New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
Federal Register, Volume 82 Issue 36 (Friday, February 24, 2017)
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
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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.
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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:
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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
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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 (http://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:
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File No. Animal drug product Sponsor
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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.
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The affected applications for manufacturing combination drug medicated feeds follow:
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File No. Animal drug product Sponsor
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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.
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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:
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File No. Product name Sponsor
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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).
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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
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The authority citation for part 558 continues to read as follows:
Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
0
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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--
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Combination in grams/
Oxytetracycline amount ton Indications for use Limitations Sponsor
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* * * * * * *
(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).
* * * * * * *
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* * * * *
0
-
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--
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Combination in grams/
Virginiamycin grams/ton ton Indications for use Limitations Sponsor
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(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
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(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.
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(2) Swine--
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Combination in grams/
Virginiamycin grams/ton ton Indications for use Limitations Sponsor
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(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.
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(3) Cattle--
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Combination in grams/
Virginiamycin grams/ton ton Indications for use Limitations Sponsor
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(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
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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
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