Lederle Laboratories et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications; Correction, 31722 [2021-12557]
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Federal Register / Vol. 86, No. 113 / Tuesday, June 15, 2021 / Notices
intended to support the approval of
NADAs, ANADAs, or applications for
conditional approval (for example,
animal drug sponsor, test facility,
developer, vendor, user of electronic
data capture (EDC) and data
visualization software, or study data
quality control (QC) and quality
assurance (QA) specialist).
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0390]
Lederle Laboratories et al.; Withdrawal
of Approval of 12 Abbreviated New
Drug Applications; Correction
khammond on DSKJM1Z7X2PROD with NOTICES
II. Other Issues for Consideration
AGENCY:
CVM seeks to continuously enhance
review efficiency and interactions with
the animal health industry. As part of
our continued effort to engage with the
animal health industry, we are
interested in understanding more about
the experiences and familiarity of those
involved in animal drug development
with the use of data exchange standards.
We specifically request public comment
regarding the questions below. When
submitting comments, it would help us
if commenters would identify their
animal health industry sector (for
example, animal drug sponsor, test
facility, developer, vendor, user of EDC
and data visualization software, or study
data QC and QA specialist). We will
consider the comments as we evaluate
the potential use of study data exchange
standards for animal studies submitted
as part of the new animal drug approval
process.
1. Which study data exchange
standards are you currently using, if
any, for the submission of study data to
CVM; and which tools do you use to
review, analyze, or validate the study
data?
2. If study data exchange standards
are included as part of your study data
management process, when are they
incorporated (for example, in protocol
development, EDC database and case
report form development, post-study
processing)?
3. What are the potential benefits or
anticipated challenges to the animal
health industry of harmonizing CVM’s
data exchange standards expectations
with other FDA Centers’ expectations?
4. What can CVM do to help industry
to be more prepared for, or to reduce the
burden of implementing, the use of
study data exchange standards?
5. What other comments do you have
regarding the use of study data exchange
standards for submission of study data
to CVM?
Dated: June 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12503 Filed 6–14–21; 8:45 am]
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Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register on May 12, 2021. The
document announced the withdrawal of
approval of 12 abbreviated new drug
applications (ANDAs) from multiple
applicants, withdrawn as of June 11,
2021. The document indicated that FDA
was withdrawing the approval of ANDA
060164, Nystatin Ointment, held by
Lederle Laboratories. However, the
document published with an incorrect
application number for this product.
This document corrects that error.
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.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Wednesday, May 12,
2021 (86 FR 26058), appearing on page
26058 in FR Doc. 2021–09980, the
following correction is made:
On page 26058, in the first column, in
the first line in the table, the application
number ‘‘060164’’ is corrected to read
‘‘061064’’.
SUMMARY:
Dated: June 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12557 Filed 6–14–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0493]
Medical Devices; Exemption From
Premarket Notification: Powered
Patient Transport, All Other Powered
Patient Transport
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00030
Fmt 4703
Sfmt 4703
The Food and Drug
Administration (FDA or Agency) is
announcing that it has received a
petition requesting exemption from the
premarket notification requirements for
the generic device type, powered patient
transport, all other powered patient
transport. These devices are motorized
devices used to mitigate mobility
impairment caused by injury or other
disease by moving a person from one
location or level to another, such as up
and down flights of stairs. This device
type does not include motorized threewheeled vehicles or wheelchairs, and is
distinct from the device type, powered
patient transport, powered patient
stairway chair lifts, which is classified
separately within the same regulation.
FDA is publishing this notice to obtain
comments in accordance with
procedures established by the Federal
Food, Drug, and Cosmetic Act (FD&C
Act).
DATES: Submit either electronic or
written comments by August 16, 2021.
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 August 16,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 16, 2021.
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.
SUMMARY:
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
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]]>Agencies
[Federal Register Volume 86, Number 113 (Tuesday, June 15, 2021)]
[Notices]
[Page 31722]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12557]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0390]
Lederle Laboratories et al.; Withdrawal of Approval of 12
Abbreviated New Drug Applications; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register on May 12, 2021. The document
announced the withdrawal of approval of 12 abbreviated new drug
applications (ANDAs) from multiple applicants, withdrawn as of June 11,
2021. The document indicated that FDA was withdrawing the approval of
ANDA 060164, Nystatin Ointment, held by Lederle Laboratories. However,
the document published with an incorrect application number for this
product. This document corrects that error.
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: In the Federal Register of Wednesday, May
12, 2021 (86 FR 26058), appearing on page 26058 in FR Doc. 2021-09980,
the following correction is made:
On page 26058, in the first column, in the first line in the table,
the application number ``060164'' is corrected to read ``061064''.
Dated: June 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12557 Filed 6-14-21; 8:45 am]
BILLING CODE 4164-01-P
