Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices 83975 

Application No. Drug Applicant 

NDA 019916 ............. Morphine Sulfate Injection, 1 mg/mL and 5 mg/mL ............................................. Do. 

NDA 020593 ............. Depacon (valproate sodium) Injection, Equivalent to (EQ) 100 mg base/mL ...... AbbVie, Inc. 

NDA 020634 ............. Levaquin (levofloxacin) Tablets, 250 mg, 500 mg, and 750 mg .......................... Janssen Pharmaceuticals, Inc. 

NDA 021241 ............. Ortho Tri-Cyclen Lo (ethinyl estradiol and norgestimate) Oral-28 (White) Tablets, 0.025 mg ethinyl estradiol and 0.18 mg norgestimate; (Light Blue) Tablets, 0.025 mg ethinyl estradiol and 0.215 mg norgestimate; (Dark Blue) Tablets, 0.025 mg ethinyl estradiol and 0.250 mg norgestimate.Do. 

NDA 206544 ............. MorphaBond ER (morphine sulfate) Extended-Release Tablets, 15 mg, 30 mg, 

60 mg, and 100 mg.

Daiichi Sankyo, Inc., 211 Mount Airy 

Rd., Basking Ridge, NJ 07920. 

NDA 208399 ............. Varubi (rolapitant HCl) Injectable Emulsion, EQ 166.5 mg base/92.5 mL (EQ 

1.8 mg base/mL).

TerSera Therapeutics LLC, 520 Lake 

Cook Rd., suite 500, Deerfield, IL 

60015. 

NDA 209203 ............. Duzallo (allopurinol and lesinurad) Tablets, 200 mg/200 mg and 300 mg/200 

mg.

Ironwood Pharmaceuticals, Inc., 100 

Summer St., suite 2300, Boston, MA 

02110. 

NDA 210895 ............. Welchol (colesevelam HCl) Chewable Bars, 3.75 g ............................................ Daiichi Sankyo, Inc. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of January 22, 

2021. 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application is withdrawn, including any 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 January 22, 

2021 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: December 16, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–28346 Filed 12–22–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Extension of Designation of Scarce 

Materials or Threatened Materials 

Subject to COVID–19 Hoarding 

Prevention Measures; Correction of 

Extension Date 

AGENCY: Office of the Secretary (OS), 

DHHS. 

ACTION: Correction. 

SUMMARY: This document updates the 

July 30, 2020, Federal Register Notice 

entitled ‘‘Extension of Designation of 

Scarce Materials or Threatened 

Materials Subject to COVID–19 

Hoarding Prevention Measures,’’ by 

revising the last sentence in the 

‘‘Summary’’ section. 

FOR FURTHER INFORMATION CONTACT: 

Paige Ezernack, Office of the Assistant 

Secretary for Preparedness and 

Response, Office of Strategy, Policy, 

Planning, and Requirements, Suite 

5440—O’Neill House Office Building, 

200 C Street SW, Washington, DC 

20201, (202) 260–0365. 

SUPPLEMENTARY INFORMATION: 

I. Correction of Errors 

In FR Doc. 2020–16458 of July 30, 

2020 (85 FR 45895–45897), make the 

following corrections: 

On page 48596, first full column, 

SUMMARY section, change second to last 

sentence to ‘‘This notice, issued on July 

23, 2020, extends the March 25 

Designation Notice to January 19, 2021.’’ 

The expiration date, January 19, 2021 is 

not 120 days from the date of issuance 

so remove that reference. 

Wilma Robinson, 

Deputy Executive Secretary, Department of 

Health and Human Services. 

[FR Doc. 2020–28374 Filed 12–22–20; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Dental & 

Craniofacial Research; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory Dental 

and Craniofacial Research Council. 

The meeting will be open to the 

public via NIH videocast. The URL link 

to this meeting is https:// 

videocast.nih.gov/watch=38984. 

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 Advisory 

Dental and Craniofacial Research Council. 

Date: January 27, 2021. 

Open: 10:00 a.m. to 1:05 p.m. 

Agenda: Report of the Director, NIDCR 

Place: National Institute of Dental and 

Craniofacial Research, National Institutes of 

Health, 6701 Democracy Boulevard, Room 

662 Bethesda, MD 20892, (Virtual Meeting). 

Closed: 1:20 p.m. to 2:00 p.m. 

Agenda: Grant applications. 

Place: National Institute of Dental and 

Craniofacial Research, National Institutes of 

Health, 6701 Democracy Boulevard, Room 

662 Bethesda, MD 20892, (Virtual Meeting). 

Contact Person: Alicia J. Dombroski, Ph.D., 

Director, Division of Extramural Activities, 

National Institute of Dental and Craniofacial 

Research, National Institutes of Health, 6701 

Democracy Boulevard, Room 662, Bethesda, 

MD 20892, 301–594–4805, adombroski@

nidcr.nih.gov. 

Any interested person may file written 

comments with the committee no later than 

15 days after the meeting by forwarding the 

statement to the Contact Person listed on this 

notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nidcr.nih.gov/about, where an agenda 

and any additional information for the 

meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.121, Oral Diseases and 

Disorders Research, National Institutes of 

Health, HHS) 


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83976 Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices 

Dated: December 17, 2020. 

Patricia B. Hansberger, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2020–28354 Filed 12–22–20; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney 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 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Fellowships in 

Digestive Diseases and Nutrition. 

Date: February 11–12, 2021. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Room 7011, Bethesda, MD 20892 

(Video Meeting). 

Contact Person: Jian Yang, Ph.D., Scientific 

Review Officer, Review Branch, Division of 

Extramural Activities, NIDDK, National 

Institutes of Health, Room 7111, 6707 

Democracy Boulevard, Bethesda, MD 20892– 

5452, (301) 594–7799, yangj@

extra.niddk.nih.go.v 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: December 18, 2020. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–28350 Filed 12–22–20; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory 

Council on Aging. 

The meeting will be open to the 

public as indicated below, with a short 

public comment period at the end. The 

open session will be videocast and can 

be accessed from the NIH Videocasting 

and Podcasting website (http://

videocast.nih.gov). 

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 Advisory 

Council on Aging. 

Date: September 14–15, 2021. 

Closed: September 14, 2021, 3:00 p.m. to 

5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892, (Virtual Meeting). 

Open: September 15, 2021, 8:00 a.m. to 

1:00 p.m. 

Agenda: Call to order and report from the 

Director; Discussion of future meeting dates; 

Consideration of minutes of last meeting; 

Reports from Task Force on Minority Aging 

Research, Working Group on Program; 

Council Speaker; Program Highlights. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Bethesda, MD 20892, (Virtual Meeting). 

Contact Person: Kenneth Santora, Ph.D., 

Director, Office of Extramural Activities, 

National Institute on Aging, National 

Institutes of Health, Gateway Building, 7201 

Wisconsin Avenue, Bethesda, MD 20814, 

(301) 496–9322, ksantora@nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: 

www.nia.nih.gov/about/naca, where an 

agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: December 18, 2020. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2020–28397 Filed 12–22–20; 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 

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 on 

Alcohol Abuse and Alcoholism Initial 

Review Group Epidemiology, Prevention and 

Behavior Research Review Subcommittee. 

Date: March 1–2, 2021. 

Time: 9:30 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, 6700 B Rockledge Drive, 

Bethesda, MD 20892, (Virtual Meeting). 

Contact Person: Anna Ghambaryan, M.D., 

Ph.D., Scientific Review Officer, Extramural 

Project Review Branch, Office of Extramural 

Activities, National Institute on Alcohol 

Abuse and Alcoholism, 6700B Rockledge 

Drive, Room 2120, MSC 6902, Bethesda, MD 

20892, 301–443–4032, anna.ghambaryan@

nih.gov. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Initial 

Review Group Biomedical Research Review 

Subcommittee. 

Date: March 9, 2021. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Health, 

National Institute on Alcohol Abuse and 

Alcoholism, 6700 B Rockledge Drive, 

Bethesda, MD 20892, (Virtual Meeting). 

Contact Person: Philippe Marmillot, Ph.D., 

Scientific Review Officer, Extramural Project 

Review Branch, National Institutes of Health, 


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