Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 15415-15417 [2023-05068]

Download as PDF Federal Register / Vol. 88, No. 48 / Monday, March 13, 2023 / Notices [FR Doc. 2023–05053 Filed 3–10–23; 8:45 am] Food and Drug Administration [Docket No. FDA–2023–N–0623] BILLING CODE 4164–01–C ddrumheller on DSK120RN23PROD with NOTICES1 DEPARTMENT OF HEALTH AND HUMAN SERVICES Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of a public docket; request for comments. ACTION: VerDate Sep<11>2014 19:32 Mar 10, 2023 Jkt 259001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory 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 virtually on April 17, 2023, from 9 a.m. to 4:30 p.m. Eastern Time. DATES: E:\FR\FM\13MRN1.SGM 13MRN1 EN13MR23.018</GPH> Dated: March 7, 2023. Lauren K. Roth, Associate Commissioner for Policy. 15415 15416 Federal Register / Vol. 88, No. 48 / Monday, March 13, 2023 / Notices Please note that due to the impact of the COVID–19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. Answers to commonly asked questions about FDA advisory committee meetings, including information regarding special accommodations due to a disability, may be accessed at: https://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2023–N–0623. Please note that late, untimely filed comments will not be considered. The docket will close on April 14, 2023. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 14, 2023. 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 April 3, 2023, 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 canceled, 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: ddrumheller on DSK120RN23PROD with NOTICES1 ADDRESSES: 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 VerDate Sep<11>2014 19:32 Mar 10, 2023 Jkt 259001 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– 2023–N–0623 for ‘‘Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.’’ 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-201509-18/pdf/2015-23389.pdf. PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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: Takyiah Stevenson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 240– 402–2507, 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 meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss new drug application (NDA) 216974, for sulbactam-durlobactam for injection, submitted by Entasis Therapeutics, Inc. The Applicant’s proposed indication is for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex including multidrug-resistant and carbapenem-resistant strains. 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 meeting room will be available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a E:\FR\FM\13MRN1.SGM 13MRN1 Federal Register / Vol. 88, No. 48 / Monday, March 13, 2023 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 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 submitted to the Docket (see ADDRESSES) on or before April 3, 2023, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 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, and an indication of the approximate time requested to make their presentation on or before March 24, 2023. 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. The contact person will notify interested persons regarding their request to speak by March 27, 2023. 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 meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Takyiah Stevenson (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/AboutAdvisory Committees/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. app. 2). Dated: March 7, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–05068 Filed 3–10–23; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 19:32 Mar 10, 2023 Jkt 259001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2007–D–0369, FDA– 2008–D–0610, FDA–2015–D–1211, FDA– 2021–D–0409, FDA–2020–D–0987, FDA– 2020–D–1057, FDA–2020–D–1106, FDA– 2020–D–1106–0002, FDA–2020–D–1108, FDA–2020–D–1136, FDA–2020–D–1137, FDA–2020–D–1138, FDA–2020–D–1139, FDA–2020–D–1140, FDA–2020–D–1304, FDA–2020–D–1370, FDA–2020–D–1386, FDA–2020–D–1414, FDA–2020–D–1824, FDA–2020–D–1825, FDA–2020–D–2016, FDA–2021–D–1311] Guidance Documents Related to Coronavirus Disease 2019 (COVID–19) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. On February 9, 2023, the Secretary of Health and Human Services (HHS) renewed the Coronavirus Disease 2019 (COVID–19) public health emergency declaration issued under section 319 of the Public Health Service Act (PHS Act) (‘‘PHE declaration’’), effective February 11, 2023. The declaration is expected to expire at the end of the day on May 11, 2023. The Food and Drug Administration (FDA, Agency, or we) has issued guidance documents to address the circumstances of the public health emergency and, more generally, COVID–19. Many of those guidance documents are tied to the duration of the PHE declaration. This notice is intended to provide clarity to stakeholders with respect to the guidance documents that will no longer be effective with the expiration of the PHE declaration and the guidances that FDA is revising to continue in effect after the expiration of the PHE declaration. FOR FURTHER INFORMATION CONTACT: Diane Maloney, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911; Erica Takai, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993– 0002, 301–796–6353; Kimberly Thomas, Center for Drug Evaluation and Research, Food and Drug Administration (CDER), 10903 New Hampshire Ave., Bldg. 51, Rm. 6282, Silver Spring, MD 20993–0002, 301– 796–2357; Philip Chao, Center for Food Safety and Applied Nutrition (CFSAN), CPK1 Rm. 1C001, HFS–024, Food and Drug Administration, College Park, MD SUMMARY: PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 15417 20740, 240–402–2112; Diane Heinz, Center for Veterinary Medicine (CVM), Food and Drug Administration, 7500 Standish Pl., HFV–6, Rockville, MD 20855, 240–402–5692; Amanda Wulf, Office of Regulatory Affairs (ORA), Food and Drug Administration, 12420 Parklawn Dr., ELEM–4044, Rockville, MD 20857, 301–796–8856. SUPPLEMENTARY INFORMATION: I. Background On January 31, 2020, as a result of confirmed cases of COVID–19, and after consultation with public health officials as necessary, the prior Secretary of HHS, pursuant to the authority under section 319 of the PHS Act (42 U.S.C. 247d), determined that a PHE existed (COVID– 19 PHE) and had existed since January 27, 2020, nationwide.1 On February 9, 2023, the Secretary of HHS renewed the COVID–19 PHE declaration, effective February 11, 2023. On February 9, based on current COVID–19 trends, HHS announced that it is planning for the declaration to expire at the end of the day on May 11, 2023. (HHS, Fact Sheet: COVID–19 Public Health Emergency Transition Roadmap (February 9, 2023), available at https://www.hhs.gov/about/ news/2023/02/09/fact-sheet-covid-19public-health-emergency-transitionroadmap.html#:∼:text= Based%20on%20current %20COVID%2D19,day%20on %20May%2011%2C%202023). Since the start of the COVID–19 pandemic in 2020, FDA has issued more than 80 COVID–19-related guidances (not including revisions). In the Federal Register of March 25, 2020 (85 FR 16949) (available at https:// www.govinfo.gov/content/pkg/FR-202003-25/pdf/2020-06222.pdf), FDA announced general procedures for making available FDA guidances related to the COVID–19 PHE. We have updated or otherwise modified our COVID–19related guidances in response to comments received, as appropriate, and as relevant needs and circumstances evolved throughout the COVID–19 PHE. We have withdrawn, and announced the 1 Secretary of HHS, ‘‘Determination that a Public Health Emergency Exists’’ (originally issued on January 31, 2020, and subsequently renewed, pursuant to the authority under section 319 of the PHS Act), available at: https://www.phe.gov/ emergency/news/healthactions/phe/Pages/ default.aspx. There are additional types of determinations and declarations related to emergencies, including public health emergencies, that are distinct from a PHE declared pursuant to section 319 of the PHS Act. For instance, the determination and declarations made under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which enable the issuance of Emergency Use Authorizations (EUAs), are independent from a declaration under section 319 of the PHS Act. E:\FR\FM\13MRN1.SGM 13MRN1

Agencies

[Federal Register Volume 88, Number 48 (Monday, March 13, 2023)]
[Notices]
[Pages 15415-15417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05068]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0623]


Antimicrobial Drugs Advisory Committee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments

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 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 virtually on April 17, 2023, from 9 
a.m. to 4:30 p.m. Eastern Time.

[[Page 15416]]


ADDRESSES: Please note that due to the impact of the COVID-19 pandemic, 
all meeting participants will be joining this advisory committee 
meeting via an online teleconferencing platform. Answers to commonly 
asked questions about FDA advisory committee meetings, including 
information regarding special accommodations due to a disability, 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-2023-N-0623. Please note that late, untimely 
filed comments will not be considered. The docket will close on April 
14, 2023. The https://www.regulations.gov electronic filing system will 
accept comments until 11:59 p.m. Eastern Time at the end of April 14, 
2023. 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 April 3, 2023, 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 canceled, 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-2023-N-0623 for ``Antimicrobial Drugs Advisory Committee; Notice of 
Meeting; Establishment of a Public Docket; Request for Comments.'' 
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: Takyiah Stevenson, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 240-
402-2507, 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 meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. The committee 
will discuss new drug application (NDA) 216974, for sulbactam-
durlobactam for injection, submitted by Entasis Therapeutics, Inc. The 
Applicant's proposed indication is for the treatment of infections due 
to Acinetobacter baumannii-calcoaceticus complex including multidrug-
resistant and carbapenem-resistant strains.
    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 meeting room will be available at 
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll 
down to the appropriate advisory committee meeting link. The meeting 
will include slide presentations with audio components to allow the 
presentation of materials in a

[[Page 15417]]

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 submitted to the Docket (see 
ADDRESSES) on or before April 3, 2023, will be provided to the 
committee. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 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, and an indication of the approximate time 
requested to make their presentation on or before March 24, 2023. 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. The contact person will notify interested 
persons regarding their request to speak by March 27, 2023.
    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 Takyiah Stevenson (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. app. 2).

    Dated: March 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05068 Filed 3-10-23; 8:45 am]
BILLING CODE 4164-01-P

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