New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications, 10819-10820 [2021-03250]
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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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PO 00000
Frm 00117
Sponsor
Fmt 4700
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Walco International, Inc., 15 West Putnam, Porterville, CA
93257.
E:\FR\FM\23FER1.SGM
23FER1
10820
Federal Register / Vol. 86, No. 34 / Tuesday, February 23, 2021 / Rules and Regulations
TABLE 1—NADAS FOR WHICH APPROVAL IS WITHDRAWN—Continued
Application No.
Trade name
(drug)
Sponsor
045–863 .............
PALOSEIN (orgotein) ...............................................................
046–922 .............
SERGEANTS SURE SHOT (n-butyl chloride) Capsules ........
046–923 .............
SERGEANTS (n-butyl chloride) Puppy Worm Capsules .........
065–067 .............
Tetracycline Hydrochloride Tablets ..........................................
140–850 .............
141–107 .............
ELITE (dichlorophene and toluene) Dog and Cat Wormer .....
BAPTEN for Injection (+-aminopropionitrile fumarate) ............
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.
The Commissioner of Food and Drugs
(the Commissioner), under section
512(e)(2)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
360b(e)(2)(A)), finds that the holders of
the applications listed in this document
have repeatedly failed to submit reports
required by § 514.80. In addition, under
§ 514.200(b), the Commissioner finds
that the holders of the applications have
waived any contentions concerning the
legal status of the drug products.
Therefore, under these findings,
approval of the applications listed in
this document, and all amendments and
supplements thereto, is hereby
withdrawn, effective February 23, 2021.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the
withdrawal of approval of these
applications.
distributed together, regardless of
whether such distribution occurs via
physical or digital media. The final rule
generally adopts the provisions set forth
in the May 2019 notice of proposed
rulemaking in this proceeding, with
certain updates to reflect the planned
implementation of new online
applications for this option.
DATES: Effective March 26, 2021.
FOR FURTHER INFORMATION CONTACT:
Regan A. Smith, General Counsel and
Associate Register of Copyrights, by
email at regans@copyright.gov; Robert
Kasunic, Associate Register of
Copyrights and Director of Registration
Policy and Practice, by email at rkas@
copyright.gov; or John R. Riley,
Assistant General Counsel, by email at
jril@copyright.gov. Each can be
contacted by telephone at 202–707–
8350.
Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2021–03250 Filed 2–22–21; 8:45 am]
BILLING CODE 4164–01–P
LIBRARY OF CONGRESS
Copyright Office
37 CFR Parts 201 and 202
[Docket No. 2019–4]
Group Registration of Works on an
Album of Music
U.S. Copyright Office, Library
of Congress.
ACTION: Final rule.
AGENCY:
The U.S. Copyright Office is
creating a new group registration option
for musical works, sound recordings,
and certain other works contained on an
album. This option will permit the
registration of a group of musical works
or a group of sound recordings
SUMMARY:
VerDate Sep<11>2014
21:28 Feb 22, 2021
Jkt 253001
I. Background
The Copyright Act authorizes the
Register of Copyrights to specify by
regulation the administrative classes of
works available for the purpose of
seeking a registration and the nature of
the deposits required for each class. In
addition, Congress gave the Register the
discretion to allow registration of groups
of related works with one application
and one filing fee, a procedure known
as ‘‘group registration.’’ 1 Pursuant to
this authority, the Register has issued
regulations permitting the Office to
issue group registrations for certain
types of works, including for groups of
newspapers, unpublished works,
newsletters and serials, unpublished
and published photographs,
contributions to periodicals, secure test
items, and short online literary works.2
On May 20, 2019, the Office
published a Notice of Proposed
Rulemaking (‘‘NPRM’’) proposing to
1 37
2 37
PO 00000
CFR 202.4; see 17 U.S.C. 408(c)(1).
CFR 202.4(c)–(k).
Frm 00118
Fmt 4700
Sfmt 4700
create a new group registration option
for musical works, sound recordings,
and associated literary, pictorial, and
graphic works contained on an album.
This option is referred to as ‘‘Group
Registration of Works on an Album of
Music,’’ or ‘‘GRAM.’’ 3 The proposed
rule would allow an applicant to
register up to twenty musical works and
twenty sound recordings, i.e., forty total
works, if the works were fixed in the
same phonorecord, if the works were
created by the same author or had at
least one common author, and if the
claimant for each work in the group was
the same. The proposed rule also would
permit the registration of associated
literary, pictorial, and graphic works in
the album, such as cover art, liner notes,
or posters. To exercise this option, the
Office proposed that applicants would
be required to submit their claims
through the online copyright
registration system using the Standard
Application.
The Office received thirteen
comments in response to the NPRM,
eleven from individuals, one from the
National Music Publishers Association
(‘‘NMPA’’), and a joint comment by the
American Association of Independent
Music (‘‘A2IM’’) and the Recording
Industry Association of America
(‘‘RIAA’’). Each commenter supported
the Office’s proposal to create the new
group registration option, though some
suggested various amendments to the
proposed rule, including removing the
proposed limit on the number of works
that may be included in each claim and
clarifying who could be listed as a
claimant of a work in a GRAM
registration.
Having reviewed and carefully
considered the submitted comments, the
Office now issues a final rule that
generally follows the proposed rule,
with some modifications. First, the rule
requires claims under this option to be
submitted using a new online
3 84
E:\FR\FM\23FER1.SGM
FR 22762 (May 20, 2019).
23FER1
]]>Agencies
[Federal Register Volume 86, Number 34 (Tuesday, February 23, 2021)]
[Rules and Regulations]
[Pages 10819-10820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03250]
-----------------------------------------------------------------------
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 Drugs; Withdrawal of Approval of New Animal Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: 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.
DATES: Withdrawal of approval 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: 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 Sec.
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 Sec. 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.
Table 1--NADAs for Which Approval Is Withdrawn
------------------------------------------------------------------------
Application No. Trade name (drug) Sponsor
------------------------------------------------------------------------
031-971................ CUPRATE (cupric Walco International,
glycinate). Inc., 15 West Putnam,
Porterville, CA
93257.
[[Page 10820]]
045-863................ PALOSEIN (orgotein).... OXIS International,
Inc., 6040 N. Cutter
Circle, suite 317,
Portland, OR 97217-
3935.
046-922................ SERGEANTS SURE SHOT ConAgra Pet Products
(n[dash]butyl Co., 3902 Leavenworth
chloride) Capsules. St., Omaha, NE 68105.
046-923................ SERGEANTS (n-butyl ConAgra Pet Products
chloride) Puppy Worm Co., 3902 Leavenworth
Capsules. St., Omaha, NE 68105.
065-067................ Tetracycline Premo Pharmaceutical
Hydrochloride Tablets. Laboratories, Inc.,
111 Leuning St.,
South Hackensack, NJ
07606.
140-850................ ELITE (dichlorophene RSR Laboratories,
and toluene) Dog and Inc., 501 Fifth St.,
Cat Wormer. Bristol, TN 37620.
141-107................ BAPTEN for Injection Alaco, Inc., 1500
([szlig][dash]aminopro North Wilmot Rd.,
pionitrile fumarate). suite 290-C, Tucson,
AZ 85712.
------------------------------------------------------------------------
The Commissioner of Food and Drugs (the Commissioner), under
section 512(e)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b(e)(2)(A)), finds that the holders of the applications
listed in this document have repeatedly failed to submit reports
required by Sec. 514.80. In addition, under Sec. 514.200(b), the
Commissioner finds that the holders of the applications have waived any
contentions concerning the legal status of the drug products.
Therefore, under these findings, approval of the applications listed in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective February 23, 2021.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the withdrawal of approval of
these applications.
Dated: February 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03250 Filed 2-22-21; 8:45 am]
BILLING CODE 4164-01-P
