5318 Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Rules and Regulations

PART 305—[AMENDED]

Accordingly, 16 CFR Part 305 is

amended as follows:

1. The authority citation for Part 305

continues to read:

Authority: 42 U.S.C. 6294.

2. Section 305.9(a) is revised to read

as follows:

§ 305.9 Representative average unit

energy costs.

(a) Table 1, below, contains the

representative unit energy costs to be

utilized for all requirements of this part.

TABLE 1.—REPRESENTATIVE AVERAGE UNIT COSTS OF ENERGY FOR FIVE RESIDENTIAL ENERGY SOURCES (1997)

Type of energy In commonly used terms As required by DOE test procedure Dollars per

million Btu 1

Electricity ................................................... 8.31¢/kWh 2 3 ............................................. $0.0831/kWh ............................................. $24.35

Natural Gas ............................................... 61.2¢/therm 4 or $6.43/MCF 5 6 ................. 0.00000612/Btu ........................................ 6.12

No. 2 heating oil ........................................ 0.99/gallon 7 .............................................. 0.00000714/Btu ........................................ 7.14

Propane ..................................................... 0.98/gallon 8 .............................................. 0.00001073/Btu ........................................ 10.73

Kerosene ................................................... 1.16/gallon 9 .............................................. 0.00000859/Btu ........................................ 8.59

1Btu stands for British thermal unit.

2 kWh stands for kilowatt hour.

3 1 kWh = 3,412 Btu.

4 1 therm = 100,000 Btu. Natural gas prices include taxes.

5 MCF stands for 1,000 cubic feet.

6For the purposes of this table, 1 cubic foot of natural gas has an energy equivalence of 1,028 Btu.

7For the purposes of this table, 1 gallon of No. 2 heating oil has an energy equivalence of 138,690 Btu.

8For the purposes of this table, 1 gallon of liquid propane has an energy equivalence of 91,333 Btu.

9For the purposes of this table, 1 gallon of kerosene has an energy equivalence of 135,000 Btu.

* * * * *

Donald S. Clark,

Secretary.

[FR Doc. 97–2802 Filed 2–4–97; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Tetracycline Hydrochloride Soluble

Powder

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of an abbreviated new animal

drug application (ANADA) filed by

Phoenix Scientific, Inc. The ANADA

provides for oral use of tetracycline

hydrochloride soluble powder in the

drinking water of calves and swine for

control and treatment of certain diseases

caused by pathogens susceptible to

tetracycline, and of chickens and

turkeys for control of certain diseases

caused by pathogens susceptible to

tetracycline.

EFFECTIVE DATE: February 5, 1997.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center For

Veterinary Medicine (HFV–135), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1643.

SUPPLEMENTARY INFORMATION: Phoenix

Scientific, Inc., 3915 South 48th Street

Ter., P.O. Box 6457, St. Joseph, MO

64506–0457, filed ANADA 200–136,

which provides for oral use of

tetracycline hydrochloride soluble

powder in the drinking water of calves

and swine for control and treatment of

certain conditions, and of chickens and

turkeys for the control of certain

conditions, as follows: (1) For calves for

control and treatment of bacterial

enteritis (scours) caused by Escherichia

coli, and bacterial pneumonia (shipping

fever complex) associated with

Pasteurella spp., Actinobacillus

pleuropneumoniae (Hemophilus spp.),

and Klebsiella spp. susceptible to

tetracycline; (2) for swine for control

and treatment of bacterial enteritis

(scours) caused by E. coli, and bacterial

pneumonia associated with Pasteurella

spp., A. pleuropneumoniae

(Hemophilus spp.), and Klebsiella spp.

susceptible to tetracycline; (3) for

chickens for control of chronic

respiratory disease (CRD or air-sac

disease) caused by Mycoplasma

gallisepticum and E. coli; infectious

synovitis caused by M. synoviae

susceptible to tetracycline; (4) for

turkeys for control of infectious

synovitis caused by M. synoviae and

bluecomb (transmissible enteritis or

coronaviral enteritis) complicated by

bacterial organisms susceptible to

tetracycline.

Approval of Phoenix’s ANADA 200–

136 tetracycline hydrochloride soluble

powder is as a generic copy of

Fermenta’s NADA 65–496 tetracycline

hydrochloride soluble powder. ANADA

200–136 is approved as of December 17,

1996, and the regulations are amended

in § 520.2345d(a)(1) (21 CFR

520.2345d(a)(1)) to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

In addition, due to enactment of the

Generic Animal Drug and Patent Term

Restoration Act of 1988, the paragraph

concerning NAS/NRC status is outdated.

Section 520.2345d is amended to

remove paragraph (c).

In accordance with the freedom of

information provisions of 21 CFR part

20 and 21 CFR 514.11(e)(2)(ii), a

summary of safety and effectiveness

data and information submitted to

support approval of this application

may be seen in the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

9 a.m. and 4 p.m., Monday through

Friday.

The agency has determined under 21

CFR 25.24 (d)(1)(i) that this action is of

a type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

List of Subjects

21 CFR Part 520

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 part 520 is amended as follows:
Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Rules and Regulations 5319

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

§ 520.2345d [Amended]

2. Section 520.2345d Tetracycline

hydrochloride soluble powder is

amended in paragraph (a)(1) by

removing ‘‘047864, 054273, and

057561’’ and adding in its place

‘‘047864, 054273, 057561, and 059130’’

and by removing and reserving

paragraph (c).

Dated: January 28, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–2819 Filed 2–4–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Ivermectin Chewables

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a new animal drug

application (NADA) filed by Merck

Research Laboratories, Div. of Merck &

Co., Inc. The NADA provides for

veterinary prescription use of

ivermectin chewables in cats for the

prevention of feline heartworm disease

for a month after infection and removal

and control of certain hookworm

infections.

EFFECTIVE DATE: February 5, 1997.

FOR FURTHER INFORMATION CONTACT:

Marcia K. Larkins, Center for Veterinary

Medicine (HFV–112), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–0614.

SUPPLEMENTARY INFORMATION: Merck

Research Laboratories, Div. of Merck &

Co., Inc., P.O. Box 2000, RY32–209,

Rahway, NJ 07065–0914, filed NADA

141–078 that provides for oral use on

veterinary prescription of HeartgardTM

for Cats (ivermectin chewables) to

prevent feline heartworm disease by

eliminating the tissue stage of

heartworm larvae Dirofilaria immitis for

a month after infection and for the

removal and control of adult and

immature (L4) hookworms Ancylostoma

tubaeforme and A. braziliense. The

NADA is approved as of December 23,

1996, and the regulations are amended

by revising 21 CFR 520.1193 to reflect

the approval. The basis of approval is

discussed in the freedom of information

summary.

Under section 512(c)(2)(F)(ii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(ii)), this

approval qualifies for 3 years of

marketing exclusivity beginning

December 23, 1996, because the NADA

contains substantial evidence of the

effectiveness of the drug involved, any

studies of animal safety required for

approval and conducted or sponsored

by the applicant.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

9 a.m. and 4 p.m., Monday through

Friday.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects in 21 CFR Part 520

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 part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 520.1193 is amended by

revising the section heading and

paragraph (a), and by adding new

paragraph (d) to read as follows:

§ 520.1193 Ivermectin tablets and

chewables.

(a) Specifications—(1) Dogs. Each

tablet or chewable contains 68, 136, or

272 micrograms of ivermectin.

(2) Cats. Each chewable contains 55 or

165 micrograms of ivermectin.

* * * * *

(d) Conditions of use in cats—(1)

Amount. Up to 2.3 kilograms (up to 5

pounds), 55 micrograms; 2.3 to 6.8

kilograms (5 to 15 pounds), 165

micrograms; over 6.8 kilograms (15

pounds), a combination of the

appropriate chewables (recommended

minimum dose of 24 micrograms of

ivermectin per kilogram of body weight

(10.9 micrograms per pound).

(2) Indications for use. To prevent

feline heartworm disease by eliminating

the tissue stage of heartworm larvae

Dirofilaria immitis for a month (30 days)

after infection, and for removal and

control of adult and immature (L4)

hookworms Ancylostoma tubaeforme

and A. braziliense.

(3) Limitations. For use in cats 6

weeks of age and older. Administer once

a month. The initial dose must be given

within a month after cats first exposure

to mosquitoes. The final dose must be

given within a month after the cats last

exposure to mosquitoes. Federal law

restricts this drug to use by or on the

order of a licensed veterinarian.

Dated: January 28, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–2821 Filed 2–4–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Naltrexone

Hydrochloride Injection

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a new animal drug

application (NADA) filed by Wildlife

Laboratories, Inc. The NADA provides

for use of naltrexone hydrochloride

sterile injection as an antagonist to

carfentanil citrate immobilization in

free-ranging or confined elk and moose

(Cervidae).

EFFECTIVE DATE: February 5, 1997.

FOR FURTHER INFORMATION CONTACT:

Marcia K. Larkins, Center for Veterinary

Medicine (HFV–112), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–0614.

SUPPLEMENTARY INFORMATION: Wildlife

Laboratories, Inc., 1401 Duff Dr., suite

600, Fort Collins, CO 80524, filed