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Federal Register / Vol. 91, No. 106 / Wednesday, June 3, 2026 / Notices
withdrawing approval of 16 abbreviated
new drug applications (ANDAs) from
multiple applicants. The applicants
notified the Agency in writing that the
drug products were no longer marketed
and requested that the approval of the
applications be withdrawn.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2026–N–5816]

Elite Laboratories, Inc. et al.;
Withdrawal of Approval of 16
Abbreviated New Drug Applications

DATES: Approval is withdrawn as of July

AGENCY: Food and Drug Administration,

HHS.

6, 2026.
FOR FURTHER INFORMATION CONTACT:

Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,

ACTION: Notice.
SUMMARY: The Food and Drug

Administration (FDA or Agency) is

33185

Silver Spring, MD 20993–0002, 301–
796–3471, [email protected].
SUPPLEMENTARY INFORMATION: The

applicants listed in table 1 have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.

TABLE 1—ANDAS FOR WHICH APPROVAL IS WITHDRAWN
Application No.

Drug

Applicant

ANDA 040227 .......
ANDA 040460 .......
ANDA 065025 .......
ANDA 075180 .......

Elite Laboratories, Inc., 165/144/135 Ludlow Ave., Northvale, NJ 07647.
Do.
AbbVie Inc., 1 N Waukegan Rd., North Chicago, IL 60064.
Par Health USA LLC, U.S. Agent for PH Health Limited, 300 Tice Blvd.,
Suite 230, Woodcliff Lake, NJ 07677.
Sunstar Americas, Inc., 301 E Central Rd., Schaumburg, IL 60195.
Par Health USA LLC, U.S. Agent for PH Health Limited, 9 Great Valley Parkway, Malvern, PA 19355.
eVenus Pharmaceutical Lab Inc., U.S. Agent for Jiangsu Hengrui Pharmaceuticals Co., Ltd., 506 Carnegie Center, Suite 102, Princeton, NJ 08540.

ANDA 207366 .......
ANDA 210653 .......

Phentermine hydrochloride (HCl) capsule, 30 milligrams (mg) ....
Phentermine HCl capsule, 15 mg .................................................
Cyclosporine solution, 100 mg/milliliters (mL) ..............................
Ranitidine HCl tablet, Equivalent to (EQ) 150 mg and EQ 300
mg.
PAROEX (chlorhexidine gluconate) solution, 0.12% ....................
OXYCODONE AND ACETAMINOPHEN (acetaminophen;
oxycodone HCl) tablet, 325 mg; 7.5 mg and 325 mg; 10 mg.
Cisatracurium besylate injectable, EQ 2 mg base/mL,
CISATRACURIUM BESYLATE PRESERVATIVE FREE
(cisatracurium besylate) injectable EQ 2 mg base/mL and EQ
10 mg base/mL.
DEXTROAMP SACCHARATE, AMP ASPARTATE,
DEXTROAMP SULFATE AND AMP SULFATE (amphetamine
aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate) (extended-release capsule, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg, 2.25 mg; 2.25 mg;
2.25 mg; 2.25 mg, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg, 5
mg; 5 mg; 5 mg; 5 mg, 6.25 mg; 6.25 mg; 6.25 mg; 6.25 mg,
and 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg.
Ribavirin solution, 6 grams/vial .....................................................
Clomipramine HCl capsule, 25 mg, 50 mg, and 75 mg ...............

ANDA 210948 .......

Albuterol sulfate tablet, EQ 2 mg base and EQ 4 mg base .........

ANDA 211538 .......

Vasopressin solution, 20 units/mL ................................................

ANDA 212106 .......

Entecavir tablet, 0.5 mg and 1 mg ...............................................

ANDA 212957 .......
ANDA 214423 .......

Fosaprepitant dimeglumine powder, EQ 150 mg base/vial ..........
Venlafaxine HCl extended-release tablet, EQ 75 mg base and
EQ 150 mg base.
Nicardipine HCl capsule, 20 mg and 30 mg .................................

ANDA 076434 .......
ANDA 090734 .......
ANDA 204960 .......

ANDA 206159 .......

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ANDA 218638 .......

Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of July 6, 2026.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms inadvertently missing
from table 1. Introduction or delivery for
introduction into interstate commerce of
products listed in table 1 without an
approved abbreviated new drug
application violates sections 505(a) and
301(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(a) and
331(d)). Drug products that are listed in
table 1 that are in inventory on July 6,
2026 may continue to be dispensed
until the inventories have been depleted
or the drug products have reached their

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Par Health USA LLC, U.S. Agent for PH Health Limited.

Navinta LLC, 1499 Lower Ferry Rd., Ewing, NJ 08618.
PTS Consulting, LLC, U.S. Agent for TP ANDA HOLDINGS, LLC., 6739 Valhalla Ct., Shawnee, KS 66217.
Makro Technologies Inc., (Makrocare) U.S. Agent for Aizant Drug Research
Solutions Private Limited, 116 Village Blvd., Suite # 200, Princeton, NJ
08540.
Eagle Pharmaceuticals, Inc., 50 Tice Blvd., Suite 315, Woodcliff Lake, NJ
07677.
CMC GMP LLC, U.S. Agent for Pharmadax Inc., 9805 NE 116th St. PMB
#A255, Kirkland, WA 98034.
Navinta LLC.
CMC GMP LLC, U.S. Agent for Pharmadax Inc.
Navinta LLC.

expiration dates or otherwise become
violative, whichever occurs first.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Grace R. Graham,
Deputy Commissioner for Policy, Legislation,
and International Affairs.

National Institutes of Health

[FR Doc. 2026–11062 Filed 6–2–26; 8:45 am]
BILLING CODE 4164–01–P

PO 00000

Submission for OMB Review; 30-Day
Comment Request Regular Clearance
for the National Institute of Mental
Health Data Archive (NDA), (NIMH)
AGENCY: National Institutes of Health,

HHS.
ACTION: Notice.
SUMMARY: In compliance with the

requirement of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and

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33186

Federal Register / Vol. 91, No. 106 / Wednesday, June 3, 2026 / Notices

approval of the information collection
listed below.
DATES: Comments regarding this

information collection are best assured
of having their full effect if received by
June 3, 2026.
ADDRESSES: Written comments and

recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function
FOR FURTHER INFORMATION CONTACT: To

request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Andrew Hooper,
National Institute of Mental Health
(NIMH) Project Clearance Liaison,
Science Policy and Evaluation Branch,
Office of Science Policy, Planning and
Communications, NIMH, Neuroscience
Center, 6001 Executive Boulevard, MSC
9667, Bethesda, Maryland 20892, call
(301) 480–8433 or Email your request,
including your address to
[email protected].

SUPPLEMENTARY INFORMATION: This

proposed information collection was
previously published in the Federal
Register on March 4, 2026 (91 FR10621)
and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment.
The National Institute of Mental
Health (NIMH), National Institutes of
Health, may not conduct or sponsor,
and the respondent is not required to
respond to, an information collection
that has been extended, revised, or
implemented on or after October 1,
1995, unless it displays a currently valid
OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the NIH has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
Proposed Collection Title: The
National Institute of Mental Health Data
Archive (NDA), NIMH, 0925–0667,
expiration date 6/30/2026, REVISION,
National Institute of Mental Health
(NIMH), National Institutes of Health
(NIH).

Need and Use of Information
Collection: The NIMH Data Archive
(NDA) is an infrastructure that allows
for the submission and storage of human
subjects’ data from researchers
conducting studies related to many
scientific domains, regardless of the
source of funding. The NIH and the
NIMH seek to encourage use of the NDA
by investigators in the field of multiple
scientific research domains to achieve
rapid scientific progress. In order to
manage access to this data system,
NIMH collects information from two
categories of NDA users: (1)
Investigators who seek permission to
access data from the NDA for the
purpose of scientific investigation,
scholarship or teaching, or other forms
of research and research development,
via the Data Use Certification (DUC),
and (2) investigators who request
permission to submit data to the NDA
for the purpose of scientific
investigation, scholarship or teaching,
or other forms of research and research
development, via the Data Submission
Agreement (DSA).
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
1,875.

ESTIMATED ANNUALIZED BURDEN HOURS
Average time
per response
(in hours)

Total burden
hours

1

90/60

450

950

1

90/60

1,425

........................

1,250

........................

1,875

Form name

Type of
respondents

NDA Data Submission Agreement
(DSA).
NDA Data Use Certification (DUC) ...

Researchers submitting data ...........

300

Researchers requesting access to
data.

Total ...........................................

...........................................................

Dated: May 29, 2026.
Andrew A. Hooper,
Project Clearance Liaison, National Institute
of Mental Health, National Institutes of
Health.

Number of
respondents

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[CBP Dec. 26–10]

[FR Doc. 2026–11045 Filed 6–2–26; 8:45 am]

Tuna Tariff-Rate Quota for Calendar
Year 2026 for Tuna Classifiable Under
Subheading 1604.14.22, Harmonized
Tariff Schedule of the United States
(HTSUS)

BILLING CODE 4140–01–P

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AGENCY: U.S. Customs and Border

Protection, Department of Homeland
Security.
ACTION: Announcement of the quota
quantity for tuna in airtight containers
for Calendar Year 2026.
SUMMARY: Each year, the tariff-rate quota

for tuna described in subheading
1604.14.22, Harmonized Tariff Schedule

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Number of
projects per
respondent

of the United States (HTSUS), is
calculated as a percentage of the tuna in
airtight containers entered, or
withdrawn from warehouse, for
consumption during the preceding
calendar year. This document sets forth
the tariff-rate quota for Calendar Year
2026.
DATES: The 2026 tariff-rate quota is

applicable to tuna in airtight containers
entered, or withdrawn from warehouse,
for consumption during the period
January 1, 2026 through December 31,
2026.
FOR FURTHER INFORMATION CONTACT: Julia

Peterson, Chief, Quota and Agricultural
Branch, Textiles and Trade Agreement
Division, Trade Programs, Office of
Trade, U.S. Customs and Border
Protection, Washington, DC 20229–

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