Federal Register / Vol. 85, No. 238 / Thursday, December 10, 2020 / Notices 79491 

Ming Marine Transport Corp.; Zim 

Integrated Shipping Services, Ltd.; and 

Matson Navigation Company, Inc. 

Filing Party: Robert Magovern; Cozen 

O’Connor. 

Synopsis: The Amendment adds 

Matson Navigation Company, Inc. as a 

party to the Agreement. 

Proposed Effective Date: 1/15/2021. 

Location: https://www2.fmc.gov/ 

FMC.Agreements.Web/Public/ 

AgreementHistory/34503. 

Dated: December 4, 2020. 

Rachel E. Dickon, 

Secretary. 

[FR Doc. 2020–27067 Filed 12–9–20; 8:45 am] 

BILLING CODE 6730–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2196] 

Allergan Pharmaceuticals 

International, Ltd.; Withdrawal of 

Approval of a New Drug Application for 

ASACOL (Mesalamine) DelayedRelease Tablets, 400 Milligrams 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

the approval of the new drug 

application (NDA) for ASACOL 

(mesalamine) delayed-release tablets, 

400 milligrams (mg), held by Allergan 

Pharmaceuticals International, Ltd., c/o 

Allergan Sales, LLC, 2525 Dupont Dr., 

Irvine, CA 92612 (Allergan). Pursuant to 

FDA’s request, Allergan agreed to 

withdrawal of this application and has 

waived its opportunity for a hearing. 

DATES: Approval is withdrawn as of 

December 10, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

January 31, 1992, FDA approved NDA 

019651 for ASACOL (mesalamine) 

delayed-release tablets, 400 mg. It is 

approved for the treatment of mildly to 

moderately active ulcerative colitis (UC) 

in patients 5 years of age and older, and 

for the maintenance of remission of 

mildly to moderately active UC in 

adults. In December 2012, FDA 

published the guidance for industry 

‘‘Limiting the Use of Certain Phthalates 

as Excipients in CDER-Regulated 

Products,’’ available at https:// 

www.fda.gov/media/83029/download, 

describing evidence that certain 

phthalate esters (phthalates), including 

dibutyl phthalate (DBP) and di(2- 

ethylhexyl) phthalate from 

pharmaceutical products, are 

developmental and reproductive 

toxicants in laboratory animals. This 

evidence has raised concerns about 

human exposure to phthalates, 

particularly in vulnerable populations 

such as pregnant women and infants. 

ASACOL (mesalamine) delayed-release 

tablets, 400 mg, contain DBP as an 

inactive ingredient. On September 6, 

2017, FDA notified Allergen that 

because ASACOL (mesalamine) 

delayed-release tablets, 400 mg, 

contains DBP, the product presents a 

potential problem that is sufficiently 

serious to warrant withdrawal of 

approval. On December 22, 2017, 

Allergan agreed to have FDA withdraw 

approval of NDA 019651 for ASACOL 

(mesalamine) delayed-release tablets, 

400 mg, under § 314.150(d) (21 CFR 

314.150(d)) and waived its opportunity 

for a hearing. 

For the reasons discussed above, and 

pursuant to the applicant’s agreement, 

approval of NDA 019651 for ASACOL 

(mesalamine) delayed-release tablets, 

400 mg, and all amendments and 

supplements thereto, is withdrawn 

under § 314.150(d). 

Distribution of ASACOL (mesalamine) 

delayed-release tablets, 400 mg, into 

interstate commerce without an 

approved application is illegal and 

subject to regulatory action (see sections 

505(a) and 301(d) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

355(a) and 331(d)). 

Dated: December 4, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27082 Filed 12–9–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2227] 

Food and Drug Administration Fiscal 

Year 2020 Performance Review Board 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

names of the members who will serve 

on its fiscal year (FY) 2020 Performance 

Review Board (PRB). The purpose of the 

PRB is to provide fair and impartial 

review of Senior Executive Service 

(SES), Senior Professional, 21st Century 

Cures Act, and Title 42(f) (SES 

Equivalents) performance appraisals, 

bonus recommendations, and pay 

adjustments. 

DATES: Approved October 1, 2020. 

FOR FURTHER INFORMATION CONTACT: Abu 

Sesay, Office of Human Capital 

Management (OHCM), Three White 

Flint North, 02C47, 11601 Landsdown 

St., North Bethesda, MD 20852, Office 

Number: 240–402–0440 (not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: This 

action is being taken pursuant to 5 

U.S.C. 4314(c)(4), which requires that 

members of performance review boards 

be appointed in a manner to ensure 

consistency, stability, and objectivity in 

performance appraisals and requires 

that notice of the appointment of an 

individual to serve as a member be 

published in the Federal Register. 

The following persons will serve on 

the FDA FY 2020 Performance Review 

Board, which oversees the evaluation of 

performance appraisals of FDA’s Senior 

Executives and Equivalents: 

• James Sigg, PRB Chair 

• Tania Tse, PRB Officiator 

• Glenda Barfell 

• Janelle Barth 

• Vincent Bunning 

• Mary Beth Clarke 

• Elizabeth Dickinson 

• Tracey Forfa 

• Denise Huttenlocker 

• Diane Maloney 

• William Tootle 

Dated: December 4, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27123 Filed 12–9–20; 8:45 am] 

BILLING CODE 4164–01–P 


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