[Federal Register Volume 79, Number 39 (Thursday, February 27, 2014)]
[Rules and Regulations]
[Pages 10965-10974]
[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.

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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.,

Rockville, MD 20855;<PHONE_NUMBER><EMAIL_ADDRESS>
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

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:

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

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.

    (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:

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.

* * * * *

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

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''

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


[Federal Register Volume 83, Number 95 (Wednesday, May 16, 2018)]
[Notices]
[Pages 22664-22666]
[FR Doc No: 2018-10401]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC18-6-000]

Commission Information Collection Activities: (FERC-65, FERC-65a,
FERC-65b, FERC-725v) Consolidated Comment Request; Extension

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the information collections,
FERC-65 (Notice of Holding Company Status), FERC-65A (Exemption
Notification of holding Company Status), and FERC-65B (Waiver
Notification of Holding Company Status), and FERC-725V (Mandatory
Reliability Standards: COM Reliability Standards) which will be
submitted to the Office of Management and Budget (OMB) for a review of
the information collection requirements.

DATES: Comments on the collection of information are due June 15, 2018.

ADDRESSES: Comments filed with OMB, identified by OMB Control No. 1902-
0218 and OMB Control No. 1902-0277, should be sent via email to the
Office of Information and Regulatory Affairs: [email protected].
Attention: Federal Energy Regulatory Commission Desk Officer. The Desk
Officer may also be reached via telephone at<PHONE_NUMBER>.
    A copy of the comments should also be sent to the Commission, in
Docket No. IC18-6-000 by either of the following methods:
     eFiling at Commission's website: http://www.ferc.gov/docs-filing/efiling.asp
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at [email protected], or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
[email protected], telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-65 (Notice of Holding Company Status), FERC-65A
(Exemption Notification of Holding Company Status), and FERC-65B
(Waiver Notification of Holding Company Status).
    OMB Control No.: 1902-0218.
    Type of Request: Three-year extension of the FERC-65, FERC-65A and
FERC-65B information collection requirements with no changes to the
current reporting requirements.
    Abstract: The Pursuant to section 366.4 of the Commission's rules
and regulations, persons who meet the definition of a holding company
shall provide the Commission notification of holding company status.
    The FERC-65 is a one-time informational filing outlined in the
Commission's regulations at 18 Code of Federal Regulations (CFR) 366.4.
The FERC-65 must be submitted within 30 days of becoming a holding
company.\1\ While the Commission does not require the information to be
reported in a specific format, the filing needs to consist of the name
of the holding company, the name of public utilities, the name of
natural gas companies in the holding company system, and the names of
service companies. In addition, the Commission requires the filing to
include the names of special-purpose subsidiaries (which provide non-
power goods and services) and the names of all affiliates and
subsidiaries (and their corporate interrelationship) to each other.
Filings may be submitted in hardcopy or electronically through the
Commission's eFiling system.
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    \1\ Persons that meet the definition of a holding company as
provided by Sec.  366.1 as of February 8, 2006 shall notify the
Commission of their status as a holding company no later than June
15, 2006. Holding companies formed after February 8, 2006 shall
notify the Commission of their status as a holding company, no later
than the latter of June 15, 2006 or 30 days after they become
holding companies.
---------------------------------------------------------------------------

FERC-65A (Exemption Notification of Holding Company Status)

    While noting the previously outlined requirements of the FERC-65,
the Commission has allowed for an exemption from the requirement of
providing the Commission with a FERC-65 if the books, accounts,
memoranda, and other records of any person are not relevant to the
jurisdictional rates of a public utility or natural gas company; or if
any class of transactions is not relevant to the jurisdictional rates
of a public utility or natural gas company. Persons seeking this
exemption file the FERC-65A, which must include a form of notice
suitable for publication in the Federal Register. Those who file a
FERC-65A in good faith will have a temporary exemption upon filing,
after 60 days if the Commission has taken no action, the exemption will
be deemed granted. Commission regulations within 18 CFR 366.3 describe
the criteria in more specificity.

1. FERC-65B (Waiver Notification of Holding Company Status)

    If an entity meets the requirements in 18 CFR 366.3(c), they may
file a FERC-65B waiver notification pursuant to the procedures outlined
in 18 CFR 366.4. Specifically, the Commission waives the requirement of
providing it with a FERC-65 for any holding company with respect to one
or more of the following: (1) Single-state holding company systems; (2)
holding companies that own generating facilities that total 100 MW or
less in size and are used fundamentally for their own load or for sales
to affiliated end-users; or (3) investors in independent transmission-
only companies. Filings may be made in hardcopy or electronically
through the Commission's website.
    Type of Respondent: Public utility companies, natural gas
companies, electric wholesale generators, foreign utility holding
companies.
    Estimate of Annual Burden: \2\ The Commission estimates the annual
public reporting burden for the information collection as:
---------------------------------------------------------------------------

    \2\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. Refer to
5 CFR 1320.3 for additional information.

   FERC-65 (Notification of Holding Company Status), FERC-65A (Exemption Notification of Holding Company Status), and FERC-65B (Waiver Notification of
                                                                 Holding Company Status)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total annual
                                                             Number of     Annual number   Total number   Average burden   burden hours      Cost per
                                                            respondents    of responses    of responses    and cost per      and total      respondent
                                                                          per respondent                   response \3\     annual cost
                                                                     (1)             (2)     (1) * (2) =             (4)     (3) * (4) =   ($) (5) / (1)
                                                                                (3)                             (5)
--------------------------------------------------------------------------------------------------------------------------------------------------------
FERC-65.................................................              12               1              12      3; $229.50      36; $2,754         $229.50
FERC-65A................................................               4            1.25               5       1; $76.50      5; $382.50          $95.63
FERC-65B................................................               4            1.75               7       1; $76.50      7; $535.50         $133.88
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............              24  ..............      48; $3,672  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Title: FERC-725V, Mandatory Reliability Standards: COM Reliability
Standards.
---------------------------------------------------------------------------

    \3\ The estimates for cost per response are derived using the
following formula: 2017 Average Burden Hours per Response * $76.50
per Hour = Average Cost per Response. The hourly cost figure of
$76.50 is the average FERC employee wage plus benefits. We assume
for FERC-65, FERC-65A and FERC-65B that respondents earn at a
similar rate.
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    OMB Control No.: 1902-0277.
    Type of Request: Three-year extension of the FERC-725V information
collection requirements with no changes to the current reporting
requirements.
    Abstract: On August 15, 2016, the North American Electric
Reliability Corporation (NERC) filed a petition for Commission
approval, pursuant to section 215(d)(1) of the Federal Power Act
(``FPA'') \4\ and Section 39.5 \5\ of the Federal Energy Regulatory
Commission's regulations, for Reliability Standard COM-001-3
(Communications), the associated Implementation Plan, retirement of
currently-effective Reliability Standard COM-001-2.1, and Violation
Risk Factors (``VRFs'') and Violation Severity Levels (``VSLs'')
associated with new Requirements R12 and R13 in Reliability Standard
COM-001-3. Reliability Standard COM-001-3 reflects revisions developed
under Project 2015-07 Internal Communications Capabilities, in
compliance with the Commission's directive in Order No. 888 that NERC
``develop modifications to COM-001-2, or develop a new standard, to
address the Commission's concerns regarding ensuring the adequacy of
internal communications capability whenever internal communications
could directly affect the reliability opera.
---------------------------------------------------------------------------

    \4\ 16 U.S.C. 824o (2012).
    \5\ 18 CFR 39.5 (2015).
---------------------------------------------------------------------------

    Reliability Standards COM-001-2 and COM-002-4 do not require
responsible entities to file information with the Commission. COM-001-2
requires that transmission operators, balancing authorities,
reliability coordinators, distribution providers, and generator
operators must maintain documentation of Interpersonal Communication
capability and designation of Alternate Interpersonal Communication, as
well as evidence of testing of the Alternate Interpersonal
Communication facilities. COM-002-4 requires balancing authorities,
distribution providers, reliability coordinators, transmission
operators, and generator operators to develop and maintain documented
communication protocols, and to be able to provide evidence of training
on the protocols and of their annual assessment of the protocols.
Additionally, all applicable entities (balancing authorities,
reliability coordinators, transmission operators, generator operators,
and distribution providers) must be able to provide evidence of three-
part communication when issuing or receiving an Operating Instruction
during an Emergency.
    Type of Respondents: Public utilities.
    Estimate of Annual Burden: \6\ The Commission estimates the annual
public reporting burden for the information collection as:
---------------------------------------------------------------------------

    \6\ The Commission defines burden as the total time, effort, or
financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal
agency. For further explanation of what is included in the
information collection burden, reference 5 Code of Federal
Regulations 1320.3.

                                                              FERC-725V, Mandatory Reliability Standards: COM Reliability Standards
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Annual number
                                             Number of respondents         of responses    Total number       Average burden and cost per      Total annual burden hours & total     Cost per
                                                                          per respondent   of responses              response \7\                         annual cost               respondent
                                      (1)...............................             (2)     (1) * (2) =  (4)...............................  (3) * (4) = (5)...................   ($) (5) / (1)
                                                                                (3)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
(One-time) \8\ Development of         201 (BA, RC & TOP)................               1             201  8 hrs. & $288.....................  1,608 hrs. & $57,888..............             288
 Communication Protocols [COM-002-4
 R1].
(On-going) \9\ Maintain evidence of   1,180 (DP & GOP)..................               1           1,180  4 hrs. & $144.....................  4,720 hrs. & $169,920.............             144
 Interpersonal Communication
 capability [COM-001-2 R7 and R8].

(On-going) Maintain evidence of       201 (BA, RC & TOP)................               1             201  8 hrs. & $288.....................  1,608 hrs. & $57,888..............             288
 training and assessments [COM-002-4
 R2, R4, R5 and R6].
(On-going) Maintain evidence of       1,880 (DP & GOP)..................               1           1,180  8 hrs. & $288.....................  15,040 hrs. & $541,440............             288
 training [COM-002-4 R3 and R6].
                                                                         -----------------------------------------------------------------------------------------------------------------------
    Total...........................  ..................................  ..............           2,762  ..................................  22,976 hrs. & $827,136............  ..............
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    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
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    \7\ The loaded hourly wage figure (includes benefits) is based
on the occupational categories for 2016 found on the Bureau of Labor
Statistics website (http://www.bls.gov/oes/current/naics2_22.htm):
    Electrical Engineer (Occupation Code: 17-2071): $68.12 (review
and documentation).
    Office and Administrative Support (Occupation Code: 43-0000):
$40.89 ($68.12 + 40.89 = 109.01 / 3 = $36.34. This figure is rounded
to $36.00 for use in collection FERC-725V for calculating wage
figures in this renewal calculation.

    Dated: May 10, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-10401 Filed 5-15-18; 8:45 am]
 BILLING CODE 6717-01-P