S. Department of Health and Human Services Food and Drug Administration Export Certification Inquiry,’’ intended to facilitate processing by crossreferencing the request with existing Agency data. A mockup of the proposed electronic form is posted to the docket to solicit public comment. For food products, respondents may identify facilities using their Food Facility Registration number, FDA Establishment Identifier number, or a Data Universal Numbering System number. The system uses these identifiers to locate and auto-populate name and address information, eliminating the need for users to manually enter this information and reducing the time to complete the application. For some applications, respondents can also upload product information via a spreadsheet, which reduces the time needed to enter product information, particularly for applications that include multiple products. Description of Respondents: The respondents to this collection of information are firms interested in exporting U.S.-manufactured human food and cosmetic products to foreign countries that require export certificates. In the Federal Register of May 15, 2024 (89 FR 42472), we published a 60day notice requesting public comment on the proposed collection of information. Although two comments were received, neither appeared to be responsive to the information collection topics solicited in the notice, nor suggested FDA modify its burden estimates. We therefore estimate the burden of the collections of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Total annual responses Average burden per response Total hours Type of certificate Form No.2 Cosmetics ........................................................................ Food ................................................................................ Export Certification Inquiry .............................................. FDA 3613d ............. FDA 3613e, 3613k FDA 5077 ............... 66 454 520 3 10 18 198 4,540 9,360 0.5 (30 minutes) ..... 0.5 (30 minutes) ..... 0.25 (15 minutes) ... 99 2,270 2,340 Total ......................................................................... ................................. ........................ .......................... ........................ ................................. 4,709 1 There are no operating and maintenance costs associated with this collection of information. 2 All forms are submitted electronically via FDA Industry Systems. lotter on DSK11XQN23PROD with NOTICES1 Since our last review of the information collection, we have adjusted our estimate of the number of respondents downward. At the same time, we have increased the number of responses per respondent and added new Form FDA 5077. Cumulatively these activities result in an estimated burden increase of 2,433 hours and 9,547 responses annually. Dated: August 5, 2024. Lauren K. Roth, Associate Commissioner for Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–3538] Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—New Drug Application 213972 for Sulopenem Etzadroxil/Probenecid Tablets AGENCY: [FR Doc. 2024–17641 Filed 8–7–24; 8:45 am] HHS. BILLING CODE 4164–01–P ACTION: VerDate Sep<11>2014 17:24 Aug 07, 2024 Food and Drug Administration, Notice; establishment of a public docket; request for comments. Jkt 262001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. SUMMARY: The meeting will be held on September 9, 2024, from 9 a.m. to 4 p.m. Eastern Time. DATES: The public may attend the meeting at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 ADDRESSES: E:\FR\FM\08AUN1.SGM 08AUN1 Federal Register / Vol. 89, No. 153 / Thursday, August 8, 2024 / Notices Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. The public will also have the option to participate, and the advisory committee meeting will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. Answers to commonly asked questions about FDA advisory committee meetings, including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2024–N–3538. The docket will close on September 6, 2024. 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 September 6, 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. Comments received on or before August 29, 2024, will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate. You may submit comments as follows: lotter on DSK11XQN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:24 Aug 07, 2024 Jkt 262001 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–3538 for ‘‘Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—New Drug Application 213972 for Sulopenem Etzadroxil/Probenecid Tablets.’’ 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.’’ FDA 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 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 the information as ‘‘confidential.’’ Any information marked PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 64927 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-201509-18/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: LaToya Bonner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–2855, email: AMDAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last-minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check FDA’s website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before the meeting. SUPPLEMENTARY INFORMATION: Agenda: The Committee will discuss new drug application 213972, for oral sulopenem etzadroxil/probenecid tablets consisting of 500 milligrams (mg) sulopenem etzadroxil and 500 mg probenecid, submitted by Iterum Therapeutics US Ltd., for the proposed indication of treatment of uncomplicated urinary tract infections caused by designated susceptible bacteria in adult women 18 years of age and older. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. Background material and the link to the online teleconference and/or video conference E:\FR\FM\08AUN1.SGM 08AUN1 lotter on DSK11XQN23PROD with NOTICES1 64928 Federal Register / Vol. 89, No. 153 / Thursday, August 8, 2024 / Notices meeting will be available at the location of the advisory committee meeting and at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting presentations will also be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform. The online presentation of materials will include slide presentations with audio and video components in a manner that most closely resembles an in-person advisory committee meeting. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee. All electronic and written submissions to the Docket (see ADDRESSES) on or before August 29, 2024, will be provided to the Committee. Oral presentations from the public will be scheduled between approximately between 1:45 p.m. to 2:45 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, whether they would like to present online or inperson, and an indication of the approximate time requested to make their presentation on or before August 21, 2024. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. Similarly, room for interested persons to participate inperson may be limited. If the number of registrants requesting to speak in-person during the open public hearing is greater than can be reasonably accommodated in the venue for the inperson portion of the advisory committee meeting, FDA may conduct a lottery to determine the speakers who will be invited to participate in-person. The contact person will notify interested persons regarding their request to speak by August 22, 2024. Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee VerDate Sep<11>2014 17:24 Aug 07, 2024 Jkt 262001 meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact LaToya Bonner (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 14.22(b), (f), and (g) relating to the location of advisory committee meetings are hereby waived to allow for this meeting to take place using an online meeting platform in conjunction with the physical meeting room (see location). This waiver is in the interest of allowing greater transparency and opportunities for public participation, in addition to convenience for advisory committee members, speakers, and guest speakers. The conditions for issuance of a waiver under 21 CFR 10.19 are met. Dated: August 5, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–17642 Filed 8–7–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2024–N–3531] Determination That DELATESTRYL (Testosterone Enanthate) Injection, 200 Milligrams/Milliliter, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to SUMMARY: PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993–0002, 301–796–8363, Stacy.Kane@fda.hhs.gov. Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug. SUPPLEMENTARY INFORMATION: E:\FR\FM\08AUN1.SGM 08AUN1

Agencies

[Federal Register Volume 89, Number 153 (Thursday, August 8, 2024)]
[Notices]
[Pages 64926-64928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17642]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-3538]


Antimicrobial Drugs Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments--New Drug 
Application 213972 for Sulopenem Etzadroxil/Probenecid Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Antimicrobial Drugs Advisory 
Committee (the Committee). The general function of the Committee is to 
provide advice and recommendations to FDA on regulatory issues. The 
meeting will be open to the public. FDA is establishing a docket for 
public comment on this document.

DATES: The meeting will be held on September 9, 2024, from 9 a.m. to 4 
p.m. Eastern Time.

ADDRESSES: The public may attend the meeting at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31

[[Page 64927]]

Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. The public will also have the option to participate, and the 
advisory committee meeting will be heard, viewed, captioned, and 
recorded through an online teleconferencing and/or video conferencing 
platform.
    Answers to commonly asked questions about FDA advisory committee 
meetings, including information regarding special accommodations due to 
a disability, visitor parking, and transportation may be accessed at: 
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting. 
The docket number is FDA-2024-N-3538. The docket will close on 
September 6, 2024. 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 
September 6, 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.
    Comments received on or before August 29, 2024, will be provided to 
the Committee. Comments received after that date will be taken into 
consideration by FDA. In the event that the meeting is cancelled, FDA 
will continue to evaluate any relevant applications or information, and 
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

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-3538 for ``Antimicrobial Drugs Advisory Committee; Notice of 
Meeting; Establishment of a Public Docket; Request for Comments--New 
Drug Application 213972 for Sulopenem Etzadroxil/Probenecid Tablets.'' 
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.'' FDA 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 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 the 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: LaToya Bonner, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-2855, email: [email protected], or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area). A notice in the Federal Register about last-minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before the 
meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: The Committee will discuss new drug application 213972, for 
oral sulopenem etzadroxil/probenecid tablets consisting of 500 
milligrams (mg) sulopenem etzadroxil and 500 mg probenecid, submitted 
by Iterum Therapeutics US Ltd., for the proposed indication of 
treatment of uncomplicated urinary tract infections caused by 
designated susceptible bacteria in adult women 18 years of age and 
older.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its website prior to the meeting, the 
background material will be made publicly available on FDA's website at 
the time of the advisory committee meeting. Background material and the 
link to the online teleconference and/or video conference

[[Page 64928]]

meeting will be available at the location of the advisory committee 
meeting and at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link. The meeting presentations will also be heard, viewed, captioned, 
and recorded through an online teleconferencing and/or video 
conferencing platform. The online presentation of materials will 
include slide presentations with audio and video components in a manner 
that most closely resembles an in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the Committee. 
All electronic and written submissions to the Docket (see ADDRESSES) on 
or before August 29, 2024, will be provided to the Committee. Oral 
presentations from the public will be scheduled between approximately 
between 1:45 p.m. to 2:45 p.m. Eastern Time. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, whether they would like to present online or 
in-person, and an indication of the approximate time requested to make 
their presentation on or before August 21, 2024. Time allotted for each 
presentation may be limited. If the number of registrants requesting to 
speak is greater than can be reasonably accommodated during the 
scheduled open public hearing session, FDA may conduct a lottery to 
determine the speakers for the scheduled open public hearing session. 
Similarly, room for interested persons to participate in-person may be 
limited. If the number of registrants requesting to speak in-person 
during the open public hearing is greater than can be reasonably 
accommodated in the venue for the in-person portion of the advisory 
committee meeting, FDA may conduct a lottery to determine the speakers 
who will be invited to participate in-person. The contact person will 
notify interested persons regarding their request to speak by August 
22, 2024. Persons attending FDA's advisory committee meetings are 
advised that FDA is not responsible for providing access to electrical 
outlets.
    For press inquiries, please contact the Office of Media Affairs at 
[email protected] or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact LaToya Bonner (see FOR FURTHER INFORMATION CONTACT) at least 7 
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves 
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR 
14.22(b), (f), and (g) relating to the location of advisory committee 
meetings are hereby waived to allow for this meeting to take place 
using an online meeting platform in conjunction with the physical 
meeting room (see location). This waiver is in the interest of allowing 
greater transparency and opportunities for public participation, in 
addition to convenience for advisory committee members, speakers, and 
guest speakers. The conditions for issuance of a waiver under 21 CFR 
10.19 are met.

    Dated: August 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-17642 Filed 8-7-24; 8:45 am]
BILLING CODE 4164-01-P

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