PolyMedica Industries Inc., et al.; Proposal To Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing, 12474-12476 [2021-04344]
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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
action. Mr. Gurry received the proposal
on September 22, 2020. He did not
request a hearing within the timeframe
prescribed by regulation and has,
therefore, waived his opportunity for a
hearing and any contentions concerning
his debarment (21 CFR part 12).
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II. Findings and Order
17:29 Mar 02, 2021
Dated: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04374 Filed 3–2–21; 8:45 am]
BILLING CODE 4164–01–P
Therefore, the Assistant
Commissioner, Office of Human and
Animal Food Operations, under section
306(a)(2)(B) of the FD&C Act, under
authority delegated to the Assistant
Commissioner, finds that Mr. Gurry has
been convicted of a felony under
Federal law for conduct otherwise
relating to the regulation of a drug
product under the FD&C Act.
As a result of the foregoing finding,
Mr. Gurry is permanently debarred from
providing services in any capacity to a
person with an approved or pending
drug product application, effective (see
DATES) (see sections 306(a)(2)(B) and
(c)(2)(A)(ii) of the FD&C Act). Any
person with an approved or pending
drug product application who
knowingly employs or retains as a
consultant or contractor, or otherwise
uses the services of Mr. Gurry in any
capacity during his debarment, will be
subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6))). If Mr. Gurry provides
services in any capacity to a person with
an approved or pending drug product
application during his period of
debarment, he will be subject to civil
money penalties (section 307(a)(7) of the
FD&C Act). In addition, FDA will not
accept or review any abbreviated new
drug application from Mr. Gurry during
his period of debarment, other than in
connection with an audit under section
306 of the FD&C Act (section
306(c)(1)(B) of the FD&C Act). Note that,
for purposes of section 306 of the FD&C
Act, a ‘‘drug product’’ is defined as a
drug subject to regulation under section
505, 512, or 802 of the FD&C Act (21
U.S.C. 355, 360b, or 382) or under
section 351 of the Public Health Service
Act (42 U.S.C. 262) (section 201(dd) of
the FD&C Act (21 U.S.C. 321(dd))).
Any application by Mr. Gurry for
special termination of debarment under
section 306(d)(4) of the FD&C Act
should be identified with Docket No.
FDA–2020–N–1413 and sent to the
Dockets Management Staff (see
ADDRESSES). The public availability of
information in these submissions is
governed by 21 CFR 10.20.
Publicly available submissions will be
placed in the docket and will be
viewable at https://www.regulations.gov
or at the Dockets Management Staff (see
VerDate Sep<11>2014
ADDRESSES) between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Jkt 253001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0104]
PolyMedica Industries Inc., et al.;
Proposal To Withdraw Approval of
Three New Drug Applications;
Opportunity for a Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is proposing to withdraw
approval of three new drug applications
(NDAs) and is announcing an
opportunity for the NDA holders to
request a hearing on this proposal. The
basis for the proposal is that the NDA
holders have repeatedly failed to file
required annual reports for those NDAs.
DATES: The NDA holders may submit a
request for a hearing by April 2, 2021.
Submit all data, information, and
analyses upon which the request for a
hearing relies by May 3, 2021. Submit
electronic or written comments by May
3, 2021.
ADDRESSES: The request for a hearing
may be submitted by the NDA holders
by either of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments to
submit your request for a hearing.
Comments submitted electronically to
https://www.regulations.gov, including
any attachments to the request for a
hearing, will be posted to the docket
unchanged.
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.
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
• Because your request for a hearing
will be made public, you are solely
responsible for ensuring that your
request 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. The request
for a hearing must include the Docket
No. FDA–2021–N–0104 for
‘‘PolyMedica Industries Inc. et al.;
Proposal to Withdraw Approval of
Three New Drug Applications;
Opportunity for a Hearing.’’ The request
for a hearing will be placed in the
docket and 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.
The NDA holders may submit all data
and analyses upon which the request for
a hearing relies in the same manner as
the request for a hearing except as
follows:
• Confidential Submissions—To
submit any data analyses with
confidential information that you do not
wish to be made publicly available,
submit your data and analyses only as
a written/paper submission. You should
submit two copies total of all data and
analyses. 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 any decisions on
this matter. 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
or available at the Dockets Management
Staff between 9 a.m. and 4 p.m.,
Monday through Friday, 240–402–7500.
Submit both copies to the Dockets
Management Staff. Any information
marked as ‘‘confidential’’ will not be
disclosed except in accordance with 21
CFR 10.20 and other applicable
disclosure law.
Comments Submitted by Other
Interested Parties: For all comments
submitted by other interested parties,
submit comments as follows:
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://
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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
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
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–
2021–N–0104 for ‘‘PolyMedica
Industries Inc. et al.; Proposal to
Withdraw Approval of Three New Drug
Applications; Opportunity for a
Hearing.’’ Received comments, those
filed in a timely manner (see DATES),
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
12475
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
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
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.
The
holder of an approved NDA to market a
new drug for human use is required to
submit annual reports to FDA
concerning its approved NDA under
§§ 314.81 and 314.98 (21 CFR 314.81
and 314.98). The holders of the
approved NDAs listed in table 1 have
repeatedly failed to submit the required
annual reports and have not responded
to the Agency’s request for submission
of the reports.
SUPPLEMENTARY INFORMATION:
TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED
Application No.
Drug
NDA holder
NDA 016401 ............
NEOPAP (acetaminophen) Suppositories, 120 milligrams
(mg).
ACHROMYCIN (tetracycline hydrochloride (HCl)) Ophthalmic Ointment, 10 mg/gram.
ACHROMYCIN (tetracycline HCl) Ophthalmic Suspension,
1%.
PolyMedica Industries Inc., 2 Constitution Way, Woburn,
MA 01801.
Storz Ophthalmics Inc. (subsidiary of American Cyanamid
Co.), 401 North Middletown Rd., Pearl River, NY 10965.
Do.
NDA 050266 ............
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NDA 050268 ............
Therefore, notice is given to the
holders of the approved NDAs listed in
table 1 and to all other interested
persons that the Director of CDER
proposes to issue an order, under
section 505(e) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(e)), withdrawing approval of the
NDAs and all amendments and
supplements thereto on the grounds that
the NDA holders have failed to submit
reports required under § 314.81.
In accordance with section 505 of the
FD&C Act and 21 CFR part 314, the
NDA holders are hereby provided an
VerDate Sep<11>2014
17:29 Mar 02, 2021
Jkt 253001
opportunity for a hearing to show why
the approval of the NDAs listed
previously should not be withdrawn
and an opportunity to raise, for
administrative determination, all issues
relating to the legal status of the drug
products covered by these NDAs.
An NDA holder who decides to seek
a hearing must file the following: (1) A
written notice of participation and
request for a hearing (see DATES and
ADDRESSES) and (2) the data,
information, and analyses relied on to
demonstrate that there is a genuine and
substantial issue of fact that requires a
PO 00000
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Fmt 4703
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hearing (see DATES and ADDRESSES). Any
other interested person may also submit
comments on this notice. The
procedures and requirements governing
this notice of opportunity for a hearing,
notice of participation and request for a
hearing, the information and analyses to
justify a hearing, other comments, and
a grant or denial of a hearing are
contained in § 314.200 (21 CFR 314.200)
and in 21 CFR part 12.
The failure of an NDA holder to file
a timely written notice of participation
and request for a hearing, as required by
§ 314.200, constitutes an election by that
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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
NDA holder not to avail itself of the
opportunity for a hearing concerning
CDER’s proposal to withdraw approval
of the NDAs and constitutes a waiver of
any contentions concerning the legal
status of the drug products. FDA will
then withdraw approval of the NDAs,
and the drug products may not
thereafter be lawfully introduced or
delivered for introduction into interstate
commerce. Any new drug product
introduced or delivered for introduction
into interstate commerce without an
approved NDA is subject to regulatory
action at any time.
A request for a hearing may not rest
upon mere allegations or denials but
must present specific facts showing that
there is a genuine and substantial issue
of fact that requires a hearing. If a
request for a hearing is not complete or
is not supported, the Commissioner of
Food and Drugs will enter summary
judgment against the person who
requests the hearing, making findings
and conclusions, and denying a hearing.
All paper submissions under this
notice of opportunity for a hearing must
be filed in two copies. Except for data
and information prohibited from public
disclosure under 21 U.S.C. 331(j) or 18
U.S.C. 1905, the submissions may be
seen at the Dockets Management Staff
(see ADDRESSES) between 9 a.m. and 4
p.m., Monday through Friday, and will
be posted to the docket at https://
www.regulations.gov.
This notice is issued under section
505(e) of the FD&C Act and under
authority delegated to the Director of
CDER by the Commissioner of Food and
Drugs.
Dated: February 25, 2021.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation
and Research.
[FR Doc. 2021–04344 Filed 3–2–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
jbell on DSKJLSW7X2PROD with NOTICES
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
054
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing a publication containing
SUMMARY:
VerDate Sep<11>2014
17:29 Mar 02, 2021
Jkt 253001
modifications the Agency is making to
the list of standards FDA recognizes for
use in premarket reviews (FDA
Recognized Consensus Standards). This
publication, entitled ‘‘Modifications to
the List of Recognized Standards,
Recognition List Number: 054’’
(Recognition List Number: 054), will
assist manufacturers who elect to
declare conformity with consensus
standards to meet certain requirements
for medical devices.
DATES: Submit either electronic or
written comments on the notice at any
time. These modifications to the list of
recognized standards are applicable
March 3, 2021.
ADDRESSES: You may submit comments
on the current list of FDA Recognized
Consensus Standards at any time as
follows:
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
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.’’
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
Instructions: All submissions received
must include the Docket No. FDA–
2004–N–0451 for ‘‘Food and Drug
Administration Modernization Act of
1997: Modifications to the List of
Recognized Standards, Recognition List
Number: 054.’’ Received comments 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. FDA will
consider any comments received in
determining whether to amend the
current listing of modifications to the
list of recognized standards, Recognition
List Number: 054.
• 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
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
An electronic copy of Recognition List
Number: 054 is available on the internet
at https://www.fda.gov/MedicalDevices/
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]]>Agencies
[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12474-12476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04344]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0104]
PolyMedica Industries Inc., et al.; Proposal To Withdraw Approval
of Three New Drug Applications; Opportunity for a Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for
Drug Evaluation and Research (CDER) is proposing to withdraw approval
of three new drug applications (NDAs) and is announcing an opportunity
for the NDA holders to request a hearing on this proposal. The basis
for the proposal is that the NDA holders have repeatedly failed to file
required annual reports for those NDAs.
DATES: The NDA holders may submit a request for a hearing by April 2,
2021. Submit all data, information, and analyses upon which the request
for a hearing relies by May 3, 2021. Submit electronic or written
comments by May 3, 2021.
ADDRESSES: The request for a hearing may be submitted by the NDA
holders by either of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments to submit your request
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a
hearing, will be posted to the docket unchanged.
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.
Because your request for a hearing will be made public,
you are solely responsible for ensuring that your request 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. The request for a hearing must include the
Docket No. FDA-2021-N-0104 for ``PolyMedica Industries Inc. et al.;
Proposal to Withdraw Approval of Three New Drug Applications;
Opportunity for a Hearing.'' The request for a hearing will be placed
in the docket and 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.
The NDA holders may submit all data and analyses upon which the
request for a hearing relies in the same manner as the request for a
hearing except as follows:
Confidential Submissions--To submit any data analyses with
confidential information that you do not wish to be made publicly
available, submit your data and analyses only as a written/paper
submission. You should submit two copies total of all data and
analyses. 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
any decisions on this matter. 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
or available at the Dockets Management Staff between 9 a.m. and 4 p.m.,
Monday through Friday, 240-402-7500. Submit both copies to the Dockets
Management Staff. Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law.
Comments Submitted by Other Interested Parties: For all comments
submitted by other interested parties, submit comments as follows:
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://
[[Page 12475]]
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 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-2021-N-0104 for ``PolyMedica Industries Inc. et al.; Proposal to
Withdraw Approval of Three New Drug Applications; Opportunity for a
Hearing.'' Received comments, those filed in a timely manner (see
DATES), 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-2015-09-18/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 docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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, [email protected].
SUPPLEMENTARY INFORMATION: The holder of an approved NDA to market a
new drug for human use is required to submit annual reports to FDA
concerning its approved NDA under Sec. Sec. 314.81 and 314.98 (21 CFR
314.81 and 314.98). The holders of the approved NDAs listed in table 1
have repeatedly failed to submit the required annual reports and have
not responded to the Agency's request for submission of the reports.
Table 1--Approved NDAs for Which Required Reports Have Not Been
Submitted
------------------------------------------------------------------------
Application No. Drug NDA holder
------------------------------------------------------------------------
NDA 016401................ NEOPAP PolyMedica Industries
(acetaminophen) Inc., 2 Constitution
Suppositories, 120 Way, Woburn, MA
milligrams (mg). 01801.
NDA 050266................ ACHROMYCIN Storz Ophthalmics
(tetracycline Inc. (subsidiary of
hydrochloride (HCl)) American Cyanamid
Ophthalmic Ointment, Co.), 401 North
10 mg/gram. Middletown Rd.,
Pearl River, NY
10965.
NDA 050268................ ACHROMYCIN Do.
(tetracycline HCl)
Ophthalmic
Suspension, 1%.
------------------------------------------------------------------------
Therefore, notice is given to the holders of the approved NDAs
listed in table 1 and to all other interested persons that the Director
of CDER proposes to issue an order, under section 505(e) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)), withdrawing
approval of the NDAs and all amendments and supplements thereto on the
grounds that the NDA holders have failed to submit reports required
under Sec. 314.81.
In accordance with section 505 of the FD&C Act and 21 CFR part 314,
the NDA holders are hereby provided an opportunity for a hearing to
show why the approval of the NDAs listed previously should not be
withdrawn and an opportunity to raise, for administrative
determination, all issues relating to the legal status of the drug
products covered by these NDAs.
An NDA holder who decides to seek a hearing must file the
following: (1) A written notice of participation and request for a
hearing (see DATES and ADDRESSES) and (2) the data, information, and
analyses relied on to demonstrate that there is a genuine and
substantial issue of fact that requires a hearing (see DATES and
ADDRESSES). Any other interested person may also submit comments on
this notice. The procedures and requirements governing this notice of
opportunity for a hearing, notice of participation and request for a
hearing, the information and analyses to justify a hearing, other
comments, and a grant or denial of a hearing are contained in Sec.
314.200 (21 CFR 314.200) and in 21 CFR part 12.
The failure of an NDA holder to file a timely written notice of
participation and request for a hearing, as required by Sec. 314.200,
constitutes an election by that
[[Page 12476]]
NDA holder not to avail itself of the opportunity for a hearing
concerning CDER's proposal to withdraw approval of the NDAs and
constitutes a waiver of any contentions concerning the legal status of
the drug products. FDA will then withdraw approval of the NDAs, and the
drug products may not thereafter be lawfully introduced or delivered
for introduction into interstate commerce. Any new drug product
introduced or delivered for introduction into interstate commerce
without an approved NDA is subject to regulatory action at any time.
A request for a hearing may not rest upon mere allegations or
denials but must present specific facts showing that there is a genuine
and substantial issue of fact that requires a hearing. If a request for
a hearing is not complete or is not supported, the Commissioner of Food
and Drugs will enter summary judgment against the person who requests
the hearing, making findings and conclusions, and denying a hearing.
All paper submissions under this notice of opportunity for a
hearing must be filed in two copies. Except for data and information
prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C.
1905, the submissions may be seen at the Dockets Management Staff (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, and will
be posted to the docket at https://www.regulations.gov.
This notice is issued under section 505(e) of the FD&C Act and
under authority delegated to the Director of CDER by the Commissioner
of Food and Drugs.
Dated: February 25, 2021.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 2021-04344 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P
