National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 24846 [2024-07499]
Download as PDF
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
Frm 00071
Fmt 4703
Sfmt 4703
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
Agencies
[Federal Register Volume 89, Number 69 (Tuesday, April 9, 2024)]
[Notices]
[Page 24846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07499]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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 would
constitute a clearly unwarranted invasion of personal privacy.
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,
[email protected].
(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)
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