Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Rules and Regulations 66983

easier for sponsors. No comments were

received on the proposed rule.

II. Conclusion

Because the agency has determined

that the underlying rationale in support

of the amendment remains sound and

because no comments or other

information were received suggesting

any modification, the revisions set forth

in the proposed rule have not been

modified in the final rule. Accordingly,

the final rule deletes the specific

requirement that required a sponsor to

conduct oral, chronic, dose-response

studies.

As stated in the proposal, this

revision is consistent with the goals of

the President’s National Performance

Review. The agency’s actions are part of

its continuing effort to achieve the

objectives set forth in that initiative,

which is intended to provide a

comprehensive review of all rules in

order to identify those that are obsolete

and burdensome and to delete or revise

them.

III. Environmental Impact

FDA has carefully considered the

potential environmental effects of this

action and has determined that this

action is categorically excluded under

21 CFR 25.30(h). This action revises the

requirements for testing the

carcinogenicity of compounds used for

food-producing animals, but will not

cause an increase in the existing level of

use or cause a change in the intended

uses of the product or its substitutes.

Therefore, neither an environmental

assessment nor an environmental

impact statement is required.

IV. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866,

under the Regulatory Flexibility Act (5

U.S.C. 601–612), and under the

Unfunded Mandates Reform Act of 1995

(Pub. L. 104–4). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages, and distributive

impacts and equity). The Regulatory

Flexibility Act requires agencies to

examine the economic impact of a rule

on small entities. The Unfunded

Mandates Reform Act requires agencies

to prepare an assessment of anticipated

costs and benefits before enacting any

rule that may result in an expenditure

in any one year by State, local and tribal

governments, in the aggregate, or by the

private sector, of $100,000,000 (adjusted

annually for inflation). This amendment to the regulations

setting forth the requirements for the

carcinogenicity testing of compounds

used in food-producing animals will

eliminate the specific requirement that

a sponsor must conduct oral, chronic,

dose-response studies, giving the agency

and sponsors greater flexibility in

choosing the types of studies used for

testing the carcinogenicity of

compounds used in food-producing

animals. The resultant expanded

flexibility will make it easier and less

costly for sponsors to complete required

testing. FDA concludes that this final rule is

consistent with the principles set forth

in the Executive order and in these two

statutes. In addition, the agency has

determined that this rule is not a

significant regulatory action as defined

by the Executive order and so is not

subject to review under the Executive

order. Because the final rule does not

impose a mandate that results in an

expenditure of $100 million or more by

State, local, and tribal governments in

the aggregate, or by the private sector in

any one year, a written statement and

economic analysis are not required as

prescribed under section 202(a) of the

Unfunded Mandates Reform Act of

1995.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because the rule will clarify

FDA policy and simplify the process for

submitting certain applications, the

agency certifies that the rule will not

have a significant economic impact on

a substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

V. Paperwork Reduction Act of 1995

FDA has determined that this rule

contains no collection of information

requirements under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501–

3520).

VI. Federalism

FDA has analyzed the final rule in

accordance with the principles set forth

in Executive Order 12612 and has

determined that this final rule does not

warrant the preparation of a Federalism

Assessment.

List of Subjects in 21 CFR Part 500

Animal drugs, Animal feeds, Cancer,

Labeling, Polychlorinated biphenyls

(PCB’s).

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 500 is

amended as follows:

PART 500—GENERAL

1. The authority citation for 21 CFR

part 500 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 342, 343,

348, 351, 352, 353, 360b, 371.

§ 500.80 [Amended]

2. Section 500.80 Scope of this

subpart is amended in paragraph (b) in

the second sentence by removing the

phrase ‘‘must be oral, chronic, doseresponse studies and’’.

Dated: December 17, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–33483 Filed 12–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation and Injectable Dosage

Form New Animal Drugs; Imidocarb

Dipropionate

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 ScheringPlough Animal Health Corp. The NADA

provides for subcutaneous or

intramuscular use of imidocarb

dipropionate solution for dogs for

treatment of babesiosis.

EFFECTIVE DATE: December 23, 1997

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1618.

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095

Morris Ave., Union, NJ 07083, has filed

NADA 141–071 Imizol (imidocarb

dipropionate) solution for subcutaneous

or intramuscular use for treatment of

dogs with clinical signs of babesiosis

and/or demonstrated Babesia organisms

in the blood. The drug is limited to use

by or on the order of a licensed

veterinarian. The NADA is approved as

of November 7, 1997, and the

regulations are amended by adding new
66984 Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Rules and Regulations

21 CFR 522.1156 to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

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.

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

Federal Food, Drug, and Cosmetic Act,

this approval for use in nonfoodproducing animals qualifies for 3 years

of marketing exclusivity beginning

November 7, 1997, because the

application contains substantial

evidence of the effectiveness of the drug

involved and any studies of animal

safety or, in the case of food-producing

animals, human food safety studies

(other than bioequivalence or residue

studies) required for approval of the

application and conducted or sponsored

by the applicant.

The agency has determined under 21

CFR 25.33(a)(1) 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 in 21 CFR Part 522

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 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

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

2. New § 522.1156 is added to read as

follows:

§ 522.1156 Imidocarb dipropionate

solution.

(a) Specifications. Each milliliter of

injectable solution contains 120

milligrams of imidocarb.

(b) Sponsor. See No. 000061 in

§ 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Dogs—(i)

Amount. 6.6 milligrams imidocarb per

kilogram (3 milligrams per pound) of

body weight.

(ii) Indications for use. Treatment of

clinical signs of babesiosis and/or

demonstrated Babesia organisms in the

blood.

(iii) Limitations. Use subcutaneously

or intramuscularly. Not for intravenous

use. Repeat the dose after 2 weeks for a

total of two treatments. Imidocarb is a

cholinesterase inhibitor. Do not use

simultaneously with or a few days

before or after treatment with or

exposure to cholinesterase-inhibiting

drugs, pesticides, or chemicals. Federal

law restricts this drug to use by or on

the order of a licensed veterinarian.

(2) [Reserved]

Dated: December 15, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–33486 Filed 12–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Salinomycin, Bacitracin Zinc,

and Roxarsone

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 two abbreviated new animal

drug applications (ANADA’s) filed by

Alpharma Inc. The ANADA’s provide

for using approved salinomycin,

bacitracin zinc, and roxarsone Type A

medicated articles to make Type C

medicated broiler chicken feeds used for

prevention of coccidiosis, increased rate

of weight gain, and improved feed

efficiency.

EFFECTIVE DATE: December 23, 1997.

FOR FURTHER INFORMATION CONTACT:

Jeffrey M. Gilbert, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1602.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, is sponsor of

ANADA’s 200–209 and 200–215 that

provide for combining approved

salinomycin, bacitracin zinc, and

roxarsone Type A medicated articles to

make Type C medicated broiler feeds

containing salinomycin 40 to 60 grams

per ton (g/t), bacitracin zinc 10 to

50 g/t, and roxarsone 34.1 g/t. The Type

C medicated feed is used for the

prevention of coccidiosis caused by

Eimeria tenella, E. necatrix, E.

acervulina, E. brunetti, E. mivati, and E.

maxima, increased rate of weight gain,

and improved feed efficiency.

Alpharma Inc.’s ANADA 200–209

provides for using approved SACOX

(Hoechst-Roussel Vet’s salinomycin

ANADA 200–075), ALBAC (Alpharma

Inc.’s bacitracin zinc ANADA 200–223),

and 3–NITRO (Alpharma Inc.’s

roxarsone NADA 7–891) Type A

medicated articles to make the

combination drug Type C medicated

feeds. Alpharma Inc.’s ANADA 200–215

provides for using approved BIO-COX

(Hoffmann-LaRoche, Inc.’s salinomycin

NADA 128–686), ALBAC (Alpharma

Inc.’s bacitracin zinc ANADA 200–223),

and 3–NITRO (Alpharma Inc.’s

roxarsone NADA 7–891) Type A

medicated articles to make the

combination drug Type C medicated

feeds.

Alpharma Inc.’s ANADA 200–209 is

approved as a generic copy of HoechstRoussel Vet’s ANADA 200–143.

Alpharma Inc.’s ANADA 200–215 is

approved as a generic copy of

Hoffmann-LaRoche, Inc.’s NADA 139–

190. The ANADA’s are approved as of

December 23, 1997, and the regulations

are amended in 21 CFR

558.550(b)(1)(ix)(c) to reflect the

approvals. The basis for approval is

discussed in the freedom of information

summaries.

This approval is for use of three single

ingredient Type A medicated articles to

make combination drug Type C

medicated feeds. One ingredient,

roxarsone, is a Category II drug as

defined in 21 CFR 558.3(b)(1)(ii). As

provided in 21 CFR 558.4(b), an

approved form FDA 1900 is required to

make Type C medicated feed from a

Category II drug. Under section 512(m)

of the act (21 U.S.C. 360b(m)), as

amended by the Animal Drug

Availability Act of 1996 (Pub. L. 104–

250), medicated feed applications have

been replaced by a requirement for feed

mill licenses. Therefore, use of

salinomycin, bacitracin zinc, and

roxarsone Type A medicated articles to

make Type C medicated feeds as

provided in ANADA’s 200–209 and

200–215 is limited to manufacture in a

licensed feed mill.

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 each of these applications

may be seen in the Dockets Management

Branch (HFA–305), Food and Drug