New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications, 18125-18126 [2020-06689]
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18125
Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations
Tylosin
grams/ton
Combination in
grams/ton
*
(ix) 8 to 10 ..
*
Monensin, 10 to 40
plus melengestrol,
0.25 to 2.0.
*
Indications for use
Limitations
*
*
Heifers fed in confinement for
slaughter: For reduction of incidence of liver abscesses caused
by Fusobacterium necrophorum
and
Arcanobacterium
(Actinomyces) pyogenes; for prevention and control of coccidiosis
caused by Eimeria bovis and E.
zuernii; and for increased rate of
weight gain, improved feed efficiency, and suppression of estrus
(heat).
*
*
Feed continuously as sole ration to heifers at a
rate of 0.5 to 2 pounds per head per day to
provide
0.25
to
0.5
mg/head/day
melengestrol acetate and 0.14 to 0.42 mg
monensin/lb body weight per day, depending
on the severity of the coccidiosis challenge,
up to 480 mg/head/day and 60 to 90 mg/
head/day tylosin. The melengestrol acetate
portion of this Type C medicated feed must
be mixed into the complete feed containing
10 to 40 g/ton monensin and 8 to 10 g/ton
tylosin at feeding into the amount of complete
feed consumed by an animal per day. A withdrawal time has not been established for preruminating calves. Do not use in calves to be
processed for veal. Tylosin provided by No.
016592 or 058198; monensin as provided by
No. 016592 or 058198; melengestrol provided by No. 054771 or 058198 in
§ 510.600(c)
of
this
chapter.
See
§§ 558.342(d) and 558.355(d).
*
*
§ 558.635
66. In § 558.635, revise paragraph
(e)(1)(iv) to read as follows:
■
*
*
*
Virginiamycin.
*
*
*
Combination in
grams/ton
Indications for use
Limitations
*
(iv) 20 .................
*
Diclazuril, 0.91 ...........
*
*
Broiler chickens: For prevention of
necrotic enteritis caused by
Clostridium perfringens susceptible to virginiamycin; and for
the prevention of coccidiosis
caused by Eimeria tenella, E.
necatrix, E. acervulina, E.
brunetti, E. mitis (mivati), and
E. maxima. Because diclazuril
is effective against E. maxima
late in its life cycle, subclinical
intestinal lesions may be
present for a short time after infection. Diclazuril was shown in
studies to reduce lesions
scores and improve performance and health of birds challenged with E. maxima.
*
*
Feed continuously as the sole ration. Do not
use in hens producing eggs for human
food. Diclazuril as provided by No. 058198
in § 510.600(c) of this chapter.
*
*
*
*
*
*
*
Dated: March 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
*
*
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Parts 520, 522, and 526
BILLING CODE 4164–01–P
[Docket No. FDA–2019–N–0002]
New Animal Drugs; Withdrawal of
Approval of New Animal Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
16:27 Mar 31, 2020
Jkt 250001
016592
054771
058198
*
Sponsor
*
ACTION:
*
058198
*
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of eight new animal drug
applications (NADAs) at the sponsor’s
request because the products are no
longer manufactured or marketed.
SUMMARY:
Food and Drug Administration
[FR Doc. 2020–06688 Filed 3–30–20; 8:45 am]
VerDate Sep<11>2014
*
(e) * * *
(1) * * *
*
Virginiamycin
grams/ton
*
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*
Sponsor
PO 00000
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Fmt 4700
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Withdrawal of approval is
effective March 30, 2020
DATES:
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
E:\FR\FM\01APR1.SGM
01APR1
18126
Federal Register / Vol. 85, No. 63 / Wednesday, April 1, 2020 / Rules and Regulations
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
Norbrook
Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, has
requested that FDA withdraw approval
SUPPLEMENTARY INFORMATION:
File No.
055–036
055–050
055–056
055–061
055–068
065–013
065–493
065–500
..........................
..........................
..........................
..........................
..........................
..........................
..........................
..........................
PRINCILLIN (ampicillin trihydrate) Capsules .........................................................................................
PRINCILLIN (ampicillin trihydrate) Soluble Powder ...............................................................................
PRINCILLIN (ampicillin trihydrate) Bolus ...............................................................................................
PRINCILLIN ‘‘125’’ For Oral Suspension ...............................................................................................
BOVICLOX (cloxacillin benzathine) .......................................................................................................
Dihydrostreptomycin (dihydrostreptomycin sulfate) ...............................................................................
JETPEN (penicillin G benzathine and penicillin G procaine) Aqueous Suspension .............................
TANDEM PEN (penicillin G procaine) ...................................................................................................
Dated: March 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–06689 Filed 3–30–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF DEFENSE
Department of the Navy
32 CFR Part 716
[Docket ID: USN–2019–HQ–0016]
RIN 0703–AB23
Death Gratuity
Department of the Navy (DON),
DoD.
ACTION:
Final rule.
This final rule removes the
Department of the Navy (DON)
regulation requiring the Secretary of the
Navy to pay a death gratuity between
$800 and $3,000 upon the death of a
member of the naval service while on
active duty, active duty for training, or
inactive duty training. That benefit is
enumerated in both U.S. Code and the
Department of Defense (DoD) Financial
Management Regulation. The DoD and
DON have robust procedures for
responding to the death of a service
member. This part has been determined
jbell on DSKJLSW7X2PROD with RULES
SUMMARY:
VerDate Sep<11>2014
21 CFR
section
Product name
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and in accordance with § 514.116 Notice
of withdrawal of approval of application
(21 CFR 514.116), notice is given that
approval of NADAs 055–036, 055–050,
055–056, 055–061, 055–068, 065–013,
065–493, and 065–500, and all
supplements and amendments thereto,
is withdrawn, effective March 30, 2020.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
AGENCY:
of the NADAs listed in the following
table because the products are no longer
manufactured or marketed:
16:27 Mar 31, 2020
Jkt 250001
to be duplicative of statute and internal
policy, thus it should be removed from
the CFR.
DATES:
This rule is effective on April 1,
2020.
520.90c.
520.90e.
520.90f.
520.90d.
526.464b.
522.650.
522.1696a.
522.1696b.
Dated: March 26, 2020.
D.J. Antenucci,
Commander, Judge Advocate General’s Corps,
U.S. Navy, Federal Register Liaison Officer.
[FR Doc. 2020–06694 Filed 3–31–20; 8:45 am]
BILLING CODE 3810–FF–P
FOR FURTHER INFORMATION CONTACT:
CDR
Dave Melson at 703–697–1311.
32 CFR
part 716, ‘‘Death Gratuity,’’ last updated
on May 2, 1979 (44 FR 25647), contains
information regarding DON payments of
death gratuity. The Department of
Defense publishes the policies, process
and requirements around death gratuity
payments in Chapter 36 of Volume 7A
of the Financial Management Regulation
(DoD 7000.14–R was updated March
2018 and is available at https://
comptroller.defense.gov/Portals/45/
documents/fmr/Volume_07a.pdf).
Additionally, 10 U.S. Code 1475–1480
captures all current guidance related to
the death gratuity. It has been
determined that publication of this CFR
part removal for public comment is
impracticable, unnecessary, and
contrary to public interest since this
subject matter is already addressed in
statute and by internal DoD policies and
procedures that are publicly available
on the Department’s website.
This rule is not significant under
Executive Order (E.O.) 12866,
‘‘Regulatory Planning and Review.’’
Therefore, E.O. 13771, ‘‘Reducing
Regulation and Controlling Regulatory
Costs’’ does not apply.
Removal of this part supports a
recommendation of the DoD Regulatory
Reform Task Force.
SUPPLEMENTARY INFORMATION:
List of Subjects in 32 CFR Part 716
Military personnel.
PART 716—[REMOVED]
Accordingly, by the authority of 5
U.S.C. 301, 32 CFR part 716 is removed.
■
PO 00000
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Fmt 4700
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R04–OAR–2019–0294; FRL–10007–
17–Region 4]
Air Plan Approval; Tennessee:
Chattanooga NSR Reform
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
The Environmental Protection
Agency (EPA) is finalizing approval of
revisions to the Tennessee State
Implementation Plan (SIP) submitted
through two letters dated June 25, 2008,
and September 12, 2018. The SIP
revisions were submitted by the
Tennessee Department of Environment
and Conservation (TDEC) on behalf of
the Chattanooga/Hamilton County Air
Pollution Control Bureau and modify
the Prevention of Significant
Deterioration (PSD) regulations in the
Chattanooga portion of the Tennessee
SIP to address changes to the federal
new source review (NSR) regulations in
recent years for the implementation of
the national ambient air quality
standards (NAAQS). Additionally, the
SIP revisions include updates to
Chattanooga’s regulations of nitrogen
oxides (NOX) and other miscellaneous
typographical and administrative
updates. This action is being taken
pursuant to the Clean Air Act (CAA or
Act).
DATES: This rule is effective May 1,
2020.
SUMMARY:
E:\FR\FM\01APR1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Rules and Regulations]
[Pages 18125-18126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06689]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, and 526
[Docket No. FDA-2019-N-0002]
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 eight new animal drug applications (NADAs) at the sponsor's request
because the products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective March 30, 2020
FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug
[[Page 18126]]
Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5761,
[email protected].
SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works,
Newry BT35 6JP, Northern Ireland, has requested that FDA withdraw
approval of the NADAs listed in the following table because the
products are no longer manufactured or marketed:
------------------------------------------------------------------------
File No. Product name 21 CFR section
------------------------------------------------------------------------
055-036...................... PRINCILLIN 520.90c.
(ampicillin
trihydrate) Capsules.
055-050...................... PRINCILLIN 520.90e.
(ampicillin
trihydrate) Soluble
Powder.
055-056...................... PRINCILLIN 520.90f.
(ampicillin
trihydrate) Bolus.
055-061...................... PRINCILLIN ``125'' 520.90d.
For Oral Suspension.
055-068...................... BOVICLOX (cloxacillin 526.464b.
benzathine).
065-013...................... Dihydrostreptomycin 522.650.
(dihydrostreptomycin
sulfate).
065-493...................... JETPEN (penicillin G 522.1696a.
benzathine and
penicillin G
procaine) Aqueous
Suspension.
065-500...................... TANDEM PEN 522.1696b.
(penicillin G
procaine).
------------------------------------------------------------------------
Therefore, under authority delegated to the Commissioner of Food
and Drugs and in accordance with Sec. 514.116 Notice of withdrawal of
approval of application (21 CFR 514.116), notice is given that approval
of NADAs 055-036, 055-050, 055-056, 055-061, 055-068, 065-013, 065-493,
and 065-500, and all supplements and amendments thereto, is withdrawn,
effective March 30, 2020.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.
Dated: March 25, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-06689 Filed 3-30-20; 8:45 am]
BILLING CODE 4164-01-P
