24694 Federal Register / Vol. 61, No. 96 / Thursday, May 16, 1996 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use In Animal

Feed; Halofuginone Hydrobromide and

Bambermycins

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 HoechstRoussel Agri-Vet Co. The NADA

provides for using approved single

ingredient Type A medicated articles to

make Type C medicated turkey feeds

containing halofuginone hydrobromide

and bambermycins.

EFFECTIVE DATE: May 16, 1996.

FOR FURTHER INFORMATION CONTACT:

James F. McCormack, Center For

Veterinary Medicine (HFV–128), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1607.

SUPPLEMENTARY INFORMATION: HoechstRoussel Agri-Vet Co., P.O. Box 2500,

Route 202–206, Somerville, NJ 08876–

1258, filed NADA 140–918 which

provides for use of approved Stenorol

(2.72 grams (g) of halofuginone

hydrobromide activity per pound) and

approved Flavomycin (4 and 10 g of

bambermycins activity per pound) Type

A medicated articles to make Type C

medicated turkey feeds containing 1.36

to 2.72 g of halofuginone hydrobromide

and 2 g of bambermycins per ton. The

Type C medicated turkey feed is used

for prevention of coccidiosis caused by

Eimeria adenoides, E. meleagrimitis,

and E. gallopavonis, and for increased

rate of weight gain in growing turkeys.

The NADA is approved as of May 16,

1996, and the regulations are amended

in 21 CFR 558.265 by adding new

paragraph (c)(2)(iii) 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 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.

This approval is for use of single

ingredient Type A medicated articles to

make Type C medicated feeds.

Halofuginone hydrobromide is a

Catagory II drug which, as provided in

21 CFR 558.4, requires an approved

form FDA 1900 for making a Type C

medicated feed. Therefore, use of

halofuginone hydrobromide and

bambermycins Type A articles to make

Type C medicated turkey feeds as in

NADA 140–918 requires an approved

form FDA 1900.

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

Federal Food, Drug, and Cosmetic Act

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

this application qualifies for 3 years of

marketing exclusivity beginning May

16, 1996, because the application

contains reports of new clinical or field

investigations (other than

bioequivalence or residue studies) or

human food safety studies (other than

bioequivalence or residue studies)

essential to the approval and conducted

or sponsored by the applicant.

The agency has determined under 21

CFR 25.24 (d)(1)(ii) 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 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).

2. Section 558.265 is amended by

adding new paragraph (c)(2)(iii) to read

as follows:

§ 558.265 Halofuginone hydrobromide.

* * * * *

(c) * * *

(2) * * *

(iii) Amount per ton. 1.36 to 2.72

grams of halofuginone hydrobromide

plus 2 grams of bambermycins.

(A) Indications for use. For the

prevention of coccidiosis caused by

Eimeria adenoides, E. meleagrimitis,

and E. gallopavonis, and for increased

rate of weight gain in growing turkeys.

(B) Limitations. Feed continuously as

sole ration. Withdraw 7 days before

slaughter. Do not feed to laying chickens

or waterfowl. Halofuginone

hydrobromide is toxic to fish and other

aquatic life. Keep out of lakes, ponds,

and streams. Halofuginone

hydrobromide is an eye and skin

irritant. Avoid contact with skin, eyes,

and clothing.

* * * * *

Dated: May 1, 1996.

Michael J. Blackwell,

Acting Director, Center for Veterinary

Medicine.

[FR Doc. 96–12262 Filed 5–15–96; 8:45 am]

BILLING CODE 4160–01–F

PENSION BENEFIT GUARANTY

CORPORATION

29 CFR Part 2627

RIN 1212–AA77

Disclosure to Participants

AGENCY: Pension Benefit Guaranty

Corporation.

ACTION: Final rule.

SUMMARY: This document amends the

PBGC’s regulation on disclosure to

participants (29 CFR part 2627) to

describe changes in the way participants

can obtain the booklet ‘‘Your

Guaranteed Pension.’’

EFFECTIVE DATE: May 16, 1996.

FOR FURTHER INFORMATION CONTACT:

Harold J. Ashner, Assistant General

Counsel, or Catherine B. Klion,

Attorney, Office of the General Counsel,

PBGC, 1200 K Street, NW., Washington,

DC 20005–4026, 202–326–4024 (202–

326–4179 for TTY and TDD).

SUPPLEMENTARY INFORMATION: The

PBGC’s regulation on disclosure to

participants (29 CFR Part 2627)

implements section 4011 of ERISA.

Section 4011 requires certain

underfunded plans to provide notice to

plan participants and beneficiaries of

the plan’s funding status and the limits

on the PBGC’s guarantee. Plans with

more than 100 participants were first

subject to the notice requirement for the

1995 plan year; plans with 100 or fewer

participants will first be subject to the

requirement for the 1996 plan year.

The PBGC is amending the regulation

to reflect the fact that the booklet ‘‘Your

Guaranteed Pension’’ can now be

obtained without charge by writing to

the Consumer Information Center.

(Previously, the booklet cost $1.25.) The

PBGC also is amending the regulation to
Federal Register / Vol. 61, No. 96 / Thursday, May 16, 1996 / Rules and Regulations 24695

allow plan administrators to include a

statement in the Participant Notice that

the booklet can be obtained on the

PBGC’s new Homepage on the World

Wide Web.

This rule also makes corresponding

changes to the Model Participant Notice

(Appendix A to Part 2627). The PBGC

is republishing the Model Participant

Notice and the Table of Maximum

Guaranteed Benefits (Appendix B to

Part 2617) in their entireties.

(Information on 1996 maximum

guaranteed benefit amounts was added

to this table on December 15, 1995 (60

FR 64324).)

In light of the minor nature of the

changes, and plan administrators’

current need for a regulation that

includes correct information, the PBGC

has for good cause found that notice and

public procedure are unnecessary and

contrary to the public interest. The

PBGC also has determined for these

reasons that good cause exists for

making these amendments effective

immediately. For a reasonable time

period, the PBGC will treat a plan

administrator that uses the existing

regulation (including the existing Model

Participant Notice) as satisfying the

Participant Notice requirements.

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

regulation, the Regulatory Flexibility

Act does not apply (5 U.S.C. 601(2)).

List of Subjects in 29 CFR Part 2627

Pension insurance, Pensions.

Accordingly, 29 CFR Part 2627 is

amended as follows:

PART 2627—DISCLOSURE TO

PARTICIPANTS

1. The authority citation for part 2627

continues to read as follows:

Authority: 29 U.S.C. 1302(b)(3), 1311.

2. § 2627.10, paragraph (h)

introductory text is republished and

paragraph (b)(9) is revised to read as

follows:

§ 2627.10 Form of notice.

* * * * *

(b) Content. The Participant Notice for

a plan year shall include—

* * * * *

(9) A statement that further

information about the PBGC’s guarantee

may be obtained by requesting a free

copy of the booklet ‘‘Your Guaranteed

Pension’’ from Consumer Information

Center, Dept. YGP, Pueblo, Colorado

81009. The Participant Notice may

include a statement that the booklet may

be obtained through electronic access

via the World Wide Web from the PBGC

Homepage at http://www.pbgc.gov/

ygp.htm.

* * * * *

3. Appendix A to Part 2627 is

amended to read as follows (and

Appendix B is republished for the

convenience of the public):

Appendix A to Part 2627—Model

Participant Notice

The following is an example of a

Participant Notice that satisfies the

requirements of § 2627.10 when the required

information is filled in (subject to

§§ 2627.10(d)-(e), where applicable).

NOTICE TO PARTICIPANTS OF [PLAN

NAME]

The law requires that you receive

information on the funding level of your

defined benefit pension plan and the benefits

guaranteed by the Pension Benefit Guaranty

Corporation (PBGC), a federal insurance

agency.

YOUR PLAN’S FUNDING

As of [DATE], your plan had [INSERT

NOTICE FUNDING PERCENTAGE

(DETERMINED IN ACCORDANCE WITH

§ 2627.10(c))] percent of the money needed to

pay benefits promised to employees and

retirees.

To pay pension benefits, your employer is

required to contribute money to the pension

plan over a period of years. A plan’s funding

percentage does not take into consideration

the financial strength of the employer. Your

employer, by law, must pay for all pension

benefits, but your benefits may be at risk if

your employer faces a severe financial crisis

or is in bankruptcy.

[INCLUDE THE FOLLOWING PARAGRAPH

ONLY IF, FOR ANY OF THE PREVIOUS

FIVE PLAN YEARS, THE PLAN HAS BEEN

GRANTED AND HAS NOT FULLY REPAID

A FUNDING WAIVER.]

Your plan received a funding waiver for

[LIST ANY OF THE FIVE PREVIOUS PLAN

YEARS FOR WHICH A FUNDING WAIVER

WAS GRANTED AND HAS NOT BEEN

FULLY REPAID]. If a company is

experiencing temporary financial hardship,

the Internal Revenue Service may grant a

funding waiver that permits the company to

delay contributions that fund the pension

plan.

[INCLUDE THE FOLLOWING WITH

RESPECT TO ANY UNPAID OR LATE

PAYMENT THAT MUST BE DISCLOSED

UNDER § 2627.10(b)(6):]

Your plan was required to receive a

payment from the employer on [LIST

APPLICABLE DUE DATE(S)]. That payment

[has not been made] [was made on [LIST

APPLICABLE PAYMENT DATE(S)]].

PBGC GUARANTEES

When a pension plan ends without enough

money to pay all benefits, the PBGC steps in

to pay pension benefits. The PBGC pays most

people all pension benefits, but some people

may lose certain benefits that are not

guaranteed.

The PBGC pays pension benefits up to

certain maximum limits.

• The maximum guaranteed benefit is

[INSERT FROM TABLE IN APPENDIX B] per

month or [INSERT FROM TABLE IN

APPENDIX B] per year for a 65-year-old

person in a plan that terminates in [INSERT

APPLICABLE YEAR].

• The maximum benefit may be reduced

for an individual who is younger than age 65.

For example, it is [INSERT FROM TABLE IN

APPENDIX B] per month or [INSERT FROM

TABLE IN APPENDIX B] per year for an

individual who starts receiving benefits at

age 55. [IN LIEU OF AGE 55, YOU MAY ADD

OR SUBSTITUTE ANY AGE(S) RELEVANT

UNDER THE PLAN. FOR EXAMPLE, YOU

MAY ADD OR SUBSTITUTE THE

MAXIMUM BENEFIT FOR AGES 62 OR 60

FROM THE TABLE IN APPENDIX B. IF THE

PLAN PROVIDES FOR NORMAL

RETIREMENT BEFORE AGE 65, YOU MUST

INCLUDE THE NORMAL RETIREMENT

AGE.]

[IF THE PLAN DOES NOT PROVIDE FOR

COMMENCEMENT OF BENEFITS BEFORE

AGE 65, YOU MAY OMIT THIS

PARAGRAPH.]

• The maximum benefit will also be

reduced when a benefit is provided for a

survivor.

The PBGC does not guarantee certain types

of benefits.

[INCLUDE THE FOLLOWING GUARANTEE

LIMITS THAT APPLY TO THE BENEFITS

AVAILABLE UNDER YOUR PLAN.]

• The PBGC does not guarantee benefits

for which you do not have a vested right

when a plan ends, usually because you have

not worked enough years for the company.

• The PBGC does not guarantee benefits

for which you have not met all age, service,

or other requirements at the time the plan

ends.

• Benefit increases and new benefits that

have been in place for less than a year are

not guaranteed. Those that have been in

place for less than 5 years are only partly

guaranteed.

• Early retirement payments that are

greater than payments at normal retirement

age may not be guaranteed. For example, a

supplemental benefit that stops when you

become eligible for Social Security may not

be guaranteed.

• Benefits other than pension benefits,

such as health insurance, life insurance,

death benefits, vacation pay, or severance

pay, are not guaranteed.

• The PBGC does not pay lump sums

exceeding $3,500.

WHERE TO GET MORE INFORMATION

Your plan, [EIN-PN], is sponsored by

[CONTRIBUTING SPONSOR(S)]. If you

would like more information about the

funding of your plan, contact [INSERT

NAME, TITLE, BUSINESS ADDRESS AND

PHONE NUMBER OF INDIVIDUAL OR

ENTITY].

For more information about the PBGC and

the benefits it guarantees, you may request a

free copy of ‘‘Your Guaranteed Pension’’ by
24696 Federal Register / Vol. 61, No. 96 / Thursday, May 16, 1996 / Rules and Regulations

writing to Consumer Information Center,

Dept. YGP, Pueblo, Colorado 81009.

[THE FOLLOWING SENTENCE MAY BE

INCLUDED:]

‘‘Your Guaranteed Pension’’ is also

available from the PBGC Homepage on the

World Wide Web at http://www.pbgc.gov/

ygp.htm.

Issued: [INSERT AT LEAST MONTH AND

YEAR]

Appendix B to Part 2627—Table of

Maximum Guaranteed Benefits

If a plan terminates in—

The maximum guaranteed benefit for an individual starting to receive benefits at the age listed below is the

amount (monthly or annual) listed below:

Age 65 Age 62 Age 60 Age 55

Monthly Annual Monthly Annual Monthly Annual Monthly Annual

1995 ................................... $2,573.86 $30,886.32 $2,033.35 $24,400.20 $1,673.01 $20,076.12 $1,158.24 $13,898.88

1996 ................................... 2,642.05 31,704.60 2,087.22 25,046.64 1,717.33 20,607.96 1,188.92 14,267.04

The maximum guaranteed benefit for an

individual starting to receive benefits at ages

other than those listed above can be

determined by applying the PBGC’s

regulation on computation of maximum

guaranteeable benefits (29 CFR § 2621.4).

Issued in Washington, DC, this 13th day of

May, 1996.

Martin Slate,

Executive Director, Pension Benefit Guaranty

Corporation.

[FR Doc. 96–12335 Filed 5–15–96; 8:45 am]

BILLING CODE 7708–01–P

DEPARTMENT OF THE TREASURY

Office of Foreign Assets Control

31 CFR Part 585

Federal Republic of Yugoslavia (Serbia

and Montenegro) and Bosnian Serb–

Controlled Areas of the Republic of

Bosnia and Herzegovina Sanctions

Regulations; Suspension of Sanctions

Against the Bosnian Serbs

AGENCY: Office of Foreign Assets

Control, Treasury.

ACTION: Final rule; amendments.

SUMMARY: This rule amends the Federal

Republic of Yugoslavia (Serbia and

Montenegro) and Bosnian Serb–

Controlled Areas of the Republic of

Bosnia and Herzegovina Sanctions

Regulations to authorize prospectively

all transactions with respect to property

and interests in property of the Bosnian

Serb forces and authorities and any

dealing by U.S. persons relating to trade

with or in, and the exportation of

services to, the areas of the Republic of

Bosnia and Herzegovina that the

Bosnian Serb forces control.

EFFECTIVE DATE: May 10, 1996.

FOR FURTHER INFORMATION CONTACT:

Steven I. Pinter, Chief of Licensing, tel.:

202/622–2480, Dennis P. Wood, Chief of

Compliance Programs, tel.: 202/622–

2490, or William B. Hoffman, Chief

Counsel, tel.: 202/622–2410, Office of

Foreign Assets Control, Department of

the Treasury, Washington, DC 20220.

SUPPLEMENTARY INFORMATION:

Electronic and Facsimile Availability

This document is available as an

electronic file on The Federal Bulletin

Board the day of publication in the

Federal Register. By modem, dial 202/

512–1387 and type ‘‘/GO FAC,’’ or call

202/512–1530 for disk or paper copies.

This file is available for downloading

without charge in WordPerfect 5.1,

ASCII, and Adobe AcrobatTM readable

(*.PDF) formats. For Internet access, the

address for use with the World Wide

Web (Home Page), Telnet, or FTP

protocol is: fedbbs.access.gpo.gov. The

document is also accessible for

downloading in ASCII format without

charge from Treasury’s Electronic

Library (‘‘TEL’’) in the ‘‘Business, Trade

and Labor Mall’’ of the FedWorld

bulletin board. By modem, dial 703/

321–3339, and select the appropriate

self–expanding file in TEL. For Internet

access, use one of the following

protocols: Telnet = fedworld.gov

(192.239.93.3); World Wide Web (Home

Page) = http://www.fedworld.gov; FTP

= ftp.fedworld.gov (192.239.92.205).

Additional information concerning the

programs of the Office of Foreign Assets

Control is available for downloading

from the Office’s Internet Home Page:

http://www.ustreas.gov/treasury/

services/fac/fac.html, or in fax form

through the Office’s 24–hour fax–on–

demand service: call 202/622–0077

using a fax machine, fax modem, or

touch tone telephone.

Background

On January 16, 1996, the Treasury

Department suspended prospectively

sanctions imposed against the Federal

Republic of Yugoslavia (Serbia and

Montenegro) (the ‘‘FRY (S&M)’’).

Sanctions against the Bosnian Serb

forces and authorities and the areas of

the Republic of Bosnia and Herzegovina

that they control were to remain in

effect until their troop withdrawal to

agreed borders, consistent with the

General Framework Agreement for

Peace in Bosnia and Herzegovina and

the Annexes thereto (collectively the

‘‘Peace Agreement’’), which was

initialled on November 21, 1995, and

signed on December 4, 1995, and with

paragraph 2 of United Nations Security

Council Resolution 1022 of November

22, 1995 (the ‘‘Resolution’’).

On February 26, in keeping with

paragraph 2 of the Resolution, the

United Nations Secretary–General

transmitted to the Security Council the

report of the commander of the

international force deployed in

accordance with the Peace Agreement

stating that all Bosnian Serb forces had

withdrawn behind the zones of

separation established by that

Agreement. Accordingly, the Office of

Foreign Assets Control is amending the

Federal Republic of Yugoslavia (Serbia

and Montenegro) and Bosnian Serb–

Controlled Areas of the Republic of

Bosnia and Herzegovina Sanctions

Regulations, 31 CFR part 585 (the

‘‘Regulations’’), by adding § 585.527 to

the Regulations to authorize

prospectively those transactions

previously prohibited with respect to

the Bosnian Serb forces and authorities

and entities organized or located in

those areas of the Republic of Bosnia

and Herzegovina under their control;

entities owned or controlled directly or

indirectly by any person in, or resident

in, those areas; and any person acting

for or on behalf of any of the foregoing.

U.S. persons are also authorized to

engage in transactions involving the

areas of the Republic of Bosnia and

Herzegovina under the control of the

Bosnian Serb forces, and services may

be exported either from the United

States or by U.S. persons to those areas.

Property and interests in property

previously blocked due to an interest of

any person described in § 585.201

remain blocked.

Because the Regulations involve a

foreign affairs function, Executive Order

12866 and the provisions of the

Administrative Procedure Act, 5 U.S.C.

553, requiring notice of proposed