Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations 24443

as paragraphs (a), (c), and (d),

respectively; by revising newly

redesignated paragraph (a); by amending

newly redesignated paragraph (d) by

adding two new sentences after the fifth

sentence; and by adding a new

paragraph (b) to read as follows:

§ 520.2325a Sulfaquinoxaline drinking

water.

(a) Sponsor. See § 510.600(c) of this

chapter for identification of the

sponsors.

(1) No. 050749 for use of a 25-percent

soluble powder and a 20-percent

solution as provided for in paragraph (c)

of this section.

(2) No. 060594 for use of 3.44- and

12.85-percent solutions as provided for

in paragraphs (c)(1), (c)(2), (c)(3),

(c)(4)(i), and (c)(4)(ii) of this section.

(3) No. 017144 for use of a 34-percent

solution as provided for in paragraphs

(c)(1), (c)(2), (c)(3), (c)(4)(i), and (c)(4)(ii)

of this section.

(b) Related tolerances. See § 556.685

of this chapter.

* * * * *

(d) Limitations. * * * A withdrawal

period has not been established for

sulfaquinoxaline in preruminating

calves. Do not use in calves to be

processed for veal. * * *

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

3. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: Secs. 402, 512, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 342, 360b, 371).

4. New § 556.685 is added to subpart

B read as follows:

§ 556.685 Sulfaquinoxaline.

A tolerance of 0.1 part per million is

established for negligible residues of

sulfaquinoxaline in the uncooked edible

tissues of chickens, turkeys, calves, and

cattle.

Dated: April 15, 1996.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–11927 Filed 5–14–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 520 and 558

Animal Drugs, Feeds, and Related

Products; Monensin

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 supplemental new animal

drug applications (NADA’s) filed by

Elanco Animal Health, Division of Eli

Lilly and Co., Moorman Manufacturing

Co., and Farmland Industries, Inc.

Elanco’s supplemental NADA provides

for use of monensin Type C medicated

feeds fed to pasture cattle weighing less

than 400 pounds (lb) for increased rate

of weight gain. Moorman’s and

Farmland’s supplemental NADA’s

provide for use of monensin blocks for

pasture cattle weighing less than 400 lb

for increased rate of weight gain.

EFFECTIVE DATE: May 15, 1996.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1638.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, Division of Eli Lilly and

Co., Lilly Corporate Center,

Indianapolis, IN 46285, filed

supplemental NADA 95–735, which

provides for use of monensin Type A

medicated articles to make monensin

Type C medicated feeds containing 25

to 400 grams per ton monensin as

monensin sodium to be fed at 50 to 200

milligrams per head per day to pasture

cattle (slaughter, stocker, feeder, and

dairy and beef replacement heifers)

weighing less than 400 lb for increased

rate of weight gain. Moorman

Manufacturing Co., Quincy, IL 62301,

filed supplemental NADA 115–581, and

Farmland Industries, Inc., Kansas City,

MO 64116, filed supplemental NADA

118–509, providing for free-choice

feeding of monensin blocks, all to

pasture cattle weighing less than 400 lb

for increased rate of weight gain.

The supplemental NADA’s provide

for removal of the restriction concerning

feeding of the products to animals

weighing less than 400 lb body weight

as currently approved. The

supplemental NADA’s are approved as

of March 15, 1996, and the regulations

are amended in 21 CFR 520.1448a(c)

and 558.355(f)(3)(iii) and (f)(3)(v) to

reflect the approvals. The basis for

approval is discussed in the freedom of

information summary for Elanco’s

supplemental NADA 95–735.

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

Federal Food, Drug, and Cosmetic Act

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

Elanco Animal Health’s supplemental

NADA 95–735 qualifies for 3 years of

marketing exclusivity beginning March

15, 1996, because the supplement

contains reports of new clinical or field

investigations (other than

bioequivalence or residue studies)

essential to the approval and conducted

or sponsored by the applicant.

Marketing exclusivity applies only to

the new use of the product.

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

Federal Food, Drug, and Cosmetic Act

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

Moorman’s supplemental NADA 115–

581 and Farmland’s supplemental

NADA 118–509 do not qualify for

marketing exclusivity because the

supplements do not contain reports of

new clinical or field investigations

(other than bioequivalence or residue

studies) or new human food safety

studies (other than bioequivalence or

residue studies) essential to the

approval and conducted or sponsored

by the applicant.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (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 basis of approval of Moorman’s

and Farmland’s supplemental NADA’s

are by authorization to reference data

and information in Elanco’s

supplemental NADA 95–735. Therefore,

a freedom of information summary of

the data and information required for

approval of these NADA’s is available

under Elanco’s supplemental NADA 95–

735.

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.

21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under the

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR parts 520 and 558 are amended as

follows:
24444 Federal Register / Vol. 61, No. 95 / Wednesday, May 15, 1996 / Rules and Regulations

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).

§ 520.1448a [Amended]

2. Section 520.1448a Monensin blocks

is amended in paragraph (c)(4)(iii) by

removing the phrase ‘‘weighing more

than 400 pounds’’.

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

3. 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).

§ 558.355 [Amended]

4. Section 558.355 Monensin is

amended in paragraph (f)(3)(iii)(b) and

(f)(3)(v)(b) by removing the phrase

‘‘weighing more than 400 pounds’’.

Dated: April 4, 1996.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 96–12156 Filed 5–14–96; 8:45 am]

BILLING CODE 4160–01–F

PENSION BENEFIT GUARANTY

CORPORATION

29 CFR Parts 2619 and 2676

Valuation of Plan Benefits in SingleEmployer Plans; Valuation of Plan

Benefits and Plan Assets Following

Mass Withdrawal; Amendments

Adopting Additional PBGC Rates

AGENCY: Pension Benefit Guaranty

Corporation.

ACTION: Final rule.

SUMMARY: This final rule amends the

Pension Benefit Guaranty Corporation’s

regulations on Valuation of Plan

Benefits in Single-Employer Plans and

Valuation of Plan Benefits and Plan

Assets Following Mass Withdrawal. The

former regulation contains the interest

assumptions that the PBGC uses to

value benefits under terminating singleemployer plans. The latter regulation

contains the interest assumptions for

valuations of multiemployer plans that

have undergone mass withdrawal. The

amendments set out in this final rule

adopt the interest assumptions

applicable to single-employer plans

with termination dates in June 1996,

and to multiemployer plans with

valuation dates in June 1996. The effect

of these amendments is to advise the

public of the adoption of these

assumptions.

EFFECTIVE DATE: June 1, 1996.

FOR FURTHER INFORMATION CONTACT:

Harold J. Ashner, Assistant General

Counsel, Office of the General Counsel,

Pension Benefit Guaranty Corporation,

1200 K Street, NW., Washington, DC

20005, 202–326–4024 (202–326–4179

for TTY and TDD).

SUPPLEMENTARY INFORMATION: This rule

adopts the June 1996 interest

assumptions to be used under the

Pension Benefit Guaranty Corporation’s

regulations on Valuation of Plan

Benefits in Single-Employer Plans (29

CFR part 2619, the ‘‘single-employer

regulation’’) and Valuation of Plan

Benefits and Plan Assets Following

Mass Withdrawal (29 CFR part 2676, the

‘‘multiemployer regulation’’).

Part 2619 sets forth the methods for

valuing plan benefits of terminating

single-employer plans covered under

title IV of the Employee Retirement

Income Security Act of 1974, as

amended. Under ERISA section 4041(c),

all single-employer plans wishing to

terminate in a distress termination must

value guaranteed benefits and ‘‘benefit

liabilities,’’ i.e., all benefits provided

under the plan as of the plan

termination date, using the formulas set

forth in part 2619, subpart C. (Plans

terminating in a standard termination

may, for purposes of the Standard

Termination Notice filed with PBGC,

use these formulas to value benefit

liabilities, although this is not required.)

In addition, when the PBGC terminates

an underfunded plan involuntarily

pursuant to ERISA section 4042(a), it

uses the subpart C formulas to

determine the amount of the plan’s

underfunding. Part 2676 prescribes

rules for valuing benefits and certain

assets of multiemployer plans under

sections 4219(c)(1)(D) and 4281(b) of

ERISA.

Appendix B to part 2619 sets forth the

interest rates and factors under the

single-employer regulation. Appendix B

to part 2676 sets forth the interest rates

and factors under the multiemployer

regulation. Because these rates and

factors are intended to reflect current

conditions in the financial and annuity

markets, it is necessary to update the

rates and factors periodically.

The PBGC issues two sets of interest

rates and factors, one set to be used for

the valuation of benefits to be paid as

annuities and one set for the valuation

of benefits to be paid as lump sums. The

same assumptions apply to terminating

single-employer plans and to

multiemployer plans that have

undergone a mass withdrawal. This

amendment adds to appendix B to parts

2619 and 2676 sets of interest rates and

factors for valuing benefits in singleemployer plans that have termination

dates during June 1996 and

multiemployer plans that have

undergone mass withdrawal and have

valuation dates during June 1996.

For annuity benefits, the interest rates

will be 6.20% for the first 20 years

following the valuation date and 4.75%

thereafter. For benefits to be paid as

lump sums, the interest assumptions to

be used by the PBGC will be 5.00% for

the period during which benefits are in

pay status, 4.25% during the seven-year

period directly preceding the benefit’s

placement in pay status, and 4.0%

during any other years preceding the

benefit’s placement in pay status. The

above annuity interest assumptions

represent an increase (from those in

effect for May 1996) of .20 percent for

the first 20 years following the valuation

date and are otherwise unchanged. The

lump sum interest assumptions are

unchanged from those in effect for May

1996.

Generally, the interest rates and

factors under these regulations are in

effect for at least one month. However,

the PBGC publishes its interest

assumptions each month regardless of

whether they represent a change from

the previous month’s assumptions. The

assumptions normally will be published

in the Federal Register by the 15th of

the preceding month or as close to that

date as circumstances permit.

The PBGC has determined that notice

and public comment on these

amendments are impracticable and

contrary to the public interest. This

finding is based on the need to

determine and issue new interest rates

and factors promptly so that the rates

and factors can reflect, as accurately as

possible, current market conditions.

Because of the need to provide

immediate guidance for the valuation of

benefits in single-employer plans whose

termination dates fall during June 1996,

and in multiemployer plans that have

undergone mass withdrawal and have

valuation dates during June 1996, the

PBGC finds that good cause exists for

making the rates and factors set forth in

this amendment effective less than 30

days after publication.

The PBGC has determined that this

action is not a ‘‘significant regulatory

action’’ under the criteria set forth in

Executive Order 12866.

Because no general notice of proposed

rulemaking is required for this

amendment, the Regulatory Flexibility