New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address, 37617-37621 [2014-15276]
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37617
Rules and Regulations
Federal Register
Vol. 79, No. 127
Wednesday, July 2, 2014
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
21 CFR Parts 510, 520, 522, 529, 556,
and 558
[Docket No. FDA–2014–N–0002]
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019,
george.haibel@fda.hhs.gov.
FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during April and May 2014, as
listed in table 1. In addition, FDA is
informing the public of the availability,
where applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
review of safety or effectiveness data,
summaries of the basis of approval (FOI
Summaries under the Freedom of
Information Act (FOIA). These public
documents may be seen in the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
SUPPLEMENTARY INFORMATION:
New Animal Drugs; Afoxalaner;
Ceftiofur Crystalline Free Acid;
Chloramine-T; Clodronate;
Enrofloxacin; Eprinomectin;
Fluralaner; Ivermectin and
Praziquantel; Niclosamide;
Ractopamine; Tylosin; Change of
Sponsor’s Address
AGENCY:
applications (NADAs) and abbreviated
new animal drug applications
(ANADAs) during April and May 2014.
FDA is also informing the public of the
availability of summaries of the basis of
approval and of environmental review
documents, where applicable. The
animal drug regulations are also being
amended to remove an obsolete entry
for a drug for which approval was
withdrawn in 1996.
DATES: This rule is effective July 2,
2014.
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 actions for new animal drug
SUMMARY:
20852, between 9 a.m. and 4 p.m.,
Monday through Friday. Persons with
access to the Internet may obtain these
documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/
AboutFDA/CentersOffices/
OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Marketing exclusivity and
patent information may be accessed in
FDA’s publication, Approved Animal
Drug Products Online (Green Book) at
https://www.fda.gov/AnimalVeterinary/
Products/
ApprovedAnimalDrugProducts/
default.htm.
Also, the regulations are being
amended in 21 CFR 510.600 to reflect a
change of address for Dechra, Ltd.; in 21
CFR 522.313a to reflect the previous
approval of revised food safety warnings
for ceftiofur sodium powder for
injection; and in 21 CFR 558.4 to
remove a listing for niclosamide which
remained codified, in error, following
the voluntary withdrawal of approval of
the sole NADA for a niclosamide
medicated feed (61 FR 34727, July 3,
1996). These amendments are being
made to improve the accuracy of the
regulations.
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.
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL AND MAY 2014
NADA/A ANADA
New animal drug
product name
Sponsor
Action
Original approval for
the treatment and
control of gastrointestinal nematodes,
cestodes, and tapeworms parasites in
horses over 5
months of age.
Original approval for
control of mortality in
certain freshwater
fish due to
Flavobacterium spp.
Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA
30096–4640.
DUOCARE (ivermectin
1.87% and
praziquantel 23.38%)
Paste.
141–423 .......................
wreier-aviles on DSK5TPTVN1PROD with RULES
141–421 .......................
Axcentive SARL, Chemin de Champouse,
Quartier Violesi,
13320 Bouc Bel Air,
France.
HALAMID (chloramine-T powder for
immersion) Aqua.
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21 CFR
section
FOIA
summary
NEPA
review
520.1198
yes ......
CE.1 2
510.600
529.382
556.118
yes ......
EA/FONSI.3
02JYR1
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Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Rules and Regulations
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL AND MAY 2014—Continued
Sponsor
New animal drug
product name
Action
141–426 .......................
Intervet, Inc., 556 Morris Ave., Summit, NJ
07901.
BRAVECTO
(fluralaner)
Chewable Tablets for
Dogs.
520.998
yes ......
CE.1 2
141–427 .......................
Dechra, Ltd., Snaygill
Industrial Estate,
Keighley Road,
Skipton, North Yorkshire, BD23 2RW,
United Kingdom.
Elanco Animal Health,
A Division of Eli Lilly
& Co., Lilly Corporate Center, Indianapolis, IN 46285.
OSPHOS (clodronate
injection).
Original approval for
the treatment and
prevention of flea infestations, and the
treatment and control
of tick infestations in
dogs and puppies.
Original approval for
the control of clinical
signs associated with
navicular syndrome
in horses.
522.454
yes ......
CE.1 2
520.2640
no ........
CE.1 5
141–327 .......................
Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA
30096–4640.
LONGRANGE
(eprinomectin) Extended-Release
Injectable
Parasiticide.
522.814
yes ......
CE.1 5
141–406 .......................
Merial Ltd., 3239 Satellite Blvd., Bldg.
500, Duluth, GA
30096–4640.
NEXGARD
(afoxolaner)
Chewable Tablets.
520.43
yes ......
CE.1 2
200–513 .......................
Norbrook Laboratories,
Ltd., Station Works,
Newry BT35 6JP,
Northern Ireland.
Huvepharma AD, 5th
Floor, 3A Nikolay
Haytov Str., 1113
Sophia, Bulgaria.
ENROFLOX
(enrofloxacin) Injection for Dogs 2.27%.
Supplemental approval
of a change in marketing status from
over-the-counter
(OTC) to by veterinary prescription
(Rx).
Supplemental approval
adding treatment and
control of a gastrointestinal roundworm
with 150 days of persistent effectiveness.
Supplemental approval
for the treatment and
control of two additional species of tick
in dogs and puppies.
Original approval as a
generic copy of
NADA 140–913.
522.812
yes ......
CE.1 5
Original approval as a
generic copy of
NADA 141–172.
558.500
yes ......
CE.1 6
Original approval as a
generic copy of
NADA 141–172.
New 522.500
yes ......
CE.1 6
Original approval as a
generic copy of
NADA 141–224.
558.500
yes ......
CE.1 6
013–076 4 .....................
200–530 .......................
Zoetis Inc., 333 Portage St., Kalamazoo,
MI 49007.
200–561 .......................
wreier-aviles on DSK5TPTVN1PROD with RULES
200–558 .......................
Zoetis Inc., 333 Portage St., Kalamazoo,
MI 49007.
TYLAN (tylosin tartrate)
Soluble Powder.
TYLOVET 100 (tylosin
phosphate) plus
PAYLEAN
(ractopamine HCl)
Type B and C medicated feeds.
ENGAIN 9 and 45
(ractopamine HCl)
plus TYLAN 100
(tylosin phosphate)
Type B and C medicated feeds.
ACTOGAIN 45
(ractopamine HCl),
RUMENSIN
(monensin), and
TYLAN 100 (tylosin
phosphate) Type B
and C medicated
feeds.
21 CFR
section
FOIA
summary
NADA/A ANADA
NEPA
review
1 The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the human environment.
2 CE granted under 21 CFR 25.33(d)(1).
3 The Agency has carefully considered an EA of the potential environmental impact of this action and has made a finding of no significant impact (FONSI).
4 The NADA listed was identified as being affected by guidance for industry (GFI) #213, ‘‘New Animal Drugs and 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.
5 CE granted under 21 CFR 25.33(a)(1).
6 CE granted under 21 CFR 25.33(a)(2).
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Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Rules and Regulations
List of Subjects
Drug labeler code
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
*
*
*
043264 ......................
21 CFR Parts 520, 522, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
*
21 CFR Part 558
*
Animal drugs, Animal feeds.
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
Drug labeler
code
Firm name and address
*
*
*
*
Axcentive SARL, Chemin de
Champouse, Quartier
Violesi, 13320 Bouc Bel
Air, France ........................
wreier-aviles on DSK5TPTVN1PROD with RULES
*
*
*
*
Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd.,
Skipton, North Yorkshire,
BD23 2RW, United Kingdom ...................................
*
*
*
*
(2) * * *
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*
Dechra, Ltd., Snaygill
Industrial Estate,
Keighley Rd.,
Skipton, North
Yorkshire, BD23
2RW, United Kingdom
*
*
Axcentive SARL,
Chemin de
Champouse,
Quartier Violesi,
13320 Bouc Bel
Air, France
*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
4. In § 520.43, revise paragraph (c)(2)
to read as follows:
■
2. In § 510.600, in the table in
paragraph (c)(1), alphabetically add an
entry for ‘‘Axcentive SARL’’ and revise
the entry for ‘‘Dechra, Ltd.’’; and in the
table in paragraph (c)(2), revise the entry
for ‘‘043264’’ and numerically add an
entry for ‘‘086009’’ to read as follows:
■
*
*
(c) * * *
(1) * * *
*
*
Authority: 21 U.S.C. 360b.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
*
*
*
*
086009 ......................
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 parts 510, 520, 522, 529, 556, and
558 are amended as follows:
Firm name and address
§ 520.43
Afoxolaner.
*
*
*
*
*
(c) * * *
(2) Indications for use. Kills adult
fleas; for the treatment and prevention
of flea infestations (Ctenocephalides
felis); and for the treatment and control
of black-legged tick (Ixodes scapularis),
American Dog tick (Dermacentor
variabilis), and lone star tick
(Amblyomma americanum) infestations
in dogs and puppies 8 weeks of age and
older, weighing 4 lb of body weight or
greater, for 1 month.
*
*
*
*
*
■ 5. Section 520.998 is added to read as
follows:
§ 520.998
Fluralaner.
(a) Specifications. Each chewable
tablet contains 112.5, 250, 500, 1000, or
1400 milligrams (mg) fluralaner.
086009
(b) Sponsor. See No. 000061 in
§ 510.600(c) of this chapter.
*
(c) Conditions of use in dogs—(1)
Amount. Administer orally as a single
dose every 12 weeks according to the
label dosage schedule to provide a
minimum dose of 11.4 mg per pound
043264 (/lb) (25 mg per kilogram) body weight.
May be administered every 8 weeks in
*
case of potential exposure to
Amblyomma americanum ticks.
(2) Indications for use. Kills adult
fleas; for the treatment and prevention
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37619
of flea infestations (Ctenocephalides
felis), and the treatment and control of
tick infestations [Ixodes scapularis
(black-legged tick), Dermacentor
variabilis (American dog tick), and
Rhipicephalus sanguineus (brown dog
tick)] for 12 weeks in dogs and puppies
6 months of age and older, and weighing
4.4 lb or greater; for the treatment and
control of A. americanum (lone star
tick) infestations for 8 weeks in dogs
and puppies 6 months of age and older,
and weighing 4.4 lb or greater.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
■ 6. In § 520.1198, add paragraphs
(a)(3), (b)(3), and (d)(1)(iii); and revise
paragraph (d)(2) to read as follows:
§ 520.1198
paste.
Ivermectin and praziquantel
(a) * * *
(3) 0.0187 mg (1.87 percent)
ivermectin and 0.2338 mg (23.38
percent) praziquantel.
(b) * * *
(3) No. 050604 for use of products
described in paragraph (a)(3) of this
section as in paragraphs (d)(1)(iii),
(d)(2)(iii) and (d)(3) of this section.
*
*
*
*
*
(d) * * *
(1) * * *
(iii) 200 mcg/kg ivermectin (91 mcg/
lb) and 2.5 mg/kg praziquantel (1.14 mg/
lb).
(2) Indications for use—(i) For
treatment and control of the following
parasites: Tapeworms—Anoplocephala
perfoliata; Large Strongyles (adults)—
Strongylus vulgaris (also early forms in
blood vessels), S. edentatus (also tissue
stages), S. equinus, Triodontophorus
spp. including T. brevicauda and T.
serratus, and Craterostomum
acuticaudatum; Small Strongyles
(adults, including those resistant to
some benzimidazole class
compounds)—Coronocyclus spp.
including C. coronatus, C. labiatus, and
C. labratus; Cyathostomum spp.
including C. catinatum and C.
pateratum; Cylicocyclus spp. including
C. insigne, C. leptostomum, C. nassatus,
and C. brevicapsulatus;
Cylicodontophorus spp.;
Cylicostephanus spp. including C.
calicatus, C. goldi, C. longibursatus, and
C. minutus, and Petrovinema
poculatum; Small Strongyles—fourthstage larvae; Pinworms (adults and
fourth-stage larvae)—Oxyuris equi;
Ascarids (adults and third- and fourthstage larvae)—Parascaris equorum;
Hairworms (adults)—Trichostrongylus
axei; Large-mouth Stomach Worms
(adults)—Habronema muscae; Bots (oral
and gastric stages)—Gasterophilus spp.
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Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Rules and Regulations
including G. intestinalis and G. nasalis;
Lungworms (adults and fourth-stage
larvae)—Dictyocaulus arnfieldi;
Intestinal Threadworms (adults)—
Strongyloides westeri; Summer Sores
caused by Habronema and Draschia
spp. cutaneous third-stage larvae;
Dermatitis caused by neck threadworm
microfilariae of Onchocerca sp.
(ii) For treatment and control of the
following parasites: Tapeworms—
Anoplocephala perfoliata; Large
Strongyles (adults)—Strongylus vulgaris
(also early forms in blood vessels), S.
edentatus (also tissue stages), S.
equinus, Triodontophorus spp.; Small
Strongyles (adults, including those
resistant to some benzimidazole class
compounds)—Cyathostomum spp.;
Cylicocyclus spp.; Cylicostephanus spp.,
Cylicodontophorus spp.; Small
Strongyles—fourth-stage larvae;
Pinworms (adults and fourth-stage
larvae)—Oxyuris equi; Ascarids (adults
and third- and fourth-stage larvae)—
Parascaris equorum; Hairworms
(adults)—Trichostrongylus axei; Largemouth Stomach Worms (adults)—
Habronema muscae; Bots (oral and
gastric stages)—Gasterophilus spp.;
Lungworms (adults and fourth-stage
larvae)—Dictyocaulus arnfieldi;
Intestinal Threadworms (adults)—
Strongyloides westeri; Summer Sores
caused by Habronema and Draschia
spp. cutaneous third-stage larvae;
Dermatitis caused by neck threadworm
microfilariae, Onchocerca sp.
(iii) For treatment and control of the
following parasites in horses over 5
months of age: Tapeworms—
Anoplocephala perfoliata; Large
Strongyles (adults)—Strongylus vulgaris
(also early forms in blood vessels), S.
edentatus (also tissue stages), S.
equinus, Triodontophorus spp.
including T. brevicauda and T. serratus,
and Craterostomum acuticaudatum;
Small Strongyles (adults, including
those resistant to some benzimidazole
class compounds)—Coronocyclus spp.
including C. coronatus, C. labiatus, and
C. labratus; Cyathostomum spp.
including C. catinatum and C.
pateratum; Cylicocyclus spp. including
C. insigne, C. leptostomum, C. nassatus,
and C. brevicapsulatus;
Cylicodontophorus spp.;
Cylicostephanus spp. including C.
calicatus, C. goldi, C. longibursatus, and
C. minutus, and Petrovinema
poculatum; Small Strongyles—fourthstage larvae; Pinworms (adults and
fourth-stage larvae)—Oxyuris equi;
Ascarids (adults and third- and fourthstage larvae)—Parascaris equorum;
Hairworms (adults)—Trichostrongylus
axei; Large-mouth Stomach Worms
(adults)—Habronema muscae; Bots (oral
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and gastric stages)—Gasterophilus spp.
including G. intestinalis and G. nasalis;
Lungworms (adults and fourth-stage
larvae)—Dictyocaulus arnfieldi;
Intestinal Threadworms (adults)—
Strongyloides westeri; Summer Sores
caused by Habronema and Draschia
spp. cutaneous third-stage larvae;
Dermatitis caused by neck threadworm
microfilariae of Onchocerca sp.
*
*
*
*
*
■ 7. Amend § 520.2640 as follows:
■ a. Revise paragraph (b);
■ b. Redesignate paragraph (d) as (e);
■ c. Add new paragraph (d); and
■ d. Revise newly designated paragraph
(e)(2)(ii).
The addition and revisions read as
follows:
§ 520.2640
Tylosin.
*
*
*
*
*
(b) Sponsors—(1) No. 000986 for use
as in paragraphs (e)(1), (e)(2)(i),
(e)(2)(ii)(A), (e)(2)(iii), (e)(3), and (e)(4)
of this section.
(2) Nos. 016592 and 061623 for use as
in paragraphs (e)(1), (e)(2)(i),
(e)(2)(ii)(B), (e)(2)(iii), (e)(3), and (e)(4)
of this section.
*
*
*
*
*
(d) Special considerations. For No.
000986, labeling shall bear ‘‘Federal law
restricts this drug to use by or on the
order of a licensed veterinarian.’’
(e) * * *
(2) * * *
(ii) Indications for use—(A) For the
reduction in severity of effects of
infectious sinusitis associated with
Mycoplasma gallisepticum.
(B) For maintaining weight gain and
feed efficiency in the presence of
infectious sinusitis associated with
Mycoplasma gallisepticum sensitive to
tylosin.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
8. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
9. In 522.313a, remove paragraph (d);
redesignate paragraph (e) as paragraph
(d); and revise newly redesignated
paragraphs (d)(1)(iii), (d)(2)(iii), and
(d)(3)(iii) to read as follows:
■
§ 522.313a
Ceftiofur crystalline free acid.
*
*
*
*
*
(d) * * *
(1) * * *
(iii) Limitations. Following label use
as a single treatment, a 14-day preslaughter withdrawal period is required.
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Federal law restricts this drug to use by
or on the order of a licensed
veterinarian. Federal law prohibits
extra-label use of this drug in swine for
disease prevention purposes; at
unapproved doses, frequencies,
durations, or routes of administration;
and in unapproved, major foodproducing species/production classes.
(2) * * *
(iii) Limitations. Following label use
as either a single-dose or 2-dose
regimen, a 13-day pre-slaughter
withdrawal period is required after the
last treatment. A withdrawal period has
not been established in preruminating
calves. Do not use in calves to be
processed for veal. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. Federal law
prohibits extra-label use of this drug in
cattle for disease prevention purposes;
at unapproved doses, frequencies,
durations, or routes of administration;
and in unapproved, major foodproducing species/production classes.
(3) * * *
(iii) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
■ 10. Add § 522.454 to read as follows:
§ 522.454
Clodronate.
(a) Specifications. Each milliliter of
solution contains 60 milligrams (mg)
clodronate disodium.
(b) Sponsor. See No. 043264 in
§ 510.600(c) of this chapter.
(c) Conditions of use in horses—(1)
Amount. Administer 1.8 mg per
kilogram of body weight by
intramuscular injection up to a
maximum dose of 900 mg per horse.
(2) Indications for use. For the control
of clinical signs associated with
navicular syndrome.
(3) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
■ 11. In § 522.812, revise paragraph
(b)(2) to read as follows:
§ 522.812
Enrofloxacin.
*
*
*
*
*
(b) * * *
(2) No. 055529 for use of product
described in paragraph (a)(1) as in
paragraph (e)(1), and use of product
described in paragraph (a)(2) as in
paragraphs (e)(2)(i)(B), (e)(2)(ii)(B),
(e)(2)(iii), (e)(3)(i), (e)(3)(ii)(B), and
(e)(3)(iii) of this section.
*
*
*
*
*
■ 12. In § 522.814, revise paragraphs
(d)(2) and (3) to read as follows:
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§ 522.814
Eprinomectin.
*
*
*
*
*
(d) * * *
(2) Indications for use. For the
treatment and control of the following
internal and external parasites:
Gastrointestinal roundworms (adults
and fourth-stage larvae) Bunostomum
phlebotomum, Cooperia oncophora, C.
punctata, C. surnabada,
Trichostrongylus axei, Ostertagia
ostertagi (including inhibited stage);
(adults) Haemonchus placei,
Oesophagostomum radiatum, O. lyrata,
T. colubriformis; lungworms (adults)
Dictyocaulus viviparus; cattle grubs
Hypoderma bovis; mites Sarcoptes
scabiei var. bovis. Prevents reinfection
with C. oncophora, C. punctata, and T.
axei for 100 days following treatment;
H. placei, O. radiatum, O. lyrata, and O.
ostertagi for 120 days following
treatment; and B. phlebotomum and D.
viviparus for 150 days following
treatment.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian. Animals
intended for human consumption must
not be slaughtered within 48 days of the
last treatment. This drug product is not
approved for use in female dairy cattle
20 months of age or older, including dry
dairy cows. Use in these cattle may
cause drug residues in milk and/or in
calves born to these cows. A withdrawal
period has not been established for preruminating calves. Do not use in calves
to be processed for veal.
PART 529—CERTAIN OTHER DOSAGE
FORM NEW ANIMAL DRUGS
13. The authority citation for 21 CFR
part 529 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
supply or as a static bath once per day
for 60 minutes on consecutive or
alternative days for three treatments.
(ii) Indications for use. For the control
of mortality in walleye due to external
columnaris disease associated with
Flavobacterium columnare.
(3) Freshwater-reared warmwater
finfish—(i) Amount. 20 mg/L water in a
continuous flow water supply or as a
static bath once per day for 60 minutes
on consecutive or alternative days for
three treatments.
(ii) Indications for use. For the control
of mortality in freshwater-reared
warmwater finfish due to external
columnaris disease associated with F.
columnare.
PART 556—TOLERANCES FOR
RESIDUES OF NEW ANIMAL DRUGS
IN FOOD
15. The authority citation for 21 CFR
part 556 continues to read as follows:
wreier-aviles on DSK5TPTVN1PROD with RULES
VerDate Mar<15>2010
14:14 Jul 01, 2014
Jkt 232001
[FR Doc. 2014–15276 Filed 6–30–14; 11:15 am]
BILLING CODE 4164–01–P
■
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
16. Add § 556.118 to read as follows:
Food and Drug Administration
§ 556.118
Chloramine-T.
(a) Acceptable Daily Intake (ADI). The
ADI for total residues of chloramine-T is
5 micrograms per kilogram of body
weight per day.
(b) Tolerances—(1) Fish—(i) Muscle/
skin (target tissue). The tolerance for
para-toluenesulfonamide (marker
residue) is 0.90 parts per million.
(ii) [Reserved]
(2) [Reserved]
(c) Related conditions of use. See
§ 529.382 of this chapter.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
17. The authority citation for 21 CFR
part 558 continues to read as follows:
■
§ 558.4
(a) Specifications. Chloramine-T
trihydrate powder for solution.
(b) Sponsor. See No. 086009 in
§ 510.600(c) of this chapter.
(c) Related tolerances. See § 556.118
of this chapter.
(d) Conditions of use—(1) Freshwaterreared salmonids—(i) Amount. 12 to 20
milligrams per liter (mg/L) water in a
continuous flow water supply or as a
static bath once per day for 60 minutes
on consecutive or alternative days for
three treatments.
(ii) Indications for use. For the control
of mortality in freshwater-reared
salmonids due to bacterial gill disease
associated with Flavobacterium spp.
(2) Walleye—(i) Amount. 10 to 20 mg/
L water in a continuous flow water
Dated: June 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
Authority: 21 U.S.C. 342, 360b, 371.
Authority: 21 U.S.C. 360b, 371.
Chloramine-T.
‘‘No. 054771’’ and in its place add ‘‘Nos.
000986 and 054771’’;
■ c. In the table in paragraph (e)(2)(x),
in the ‘‘Limitations’’ column, remove
‘‘Nos. 054771 and 021641’’ and in its
place add ‘‘Nos. 000986 and 054771’’;
and
■ d. In the table in paragraphs (e)(2)(ix)
and (xiii), in the ‘‘Limitations’’ column,
add at the end of the entry
‘‘Ractopamine as provided by Nos.
000986 or 054771 with tylosin as
provided by No. 000986 in § 510.600(c)
of this chapter.’’ and in the ‘‘Sponsor’’
column, remove ‘‘000986’’ and in its
place add ‘‘000986, 054771’’.
■
14. Add 529.382 to read as follows:
§ 529.382
37621
[Amended]
18. In § 558.4, in paragraph (d), in the
‘‘Category I’’ table, remove the entry for
‘‘Niclosamide’’.
■
§ 558.500
[Amended]
19. Amend § 558.500 as follows:
a. In the table in paragraphs (e)(1)(ii),
(iii), and (iv), in the ‘‘Limitations’’
column, add at the end of the entry
‘‘Ractopamine as provided by No.
000986 with tylosin as provided by Nos.
000986 or 016592 in § 510.600(c) of this
chapter; or ractopamine as provided by
No. 054771 with tylosin as provided by
No. 000986 in § 510.600(c) of this
chapter.’’ and in the ‘‘Sponsor’’ column,
remove ‘‘000986’’ and in its place add
‘‘000986, 016592, 054771’’;
■ b. In the table in paragraph (e)(2)(viii),
in the ‘‘Limitations’’ column, remove
■
■
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
21 CFR Part 558
[Docket No. FDA–2014–N–0002]
Withdrawal of Approval of Part of a
New Animal Drug Application;
Procaine Penicillin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of those parts of a new animal
drug application (NADA) for a threeway, fixed-ratio, combination drug Type
A medicated article that pertain to use
of the procaine penicillin component for
growth promotion indications in swine.
This action is being taken at the
sponsor’s request because the three-way
Type A medicated article is no longer
manufactured.
DATES: Withdrawal of approval is
effective July 2, 2014.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Zoetis Inc.
(Zoetis), 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw
approval of those parts of NADA 035–
688 for AUREOMIX Granular 500
(chlortetracycline, procaine penicillin,
and sulfamethazine) Type A medicated
article that pertain to use of the procaine
penicillin component for growth
SUMMARY:
E:\FR\FM\02JYR1.SGM
02JYR1
]]>Agencies
[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Rules and Regulations]
[Pages 37617-37621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15276]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Rules
and Regulations
[[Page 37617]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 529, 556, and 558
[Docket No. FDA-2014-N-0002]
New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid;
Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner;
Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change
of Sponsor's Address
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 actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during April and May 2014. FDA is also informing the public of
the availability of summaries of the basis of approval and of
environmental review documents, where applicable. The animal drug
regulations are also being amended to remove an obsolete entry for a
drug for which approval was withdrawn in 1996.
DATES: This rule is effective July 2, 2014.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9019,
george.haibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during April and May
2014, as listed in table 1. In addition, FDA is informing the public of
the availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries under the Freedom of
Information Act (FOIA). These public documents may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4
p.m., Monday through Friday. Persons with access to the Internet may
obtain these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and
patent information may be accessed in FDA's publication, Approved
Animal Drug Products Online (Green Book) at https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.
Also, the regulations are being amended in 21 CFR 510.600 to
reflect a change of address for Dechra, Ltd.; in 21 CFR 522.313a to
reflect the previous approval of revised food safety warnings for
ceftiofur sodium powder for injection; and in 21 CFR 558.4 to remove a
listing for niclosamide which remained codified, in error, following
the voluntary withdrawal of approval of the sole NADA for a niclosamide
medicated feed (61 FR 34727, July 3, 1996). These amendments are being
made to improve the accuracy of the regulations.
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.
Table 1--Original and Supplemental NADAs and ANADAs Approved During April and May 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug
NADA/ ANADA Sponsor product name Action 21 CFR section FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-421.......................... Merial Ltd., 3239 DUOCARE (ivermectin Original approval 520.1198 yes........... CE.1 2
Satellite Blvd., 1.87% and for the treatment
Bldg. 500, Duluth, praziquantel and control of
GA 30096-4640. 23.38%) Paste. gastrointestinal
nematodes,
cestodes, and
tapeworms
parasites in
horses over 5
months of age.
141-423.......................... Axcentive SARL, HALAMID Original approval 510.600 yes........... EA/FONSI.\3\
Chemin de (chloramine[dash]T for control of 529.382
Champouse, Quartier powder for mortality in 556.118
Violesi, 13320 Bouc immersion) Aqua. certain freshwater
Bel Air, France. fish due to
Flavobacterium spp.
[[Page 37618]]
141-426.......................... Intervet, Inc., 556 BRAVECTO Original approval 520.998 yes........... CE.1 2
Morris Ave., (fluralaner) for the treatment
Summit, NJ 07901. Chewable Tablets and prevention of
for Dogs. flea infestations,
and the treatment
and control of
tick infestations
in dogs and
puppies.
141-427.......................... Dechra, Ltd., OSPHOS (clodronate Original approval 522.454 yes........... CE.1 2
Snaygill Industrial injection). for the control of
Estate, Keighley clinical signs
Road, Skipton, associated with
North Yorkshire, navicular syndrome
BD23 2RW, United in horses.
Kingdom.
013-076 \4\...................... Elanco Animal TYLAN (tylosin Supplemental 520.2640 no............ CE.1 5
Health, A Division tartrate) Soluble approval of a
of Eli Lilly & Co., Powder. change in
Lilly Corporate marketing status
Center, from over-the-
Indianapolis, IN counter (OTC) to
46285. by veterinary
prescription (Rx).
141-327.......................... Merial Ltd., 3239 LONGRANGE Supplemental 522.814 yes........... CE.1 5
Satellite Blvd., (eprinomectin) approval adding
Bldg. 500, Duluth, Extended-Release treatment and
GA 30096-4640. Injectable control of a
Parasiticide. gastrointestinal
roundworm with 150
days of persistent
effectiveness.
141-406.......................... Merial Ltd., 3239 NEXGARD (afoxolaner) Supplemental 520.43 yes........... CE.1 2
Satellite Blvd., Chewable Tablets. approval for the
Bldg. 500, Duluth, treatment and
GA 30096-4640. control of two
additional species
of tick in dogs
and puppies.
200-513.......................... Norbrook ENROFLOX Original approval 522.812 yes........... CE.1 5
Laboratories, Ltd., (enrofloxacin) as a generic copy
Station Works, Injection for Dogs of NADA 140-913.
Newry BT35 6JP, 2.27%.
Northern Ireland.
200-530.......................... Huvepharma AD, 5th TYLOVET 100 (tylosin Original approval 558.500 yes........... CE.1 6
Floor, 3A Nikolay phosphate) plus as a generic copy
Haytov Str., 1113 PAYLEAN of NADA 141-172.
Sophia, Bulgaria. (ractopamine HCl)
Type B and C
medicated feeds.
200-558.......................... Zoetis Inc., 333 ENGAIN 9 and 45 Original approval New 522.500 yes........... CE.1 6
Portage St., (ractopamine HCl) as a generic copy
Kalamazoo, MI 49007. plus TYLAN 100 of NADA 141-172.
(tylosin phosphate)
Type B and C
medicated feeds.
200-561.......................... Zoetis Inc., 333 ACTOGAIN 45 Original approval 558.500 yes........... CE.1 6
Portage St., (ractopamine HCl), as a generic copy
Kalamazoo, MI 49007. RUMENSIN of NADA 141-224.
(monensin), and
TYLAN 100 (tylosin
phosphate) Type B
and C medicated
feeds.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
assessment or an environmental impact statement because it is of a type that does not individually or cumulatively have a significant effect on the
human environment.
\2\ CE granted under 21 CFR 25.33(d)(1).
\3\ The Agency has carefully considered an EA of the potential environmental impact of this action and has made a finding of no significant impact
(FONSI).
\4\ The NADA listed was identified as being affected by guidance for industry (GFI) 213, ``New Animal Drugs and 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.
\5\ CE granted under 21 CFR 25.33(a)(1).
\6\ CE granted under 21 CFR 25.33(a)(2).
[[Page 37619]]
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522, and 529
Animal drugs.
21 CFR Part 556
Animal drugs, Foods.
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 parts 510,
520, 522, 529, 556, and 558 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``Axcentive SARL'' and revise the entry for ``Dechra,
Ltd.''; and in the table in paragraph (c)(2), revise the entry for
``043264'' and numerically add an entry for ``086009'' to read as
follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
Axcentive SARL, Chemin de Champouse, Quartier Violesi, 086009
13320 Bouc Bel Air, France.............................
* * * * *
Dechra, Ltd., Snaygill Industrial Estate, Keighley Rd., 043264
Skipton, North Yorkshire, BD23 2RW, United Kingdom.....
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
043264.................................... Dechra, Ltd., Snaygill
Industrial Estate, Keighley
Rd., Skipton, North
Yorkshire, BD23 2RW, United
Kingdom
* * * * *
086009.................................... Axcentive SARL, Chemin de
Champouse, Quartier
Violesi, 13320 Bouc Bel
Air, France
* * * * *
------------------------------------------------------------------------
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 520.43, revise paragraph (c)(2) to read as follows:
Sec. 520.43 Afoxolaner.
* * * * *
(c) * * *
(2) Indications for use. Kills adult fleas; for the treatment and
prevention of flea infestations (Ctenocephalides felis); and for the
treatment and control of black-legged tick (Ixodes scapularis),
American Dog tick (Dermacentor variabilis), and lone star tick
(Amblyomma americanum) infestations in dogs and puppies 8 weeks of age
and older, weighing 4 lb of body weight or greater, for 1 month.
* * * * *
0
5. Section 520.998 is added to read as follows:
Sec. 520.998 Fluralaner.
(a) Specifications. Each chewable tablet contains 112.5, 250, 500,
1000, or 1400 milligrams (mg) fluralaner.
(b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in dogs--(1) Amount. Administer orally as a
single dose every 12 weeks according to the label dosage schedule to
provide a minimum dose of 11.4 mg per pound (/lb) (25 mg per kilogram)
body weight. May be administered every 8 weeks in case of potential
exposure to Amblyomma americanum ticks.
(2) Indications for use. Kills adult fleas; for the treatment and
prevention of flea infestations (Ctenocephalides felis), and the
treatment and control of tick infestations [Ixodes scapularis (black-
legged tick), Dermacentor variabilis (American dog tick), and
Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and
puppies 6 months of age and older, and weighing 4.4 lb or greater; for
the treatment and control of A. americanum (lone star tick)
infestations for 8 weeks in dogs and puppies 6 months of age and older,
and weighing 4.4 lb or greater.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
6. In Sec. 520.1198, add paragraphs (a)(3), (b)(3), and (d)(1)(iii);
and revise paragraph (d)(2) to read as follows:
Sec. 520.1198 Ivermectin and praziquantel paste.
(a) * * *
(3) 0.0187 mg (1.87 percent) ivermectin and 0.2338 mg (23.38
percent) praziquantel.
(b) * * *
(3) No. 050604 for use of products described in paragraph (a)(3) of
this section as in paragraphs (d)(1)(iii), (d)(2)(iii) and (d)(3) of
this section.
* * * * *
(d) * * *
(1) * * *
(iii) 200 mcg/kg ivermectin (91 mcg/lb) and 2.5 mg/kg praziquantel
(1.14 mg/lb).
(2) Indications for use--(i) For treatment and control of the
following parasites: Tapeworms--Anoplocephala perfoliata; Large
Strongyles (adults)--Strongylus vulgaris (also early forms in blood
vessels), S. edentatus (also tissue stages), S. equinus,
Triodontophorus spp. including T. brevicauda and T. serratus, and
Craterostomum acuticaudatum; Small Strongyles (adults, including those
resistant to some benzimidazole class compounds)--Coronocyclus spp.
including C. coronatus, C. labiatus, and C. labratus; Cyathostomum spp.
including C. catinatum and C. pateratum; Cylicocyclus spp. including C.
insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus;
Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C.
goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum;
Small Strongyles--fourth-stage larvae; Pinworms (adults and fourth-
stage larvae)--Oxyuris equi; Ascarids (adults and third- and fourth-
stage larvae)--Parascaris equorum; Hairworms (adults)--Trichostrongylus
axei; Large-mouth Stomach Worms (adults)--Habronema muscae; Bots (oral
and gastric stages)--Gasterophilus spp.
[[Page 37620]]
including G. intestinalis and G. nasalis; Lungworms (adults and fourth-
stage larvae)--Dictyocaulus arnfieldi; Intestinal Threadworms
(adults)--Strongyloides westeri; Summer Sores caused by Habronema and
Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck
threadworm microfilariae of Onchocerca sp.
(ii) For treatment and control of the following parasites:
Tapeworms--Anoplocephala perfoliata; Large Strongyles (adults)--
Strongylus vulgaris (also early forms in blood vessels), S. edentatus
(also tissue stages), S. equinus, Triodontophorus spp.; Small
Strongyles (adults, including those resistant to some benzimidazole
class compounds)--Cyathostomum spp.; Cylicocyclus spp.; Cylicostephanus
spp., Cylicodontophorus spp.; Small Strongyles--fourth-stage larvae;
Pinworms (adults and fourth-stage larvae)--Oxyuris equi; Ascarids
(adults and third- and fourth-stage larvae)--Parascaris equorum;
Hairworms (adults)--Trichostrongylus axei; Large-mouth Stomach Worms
(adults)--Habronema muscae; Bots (oral and gastric stages)--
Gasterophilus spp.; Lungworms (adults and fourth-stage larvae)--
Dictyocaulus arnfieldi; Intestinal Threadworms (adults)--Strongyloides
westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous
third-stage larvae; Dermatitis caused by neck threadworm microfilariae,
Onchocerca sp.
(iii) For treatment and control of the following parasites in
horses over 5 months of age: Tapeworms--Anoplocephala perfoliata; Large
Strongyles (adults)--Strongylus vulgaris (also early forms in blood
vessels), S. edentatus (also tissue stages), S. equinus,
Triodontophorus spp. including T. brevicauda and T. serratus, and
Craterostomum acuticaudatum; Small Strongyles (adults, including those
resistant to some benzimidazole class compounds)--Coronocyclus spp.
including C. coronatus, C. labiatus, and C. labratus; Cyathostomum spp.
including C. catinatum and C. pateratum; Cylicocyclus spp. including C.
insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus;
Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C.
goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum;
Small Strongyles--fourth-stage larvae; Pinworms (adults and fourth-
stage larvae)--Oxyuris equi; Ascarids (adults and third- and fourth-
stage larvae)--Parascaris equorum; Hairworms (adults)--Trichostrongylus
axei; Large-mouth Stomach Worms (adults)--Habronema muscae; Bots (oral
and gastric stages)--Gasterophilus spp. including G. intestinalis and
G. nasalis; Lungworms (adults and fourth-stage larvae)--Dictyocaulus
arnfieldi; Intestinal Threadworms (adults)--Strongyloides westeri;
Summer Sores caused by Habronema and Draschia spp. cutaneous third-
stage larvae; Dermatitis caused by neck threadworm microfilariae of
Onchocerca sp.
* * * * *
0
7. Amend Sec. 520.2640 as follows:
0
a. Revise paragraph (b);
0
b. Redesignate paragraph (d) as (e);
0
c. Add new paragraph (d); and
0
d. Revise newly designated paragraph (e)(2)(ii).
The addition and revisions read as follows:
Sec. 520.2640 Tylosin.
* * * * *
(b) Sponsors--(1) No. 000986 for use as in paragraphs (e)(1),
(e)(2)(i), (e)(2)(ii)(A), (e)(2)(iii), (e)(3), and (e)(4) of this
section.
(2) Nos. 016592 and 061623 for use as in paragraphs (e)(1),
(e)(2)(i), (e)(2)(ii)(B), (e)(2)(iii), (e)(3), and (e)(4) of this
section.
* * * * *
(d) Special considerations. For No. 000986, labeling shall bear
``Federal law restricts this drug to use by or on the order of a
licensed veterinarian.''
(e) * * *
(2) * * *
(ii) Indications for use--(A) For the reduction in severity of
effects of infectious sinusitis associated with Mycoplasma
gallisepticum.
(B) For maintaining weight gain and feed efficiency in the presence
of infectious sinusitis associated with Mycoplasma gallisepticum
sensitive to tylosin.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
9. In 522.313a, remove paragraph (d); redesignate paragraph (e) as
paragraph (d); and revise newly redesignated paragraphs (d)(1)(iii),
(d)(2)(iii), and (d)(3)(iii) to read as follows:
Sec. 522.313a Ceftiofur crystalline free acid.
* * * * *
(d) * * *
(1) * * *
(iii) Limitations. Following label use as a single treatment, a 14-
day pre-slaughter withdrawal period is required. Federal law restricts
this drug to use by or on the order of a licensed veterinarian. Federal
law prohibits extra-label use of this drug in swine for disease
prevention purposes; at unapproved doses, frequencies, durations, or
routes of administration; and in unapproved, major food-producing
species/production classes.
(2) * * *
(iii) Limitations. Following label use as either a single-dose or
2-dose regimen, a 13-day pre-slaughter withdrawal period is required
after the last treatment. A withdrawal period has not been established
in preruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian. Federal law prohibits extra-label use of this drug in
cattle for disease prevention purposes; at unapproved doses,
frequencies, durations, or routes of administration; and in unapproved,
major food-producing species/production classes.
(3) * * *
(iii) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
0
10. Add Sec. 522.454 to read as follows:
Sec. 522.454 Clodronate.
(a) Specifications. Each milliliter of solution contains 60
milligrams (mg) clodronate disodium.
(b) Sponsor. See No. 043264 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in horses--(1) Amount. Administer 1.8 mg per
kilogram of body weight by intramuscular injection up to a maximum dose
of 900 mg per horse.
(2) Indications for use. For the control of clinical signs
associated with navicular syndrome.
(3) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
0
11. In Sec. 522.812, revise paragraph (b)(2) to read as follows:
Sec. 522.812 Enrofloxacin.
* * * * *
(b) * * *
(2) No. 055529 for use of product described in paragraph (a)(1) as
in paragraph (e)(1), and use of product described in paragraph (a)(2)
as in paragraphs (e)(2)(i)(B), (e)(2)(ii)(B), (e)(2)(iii), (e)(3)(i),
(e)(3)(ii)(B), and (e)(3)(iii) of this section.
* * * * *
0
12. In Sec. 522.814, revise paragraphs (d)(2) and (3) to read as
follows:
[[Page 37621]]
Sec. 522.814 Eprinomectin.
* * * * *
(d) * * *
(2) Indications for use. For the treatment and control of the
following internal and external parasites: Gastrointestinal roundworms
(adults and fourth-stage larvae) Bunostomum phlebotomum, Cooperia
oncophora, C. punctata, C. surnabada, Trichostrongylus axei, Ostertagia
ostertagi (including inhibited stage); (adults) Haemonchus placei,
Oesophagostomum radiatum, O. lyrata, T. colubriformis; lungworms
(adults) Dictyocaulus viviparus; cattle grubs Hypoderma bovis; mites
Sarcoptes scabiei var. bovis. Prevents reinfection with C. oncophora,
C. punctata, and T. axei for 100 days following treatment; H. placei,
O. radiatum, O. lyrata, and O. ostertagi for 120 days following
treatment; and B. phlebotomum and D. viviparus for 150 days following
treatment.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Animals intended for human
consumption must not be slaughtered within 48 days of the last
treatment. This drug product is not approved for use in female dairy
cattle 20 months of age or older, including dry dairy cows. Use in
these cattle may cause drug residues in milk and/or in calves born to
these cows. A withdrawal period has not been established for pre-
ruminating calves. Do not use in calves to be processed for veal.
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
0
13. The authority citation for 21 CFR part 529 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
14. Add 529.382 to read as follows:
Sec. 529.382 Chloramine-T.
(a) Specifications. Chloramine-T trihydrate powder for solution.
(b) Sponsor. See No. 086009 in Sec. 510.600(c) of this chapter.
(c) Related tolerances. See Sec. 556.118 of this chapter.
(d) Conditions of use--(1) Freshwater-reared salmonids--(i) Amount.
12 to 20 milligrams per liter (mg/L) water in a continuous flow water
supply or as a static bath once per day for 60 minutes on consecutive
or alternative days for three treatments.
(ii) Indications for use. For the control of mortality in
freshwater-reared salmonids due to bacterial gill disease associated
with Flavobacterium spp.
(2) Walleye--(i) Amount. 10 to 20 mg/L water in a continuous flow
water supply or as a static bath once per day for 60 minutes on
consecutive or alternative days for three treatments.
(ii) Indications for use. For the control of mortality in walleye
due to external columnaris disease associated with Flavobacterium
columnare.
(3) Freshwater-reared warmwater finfish--(i) Amount. 20 mg/L water
in a continuous flow water supply or as a static bath once per day for
60 minutes on consecutive or alternative days for three treatments.
(ii) Indications for use. For the control of mortality in
freshwater-reared warmwater finfish due to external columnaris disease
associated with F. columnare.
PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
0
15. The authority citation for 21 CFR part 556 continues to read as
follows:
Authority: 21 U.S.C. 342, 360b, 371.
0
16. Add Sec. 556.118 to read as follows:
Sec. 556.118 Chloramine-T.
(a) Acceptable Daily Intake (ADI). The ADI for total residues of
chloramine-T is 5 micrograms per kilogram of body weight per day.
(b) Tolerances--(1) Fish--(i) Muscle/skin (target tissue). The
tolerance for para-toluenesulfonamide (marker residue) is 0.90 parts
per million.
(ii) [Reserved]
(2) [Reserved]
(c) Related conditions of use. See Sec. 529.382 of this chapter.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
17. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.4 [Amended]
0
18. In Sec. 558.4, in paragraph (d), in the ``Category I'' table,
remove the entry for ``Niclosamide''.
Sec. 558.500 [Amended]
0
19. Amend Sec. 558.500 as follows:
0
a. In the table in paragraphs (e)(1)(ii), (iii), and (iv), in the
``Limitations'' column, add at the end of the entry ``Ractopamine as
provided by No. 000986 with tylosin as provided by Nos. 000986 or
016592 in Sec. 510.600(c) of this chapter; or ractopamine as provided
by No. 054771 with tylosin as provided by No. 000986 in Sec.
510.600(c) of this chapter.'' and in the ``Sponsor'' column, remove
``000986'' and in its place add ``000986, 016592, 054771'';
0
b. In the table in paragraph (e)(2)(viii), in the ``Limitations''
column, remove ``No. 054771'' and in its place add ``Nos. 000986 and
054771'';
0
c. In the table in paragraph (e)(2)(x), in the ``Limitations'' column,
remove ``Nos. 054771 and 021641'' and in its place add ``Nos. 000986
and 054771''; and
0
d. In the table in paragraphs (e)(2)(ix) and (xiii), in the
``Limitations'' column, add at the end of the entry ``Ractopamine as
provided by Nos. 000986 or 054771 with tylosin as provided by No.
000986 in Sec. 510.600(c) of this chapter.'' and in the ``Sponsor''
column, remove ``000986'' and in its place add ``000986, 054771''.
Dated: June 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-15276 Filed 6-30-14; 11:15 am]
BILLING CODE 4164-01-P
