New Animal Drug Applications; Beta-Aminopropionitrile Fumarate; n, 10818-10819 [2021-03251]
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10818
Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations
appropriate guidance to CBP personnel
on the continued implementation of the
temporary measures set forth in this
Notification. The CBP Commissioner
may determine that other forms of
travel, such as travel in furtherance of
economic stability or social order,
constitute ‘‘essential travel’’ under this
Notification. Further, the CBP
Commissioner may, on an
individualized basis and for
humanitarian reasons or for other
purposes in the national interest, permit
the processing of travelers to the United
States not engaged in ‘‘essential travel.’’
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Alejandro N. Mayorkas,
Secretary, U.S. Department of Homeland
Security.
HHS.
Food and Drug Administration
21 CFR Parts 510, 520, and 522
[Docket No. FDA–2019–N–5405]
New Animal Drug Applications; BetaAminopropionitrile Fumarate; n-Butyl
Chloride; Cupric Glycinate Injection;
Dichlorophene and Toluene; Orgotein
for Injection; Tetracycline Tablets
AGENCY:
Food and Drug Administration,
Final rule, technical
amendment.
ACTION:
[FR Doc. 2021–03776 Filed 2–19–21; 11:15 am]
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
withdrawal of approval of seven new
animal drug applications (NADAs) for
lack of compliance with the reporting
requirements in an FDA regulation.
SUMMARY:
BILLING CODE 9111–FP–P
This rule is effective February
23, 2021.
FOR FURTHER INFORMATION CONTACT:
David Alterman, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5720,
david.alterman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of the seven NADAs listed in table 1,
and all supplements and amendments
thereto, is withdrawn, effective
February 23, 2021, for lack of
compliance with reporting requirements
in 21 CFR 514.80. As provided in the
regulatory text of this document, the
animal drug regulations are amended to
reflect withdrawal of approval of the
following applications and a current
format. Withdrawal of approval of
NADA 065–067 for Tetracycline
Hydrochloride (HCl) Tablets did not
require amending the regulations.
TABLE 1—NADAS FOR WHICH APPROVAL IS WITHDRAWN
Application No.
Trade name
(drug)
Sponsor
031–971 ............
CUPRATE (cupric glycinate) .....................................
045–863 ............
PALOSEIN (orgotein) ................................................
046–922 ............
SERGEANTS SURE SHOT (n-butyl chloride) Capsules.
SERGEANTS (n-butyl chloride) Puppy Worm Capsules.
Tetracycline HCl Tablets ...........................................
Walco International, Inc., 15 West Putnam, Porterville, CA 93257.
OXIS International, Inc., 6040 N Cutter Circle, Suite
317, Portland, OR 97217–3935.
ConAgra Pet Products Co., 3902 Leavenworth St.,
Omaha, NE 68105.
ConAgra Pet Products Co., 3902 Leavenworth St.,
Omaha, NE 68105.
Premo Pharmaceutical Laboratories, Inc., 111
Leuning St., South Hackensack, NJ 07606.
RSR Laboratories, Inc., 501 Fifth St., Bristol, TN
37620.
Alaco, Inc., 1500 North Wilmot Rd., Suite 290–C,
Tucson, AZ 85712.
046–923 ............
065–067 ............
140–850 ............
141–107 ............
ELITE (dichlorophene and toluene) Dog and Cat
Wormer.
BAPTEN for Injection (+-aminopropionitrile fumarate).
Following these withdrawals of
approval, Alaco, Inc.; ConAgra Pet
Products Co.; OXIS International, Inc.;
RSR Laboratories, Inc.; and Walco
International, Inc., are no longer the
sponsors of an approved application.
Accordingly, 21 CFR 510.600(c) is being
amended to remove the entries for these
firms.
II. Legal Authority
This rule sets forth technical
amendments to the regulations to codify
recent actions on approved new animal
drug applications and corrections to
improve the accuracy of the regulations,
and as such does not impose any burden
on regulated entities. This rule is issued
under section 512(i) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360b(i)), which requires
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21:28 Feb 22, 2021
Jkt 253001
Federal Register publication of the
conditions of use of an approved or
conditionally approved new animal
drug and the name and address of the
drug’s sponsor in a ‘‘notice, which upon
publication shall be effective as a
regulation.’’ A notice published
pursuant to section 512(i) is not subject
to the notice-and-comment rulemaking
requirements of the Administrative
Procedure Act, 5 U.S.C. 551 et seq. See
section 512(i) of the FD&C Act (21
U.S.C. 360b(i)); 21 CFR 10.40(e)(3); S.
Rep. 90–1308, at 5 (1968).
This document does not meet the
definition of ‘‘rule’’ in 5 U.S.C.
804(3)(A) because it is a ‘‘rule of
particular applicability.’’ Therefore, it is
not subject to the congressional review
requirements in 5 U.S.C. 801–808.
PO 00000
Frm 00116
Fmt 4700
Sfmt 4700
21 CFR section
522.518
522.1620
520.260
520.260
Not codified
520.580
522.84
Likewise, this is not a rule subject to
Executive Order 12866, which defines a
rule as ‘‘an agency statement of general
applicability and future effect, which
the agency intends to have the force and
effect of law, that is designed to
implement, interpret, or prescribe law
or policy or to describe the procedure or
practice requirements of an agency.’’
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 520 and 522
Animal drugs.
E:\FR\FM\23FER1.SGM
23FER1
Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 510,
520, and 522 are amended as follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for part 510
continues to read as follows:
■
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
§ 510.600
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entries for
‘‘Alaco, Inc.’’, ‘‘OXIS International,
Inc.’’, ‘‘RSR Laboratories, Inc.’’, and
‘‘Walco International, Inc.’’; and in the
table in paragraph (c)(2), remove the
entries for ‘‘024991’’, ‘‘049185’’,
‘‘058670’’, and ‘‘064146’’.
■
§ 520.580
5. In § 520.580, in paragraph (b)(1),
remove ‘‘Nos. 017135, 023851, and
058670’’ and in its place add ‘‘Nos.
017135 and 023851’’.
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for part 520
continues to read as follows:
■
6. The authority citation for part 522
continues to read as follows:
■
Authority: 21 U.S.C. 360b.
4. Revise § 520.260 to read as follows:
§ 520.260
[Amended]
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
■
(2) Indications for use. For the
removal of ascarids (Toxocara canis and
Toxascaris leonina) and hookworms
(Ancylostoma caninum, Ancylostoma
braziliense, and Uncinaria
stenocephala) from dogs.
(3) Limitations. Dogs should not be
fed for 18 to 24 hours before being given
the drug. Administration of the drug
should be followed in 1⁄2 to 1 hour with
a mild cathartic. Normal feeding may be
resumed 4 to 8 hours after treatment.
Animals subject to reinfection may be
retreated in 2 weeks. A veterinarian
should be consulted before using in
severely debilitated dogs.
Authority: 21 U.S.C. 360b.
n-Butyl chloride.
(a) Specifications. Each capsule
contains 221, 442, 884, or 1,768
milligrams (mg); or 4.42 grams of nbutyl chloride.
(b) Sponsors. See sponsors in
§ 510.600(c) of this chapter:
(1) No. 023851 for capsules containing
221, 442, 884, or 1,768 mg, or 4.42
grams (g); and
(2) No. 054771 for capsules containing
221 mg.
(c) Conditions of use in dogs—(1)
Amount. Administer capsules orally
based on body weight as follows:
(i) Capsules containing 221 mg: Under
5 pounds, 1 capsule per 11⁄4 pounds of
body weight.
(ii) Capsules containing 442 mg:
Under 5 pounds, 1 capsule per 21⁄2
pounds of body weight.
(iii) Capsules containing 884 mg:
(A) Under 5 pounds, 1 capsule;
(B) 5 to 10 pounds, 2 capsules;
(C) 10 to 20 pounds, 3 capsules;
(D) 20 to 40 pounds, 4 capsules;
(E) Over 40 pounds, 5 capsules.
(iv) Capsules containing 1,768 mg:
Dogs weighing 5 to 10 pounds, 1
capsule.
(v) Capsules containing 4.42 g: Dogs
weighing 40 pounds or over, 1 capsule.
§ 522.84
■
[Removed]
7. Remove § 522.84.
§ 522.518
■
[Removed]
8. Remove § 522.518.
§ 522.1620
■
[Removed]
9. Remove § 522.1620.
Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03251 Filed 2–22–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ACTION:
10819
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of seven new animal drug
applications (NADAs) from multiple
holders of these applications. The basis
for the withdrawals is that the holders
of these applications have repeatedly
failed to file required annual reports for
the applications.
SUMMARY:
Withdrawal of approval is
effective February 23, 2021.
DATES:
FOR FURTHER INFORMATION CONTACT:
David Alterman, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5720,
david.alterman@fda.hhs.gov.
The
holders of approved applications to
market new animal drugs are required to
submit annual reports to FDA
concerning each of their approved
applications in accordance with
§ 514.80 (21 CFR 514.80).
In the Federal Register of January 8,
2020 (85 FR 919), FDA published a
notice offering an opportunity for a
hearing (NOOH) on a proposal to
withdraw approval of seven NADAs
because the sponsors had failed to
submit the required annual reports for
these applications. The holders of these
applications did not respond to the
NOOH. Failure to file a written notice
of participation and request for a
hearing as required by § 514.200(b) (21
CFR 514.200(b)) constitutes an election
by the applicant not to make use of the
opportunity for a hearing concerning the
proposal to withdraw approval of the
applications and a waiver of any
contentions concerning the legal status
of the drug products. Therefore,
approval of the seven applications listed
in table 1 is being withdrawn.
SUPPLEMENTARY INFORMATION:
21 CFR Parts 510, 520, and 522
[Docket No. FDA–2019–N–5405]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
TABLE 1—NADAS FOR WHICH APPROVAL IS WITHDRAWN
Application No.
Trade name
(drug)
031–971 .............
CUPRATE (cupric glycinate) ....................................................
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Frm 00117
Sponsor
Fmt 4700
Sfmt 4700
Walco International, Inc., 15 West Putnam, Porterville, CA
93257.
E:\FR\FM\23FER1.SGM
23FER1
]]>Agencies
[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Rules and Regulations]
[Pages 10818-10819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03251]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, and 522
[Docket No. FDA-2019-N-5405]
New Animal Drug Applications; Beta-Aminopropionitrile Fumarate;
n-Butyl Chloride; Cupric Glycinate Injection; Dichlorophene and
Toluene; Orgotein for Injection; Tetracycline Tablets
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule, technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the withdrawal of approval of seven new
animal drug applications (NADAs) for lack of compliance with the
reporting requirements in an FDA regulation.
DATES: This rule is effective February 23, 2021.
FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-5720, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of the seven NADAs listed in table 1, and all supplements
and amendments thereto, is withdrawn, effective February 23, 2021, for
lack of compliance with reporting requirements in 21 CFR 514.80. As
provided in the regulatory text of this document, the animal drug
regulations are amended to reflect withdrawal of approval of the
following applications and a current format. Withdrawal of approval of
NADA 065-067 for Tetracycline Hydrochloride (HCl) Tablets did not
require amending the regulations.
Table 1--NADAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
Trade name
Application No. (drug) Sponsor 21 CFR section
------------------------------------------------------------------------
031-971.............. CUPRATE (cupric Walco 522.518
glycinate). International,
Inc., 15 West
Putnam,
Porterville,
CA 93257.
045-863.............. PALOSEIN OXIS 522.1620
(orgotein). International,
Inc., 6040 N
Cutter Circle,
Suite 317,
Portland, OR
97217-3935.
046-922.............. SERGEANTS SURE ConAgra Pet 520.260
SHOT Products Co.,
(n[dash]butyl 3902
chloride) Leavenworth
Capsules. St., Omaha, NE
68105.
046-923.............. SERGEANTS (n- ConAgra Pet 520.260
butyl Products Co.,
chloride) 3902
Puppy Worm Leavenworth
Capsules. St., Omaha, NE
68105.
065-067.............. Tetracycline Premo Not codified
HCl Tablets. Pharmaceutical
Laboratories,
Inc., 111
Leuning St.,
South
Hackensack, NJ
07606.
140-850.............. ELITE RSR 520.580
(dichlorophene Laboratories,
and toluene) Inc., 501
Dog and Cat Fifth St.,
Wormer. Bristol, TN
37620.
141-107.............. BAPTEN for Alaco, Inc., 522.84
Injection 1500 North
([szlig][dash] Wilmot Rd.,
aminopropionit Suite 290-C,
rile fumarate). Tucson, AZ
85712.
------------------------------------------------------------------------
Following these withdrawals of approval, Alaco, Inc.; ConAgra Pet
Products Co.; OXIS International, Inc.; RSR Laboratories, Inc.; and
Walco International, Inc., are no longer the sponsors of an approved
application. Accordingly, 21 CFR 510.600(c) is being amended to remove
the entries for these firms.
II. Legal Authority
This rule sets forth technical amendments to the regulations to
codify recent actions on approved new animal drug applications and
corrections to improve the accuracy of the regulations, and as such
does not impose any burden on regulated entities. This rule is issued
under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360b(i)), which requires Federal Register publication
of the conditions of use of an approved or conditionally approved new
animal drug and the name and address of the drug's sponsor in a
``notice, which upon publication shall be effective as a regulation.''
A notice published pursuant to section 512(i) is not subject to the
notice-and-comment rulemaking requirements of the Administrative
Procedure Act, 5 U.S.C. 551 et seq. See section 512(i) of the FD&C Act
(21 U.S.C. 360b(i)); 21 CFR 10.40(e)(3); S. Rep. 90-1308, at 5 (1968).
This document does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a ``rule of particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive
Order 12866, which defines a rule as ``an agency statement of general
applicability and future effect, which the agency intends to have the
force and effect of law, that is designed to implement, interpret, or
prescribe law or policy or to describe the procedure or practice
requirements of an agency.''
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520 and 522
Animal drugs.
[[Page 10819]]
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, and 522 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for part 510 continues to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
Sec. 510.600 [Amended]
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the
entries for ``Alaco, Inc.'', ``OXIS International, Inc.'', ``RSR
Laboratories, Inc.'', and ``Walco International, Inc.''; and in the
table in paragraph (c)(2), remove the entries for ``024991'',
``049185'', ``058670'', and ``064146''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
0
4. Revise Sec. 520.260 to read as follows:
Sec. 520.260 n-Butyl chloride.
(a) Specifications. Each capsule contains 221, 442, 884, or 1,768
milligrams (mg); or 4.42 grams of n-butyl chloride.
(b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter:
(1) No. 023851 for capsules containing 221, 442, 884, or 1,768 mg,
or 4.42 grams (g); and
(2) No. 054771 for capsules containing 221 mg.
(c) Conditions of use in dogs--(1) Amount. Administer capsules
orally based on body weight as follows:
(i) Capsules containing 221 mg: Under 5 pounds, 1 capsule per 1\1/
4\ pounds of body weight.
(ii) Capsules containing 442 mg: Under 5 pounds, 1 capsule per 2\1/
2\ pounds of body weight.
(iii) Capsules containing 884 mg:
(A) Under 5 pounds, 1 capsule;
(B) 5 to 10 pounds, 2 capsules;
(C) 10 to 20 pounds, 3 capsules;
(D) 20 to 40 pounds, 4 capsules;
(E) Over 40 pounds, 5 capsules.
(iv) Capsules containing 1,768 mg: Dogs weighing 5 to 10 pounds, 1
capsule.
(v) Capsules containing 4.42 g: Dogs weighing 40 pounds or over, 1
capsule.
(2) Indications for use. For the removal of ascarids (Toxocara
canis and Toxascaris leonina) and hookworms (Ancylostoma caninum,
Ancylostoma braziliense, and Uncinaria stenocephala) from dogs.
(3) Limitations. Dogs should not be fed for 18 to 24 hours before
being given the drug. Administration of the drug should be followed in
\1/2\ to 1 hour with a mild cathartic. Normal feeding may be resumed 4
to 8 hours after treatment. Animals subject to reinfection may be
retreated in 2 weeks. A veterinarian should be consulted before using
in severely debilitated dogs.
Sec. 520.580 [Amended]
0
5. In Sec. 520.580, in paragraph (b)(1), remove ``Nos. 017135, 023851,
and 058670'' and in its place add ``Nos. 017135 and 023851''.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
6. The authority citation for part 522 continues to read as follows:
Authority: 21 U.S.C. 360b.
Sec. 522.84 [Removed]
0
7. Remove Sec. 522.84.
Sec. 522.518 [Removed]
0
8. Remove Sec. 522.518.
Sec. 522.1620 [Removed]
0
9. Remove Sec. 522.1620.
Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03251 Filed 2-22-21; 8:45 am]
BILLING CODE 4164-01-P
