[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]


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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.

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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


