Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 1517 

Application 

No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant 

NDA 016801 XYLOCAINE PRESERVATIVE FREE.Lidocaine Hydrochloride.1%; 2%; 4%; 10%; 20% ............ Injectable; Injection ... Fresenius Kabi USA, 

LLC. 

NDA 018238 MICRO–K ................. Potassium Chloride .. 8 milliequivalents (mEq); 10 

mEq.

Extended-Release 

Capsule; Oral.

Nesher Pharmaceuticals LLC. 

NDA 019568 DERMATOP ............. Prednicarbate ........... 0.10% ......................................... Ointment; Topical ..... Valeant Pharmaceuticals. 

NDA 020192 LAMISIL .................... Terbinafine Hydrochloride.1% .............................................. Cream; Topical ......... Novartis. 

NDA 020482 PRECOSE ................ Acarbose .................. 25 mg; 50 mg; 100 mg .............. Tablet; Oral ............... Bayer Healthcare. 

NDA 020591 TARKA ...................... Trandolapril; 

Verapamil Hydrochloride.

1 mg; 240 mg ............................. Extended-Release 

Tablet; Oral.

AbbVie Inc. 

NDA 020635 LEVAQUIN ............... Levofloxacin .............. EQ 500 mg/20 mL; EQ 750 mg/ 

30 mL.

Injectable; Injection ... Janssen Pharmaceuticals, Inc. 

NDA 020823 EXELON ................... Rivastigmine Tartrate EQ 1.5 mg Base; EQ 3 mg 

Base; EQ 4.5 mg Base; EQ 6 

mg Base.

Capsule; Oral ........... Novartis. 

NDA 020920 NATRECOR ............. Nesiritide ................... 1.5 mg/Vial ................................. For Solution; Intravenous.Scios Inc. 

NDA 021549 EMEND ..................... Aprepitant ................. 40 mg ......................................... Capsule; Oral ........... Merck. 

NDA 021590 FAZACLO ODT ........ Clozapine .................. 12.5 mg; 25 mg; 100 mg; 150 

mg; and 200 mg.

Orally Disintegrating 

Tablet; Oral.

Jazz Pharmaceuticals 

PLC. 

NDA 202535 PREPOPIK ............... Citric Acid, Magnesium Oxide, and 

Sodium Picosulfate.

12 grams (g)/Packet; 3.5 g/ 

Packet; 10 mg/Packet.

For Solution; Oral ..... Ferring Pharmaceuticals Inc. 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed were not 

withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

Agency will continue to list the drug 

products in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. 

Approved ANDAs that refer to the 

NDAs and ANDAs listed are unaffected 

by the discontinued marketing of the 

products subject to those NDAs and 

ANDAs. Additional ANDAs that refer to 

these products may also be approved by 

the Agency if they comply with relevant 

legal and regulatory requirements. If 

FDA determines that labeling for these 

drug products should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: January 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00118 Filed 1–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the National Advisory 

Committee on the National Health 

Service Corps 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the National 

Advisory Committee on the National 

Health Service Corps (NACNHSC) will 

hold public meetings for the 2021 

calendar year (CY). Information about 

NACNHSC, agendas, and materials for 

these meetings can be found on the 

NACNHSC website at https://

nhsc.hrsa.gov/about/national-advisorycouncil-nhsc/index.html. 

DATES: NACNHSC meetings will be held 

on 

• March 16, 2021, 9:00 a.m.–5:00 p.m. 

Eastern Time (ET) and March 17, 2021, 

9:00 a.m.–2:00 p.m. ET; 

• June 22, 2021, 9:00 a.m.–5:00 p.m. 

ET and June 23, 2021, 9:00 a.m.–2:00 

p.m. ET; 

• November 9, 2021, 9:00 a.m.–5: 00 

p.m. ET and November 10, 2021, 9:00 

a.m.–2:00 p.m. ET. 

ADDRESSES: Meetings may be held inperson, by teleconference, and/or Adobe 

Connect webinar. For updates on how 

the meeting will be held, visit the 

NACNHSC website 30 business days 

before the date of the meeting, where 

instructions for joining meetings either 

in-person or remotely will also be 

posted. In-person NACNHSC meetings 

will be held at 5600 Fishers Lane, 

Rockville, Maryland 20857. For meeting 

information updates, go to the 

NACNHSC website meeting page at 

https://nhsc.hrsa.gov/nac/ 

meetings.html. 

FOR FURTHER INFORMATION CONTACT: 

Diane Fabiyi-King (DFO), Division of 

National Health Service Corps, Bureau 

of Health Workforce, HRSA, 5600 

Fishers Lane, Rockville, Maryland 

20857; 301–443–3609; or 

NHSCAdvisoryCouncil@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

NACNHSC provides advice and 

recommendations to the Secretary of 

HHS (Secretary) on policy, program 

development, and other matters of 

significance concerning the activities 

under Subpart II, Part D of Title III of 

the Public Health Service Act (42 U.S.C. 

254d–254k). NACNHSC designates areas 

of the United States with health 

professional shortages and assigns 

National Health Service Corps clinicians 

to improve the delivery of health 

services in health professional shortage 

areas. Since priorities dictate meeting 

times and agenda items, be advised that 

start times, end times, and agenda items 

are subject to change. For CY 2021 

meetings, agenda items may include, 

but are not limited to, the identification 

of NACNHSC priorities for future 


tkelley on DSKBCP9HB2PROD with NOTICES
1518 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 

program issues and concerns; propose 

policy changes using the varying levels 

of expertise represented on the Council 

to advise on specific program areas; 

updates from clinician workforce 

experts; and education and practice 

improvement in the training 

development of primary care clinicians. 

More general items may include: 

Presentations and discussions on the 

current and emerging needs of health 

workforce; public health priorities; 

healthcare access and evaluation; 

NACNHSC-approved sites; HRSA 

priorities and other federal health 

workforce and education programs that 

impact the NACNHSC. 

Refer to the NACNHSC website listed 

above for all current and updated 

information concerning the CY 2021 

NACNHSC meetings, including draft 

agendas and meeting materials that will 

be posted 30 calendar days before the 

meeting. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may submit written 

statements in advance of the scheduled 

meeting(s). Oral comments will be 

honored in the order they are requested 

and may be limited as time allows. 

Requests to submit a written statement 

or make oral comments to the 

NACNHSC should be sent to Diane 

Fabiyi-King using the contact 

information above at least 5 business 

days before the meeting date(s). 

Individuals who need special 

assistance or another reasonable 

accommodation should notify Diane 

Fabiyi-King using the contact 

information listed above at least 10 

business days before the meeting(s) they 

wish to attend. 

If a meeting is held in-person, it will 

occur in a federal government building 

and attendees must go through a 

security check to enter. Non-U.S. 

Citizen attendees must notify HRSA of 

their planned attendance at an in-person 

meeting at least 20 business days prior 

to the meeting in order to facilitate their 

entry into the building. All attendees are 

required to present government-issued 

identification prior to entry. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–00093 Filed 1–7–21; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Council on Graduate 

Medical Education 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Council on 

Graduate Medical Education (COGME or 

Council) will hold public meetings for 

the 2021 calendar year (CY). 

Information about COGME, agendas, 

and materials for these meetings can be 

found on the COGME website at https:// 

www.hrsa.gov/advisory-committees/ 

graduate-medical-edu/index.html. 

DATES: COGME meetings will be held on 

• April 14, 2021, 8:30 a.m.–5:00 p.m. 

Eastern Time (ET) and April 15, 2021, 

8:30 a.m.–2:00 p.m. ET; 

• August 19, 2021, 10:00 a.m.–5:00 

p.m. ET. 

ADDRESSES: Meetings may be held inperson, by teleconference, and/or Adobe 

Connect webinar. For updates on how 

the meeting will be held, visit the 

COGME website 30 business days before 

the date of the meeting where 

instructions for joining meetings either 

in-person or remotely will also be 

posted. In-person meetings will be held 

at 5600 Fishers Lane, Rockville, 

Maryland 20857. For meeting 

information updates, go to the COGME 

website meeting page at https://

www.hrsa.gov/advisory-committees/ 

graduate-medical-edu/meetings/ 

index.html. 

FOR FURTHER INFORMATION CONTACT: 

Shane Rogers, Designated Federal 

Official, Division of Medicine and 

Dentistry, Bureau of Health Workforce, 

HRSA, 5600 Fishers Lane, Room 

15N142, Rockville, Maryland 20857; 

301–443–5260; or SRogers@hrsa.gov. 

SUPPLEMENTARY INFORMATION: COGME 

makes recommendations to the 

Secretary of HHS (Secretary) and 

Congress on policy, program 

development, and other matters of 

significance as specified by section 762 

of Title VII of the Public Health Service 

(PHS) Act. Issues addressed by COGME 

include the supply and distribution of 

the physician workforce in the United 

States, including any projected 

shortages or excesses; foreign medical 

school graduates; the nature and 

financing of undergraduate and graduate 

medical education; appropriation levels 

for certain programs under Title VII of 

the PHS Act; and deficiencies in 

databases of the supply and distribution 

of the physician workforce and 

postgraduate programs for training 

physicians. COGME submits reports to 

the Secretary of HHS; the Senate 

Committee on Health, Education, Labor 

and Pensions; and the House of 

Representatives Committee on Energy 

and Commerce. Additionally, COGME 

encourages entities providing graduate 

medical education to conduct activities 

to voluntarily achieve the 

recommendations of the Council. Since 

priorities dictate meeting times, be 

advised that start times, end times, and 

agenda items are subject to change. For 

CY 2021 meetings, agenda items may 

include, but are not limited to, 

discussion on topics surrounding rural 

health workforce and training. Refer to 

the COGME website listed above for all 

current and updated information 

concerning the CY 2021 COGME 

meetings, including draft agendas and 

meeting materials that will be posted 30 

calendar days before the meeting. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may submit written 

statements in advance of the scheduled 

meeting(s). Oral comments will be 

honored in the order they are requested 

and may be limited as time allows. 

Requests to submit a written statement 

or make oral comments to COGME 

should be sent to Shane Rogers using 

the contact information above at least 5 

business days before the meeting 

date(s). 

Individuals who need special 

assistance or another reasonable 

accommodation should notify Shane 

Rogers using the contact information 

listed above at least 10 business days 

before the meeting(s) they wish to 

attend. 

If a meeting is held in-person, it will 

occur in a federal government building 

and attendees must go through a 

security check to enter. Non-U.S. citizen 

attendees must notify HRSA of their 

planned attendance at an in-person 

meeting at least 20 business days prior 

to the meeting in order to facilitate their 

entry into the building. All attendees are 

required to present government-issued 

identification prior to entry. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2021–00058 Filed 1–7–21; 8:45 am] 

BILLING CODE 4165–15–P 


tkelley on DSKBCP9HB2PROD with NOTICES