Document ID: FDA-2019-N-5405-0001
Agency: fda
Document Type: Notice
Title: Alaco, Inc., et al.; Proposal To Withdraw Approval of Seven New Animal Drug Applications; Opportunity for a Hearing
Posted Date: 2020-01-08T05:00Z

[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 919-921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00072]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5405]

Alaco, Inc., et al.; Proposal To Withdraw Approval of Seven New 
Animal 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 
Veterinary Medicine (CVM) is proposing to withdraw approval of seven 
new animal drug applications (NADAs) and is announcing an opportunity 
for the NADA holders to request a hearing on this proposal. The basis 
for the proposal is that the NADA holders have repeatedly failed to 
file required annual reports for those NADAs.

DATES: The NADA holders may submit a request for a hearing by February 
7, 2020. Submit all data, information, and analyses upon which the 
request for a hearing relies March 9, 2020. Submit electronic or 
written comments by March 9, 2020.

ADDRESSES: The request for a hearing may be submitted by the NADA 
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-2019-N-5405 for ``Alaco, Inc., et al.; Proposal to 
Withdraw Approval of Seven New Animal 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.
    The NADA 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. 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

[[Page 920]]

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-2019-N-5405 for ``Alaco, Inc., et al.; Proposal to Withdraw 
Approval of Seven New Animal 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.
     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.

FOR FURTHER INFORMATION CONTACT: Vernon Toelle, Center for Veterinary 
Medicine (HFV-234), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-5637.

SUPPLEMENTARY INFORMATION: The FDA's CVM is proposing to withdraw 
approval of seven new animal drug applications (NADAs) and is 
announcing an opportunity for the NADA sponsors to request a hearing on 
this proposal. The new animal drugs approved in these NADAs have not 
been marketed for several years. The establishments associated with 
these drug products are not registered under 21 CFR 207.21 nor are 
these drug products listed under 21 CFR 207.45. The basis for this 
proposal is that these NADA sponsors have repeatedly failed to submit 
annual drug experience reports to FDA concerning their approved NADA as 
required under Sec.  514.80 (21 CFR 514.80). These sponsors have not 
responded to the Agency's requests, sent by certified mail, for 
submission of the reports. The delinquent approved NADAs and their 
sponsors are listed in table 1.

                   Table 1--Approved NADAs for Which Required Reports Have Not Been Submitted
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                                                                                                  Citation in 21
           Application No.                   Trade name (drug)                 Sponsor                  CFR
----------------------------------------------------------------------------------------------------------------
031-971..............................  CUPRATE (cupric glycinate)..  Walco International, Inc.,          522.518
                                                                      15 West Putnam,
                                                                      Porterville, CA 93257.
045-863..............................  PALOSEIN (orgotein).........  OXIS International, Inc.,          522.1620
                                                                      6040 N Cutter Circle,
                                                                      Suite 317, Portland, OR
                                                                      97217-3935.
046-922..............................  SERGEANTS SURE SHOT (n-butyl  ConAgra Pet Products Co.,           520.260
                                        chloride) Capsules.           3902 Leavenworth St.,
                                                                      Omaha, NE 68105.
046-923..............................  SERGEANTS (n-butyl chloride)  ConAgra Pet Products Co.,           520.260
                                        Puppy Worm Capsules.          3902 Leavenworth St.,
                                                                      Omaha, NE 68105.
065-067..............................  Tetracycline HCl Tablets....  Premo Pharmaceutical           Not codified
                                                                      Laboratories, Inc., 111
                                                                      Leuning St., South
                                                                      Hackensack, NJ 07606.
140-850..............................  ELITE (dichlorophene and      RSR Laboratories, Inc., 501         520.580
                                        toluene) Dog & Cat Wormer.    Fifth St., Bristol, TN
                                                                      37620.
141-107..............................  BAPTEN for Injection          Alaco, Inc., 1500 N Wilmot           522.84
                                        ([szlig]-aminopropionitrile   Rd., Suite 290-C, Tucson,
                                        fumarate).                    AZ 85712.
----------------------------------------------------------------------------------------------------------------

    Therefore, notice is given to the holders of the approved NADAs 
listed in table 1 and to all other interested persons that the Director 
of CVM proposes to issue an order, under section 512(e) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(e)), 
withdrawing approval of the NADAs and all amendments and supplements 
thereto on the grounds that the NADA holders have failed to submit the 
reports required under Sec.  514.80. Upon withdrawal of approval of 
these NADAs, the regulations published pursuant to section 512(i) of 
the FD&C Act in 21 CFR 510.600, 520.260, 520.580, 522.84, 522.518, and 
522.1620 will be revoked.
    In accordance with section 512 of the FD&C Act and parts 12 and 514 
(21 CFR parts 12 and 514), the NADA holders are hereby provided an 
opportunity for a hearing to show why the approval of the NADAs listed 
previously should not be withdrawn (and the corresponding regulations 
revoked) and an opportunity to raise, for administrative determination, 
all issues relating to the legal status of the new animal drug products 
covered by these NADAs.
    An NADA holder who decides to seek a hearing must file the 
following: (1) A written notice of participation and a request for a 
hearing (see DATES and ADDRESSES) and (2) the data, information, and 
analyses relied on to justify 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

[[Page 921]]

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.  514.200 (21 CFR 514.200) and in part 12.
    The failure of an NADA holder to file a timely written notice of 
participation and request for a hearing, as required by Sec.  514.200 
and part 12, constitutes an election by that NADA holder not to avail 
itself of the opportunity for a hearing concerning CVM's proposal to 
withdraw approval of the NADAs and constitutes a waiver of any 
contentions concerning the legal status of the drug products. FDA will 
then withdraw approval of the NADAs, and the new animal drug products 
may not thereafter be lawfully introduced or delivered for introduction 
into interstate commerce. Any new animal drug product introduced or 
delivered for introduction into interstate commerce without an approved 
NADA, conditional approval, or index listing 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. Reports 
submitted to remedy the deficiencies must be complete in all respects 
in accordance with Sec.  514.80. 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 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 512 of the FD&C Act and under 
authority delegated to the Principal Associate Commissioner for Policy 
by the Commissioner of Food and Drugs.

    Dated: January 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00072 Filed 1-7-20; 8:45 am]
 BILLING CODE 4164-01-P