[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]]
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 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