30132 Federal Register / Vol. 61, No. 116 / Friday, June 14, 1996 / Rules and Regulations

affecting the quality of the human

environment and therefore, an

environmental impact statement is not

required. The rule will update and

clarify the emergency planning

regulations relating to exercises. It does

not involve any modification to any

plant or revise the need for or the

standards for emergency plans. There is

no adverse effect on the quality of the

environment. The environmental

assessment and finding of no significant

impact on which this determination is

based are available for inspection at the

NRC Public Document Room, 2120 L

Street, NW. (Lower Level), Washington,

DC.

Paperwork Reduction Act Statement

This final rule does not contain a new

or amended information collection

requirement subject to the Paperwork

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

et. seq.). Existing requirements were

approved by the Office of Management

and Budget approval Number 3150–

0011.

Regulatory Analysis

The Commission has prepared a

regulatory analysis on this final

regulation. The analysis examines the

costs and benefits of the alternatives

considered by the Commission. The

analysis is available for inspection in

the NRC Public Document Room, 2120

L Street, NW. (Lower Level),

Washington, DC. Single copies of the

analysis may be obtained from Michael

T. Jamgochian, Office of Nuclear

Regulatory Research, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555–0001; Telephone: (301) 415–

6534.

Regulatory Flexibility Act Certification

The final rule does not have a

significant impact on a substantial

number of small entities. The final rule

updates and clarifies the emergency

planning regulations relating to

exercises at nuclear power plants.

Nuclear power plant licensees do not

fall within the definition of small

business in Section 3 of the Small

Business Act (15 U.S.C. 632), the Small

Business Size Standards of the Small

Business Administration in 13 CFR part

121, or the Commission’s Size

Standards published at 56 FR 56671

(November 6, 1991). As required by the

Regulatory Flexibility Act of 1980, 5

U.S.C. 605(b), the Commission hereby

certifies that the final rule will not have

a significant economic impact on a

substantial number of small entities.

Therefore, a regulatory flexibility

analysis is not required.

Backfit Analysis

The final rule clarifies the intent of

the existing regulation and facilitates

greater flexibility in licensees’ conduct

of ‘‘off-year’’ emergency response

training activities. This action does not

seek to impose any new or increased

requirements in this area. The changes

permit, but do not require, licensees to

change their existing emergency plans

and procedures to employ scenarios in

‘‘off-year’’ training or drills that do not

go to severe core damage or result in

offsite exposures. No backfitting is

intended or approved in connection

with this final rule change.

List of Subjects in 10 CFR Part 50

Antitrust, Classified information,

Criminal penalties, Fire protection,

Intergovernmental relations, Nuclear

power plants and reactors, Penalty,

Radiation protection, Reactor siting

criteria, reporting and record keeping

requirements.

For the reasons set out in the

preamble, and under the authority of the

Atomic Energy Act of 1954, as amended;

the Energy Reorganization Act of 1974,

as amended; and 5 U.S.C. 553; the NRC

is adopting the following amendments

to 10 CFR part 50.

PART 50—DOMESTIC LICENSING OF

PRODUCTION AND UTILIZATION

FACILITIES

1. The authority citation for Part 50

continues to read as follows:

Authority: Secs. 102, 103, 104, 105, 161,

182, 183, 186, 189, 68 Stat. 936, 937, 938,

948, 953, 954, 955, 956, as amended, sec.

234, 83 Stat. 1244, as amended (42 U.S.C.

2132, 2133, 2134, 2135, 2201, 2232, 2233,

2236, 2239, 2282); secs. 201, as amended,

202, 206, 88 Stat. 1242, as amended, 1244,

1246 (42 U.S.C. 5841, 5842, 5846).

2. In § 50.47, paragraph (a)(1) is

revised to read as follows:

§ 50.47 Emergency plans.

(a)(1) Except as provided in paragraph

(d) of this section, no initial operating

license for a nuclear power reactor will

be issued unless a finding is made by

the NRC that there is reasonable

assurance that adequate protective

measures can and will be taken in the

event of a radiological emergency. No

finding under this section is necessary

for issuance of a renewed nuclear power

reactor operating license.

* * * * *

3. Appendix E to part 50 is amended

by revising section IV, F. paragraphs

2.b., and e. to read as follows:

Appendix E—Emergency Planning and

Preparedness for Production and Utilization

Facilities

IV. Content of Emergency Plans

F. Training

* * * * *

2. * * *

b. Each licensee at each site shall

conduct an exercise of its onsite

emergency plan every 2 years. The

exercise may be included in the full

participation biennial exercise required

by paragraph 2.c. of this section. In

addition, the licensee shall take actions

necessary to ensure that adequate

emergency response capabilities are

maintained during the interval between

biennial exercises by conducting drills,

including at least one drill involving a

combination of some of the principal

functional areas of the licensee’s onsite

emergency response capabilities. The

principal functional areas of emergency

response include activities such as

management and coordination of

emergency response, accident

assessment, protective action

decisionmaking, and plant system repair

and corrective actions. During these

drills, activation of all of the licensee’s

emergency response facilities (Technical

Support Center (TSC), Operations

Support Center (OSC), and the

Emergency Operations Facility (EOF))

would not be necessary, licensees

would have the opportunity to consider

accident management strategies,

supervised instruction would be

permitted, operating staff would have

the opportunity to resolve problems

(success paths) rather than have

controllers intervene, and the drills

could focus on onsite training

objectives.

* * * * *

e. Licensees shall enable any State or local

Government located within the plume

exposure pathway EPZ to participate in the

licensee’s drills when requested by such

State or local Government.

* * * * *

Dated at Rockville, MD., this 10th day of

June, 1996.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Secretary of the Commission.

[FR Doc. 96–15155 Filed 6–13–96; 8:45 am]

BILLING CODE 7590–01–P
Federal Register / Vol. 61, No. 116 / Friday, June 14, 1996 / Rules and Regulations 30133

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Virginiamycin

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 supplemental new animal

drug application (NADA) filed by Pfizer

Inc. The supplement provides for use of

a 30% virginiamycin formulation of a

Type A medicated article to be used for

the manufacture of Type C medicated

feeds for cattle fed in confinement for

slaughter.

EFFECTIVE DATE: June 14, 1996.

FOR FURTHER INFORMATION CONTACT:

Russell G. Arnold, Center for Veterinary

Medicine (HFV–142), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1674.

SUPPLEMENTARY INFORMATION: Pfizer Inc.,

235 East 42d St., New York, NY 10017,

filed a supplement to NADA 140–998

which provided for use of a 30%

virginiamycin Type A medicated article

formulation to be used in a microingredient production process for the

preparation of Type C medicated feeds

for cattle fed in confinement for

slaughter. The Type C medicated feed is

fed at 11 to 16 grams per ton (g/t) for

improved feed efficiency, 13.5 to 16 g/

t for reduction of incidence of liver

abscesses, and 16 to 22.5 g/t for

increased rate of weight gain. The feed

is not for animals intended for breeding.

The supplement is approved as of May

3, 1996, and the regulations are

amended in 21 CFR 558.635(b) to reflect

the approval.

Approval of this supplement does not

require submission of new safety or

effectiveness data. The supplement

provides for use of an additional level

of Type A medicated article to make a

Type C medicated feed fed at previously

approved levels and for previously

approved conditions of use.

The agency has determined under 21

CFR 25.24(d)(1)(iii) 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.

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

Federal Food, Drug, and Cosmetic Act

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

approval does not qualify for marketing

exclusivity because reports of new

clinical or field investigations (other

than bioequivalence or residue studies)

and, in the case of food producing

animals, human food safety studies

(other than bioequivalence or residue

studies) essential to the approval and

conducted or sponsored by the

applicant were not required.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

§ 558.635 [Amended]

2. Section 558.635 Virginiamycin is

amended in paragraph (b)(1) by

removing ‘‘to 000069’’ and by adding in

its place ‘‘used as in paragraph (f) of this

section; and 30 percent activity (136.2

grams per pound) for the manufacture of

Type C medicated feed for cattle used as

in paragraph (f)(3); to 000069’’.

Dated: June 7, 1996.

Andrew J. Beaulieau,

Deputy Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–15202 Filed 6–13–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 1 and 602

[TD 8674]

RIN 1545–AQ86; 1545–AS35

Debt Instruments With Original Issue

Discount; Contingent Payments; AntiAbuse Rule

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final regulations.

SUMMARY: This document contains final

regulations relating to the tax treatment

of debt instruments that provide for one

or more contingent payments. This

document also contains final regulations

that treat a debt instrument and a

related hedge as an integrated

transaction. In addition, this document

contains amendments to the original

issue discount regulations, and finalizes

the anti-abuse rule relating to those

regulations. The final regulations in this

document provide needed guidance to

holders and issuers of contingent

payment debt instruments.

DATES: Except as noted below, the

regulations are effective August 13,

1996. The amendments to § 1.1275–5

are effective June 14, 1996, except for

paragraphs (a)(6), (b)(2), and (c)(1),

which are effective August 13, 1996.

The removal of § 1.483–2T is effective

June 14, 1996. The removal of § 1.1275–

2T is effective August 13, 1996.

For dates of applicability of these

regulations, see Effective Dates under

SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT:

Concerning the regulations (other than

§ 1.1275–6), William E. Blanchard, (202)

622–3950, or Jeffrey W. Maddrey, (202)

622–3940; or concerning § 1.1275–6,

Michael S. Novey, (202) 622–3900 (not

toll-free numbers).

SUPPLEMENTARY INFORMATION:

Paperwork Reduction Act

The collections of information

contained in these final regulations have

been reviewed and approved by the

Office of Management and Budget in

accordance with the Paperwork

Reduction Act (44 U.S.C. 3507) under

control number 1545–1450. Responses

to these collections of information are

required to determine a taxpayer’s

interest income or deductions on a

contingent payment debt instrument.

An agency may not conduct or

sponsor, and a person is not required to

respond to, a collection of information

unless the collection of information

displays a valid control number.

The estimated annual burden per

respondent/recordkeeper varies from .3

hours to .5 hours, depending on

individual circumstances, with an

estimated average of .47 hours.

Comments concerning the accuracy of

this burden estimate and suggestions for

reducing this burden should be sent to

the Internal Revenue Service, Attn: IRS

Reports Clearance Officer, T:FP,

Washington, DC 20224, and to the

Office of Management and Budget, Attn:

Desk Officer for the Department of the

Treasury, Office of Information and

Regulatory Affairs, Washington, DC

20503.

Books or records relating to the

collections of information must be

retained as long as their contents may

become material in the administration