Food and Drug Administration Fiscal Year 2020 Performance Review Board, 79491 [2020-27123]
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Federal Register / Vol. 85, No. 238 / Thursday, December 10, 2020 / Notices
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.
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DATES: Approval is withdrawn as of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.
SUMMARY:
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
jbell on DSKJLSW7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:36 Dec 09, 2020
Jkt 253001
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(2ethylhexyl) 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
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.
SUMMARY:
DATES:
Approved October 1, 2020.
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).
FOR FURTHER INFORMATION CONTACT:
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:
SUPPLEMENTARY INFORMATION:
•
•
•
•
•
•
•
•
•
•
•
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
[Docket No. FDA–2020–N–2227]
Food and Drug Administration Fiscal
Year 2020 Performance Review Board
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
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[Federal Register Volume 85, Number 238 (Thursday, December 10, 2020)]
[Notices]
[Page 79491]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27123]
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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
