New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, 11510-11513 [2017-03596]
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11510
Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations
File No.
Product name
Sponsor
Zoetis Inc.
Zoetis Inc.
Zoetis Inc.
Zoetis Inc.
Phibro Animal Health Corp., GlenPointe Centre East,
3d floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666 (Phibro Animal Health Corp.).
Zoetis Inc.
Zoetis Inc.
Zoetis Inc.
Phibro Animal Health Corp.
Phibro Animal Health Corp.
Phibro Animal Health Corp.
044–972
047–261
047–262
048–954
091–513
......................................
......................................
......................................
......................................
......................................
LINCOMIX (lincomycin)/COYDEN (clopidol) ...............
LINCOMIX (lincomycin)/DECCOX (decoquinate) .......
LINCOMIX (lincomycin)/DECCOX (decoquinate) .......
LINCOMIX (lincomycin)/ZOAMIX (zoalene) ................
STAFAC (virginiamycin) Type A Medicated Article .....
092–482
093–106
101–689
122–481
122–608
122–822
......................................
......................................
......................................
......................................
......................................
......................................
141–110 ......................................
141–150 ......................................
200–092 ......................................
LINCOMIX (lincomycin)/COBAN (monensin) ..............
LINCOMIX (lincomycin)/ROBENZ (robenidine) ...........
LINCOMIX (lincomycin)/AVATEC (lasalocid) ..............
STAFAC (virginiamycin)/COBAN (monensin) .............
STAFAC (virginiamycin)/AVATEC (lasalocid) .............
STAFAC (virginiamycin)/AMPROL PLUS (amprolium
and ethopabate).
LINCOMIX (lincomycin)/BIO–COX (salinomycin) ........
TYLAN
(tylosin)/RUMENSIN
(monensin)/MGA
(melengestrol acetate).
STAFAC (virginiamycin)/BIO–COX (salinomycin) .......
TYLAN
(tylosin)/BOVATEC
(lasalocid)/MGA
(melengestrol acetate).
STAFAC (virginiamycin)/COBAN (monensin) .............
STAFAC (virginiamycin)/AVATEC (lasalocid) .............
STAFAC (virginiamycin)/SACOX (salinomycin) ..........
200–093 ......................................
LINCOMIX (lincomycin)/SACOX (salinomycin) ...........
137–537 ......................................
138–792 ......................................
138–828 ......................................
138–904 ......................................
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of NADAs 044–820, 044–972, 047–261,
047–262, 048–954, 091–513, 092–482,
093–106, 101–689, 122–481, 122–608,
122–822, 137–537, 138–792, 138–828,
138–904, 141–110, 141–150, 200–092,
and 200–093, and all supplements and
amendments thereto, is hereby
withdrawn, effective February 24, 2017.
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: February 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03595 Filed 2–23–17; 8:45 am]
pmangrum on DSK3GDR082PROD with RULES
BILLING CODE 4164–01–P
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Zoetis Inc.
Zoetis Inc.
Phibro Animal Health Corp.
Zoetis Inc.
Phibro Animal Health Corp.
Phibro Animal Health Corp.
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov
Str., 1113 Sophia, Bulgaria (Huvepharma EOOD).
Huvepharma EOOD.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2016–N–0002]
New Animal Drugs for Use in Animal
Feed; Approval of New Animal Drug
Applications; Withdrawal of Approval
of New Animal Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of eight supplemental new
animal drug applications (NADAs). The
effect of these supplemental
applications will be to change the
marketing status from over-the-counter
(OTC) use to use by veterinary feed
directive (VFD) for these antimicrobial
drugs of importance to human
medicine, administered to foodproducing animals in medicated feed.
Where applicable, FDA is also
withdrawing approval of those parts of
the NADAs that pertain to use of these
antimicrobial drugs for production
indications. These actions are being
taken at the sponsors’ requests because
these particular medicated feeds will no
longer be manufactured or marketed.
These applications were submitted in
voluntary compliance with the goals of
FDA Center for Veterinary Medicine’s
SUMMARY:
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(CVM’s) Judicious Use Initiative. In
addition, the animal drug regulations
are being amended to reflect the
voluntary withdrawal of approval of
certain entire NADAs and abbreviated
new animal drug applications
(ANADAs) that were affected by this
initiative.
DATES: This rule is effective February
24, 2017.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Supplemental Approval of Revised
Labeling and Withdrawal of Approval
of Portions of NADAs Pertaining to
Production Indications
FDA is amending the animal drug
regulations to reflect approval of eight
supplemental NADAs for revised
labeling reflecting a change in marketing
status from OTC use to use by VFD for
antimicrobial drugs of importance to
human medicine administered to foodproducing animals in medicated feed.
Where applicable, FDA is also
withdrawing approval of those parts of
the NADAs that pertain to use of these
antimicrobial drugs for production
indications. These actions are being
taken at the sponsors’ requests because
these particular medicated feeds will no
longer be manufactured or marketed.
These applications were identified as
being affected by guidance for industry
(GFI) #213, ‘‘New Animal Drugs and
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Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations
New Animal Drug Combination
Products Administered in or on
Medicated Feed or Drinking Water of
Food-Producing Animals:
Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use
Conditions with GFI #209’’, December
2013 (https://www.fda.gov/downloads/
AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/UCM299624.pdf).
Their change from OTC to VFD
marketing status is consistent with FDA
11511
CVM’s initiative for the Judicious Use of
Antimicrobials.
The affected applications for Type A
medicated articles for which
supplemental applications with revised
labeling were approved are as follows:
File No.
Animal drug product
Sponsor
091–467 .............
STAFAC 500 (virginiamycin) Type A Medicated Article ..........
140–998 .............
V–MAX (virginiamycin) Type A Medicated Article ...................
Phibro Animal Health Corp., GlenPointe Centre East, 3d
Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ
07666 (Phibro Animal Health Corp.).
Phibro Animal Health Corp.
The affected applications for
manufacturing combination drug
medicated feeds follow:
File No.
Animal drug product
Sponsor
046–718 .............
TERRAMYCIN (oxytetracycline)/MGA (melengestrol acetate)
046–719
140–579
141–114
141–289
141–430
TERRAMYCIN (oxytetracycline)/MGA (melengestrol acetate)
TERRAMYCIN (oxytetracycline)/BOVATEC (lasalocid) ..........
STAFAC (virginiamycin)/AVIAX (semduramicin) .....................
STAFAC (virginiamycin)/AVIAX II (semduramicin) (biomass)
STAFAC (virginiamycin)/COBAN (monensin) ..........................
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis
Inc.).
Zoetis Inc.
Zoetis Inc.
Phibro Animal Health Corp.
Phibro Animal Health Corp.
Phibro Animal Health Corp.
.............
.............
.............
.............
.............
II. Withdrawals of Approval
At the sponsors’ requests, approval of
applications is being withdrawn for
medicated feeds containing
antimicrobial drugs of importance to
human medicine administered to foodproducing animals because these
products are no longer manufactured or
marketed. The applications being
withdrawn are as follows:
File No.
Product name
Sponsor
044–820 .............
LINCOMIX (lincomycin)/AMPROL PLUS (amprolium and
ethopabate).
LINCOMIX (lincomycin)/COYDEN (clopidol) ...........................
LINCOMIX (lincomycin)/DECCOX (decoquinate) ....................
LINCOMIX (lincomycin)/DECCOX (decoquinate) ....................
LINCOMIX (lincomycin)/ZOAMIX (zoalene) .............................
STAFAC (virginiamycin) Type A Medicated Article .................
Zoetis Inc., 333 Portage St., Kalamazoo, MI 49007 (Zoetis
Inc.).
Zoetis Inc.
Zoetis Inc.
Zoetis Inc.
Zoetis Inc.
Phibro Animal Health Corp., GlenPointe Centre East, 3d
Floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ
07666 (Phibro Animal Health Corp.).
Zoetis Inc.
Zoetis Inc.
Zoetis Inc.
Phibro Animal Health Corp.
Phibro Animal Health Corp.
Phibro Animal Health Corp.
044–972
047–261
047–262
048–954
091–513
.............
.............
.............
.............
.............
092–482
093–106
101–689
122–481
122–608
122–822
.............
.............
.............
.............
.............
.............
141–110 .............
141–150 .............
200–092 .............
LINCOMIX (lincomycin)/COBAN (monensin) ...........................
LINCOMIX (lincomycin)/ROBENZ (robenidine) .......................
LINCOMIX (lincomycin)/AVATEC (lasalocid) ...........................
STAFAC (virginiamycin)/COBAN (monensin) ..........................
STAFAC (virginiamycin)/AVATEC (lasalocid) ..........................
STAFAC (virginiamycin)/AMPROL PLUS (amprolium and
ethopabate).
LINCOMIX (lincomycin)/BIO–COX (salinomycin) ....................
TYLAN (tylosin)/RUMENSIN (monensin)/MGA (melengestrol
acetate).
STAFAC (virginiamycin)/BIO–COX (salinomycin) ...................
TYLAN (tylosin)/BOVATEC (lasalocid)/MGA (melengestrol
acetate).
STAFAC (virginiamycin)/COBAN (monensin) ..........................
STAFAC (virginiamycin)/AVATEC (lasalocid) ..........................
STAFAC (virginiamycin)/SACOX (salinomycin) .......................
200–093 .............
LINCOMIX (lincomycin)/SACOX (salinomycin) ........................
137–537 .............
138–792 .............
pmangrum on DSK3GDR082PROD with RULES
138–828 .............
138–904 .............
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADAs 044–820, 044–972, 047–261,
047–262, 048–954, 091–513, 092–482,
VerDate Sep<11>2014
14:13 Feb 23, 2017
Jkt 241001
Zoetis Inc.
Zoetis Inc.
Phibro Animal Health Corp.
Zoetis Inc.
Phibro Animal Health Corp.
Phibro Animal Health Corp.
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113
Sophia, Bulgaria (Huvepharma EOOD).
Huvepharma EOOD.
093–106, 101–689, 122–481, 122–608,
122–822, 137–537, 138–792, 138–828,
138–904, 141–110, and 141–150, and
ANADAs 200–092 and 200–093, and all
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supplements and amendments thereto,
is withdrawn, effective February 24,
2017. As provided in the regulatory text
of this document, the animal drug
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Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations
regulations are amended to reflect these
voluntary withdrawals of approval.
A similar rule published in the
Federal Register of December 27, 2016
(81 FR 94991), amended the approved
conditions of use in 21 CFR part 558 to
reflect approval of an additional 106
supplemental NADAs and supplemental
ANADAs for the manufacture of
medicated feeds for administration of
antimicrobial drugs to food-producing
animals and the voluntary withdrawal
of approval of 11 NADAs and 4
ANADAs.
This rule 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.
List of Subjects in 21 CFR Part 558
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:
Combination in grams/ton
*
*
(iii) 75 mg/head/day ..................
*
Lasalocid 25 to 30 ...................
(iv) 75 mg/head/day ..................
Melengestrol acetate, 0.25 to
2.0.
*
*
*
*
*
*
3. In § 558.635, revise paragraphs (a)
and (e) and add paragraphs (d)(1) and
(2) to read as follows:
■
§ 558.450
*
Oxytetracycline.
*
*
(e) * * *
(4) Cattle—
*
*
Limitations
*
*
*
Heifers fed in confinement for
Feed continuously to provide
slaughter (over 400 lb): For
250 to 360 mg lasalocid and
reduction of incidence of
75 mg of oxytetracycline per
liver abscesses; and for inhead per day. Lasalocid as
creased rate of weight gain
provided by No. 054771 in
and improved feed efficiency.
§ 510.600(c) of this chapter.
Heifers fed in confinement for
Feed continuously to provide
slaughter (over 400 lb): For
0.25 to 0.5 mg of
reduction of incidence of
melengestrol acetate and 75
liver abscesses; and for inmg of oxytetracycline per
creased rate of weight gain,
head per day. Melengestrol
improved feed efficiency,
as provided by No. 054771
and suppression of estrus
in § 510.600(c) of this chap(heat).
ter.
*
§ 558.635
2. In § 558.450, redesignate paragraph
(e)(4)(iii) as paragraph (e)(4)(v) and add
paragraphs (e)(4)(iii) and (iv) to read as
follows:
■
Indications for use
*
*
1. The authority citation for part 558
continues to read as follows:
■
Authority: 21 U.S.C. 354, 360b, 360ccc,
360ccc–1, 371.
Animal drugs, Animal feeds.
Oxytetracycline amount
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
*
Virginiamycin.
(a) Specifications. Type A medicated
articles containing 10, 20, 50, or 227
grams virginiamycin per pound.
*
*
*
*
*
(d) Special considerations. (1) Federal
law restricts medicated feed containing
this veterinary feed directive (VFD) drug
to use by or on the order of a licensed
*
Sponsor
*
054771
054771
*
veterinarian. See § 558.6 for additional
requirements.
(2) The expiration date of VFDs for
virginiamycin medicated feeds must not
exceed 6 months from the date of
issuance. VFDs for virginiamycin shall
not be refilled.
*
*
*
*
*
(e) Conditions of use—(1) Chickens—
Combination in grams/ton
Indications for use
Limitations
(i) 20 .........................................
..................................................
Broiler chickens: For prevention of necrotic enteritis
caused by Clostridium spp.
susceptible to virginiamycin.
Not for use in layers ................
066104
(ii)–(vi) [Reserved]
(vii) 20 ......................................
pmangrum on DSK3GDR082PROD with RULES
Virginiamycin grams/ton
Monensin, 90 to 110 ...............
Broiler chickens: For prevention of necrotic enteritis
caused by Clostridium spp.
susceptible to virginiamycin;
and as an aid in the prevention of coccidiosis caused by
Eimeria necatrix, E. tenella,
E. acervulina, E. brunetti, E.
maxima, and E. mivati.
Feed continuously as the sole
ration. Do not feed to laying
chickens. Monensin as provided by No. 058198 in
§ 510.600(c) of this chapter.
066104
(viii) [Reserved]
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Sponsor
Federal Register / Vol. 82, No. 36 / Friday, February 24, 2017 / Rules and Regulations
11513
Virginiamycin grams/ton
Combination in grams/ton
Indications for use
Limitations
Sponsor
(ix) 20 .......................................
Semduramicin, 22.7 ................
Feed continuously as the sole
ration. Do not feed to laying
hens. Semduramicin as provided by No. 066104 in
§ 510.600(c) of this chapter.
066104
(x) 20 ........................................
Semduramicin (biomass), 22.7
Broiler chickens: For prevention of necrotic enteritis
caused by Clostridium spp.
susceptible to virginiamycin;
for the prevention of coccidiosis caused by Eimeria
acervulina, E. brunetti, E.
maxima, E mivati/mitis, E.
necatrix, and E. tenella.
Broiler chickens: For prevention of necrotic enteritis
caused by Clostridium spp.
susceptible to virginiamycin;
for the prevention of coccidiosis caused by Eimeria
acervulina, E. brunetti, E.
maxima, E mivati/mitis, E.
necatrix, and E. tenella.
Feed continuously as the sole
ration. Withdraw 1 day before slaughter. Do not feed
to laying hens.
Semduramicin as provided
by No. 066104 in
§ 510.600(c) of this chapter.
066104
(2) Swine—
Virginiamycin grams/ton
Combination in grams/ton
Indications for use
Limitations
Sponsor
(i) 25 .........................................
..................................................
..................................................
066104
(ii) 50 or 100 .............................
..................................................
Feed 100 grams per ton for 2
weeks, 50 grams per ton
thereafter.
066104
(iii) 100 .....................................
..................................................
Growing-finishing swine: As an
aid in control of dysentery in
swine up to 120 pounds in
animals or on premises with
a history of swine dysentery
but where symptoms have
not yet occurred.
Growing-finishing swine: For
treatment and control of
swine dysentery in swine up
to 120 pounds.
Growing-finishing swine: For
treatment of swine dysentery in nonbreeding swine
over 120 pounds.
Feed for 2 weeks ....................
066104
(3) Cattle—
Virginiamycin grams/ton
Combination in grams/ton
Indications for use
Limitations
(i) 13.5 to 16.0 ..........................
..................................................
Cattle fed in confinement for
slaughter: For reduction of
incidence of liver abscesses.
Feed continuously as the sole
ration to provide 85 to 240
milligrams per head per day.
Not for use in animals intended for breeding.
Sponsor
066104
(ii) [Reserved]
Dated: February 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–03596 Filed 2–23–17; 8:45 am]
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 174
[EPA–HQ–OPP–2014–0457; FRL–9957–97]
BILLING CODE 4164–01–P
pmangrum on DSK3GDR082PROD with RULES
VNT1 Protein in Potato; Exemption
From the Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of VNT1 protein
in potato when used as a plant-
SUMMARY:
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14:13 Feb 23, 2017
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incorporated protectant. J.R. Simplot
Company submitted a petition to EPA
under the Federal Food, Drug, and
Cosmetic Act (FFDCA), requesting a
permanent exemption from the
requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of VNT1 protein in potato
under FFDCA.
This regulation is effective
February 24, 2017. Objections and
requests for hearings must be received
on or before April 25, 2017 and must be
filed in accordance with the instructions
provided in 40 CFR part 178 (see also
DATES:
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]]>Agencies
[Federal Register Volume 82, Number 36 (Friday, February 24, 2017)]
[Rules and Regulations]
[Pages 11510-11513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03596]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2016-N-0002]
New Animal Drugs for Use in Animal Feed; Approval of New Animal
Drug Applications; Withdrawal of Approval of New Animal Drug
Applications
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 approval of eight supplemental new animal
drug applications (NADAs). The effect of these supplemental
applications will be to change the marketing status from over-the-
counter (OTC) use to use by veterinary feed directive (VFD) for these
antimicrobial drugs of importance to human medicine, administered to
food-producing animals in medicated feed. Where applicable, FDA is also
withdrawing approval of those parts of the NADAs that pertain to use of
these antimicrobial drugs for production indications. These actions are
being taken at the sponsors' requests because these particular
medicated feeds will no longer be manufactured or marketed. These
applications were submitted in voluntary compliance with the goals of
FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative.
In addition, the animal drug regulations are being amended to reflect
the voluntary withdrawal of approval of certain entire NADAs and
abbreviated new animal drug applications (ANADAs) that were affected by
this initiative.
DATES: This rule is effective February 24, 2017.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-402-5689,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Supplemental Approval of Revised Labeling and Withdrawal of Approval
of Portions of NADAs Pertaining to Production Indications
FDA is amending the animal drug regulations to reflect approval of
eight supplemental NADAs for revised labeling reflecting a change in
marketing status from OTC use to use by VFD for antimicrobial drugs of
importance to human medicine administered to food-producing animals in
medicated feed. Where applicable, FDA is also withdrawing approval of
those parts of the NADAs that pertain to use of these antimicrobial
drugs for production indications. These actions are being taken at the
sponsors' requests because these particular medicated feeds will no
longer be manufactured or marketed.
These applications were identified as being affected by guidance
for industry (GFI) #213, ``New Animal Drugs and
[[Page 11511]]
New Animal Drug Combination Products Administered in or on Medicated
Feed or Drinking Water of Food-Producing Animals: Recommendations for
Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI
#209'', December 2013 (https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM299624.pdf). Their
change from OTC to VFD marketing status is consistent with FDA CVM's
initiative for the Judicious Use of Antimicrobials.
The affected applications for Type A medicated articles for which
supplemental applications with revised labeling were approved are as
follows:
------------------------------------------------------------------------
File No. Animal drug product Sponsor
------------------------------------------------------------------------
091-467................ STAFAC 500 Phibro Animal Health
(virginiamycin) Type A Corp., GlenPointe
Medicated Article. Centre East, 3d
Floor, 300 Frank W.
Burr Blvd., Suite 21,
Teaneck, NJ 07666
(Phibro Animal Health
Corp.).
140-998................ V-MAX (virginiamycin) Phibro Animal Health
Type A Medicated Corp.
Article.
------------------------------------------------------------------------
The affected applications for manufacturing combination drug
medicated feeds follow:
------------------------------------------------------------------------
File No. Animal drug product Sponsor
------------------------------------------------------------------------
046-718................ TERRAMYCIN Zoetis Inc., 333
(oxytetracycline)/MGA Portage St.,
(melengestrol acetate). Kalamazoo, MI 49007
(Zoetis Inc.).
046-719................ TERRAMYCIN Zoetis Inc.
(oxytetracycline)/MGA
(melengestrol acetate).
140-579................ TERRAMYCIN Zoetis Inc.
(oxytetracycline)/
BOVATEC (lasalocid).
141-114................ STAFAC (virginiamycin)/ Phibro Animal Health
AVIAX (semduramicin). Corp.
141-289................ STAFAC (virginiamycin)/ Phibro Animal Health
AVIAX II Corp.
(semduramicin)
(biomass).
141-430................ STAFAC (virginiamycin)/ Phibro Animal Health
COBAN (monensin). Corp.
------------------------------------------------------------------------
II. Withdrawals of Approval
At the sponsors' requests, approval of applications is being
withdrawn for medicated feeds containing antimicrobial drugs of
importance to human medicine administered to food-producing animals
because these products are no longer manufactured or marketed. The
applications being withdrawn are as follows:
------------------------------------------------------------------------
File No. Product name Sponsor
------------------------------------------------------------------------
044-820................ LINCOMIX (lincomycin)/ Zoetis Inc., 333
AMPROL PLUS (amprolium Portage St.,
and ethopabate). Kalamazoo, MI 49007
(Zoetis Inc.).
044-972................ LINCOMIX (lincomycin)/ Zoetis Inc.
COYDEN (clopidol).
047-261................ LINCOMIX (lincomycin)/ Zoetis Inc.
DECCOX (decoquinate).
047-262................ LINCOMIX (lincomycin)/ Zoetis Inc.
DECCOX (decoquinate).
048-954................ LINCOMIX (lincomycin)/ Zoetis Inc.
ZOAMIX (zoalene).
091-513................ STAFAC (virginiamycin) Phibro Animal Health
Type A Medicated Corp., GlenPointe
Article. Centre East, 3d
Floor, 300 Frank W.
Burr Blvd., Suite 21,
Teaneck, NJ 07666
(Phibro Animal Health
Corp.).
092-482................ LINCOMIX (lincomycin)/ Zoetis Inc.
COBAN (monensin).
093-106................ LINCOMIX (lincomycin)/ Zoetis Inc.
ROBENZ (robenidine).
101-689................ LINCOMIX (lincomycin)/ Zoetis Inc.
AVATEC (lasalocid).
122-481................ STAFAC (virginiamycin)/ Phibro Animal Health
COBAN (monensin). Corp.
122-608................ STAFAC (virginiamycin)/ Phibro Animal Health
AVATEC (lasalocid). Corp.
122-822................ STAFAC (virginiamycin)/ Phibro Animal Health
AMPROL PLUS (amprolium Corp.
and ethopabate).
137-537................ LINCOMIX (lincomycin)/ Zoetis Inc.
BIO-COX (salinomycin).
138-792................ TYLAN (tylosin)/ Zoetis Inc.
RUMENSIN (monensin)/
MGA (melengestrol
acetate).
138-828................ STAFAC (virginiamycin)/ Phibro Animal Health
BIO-COX (salinomycin). Corp.
138-904................ TYLAN (tylosin)/BOVATEC Zoetis Inc.
(lasalocid)/MGA
(melengestrol acetate).
141-110................ STAFAC (virginiamycin)/ Phibro Animal Health
COBAN (monensin). Corp.
141-150................ STAFAC (virginiamycin)/ Phibro Animal Health
AVATEC (lasalocid). Corp.
200-092................ STAFAC (virginiamycin)/ Huvepharma EOOD, 5th
SACOX (salinomycin). Floor, 3A Nikolay
Haytov Str., 1113
Sophia, Bulgaria
(Huvepharma EOOD).
200-093................ LINCOMIX (lincomycin)/ Huvepharma EOOD.
SACOX (salinomycin).
------------------------------------------------------------------------
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 044-820, 044-972, 047-261, 047-262, 048-954,
091-513, 092-482, 093-106, 101-689, 122-481, 122-608, 122-822, 137-537,
138-792, 138-828, 138-904, 141-110, and 141-150, and ANADAs 200-092 and
200-093, and all supplements and amendments thereto, is withdrawn,
effective February 24, 2017. As provided in the regulatory text of this
document, the animal drug
[[Page 11512]]
regulations are amended to reflect these voluntary withdrawals of
approval.
A similar rule published in the Federal Register of December 27,
2016 (81 FR 94991), amended the approved conditions of use in 21 CFR
part 558 to reflect approval of an additional 106 supplemental NADAs
and supplemental ANADAs for the manufacture of medicated feeds for
administration of antimicrobial drugs to food-producing animals and the
voluntary withdrawal of approval of 11 NADAs and 4 ANADAs.
This rule 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.
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is
amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
2. In Sec. 558.450, redesignate paragraph (e)(4)(iii) as paragraph
(e)(4)(v) and add paragraphs (e)(4)(iii) and (iv) to read as follows:
Sec. 558.450 Oxytetracycline.
* * * * *
(e) * * *
(4) Cattle--
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Oxytetracycline amount ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(iii) 75 mg/head/day.............. Lasalocid 25 to 30.. Heifers fed in Feed continuously to 054771
confinement for provide 250 to 360
slaughter (over 400 mg lasalocid and 75
lb): For reduction mg of
of incidence of oxytetracycline per
liver abscesses; head per day.
and for increased Lasalocid as
rate of weight gain provided by No.
and improved feed 054771 in Sec.
efficiency. 510.600(c) of this
chapter.
(iv) 75 mg/head/day............... Melengestrol Heifers fed in Feed continuously to 054771
acetate, 0.25 to confinement for provide 0.25 to 0.5
2.0. slaughter (over 400 mg of melengestrol
lb): For reduction acetate and 75 mg
of incidence of of oxytetracycline
liver abscesses; per head per day.
and for increased Melengestrol as
rate of weight provided by No.
gain, improved feed 054771 in Sec.
efficiency, and 510.600(c) of this
suppression of chapter.
estrus (heat).
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
0
3. In Sec. 558.635, revise paragraphs (a) and (e) and add paragraphs
(d)(1) and (2) to read as follows:
Sec. 558.635 Virginiamycin.
(a) Specifications. Type A medicated articles containing 10, 20,
50, or 227 grams virginiamycin per pound.
* * * * *
(d) Special considerations. (1) Federal law restricts medicated
feed containing this veterinary feed directive (VFD) drug to use by or
on the order of a licensed veterinarian. See Sec. 558.6 for additional
requirements.
(2) The expiration date of VFDs for virginiamycin medicated feeds
must not exceed 6 months from the date of issuance. VFDs for
virginiamycin shall not be refilled.
* * * * *
(e) Conditions of use--(1) Chickens--
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Virginiamycin grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 20............................ .................... Broiler chickens: Not for use in 066104
For prevention of layers.
necrotic enteritis
caused by
Clostridium spp.
susceptible to
virginiamycin.
(ii)-(vi) [Reserved]
(vii) 20.......................... Monensin, 90 to 110. Broiler chickens: Feed continuously as 066104
For prevention of the sole ration. Do
necrotic enteritis not feed to laying
caused by chickens. Monensin
Clostridium spp. as provided by No.
susceptible to 058198 in Sec.
virginiamycin; and 510.600(c) of this
as an aid in the chapter.
prevention of
coccidiosis caused
by Eimeria
necatrix, E.
tenella, E.
acervulina, E.
brunetti, E.
maxima, and E.
mivati.
(viii) [Reserved]
[[Page 11513]]
(ix) 20........................... Semduramicin, 22.7.. Broiler chickens: Feed continuously as 066104
For prevention of the sole ration. Do
necrotic enteritis not feed to laying
caused by hens. Semduramicin
Clostridium spp. as provided by No.
susceptible to 066104 in Sec.
virginiamycin; for 510.600(c) of this
the prevention of chapter.
coccidiosis caused
by Eimeria
acervulina, E.
brunetti, E.
maxima, E mivati/
mitis, E. necatrix,
and E. tenella.
(x) 20............................ Semduramicin Broiler chickens: Feed continuously as 066104
(biomass), 22.7. For prevention of the sole ration.
necrotic enteritis Withdraw 1 day
caused by before slaughter.
Clostridium spp. Do not feed to
susceptible to laying hens.
virginiamycin; for Semduramicin as
the prevention of provided by No.
coccidiosis caused 066104 in Sec.
by Eimeria 510.600(c) of this
acervulina, E. chapter.
brunetti, E.
maxima, E mivati/
mitis, E. necatrix,
and E. tenella.
----------------------------------------------------------------------------------------------------------------
(2) Swine--
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Virginiamycin grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 25............................ .................... Growing-finishing .................... 066104
swine: As an aid in
control of
dysentery in swine
up to 120 pounds in
animals or on
premises with a
history of swine
dysentery but where
symptoms have not
yet occurred.
(ii) 50 or 100.................... .................... Growing-finishing Feed 100 grams per 066104
swine: For ton for 2 weeks, 50
treatment and grams per ton
control of swine thereafter.
dysentery in swine
up to 120 pounds.
(iii) 100......................... .................... Growing-finishing Feed for 2 weeks.... 066104
swine: For
treatment of swine
dysentery in
nonbreeding swine
over 120 pounds.
----------------------------------------------------------------------------------------------------------------
(3) Cattle--
----------------------------------------------------------------------------------------------------------------
Combination in grams/
Virginiamycin grams/ton ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 13.5 to 16.0.................. .................... Cattle fed in Feed continuously as 066104
confinement for the sole ration to
slaughter: For provide 85 to 240
reduction of milligrams per head
incidence of liver per day. Not for
abscesses. use in animals
intended for
breeding.
(ii) [Reserved]
----------------------------------------------------------------------------------------------------------------
Dated: February 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-03596 Filed 2-23-17; 8:45 am]
BILLING CODE 4164-01-P
