New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin, 53134-53138 [2014-20325]
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53134
Federal Register / Vol. 79, No. 173 / Monday, September 8, 2014 / Rules and Regulations
The Food and Drug
Administration (FDA) is correcting a
final rule entitled ‘‘Postmarketing Safety
Reports for Human Drug and Biological
Products; Electronic Submission
Requirements’’ that appeared in the
Federal Register of June 10, 2014 (79 FR
33072). The document amended FDA’s
postmarketing safety reporting
regulations for human drug and
biological products to require that
persons subject to mandatory reporting
requirements submit safety reports in an
electronic format that FDA can process,
review, and archive. The document was
published with an incorrect RIN
number. This document corrects the
error.
SUMMARY:
DATES:
Effective date: September 8,
2014.
Jean
Chung, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4466, Silver Spring,
MD 20993–0002, 301–796–1874; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7268,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION: In the
Federal Register of June 10, 2014, in FR
Doc. 2014–13480, the following
correction is made:
1. On page 33073, in the third
column, the RIN number heading is
corrected to read ‘‘RIN 0910–AF96’’.
FOR FURTHER INFORMATION CONTACT:
Dated: September 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
New Animal Drugs; Buprenorphine;
Carprofen; Danofloxacin; Follicle
Stimulating Hormone; Ractopamine;
Salinomycin; Tylosin
21 CFR Part 310, 314, 329, and 600
[Docket No. FDA–2008–N–0334]
AGENCY:
Food and Drug Administration,
HHS.
RIN 0910–AF96
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BILLING CODE 4164–01–P
[Docket No. FDA–2014–N–0002]
Food and Drug Administration
Final rule; technical
amendment.
ACTION:
Postmarketing Safety Reports for
Human Drug and Biological Products;
Electronic Submission Requirements;
Corrections
Food and Drug Administration,
HHS.
Final rule; corrections.
15:13 Sep 05, 2014
[FR Doc. 2014–21267 Filed 9–5–14; 8:45 am]
21 CFR Parts 520, 522, and 558
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Mar<15>2010
Dated: September 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Food and Drug Administration
BILLING CODE 4164–01–P
ACTION:
Jean
Chung, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4466, Silver Spring,
MD 20993–0002, 301–796–1874; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7268,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 14, 2014, in
FR Doc. 2014–19255, the following
correction is made:
1. On page 47655, in the first column,
add the heading ‘‘RIN 0910–AF96’’
between the Docket No. and the title of
the document.
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2014–21266 Filed 9–5–14; 8:45 am]
AGENCY:
The Food and Drug
Administration (FDA) is correcting a
document entitled ‘‘Postmarketing
Safety Reports for Human Drug and
Biological Products; Electronic
Submission Requirements; Correction’’
that appeared in the Federal Register of
August 14, 2014 (79 FR 47655). The
document published without the
required RIN number and in the Notice
category. This document corrects those
errors.
DATES: Effective Date: September 8,
2014.
SUMMARY:
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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 July 2014. FDA is
SUMMARY:
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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 add a cross reference to a
tolerance.
This rule is effective September
8, 2014.
DATES:
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.
FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during July 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 Center for Veterinary
Medicine (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.
SUPPLEMENTARY INFORMATION:
Also, the animal drug regulations are
being amended in 21 CFR 522.955 to
add a cross reference to a tolerance for
an inactive vehicle in an injectable
dosage form product. This amendment
is 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.
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Federal Register / Vol. 79, No. 173 / Monday, September 8, 2014 / Rules and Regulations
53135
TABLE 1—ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY 2014
NADA/
ANADA
Sponsor
013–076 1 ....
Elanco Animal Health, A
Division of Eli Lilly &
Co., Lilly Corporate
Center, Indianapolis, IN
46285.
TYLAN (tylosin tartrate)
Soluble Powder.
141–207 ......
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
ADVOCIN (danofloxacin
injection) Sterile
Injectable Solution.
141–431 ......
Bioniche Animal Health
USA, Inc., 119 Rowe
Rd., Athens, GA 30601.
141–434 ......
Abbott Laboratories, North
Chicago, IL 60064.
FOLLTROPIN (porcine pituitary-derived follicle
stimulating hormone for
injection).
SIMBADOL
(buprenorphine injection).
200–520 ......
Norbrook Laboratories,
Ltd., Station Works,
Newry BT35 6JP,
Northern Ireland.
Zoetis Inc., 333 Portage
St., Kalamazoo, MI
49007.
200–559 ......
Huvepharma AD, 5th
Floor, 3A Nikolay
Haytov Str., 1113 Sophia, Bulgaria.
200–567 1 ....
Huvepharma AD, 5th
Floor, 3A Nikolay
Haytov Str., 1113 Sophia, Bulgaria.
200–569 1 ....
Huvepharma AD, 5th
Floor, 3A Nikolay
Haytov Str., 1113 Sophia, Bulgaria.
200–570 1 ....
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200–566 1 ....
Huvepharma AD, 5th
Floor, 3A Nikolay
Haytov Str., 1113 Sophia, Bulgaria.
New animal drug product
name
CARPRIEVE (carprofen)
Injection.
ACTOGAIN 45
(ractopamine HCl) plus
RUMENSIN (monensin)
Type B and C medicated feeds.
OPTAFLEXX 45
(ractopamine HCl) plus
RUMENSIN (monensin)
plus TYLOVET (tylosin
phosphate) Type B and
C medicated feeds.
OPTAFLEXX 45
(ractopamine HCl) plus
RUMENSIN (monensin)
plus TYLOVET (tylosin
phosphate) plus MGA
(melengestrol acetate)
Type B and C medicated feeds.
TYLAN (tylosin phosphate) plus SACOX
(salinomycin sodium)
Type C medicated
feeds.
TYLOVET (tylosin phosphate) plus BIO–COX
(salinomycin sodium)
Type C medicated
feeds.
FOIA
summary
NEPA
review
520.2640
yes .........
EA/FONSI 2
522.522
yes .........
CE 3 4
522.1002
yes .........
CE 3 5
522.230
yes .........
CE 3 6
522.304
yes .........
CE 3 7
Original approval as a generic copy of NADA
141–225.
558.500
yes .........
CE 3 7
Original approval as a generic copy of NADA
141–224.
558.500
yes .........
CE 3 7
Original approval as a generic copy of NADA
141–233.
558.500
yes .........
CE 3 7
Original approval as a generic copy of NADA
141–198.
558.550
yes .........
CE 3 7
Original approval as a generic copy of NADA
141–198.
558.550
yes .........
CE 3 7
Action
Supplemental approval for
the control of mortality
caused by necrotic enteritis associated with
Clostridium perfringens
in broiler chickens.
Supplemental approval for
control of bovine respiratory disease (BRD)
in beef cattle at high
risk of developing BRD
associated with
Mannheimia
haemolytica and
Pasteurella multocida.
Original approval for the
induction of superovulation in beef and dairy
heifers and cows.
Original approval for control of postoperative
pain associated with
surgical procedures in
cats.
Original approval as a generic copy of NADA
141–199.
21 CFR
sections
1 The listed application is 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.
2 The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a
finding of no significant impact (FONSI).
3 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.
4 CE granted under 21 CFR 25.33(d)(5).
5 CE granted under 21 CFR 25.33(c).
6 CE granted under 21 CFR 25.33(d)(1).
7 CE granted under 21 CFR 25.33(a)(1).
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Federal Register / Vol. 79, No. 173 / Monday, September 8, 2014 / Rules and Regulations
(ii) Limitations. Do not use in layers
producing eggs for human consumption.
Do not administer within 24 hours of
slaughter.
*
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List of Subjects
21 CFR Parts 520 and 522
Animal drugs.
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 520, 522, and 558 are
amended as follows:
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 520 continues to read as follows:
Authority: 21 U.S.C. 360b.
2. In § 520.2640, revise paragraphs (b)
and (e)(1) to read as follows:
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Tylosin.
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(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) No. 016592 for use as in
paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2)(i),
(e)(2)(ii)(A), (e)(2)(iii), (e)(3), and (e)(4)
of this section.
(3) No. 061623 for use as in
paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2)(i),
(e)(2)(ii)(B), (e)(2)(iii), (e)(3), and (e)(4)
of this section.
*
*
*
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(e) * * *
(1) Chickens—(i) Amounts and
indications for use.—(A) Administer 2
grams per gallon (528 parts per million
(ppm)) for 1 to 5 days as an aid in the
treatment of chronic respiratory disease
(CRD) associated with Mycoplasma
gallisepticum in broiler and
replacement chickens. For the control of
CRD associated with M. gallisepticum at
time of vaccination or other stress in
chickens. For the control of CRD
associated with Mycoplasma synoviae
in broiler chickens. Treated chickens
should consume enough medicated
drinking water to provide 50 milligrams
(mg) tylosin per pound of body weight
per day.
(B) Administer 851 to 1,419 mg/gallon
(225 to 375 ppm) for 5 days for the
control of mortality caused by necrotic
enteritis associated with Clostridium
perfringens in broiler chickens.
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3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
■
Buprenorphine.
(a) Specifications. Each milliliter of
solution contains 1.8 milligrams (mg)
buprenorphine.
(b) Sponsor. See No. 000044 in
§ 510.600(c) of this chapter.
(c) Conditions of use in cats—(1)
Amount. Administer 0.24 mg per
kilogram (0.11 mg per pound) by
subcutaneous injection once daily, for
up to 3 days. Administer the first dose
approximately 1 hour prior to surgery.
(2) Indications for use. For the control
of postoperative pain associated with
surgical procedures in cats.
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 522.304
[Amended]
5. In § 522.304, paragraph (b), remove
‘‘No. 054771’’ and in its place add ‘‘Nos.
054771 and 055529’’.
■ 6. In § 522.522, remove paragraph
(d)(2); redesignate paragraph (d)(3) as
paragraph (d)(2); and revise paragraph
(d)(1) to read as follows:
■
§ 522.522
Danofloxacin.
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(d) * * *
(1) Amount and indications for use.
Administer by subcutaneous injection
either:
(i) 6 mg per kilogram (/kg) of body
weight, repeated in 48 hours, for the
treatment of bovine respiratory disease
(BRD) associated with Mannheimia
haemolytica and Pasteurella multocida;
or
(ii) 8 mg/kg of body weight as a single
dose for the treatment of BRD associated
with M. haemolytica and P. multocida
and for the control of BRD in beef cattle
at high risk of developing BRD
associated with M. haemolytica and P.
multocida.
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§ 522.955
Florfenicol.
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(c) Related tolerances. See
§§ 500.1410 and 556.283 of this chapter.
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8. In § 522.1002, add paragraph (c) to
read as follows:
■
§ 522.1002
Follicle stimulating hormone.
*
4. Add § 522.230 to read as follows:
§ 522.230
■
§ 520.2640
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
7. In § 522.955, revise paragraph (c) to
read as follows:
■
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(c)(1) Specifications. Each package
contains 2 vials. One vial contains 700
international units (IU) porcinepituitary derived follicle stimulating
hormone (FSH) equivalent to 400
milligrams NIH–FSH–P1, as a dry
powder. The other vial contains 20
milliliters (mL) of bacteriostatic sodium
chloride injection. When reconstituted,
each milliliter of constituted solution
contains 35 IU FSH.
(2) Sponsor. See No. 064847 in
§ 510.600(c) of this chapter.
(3) Conditions of use—(i) Dosage.
Administer 2.5 mL (87.5 IU)
intramuscularly, twice daily at 12-hour
intervals, for 4 consecutive days. In
conjunction with the 6th dose,
administer an approved prostaglandin
product for cattle (cloprostenol sodium
or dinoprost tromethamine), using the
labeled dosage and administration
instructions to cause luteolysis and
induce estrus. See § 522.460 for use of
cloprostenol sodium or § 522.690 for use
of dinoprost tromethamine.
(ii) Indications for use. For the
induction of superovulation in beef and
dairy heifers and cows.
(iii) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
9. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
10. In § 558.500, revise paragraphs
(e)(2)(ii), (e)(2)(iv), (e)(2)(vii), (e)(2)(ix),
(e)(2)(x), (e)(2)(xii), and (e)(2)(xiii), to
read as follows:
■
§ 558.500
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Ractopamine.
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(e) * * *
(2) * * *
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Ractopamine in grams/ton
Combination in grams/ton
Indications for use
Limitations
53137
Sponsor
*
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Cattle fed in confinement for
slaughter: As in paragraph
(e)(2)(i) of this section; for
prevention and control of
coccidiosis due to Eimeria
bovis and E zuernii.
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*
As in paragraph (e)(2)(i) of
000986, 054771
this section; see paragraph
§§ 558.355(d) of this chapter. Ractopamine as provided by Nos. 000986 or
054771 in § 510.600(c) of
this chapter; monensin as
provided by No. 000986 in
§ 510.600(c) of this chapter.
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(iv) 8.2 to 24.6 ........................ Monensin 10 to 40 to provide
0.14 to 0.42 mg monensin/
lb of body weight, depending on severity of coccidiosis challenge, up to 480
mg/head/day, plus tylosin
8 to 10.
*
*
Cattle fed in confinement for
slaughter: As in paragraph
(e)(2)(i) of this section; for
prevention and control of
coccidiosis due to Eimeria
bovis and E zuernii; and
for reduction of incidence
of liver abscesses caused
by Fusobacterium
necrophorum and
Arcanobacterium
(Actinomyces) pyogenes.
*
As in paragraph (e)(2)(i) of
this section; see
§§ 558.355(d) and
558.625(c) of this chapter.
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.
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(vii) 9.8 to 24.6 ....................... Monensin 10 to 40 to provide
0.14 to 0.42 mg monensin/
lb of body weight, depending on severity of coccidiosis challenge, up to 480
mg/head/day.
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Cattle fed in confinement for
slaughter: As in paragraph
(e)(2)(vi) of this section; for
prevention and control of
coccidiosis due to Eimeria
bovis and E zuernii.
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As in paragraph (e)(2)(vi) of
000986, 054771
this section; see paragraph
§§ 558.355(d) of this chapter. Ractopamine as provided by Nos. 000986 or
054771 in § 510.600(c) of
this chapter; monensin as
provided by No. 000986 in
§ 510.600(c) of this chapter.
*
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*
(ix) 9.8 to 24.6 ........................ Monensin 10 to 40 to provide
0.14 to 0.42 mg monensin/
lb of body weight, depending on severity of coccidiosis challenge, up to 480
mg/head/day, plus tylosin
8 to 10.
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(ii) 8.2 to 24.6 ......................... Monensin 10 to 40 to provide
0.14 to 0.42 mg monensin/
lb of body weight, depending on severity of coccidiosis challenge, up to 480
mg/head/day.
*
*
Cattle fed in confinement for
slaughter: As in paragraph
(e)(2)(vi) of this section; for
prevention and control of
coccidiosis due to Eimeria
bovis and E zuernii; and
for reduction of incidence
of liver abscesses caused
by Fusobacterium
necrophorum and
Arcanobacterium
(Actinomyces) pyogenes.
*
*
As in paragraph (e)(2)(vi) of
000986,
this section; see
016592,
§§ 558.355(d) and
054771
558.625(c) of this chapter.
Ractopamine and
monensin 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
monensin and tylosin as
provided by No. 000986 in
§ 510.600(c) of this chapter.
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000986,
016592,
054771
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Federal Register / Vol. 79, No. 173 / Monday, September 8, 2014 / Rules and Regulations
Ractopamine in grams/ton
Combination in grams/ton
Indications for use
(x) 9.8 to 24.6 .........................
Monensin 10 to 40 to provide
0.14 to 0.42 mg monensin/
lb of body weight, depending on severity of coccidiosis challenge, up to 480
mg/head/day, plus tylosin
8 to 10, plus melengestrol
acetate to provide 0.25 to
0.5 mg/head/day.
Heifers fed in confinement for
slaughter: As in paragraph
(e)(2)(vi) of this section; for
prevention and control of
coccidiosis due to Eimeria
bovis and E zuernii; for reduction of incidence of liver
abscesses caused by
Fusobacterium
necrophorum and
Arcanobacterium
(Actinomyces) pyogenes;
and for suppression of
estrus (heat).
As in paragraph (e)(2)(vi) of
000986,
this section; see para016592,
graphs §§ 558.342(d),
054771
558.355(d) and 558.625(c)
of this chapter.
Ractopamine, monensin,
and tylosin as provided by
No. 000986 with
melengestrol acetate as
provided by Nos. 000986
or 054771 in § 510.600(c)
of this chapter; or
ractopamine and monensin
as provided by No. 000986
with tylosin as provided by
Nos. 000986 or 016592
and melengestrol acetate
as provided by No. 054771
in § 510.600(c) of this
chapter; or ractopamine as
provided by No. 054771
with monensin and tylosin
as provided by No. 000986
and melengestrol acetate
provided by No. 054771 in
§ 510.600(c) of this chapter.
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(xii) Not to exceed 800; to
Monensin 10 to 40 to provide
provide 70 to 400 mg/head/
0.14 to 0.42 mg monensin/
day.
lb of body weight, depending on severity of coccidiosis challenge, up to 480
mg/head/day.
*
*
Cattle fed in confinement for
slaughter: As in paragraph
(e)(2)(i) of this section; for
prevention and control of
coccidiosis due to Eimeria
bovis and E zuernii.
(xiii) Not to exceed 800; to
provide 70 to 400 mg/head/
day.
Cattle fed in confinement for
slaughter: As in paragraph
(e)(2)(i) of this section; for
prevention and control of
coccidiosis due to Eimeria
bovis and E zuernii; and
for reduction of incidence
of liver abscesses caused
by Fusobacterium
necrophorum and
Arcanobacterium
(Actinomyces) pyogenes.
*
*
Top dress ractopamine in a
000986, 054771
minimum of 1.0 lb of medicated feed during the last
28 to 42 days on feed. Not
for animals intended for
breeding. See
§ 558.355(d). Ractopamine
as provided by Nos.
000986 or 054771 in
§ 510.600(c) of this chapter; monensin as provided
by No. 000986 in
§ 510.600(c) of this chapter.
Top dress ractopamine in a
000986,
minimum of 1.0 lb of medi016592,
cated feed during the last
054771
28 to 42 days on feed. Not
for animals intended for
breeding. See
§§ 558.355(d) and
558.625(c). Ractopamine
and monensin 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
monensin and tylosin as
provided by No. 000986 in
§ 510.600(c) of this chapter.
Monensin 10 to 40 to provide
0.14 to 0.42 mg monensin/
lb of body weight, depending on severity of coccidiosis challenge, up to 480
mg/head/day, plus tylosin
8 to 10.
*
*
*
*
*
11. In § 558.550, revise the last
sentence in paragraph (d)(1)(xxii)(B) to
read as follows:
rmajette on DSK2TPTVN1PROD with RULES
■
§ 558.550
*
Salinomycin.
*
*
(d) * * *
VerDate Mar<15>2010
*
*
15:13 Sep 05, 2014
Jkt 232001
(1) * * *
(xxii) * * *
(B) * * * Salinomycin as provided by
Nos. 016592 and 054771; tylosin
phosphate as provided by Nos. 000986
and 016592 in § 510.600(c) of this
chapter.
*
*
*
*
*
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
Limitations
Sponsor
Dated: August 21, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–20325 Filed 9–5–14; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\08SER1.SGM
08SER1
]]>Agencies
[Federal Register Volume 79, Number 173 (Monday, September 8, 2014)]
[Rules and Regulations]
[Pages 53134-53138]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20325]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, and 558
[Docket No. FDA-2014-N-0002]
New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin;
Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
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 July 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 add a cross reference to a tolerance.
DATES: This rule is effective September 8, 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 July 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 Center for Veterinary Medicine (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 animal drug regulations are being amended in 21 CFR
522.955 to add a cross reference to a tolerance for an inactive vehicle
in an injectable dosage form product. This amendment is 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.
[[Page 53135]]
Table 1--Original and Supplemental NADAs and ANADAs Approved During July 2014
--------------------------------------------------------------------------------------------------------------------------------------------------------
New animal drug 21 CFR
NADA/ANADA Sponsor product name Action sections FOIA summary NEPA review
--------------------------------------------------------------------------------------------------------------------------------------------------------
013-076 \1\............ Elanco Animal Health, TYLAN (tylosin Supplemental approval 520.2640 yes............... EA/FONSI \2\
A Division of Eli tartrate) Soluble for the control of
Lilly & Co., Lilly Powder. mortality caused by
Corporate Center, necrotic enteritis
Indianapolis, IN associated with
46285. Clostridium
perfringens in
broiler chickens.
141-207................ Zoetis Inc., 333 ADVOCIN (danofloxacin Supplemental approval 522.522 yes............... CE \3\ \4\
Portage St., injection) Sterile for control of
Kalamazoo, MI 49007. Injectable Solution. bovine respiratory
disease (BRD) in
beef cattle at high
risk of developing
BRD associated with
Mannheimia
haemolytica and
Pasteurella
multocida.
141-431................ Bioniche Animal Health FOLLTROPIN (porcine Original approval for 522.1002 yes............... CE \3\ \5\
USA, Inc., 119 Rowe pituitary-derived the induction of
Rd., Athens, GA 30601. follicle stimulating superovulation in
hormone for beef and dairy
injection). heifers and cows.
141-434................ Abbott Laboratories, SIMBADOL Original approval for 522.230 yes............... CE \3\ \6\
North Chicago, IL (buprenorphine control of
60064. injection). postoperative pain
associated with
surgical procedures
in cats.
200-520................ Norbrook Laboratories, CARPRIEVE (carprofen) Original approval as 522.304 yes............... CE \3\ \7\
Ltd., Station Works, Injection. a generic copy of
Newry BT35 6JP, NADA 141-199.
Northern Ireland.
200-559................ Zoetis Inc., 333 ACTOGAIN 45 Original approval as 558.500 yes............... CE \3\ \7\
Portage St., (ractopamine HCl) a generic copy of
Kalamazoo, MI 49007. plus RUMENSIN NADA 141-225.
(monensin) Type B
and C medicated
feeds.
200-566 \1\............ Huvepharma AD, 5th OPTAFLEXX 45 Original approval as 558.500 yes............... CE \3\ \7\
Floor, 3A Nikolay (ractopamine HCl) a generic copy of
Haytov Str., 1113 plus RUMENSIN NADA 141-224.
Sophia, Bulgaria. (monensin) plus
TYLOVET (tylosin
phosphate) Type B
and C medicated
feeds.
200-567 \1\............ Huvepharma AD, 5th OPTAFLEXX 45 Original approval as 558.500 yes............... CE \3\ \7\
Floor, 3A Nikolay (ractopamine HCl) a generic copy of
Haytov Str., 1113 plus RUMENSIN NADA 141-233.
Sophia, Bulgaria. (monensin) plus
TYLOVET (tylosin
phosphate) plus MGA
(melengestrol
acetate) Type B and
C medicated feeds.
200-569 \1\............ Huvepharma AD, 5th TYLAN (tylosin Original approval as 558.550 yes............... CE \3\ \7\
Floor, 3A Nikolay phosphate) plus a generic copy of
Haytov Str., 1113 SACOX (salinomycin NADA 141-198.
Sophia, Bulgaria. sodium) Type C
medicated feeds.
200-570 \1\............ Huvepharma AD, 5th TYLOVET (tylosin Original approval as 558.550 yes............... CE \3\ \7\
Floor, 3A Nikolay phosphate) plus BIO- a generic copy of
Haytov Str., 1113 COX (salinomycin NADA 141-198.
Sophia, Bulgaria. sodium) Type C
medicated feeds.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The listed application is 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.
\2\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
no significant impact (FONSI).
\3\ 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.
\4\ CE granted under 21 CFR 25.33(d)(5).
\5\ CE granted under 21 CFR 25.33(c).
\6\ CE granted under 21 CFR 25.33(d)(1).
\7\ CE granted under 21 CFR 25.33(a)(1).
[[Page 53136]]
List of Subjects
21 CFR Parts 520 and 522
Animal drugs.
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 520,
522, and 558 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.2640, revise paragraphs (b) and (e)(1) to 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) No. 016592 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii),
(e)(2)(i), (e)(2)(ii)(A), (e)(2)(iii), (e)(3), and (e)(4) of this
section.
(3) No. 061623 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii),
(e)(2)(i), (e)(2)(ii)(B), (e)(2)(iii), (e)(3), and (e)(4) of this
section.
* * * * *
(e) * * *
(1) Chickens--(i) Amounts and indications for use.--(A) Administer
2 grams per gallon (528 parts per million (ppm)) for 1 to 5 days as an
aid in the treatment of chronic respiratory disease (CRD) associated
with Mycoplasma gallisepticum in broiler and replacement chickens. For
the control of CRD associated with M. gallisepticum at time of
vaccination or other stress in chickens. For the control of CRD
associated with Mycoplasma synoviae in broiler chickens. Treated
chickens should consume enough medicated drinking water to provide 50
milligrams (mg) tylosin per pound of body weight per day.
(B) Administer 851 to 1,419 mg/gallon (225 to 375 ppm) for 5 days
for the control of mortality caused by necrotic enteritis associated
with Clostridium perfringens in broiler chickens.
(ii) Limitations. Do not use in layers producing eggs for human
consumption. Do not administer within 24 hours of slaughter.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. Add Sec. 522.230 to read as follows:
Sec. 522.230 Buprenorphine.
(a) Specifications. Each milliliter of solution contains 1.8
milligrams (mg) buprenorphine.
(b) Sponsor. See No. 000044 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cats--(1) Amount. Administer 0.24 mg per
kilogram (0.11 mg per pound) by subcutaneous injection once daily, for
up to 3 days. Administer the first dose approximately 1 hour prior to
surgery.
(2) Indications for use. For the control of postoperative pain
associated with surgical procedures in cats.
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 522.304 [Amended]
0
5. In Sec. 522.304, paragraph (b), remove ``No. 054771'' and in its
place add ``Nos. 054771 and 055529''.
0
6. In Sec. 522.522, remove paragraph (d)(2); redesignate paragraph
(d)(3) as paragraph (d)(2); and revise paragraph (d)(1) to read as
follows:
Sec. 522.522 Danofloxacin.
* * * * *
(d) * * *
(1) Amount and indications for use. Administer by subcutaneous
injection either:
(i) 6 mg per kilogram (/kg) of body weight, repeated in 48 hours,
for the treatment of bovine respiratory disease (BRD) associated with
Mannheimia haemolytica and Pasteurella multocida; or
(ii) 8 mg/kg of body weight as a single dose for the treatment of
BRD associated with M. haemolytica and P. multocida and for the control
of BRD in beef cattle at high risk of developing BRD associated with M.
haemolytica and P. multocida.
* * * * *
0
7. In Sec. 522.955, revise paragraph (c) to read as follows:
Sec. 522.955 Florfenicol.
* * * * *
(c) Related tolerances. See Sec. Sec. 500.1410 and 556.283 of this
chapter.
* * * * *
0
8. In Sec. 522.1002, add paragraph (c) to read as follows:
Sec. 522.1002 Follicle stimulating hormone.
* * * * *
(c)(1) Specifications. Each package contains 2 vials. One vial
contains 700 international units (IU) porcine-pituitary derived
follicle stimulating hormone (FSH) equivalent to 400 milligrams NIH-
FSH-P1, as a dry powder. The other vial contains 20 milliliters (mL) of
bacteriostatic sodium chloride injection. When reconstituted, each
milliliter of constituted solution contains 35 IU FSH.
(2) Sponsor. See No. 064847 in Sec. 510.600(c) of this chapter.
(3) Conditions of use--(i) Dosage. Administer 2.5 mL (87.5 IU)
intramuscularly, twice daily at 12-hour intervals, for 4 consecutive
days. In conjunction with the 6th dose, administer an approved
prostaglandin product for cattle (cloprostenol sodium or dinoprost
tromethamine), using the labeled dosage and administration instructions
to cause luteolysis and induce estrus. See Sec. 522.460 for use of
cloprostenol sodium or Sec. 522.690 for use of dinoprost tromethamine.
(ii) Indications for use. For the induction of superovulation in
beef and dairy heifers and cows.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
9. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
10. In Sec. 558.500, revise paragraphs (e)(2)(ii), (e)(2)(iv),
(e)(2)(vii), (e)(2)(ix), (e)(2)(x), (e)(2)(xii), and (e)(2)(xiii), to
read as follows:
Sec. 558.500 Ractopamine.
* * * * *
(e) * * *
(2) * * *
[[Page 53137]]
----------------------------------------------------------------------------------------------------------------
Combination in Indications for
Ractopamine in grams/ton grams/ton use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
* * * * * * *
(ii) 8.2 to 24.6............... Monensin 10 to 40 Cattle fed in As in paragraph 000986, 054771
to provide 0.14 confinement for (e)(2)(i) of
to 0.42 mg slaughter: As in this section;
monensin/lb of paragraph see paragraph
body weight, (e)(2)(i) of Sec. Sec.
depending on this section; 558.355(d) of
severity of for prevention this chapter.
coccidiosis and control of Ractopamine as
challenge, up to coccidiosis due provided by Nos.
480 mg/head/day. to Eimeria bovis 000986 or 054771
and E zuernii. in Sec.
510.600(c) of
this chapter;
monensin as
provided by No.
000986 in Sec.
510.600(c) of
this chapter.
* * * * * * *
(iv) 8.2 to 24.6............... Monensin 10 to 40 Cattle fed in As in paragraph 000986, 016592, 054771
to provide 0.14 confinement for (e)(2)(i) of
to 0.42 mg slaughter: As in this section;
monensin/lb of paragraph see Sec. Sec.
body weight, (e)(2)(i) of 558.355(d) and
depending on this section; 558.625(c) of
severity of for prevention this chapter.
coccidiosis and control of Ractopamine as
challenge, up to coccidiosis due provided by No.
480 mg/head/day, to Eimeria bovis 000986 with
plus tylosin 8 and E zuernii; tylosin as
to 10. and for provided by Nos.
reduction of 000986 or 016592
incidence of in Sec.
liver abscesses 510.600(c) of
caused by this chapter; or
Fusobacterium ractopamine as
necrophorum and provided by No.
Arcanobacterium 054771 with
(Actinomyces) tylosin as
pyogenes. provided by No.
000986 in Sec.
510.600(c) of
this chapter.
* * * * * * *
(vii) 9.8 to 24.6.............. Monensin 10 to 40 Cattle fed in As in paragraph 000986, 054771
to provide 0.14 confinement for (e)(2)(vi) of
to 0.42 mg slaughter: As in this section;
monensin/lb of paragraph see paragraph
body weight, (e)(2)(vi) of Sec. Sec.
depending on this section; 558.355(d) of
severity of for prevention this chapter.
coccidiosis and control of Ractopamine as
challenge, up to coccidiosis due provided by Nos.
480 mg/head/day. to Eimeria bovis 000986 or 054771
and E zuernii. in Sec.
510.600(c) of
this chapter;
monensin as
provided by No.
000986 in Sec.
510.600(c) of
this chapter.
* * * * * * *
(ix) 9.8 to 24.6............... Monensin 10 to 40 Cattle fed in As in paragraph 000986, 016592, 054771
to provide 0.14 confinement for (e)(2)(vi) of
to 0.42 mg slaughter: As in this section;
monensin/lb of paragraph see Sec. Sec.
body weight, (e)(2)(vi) of 558.355(d) and
depending on this section; 558.625(c) of
severity of for prevention this chapter.
coccidiosis and control of Ractopamine and
challenge, up to coccidiosis due monensin as
480 mg/head/day, to Eimeria bovis provided by No.
plus tylosin 8 and E zuernii; 000986 with
to 10. and for tylosin as
reduction of provided by Nos.
incidence of 000986 or 016592
liver abscesses in Sec.
caused by 510.600(c) of
Fusobacterium this chapter; or
necrophorum and ractopamine as
Arcanobacterium provided by No.
(Actinomyces) 054771 with
pyogenes. monensin and
tylosin as
provided by No.
000986 in Sec.
510.600(c) of
this chapter.
[[Page 53138]]
(x) 9.8 to 24.6................ Monensin 10 to 40 Heifers fed in As in paragraph 000986, 016592, 054771
to provide 0.14 confinement for (e)(2)(vi) of
to 0.42 mg slaughter: As in this section;
monensin/lb of paragraph see paragraphs
body weight, (e)(2)(vi) of Sec. Sec.
depending on this section; 558.342(d),
severity of for prevention 558.355(d) and
coccidiosis and control of 558.625(c) of
challenge, up to coccidiosis due this chapter.
480 mg/head/day, to Eimeria bovis Ractopamine,
plus tylosin 8 and E zuernii; monensin, and
to 10, plus for reduction of tylosin as
melengestrol incidence of provided by No.
acetate to liver abscesses 000986 with
provide 0.25 to caused by melengestrol
0.5 mg/head/day. Fusobacterium acetate as
necrophorum and provided by Nos.
Arcanobacterium 000986 or 054771
(Actinomyces) in Sec.
pyogenes; and 510.600(c) of
for suppression this chapter; or
of estrus (heat). ractopamine and
monensin as
provided by No.
000986 with
tylosin as
provided by Nos.
000986 or 016592
and melengestrol
acetate as
provided by No.
054771 in Sec.
510.600(c) of
this chapter; or
ractopamine as
provided by No.
054771 with
monensin and
tylosin as
provided by No.
000986 and
melengestrol
acetate provided
by No. 054771 in
Sec.
510.600(c) of
this chapter.
* * * * * * *
(xii) Not to exceed 800; to Monensin 10 to 40 Cattle fed in Top dress 000986, 054771
provide 70 to 400 mg/head/day. to provide 0.14 confinement for ractopamine in a
to 0.42 mg slaughter: As in minimum of 1.0
monensin/lb of paragraph lb of medicated
body weight, (e)(2)(i) of feed during the
depending on this section; last 28 to 42
severity of for prevention days on feed.
coccidiosis and control of Not for animals
challenge, up to coccidiosis due intended for
480 mg/head/day. to Eimeria bovis breeding. See
and E zuernii. Sec.
558.355(d).
Ractopamine as
provided by Nos.
000986 or 054771
in Sec.
510.600(c) of
this chapter;
monensin as
provided by No.
000986 in Sec.
510.600(c) of
this chapter.
(xiii) Not to exceed 800; to Monensin 10 to 40 Cattle fed in Top dress 000986, 016592, 054771
provide 70 to 400 mg/head/day. to provide 0.14 confinement for ractopamine in a
to 0.42 mg slaughter: As in minimum of 1.0
monensin/lb of paragraph lb of medicated
body weight, (e)(2)(i) of feed during the
depending on this section; last 28 to 42
severity of for prevention days on feed.
coccidiosis and control of Not for animals
challenge, up to coccidiosis due intended for
480 mg/head/day, to Eimeria bovis breeding. See
plus tylosin 8 and E zuernii; Sec. Sec.
to 10. and for 558.355(d) and
reduction of 558.625(c).
incidence of Ractopamine and
liver abscesses monensin as
caused by provided by No.
Fusobacterium 000986 with
necrophorum and tylosin as
Arcanobacterium provided by Nos.
(Actinomyces) 000986 or 016592
pyogenes. in Sec.
510.600(c) of
this chapter; or
ractopamine as
provided by No.
054771 with
monensin and
tylosin as
provided by No.
000986 in Sec.
510.600(c) of
this chapter.
----------------------------------------------------------------------------------------------------------------
* * * * *
0
11. In Sec. 558.550, revise the last sentence in paragraph
(d)(1)(xxii)(B) to read as follows:
Sec. 558.550 Salinomycin.
* * * * *
(d) * * *
(1) * * *
(xxii) * * *
(B) * * * Salinomycin as provided by Nos. 016592 and 054771;
tylosin phosphate as provided by Nos. 000986 and 016592 in Sec.
510.600(c) of this chapter.
* * * * *
Dated: August 21, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-20325 Filed 9-5-14; 8:45 am]
BILLING CODE 4164-01-P
