Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations 48175

those in the 1985 edition with the

following exceptions:

(1) In the second paragraph under

‘‘Apparatus,’’ the 1985 edition states ‘‘A

membrane generally suitable for sterility

testing has a normal porosity of .45 +/

-0.02um, * * *,’’ while the 1995 edition

does not include the ‘‘+/-0.02um’’; and

(2) the 1985 edition did not have a

section on ‘‘Filterable Solids,’’ because

information of filterable solids was not

available in 1985. The 1995 edition now

has this information.

Because these differences in the two

editions of the USP are insignificant,

and the 1995 edition is more readily

available to the public, the agency

believes that the regulation should be

amended, as indicated herein, to reflect

the more recent version of the test

standards. Accordingly § 610.12(f) is

being amended to reflect the 1995

edition of the USP (23d Revision, 1995).

Publication of this document

constitutes final action on this change

under the Administrative Procedure Act

(5 U.S.C. 553(b)(3)(B)). Notice and

public procedure are unnecessary

because FDA is merely updating a

reference in its regulations.

List of Subjects in 21 CFR Part 610

Biologics, Incorporation by reference,

Labeling, Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 610 is

amended as follows:

PART 610—GENERAL BIOLOGICAL

PRODUCTS STANDARDS

1. The authority citation for 21 CFR

part 610 continues to read as follows:

Authority: Secs. 201, 501, 502, 503, 505,

510, 701 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371); secs. 215, 351, 352, 353, 361

of the Public Health Service Act (42 U.S.C.

216, 262, 263, 263a, 264).

2. Section 610.12 is amended by

revising paragraph (f) to read as follows:

§ 610.12 Sterility.

* * * * *

(f) Membrane filtration. Bulk and final

container material or products

containing oil products in waterinsoluble ointments may be tested for

sterility using the membrane filtration

procedure set forth in the United States

Pharmacopeia (23d Revision, 1995),

section entitled ‘‘Test Procedures Using

Membrane Filtration,’’ pp. 1689 to 1690,

which is incorporated by reference in

accordance with 5 U.S.C. 552(a) and 1

CFR part 51. Copies are available from

the United States Pharmacopeial

Convention, Inc., 12601 Twinbrook

Pkwy., Rockville, MD 20852, or

available for inspection at the Center for

Drug Evaluation and Research’s

Division of Medical Library, 5600

Fishers Lane, rm. 11B–40, Rockville,

MD, or at the Office of the Federal

Register, 800 North Capitol St. NW.,

suite 700, Washington, DC, except that:

(1) The test samples shall conform

with paragraph (d) of this section; and

(2) In addition, for products

containing a mercurial preservative, the

product shall be tested in a second test

using Fluid Thioglycollate Medium

incubated at 20 to 25 °C in lieu of the

test in Soybean-Casein Digest Medium.

* * * * *

Dated: September 2, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–24349 Filed 9-12-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF LABOR

Occupational Safety and Health

Administration

29 CFR Part 1910

RIN 1218–AA95

Methylene Chloride; Amendment;

Extension of Start-Up Date

AGENCY: Occupational Safety and Health

Administration (OSHA), Department of

Labor.

ACTION: Final Rule; amendment;

extension of start-up date for

compliance.

SUMMARY: The Occupational Safety and

Health Administration (OSHA) is

extending the start-up date for most

provisions of the methylene chloride by

30 days to November 6, 1997 for larger

employers. Employers with fewer than

20 employees and foam manufacturers

with 20 to 99 employees have

substantially later start-up dates which

are not changed.

DATES: The effective date of this

amendment is September 15, 1997.

Compliance: The start-up date for all

provisions of the methylene chloride

standard except initial monitoring and

engineering controls for employers

specified in § 1910.1052(n)(2)(iii)(c) is

extended to November 6, 1997 (210 days

after the effective date of the standard).

FOR FURTHER INFORMATION CONTACT:

Bonnie Freeman, Director, OSHA Office

of Public Affairs, U.S. Department of

Labor, Room N3647, 200 Constitution

Avenue, NW., Washington, DC 20210,

telephone (202) 219–8151.

SUPPLEMENTARY INFORMATION: OSHA

published a new methylene chloride

standard January 10, 1997 (62 FR 1494).

That standard included extended startup dates for its various provisions

depending on the size of the employer.

The three categories of employers were

employers with fewer than 20

employees, foam manufacturers with

20–99 employees and ‘‘all other

employers.’’

OSHA published notification of OMB

approval of information collection

requirements on August 8, 1997 (62 FR

42666). As the start-up date for initial

monitoring for ‘‘all other employers’’

was August 8, 1997, OSHA extended

that date to September 7, 1997 to

provide added notice to implement

compliance.

The next start-up date specified for

‘‘all other employers’’ is October 7, 1997

for all provisions except engineering

controls and initial monitoring. That is

only 30 days after the extended date for

completion of initial monitoring.

OSHA has concluded that more time

is needed between completion of initial

monitoring and implementation of the

other provisions except engineering

controls. This allows for a more efficient

and effective implementation of those

provisions such as for training, medical

surveillance and other specified

provisions. This is also consistent with

OSHA’s initial determination that 60

days is needed between completion of

initial monitoring and implementation

of the other provisions. OSHA is

amending § 1910.1052(n)(2)(iii)(c) to

implement this decision.

The date for completion of initial

monitoring for employers with fewer

than 20 employees is February 4, 1998

and for foam manufacturers with 20–99

employees is November 6, 1997. The

date for all other provisions except

engineering controls is 60 days later for

each group. See 62 FR 1606 (January 10,

1997) for a listing of effective and startup dates.

OSHA finds that there is good cause

to issue this extension without notice

and public comment because following

such procedures would be impractical,

unnecessary or contrary to the public

interest in this case. OSHA believes that

it is in the public interest to give certain

employers additional time between

completion of initial monitoring and

implementation of other provisions.

Authority And Signature

This document was prepared under

the direction of Gregory R. Watchman,

Acting Assistant Secretary of Labor for

Occupational Safety and Health, U.S.
48176 Federal Register / Vol. 62, No. 178 / Monday, September 15, 1997 / Rules and Regulations

Department of Labor, 200 Constitution

Avenue, NW., Washington, DC 20210.

Signed at Washington, DC, this 9th day of

September 1997.

Gregory R. Watchman,

Acting Assistant Secretary of Labor.

PART 1910—[AMENDED]

1. The general authority citation for

subpart Z of CFR 29 part 1910 continues

to read, in part, as follows:

Authority: Sections 4, 6, and 8 of the

Occupational Safety and Health Act of 1970

(29 U.S.C. 653, 655, and 657); Secretary of

Labor’s Order No. 12–71 (36 FR 8754), 8–76

(41 FR 25059), 9–83 (48 FR 35736), 1–90 (55

FR 9033), or 6–96 (62 FR 111), as applicable;

and 29 CFR Part 1911.

* * * * *

2. Paragraph (n)(2)(iii)(C) of

§ 1910.1052 is revised to read as

follows:

§ 1910.1052 Methylene chloride.

* * * * *

(n) * * *

(2) * * *

(iii) * * *

(C) For all other employers, within

210 days after the effective date of this

section.

* * * * *

[FR Doc. 97–24350 Filed 9–12–97; 8:45 am]

BILLING CODE 4510–26–M

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 October 1997.

EFFECTIVE DATE: October 1, 1997.

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: 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

October 1997.

For annuity benefits, the interest

assumptions will be 5.90 percent for the

first 25 years following the valuation

date and 5.00 percent thereafter. The

annuity interest assumptions represent

an increase (from those in effect for

September 1997) of 0.20 percent for the

first 25 years following the valuation

date and are otherwise unchanged. For

benefits to be paid as lump sums, the

interest assumptions to be used by the

PBGC will be 4.75 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. The lump sum interest

assumptions represent an increase (from

those in effect for September 1997) of

0.25 percent for the period during

which a benefit is in pay status; they are

otherwise unchanged.

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 October 1997, 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).

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 48 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=

* * * * * * *

October 1997 ......................................................................... .0590 1–25 .0500 >25 N/A N/A