Aurolife Pharma LLC, et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications, 68502-68503 [2021-26170]
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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
records regarding clinical investigators,
including protocol agreements and
investigator resumes or curriculum
vitae. FDA estimates than an average of
15 minutes will be required for each
recordkeeper to add this record to the
clinical investigators’ file.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours 2
Recordkeeping—54.6 ..........................................................
715
1
715
0.25
179
1 There
2
are no capital costs or operating and maintenance costs associated with this collection of information.
Numbers have been rounded.
Third-Party Disclosure Burden
Under § 54.4(b), clinical investigators
supply to the sponsor of a covered study
financial information sufficient to allow
the sponsor to submit complete and
accurate certification or disclosure
statements. Clinical investigators are
accustomed to supplying such
information when applying for research
grants. Also, most people know the
financial holdings of their immediate
family and records of such interests are
generally accessible because they are
needed for preparing tax records. For
these reasons, FDA estimates that the
time required for this task may range
from 5 to 15 minutes; we used the
median, 10 minutes, for the average
burden per disclosure (see table 1).
TABLE 4—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
21 CFR section
Number of
respondents
Number of
disclosures per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours 2
54.4(b)—Clinical Investigators ...........................................
13,082
1
13,082
0.17
2,224
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
The burden for this information
collection request has changed since the
last OMB approval. Our estimated
burden for the information collection
reflects a 298 hour increase. We have
adjusted our estimated burden for the
information collection to reflect the
number of submissions we received in
the last few years. Additionally, for
products regulated by the Center for
Devices and Radiological Health, we
now include De Novo requests as a type
of application that may rely on clinical
studies. For products regulated by the
Center for Drug Evaluation and
Research, we now include biologics
license applications (BLAs) and BLA
efficacy supplements that were
inadvertently excluded from our last
information collection request as a type
of application.
Food and Drug Administration
[Docket No. FDA–2021–N–1145]
Aurolife Pharma LLC, et al.;
Withdrawal of Approval of Five
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Dated: November 24, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of five
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.
[FR Doc. 2021–26182 Filed 12–1–21; 8:45 am]
DATES:
BILLING CODE 4164–01–P
lotter on DSK11XQN23PROD with NOTICES1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process
described 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.
SUPPLEMENTARY INFORMATION:
Approval is withdrawn as of
January 3, 2022.
Application No.
Drug
Applicant
ANDA 072514 ....
Clorazepate Dipotassium Tablets, 3.75 milligrams (mg), 7.5
mg, and 15 mg.
Ondansetron Hydrochloride Injection, Equivalent to (EQ) 2
mg base/milliliters (mL).
Fluconazole in Dextrose 5% Injection, 200 mg/100 mL (2 mg/
mL) and 400 mg/200 mL (2 mg/mL).
Aurolife Pharma LLC, 2400 U.S. Hwy. 130 N, Dayton, NJ
08810.
Hospira, Inc., 275 N Field Dr., Bldg. H1, Lake Forest, IL
60045.
Woodward Pharma Services LLC, 47220 Cartier Dr., Wixom,
MI 48393.
ANDA 077840 ....
ANDA 077988 ....
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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
Application No.
Drug
ANDA 203265 ....
Lidocaine Patch, 5% ................................................................
ANDA 203967 ....
Escitalopram Oxalate Solution, EQ 5 mg base/5 mL ..............
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 3,
2022. 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 3, 2022
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: November 23, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26170 Filed 12–1–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0530]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Tropical Disease
Priority Review Vouchers
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on Tropical Disease
Priority Review Vouchers.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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Applicant
Noven Pharmaceuticals, Inc., 11960 SW 144th St., Miami,
FL 33186.
Antrim Pharmaceuticals LLC, 655 W Northcroft Ct., Lake
Forest, IL 60045.
Submit either electronic or
written comments on the collection of
information by January 31, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 31,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 31, 2022.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
PO 00000
68503
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Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2008–D–0530 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Tropical
Disease Priority Review Vouchers.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
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]]>Agencies
[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Pages 68502-68503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26170]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1145]
Aurolife Pharma LLC, et al.; Withdrawal of Approval of Five
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of five 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.
DATES: Approval is withdrawn as of January 3, 2022.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec. 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 Sec. 314.150(c) is without prejudice to refiling.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 072514............ Clorazepate Dipotassium Aurolife Pharma LLC,
Tablets, 3.75 2400 U.S. Hwy. 130 N,
milligrams (mg), 7.5 Dayton, NJ 08810.
mg, and 15 mg.
ANDA 077840............ Ondansetron Hospira, Inc., 275 N
Hydrochloride Field Dr., Bldg. H1,
Injection, Equivalent Lake Forest, IL
to (EQ) 2 mg base/ 60045.
milliliters (mL).
ANDA 077988............ Fluconazole in Dextrose Woodward Pharma
5% Injection, 200 mg/ Services LLC, 47220
100 mL (2 mg/mL) and Cartier Dr., Wixom,
400 mg/200 mL (2 mg/ MI 48393.
mL).
[[Page 68503]]
ANDA 203265............ Lidocaine Patch, 5%.... Noven Pharmaceuticals,
Inc., 11960 SW 144th
St., Miami, FL 33186.
ANDA 203967............ Escitalopram Oxalate Antrim Pharmaceuticals
Solution, EQ 5 mg base/ LLC, 655 W Northcroft
5 mL. Ct., Lake Forest, IL
60045.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 3, 2022. 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 3, 2022 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: November 23, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26170 Filed 12-1-21; 8:45 am]
BILLING CODE 4164-01-P
