Center for Scientific Review; Notice of Closed Meetings, 9945-9946 [2021-03098]
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Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Notices
neurological condition (i.e., Hunt and
Hess Grades I through V).
In a letter dated May 4, 2020, Arbor
notified FDA that NYMALIZE
(nimodipine), oral solution, 3 mg/mL
was being discontinued, and FDA
moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the Orange Book. As
indicated in the Orange Book, Arbor
markets a 6 mg/mL strength of
NYMALIZE (nimodipine) oral solution,
which was approved through NDA
203340/S–011 on April 8, 2020.
Annora Pharma Private Limited
submitted a citizen petition dated June
6, 2020 (Docket No. FDA–2020–P–1511)
and Windels Marx Lane & Mittendorf,
LLC submitted a citizen petition dated
June 10, 2020 (Docket No. FDA–2020–
P–1549), both under 21 CFR 10.30,
requesting that the Agency determine
whether NYMALIZE (nimodipine), oral
solution, 3 mg/mL was withdrawn from
sale for reasons of safety or
effectiveness.
After considering the citizen petitions
and comments submitted to the dockets
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that NYMALIZE
(nimodipine), oral solution, 3 mg/mL,
was not withdrawn for reasons of safety
or effectiveness. The petitioner has
identified no data or other information
suggesting that NYMALIZE
(nimodipine), oral solution, 3 mg/mL,
was withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
NYMALIZE (nimodipine), oral solution,
3 mg/mL, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events.
A comment submitted by Arbor
suggests that it was necessary to
discontinue marketing the 3 mg/mL
strength to mitigate potential confusion
between the 3 mg/mL and 6 mg/mL
strengths of NYMALIZE (nimodipine),
oral solution. FDA disagrees. While
discontinuation of the 3 mg/mL strength
is one way to reduce the risk of
confusion between the two strengths,
there are other (often-used) mitigation
strategies that may be employed to
reduce the risk of confusion among
multiple marketed strengths of a drug
that could have been used by Arbor.
Arbor’s comment also states that FDA
should find that the 3 mg/mL strength
was discontinued for safety reasons
because the Agency made similar
determinations for BREVIBLOC
(esmolol hydrochloride) injection, 250
mg/mL, 10-mL ampule, and the original
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formulation of PROTONIX I.V.
(pantoprazole sodium) for injection. Our
finding that the 3 mg/mL strength for
NYMALIZE was not withdrawn from
sale for reasons of safety is factually
distinguishable from BREVIBLOC and
PROTONIX I.V.
Based on a thorough evaluation of the
information we have available to us and
the latest version of the approved
labeling for NYMALIZE (nimodipine),
oral solution, 3 mg/mL, we have
determined that this drug product
would be considered safe and effective
if it were reintroduced to the market
today. Certain labeling changes should
be considered to prevent future
medication errors due to the presence of
two different strengths of NYMALIZE
(nimodipine), oral solution, on the
market (i.e., NYMALIZE (nimodipine),
oral solution, 3 mg/mL and NYMALIZE
(nimodipine), oral solution, 6 mg/mL),
but no existing safety signals or efficacy
concerns make labeling changes
necessary.
Accordingly, the Agency will
continue to list NYMALIZE
(nimodipine), oral solution, 3 mg/mL, in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. ANDAs that refer
to NYMALIZE (nimodipine), oral
solution, 3 mg/mL, may be approved by
the Agency as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If FDA
determines that labeling for this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: February 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03083 Filed 2–16–21; 8:45 am]
BILLING CODE 4164–01–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
PO 00000
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9945
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;
Fellowships: Surgical Sciences, Biomedical
Imaging and Bioengineering.
Date: March 16, 2021.
Time: 1:00 p.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: Yuanna Cheng, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
MSC 7814, Bethesda, MD 20892, (301) 435–
1195, Chengy5@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR20–117:
Maximizing Investigators’ Research Award
(MIRA) for Early Stage Investigators (R35—
Clinical Trial Optional).
Date: March 17–18, 2021.
Time: 9:00 a.m. to 7:00 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: Guoqin Yu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 435–1276, guoqin.yu@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Immune Responses and Vaccines
to Microbial Infections.
Date: March 17–18, 2021.
Time: 9:30 a.m. to 7:00 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: Barna Dey, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3184,
Bethesda, MD 20892, 301–451–2796, bdey@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Healthcare Delivery and
Methodologies.
Date: March 17, 2021.
Time: 9:30 a.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: Karen Nieves Lugo, MPH,
Ph.D., Scientific Review Officer, Center for
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9946
Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Notices
Scientific Review, National Institutes of
Health, Bethesda, MD 20892, 301–594–9088,
karen.nieveslugo@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–20–
131: Mammalian Models for Translational
Research.
Date: March 17, 2021.
Time: 10:00 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: Malaya Chatterjee, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6192,
MSC 7804, Bethesda, MD 20892, 301–806–
2515, chatterm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Biomedical
Data Repositories and Knowledgebases.
Date: March 17–18, 2021.
Time: 10:00 a.m. to 7:30 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: Joseph Thomas Peterson,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118,
MSC 7814, Bethesda, MD 20892, 301–408–
9694, petersonjt@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Digestive system inflammatory
disease.
Date: March 17, 2021.
Time: 11:00 a.m. to 3:00 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: Ganesan Ramesh, Ph.D.,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 2182, MSC 7818, Bethesda, MD 20892,
(301) 827–5467, ganesan.ramesh@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Cancer Prevention.
Date: March 17, 2021.
Time: 1:00 p.m. to 3:00 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: Mehrdad Mohseni, MD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5211,
MSC 7854, Bethesda, MD 20892, 301–435–
0484, mohsenim@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR 20–
153: NIH Science Education Partnership
Award (SEPA) (R25—Clinical Trial Not
Allowed).
Date: March 17, 2021.
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Time: 12:00 p.m. to 1:00 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.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: February 10, 2021.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–03098 Filed 2–16–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
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: National Institute of
Mental Health Special Emphasis Panel;
NIMH Pilot Effectiveness Trials for
Treatment, Preventive, and Services
Interventions (R34).
Date: March 10, 2021.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Serena Chu, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6000, MSC 9606,
Bethesda, MD 20852, 301–500–5829,
serena.chu@nih.gov.
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Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Computational Psychiatry Review Meeting
(R01, R21).
Date: March 11, 2021.
Time: 11:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Rebecca Steiner Garcia,
Ph.D., Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6149, MSC 9608,
Bethesda, MD 20892–9608, 301–443–4525,
steinerr@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Pharmacologic or Device-based Interventions
for the Treatment of Mental Disorders.
Date: March 12, 2021.
Time: 11:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Serena Chu, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6000, MSC 9606,
Bethesda, MD 20852, 301–500–5829,
serena.chu@nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: February 10, 2021.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–03113 Filed 2–16–21; 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 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\17FEN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 30 (Wednesday, February 17, 2021)]
[Notices]
[Pages 9945-9946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03098]
-----------------------------------------------------------------------
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; Fellowships: Surgical Sciences, Biomedical Imaging and
Bioengineering.
Date: March 16, 2021.
Time: 1:00 p.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: Yuanna Cheng, MD, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138, MSC 7814, Bethesda, MD
20892, (301) 435-1195, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR20-117: Maximizing Investigators' Research Award (MIRA)
for Early Stage Investigators (R35--Clinical Trial Optional).
Date: March 17-18, 2021.
Time: 9:00 a.m. to 7:00 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: Guoqin Yu, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892, (301) 435-1276,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Immune Responses and Vaccines to Microbial
Infections.
Date: March 17-18, 2021.
Time: 9:30 a.m. to 7:00 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: Barna Dey, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3184, Bethesda, MD 20892, 301-451-2796,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflicts: Healthcare Delivery and Methodologies.
Date: March 17, 2021.
Time: 9:30 a.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: Karen Nieves Lugo, MPH, Ph.D., Scientific Review
Officer, Center for
[[Page 9946]]
Scientific Review, National Institutes of Health, Bethesda, MD
20892, 301-594-9088, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR-20-131: Mammalian Models for Translational Research.
Date: March 17, 2021.
Time: 10:00 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: Malaya Chatterjee, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6192, MSC 7804, Bethesda, MD
20892, 301-806-2515, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Biomedical Data Repositories and Knowledgebases.
Date: March 17-18, 2021.
Time: 10:00 a.m. to 7:30 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: Joseph Thomas Peterson, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118, MSC 7814, Bethesda, MD
20892, 301-408-9694, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Digestive system inflammatory disease.
Date: March 17, 2021.
Time: 11:00 a.m. to 3:00 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: Ganesan Ramesh, Ph.D., Center for Scientific
Review, National Institutes of Health, 6701 Rockledge Drive, Room
2182, MSC 7818, Bethesda, MD 20892, (301) 827-5467,
[email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Cancer Prevention.
Date: March 17, 2021.
Time: 1:00 p.m. to 3:00 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: Mehrdad Mohseni, MD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5211, MSC 7854, Bethesda, MD 20892, 301-435-
0484, [email protected].
Name of Committee: Center for Scientific Review Special Emphasis
Panel; PAR 20-153: NIH Science Education Partnership Award (SEPA)
(R25--Clinical Trial Not Allowed).
Date: March 17, 2021.
Time: 12:00 p.m. to 1:00 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, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: February 10, 2021.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2021-03098 Filed 2-16-21; 8:45 am]
BILLING CODE 4140-01-P
