[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12474-12476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04344]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0104]


PolyMedica Industries Inc., et al.; Proposal To Withdraw Approval 
of Three New Drug Applications; Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 three new drug applications (NDAs) and is announcing an opportunity 
for the NDA holders to request a hearing on this proposal. The basis 
for the proposal is that the NDA holders have repeatedly failed to file 
required annual reports for those NDAs.

DATES: The NDA holders may submit a request for a hearing by April 2, 
2021. Submit all data, information, and analyses upon which the request 
for a hearing relies by May 3, 2021. Submit electronic or written 
comments by May 3, 2021.

ADDRESSES: The request for a hearing may be submitted by the NDA 
holders by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments to submit your request 
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a 
hearing, will be posted to the docket unchanged.

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     Because your request for a hearing will be made public, 
you are solely responsible for ensuring that your request does not 
include any confidential information that you or a third party may not 
wish to be posted, such as medical information, your or anyone else's 
Social Security number, or confidential business information, such as a 
manufacturing process. The request for a hearing must include the 
Docket No. FDA-2021-N-0104 for ``PolyMedica Industries Inc. et al.; 
Proposal to Withdraw Approval of Three New Drug Applications; 
Opportunity for a Hearing.'' The request for a hearing will be placed 
in the docket and publicly viewable at https://www.regulations.gov or 
at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday 
through Friday, 240-402-7500.
    The NDA holders may submit all data and analyses upon which the 
request for a hearing relies in the same manner as the request for a 
hearing except as follows:
     Confidential Submissions--To submit any data analyses with 
confidential information that you do not wish to be made publicly 
available, submit your data and analyses only as a written/paper 
submission. You should submit two copies total of all data and 
analyses. One copy will include the information you claim to be 
confidential with a heading or cover note that states ``THIS DOCUMENT 
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, 
including the claimed confidential information, in its consideration of 
any decisions on this matter. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov 
or available at the Dockets Management Staff between 9 a.m. and 4 p.m., 
Monday through Friday, 240-402-7500. Submit both copies to the Dockets 
Management Staff. Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law.
    Comments Submitted by Other Interested Parties: For all comments 
submitted by other interested parties, submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://

[[Page 12475]]

www.regulations.gov will be posted to the docket unchanged. Because 
your comment will be made public, you are solely responsible for 
ensuring that your comment does not include any confidential 
information that you or a third party may not wish to be posted, such 
as medical information, your or anyone else's Social Security number, 
or confidential business information, such as a manufacturing process. 
Please note that if you include your name, contact information, or 
other information that identifies you in the body of your comments, 
that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-N-0104 for ``PolyMedica Industries Inc. et al.; Proposal to 
Withdraw Approval of Three New Drug Applications; Opportunity for a 
Hearing.'' Received comments, those filed in a timely manner (see 
DATES), will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, Kimberly.Lehrfeld@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The holder of an approved NDA to market a 
new drug for human use is required to submit annual reports to FDA 
concerning its approved NDA under Sec. Sec.  314.81 and 314.98 (21 CFR 
314.81 and 314.98). The holders of the approved NDAs listed in table 1 
have repeatedly failed to submit the required annual reports and have 
not responded to the Agency's request for submission of the reports.

     Table 1--Approved NDAs for Which Required Reports Have Not Been
                                Submitted
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      Application No.                Drug                NDA holder
------------------------------------------------------------------------
NDA 016401................  NEOPAP                 PolyMedica Industries
                             (acetaminophen)        Inc., 2 Constitution
                             Suppositories, 120     Way, Woburn, MA
                             milligrams (mg).       01801.
NDA 050266................  ACHROMYCIN             Storz Ophthalmics
                             (tetracycline          Inc. (subsidiary of
                             hydrochloride (HCl))   American Cyanamid
                             Ophthalmic Ointment,   Co.), 401 North
                             10 mg/gram.            Middletown Rd.,
                                                    Pearl River, NY
                                                    10965.
NDA 050268................  ACHROMYCIN             Do.
                             (tetracycline HCl)
                             Ophthalmic
                             Suspension, 1%.
------------------------------------------------------------------------

    Therefore, notice is given to the holders of the approved NDAs 
listed in table 1 and to all other interested persons that the Director 
of CDER proposes to issue an order, under section 505(e) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)), withdrawing 
approval of the NDAs and all amendments and supplements thereto on the 
grounds that the NDA holders have failed to submit reports required 
under Sec.  314.81.
    In accordance with section 505 of the FD&C Act and 21 CFR part 314, 
the NDA holders are hereby provided an opportunity for a hearing to 
show why the approval of the NDAs listed previously should not be 
withdrawn and an opportunity to raise, for administrative 
determination, all issues relating to the legal status of the drug 
products covered by these NDAs.
    An NDA holder who decides to seek a hearing must file the 
following: (1) A written notice of participation and request for a 
hearing (see DATES and ADDRESSES) and (2) the data, information, and 
analyses relied on to demonstrate that there is a genuine and 
substantial issue of fact that requires a hearing (see DATES and 
ADDRESSES). Any other interested person may also submit comments on 
this notice. The procedures and requirements governing this notice of 
opportunity for a hearing, notice of participation and request for a 
hearing, the information and analyses to justify a hearing, other 
comments, and a grant or denial of a hearing are contained in Sec.  
314.200 (21 CFR 314.200) and in 21 CFR part 12.
    The failure of an NDA holder to file a timely written notice of 
participation and request for a hearing, as required by Sec.  314.200, 
constitutes an election by that

[[Page 12476]]

NDA holder not to avail itself of the opportunity for a hearing 
concerning CDER's proposal to withdraw approval of the NDAs and 
constitutes a waiver of any contentions concerning the legal status of 
the drug products. FDA will then withdraw approval of the NDAs, and the 
drug products may not thereafter be lawfully introduced or delivered 
for introduction into interstate commerce. Any new drug product 
introduced or delivered for introduction into interstate commerce 
without an approved NDA is subject to regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or 
denials but must present specific facts showing that there is a genuine 
and substantial issue of fact that requires a hearing. If a request for 
a hearing is not complete or is not supported, the Commissioner of Food 
and Drugs will enter summary judgment against the person who requests 
the hearing, making findings and conclusions, and denying a hearing.
    All paper submissions under this notice of opportunity for a 
hearing must be filed in two copies. Except for data and information 
prohibited from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 
1905, the submissions may be seen at the Dockets Management Staff (see 
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, and will 
be posted to the docket at https://www.regulations.gov.
    This notice is issued under section 505(e) of the FD&C Act and 
under authority delegated to the Director of CDER by the Commissioner 
of Food and Drugs.

    Dated: February 25, 2021.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 2021-04344 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P


