9944 Federal Register / Vol. 86, No. 30 / Wednesday, February 17, 2021 / Notices 

learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On April 15, 

2021, the committee will discuss 

biologics license application (BLA) 

125734 for donislecel (purified 

allogeneic deceased donor pancreas 

derived islets of Langerhans). The 

applicant, CellTrans, Inc., has requested 

an indication for the ‘‘treatment of 

brittle Type 1 diabetes mellitus (T1D).’’ 

The morning session will discuss issues 

related to the characterization and 

critical quality attributes of donislecel 

as they relate to product comparability 

in the context of consistent product 

quality and clinical effectiveness. The 

afternoon session will discuss results 

from the clinical trials included in BLA 

125734. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting. Background 

material and the link to the online 

teleconference meeting room will be 

available at https://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. The meeting will include slide 

presentations with audio components to 

allow the presentation of materials in a 

manner that most closely resembles an 

in-person advisory committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. All electronic and 

written submissions submitted to the 

Docket (see ADDRESSES) on or before 

April 8, 2021, will be provided to the 

committee. Oral presentations from the 

public will be scheduled between 

approximately 1:45 p.m. and 2:45 p.m. 

Those individuals interested in making 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before March 31, 2021. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 1, 2021. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Jarrod Collier 

at ctgtac@fda.hhs.gov (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/advisorycommittees/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: February 10, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–03173 Filed 2–16–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–P–1511 and FDA– 

2020–P–1549] 

Determination That NYMALIZE 

(nimodipine), Oral Solution, 3 

Milligrams/Milliliter, Was Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) has determined that NYMALIZE 

(nimodipine), oral solution, 3 

milligrams (mg)/milliliter (mL), was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for nimodipine, 

oral solution, 3 mg/mL, if all other legal 

and regulatory requirements are met. 

FOR FURTHER INFORMATION CONTACT: 

Ayako Sato, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6206, Silver Spring, 

MD 20993–0002, 240–402–4191, 

Ayako.sato@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 355(j)(7)), which 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Drugs are 

removed from the list if the Agency 

withdraws or suspends approval of the 

drug’s NDA or ANDA for reasons of 

safety or effectiveness or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162; 

section 505(j)(7) of the FD&C Act). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness 

(§ 314.161 (21 CFR 314.161)). This 

determination may be made at any time 

after the drug has been withdrawn from 

sale but must be made prior to 

approving an ANDA that refers to the 

listed drug. FDA may not approve an 

ANDA that does not refer to a listed 

drug (see section 505(j)(4) of the FD&C 

Act). 

NYMALIZE (nimodipine), oral 

solution, 3 mg/mL, is the subject of 

NDA 203340, held by Arbor 

Pharmaceuticals, LLC (Arbor), and 

initially approved on May 10, 2013. 

NYMALIZE is indicated for the 

improvement of neurological outcome 

by reducing the incidence and severity 

of ischemic deficits in adult patients 

with subarachnoid hemorrhage from 

ruptured intracranial berry aneurysms 

regardless of their post-ictus 


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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 


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