
[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Rules and Regulations]
[Pages 10965-10974]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01958]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 524, 526, and 529

[Docket No. FDA-2014-N-0002]


New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect a change of sponsor for 54 approved new 
animal drug applications (NADAs) and 1 approved abbreviated new animal 
drug application (ANADA) for topical, intramammary, and certain other 
dosage form new animal drug products from Pfizer, Inc., including its 
several subsidiaries and divisions, to Zoetis, Inc.

DATES: This rule is effective February 27, 2014.

FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for 
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520 
Standish Pl.,

[[Page 10966]]

Rockville, MD 20855; 240-276-8300, steven.vaughn@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 E. 42d St., New York, NY 
10017, and its wholly owned subsidiaries Alpharma, LLC; Fort Dodge 
Animal Health, Division of Wyeth; Fort Dodge Animal Health, Division of 
Wyeth Holdings Corp.; and its division, Pharmacia & Upjohn Co., have 
informed FDA that they have transferred ownership of, and all rights 
and interest in, the 54 approved NADAs and 1 approved ANADA in table 1 
to Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007.

 Table 1--NADAs and ANADA Transferred From Pfizer, Inc., to Zoetis, Inc.
------------------------------------------------------------------------
         File No.                           Product name
------------------------------------------------------------------------
008-763..................  TERRAMYCIN (oxytetracycline hydrochloride)
                            Ophthalmic Ointment with Polymyxin.
009-035..................  OPHTHAINE (proparacaine hydrochloride)
                            Solution.
009-782..................  NOLVASAN (chlorhexidine acetate) Antiseptic
                            Ointment.
009-809..................  NOLVASAN CAP-TABS (chlorhexidine acetate)
                            Tablets.
010-434..................  NOLVASAN (chlorhexidine acetate) Suspension.
010-524..................  NEO-CORTEF with Tetracaine (neomycin sulfate,
                            hydrocortisone acetate, tetracaine
                            hydrochloride) Ointment.
011-703..................  NEO-DELTA CORTEF with Tetracaine (neomycin
                            sulfate, prednisolone acetate, tetracaine
                            hydrochloride) Ointment.
012-258..................  PANOLOG (triamcinolone acetonide, nystatin,
                            thiostrepton, neomycin sulfate) Ointment.
012-991..................  KOPERTOX (copper naphthenate) Topical.
013-293..................  TERRA-CORTRIL (oxytetracycline hydrochloride
                            and hydrocortisone) Topical Spray.
014-170..................  FLUOTHANE (halothane, USP).
015-433..................  NEO-PREDEF with Tetracaine (neomycin sulfate,
                            isoflupredone acetate, tetracaine
                            hydrochloride, and myristyl-gammapicolinium
                            chloride) Ointment.
030-025..................  NEO-PREDEF with Tetracaine (neomycin sulfate,
                            isoflupredone acetate, tetracaine
                            hydrochloride) Topical Ointment.
032-168..................  DOMOSO (dimethyl sulfoxide) Solution.
032-319..................  TOPAZONE (furazolidone) Aerosol Powder.
034-872..................  NEO PREDEF (neomycin sulfate and
                            isoflupredone acetate) Ointment.
037-586..................  ERYTHROMAST 36 (erythromycin) Intramammary
                            Infusion.
038-801..................  ANAPRIME (flumethasone, polymyxin B sulfate,
                            and neomycin sulfate) Ophthalmic Solution.
042-661..................  KANTRIM (kanamycin sulfate) Ophthalmic
                            Ointment.
042-883..................  KANTRIM (kanamycin sulfate) Ophthalmic
                            Solution.
043-784..................  KANFOSONE (kanamycin sulfate, calcium
                            amphomycin, and hydrocortisone acetate)
                            Ointment.
045-512..................  SYNOTIC(fluocinolone acetonide and dimethyl
                            sulfoxide) Otic Solution.
047-334..................  SYNSAC (fluocinolone acetonide and dimethyl
                            sulfoxide) Topical Solution.
047-925..................  DOMOSO (dimethyl sulfoxide) Gel.
047-997..................  AMPHODERM (kanamycin sulfate, calcium
                            amphomycin, and hydrocortisone acetate)
                            Ointment.
049-725..................  ANAPRIME Opthakote (flumethasone, polymyxin B
                            sulfate, and neomycin sulfate) Ophthalmic.
049-726..................  OPTIPRIME OPTHAKOTE (neomycin sulfate and
                            polymixin B sulfate) Ophthalmic Solution.
055-072..................  ALBACILLIN (procaine penicillin G/novobiocin)
                            Suspension for Intramammary Infusion.
055-095..................  TICILLIN (ticarcillin disodium) Powder for
                            Intrauterine Infusion.
055-098..................  ALBADRY Plus (procaine penicillin G and
                            novobiocin sodium) Suspension for
                            Intramammary Infusion.
065-114..................  MYCITRACIN (bacitracin zinc, neomycin
                            sulfate, and polymyxin B sulfate) Ophthalmic
                            Ointment.
065-119..................  FORTE (neomycin sulfate, penicillin,
                            polymyxin B, hydrocortisone) Topical
                            Ointment.
065-122..................  TETRACYN (tetracycline hydrochloride)
                            Ointment.
065-149..................  CHLOROMYCETIN (chloramphenicol) Ophthalmic
                            Ointment.
091-534..................  NEO-DELTA CORTEF (prednisolone acetate and
                            neomycin sulfate) Solution.
093-514..................  NEO-CORTEF (neomycin sulfate and
                            hydrocortisone acetate) Ointment.
096-676..................  PANOLOG (triamcinolone acetonide, nystatin,
                            thiostrepton, neomycin sulfate) Cream.
100-808..................  ALBAMAST (novobiocin sodium) Suspension for
                            Intramammary Infusion.
102-511..................  BIODRY (novobiocin sodium) Suspension for
                            Intramammary Infusion.
120-299..................  MITABAN (amitraz) Liquid Concentrate.
127-892..................  AMIGLYDE-V (amikacin sulfate) Intrauterine
                            Infusion.
130-435..................  OXYMARINE (oxytetracycline hydrochloride)
                            Fish Marker.
140-839..................  BACTODERM (mupirocin) Ointment.
140-844..................  TRAMISOL (levamisole) Pour-On Topical
                            Solution.
140-879..................  DERMA 4 (nystatin, neomycin sulfate,
                            thiostrepton, and triamcinolone acetonide)
                            Ointment.
141-003..................  DERM-OTIC (nystatin, neomycin, thiostrepton,
                            and triamcinolone acetonide) Ointment.
141-036..................  PIRSUE (pirlimycin hydrochloride)
                            Intramammary Infusion.
141-082..................  DOXIROBE (doxycycline hyclate) Gel.
141-095..................  DECTOMAX (doramectin) Pour-on Solution.
141-152..................  REVOLUTION (selamectin) Topical Solution.
141-200..................  EAZI-Breed CIDR (progesterone) Cattle Insert.
141-238..................  SPECTRAMAST LC (ceftiofur hydrochloride)
                            Sterile Suspension for Intramammary
                            Infusion.
141-239..................  SPECTRAMAST DC (ceftiofur hydrochloride)
                            Sterile Suspension for Intramammary
                            Infusion.
141-302..................  EAZI-BREED CIDR (progesterone) Sheep Insert.
200-102..................  GENTAGLYDE (gentamicin sulfate) Solution.
------------------------------------------------------------------------

    Accordingly, the Agency is amending the regulations in 21 CFR parts 
524, 526, and 529 to reflect these transfers of ownership. In addition, 
the regulations are being amended to make minor corrections and to 
reflect a current format. This is being done to increase the accuracy 
and readability of the regulations.
    In addition, FDA has noticed that certain sections of part 526 
contain entries describing conditions of use for new animal drug 
products for which no NADA is approved. These errors were

[[Page 10967]]

introduced by the Agency during the 1992 recodification of the 
regulations for certifiable antibiotics (57 FR 37318, August 18, 1992). 
That rule did not identify whether particular regulations were the 
subject of an approved NADA and consequently resulted in codification 
of certain conditions of use for which there is no approved NADA. At 
this time, the Agency is amending the regulations to remove these 
entries. This action is being taken 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.

List of Subjects in 21 CFR Parts 524, 526, and 529

    Animal drugs.

    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 524, 
526, and 529 are amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


0
2. In Sec.  524.86, revise the section heading, and paragraphs (b) and 
(c)(3) to read as follows:


Sec.  524.86  Amitraz.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
3. In Sec.  524.154, revise the section heading, redesignate paragraphs 
(a) and (b) as paragraphs (b) and (c); add new paragraph (a); and 
revise paragraph (b), and the introductory text in paragraph (c) to 
read as follows:


Sec.  524.154  Bacitracin, neomycin, and polymyxin B ophthalmic 
ointment.

    (a) Specifications. Each gram of ointment contains:
    (1) 500 units of bacitracin, 3.5 milligrams of neomycin, and 10,000 
units of polymyxin B sulfate; or
    (2) 400 units of bacitracin zinc, 3.5 milligrams of neomycin, and 
10,000 units of polymyxin B sulfate.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter as follows:
    (1) No. 054771 for use of product described in paragraph (a)(1) as 
in paragraph (c) of this section.
    (2) Nos. 000061 and 043264 for use of product described in 
paragraph (a)(2) as in paragraph (c) of this section.
    (c) Conditions of use in dogs and cats.* * *
* * * * *

0
4. In Sec.  524.155, revise the section heading, redesignate paragraphs 
(a) and (b) as paragraphs (b) and (c); add new paragraph (a); and 
revise paragraph (b), and the introductory text in paragraph (c) to 
read as follows:


Sec.  524.155  Bacitracin, neomycin, polymyxin B, and hydrocortisone 
ophthalmic ointment.

    (a) Specifications. Each gram of ointment contains 400 units of 
bacitracin zinc, 5 milligrams (mg) of neomycin sulfate (equivalent to 
3.5 mg of neomycin sulfate), 10,000 units of polymyxin B sulfate, and10 
mg of hydrocortisone.
    (b) Sponsors. See Nos. 000061 and 043264 in Sec.  510.600(c) of 
this chapter.
    (c) Conditions of use in dogs and cats.* * *
* * * * *


Sec.  524.390  [Amended]

0
5. In Sec.  524.390, revise paragraphs (b) and (c)(3) to read as 
follows:


Sec.  524.390  Chloramphenicol ophthalmic ointment.

* * * * *
    (b) Sponsors. See Nos. 043264 and 054771 in Sec.  510.600(c) of 
this chapter.
    (c) * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Federal law prohibits the use of 
this drug in food-producing animals.


Sec.  524.402  [Amended]

0
6. In paragraph (b) of Sec.  524.402, remove ``000856'' and in its 
place add ``054771''.

0
7. In Sec.  524.450, revise the section heading, and paragraphs (b) and 
(c)(3) to read as follows:


Sec.  524.450  Clotrimazole.

* * * * *
    (b) Sponsors. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  524.463  [Amended]

0
8. In paragraph (b) of Sec.  524.463, remove ``000856, 017135, and 
058829'' and in its place add ``017135, 054771, and 058829''.

0
9. In Sec.  524.575, revise paragraphs (c)(1) and (c)(3) to read as 
follows:


Sec.  524.575  Cyclosporine ophthalmic ointment.

* * * * *
    (c) * * *
    (1) Amount. Apply a \1/4\-inch strip of ointment directly on the 
cornea or into the conjunctival sac of the affected eye(s) every 12 
hours.
* * * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
10. Revise Sec.  524.660 to read as follows:


Sec.  524.660  Dimethyl sulfoxide.

    (a) Specifications--(1) Each milliliter (mL) of solution contains 
90 percent dimethyl sulfoxide and 10 percent water.
    (2) Each milliliter (mL) of gel product contains 90 percent 
dimethyl sulfoxide.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses and dogs--(1) Amount--(i) Horses. 
Apply topically two to three times daily in an amount not to exceed 100 
mL per day. Total duration of therapy should not exceed 30 days.
    (ii) Dogs. Apply topically three to four times daily in an amount 
not to exceed 20 mL per day. Total duration of therapy should not 
exceed 14 days.
    (2) Indications for use. To reduce acute swelling due to trauma.
    (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.


Sec. Sec.  524.660a and 524.660b  [Removed]

0
11. Remove Sec. Sec.  524.660a and 524.660b.

0
12. In Sec.  524.770, in paragraph (b), remove ``000069'' and in its 
place add ``054771''; and revise paragraph (e)(3) to read as follows:


Sec.  524.770  Doramectin.

* * * * *
    (e) * * *
    (3) Limitations. Do not slaughter cattle within 45 days of latest 
treatment. This 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 this product in 
preruminating calves. Do not use in calves to be processed for veal.

0
13. In Sec.  524.802, revise the section heading and paragraph (c)(3) 
to read as follows:

[[Page 10968]]

Sec.  524.802  Enrofloxacin and silver sulfadiazine otic emulsion.

* * * * *
    (c) * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Federal law prohibits the 
extralabel use of this drug in food-producing animals.

0
14. In Sec.  524.900, remove paragraph (a); redesignate paragraphs (b) 
through (f) as paragraphs (a) through (e); and revise newly 
redesignated (e) to read as follows:


Sec.  524.900  Famphur.

* * * * *
    (e) Conditions of use--(1) Amount. Apply 1 ounce per 200 pounds 
body weight, not to exceed a total dosage of 4 ounces, from the 
shoulder to the tail head as a single treatment. Apply as soon as 
possible after heel fly activity ceases.
    (2) Indications for use in beef and nonlactating dairy cattle. For 
control of cattle grubs and to reduce cattle lice infestations.
    (3) Limitations. Do not slaughter within 35 days after treatment. 
Do not use on lactating dairy cows or dry dairy cows within 21 days of 
freshening, calves less than 3 months old, animals stressed from 
castration, overexcitement or dehorning, sick or convalescent animals. 
Animals may become dehydrated and under stress following shipment. Do 
not treat until they are in good condition. Brahman and Brahman 
crossbreeds are less tolerant of cholinesterase-inhibiting insecticides 
than other breeds. Do not treat Brahman bulls. Swine should be 
eliminated from area where runoff occurs.

0
15. Revise Sec.  524.920, to read as follows:


Sec.  524.920  Fenthion.

    (a) Specifications. (1) The drug is a liquid containing:
    (i) 3 percent of fenthion; or
    (ii) 20 percent fenthion.
    (2) The drug is a solution containing either 5.6 or 13.8 percent 
fenthion. Each concentration is available in 2 volumes which are 
contained in single-dose applicators.
    (b) Sponsor. See sponsors in Sec.  510.600(c) of this chapter:
    (1) No. 000859 for use of product described in paragraph (a)(1)(i) 
as in paragraph (d)(1) of this section.
    (2) No. 000859 for use of product described in paragraph (a)(1)(ii) 
as in paragraph (d)(2) of this section.
    (3) No. 000859 for use of products described in paragraph (a)(2) as 
in paragraph (d)(3) of this section.
    (c) Related tolerances. See 40 CFR 180.214.
    (d) Conditions of use--(1) Beef cattle and nonlactating dairy 
cattle--(i) Amount. It is used at the rate of one-half fluid ounce per 
100 pounds of body weight applied topically on the backline of the 
animal. Only one application per season should be made for grub control 
and this will also provide initial control of lice. A second 
application for lice control may be made if animals become reinfested, 
but no sooner than 35 days after the first treatment. Proper timing of 
treatment is important for grub control; cattle should be treated as 
soon as possible after heel-fly activity ceases.
    (ii) Indications for use. For the control of grubs and lice in beef 
and nonlactating cattle.
    (iii) Limitations. Do not use on animals simultaneously or within a 
few days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, pesticides, or chemicals. Cattle should not be 
slaughtered within 35 days following a single treatment. If a second 
application is made for lice control, cattle should not be slaughtered 
within 45 days of the second treatment. The drug must not be used 
within 28 days of freshening of dairy cattle. If freshening should 
occur within 28 days after treatment, do not use milk as human food for 
the balance of the 28-day interval. Do not treat lactating dairy 
cattle; calves less than 3 months old; or sick, convalescent, or 
stressed livestock. Do not treat cattle for 10 days before or after 
shipping, weaning, or dehorning or after exposure to contagious 
infectious diseases.
    (2) Beef cattle and dairy cattle not of breeding age--(i) Amount. 
It is administered as a single, topical application placed on the 
backline of animals as follows: For animals weighing 150 to 300 pounds, 
apply 4 milliliters (mL); for animals weighing 301 to 600 pounds, apply 
8 mL; for animals weighing 601 to 900 pounds, apply 12 mL; for animals 
weighing 901 to 1,200 pounds, apply 16 mL; and for animal weighing over 
1,200 pounds, apply 20 mL. For most effective results, cattle should be 
treated as soon as possible after heel-fly activity ceases. A second 
application is required for animals heavily infested with lice or for 
those which become reinfested. A second application should be made no 
sooner than 35 days after the first treatment.
    (ii) Indications for use. For control of cattle grubs and as an aid 
in controlling lice on beef cattle and on dairy cattle not of breeding 
age.
    (iii) Limitations. Do not use on animals simultaneously or within a 
few days before or after treatment with or exposure to cholinesterase-
inhibiting drugs, pesticides, or chemicals. Host-parasite reactions 
such as bloat, salivation, staggering and paralysis may sometimes occur 
when cattle are treated while the common cattle grub (Hypoderma 
lineatum) is in the gullet, or while the northern cattle grub (H. 
bovis) is in the area of the spinal cord. Cattle should be treated 
before these stages of grub development. Consult your veterinarian, 
extension livestock specialist, or extension entomologist regarding the 
timing of treatment. If it is impossible to determine the area from 
which the cattle came and/or exact stage of the grubs, it is 
recommended that the cattle receive only a maintenance ration of low-
energy feed during the treatment period. This lessens the likelihood of 
severe bloat which may occur in cattle on full feed when the common 
grub is killed while in the gullet. Do not treat dairy cattle of 
breeding age; calves less than 3 months old; sick, convalescent, or 
severely stressed livestock. Do not treat cattle for 10 days before or 
after shipping, weaning, dehorning, or after exposure to contagious or 
infectious diseases. Do not slaughter within 45 days of treatment.
    (3) Dogs--(i) Amount. Four to 8 milligrams per kilogram of body 
weight. Apply the contents of the proper size, single-dose tube 
directly to one spot on the dog's skin.
    (ii) Indications for use. For flea control on dogs only.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
16. In Sec.  524.960, in paragraph (b), remove ``000856'' and in its 
place add ``054771''; and revise the section heading and paragraph 
(c)(3) to read as follows:


Sec.  524.960  Flumethasone, neomycin, and polymyxin B ophthalmic 
solution.

* * * * *
    (c) * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  524.981  [Removed and Reserved]

0
17. Remove and reserve Sec.  524.981.

0
18. In Sec.  524.981a, revise the section heading, the introductory 
text in paragraph (c), and paragraphs (c)(1) and (c)(2) to read as 
follows:


Sec.  524.981a  Fluocinolone cream.

* * * * *
    (c) Conditions of use in dogs--(1) Amount--A small amount is 
applied to the affected area two or three times daily.
    (2) Indications for use. For the relief of pruritis and 
inflammation associated

[[Page 10969]]

with certain superficial acute and chronic dermatoses. It is used in 
the treatment of allergic and acute moist dermatitis and for the relief 
of superficial inflammation caused by chemical burns and physical 
abrasions.
* * * * *

0
19. In Sec.  524.981b, revise the section heading, paragraph (a), the 
introductory text in paragraph (c), and paragraphs (c)(1) and (c)(2) to 
read as follows:


Sec.  524.981b  Fluocinolone solution.

    (a) Specifications. The drug contains 0.01 percent fluocinolone 
acetonide.
* * * * *
    (c) Conditions of use in dogs--(1) Amount--A small amount of 
solution is applied to the affected area two or three times daily.
    (2) Indications for use--(i) Dogs. For the relief of pruritis and 
inflammation associated with otitis externa and certain superficial 
acute and chronic dermatoses.
    (ii) Cats. For the relief of pruritis and inflammation associated 
with acute otitis externa and certain superficial acute and chronic 
dermatoses.
* * * * *

0
20. In Sec.  524.981c, revise the section heading, the introductory 
text in paragraph (c), and paragraphs (c)(1) and (c)(2) to read as 
follows:


Sec.  524.981c  Fluocinolone and neomycin cream.

* * * * *
    (c) Conditions of use in dogs--(1) Amount--A small amount is 
applied to the affected area two or three times daily.
    (2) Indications for use--(i) Dogs. For the relief of pruritis and 
inflammation associated with superficial acute and chronic dermatoses. 
It is used in the treatment of allergic and acute moist dermatitis and 
nonspecific dermatoses.
    (ii) Dogs and cats. Used in the treatment of wound infections.
* * * * *

0
21. Revise Sec.  524.981d to read as follows:


Sec.  524.981d  Fluocinolone and dimethyl sulfoxide solution.

    (a) Specifications. Each milliliter of solution contains 0.01 
percent fluocinolone acetonide and 20 percent dimethyl sulfoxide.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount--Instill 1 to 2 
milliliters into each anal sac following expression of anal sac 
contents.
    (2) Indications for use. For the relief of impaction commonly 
present in apparently normal anal sacs, for the reversal of 
inflammatory changes associated with abnormal anal sacs, and to 
counteract the offensive odor of anal sac secretions.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
22. Revise Sec.  524.981e to read as follows:


Sec.  524.981e  Fluocinolone and dimethyl sulfoxide otic solution.

    (a) Specifications. Each milliliter of solution contains 0.01 
percent fluocinolone acetonide and 60 percent dimethyl sulfoxide.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount--Instill 4 to 6 drops 
(0.2 milliliter) twice daily into the ear canal for a maximum period of 
14 days. The total dosage used should not exceed 17 milliliters.
    (2) Indications for use. For the relief of pruritis and 
inflammation associated with acute and chronic otitis.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
23. In Sec.  524.1005, in paragraph (b)(1), remove ``053501'' and in 
its place add ``054771''; in paragraph (c)(3), remove the last sentence 
and in its place add ``Do not use in horses intended for human 
consumption.''; and revise the section heading to read as follows:


Sec.  524.1005  Furazolidone powder.

* * * * *

0
24. In Sec.  524.1044, revise the section heading to read as follows:


Sec.  524.1044  Gentamicin ophthalmic and topical dosage forms.

0
25. In Sec.  524.1044b, revise the section heading to read as follows:


Sec.  524.1044b  Gentamicin and betamethasone otic solution.

* * * * *

0
26. In Sec.  524.1044c, revise the section heading to read as follows:


Sec.  524.1044c  Gentamicin ophthalmic ointment.

* * * * *

0
27. In Sec.  524.1044d, revise the section heading and paragraph (c) to 
read as follows:


Sec.  524.1044d  Gentamicin and betamethasone ointment.

* * * * *
    (c) Conditions of use in dogs--(1) Amount--(i) Otitis externa. 
Instill 3 to 8 drops into the ear canal twice daily for 7 days.
    (ii) Infected superficial lesions. Apply to cover the treatment 
area twice daily for 7 to 14 days.
    (2) Indications for use. For the treatment of acute and chronic 
otitis externa and infected superficial lesions caused by bacteria 
sensitive to gentamicin.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
28. In Sec.  524.1044e, revise the section heading and paragraph (c) to 
read as follows:


Sec.  524.1044e  Gentamicin spray.

* * * * *
    (c) Conditions of use in cattle--(1) Amount. Hold the sprayer 
upright 3 to 6 inches from the affected eye, with the opening directed 
towards the eye, and pump once. Treat once daily for up to 3 days.
    (2) Indications for use. For the treatment of pinkeye in cattle 
(infectious bovine keratoconjunctivitis) caused by Moraxella bovis.
    (3) Limitations. Conditions other than bacterial infections of the 
bovine eye and infectious keratoconjunctivitis caused by Moraxella 
bovis may produce similar signs. If conditions persists or increases, 
discontinue use and consult a veterinarian.

0
29. In Sec.  524.1044g, remove the second occurrence of paragraph 
(b)(3); and revise the section heading to read as follows:


Sec.  524.1044g  Gentamicin, betamethasone, and clotrimazole ointment.

* * * * *

0
30. In Sec.  524.1044h, revise the section heading and add paragraph 
(c)(3) to read as follows:


Sec.  524.1044h  Gentamicin, mometasone, and clotrimazole otic 
suspension.

* * * * *
    (c) * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
31. In Sec.  524.1132, revise the section heading to read as follows:


Sec.  524.1132  Hydrocortisone, miconazole, and gentamicin otic 
suspension.

* * * * *

0
32. Revise Sec.  524.1200a to read as follows:


Sec.  524.1200a  Kanamycin ophthalmic ointment.

    (a) Specifications. Each gram of ointment contains 3.5 milligrams 
kanamycin activity as kanamycin sulfate.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.

[[Page 10970]]

    (c) Conditions of use in dogs--(1) Amount. Apply a thin film to the 
affected eye three or four times daily or more frequently if deemed 
advisable. Treatment should be continued for at least 48 hours after 
the eye appears normal.
    (2) Indications for use. For the treatment of various eye 
infections (conjunctivitis, blepharitis, dacryocystitis, keratitis, and 
corneal ulcerations) due to bacteria sensitive to kanamycin. For 
prophylaxis in traumatic conditions, removal of foreign bodies, and 
intraocular surgery.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
33. Revise Sec.  524.1200b to read as follows:


Sec.  524.1200b  Kanamycin ophthalmic solution.

    (a) Specifications. Each milliliter of solution contains 10 
milligrams kanamycin activity as kanamycin sulfate.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill a few drops into 
the affected eye every 3 hours or more frequently if deemed advisable. 
Administer as frequently as possible for the first 48 hours, after 
which the frequency of applications may be decreased. Treatment should 
be continued for at least 48 hours after the eye appears normal.
    (2) Indications for use. For the treatment of various eye 
infections (conjunctivitis, blepharitis, dacryocystitis, keratitis, and 
corneal ulcerations) due to bacteria sensitive to kanamycin. For 
prophylaxis in traumatic conditions, removal of foreign bodies, and 
intraocular surgery.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
34. Revise Sec.  524.1204 to read as follows:


Sec.  524.1204  Kanamycin, amphomycin, and hydrocortisone ointment.

    (a) Specifications. Each gram of ointment contains 5 milligrams 
kanamycin activity as kanamycin sulfate, 5 milligrams of amphomycin 
activity as the calcium salt, and 10 milligrams of hydrocortisone 
acetate.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Apply to the affected 
areas of the skin at least twice daily. In severe or widespread lesions 
it may be desirable to apply the ointment more than twice daily. After 
some improvement is observed, treatment can usually be reduced to once 
daily.
    (2) Indications for use. For the treatment of acute otitis externa, 
furunculosis, folliculitis, pruritus, anal gland infections, erythema, 
decubital ulcers, superficial wounds, and superficial abscesses 
associated with bacterial infections caused by organisms susceptible to 
one or both antibiotics.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
35. In Sec.  524.1240, revise paragraph (b) to read as follows:


Sec.  524.1240  Levamisole.

* * * * *
    (b) Sponsors. See Nos. 000061 and 054771 in Sec.  510.600(c) of 
this chapter.
* * * * *

0
36. In Sec.  524.1446, revise the section heading to read as follows:


Sec.  524.1446  Milbemycin otic solution.

* * * * *


Sec.  524.1465  [Amended]

0
37. In paragraph (b) of Sec.  524.1465, remove ``000069, 025463, 
026637, and 051672'' and in its place add ``025463, 026637, 051672, and 
054771''.

0
38. In Sec.  524.1484, revise the section heading to read as follows:


Sec.  524.1484  Neomycin ophthalmic and topical dosage forms.

* * * * *

0
39. In Sec.  524.1484b, revise the section heading and paragraphs (b) 
and (c) to read as follows:


Sec.  524.1484b  Neomycin, isoflupredone, tetracaine, and myristyl-
gamma-picolinium powder.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses, dogs, and cats--(1) Amount. Apply 
to affected areas as a dusting powder.
    (2) Indications for use. For the treatment or as adjunctive therapy 
of certain ear and skin conditions caused by or associated with 
neomycin-susceptible organisms and/or allergy; as a superficial 
dressing applied to minor cuts, wounds, lacerations, abrasions, and for 
postsurgical application where reduction of pain and inflammatory 
response is deemed desirable; as a dusting powder following amputation 
of tails, claws, and dewclaws and following ear trimming, castrating, 
and such surgical procedures as ovariohysterectomies. For the treatment 
of acute otitis externa, acute moist dermatitis, and interdigital 
dermatitis in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
40. In Sec.  524.1484c, revise the section heading and paragraphs (b) 
and (c) to read as follows:


Sec.  524.1484c  Neomycin, isoflupredone, and tetracaine ointment.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. In treatment of otitis 
externa and other inflammatory conditions of the external ear canal, a 
quantity of ointment sufficient to fill the external ear canal; may be 
applied one to three times daily. When used on the skin or mucous 
membranes, the affected area should be cleansed, and a small amount of 
the ointment applied and spread or rubbed in gently. The involved area 
may be treated one to three times a day and these daily applications 
continued in accordance with the clinical response.
    (2) Indications for use. For the treatment of acute otitis externa 
in dogs and to a lesser degree, chronic otitis externa in dogs. It also 
is effective in treating anal gland infections and moist dermatitis in 
the dog and is a useful dressing for minor cuts, lacerations, 
abrasions, and post-surgical therapy in the horse, cat, and dog. It may 
also be used following amputation of dewclaws, tails and claws, 
following ear trimming and castrating operations.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
41. In Sec.  524.1484d, revise the section heading and paragraphs (b) 
and (c) to read as follows:


Sec.  524.1484d  Neomycin, hydrocortisone, and tetracaine otic 
ointment.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Instill a 
quantity of ointment sufficient to fill the external ear canal; may be 
applied one to three times daily.
    (2) Indications for use. For the treatment of ear canker and other 
inflammatory conditions of the external ear canal, acute otitis externa 
and, to a lesser degree, chronic otitis externa.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
42. In Sec.  524.1484e, revise the section heading and paragraphs (b) 
and (c) to read as follows:

[[Page 10971]]

Sec.  524.1484e  Neomycin and polymyxin B ophthalmic solution.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Instill 1 to 2 drops per 
eye every 6 hours.
    (2) Indications for use. For the treatment of bacterial infections 
associated with topical ophthalmological conditions such as corneal 
injuries, superficial keratitis, conjunctivitis, keratoconjunctivitis, 
and blepharitis.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
43. In Sec.  524.1484f, revise the section heading and paragraphs (b) 
and (c) to read as follows:


Sec.  524.1484f  Neomycin, prednisolone, and tetracaine otic 
suspension.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Instill 2 to 6 
drops in the external ear canal 2 or 3 times daily.
    (2) Indications for use. For the treatment of acute otitis externa 
and, to a lesser degree, chronic otitis externa; as treatment or 
adjunctive therapy of certain ear conditions caused by or associated 
with neomycin-susceptible organisms and/or allergy.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
44. In Sec.  524.1484g, revise the section heading and paragraph (c) to 
read as follows:


Sec.  524.1484g  Neomycin, thiabendazole, and dexamethasone solution.

* * * * *
    (c) Conditions of use in dogs and cats--(1) Amount. In treating 
dermatoses affecting areas other than the ear, the surface of the 
lesions should be well moistened (2 to 4 drops per square inch) twice 
daily. In treating otitis externa, instill 5 to 15 drops in the ear 
twice daily. Treat for up to 7 days.
    (2) Indications for use. As an aid in the treatment of bacterial, 
mycotic, and inflammatory dermatoses and otitis externa.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
45. In Sec.  524.1484h, revise the section heading and paragraphs (b) 
and (c) to read as follows:


Sec.  524.1484h  Neomycin, penicillin, polymyxin B, and hydrocortisone 
suspension.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Rub a small amount into 
the affected area 1 to 3 times a day. After definite improvement, apply 
once daily or every other day.
    (2) Indications for use. For the treatment of summer eczema, atopic 
dermatitis, interdigital eczema, and otitis externa caused by bacteria 
susceptible to neomycin, penicillin, and polymyxin B.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
46. In Sec.  524.1484i, revise the section heading and paragraphs (b) 
and (c) to read as follows:


Sec.  524.1484i  Neomycin and hydrocortisone ointment.

* * * * *
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. Apply 3 or 4 
times daily into the conjunctival sac. With improvement, frequency may 
be reduced to 2 or 3 times daily. For treatment of ear canker and other 
inflammatory conditions of the external ear canal, fill external ear 
canal 1 to 3 times daily.
    (2) Indications for use. For the treatment of infections, allergic 
and traumatic keratitis, conjunctivitis, acute otitis externa and, to a 
lesser degree, chronic otitis externa.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
47. Add Sec.  524.1484j to read as follows:


Sec.  524.1484j  Neomycin and prednisolone ophthalmic ointment.

    (a) Specifications. Each gram of ointment contains prednisolone 
sodium phosphate equivalent to 2.5 milligrams prednisolone 21-phosphate 
and 5 milligrams neomycin sulfate equivalent to 3.5 milligrams neomycin 
base.
    (b) Sponsor. See No. 050604 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. A small 
quantity of the ointment should be expressed into the conjunctival sac 
4 times a day (at intervals of 1 to 8 hours) for a few days until there 
is a favorable response, then the frequency of application may be 
reduced to twice daily as long as the condition remains under control. 
Treatment may require from a few days to several weeks.
    (2) Indications for use. For use in superficial ocular 
inflammations or infections limited to the conjunctiva or the anterior 
segment of the eye, such as those associated with allergic reactions or 
gross irritants.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
48. Add Sec.  524.1484k to read as follows:


Sec.  524.1484k  Prednisolone and neomycin suspension.

    (a) Specifications. Each milliliter of suspension contains 2.5 
milligrams of prednisolone acetate and 5 milligrams of neomycin sulfate 
equivalent to 3.5 milligrams of neomycin base.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. For beginning 
treatment of acute ocular inflammations place 1 or 2 drops in the 
conjunctival sac 3 to 6 times during a 24 hour period. When improvement 
occurs, reduce the dosage to 1 drop 2 to 4 times daily. For otitis 
externa, place 2 to 6 drops in the external ear canal 2 or 3 times 
daily.
    (2) Indications for use. For the treatment of treating infectious, 
allergic and traumatic keratitis and conjunctivitis, acute otitis 
externa, and chronic otitis externa.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
49. In Sec.  524.1580, revise the section heading to read as follows:


Sec.  524.1580  Nitrofurazone topical dosage forms.

* * * * *


Sec.  524.1580a  [Removed]

0
50. Remove Sec.  524.1580a.


Sec.  524.1580b  [Amended]

0
51. Redesignate Sec.  524.1580b as Sec.  524.1580a; and in newly 
designated paragraph (b)(1), remove ``000069,''.


Sec.  524.1580c  [Amended]

0
52. Redesignate Sec.  524.1580c as Sec.  524.1580b; in paragraph (b), 
remove ``Nos. 000069 and 054628'' and in its place add ``No. 054628''; 
and in paragraphs (c)(2) and (c)(3), remove footnote 1.


Sec.  524.1580d  [Removed]

0
53. Remove Sec.  524.1580d.


Sec.  524.1580e  [Amended]

0
54. Redesignate Sec.  524.1580e as Sec.  524.1580c; in paragraph (c)(1) 
and (c)(2), remove footnote 1; and revise the section heading to read 
as follows:


Sec.  524.1580c  Nitrofurazone and butacaine ointment.

* * * * *

[[Page 10972]]


0
55. In Sec.  524.1600a, revise the section heading, paragraphs (b) and 
(c)(3) to read as follows:


Sec.  524.1600a  Nystatin, neomycin, thiostrepton, and triamcinolone 
ointment.

* * * * *
    (b) Sponsors. For petrolatum base ointments see Nos. 000856, 
025463, 054771, and 054925 in Sec.  510.600(c) of this chapter. For 
vanishing cream base ointments see Nos. 025463, 054771, and 054925.
    (c) * * *
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
56. In Sec.  524.1600b, revise the section heading, and paragraph (c) 
to read as follows:


Sec.  524.1600a  Nystatin, neomycin, thiostrepton, and triamcinolone 
ophthalmic ointment.

* * * * *
    (c) Conditions of use--(1) Dogs and cats--(i) Amount. Apply 1 drop 
of ointment to the affected eye(s) 2 or 3 times daily. Treatment may be 
continued for up to 2 weeks if necessary.
    (ii) Indications for use. For use as an anti-inflammatory, 
antipruritic, antifungal (Candida albicans), and antibacterial ointment 
for local therapy in keratitis and conjunctivitis.
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) Cattle--(i) Amount. Apply small line of ointment to the 
affected eye(s) once daily. Treatment may be continued for up to 2 
weeks if necessary.
    (ii) Indications for use. For infectious kerato-conjunctivitis 
(pinkeye).
    (iii) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
57. In Sec.  524.1662, revise the section heading to read as follows:


Sec.  524.1662  Oxytetracycline ophthalmic and topical dosage forms.

* * * * *

0
58. In Sec.  524.1662a, in paragraph (b), remove ``000069'' and in its 
place add ``054771''; and revise the section heading and paragraph (c) 
to read as follows:


Sec.  524.1662a  Oxytetracycline and hydrocortisone spray.

* * * * *
    (c) Conditions of use in dogs and cats--(1) Amount. A small 
quantity should be sprayed on the affected surface by holding the 
container about 6 inches from the area to be treated and pressing the 
nozzle for 1 or 2 seconds. Only sufficient spray to coat the skin 
thinly is necessary. The application of small amounts at frequent 
intervals will give best results. Before treating animals with long or 
matted hair, it may be necessary to clip the affected area or spread 
the hairs to allow the medication to contact the skin surface. Relief 
may be noted following the first or second treatment; however, 
treatment should not be discontinued too soon after the initial 
favorable response has been obtained.
    (2) Indications for use. For the relief of discomfort and continued 
treatment of many allergic, infectious, and traumatic skin conditions; 
for the prevention of bacterial infections in superficial wounds, cuts, 
and abrasions, treatment of allergic dermatoses, including urticaria, 
eczemas, insect bites, and cutaneous drug reactions, infections 
associated with minor burns and wounds, and nonspecific pruritus.
    (3) Limitations. Keep away from eyes or other mucous membranes; 
avoid inhaling; use with adequate ventilation; in case of deep or 
puncture wounds or serious burns, consult a veterinarian.

0
59. In Sec.  524.1662b, in paragraph (b), remove ``000069'' and in its 
place add ``054771''; and revise the section heading and paragraph (c) 
to read as follows:


Sec.  524.1662b  Oxytetracycline and polymyxin B ophthalmic ointment.

* * * * *
    (c) Conditions of use in dogs and cats--(1) Amount. Administer 
topically to the eye two to four times daily.
    (2) Indications for use. For the prophylaxis and local treatment of 
superficial ocular infections due to oxytetracycline- and polymyxin-
sensitive organisms including ocular infections due to streptococci, 
rickettsiae, E. coli, and A. aerogenes (such as conjunctivitis, 
keratitis, pinkeye, corneal ulcer, and blepharitis in dogs, cats, 
cattle, sheep, and horses); ocular infections due to secondary 
bacterial complications associated with distemper in dogs; and ocular 
infections due to bacterial inflammatory conditions which may occur 
secondary to other infectious diseases in dogs, cats, cattle, sheep, 
and horses.
    (3) Limitations. Allergic reactions may occasionally occur. 
Treatment should be discontinued if reactions are severe. If new 
infections due to nonsensitive bacteria or fungi appear during therapy, 
appropriate measures should be taken.


Sec. Sec.  524.1881, 524.1881a, and 524.1881b  [Removed]

0
60. Remove Sec. Sec.  524.1881, 524.1881a, and 524.1881b.


Sec.  524.1883  [Removed]

0
61. Remove Sec.  524.1883.

0
62. In Sec.  524.1982, in paragraph (b), remove ``053501'' and in its 
place add ``054771''; and revise the section heading and paragraph (c) 
to read as follows:


Sec.  524.1982  Proparacaine ophthalmic solution.

* * * * *
    (c) Conditions of use in dogs and cats--(1) Amount. It is 
administered as follows:
    (i) For removal of sutures: Instill one to two drops 2 or 3 minutes 
before removal of stitches.
    (ii) For removal of foreign bodies from eye, ear, and nose: For 
ophthalmic use, instill three to five drops in the eye prior to 
examination; for otic use, instill five to ten drops in the ear; for 
nasal use, instill five to ten drops in each nostril every 3 minutes 
for three doses.
    (iii) For tonometry: Instill one to two drops immediately before 
measurement.
    (iv) As an aid in treatment of otitis: Instill two drops into the 
ear every 5 minutes for three doses.
    (v) For minor surgery: Instill one or more drops as required.
    (vi) For catheterization: Instill two to three drops with a blunt 
20-gauge needle immediately before inserting catheter.
    (2) Indications for use. For use as a topical ophthalmic 
anesthetic. It is used as an anesthetic in cauterization of corneal 
ulcers, removal of foreign bodies and sutures from the cornea, and 
measurement of intraocular pressure (tonometry) when glaucoma is 
suspected; as an aid in the removal of foreign bodies from the nose and 
ear canal; as an accessory in the examination and treatment of painful 
otitis, in minor surgery, and prior to catheterization.
    (3) Limitations. Keep away from eyes or other mucous membranes; 
avoid inhaling; use with adequate ventilation; in case of deep or 
puncture wounds or serious burns, consult a veterinarian.


Sec.  524.2098  [Amended]

0
63. In paragraph (b) of Sec.  524.2098, remove ``000069'' and in its 
place add ``No. 054771''.

0
64. Revise Sec.  524.2350 to read as follows:


Sec.  524.2350  Tolnaftate cream.

    (a) Specifications. The drug contains 1 percent tolnaftate in an 
anhydrous cream base.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Apply a small amount of the 
cream to

[[Page 10973]]

the affected areas once or twice a day for 2 to 4 weeks.
    (2) Indications for use. For the treatment of ringworm lesions due 
to Microsporum canis and Microsporum gypseum.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

0
65. Revise Sec.  524.2620 to read as follows:


Sec.  524.2620  Liquid crystalline trypsin, Peru balsam, castor oil.

    (a) Specifications--(1) Each gram of liquid or aerosol contains 
0.12 milligram of crystalline trypsin, 87.0 milligrams of Peru balsam, 
and 788.0 milligrams of castor oil.
    (2) Each gram of liquid or aerosol contains 0.1 milligram of 
crystalline trypsin, 72.5 milligrams of Peru balsam, and 800 milligrams 
of castor oil.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter for use as in paragraph (c) in this section:
    (1) No. 051079 for use of product described in paragraph (a)(1).
    (2) No. 017135 for use of product described in paragraph (a)(2).
    (c) Conditions of use--(1) Amount. Apply directly to the wound 
site.
    (2) Indications for use. As an aid in the treatment of external 
wounds and assists healing by facilitating the removal of necrotic 
tissue, exudate, and organic debris.

PART 526--INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

0
66. The authority citation for 21 CFR part 526 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.


Sec.  526.313  [Amended]

0
67. In paragraph (b) of Sec.  526.313, remove ``000009'' and in its 
place add ``054771''.


Sec.  526.464a  [Amended]

0
68. In Sec.  526.464a, remove paragraph (d).


Sec.  526.464d  [Removed]

0
69. Remove Sec.  526.464d.


Sec.  526.820  [Amended]

0
70. In paragraph (b) of Sec.  526.820, remove ``No. 061623'' and in its 
place add ``Nos. 054771 and 061623''.

0
71. In Sec.  526.1130, revise the section heading to read as set forth 
below:


Sec.  529.1130  Hetacillin infusion.

* * * * *

0
72. In Sec.  526.1590, in paragraphs (a)(2) and (b)(2), remove 
``000009'' and in its place add ``054771''; and revise the section 
heading to read as follows:


Sec.  526.1590  Novobiocin infusion.

* * * * *


Sec.  526.1696d  [Amended]

0
73. In paragraph (b) of Sec.  526.1696d, remove ``000009'' and in its 
place add ``054771''.


Sec.  526.1810  [Amended]

0
74. In paragraph (b) of Sec.  526.1810, remove ``000009'' and in its 
place add ``054771''.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
75. The authority citation for 21 CFR part 529 continues to read as 
follows:


    Authority:  21 U.S.C. 360b.

0
76. In Sec.  529.40, remove paragraph (c); redesignate paragraph (d) as 
paragraph (c); and revise newly redesignated paragraph (c)(3) to read 
as follows:


Sec.  529.40  Albuterol.

* * * * *
    (c) * * *
    (3) Not for use in horses intended for food. Federal law restricts 
this drug to use by or on the order of a licensed veterinarian.


Sec.  529.56  [Amended]

0
77. In paragraph (b) of Sec.  529.56, remove ``000856 and 000859'' and 
in its place add ``000859 and 054771''.


Sec.  529.400  [Amended]

0
78. In Sec.  529.400, revise the section heading; in paragraph (b), 
remove ``000856'' and in its place add ``054771''; and in paragraphs 
(c)(1), (c)(2), and (c)(3), remove the footnote.

0
79. Add Sec.  529.778 to read as follows:


Sec.  529.778  Doxycycline.

    (a) Specifications. Doxycycline hyclate solution contains 8.5 
percent doxycycline activity. A syringe of N-methyl-2-pyrrolidone and 
poly (DL-lactide) mixed with a syringe of doxycycline produces 0.5 
milliliter of solution.
    (b) Sponsor. See 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Apply subgingivally to 
periodontal pocket(s) of affected teeth.
    (2) Indications for use. For treatment and control of periodontal 
disease.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.


Sec.  529.1044  [Amended]

0
80. In Sec.  529.1044, remove the word ``sulfate'' in the section 
heading.

0
81. In Sec.  529.1044a, revise the section heading and paragraph (b) to 
read as follows:


Sec.  529.1044a  Gentamicin solution for infusion.

* * * * *
    (b) Sponsors. See Nos. 000061, 000859, 054628, 054771, 057561, 
058005, and 061623 in Sec.  510.600(c) of this chapter.
* * * * *

0
82. In Sec.  529.1044b, revise the section heading and paragraph (c) to 
read as follows:


Sec.  529.1044b  Gentamicin solution for dipping eggs.

* * * * *
    (c) Conditions of use in turkeys--(1) Amount. The drug is added to 
clean water to provide a dip solution with a gentamicin concentration 
of 250 to 1,000 parts per million. A concentration of 500 parts per 
million is recommended. Clean eggs should be held submerged in the 
gentamicin solution under a vacuum of about 27.5 to 38 centimeters of 
mercury for 5 minutes followed by additional soaking in gentamicin 
solution for approximately 10 minutes at atmospheric pressure. Eggs can 
also be treated by warming them for 3 to 6 hours at approximately 100 
[deg]F then immediately submerging them in gentamicin solution 
maintained at about 40 [deg]F, keeping the eggs submerged for 10 to 15 
minutes.
    (2) Indications for use. As an aid in the reduction or elimination 
of the following microorganisms from turkey-hatching eggs: Arizona 
hinshawii (paracolon), Salmonella Saintpaul, and Mycoplasma 
meleagridis.
    (3) Limitations. For use in the dipping treatment of turkey-
hatching eggs only. Eggs which have been dipped in the drug shall not 
be used for food.

0
83. In Sec.  529.1115, remove the footnote in paragraphs (c)(1), 
(c)(2), and (c)(3); and revise paragraphs (b) and (c)(3) to read as 
follows:


Sec.  529.1115  Halothane.

* * * * *
    (b) Sponsor. See Nos. 012164 and 054771 in Sec.  510.600(c) of this 
chapter.
    (c) * * *
    (3) Limitations. Not for use in animals intended for food. Federal 
law restricts this drug to use by or on the order of a licensed 
veterinarian.


Sec.  529.1660  [Amended]

0
84. In Sec.  529.1660, in paragraph (b)(1), remove ``046573'' and in 
its place add ``054771''; and in paragraph (b)(2), remove ``000069, 
048164, and 059130''

[[Page 10974]]

and in its place add ``048164, 054771, and 061623''.


Sec.  529.1940  [Amended]

0
85. In paragraph (b) of Sec.  529.1940, remove ``000009'' and in its 
place add ``054771''.

0
86. Revise Sec.  529.2464 to read as follows:


Sec.  529.2464  Ticarcillin.

    (a) Specifications. Each vial contains ticarcillin disodium powder 
equivalent to 6 grams of ticarcillin for reconstitution with 25 
milliliters of sterile water for injection or sterile physiological 
saline.
    (b) Sponsor. See No. 054771 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in horses--(1) Amount. Administer 6 grams 
daily by intrauterine infusion for 3 consecutive days during estrus.
    (2) Indications for use. For the treatment of endometritis caused 
by beta-hemolytic streptococci.
    (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
87. Revise Sec.  529.2503 to read as follows:


Sec.  529.2503  Tricaine methanesulfonate.

    (a) Specifications. The drug is ethyl-m-amino-benzoate 
methanesulfonate.
    (b) Sponsor. See Nos. 050378 and 051212 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. It is used as follows:
    (i) Fish. The drug is added to ambient water at a concentration of 
from 15 to 330 milligrams per liter depending upon the degree of 
anesthetization or sedation desired, the species and size of the fish, 
and the temperature and softness of the water. Preliminary tests of 
solutions must be made with small numbers of fish to determine the 
desired rates of sedation or anesthesia and the appropriate exposure 
times for the specific lots of fish under prevailing conditions.
    (ii) Amphibians and other aquatic coldblooded animals. The drug is 
added to ambient water in concentrations of from 1:1000 to 1:20,000 
depending upon species and stage of development.
    (2) Indications for use. For the temporary immobilization of fish, 
amphibians, and other aquatic coldblooded animals (poikilotherms) as an 
aid in handling during manual spawning (fish stripping), weighing, 
measuring, marking, surgical operations, transport, photography, and 
research.
    (3) Limitations. Do not use within 21 days of harvesting fish for 
food. Use in fish intended for food should be restricted to 
Ictaluridae, Salmonidae, Esocidae, and Percidae, and water temperature 
exceeding 10 [deg]C (50 [deg]F). In other fish and in coldblooded 
animals, the drug should be limited to hatchery or laboratory use.

    Dated: January 27, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-01958 Filed 2-26-14; 8:45 am]
BILLING CODE 4160-01-P


