National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting, 24846-24847 [2024-07500]
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24846
Federal Register / Vol. 89, No. 69 / Tuesday, April 9, 2024 / Notices
TABLE 1—NOTICES OF UPDATES TO RECOGNIZED OR UPDATED SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA (STIC) BY
DRUG 1—Continued
Drug
Route of administration
Action taken
Therapeutic category
Date
Piperacillin and
Tazobactam.
Injection ........................
Antibacterial .................
1/17/2023
Plazomicin .....................
Injection ........................
Antibacterial .................
4/21/2023
Polymyxin B ..................
Injection ........................
Antibacterial .................
1/17/2023
Rezafungin ....................
Injection ........................
Antifungal .....................
4/18/2023
Sulbactam and
Durlobactam.
Injection ........................
Antibacterial .................
5/25/2023
Tobramycin ....................
Injection ........................
FDA has updated STIC (MIC and disk diffusion)
for Enterobacterales. FDA has recognized
M100 standard for susceptible and resistant
breakpoints and updated an intermediate
breakpoint. FDA does not recognize M100
standard for a susceptible dose dependent
breakpoint. (Rationale available at https://
www.fda.gov/drugs/development-resources/
fda-rationale-piperacillin-tazobactambreakpoints-enterobacterales.).
FDA recognizes M100 standard (MIC and disk
diffusion) for Enterobacterales.
FDA does not recognize M100 standard (MIC)
for
Enterobacterales,
Pseudomonas
aeruginosa, or Acinetobacter spp. (Rationale
available at https://www.fda.gov/drugs/development-resources/fda-rationale-polymyxinbreakpoints-enterobacterales-pseudomonasaeruginosa-and-acinetobacter-spp.).
FDA identified STIC (MIC and disk diffusion) for
C. albicans, C. glabrata, and C. tropicalis.
FDA has reviewed STIC (MIC) for C.
parapsilosis, and the M27M44S standard is
recognized.
FDA identified STIC (disk diffusion) for C.
parapsilosis.
FDA identified STIC (MIC and disk diffusion) for
Acinetobacter baumannii-calcoaceticus complex.
FDA does not recognize M100 standard (MIC
and disk diffusion) for Enterobacterales and
Pseudomonas aeruginosa.
Antibacterial .................
4/21/2023
1 M100 standard in the table refers to Clinical and Laboratory Standards Institute (CLSI) Performance Standards for Antimicrobial Susceptibility
Testing, 33rd ed. CLSI supplement M100; 2023.
Dated: April 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2024–07495 Filed 4–8–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
ddrumheller on DSK120RN23PROD with NOTICES1
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
VerDate Sep<11>2014
19:57 Apr 08, 2024
Jkt 262001
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Hispanic Community Health Study—Study
of Latinos (HCHS–SOL) Coordinating Center.
Date: April 30, 2024.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Rockledge I, 6705 Rockledge Drive, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Susan Wohler Sunnarborg,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA National, Heart,
Lung, and Blood Institute, National Institutes
of Health, 6705 Rockledge Drive, Room 208–
Z, Bethesda, MD 20892, (301) 827–7987,
susan.sunnarborg@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
PO 00000
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Dated: April 4, 2024.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–07499 Filed 4–8–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse
and Alcoholism; Notice of Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
Council on Alcohol Abuse and
Alcoholism.
This will be a hybrid meeting held inperson and virtually and will be open to
the public as indicated below.
Individuals who plan to attend inperson or view the virtual meeting and
need special assistance or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting. The meeting
E:\FR\FM\09APN1.SGM
09APN1
Federal Register / Vol. 89, No. 69 / Tuesday, April 9, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
can be accessed from the NIH Videocast
at the following link: https://
videocast.nih.gov/.
A portion of this meeting will be
closed to the public in accordance with
the provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council on Alcohol Abuse and Alcoholism.
Date: May 7, 2024.
Closed: 10:00 a.m. to 10:50 a.m.
Agenda: To review and evaluate grant
applications.
Open: 11:00 a.m. to 3:30 p.m.
Agenda: Presentations and other business
of the Council.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, Conference Rooms A, B & C,
6700B Rockledge Drive, Bethesda, MD 20817
(Hybrid Meeting).
Contact Person: Ranga V. Srinivas, Ph.D.,
Acting Executive Secretary, National
Advisory Council, Extramural Project Review
Branch, National Institute on Alcohol Abuse
and Alcoholism, National Institutes of
Health, 6700 B Rockledge Drive, Room 2114,
Bethesda, MD 20892, (301) 451–2067,
srinivar@mail.nih.gov.
Name of Committee: National Advisory
Council on Alcohol Abuse and Alcoholism,
National Cancer Advisory Board, and
National Advisory Council on Drug Abuse.
Date: May 8, 2024.
Open: 10:00 a.m. to 3:30 p.m.
Agenda: Presentation of NIAAA, NCI, and
NIDA Director’s Update, Scientific Reports,
and other topics within the scope of the
Collaborative Research on Addiction at NIH
(CRAN).
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, Conference Rooms A, B & C,
6700B Rockledge Drive, Bethesda, MD 20817
(Hybrid Meeting).
Contact Persons: Ranga V. Srinivas, Ph.D.,
Acting Executive Secretary, National
Advisory Council Extramural Project Review
Branch, National Institute on Alcohol Abuse
and Alcoholism National, Institutes of
Health, 6700 B Rockledge Drive, Room 2114,
Bethesda, MD 20892, (301) 451–2067,
srinivar@mail.nih.gov.
Paulette S. Gray, Ph.D., Director, Division
of Extramural Activities, National Cancer
Institute, National Institutes of Health, 9609
Medical Center Drive, Room 7W444,
Bethesda, MD 20892, (240) 276–6340, grayp@
dea.nci.nih.gov.
Susan R.B. Weiss, Ph.D., Director, Division
of Extramural Research, Office of the
Director, National Institute on Drug Abuse,
National Institutes of Health, Three White
Flint North, RM 09D08, 1601 Landsdown
VerDate Sep<11>2014
19:57 Apr 08, 2024
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Street, Bethesda, MD 20892, (301) 443–6480,
sweiss@nida.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors attending a meeting on
campus or at an off-campus federal facility
will be asked to show one form of
identification (for example, a governmentissued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.niaaa.nih.gov/AboutNIAAA/
AdvisoryCouncil/Pages/default.aspx, where
an agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.273, Alcohol Research
Programs, National Institutes of Health, HHS)
Dated: April 4, 2024.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–07500 Filed 4–8–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The cooperative agreement
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the cooperative agreement applications,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Clinical Trial
Implementation Cooperative Agreement (U01
Clinical Trial Required).
Date: April 29, 2024.
PO 00000
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24847
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G31B,
Rockville, MD 20852 (Video Assisted
Meeting).
Contact Person: James T. Snyder, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3G31B, Rockville, MD
20892, (240) 669–5060, james.snyder@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: April 4, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–07497 Filed 4–8–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; NCATS SBIR Rare Diseases
Basket Clinical Trials.
Date: May 9, 2024.
Time: 11:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Alumit Ishai, Ph.D.,
Scientific Review Officer, Office of Grants
Management and Scientific Review, National
Center for Advancing Translational Sciences,
National Institutes of Health, 6701
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]]>Agencies
[Federal Register Volume 89, Number 69 (Tuesday, April 9, 2024)]
[Notices]
[Pages 24846-24847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07500]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of
Meeting
Pursuant to section 1009 of the Federal Advisory Committee Act, as
amended, notice is hereby given of a meeting of the National Advisory
Council on Alcohol Abuse and Alcoholism.
This will be a hybrid meeting held in-person and virtually and will
be open to the public as indicated below. Individuals who plan to
attend in-person or view the virtual meeting and need special
assistance or other reasonable accommodations, should notify the
Contact Person listed below in advance of the meeting. The meeting
[[Page 24847]]
can be accessed from the NIH Videocast at the following link: https://videocast.nih.gov/.
A portion of this meeting will be closed to the public in
accordance with the provisions set forth in sections 552b(c)(4) and
552b(c)(6), title 5 U.S.C., as amended. The grant applications and the
discussions could disclose confidential trade secrets or commercial
property such as patentable material, and personal information
concerning individuals associated with the grant applications, the
disclosure of which would constitute a clearly unwarranted invasion of
personal privacy.
Name of Committee: National Advisory Council on Alcohol Abuse
and Alcoholism.
Date: May 7, 2024.
Closed: 10:00 a.m. to 10:50 a.m.
Agenda: To review and evaluate grant applications.
Open: 11:00 a.m. to 3:30 p.m.
Agenda: Presentations and other business of the Council.
Place: National Institutes of Health, National Institute on
Alcohol Abuse and Alcoholism, Conference Rooms A, B & C, 6700B
Rockledge Drive, Bethesda, MD 20817 (Hybrid Meeting).
Contact Person: Ranga V. Srinivas, Ph.D., Acting Executive
Secretary, National Advisory Council, Extramural Project Review
Branch, National Institute on Alcohol Abuse and Alcoholism, National
Institutes of Health, 6700 B Rockledge Drive, Room 2114, Bethesda,
MD 20892, (301) 451-2067, [email protected].
Name of Committee: National Advisory Council on Alcohol Abuse
and Alcoholism, National Cancer Advisory Board, and National
Advisory Council on Drug Abuse.
Date: May 8, 2024.
Open: 10:00 a.m. to 3:30 p.m.
Agenda: Presentation of NIAAA, NCI, and NIDA Director's Update,
Scientific Reports, and other topics within the scope of the
Collaborative Research on Addiction at NIH (CRAN).
Place: National Institutes of Health, National Institute on
Alcohol Abuse and Alcoholism, Conference Rooms A, B & C, 6700B
Rockledge Drive, Bethesda, MD 20817 (Hybrid Meeting).
Contact Persons: Ranga V. Srinivas, Ph.D., Acting Executive
Secretary, National Advisory Council Extramural Project Review
Branch, National Institute on Alcohol Abuse and Alcoholism National,
Institutes of Health, 6700 B Rockledge Drive, Room 2114, Bethesda,
MD 20892, (301) 451-2067, [email protected].
Paulette S. Gray, Ph.D., Director, Division of Extramural
Activities, National Cancer Institute, National Institutes of
Health, 9609 Medical Center Drive, Room 7W444, Bethesda, MD 20892,
(240) 276-6340, [email protected].
Susan R.B. Weiss, Ph.D., Director, Division of Extramural
Research, Office of the Director, National Institute on Drug Abuse,
National Institutes of Health, Three White Flint North, RM 09D08,
1601 Landsdown Street, Bethesda, MD 20892, (301) 443-6480,
[email protected].
Any interested person may file written comments with the
committee by forwarding the statement to the Contact Person listed
on this notice. The statement should include the name, address,
telephone number and when applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has procedures at https://www.nih.gov/about-nih/visitor-information/campus-access-security for
entrance into on-campus and off-campus facilities. All visitor
vehicles, including taxicabs, hotel, and airport shuttles will be
inspected before being allowed on campus. Visitors attending a
meeting on campus or at an off-campus federal facility will be asked
to show one form of identification (for example, a government-issued
photo ID, driver's license, or passport) and to state the purpose of
their visit.
Information is also available on the Institute's/Center's home
page: https://www.niaaa.nih.gov/AboutNIAAA/AdvisoryCouncil/Pages/default.aspx, where an agenda and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance Program Nos. 93.273,
Alcohol Research Programs, National Institutes of Health, HHS)
Dated: April 4, 2024.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2024-07500 Filed 4-8-24; 8:45 am]
BILLING CODE 4140-01-P
