Miles Laboratories Inc.; Proposal To Withdraw Approval of an Abbreviated New Drug Application for Alcohol and Dextrose Injection; 5 Milliliters/100 Milliliters, 5 Grams/100 Milliliters; Opportunity for a Hearing, 64227-64229 [2022-23034]
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Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
64227
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity; 21 CFR citation
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
(in hours)
Total hours
Sponsors and manufacturers submit annual summaries in
accordance with the Right to Try Act (§ 300.200) using
Form FDA 5023 ................................................................
6
1
6
2.5
15
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Consistent with estimates in our Final
Regulatory Impact Analysis for the
associated final rule, we estimate that
six sponsors and manufacturers will
prepare and submit Form FDA 5023 and
assume it takes 2.5 hours to prepare and
submit each summary, which results in
a total of 15 hours annually.
2022. Submit all data, information, and
analyses upon which the request for a
hearing relies by December 23, 2022.
Submit electronic or written comments
by December 23, 2022.
ADDRESSES: The request for a hearing
may be submitted by the ANDA holder
by either of the following methods:
Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
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.
[FR Doc. 2022–23035 Filed 10–21–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2391]
Miles Laboratories Inc.; Proposal To
Withdraw Approval of an Abbreviated
New Drug Application for Alcohol and
Dextrose Injection; 5 Milliliters/100
Milliliters, 5 Grams/100 Milliliters;
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 an abbreviated new drug
application (ANDA) for Alcohol and
Dextrose Injection, 5 milliliters (mL)/
100 mL, 5 grams (g)/100 mL, and is
announcing an opportunity for the
ANDA holder to request a hearing on
this proposal: Miles Laboratories Inc.,
P.O. Box 1986, 4th and Parker St.,
Berkeley, CA 94701, is the last holder of
record. The bases for the proposal are
that the ANDA holder has repeatedly
failed to file required annual reports for
this ANDA and that the Agency has
scientific data and experience to show
that the drug product under this ANDA
is unsafe for use under the conditions of
use for which the product was
approved.
DATES: The ANDA holder may submit a
request for a hearing by November 23,
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SUMMARY:
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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–2022–N–2391 for ‘‘Miles
Laboratories Inc.; Proposal To Withdraw
Approval of an Abbreviated New Drug
Application for Alcohol and Dextrose
Injection, 5 Milliliters/100 Milliliters, 5
Grams/100 Milliliters; 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 ANDA holder may submit all
data and analyses upon which the
request for a hearing relies in the same
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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
§ 10.20 (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://
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
E:\FR\FM\24OCN1.SGM
24OCN1
64228
Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
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–
2022–N–2391 for ‘‘Miles Laboratories
Inc.; Proposal To Withdraw Approval of
an Abbreviated New Drug Application
for Alcohol and Dextrose Injection, 5
Milliliters/100 Milliliters, 5 Grams/100
Milliliters; Opportunity for a Hearing.’’
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
VerDate Sep<11>2014
17:07 Oct 21, 2022
Jkt 259001
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 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:
Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224,
Silver Spring, MD 20993–0002, 301–
796–1546.
SUPPLEMENTARY INFORMATION: On
November 22, 1974, FDA approved
ANDA 083483 for Alcohol and Dextrose
Injection. In a letter dated June 23, 1999,
Bayer Corporation, which had at least
partially acquired Miles Laboratories
Inc., notified FDA that Alcohol and
Dextrose Injection, 5 mL/100 mL, 5
g/100 mL, the subject of ANDA 083483,
was no longer marketed, and FDA
moved the drug product to the
‘‘Discontinued Drug Product List’’
section of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ FDA has not
received information specified in 21
CFR 314.72 to change the ownership of
ANDA 083483, although Miles
Laboratories Inc. does not appear to be
separately manufacturing drug products.
The Agency is therefore identifying
Miles Laboratories Inc. as the ANDA
holder of record in this Federal Register
notice, but in the event that another
entity holds ANDA 083483, the Agency
is also providing notice to that entity.
The holder of an approved ANDA to
market a new drug for human use is
required to submit annual reports to
FDA concerning its approved ANDA
under §§ 314.81 and 314.98 (21 CFR
314.81 and 314.98). Because the holder
of ANDA 083483 for Alcohol and
Dextrose Injection, 5 mL/100 mL, 5
g/100 mL, has repeatedly failed to
submit the required annual reports, FDA
proposes to withdraw approval of
ANDA 083483 under § 314.150(b)(1) (21
CFR 314.150(b)(1)).
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Additionally, under 21 CFR 314.161,
FDA has determined that Alcohol and
Dextrose Injection, 5 mL/100 mL, 5
g/100 mL, approved under ANDA
083483 was withdrawn from sale for
safety and effectiveness reasons (see 86
FR 72606 (December 22, 2021)) (this
determination also applied to other
applications and to the 10 mL/100 mL,
5 g/100 mL strength of Alcohol and
Dextrose Injection approved under NDA
004589). In light of our determination,
FDA proposes to withdraw approval of
ANDA 083483 under § 314.150(a)(2)(i)
because the Agency has scientific data
and experience to show that Alcohol
and Dextrose Injection, 5 mL/100 mL, 5
g/100 mL, is unsafe for use under the
conditions of use for which the product
was approved.
As explained in our Federal Register
notice determining that Alcohol and
Dextrose was withdrawn for safety and
effectiveness reasons, Alcohol and
Dextrose Injection is indicated to
provide increased caloric intake. The
use of Alcohol and Dextrose raises
several safety concerns because there
are many risks associated with the
exposure to alcohol. Today, alcohol is
contraindicated for use in patients with
neurologic disorders, such as seizures,
who have current or past substance
abuse problems or who are pregnant. It
can cause intoxication, respiratory
depression, and disturbances in serum
glucose levels. FDA-approved
alternatives for intravenous calorie
supplementation that do not include
alcohol were approved after these
Alcohol and Dextrose products and are
available today.
Therefore, notice is given to the
ANDA holder and to all other interested
persons that the Director of CDER
proposes to issue an order, under
section 505(e)(2) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 355(e)(2)), withdrawing approval
of ANDA 083483 and all amendments
and supplements thereto on the grounds
that: (1) the ANDA holder has failed to
submit reports required under §§ 314.81
and 314.98 and section 505(k) of the
FD&C Act, and (2) the Agency has
scientific data and experience to show
that Alcohol and Dextrose Injection, 5
mL/100 mL, 5 g/100 mL, is unsafe for
use under the conditions of use for
which the product was approved.
In accordance with section 505(e) of
the FD&C Act and §§ 314.150(a)(2)(i)
and (b)(1) and § 314.200 (21 CFR
314.200), the ANDA holder is hereby
provided an opportunity for a hearing to
show why the approval of ANDA
083483 should not be withdrawn and an
opportunity to raise, for administrative
determination, all issues relating to the
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Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
legal status of the drug product covered
by ANDA 083483.
An ANDA 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 § 314.200 and in 21 CFR
part 12.
The failure of an ANDA holder to file
a timely written notice of participation
and request for a hearing, as required by
§ 314.200, constitutes an election by that
ANDA holder not to avail itself of the
opportunity for a hearing concerning
CDER’s proposal to withdraw approval
of the ANDA and constitutes a waiver
of any contentions concerning the legal
status of the drug product. FDA will
then withdraw approval of the ANDA,
and the drug product 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 ANDA
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
(§ 314.200(g)). 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 (§ 314.200(g)(1)).
All 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.
VerDate Sep<11>2014
17:07 Oct 21, 2022
Jkt 259001
Dated: October 14, 2022.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation
and Research.
[FR Doc. 2022–23034 Filed 10–21–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–2170]
Topical Dermatologic Corticosteroids:
In Vivo Bioequivalence; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Topical
Dermatologic Corticosteroids: In Vivo
Bioequivalence.’’ This draft guidance is
intended to assist applicants who
submit abbreviated new drug
applications (ANDAs) for topical
dermatologic corticosteroid products of
all potency groups (referred to in this
notice as topical corticosteroids). The
draft guidance describes
recommendations for an in vivo
pharmacodynamic approach to
demonstrate the bioequivalence of
topical corticosteroids. When finalized,
this guidance will replace FDA’s 1995
guidance for industry of the same name.
Revising this guidance will provide
clarity for potential ANDA applicants
on the appropriate pilot and pivotal
studies and other recommendations for
pharmacodynamic approach to assess
the bioequivalence of topical
dermatologic corticosteroids. These
recommendations have evolved since
the original guidance was issued in
1995.
SUMMARY:
Submit either electronic or
written comments on the draft guidance
by December 23, 2022 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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://
PO 00000
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64229
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–
2022–D–2170 for ‘‘Topical Dermatologic
Corticosteroids: In Vivo
Bioequivalence.’’ 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.
• 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
E:\FR\FM\24OCN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64227-64229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23034]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2391]
Miles Laboratories Inc.; Proposal To Withdraw Approval of an
Abbreviated New Drug Application for Alcohol and Dextrose Injection; 5
Milliliters/100 Milliliters, 5 Grams/100 Milliliters; 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 an abbreviated new drug application (ANDA) for Alcohol and Dextrose
Injection, 5 milliliters (mL)/100 mL, 5 grams (g)/100 mL, and is
announcing an opportunity for the ANDA holder to request a hearing on
this proposal: Miles Laboratories Inc., P.O. Box 1986, 4th and Parker
St., Berkeley, CA 94701, is the last holder of record. The bases for
the proposal are that the ANDA holder has repeatedly failed to file
required annual reports for this ANDA and that the Agency has
scientific data and experience to show that the drug product under this
ANDA is unsafe for use under the conditions of use for which the
product was approved.
DATES: The ANDA holder may submit a request for a hearing by November
23, 2022. Submit all data, information, and analyses upon which the
request for a hearing relies by December 23, 2022. Submit electronic or
written comments by December 23, 2022.
ADDRESSES: The request for a hearing may be submitted by the ANDA
holder 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-2022-N-2391 for ``Miles Laboratories Inc.; Proposal To
Withdraw Approval of an Abbreviated New Drug Application for Alcohol
and Dextrose Injection, 5 Milliliters/100 Milliliters, 5 Grams/100
Milliliters; 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 ANDA holder 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 Sec. 10.20 (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://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
[[Page 64228]]
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-2022-N-2391 for ``Miles Laboratories Inc.; Proposal To Withdraw
Approval of an Abbreviated New Drug Application for Alcohol and
Dextrose Injection, 5 Milliliters/100 Milliliters, 5 Grams/100
Milliliters; Opportunity for a Hearing.'' 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 Sec. 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: Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-
796-1546.
SUPPLEMENTARY INFORMATION: On November 22, 1974, FDA approved ANDA
083483 for Alcohol and Dextrose Injection. In a letter dated June 23,
1999, Bayer Corporation, which had at least partially acquired Miles
Laboratories Inc., notified FDA that Alcohol and Dextrose Injection, 5
mL/100 mL, 5 g/100 mL, the subject of ANDA 083483, was no longer
marketed, and FDA moved the drug product to the ``Discontinued Drug
Product List'' section of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' FDA has not received information specified in 21 CFR 314.72 to
change the ownership of ANDA 083483, although Miles Laboratories Inc.
does not appear to be separately manufacturing drug products. The
Agency is therefore identifying Miles Laboratories Inc. as the ANDA
holder of record in this Federal Register notice, but in the event that
another entity holds ANDA 083483, the Agency is also providing notice
to that entity.
The holder of an approved ANDA to market a new drug for human use
is required to submit annual reports to FDA concerning its approved
ANDA under Sec. Sec. 314.81 and 314.98 (21 CFR 314.81 and 314.98).
Because the holder of ANDA 083483 for Alcohol and Dextrose Injection, 5
mL/100 mL, 5 g/100 mL, has repeatedly failed to submit the required
annual reports, FDA proposes to withdraw approval of ANDA 083483 under
Sec. 314.150(b)(1) (21 CFR 314.150(b)(1)).
Additionally, under 21 CFR 314.161, FDA has determined that Alcohol
and Dextrose Injection, 5 mL/100 mL, 5 g/100 mL, approved under ANDA
083483 was withdrawn from sale for safety and effectiveness reasons
(see 86 FR 72606 (December 22, 2021)) (this determination also applied
to other applications and to the 10 mL/100 mL, 5 g/100 mL strength of
Alcohol and Dextrose Injection approved under NDA 004589). In light of
our determination, FDA proposes to withdraw approval of ANDA 083483
under Sec. 314.150(a)(2)(i) because the Agency has scientific data and
experience to show that Alcohol and Dextrose Injection, 5 mL/100 mL, 5
g/100 mL, is unsafe for use under the conditions of use for which the
product was approved.
As explained in our Federal Register notice determining that
Alcohol and Dextrose was withdrawn for safety and effectiveness
reasons, Alcohol and Dextrose Injection is indicated to provide
increased caloric intake. The use of Alcohol and Dextrose raises
several safety concerns because there are many risks associated with
the exposure to alcohol. Today, alcohol is contraindicated for use in
patients with neurologic disorders, such as seizures, who have current
or past substance abuse problems or who are pregnant. It can cause
intoxication, respiratory depression, and disturbances in serum glucose
levels. FDA-approved alternatives for intravenous calorie
supplementation that do not include alcohol were approved after these
Alcohol and Dextrose products and are available today.
Therefore, notice is given to the ANDA holder and to all other
interested persons that the Director of CDER proposes to issue an
order, under section 505(e)(2) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 355(e)(2)), withdrawing approval of ANDA
083483 and all amendments and supplements thereto on the grounds that:
(1) the ANDA holder has failed to submit reports required under
Sec. Sec. 314.81 and 314.98 and section 505(k) of the FD&C Act, and
(2) the Agency has scientific data and experience to show that Alcohol
and Dextrose Injection, 5 mL/100 mL, 5 g/100 mL, is unsafe for use
under the conditions of use for which the product was approved.
In accordance with section 505(e) of the FD&C Act and Sec. Sec.
314.150(a)(2)(i) and (b)(1) and Sec. 314.200 (21 CFR 314.200), the
ANDA holder is hereby provided an opportunity for a hearing to show why
the approval of ANDA 083483 should not be withdrawn and an opportunity
to raise, for administrative determination, all issues relating to the
[[Page 64229]]
legal status of the drug product covered by ANDA 083483.
An ANDA 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 and in 21 CFR part 12.
The failure of an ANDA 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 ANDA holder not to avail itself of the
opportunity for a hearing concerning CDER's proposal to withdraw
approval of the ANDA and constitutes a waiver of any contentions
concerning the legal status of the drug product. FDA will then withdraw
approval of the ANDA, and the drug product 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 ANDA 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 (Sec.
314.200(g)). 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 (Sec. 314.200(g)(1)).
All 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: October 14, 2022.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 2022-23034 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P
