66982 Federal Register / Vol. 62, No. 246 / Tuesday, December 23, 1997 / Rules and Regulations

Compliance: Required as indicated, unless

accomplished previously.

To detect and correct fatigue cracking in

the lower lugs of the barrel of the main

landing gear (MLG), and consequent collapse

of the MLG, accomplish the following:

(a) Perform an ultrasonic inspection to

detect fatigue cracks of the lower lugs of the

barrel of the MLG, in accordance with

Messier-Dowty Service Bulletin 631–32–132,

dated January 21, 1997, at the time specified

in paragraph (a)(1) or (a)(2) of this AD, as

applicable:

(1) Within 2 years after the last overhaul

or repair of the lower lugs of the barrel of the

MLG, or within 60 days after March 7, 1997

(the effective date of AD 97–04–09,

amendment 39–9933), whichever occurs

later; or

(2) Within 5 years after the installation of

a new MLG barrel assembly, or within 60

days after the effective date of this AD,

whichever occurs later.

(b) If, during any inspection required by

this AD, no echo is detected, or if the echo

is less than 20%, repeat the ultrasonic

inspection thereafter at intervals not to

exceed 900 landings.

(c) If, during any inspection required by

this AD, the echo is greater than or equal to

20%, prior to further flight, replace the MLG

barrel assembly with a new or serviceable

MLG barrel assembly, in accordance with the

service bulletin.

(1) If the damaged barrel assembly is

replaced with an overhauled or repaired

assembly, within 2 years after installation of

that overhauled or repaired part, accomplish

the actions specified in paragraph (a) of this

AD.

(2) If the damaged barrel assembly is

replaced with a new barrel assembly, within

5 years after installation of that new part,

accomplish the actions specified in

paragraph (a) of this AD.

(d) Modification of the lower lugs of the

barrel of the MLG in accordance with

Messier-Dowty Service Bulletin 631–32–133,

dated February 24, 1997, as revised by

Messier-Dowty Service Bulletin Change

Notice No. 1, dated March 18, 1997,

constitutes terminating action for the

repetitive inspection requirements of this

AD.

(e) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager,

International Branch, ANM–116, FAA,

Transport Airplane Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, International Branch,

ANM–116.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the International Branch,

ANM–116.

(f) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(g) The actions shall be done in accordance

with Messier-Dowty Service Bulletin 631–

32–133, dated February 24, 1997, as revised

by Messier-Dowty Service Bulletin Change

Notice No. 1, dated March 18, 1997; and

Messier-Dowty Service Bulletin 631–32–132,

dated January 21, 1997.

(1) The incorporation by reference of

Messier-Dowty Service Bulletin 631–32–133,

dated February 24, 1997, as revised by

Messier-Dowty Service Bulletin Change

Notice No. 1, dated March 18, 1997, is

approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51.

(2) The incorporation by reference of

Messier-Dowty Service Bulletin 631–32–132,

dated January 21, 1997, was approved

previously by the Director of the Federal

Register as of March 7, 1997 (62 FR 7665,

February 20, 1997).

(3) Copies may be obtained from

Aerospatiale, 316 Route de Bayonne, 31060

Toulouse, Cedex 03, France. Copies may be

inspected at the FAA, Transport Airplane

Directorate, 1601 Lind Avenue, SW., Renton,

Washington; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

Note 3: The subject of this AD is addressed

in French airworthiness directive 96–

294(B)R1, dated September 10, 1997.

(h) This amendment becomes effective on

January 7, 1998.

Issued in Renton, Washington, on

December 15, 1997.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–33509 Filed 12–22–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 500

[Docket No. 95N–0417]

Carcinogenicity Testing of Compounds

Used in Food-Producing Animals

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

regulations that set forth the

requirements for the carcinogenicity

testing of compounds used in foodproducing animals. The amended

regulations will eliminate the specific

requirement that a sponsor must

conduct oral, chronic, dose-response

studies. This action is intended to allow

FDA and sponsors greater flexibility in

choosing the types of studies used for

testing the carcinogenicity of

compounds used in food-producing

animals. The increased flexibility will

make it easier and more economical for

sponsors to complete required testing.

These actions are part of FDA’s

continuing effort to achieve the

objectives set forth in the President’s

‘‘National Performance Review’’

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.

EFFECTIVE DATE: February 23, 1998.

FOR FURTHER INFORMATION CONTACT:

Margaret A. Miller, Center for

Veterinary Medicine (HFV–100), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0205.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 20,

1996 (61 FR 31468), FDA proposed to

revise the requirements for the

carcinogenicity testing of compounds

used in food-producing animals as set

forth in § 500.80(b) (21 CFR 500.80(b))

of the new animal drug approval

regulations. The second sentence of

§ 500.80(b) of the existing regulation

states, ‘‘The bioassays that a sponsor

conducts must be oral, chronic, doseresponse studies and must be designed

to assess carcinogenicity and to

determine the quantitative aspects of

any carcinogenic response.’’ The

proposed rule would revise the existing

language to eliminate the words ‘‘must

be oral, chronic, dose-response studies

and’’ * * *.

When the existing regulation was

issued, a chronic study was the standard

test for carcinogenicity. However,

advances in models used to assess

carcinogenicity have been made in

recent years. For example, scientists

now agree that a chronic study, as

required under current regulations, may

not measure the appropriate time point

necessary to assess carcinogenicity for

some compounds. Study designs other

than a chronic study may result in a

better evaluation of the compound in a

number of cases.

FDA recognized these scientific

advances by proposing to remove the

requirement for oral, chronic, doseresponse studies so that sponsors would

have the option of using other study

designs when assessing the

carcinogenicity of compounds used for

food-producing animals. This proposed

change would allow FDA and sponsors

greater flexibility in choosing types of

studies for testing the carcinogenicity of

compounds used in food-producing

animals, making it more economical and
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