Federal Register / Vol. 64, No. 93 / Friday, May 14, 1999 /Rules and Regulations 26287

§ 640.100 Immune Globulin (Human).

(a) * * * The product is defined as a

sterile solution containing antibodies

derived from human plasma.

(b) Source material. The source

material of Immune Globulin (Human)

shall be plasma recovered from Whole

Blood prepared as prescribed in

§§ 640.1 through 640.5, or Source

Plasma prepared as prescribed in

§§ 640.60 through 640.76.

(c) Additives in source material. The

source material shall contain no

additives other than citrate or acid

citrate dextrose anticoagulant solution,

unless it is shown that the processing

method yields a product free of the

additive to such an extent that the

safety, purity, and potency of the

product will not be affected adversely.

§ 640.101 [Amended]

11. Section 640.101 General

requirements is amended by removing

the heading of paragraph (b) ‘‘Hydrogen

ion concentration’’ and by adding in its

place ‘‘pH’’ and by removing paragraphs

(e)(3), (e)(4), and (f).

12. Section 640.102 is amended by

revising the last sentence of paragraph

(e) to read as follows:

640.102 Manufacture of Immune Globulin

(Human).

* * * * *

(e) * * * At no time during

processing shall the product be exposed

to temperatures above 45 °C and after

sterilization the product shall not be

exposed to temperatures above 32 °C for

more than 72 hours.

13. Section 640.103 is amended by

revising paragraph (b) to read as follows:

§ 640.103 The final product.

* * * * *

(b) Protein composition. At least 96

percent of the total protein shall be

immunoglobulin G (IgG), as determined

by a method that has been approved for

each manufacturer by the Director,

Center for Biologics Evaluation and

Research, Food and Drug

Administration.

14. Section 640.104 is amended by

revising paragraphs (b)(2), (b)(3), (c)(1),

and (c)(2) to read as follows:

§ 640.104 Potency.

* * * * *

(b) * * *

(2) A measles neutralizing antibody

level that, when compared with that of

a reference material designated by the

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, as indicated in

paragraph (c) of this section,

demonstrates adequate potency. The

Director, CBER, shall notify

manufacturers when a new reference

material will be used and will advise

manufacturers of an appropriate

antibody level taking into account a

comparison of the new reference

material to the previous reference

material.

(3) A poliomyelitis Type 1, Type 2, or

Type 3 neutralizing antibody level that,

when compared with that of a reference

material designated by the Center for

Biologics Evaluation and Research,

Food and Drug Administration, as

indicated in paragraph (c) of this

section, demonstrates adequate potency.

The Director, CBER, shall notify

manufacturers when a new reference

material will be used and will advise

manufacturers of an appropriate

antibody level taking into account a

comparison of the new reference

material to the previous reference

material.

(c) * * *

(1) Reference Immune Globulin for

correlation of measles antibody titers.

(2) Reference Immune Globulin for

correlation of poliomyelitis antibody

titers, Types 1, 2, and 3.

Dated: April 20, 1999.

Jane E. Henney,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 99–11897 Filed 5–13–99; 8:45 am]

BILLING CODE 4160–01–F

PENSION BENEFIT GUARANTY

CORPORATION

29 CFR Part 4044

Allocation of Assets in SingleEmployer Plans; Interest Assumptions

for Valuing Benefits

AGENCY: Pension Benefit Guaranty

Corporation.

ACTION: Final rule.

SUMMARY: The Pension Benefit Guaranty

Corporation’s regulation on Allocation

of Assets in Single-Employer Plans

prescribes interest assumptions for

valuing benefits under terminating

single-employer plans. This final rule

amends the regulation to adopt interest

assumptions for plans with valuation

dates in June 1999. Interest assumptions

are also published on the PBGC’s web

site (http://www.pbgc.gov).

EFFECTIVE DATE: June 1, 1999.

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. (For TTY/TDD

users, call the Federal relay service tollfree at 1–800–877–8339 and ask to be

connected to 202–326–4024.)

SUPPLEMENTARY INFORMATION: The

PBGC’s regulation on Allocation of

Assets in Single-Employer Plans (29

CFR part 4044) prescribes actuarial

assumptions for valuing plan benefits of

terminating single-employer plans

covered by title IV of the Employee

Retirement Income Security Act of 1974.

Among the actuarial assumptions

prescribed in part 4044 are interest

assumptions. These interest

assumptions are intended to reflect

current conditions in the financial and

annuity markets.

Two sets of interest assumptions are

prescribed, one set for the valuation of

benefits to be paid as annuities and one

set for the valuation of benefits to be

paid as lump sums. This amendment

adds to appendix B to part 4044 the

annuity and lump sum interest

assumptions for valuing benefits in

plans with valuation dates during June

1999.

For annuity benefits, the interest

assumptions will be 5.70 percent for the

first 20 years following the valuation

date and 5.25 percent thereafter. For

benefits to be paid as lump sums, the

interest assumptions to be used by the

PBGC will be 4.25 percent for the period

during which a benefit is in pay status

and 4.00 percent during any years

preceding the benefit’s placement in pay

status. These annuity and lump sum

interest assumptions are unchanged

from those in effect for May 1999.

The PBGC has determined that notice

and public comment on this amendment

are impracticable and contrary to the

public interest. This finding is based on

the need to determine and issue new

interest assumptions promptly so that

the assumptions can reflect, as

accurately as possible, current market

conditions.

Because of the need to provide

immediate guidance for the valuation of

benefits in plans with valuation dates

during June 1999, the PBGC finds that

good cause exists for making the

assumptions 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

Act of 1980 does not apply. See 5 U.S.C.

601(2).
26288 Federal Register / Vol. 64, No. 93 / Friday, May 14, 1999 /Rules and Regulations

List of Subjects in 29 CFR Part 4044

Pension insurance, Pensions.

In consideration of the foregoing, 29

CFR part 4044 is amended as follows:

PART 4044—ALLOCATION OF

ASSETS IN SINGLE-EMPLOYER

PLANS

1. The authority citation for part 4044

continues to read as follows:

Authority: 29 U.S.C. 1301(a), 1302(b)(3),

1341, 1344, 1362.

2. In appendix B, a new entry is

added to Table I, and Rate Set 68 is

added to Table II, as set forth below.

The introductory text of each table is

republished for the convenience of the

reader and remains unchanged.

Appendix B to Part 4044—Interest Rates

Used to Value Annuities and Lump Sums

TABLE I.—ANNUITY VALUATIONS

[This table sets forth, for each indicated calendar month, the interest rates (denoted by i1, i2, * * * , and referred to generally as it) assumed to

be in effect between specified anniversaries of a valuation date that occurs within that calendar month; those anniversaries are specified in

the columns adjacent to the rates. The last listed rate is assumed to be in effect after the last listed anniversary date.]

For valuation dates occurring in the month—

The values of it are:

it for t = it for t = it for t =

* * * * * * *

June 1999 ............................................................................. .0570 1–20 .0525 >20 N/A N/A

TABLE II.—LUMP SUM VALUATIONS

[In using this table: (1) For benefits for which the participant or beneficiary is entitled to be in pay status on the valuation date, the immediate annuity rate shall apply; (2) For benefits for which the deferral period is y years (where y is an integer and 0 < y ≤ n1), interest rate i1 shall

apply from the valuation date for a period of y years, and thereafter the immediate annuity rate shall apply; (3) For benefits for which the deferral period is y years (where y is an integer and n1 < y ≤ n1 + n2), interest rate i2 shall apply from the valuation date for a period of y¥n1

years, interest rate i1 shall apply for the following n1 years, and thereafter the immediate annuity rate shall apply; (4) For benefits for which

the deferral period is y years (where y is an integer and y > n1+n2), interest rate i3 shall apply from the valuation date for a period of

y¥n1¥n2 years, interest rate i2 shall apply for the following n2 years, interest rate i1 shall apply for the following n1 years, and thereafter the

immediate annuity rate shall apply.]

Rate set

For plans with a valuation

date Immediate

annuity rate

(percent)

Deferred annuities (percent)

On or after Before i1 i2 i3 n1 n2

* * * * * * *

68 06–1–99 07–1–99 4.25 4.00 4.00 4.00 7 8

Issued in Washington, DC, on this 10th day

of May 1999.

David M. Strauss,

Executive Director, Pension Benefit Guaranty

Corporation.

[FR Doc. 99–12175 Filed 5–13–99; 8:45 am]

BILLING CODE 7708–01–P

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 948

[WV–077–FOR]

West Virginia Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Final rule; decision on

amendment.

SUMMARY: OSM is announcing that it is

not approving an amendment to the

West Virginia permanent regulatory

program under the Surface Mining

Control and Reclamation Act of 1977

(SMCRA). The amendment would have

revised the West Virginia Surface Coal

Mining and Reclamation Act, and

concerns fish and wildlife habitat and

recreation lands as a postmining land

use for mountaintop removal operations

with variances from approximate

original contour.

EFFECTIVE DATE: May 14, 1999.

FOR FURTHER INFORMATION CONTACT: Mr.

Roger W. Calhoun, Director, Charleston

Field Office, Telephone: (304) 347–

7158.

SUPPLEMENTARY INFORMATION:

I. Background on the West Virginia Program

II. Submission of the Amendment

III. Director’s Finding

IV. Summary and Disposition of Comments

V. Director’s Decision

VI. Procedural Determinations

I. Background on the West Virginia

Program

On January 21, 1981, the Secretary of

the Interior conditionally approved the

West Virginia program. You can find

background information on the West

Virginia program, including the

Secretary’s findings, the disposition of

comments, and the conditions of the

approval in the January 21, 1981,

Federal Register (46 FR 5915–5956).

You can find later actions concerning

the West Virginia program and previous

amendments at 30 CFR 948.10, 948.12,

948.13, 948.15, and 948.16.

II. Submission of the Amendment

By letter dated April 28, 1997

(Administrative Record Number WV–

1056), the West Virginia Division of

Environmental Protection (WVDEP)

submitted an amendment to its

approved permanent regulatory program

pursuant to 30 CFR 732.17. By letter

dated May 14, 1997 (Administrative

Record Number WV–1057), WVDEP

submitted some revisions to the original

submittal. The amendment contained

revisions to section 38–2–1 et seq. of the

West Virginia Surface Mining

Reclamation Regulations [Code of State

Regulations (CSR)] and to section 22–3–

1 et seq. of the West Virginia Surface

Coal Mining and Reclamation Act

(WVSCMRA). The amendment mainly

consisted of changes to implement the