Bristol Myers Products Inc.; Proposal To Withdraw Approval of a New Drug Application for Bufferin (Aspirin) Tablets; Opportunity for a Hearing, 71652-71654 [2022-25516]
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Federal Register / Vol. 87, No. 225 / Wednesday, November 23, 2022 / Notices
identify an attribute of the approved
drug products that the proposed
compounded drug product is intended
to address. FDA finds no basis to
conclude that an attribute of the FDAapproved products makes them
medically unsuitable to treat certain
patients for a condition that FDA has
identified for evaluation and that a
proposed compounded product is
intended to address.
2. Whether the Drug Product Must Be
Compounded from a Bulk Drug
Substance
Because the nominations do not
identify specific differences between
drug products that would be
compounded using rocuronium bromide
and approved drug products containing
rocuronium bromide, there is nothing
for FDA to evaluate under question 2.
lotter on DSK11XQN23PROD with NOTICES1
VI. Conclusion
For the reasons stated above, we
tentatively conclude that there is a
clinical need for outsourcing facilities to
compound drug products using the bulk
drug substances arginine HCl for oral
use only, lysine HCl for oral use only,
and lysine HCl in combination with
FDA-approved single-ingredient
arginine HCl for injection for
intravenous use only. We therefore
propose to include those bulk drug
substances on the 503B Bulks List as
described in this notice.
At this time, we find no basis to
conclude that there is a clinical need for
outsourcing facilities to compound drug
products using the bulk drug substances
etomidate, furosemide, and rocuronium
bromide. Therefore, we propose not to
include these bulk drug substances on
the 503B Bulks List.
VII. References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (see
ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. FDA
has verified the website addresses, as of
the date this document publishes in the
Federal Register, but websites are
subject to change over time.
*1. FDA, Guidance for Industry, ‘‘Interim
Policy on Compounding Using Bulk
VerDate Sep<11>2014
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Jkt 259001
Drug Substances Under Section 503B of
the Federal Food, Drug, and Cosmetic
Act,’’ January 2017 (available at https://
www.fda.gov/media/94402/download).
*2. FDA, Guidance for Industry, ‘‘Evaluation
of Bulk Drug Substances Nominated for
Use in Compounding Under Section
503B of the Federal Food, Drug, and
Cosmetic Act,’’ March 2019 (available at
https://www.fda.gov/media/121315/
download).
*3. FDA Memorandum to File, ‘‘Clinical
Need for Arginine Hydrochloride in
Compounding Under Section 503B of the
FD&C Act,’’ October 2022.
*4. FDA Memorandum to File, ‘‘Clinical
Need for Lysine Hydrochloride in
Compounding Under Section 503B of the
FD&C Act,’’ October 2022.
5. Singh, B.B., J. Udani, S.P, Vinjamury, C,
Der-Martirosian, et al, 2005, ‘‘Safety and
Effectiveness of an L-lysine, Zinc, and
Herbal-Based Product on the Treatment
of Facial and Circumoral Herpes,’’
Alternative Medicine Review, 10: 123–7
*6. FDA Memorandum to File, ‘‘Clinical
Need for Lysine Hydrochloride (HCl)
Alone and in Combination With
Arginine HCl in Compounding Under
Section 503B of the FD&C Act,’’ October
2022.
*7. Letter from SNMMI to FDA dated May 25,
2018, requesting FDA place arginine and
lysine on the 503B Bulks List.
Dated: November 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–25549 Filed 11–22–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2796]
Bristol Myers Products Inc.; Proposal
To Withdraw Approval of a New Drug
Application for Bufferin (Aspirin)
Tablets; 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 a new drug application
(NDA) for Bufferin (aspirin) tablets, for
which Bristol Myers Products Inc., 1350
Liberty Ave., Hillside, NJ 07205 is the
last holder of record, and is announcing
an opportunity for the holder of the
NDA to request a hearing on this
proposal. The basis for the proposal is
that the holder of the NDA has
repeatedly failed to file required annual
reports for this NDA.
SUMMARY:
PO 00000
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The holder of the NDA may
submit a request for a hearing by
December 23, 2022. Submit all data,
information, and analyses upon which
the request for a hearing relies by
January 23, 2023. Submit electronic or
written comments by January 23, 2023.
ADDRESSES: The request for a hearing
may be submitted by the holder of the
NDA by either of the following methods:
DATES:
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–2796 for ‘‘Bristol
Myers Products Inc.; Proposal To
Withdraw Approval of a New Drug
Application for Bufferin (Aspirin)
Tablets; 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. The holder of the NDA 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
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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. 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:
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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.’’
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16:45 Nov 22, 2022
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Instructions: All submissions received
must include the Docket No. FDA–
2022–N–2796 for ‘‘Bristol Myers
Products Inc.; Proposal To Withdraw
Approval of a New Drug Application for
Bufferin (Aspirin) Tablets; 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 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:
Jennifer Forde, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228,
PO 00000
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71653
Silver Spring, MD 20993–0002, 301–
348–3035.
SUPPLEMENTARY INFORMATION: On June
30, 1948, NDA 006499 for Bufferin
(aspirin) tablets became effective. The
holder of NDA 006499 is currently
identified in FDA’s records as Bristol
Myers Products Inc. The Agency has
received conflicting information
regarding the identity of the current
NDA holder. However, to change the
holder of record, information specified
in § 314.72 (21 CFR 314.72) must be
provided to the Agency. Since the time
that the holder of record was identified
as Bristol Myers Products Inc., the
Agency has not received change of
application ownership information that
would satisfy the requirements of
§ 314.72. The Agency therefore is
identifying Bristol Myers Products Inc.
as the NDA holder of record in this
Federal Register notice, but in the event
that another entity holds NDA 006499,
the Agency is also providing notice to
that entity.
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 (21 CFR 314.81). The
holder of NDA 006499 for Bufferin
(aspirin) tablets has repeatedly failed to
submit the required annual reports.
Therefore, notice is given to the
holder of NDA 006499 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 NDA
006499 and all amendments and
supplements thereto on the grounds that
the holder of the NDA has failed to
submit reports required under § 314.81.
In accordance with section 505 of the
FD&C Act and part 314 (21 CFR part
314), the holder of NDA 006499 is
hereby provided an opportunity for a
hearing to show why the approval of
NDA 006499 should not be withdrawn
and an opportunity to raise, for
administrative determination, all issues
relating to the legal status of the drug
product covered by NDA 006499.
Withdrawal of the approval of NDA
006499 will not impact nonprescription
aspirin products that are legally
marketed without an approved
application as over the counter (OTC)
monograph drugs in accordance with
section 505G of the FD&C Act (21 U.S.C
355h), including conforming to
applicable conditions of use specified in
OTC Monograph M013: Internal
Analgesic, Antipyretic, and
Antirheumatic Drug Products for Overthe-Counter Human Use (See OTC
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Federal Register / Vol. 87, No. 225 / Wednesday, November 23, 2022 / Notices
Monographs@FDA web page available at
https://www.accessdata.fda.gov/scripts/
cder/omuf/?event=reqOrders). Based on
information available to the Agency, it
appears that the product covered by
NDA 006499 has not been marketed for
many years and another buffered aspirin
drug product, using the same trade
name ‘‘Bufferin’’ but with a different
formulation, is currently being marketed
as an OTC monograph drug. The
marketing of this current ‘‘Bufferin’’
product is subject to the requirements
for legal marketing of OTC monograph
drugs under section 505G of the FD&C
Act and will be unaffected by
withdrawal of approval of NDA 006499.
To seek a hearing, the NDA holder
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 the NDA holder to file
a timely written notice of participation
and request for a hearing, as required by
§ 314.200, constitutes an election by the
NDA holder not to avail itself of the
opportunity for a hearing concerning
CDER’s proposal to withdraw approval
of the application and constitutes a
waiver of any contentions concerning
the legal status of the drug product. FDA
will then withdraw approval of the
application, 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 application 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.
Paper submissions under this notice
of opportunity for a hearing must be
filed in two copies. Except for data and
information prohibited from public
VerDate Sep<11>2014
16:45 Nov 22, 2022
Jkt 259001
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: November 17, 2022.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation
and Research.
[FR Doc. 2022–25516 Filed 11–22–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–2922]
Compounding Certain Beta-Lactam
Products in Shortage Under Section
503A of the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry entitled
‘‘Compounding Certain Beta-Lactam
Products in Shortage Under Section
503A of the Federal Food, Drug, and
Cosmetic Act.’’ This guidance describes
FDA’s regulatory and enforcement
priorities regarding preparation of betalactam oral antibiotic suspension
products that appear on FDA’s drug
shortage list by a licensed pharmacist in
a State-licensed pharmacy or Federal
facility.
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on November 23, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances 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://
www.regulations.gov will be posted to
PO 00000
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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–2922 for ‘‘Compounding
Certain Beta-Lactam Products in
Shortage Under Section 503A of the
Federal Food, Drug, and Cosmetic Act.’’
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
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]]>Agencies
[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Notices]
[Pages 71652-71654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25516]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-2796]
Bristol Myers Products Inc.; Proposal To Withdraw Approval of a
New Drug Application for Bufferin (Aspirin) Tablets; 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 a new drug application (NDA) for Bufferin (aspirin) tablets, for
which Bristol Myers Products Inc., 1350 Liberty Ave., Hillside, NJ
07205 is the last holder of record, and is announcing an opportunity
for the holder of the NDA to request a hearing on this proposal. The
basis for the proposal is that the holder of the NDA has repeatedly
failed to file required annual reports for this NDA.
DATES: The holder of the NDA may submit a request for a hearing by
December 23, 2022. Submit all data, information, and analyses upon
which the request for a hearing relies by January 23, 2023. Submit
electronic or written comments by January 23, 2023.
ADDRESSES: The request for a hearing may be submitted by the holder of
the NDA 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-2796 for ``Bristol Myers Products Inc.; Proposal
To Withdraw Approval of a New Drug Application for Bufferin (Aspirin)
Tablets; 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. The holder of the NDA 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
[[Page 71653]]
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. 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://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-N-2796 for ``Bristol Myers Products Inc.; Proposal To Withdraw
Approval of a New Drug Application for Bufferin (Aspirin) Tablets;
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 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: Jennifer Forde, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
348-3035.
SUPPLEMENTARY INFORMATION: On June 30, 1948, NDA 006499 for Bufferin
(aspirin) tablets became effective. The holder of NDA 006499 is
currently identified in FDA's records as Bristol Myers Products Inc.
The Agency has received conflicting information regarding the identity
of the current NDA holder. However, to change the holder of record,
information specified in Sec. 314.72 (21 CFR 314.72) must be provided
to the Agency. Since the time that the holder of record was identified
as Bristol Myers Products Inc., the Agency has not received change of
application ownership information that would satisfy the requirements
of Sec. 314.72. The Agency therefore is identifying Bristol Myers
Products Inc. as the NDA holder of record in this Federal Register
notice, but in the event that another entity holds NDA 006499, the
Agency is also providing notice to that entity.
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. 314.81 (21 CFR 314.81). The holder of NDA 006499 for
Bufferin (aspirin) tablets has repeatedly failed to submit the required
annual reports.
Therefore, notice is given to the holder of NDA 006499 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 NDA 006499 and
all amendments and supplements thereto on the grounds that the holder
of the NDA has failed to submit reports required under Sec. 314.81.
In accordance with section 505 of the FD&C Act and part 314 (21 CFR
part 314), the holder of NDA 006499 is hereby provided an opportunity
for a hearing to show why the approval of NDA 006499 should not be
withdrawn and an opportunity to raise, for administrative
determination, all issues relating to the legal status of the drug
product covered by NDA 006499.
Withdrawal of the approval of NDA 006499 will not impact
nonprescription aspirin products that are legally marketed without an
approved application as over the counter (OTC) monograph drugs in
accordance with section 505G of the FD&C Act (21 U.S.C 355h), including
conforming to applicable conditions of use specified in OTC Monograph
M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products
for Over-the-Counter Human Use (See OTC
[[Page 71654]]
[email protected] web page available at https://www.accessdata.fda.gov/scripts/cder/omuf/?event=reqOrders). Based on information available to
the Agency, it appears that the product covered by NDA 006499 has not
been marketed for many years and another buffered aspirin drug product,
using the same trade name ``Bufferin'' but with a different
formulation, is currently being marketed as an OTC monograph drug. The
marketing of this current ``Bufferin'' product is subject to the
requirements for legal marketing of OTC monograph drugs under section
505G of the FD&C Act and will be unaffected by withdrawal of approval
of NDA 006499.
To seek a hearing, the NDA holder 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 the 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 the NDA holder not to avail itself of the
opportunity for a hearing concerning CDER's proposal to withdraw
approval of the application and constitutes a waiver of any contentions
concerning the legal status of the drug product. FDA will then withdraw
approval of the application, 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 application 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.
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: November 17, 2022.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 2022-25516 Filed 11-22-22; 8:45 am]
BILLING CODE 4164-01-P
