National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 38145-38146 [2020-13699]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 123 / Thursday, June 25, 2020 / Notices
Application No.
Drug
Applicant
ANDA 078288 ....
Ondansetron HCl Injection, EQ 2 mg base/mL .......................
ANDA 080426 ....
Hydrocortisone Lotion, 0.5% ....................................................
ANDA 090813 ....
Levetiracetam Injection, 500 mg/5 mL (100 mg/mL) ...............
ANDA 201751 ....
ANDA 202684 ....
Articaine HCl; Epinephrine Bitartrate Injection, 4%; EQ
0.0085 mg base/1.7 mL; 4%; EQ 0.005 mg base/mL.
Levonorgestrel Tablets, 0.75 mg .............................................
Baxter Healthcare Corp., 1 Baxter Parkway, Deerfield, IL
60015.
Bausch Health Americas Inc., 400 Somerset Corporate Blvd.,
Bridgewater, NJ 08807.
Fresenius Kabi USA, LLC., Three Corporate Dr., Lake Zurich, IL 60047.
Hansamed Ltd., 4761 Tara Ct., West Bloomfield, MI 48323.
ANDA 204796 ....
Capreomycin Sulfate for Injection, EQ 1 gm base/vial ............
ANDA 205943 ....
Ethinyl Estradiol; Levonorgestrel Tablets, 0.02 mg, 0.15 mg;
0.025 mg, 0.15 mg; 0.03 mg, 0.15 mg; 0.01 mg, N/A.
Fluoxetine HCl Tablets, EQ 60 mg base .................................
ANDA 212191 ....
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of July 27, 2020.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms inadvertently missing
from the table. Introduction or delivery
for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
products that are listed in the table that
are in inventory on July 27, 2020, may
continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: June 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13661 Filed 6–24–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
jbell on DSKJLSW7X2PROD with NOTICES
38145
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
National Advisory Committee on Rural
Health and Human Services
(NACRHHS) has scheduled a public
meeting. Information about NACRHHS
SUMMARY:
VerDate Sep<11>2014
19:15 Jun 24, 2020
Jkt 250001
Alvogen PB Research and Development LLC, U.S. Agent for
Lotus Pharmaceutical Co., Ltd. Nantou Plant, 44 Whippany
Rd., Suite 300, Morristown, NJ 07960.
Hisun Pharmaceuticals USA, Inc., U.S. Agent for Hisun Pharmaceutical (Hangzhou) Co., Ltd., 200 Crossing Blvd., 2nd
Floor, Bridgewater, NJ 08807.
Lupin Pharmaceuticals, Inc., 111 South Calvert St., Baltimore, MD 21202.
G&W Laboratories, Inc.
and the agenda for this meeting can be
found on the NACRHHS website at
https://www.hrsa.gov/advisorycommittees/rural-health/.
DATES: July 30, 2020, 12:00 p.m.–5:00
p.m. Eastern Time.
ADDRESSES: The meeting scheduled on
July 30, 2020, will be held by
teleconference/webinar. Instructions for
joining the meeting remotely will be
posted on the NACRHHS website 30
calendar days before the date of the
meeting. For meeting information
updates, go to the NACRHHS website
meeting page at https://www.hrsa.gov/
advisory-committees/rural-health/
meetings/.
FOR FURTHER INFORMATION CONTACT:
Steven Hirsch, Administrative
Coordinator at the Federal Office of
Rural Health Policy, HRSA, 5600
Fishers Lane, Rockville, Maryland
20857; 301–443–7322; or shirsch@
hrsa.gov.
and are seen as an essential part of the
economic fabric.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Requests to submit a written
statement or make oral comments to
NACRHHS should be sent to Steven
Hirsch, using the contact information
above, at least 3 business days prior to
the meeting.
Individuals who plan to attend the
teleconference/webinar meeting and
need special assistance or another
reasonable accommodation should
notify Steven Hirsch at the address and
phone number listed above at least 10
business days prior to the meeting.
SUPPLEMENTARY INFORMATION:
NACRHHS provides advice and
recommendations to the Secretary of
HHS (Secretary) on policy, program
development, and other matters of
significance concerning both rural
health and rural human services.
At this meeting, NACRHHS will
discuss the development of a vision
statement that emphasizes rural
community transformation, sustainable
services, and resiliency. By focusing on
this vision, NACRHHS will define what
it wants to accomplish and how to
articulate a policy framework that
informs the HHS leadership and
empowers rural communities. The
intent is to use this process to create a
path forward that would help
NACRHHS identify policies that
empower rural communities to ensure
access to core health and human service
needs that are focused on local residents
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–13670 Filed 6–24–20; 8:45 am]
BILLING CODE 4165–15–P
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) 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
E:\FR\FM\25JNN1.SGM
25JNN1
38146
Federal Register / Vol. 85, No. 123 / Thursday, June 25, 2020 / Notices
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01).
Date: July 30, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G42,
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: Sandip Bhattacharyya,
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 3G42,
Rockville, MD 20892, 240–292–0189,
sandip.bhattacharyya@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: June 19, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–13699 Filed 6–24–20; 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
jbell on DSKJLSW7X2PROD with NOTICES
Pursuant to section 10(d) 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 Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Emergency Awards: Rapid
Investigation of Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS–CoV–2) and
Coronavirus Disease 2019 (COVID–19).
Date: July 17, 2020.
Time: 10:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Sep<11>2014
19:15 Jun 24, 2020
Jkt 250001
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G22A,
Rockville, MD 20892 (Telephone Conference
Call).
Contact Person: Inka I. Sastalla, 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 3G22A, Rockville, MD
20852, 301–761–6431, inka.sastalla@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: June 19, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–13698 Filed 6–24–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel; PAR 17–
203, PAR 17–204: Inter-Organelle
Communication in Cancer (R01 and R21).
Date: July 22, 2020.
Time: 11:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Thomas Y Cho, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, 6701 Rockledge Drive, Rm.
5144, MSC 7840, Bethesda, MD 20892, (301)
402–4179, thomas.cho@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Addiction
Mechanisms and Interventions.
Date: July 23, 2020.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Kristen Prentice, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3112,
MSC 7808, Bethesda, MD 20892, 301–496–
0726, prenticekj@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Addiction
Mechanisms and Interventions.
Date: July 23, 2020.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Miriam Mintzer, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108,
MSC 7808, Bethesda, MD 20892, (301) 523–
0646, mintzermz@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Gastroenterology.
Date: July 23, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jonathan K Ivins, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2190,
MSC 7850, Bethesda, MD 20892, (301) 594–
1245, ivinsj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Visual Biology.
Date: July 23, 2020.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Jonathan Arias, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5170,
MSC 7840, Bethesda, MD 20892, 301–435–
2406, ariasj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Risk Prevention and Social
Development.
Date: July 23, 2020.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Weijia Ni, Ph.D., Chief/
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3100,
MSC 7808, Bethesda, MD 20892, 301–594–
3292, niw@csr.nih.gov.
E:\FR\FM\25JNN1.SGM
25JNN1
]]>Agencies
[Federal Register Volume 85, Number 123 (Thursday, June 25, 2020)]
[Notices]
[Pages 38145-38146]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13699]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meeting
Pursuant to section 10(d) 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
[[Page 38146]]
would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; NIAID Investigator Initiated
Program Project Applications (P01).
Date: July 30, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G42,
Rockville, MD 20892 (Telephone Conference Call).
Contact Person: Sandip Bhattacharyya, 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 3G42,
Rockville, MD 20892, 240-292-0189, [email protected].
(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: June 19, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2020-13699 Filed 6-24-20; 8:45 am]
BILLING CODE 4140-01-P
