Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Notices 9945 

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solution, 3 mg/mL was withdrawn from 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was not withdrawn for reasons of safety 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was withdrawn for reasons of safety or 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 

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 

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 


jbell on DSKJLSW7X2PROD with NOTICES
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. 

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. 

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 


jbell on DSKJLSW7X2PROD with NOTICES