[Federal Register Volume 78, Number 207 (Friday, October 25, 2013)]
[Rules and Regulations]
[Pages 63870-63872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-25172]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2013-N-0002]
New Animal Drugs; Change of Sponsor; Gonadorelin; Ivermectin;
Ractopamine; Trimethoprim and Sulfadiazine Suspension; Tulathromycin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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 2013. 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 reflect a change of sponsorship for an ANADA.
DATES: This rule is effective October 25, 2013.
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;
[email protected].
SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations
to reflect approval actions for NADAs and ANADAs during July 2013, as
listed in table 1. In addition, FDA is informing the public of the
availability, where
[[Page 63871]]
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: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.
In addition, ECO LLC, 344 Nassau St., Princeton, NJ 08540 has
informed FDA that it has transferred ownership of, and all rights and
interest in, ANADA 200-348 for ECOMECTIN (ivermectin) Topical Solution
to SmartVet USA, Inc., 22201 West Innovation Dr., Suite 170A, Olathe,
KS 66061-1304. Accordingly, the Agency is amending the regulations to
reflect this change of sponsorship.
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 July 2013
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New Animal drug 21 CFR
NADA/ANADA Sponsor product name Action Section FOIA Summary NEPA Review
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139-237.......... Zoetis Inc., FACTREL Supplemental 522.1077 Yes......... CE \1\
333 Portage (gonadorelin approval for use
St., injection) with LUTALYSE
Kalamazoo, MI Injection. (dinoprost
49007. tromethamine)
Sterile Solution to
synchronize estrous
cycles to allow
fixed-time
artificial
insemination (FTAI)
in lactating dairy
cows.
141-349.......... Zoetis Inc., DRAXXIN 25 Original approval 522.2630 Yes......... CE \1\
333 Portage (tulathromycin for the treatment
St., ) Injectable and control of
Kalamazoo, MI Solution. swine respiratory
49007. disease (SRD).
141-360.......... Aurora EQUISUL-SDT Original approval 520.2612 Yes......... CE \1\
Pharmaceutical (sulfadiazine/ for the treatment
, LLC, 1196 trimethoprim) of lower
Highway 3 Oral respiratory tract
South, Suspension. infections in
Northfield, MN horses caused by
55057-3009. susceptible strains
of Streptococcus
equi subsp.
zooepidemicus.
200-542.......... Zoetis Inc., ENGAIN 9 and Original approval as 558.500 Yes......... CE \1\
333 Portage ENGAIN 45 a generic copy of
St., (ractopamine NADA 140-863.
Kalamazoo, MI hydrochloride)
49007. Type A
medicated
articles.
200-548.......... Zoetis Inc., ACTOGAIN 45 Original approval as 558.500 Yes......... CE \1\
333 Portage (ractopamine a generic copy of
St., hydrochloride) NADA 141-221.
Kalamazoo, MI Type A
49007. medicated
articles.
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\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.
List of Subjects
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520, 522 and 524
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 510,
520, 522, 524, 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 entries for ``Aurora Pharmaceutical, LLC'' and ``SmartVet USA,
Inc.''; and in the table in paragraph (c)(2), numerically add entries
for ``051072'' and ``086001'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
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Drug labeler
Firm name and address code
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* * * * *
Aurora Pharmaceutical, LLC, 1196 Highway 3 South, 051072
Northfield, MN 55057-3009..............................
* * * * *
SmartVet USA, Inc., 22201 West Innovation Dr., Suite 086001
170A, Olathe, KS 66061-1304............................
* * * * *
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(2) * * *
[[Page 63872]]
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Drug labeler code Firm name and address
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* * * * *
051072.............................. Aurora Pharmaceutical, LLC, 1196
Highway 3 South, Northfield, MN
55057-3009
* * * * *
086001.............................. SmartVet USA, Inc., 22201 West
Innovation Dr., Suite 170A,
Olathe, KS 66061-1304
* * * * *
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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. Revise Sec. 520.2612 to read as follows:
Sec. 520.2612 Trimethoprim and sulfadiazine suspension.
(a) Specifications. Each milliliter (mL) of suspension contains:
(1) 10 milligrams (mg) trimethoprim and 50 mg sulfadiazine; or
(2) 400 mg combined active ingredients (67 mg trimethoprim and 333
mg sulfadiazine).
(b) Sponsors. See sponsor numbers in Sec. 510.600 of this chapter:
(1) No. 000061 for use of product described in paragraph (a)(1) for
use as in paragraph (c)(1) of this section.
(2) No. 051072 for use of product described in paragraph (a)(2) for
use as in paragraph (c)(2) of this section.
(c) Conditions of use--(1) Dogs--(i) Amount. Administer 1 mL (10 mg
trimethoprim and 50 mg sulfadiazine) per 5 pounds (lb) of body weight
once daily, or one-half the recommended daily dose every 12 hours, for
up to 14 consecutive days.
(ii) Indications for use. The drug is used in dogs where systemic
antibacterial action against sensitive organisms is required, either
alone or as an adjunct to surgery or debridement with associated
infection. The drug is indicated where control of bacterial infection
is required during the treatment of acute urinary tract infections,
acute bacterial complications of distemper, acute respiratory tract
infections, acute alimentary tract infections, wound infections, and
abscesses.
(iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
(2) Horses--(i) Amount. Administer 24 mg combined active
ingredients per kilogram of body weight (2.7 mL/100 lb) twice daily for
10 days.
(ii) Indications for use. For the treatment of lower respiratory
tract infections in horses caused by susceptible strains of
Streptococcus equi subsp. zooepidemicus.
(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.
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
6. Revise Sec. 522.1077 to read as follows:
Sec. 522.1077 Gonadorelin hydrochloride.
(a) Specifications. Each milliliter of solution contains 50
micrograms (mcg) of gonadorelin (as hydrochloride).
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter.
(c) Conditions of use in cattle--(1) Indications for use and
amounts--(i) For the treatment of ovarian follicular cysts in cattle,
administer 100 mcg gonadorelin by intramuscular injection.
(ii) For use with dinoprost tromethamine to synchronize estrous
cycles to allow fixed-time artificial insemination (FTAI) in lactating
dairy cows, administer to each cow 100 to 200 mcg gonadorelin by
intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost
tromethamine by intramuscular injection, followed 30 to 72 hours later
by 100 to 200 mcg gonadorelin by intramuscular injection.
(2) Limitations. Dinoprost tromethamine as provided by sponsor No.
054771 in Sec. 510.600(c) of this chapter. Federal law restricts this
drug to use by or on the order of a licensed veterinarian.
0
7. In Sec. 522.2630, revise paragraphs (a) and (b) to read as follows:
Sec. 522.2630 Tulathromycin.
(a) Specifications. Each milliliter of solution contains:
(1) 100 milligrams (mg) tulathromycin
(2) 25 mg tulathromycin
(b) Sponsor. See No. 054771 in Sec. 510.600(c) of this chapter for
use as in paragraph (d) of this section:
(1) Product described as in paragraph (a)(1) for use as in
paragraph (d).
(2) Product described as in paragraph (a)(2) for use as in
paragraph (d)(2).
* * * * *
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
8. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1193 [Amended]
0
9. In paragraph (b)(2) of Sec. 524.1193, remove ``066916'' and in its
place add ``086001''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
10. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.500 [Amended]
0
11. In Sec. 558.500, in paragraph (a), remove ``45'' and in its place
add ``45.4''; in paragraph (b), remove ``No. 000986'' and in its place
add ``Nos. 000986 and 054771''; in the table in paragraph (e)(1), in
the ``Ractopamine in grams/ton'' column, remove ``4.5 to 9'' wherever
it occurs and in its place add ``4.5 to 9.0''; and in the table in
paragraphs (e)(1)(i), (e)(2)(i), (e)(2)(vi), and (e)(2)(xi), in the
``Sponsor'' column, add ``054771''.
Dated: October 22, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-25172 Filed 10-24-13; 8:45 am]
BILLING CODE 4160-01-P