38304 Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 /Rules and Regulations

filed by Pharmacia & Upjohn Co. The

NADA provides for veterinary

prescription use of AdspecTM

(spectinomycin) sterile solution for

cattle. The document incorrectly listed

the tolerance for spectinomycin residues

in cattle muscle. This document corrects

that error.

EFFECTIVE DATE: July 16, 1998.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION: In FR Doc.

98–11686 appearing on page 24106 in

the Federal Register of Friday, May 1,

1998, the following correction is made:

§ 556.600 [Corrected]

1. On page 24107, in the second

column, in § 556.600 Spectinomycin, in

paragraph (c), in the fourth line, ‘‘0.4’’

is corrected to read ‘‘0.25’’.

Dated: July 9, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–18956 Filed 7–15–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

Certain Other Dosage Form New

Animal Drugs; Formalin Solution

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

Western Chemical, Inc. The supplement

provides for use of formalin solution in

the water of all finfish as a parasiticide

and all finfish eggs as a fungicide.

EFFECTIVE DATE: July 16, 1998.

FOR FURTHER INFORMATION CONTACT:

Thomas A. Bell, Center for Veterinary

Medicine (HFV–130), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1649.

SUPPLEMENTARY INFORMATION: Western

Chemical, Inc., 1269 Lattimore Rd.,

Ferndale, WA 98248, is sponsor of

NADA 140–989 that provides for use of

Parasite-S (formalin, an aqueous

solution of 37 percent formaldehyde) in

the water (tanks, raceways, and ponds)

of select fish and penaeid shrimp for the

control of specific external parasites,

and as a fungicide for select fish eggs.

Western Chemical, Inc., filed a

supplemental NADA that provides for

use of formalin in the water of all finfish

for the control of specific external

parasites and as a fungicide for all

finfish eggs. The supplemental NADA is

approved as of June 18, 1998, and the

regulations are amended in 21 CFR

529.1030 to reflect the approval.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this supplement may be

seen in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects in 21 CFR Part 529

Animal drugs.

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 529 is amended as follows:

PART 529—CERTAIN OTHER DOSAGE

FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 529 continues to read as follows:

Authority: 21 U.S.C. 360b.

2. Section 529.1030 is amended by

revising paragraphs (b)(1) and (b)(2), by

redesignating paragraph (c) as paragraph

(d) and reserving paragraph (c), by

revising newly redesignated paragraphs

(d) introductory text, (d)(1) and (d)(2)(i),

and by adding paragraphs (d)(2)(iv) and

(d)(2)(v) to read as follows:

§ 529.1030 Formalin solution.

* * * * *

(b) * * *

(1) No. 050378 for use as in

paragraphs (d)(1)(iii), (d)(1)(iv), (d)(1)(v),

(d)(2)(iii), (d)(2)(iv), (d)(2)(v), and (d)(3).

(2) Nos. 049968 and 051212 for use as

in paragraphs (d)(1)(i), (d)(1)(ii),

(d)(2)(i), (d)(2)(ii), and (d)(3).

* * * * *

(c) [Reserved]

(d) Conditions of use. It is added to

environmental water as follows:

(1) Indications for use. (i) Select

finfish. For control of external protozoa

Ichthyophthirius spp., Chilodonella

spp., Costia spp., Scyphidia spp.,

Epistylis spp., and Trichodina spp., and

monogenetic trematodes Cleidodiscus

spp., Gyrodactylus spp., and

Dactylogyrus spp., on salmon, trout,

catfish, largemouth bass, and bluegill.

(ii) Select finfish eggs. For control of

fungi of the family Saprolegniaceae on

salmon, trout, and esocid eggs.

(iii) Penaeid shrimp. For control of

external protozoan parasites Bodo spp.,

Epistylis spp., and Zoothamnium spp.

(iv) All finfish. For control of external

protozoa Ichthyophthirius spp.,

Chilodonella spp., Costia spp.,

Scyphidia spp., Epistylis spp., and

Trichodina spp., and monogenetic

trematodes Cleidodiscus spp.,

Gyrodactylus spp., and Dactylogyrus

spp.

(v) All finfish eggs: For control of

fungi of the family Saprolegniaceae.

(2) * * *

(i) For control of external parasites on

select finfish:

* * * * *

(iv) For control of external parasites

on all finfish:

Aquatic species

Administer in

tanks and

raceways for

up to 1 hour

(microliter/

liter or part

per million

(μL/L or

ppm))

Administer in

earthen

ponds

indefinitely

(μL/L or ppm)

Salmon and

trout:

Above 50 °F Up to 170 15 to 251, 2

Below 50 °F Up to 250 15 to 251, 2

All other

finfish

Up to 250 15 to 251, 2

1 Use the lower concentration when ponds,

tanks, or raceways are heavily loaded with

phytoplankton or fish to avoid oxygen depletion due to the biological oxygen demand by

decay of dead phytoplankton. Alternatively, a

higher concentration may be used if dissolved

oxygen is strictly monitored. 2Although the indicated concentrations are

considered safe for cold and warm water

finfish, a small number of each lot or pond to

be treated should always be used to check for

any unusual sensitivity to formalin before proceeding.

(v) For control of fungi of the family

Saprolegniaceae on all finfish eggs: Eggs
Federal Register / Vol. 63, No. 136 /Thursday, July 16, 1998 /Rules and Regulations 38305

of all finfish except Acipenseriformes,

1,000 to 2,000 μL/L (ppm) for 15

minutes; eggs of Acipenseriformes, up

to 1,500 μL/L (ppm) for 15 minutes.

* * * * *

Dated: July 9, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–18955 Filed 7–15–98; 8:45 am]

BILLING CODE 4160–01–F

PENSION BENEFIT GUARANTY

CORPORATION

29 CFR Parts 4011, 4022, 4041A, 4044,

4050 and 4281

RIN 1212–AA88

Valuation and Payment of Lump Sum

Benefits

AGENCY: Pension Benefit Guaranty

Corporation.

ACTION: Final rule.

SUMMARY: The Pension Benefit Guaranty

Corporation is amending its regulations

to increase the maximum value of

benefits that the PBGC may pay in lump

sum form, and certain other lump sum

thresholds, from $3,500 to $5,000. The

amendments do not affect lump sum

benefits paid by ongoing plans.

DATES: The amendments to 29 CFR

4022.7, 4044.52(b), and 4044.54 are

effective July 16, 1998. (However,

except to the extent they affect

determinations under § 4022.7, the

amendments to 29 CFR 4044.52(b) and

4044.54 apply only to a plan with a

termination date on or after August 17,

1998.) The final rule is otherwise

effective August 17, 1998.

FOR FURTHER INFORMATION CONTACT:

Harold J. Ashner, Assistant General

Counsel, or Marc L. Jordan, Attorney,

Pension Benefit Guaranty Corporation,

Office of the General Counsel, Suite 340,

1200 K Street, NW., Washington, DC

20005–4026, 202–326–4024. (For TTY/

TTD users, call the Federal relay service

toll-free at 1–800–877–8339 and ask to

be connected to 202–326–4024.)

SUPPLEMENTARY INFORMATION: Section

203(e) of ERISA specifies the maximum

value that a plan may provide it will

pay in a lump sum (i.e., single

installment) to a participant or surviving

spouse without consent. The Taxpayer

Relief Act of 1997 increased the section

203(e) maximum from $3,500 to $5,000

effective for plan years beginning after

August 5, 1997.

On April 30, 1998, the PBGC

proposed to amend its regulations to

increase various $3,500 thresholds to

$5,000 and to make other changes

relating to lump sum payments. The

PBGC received no comments in

response to the proposed rule and is

issuing the final rule without change, as

follows:

• Under the final rule, the PBGC may

make a lump sum payment of a benefit

that has a value of $5,000 or less as of

the plan’s termination date. (See

§ 4022.7 and, to the extent they affect

determinations under § 4022.7,

§§ 4044.52(b), and 4044.54.) There are

special rules for applying the lump sum

threshold where the PBGC issues a

determination on title IV benefits before

it issues a determination on benefits

payable under ERISA section 4022(c).

Consistent with its current practice, the

PBGC will give the participant the

option to receive the benefit in the form

of an annuity if the monthly benefit (at

normal retirement age in the normal

form for an unmarried participant) is

equal to or greater than $25.

Applicability: This amendment

applies to any initial determination

issued on or after July 16, 1998. For any

initial determination issued before July

16, 1998, the PBGC may make a lump

sum payment of a benefit with a value

of $5,000 or less, provided (1) the

benefit is not yet in pay status, and (2)

the participant (with spousal consent) or

beneficiary elects the lump sum

payment.

• Under the final rule, the lump sum

threshold under §§ 4044.52(b) and

4044.54, which is used for determining

whether lump sum or annuity

assumptions are used to value benefits

for purposes of allocating assets to

benefits under ERISA section 4044, is

$5,000.

Applicability: This amendment

applies to any plan with a termination

date on or after August 17, 1998.

• The reference to the lump sum

threshold in the PBGC’s Model

Participant Notice (Part 4011, Appendix

A) is changed from $3,500 to $5,000.

Applicability: This amendment

applies to any Participant Notice issued

on or after August 17, 1998. However,

for a reasonable time period, the PBGC

will not treat a Participant Notice as

failing to satisfy the Participant Notice

requirements merely because it refers to

the $3,500 threshold.

• The dollar thresholds in the

Missing Participants regulation are

increased from $3,500 to $5,000. See

§§ 4050.2 (definition of missing

participant annuity assumptions) and

4050.5(a)(2) (de minimis lump sum).

Applicability: This amendment

applies to missing participants for

whom the deemed distribution date is

on or after August 17, 1998.

• The dollar threshold up to which

the plan sponsor of a terminated

multiemployer plan that is closing out

may make a lump sum payment of

nonforfeitable benefits is increased from

$3,500 to $5,000 (see § 4041A.43(b)(1)).

Applicability: This amendment

applies to any distribution made on or

after August 17, 1998.

• In the case of participant deaths

after the termination date, the final rule

allows the PBGC to make a lump sum

payment of a qualified preretirement

survivor annuity with a value of $5,000

or less if the surviving spouse elects a

lump sum (§ 4022.7(b)(1)(iii)).

Applicability: This amendment

applies to any lump sum payment made

on or after July 16, 1998.

• The final rule allows the PBGC to

make a lump sum payment, without

regard to amount, of any benefits due to

an estate (e.g., under a certain and

continuous benefit where the designated

beneficiary predeceases the participant)

if the estate elects a lump sum (see

§ 4022.7(b)(1)(iv)).

Applicability: This amendment

applies to any payment made on or after

July 16, 1998.

Finally, the final rule (1) eliminates,

as unnecessary, two provisions in its

multiemployer valuation regulation that

refer to the $3,500 limit, and (2) makes

clear that the lump sum value of a

benefit is calculated by valuing the

monthly annuity benefit (which

excludes the value of certain

preretirement death benefits, such as a

qualified preretirement survivor

annuity).

Rulemaking Requirements

The PBGC has determined that good

cause exists to make certain

amendments (the amendments to 29

CFR 4022.7 and, to the extent they affect

determinations under 29 CFR 4022.7,

the amendments to §§ 4044.52(b) and

4044.54) effective and applicable

immediately. These amendments

impose requirements only on the PBGC.

A delayed effective date is unnecessary

because no person other than the PBGC

needs time to prepare. See 5 U.S.C.

553(d)(3).

E.O. 12866 and the Regulatory

Flexibility Act

The PBGC has determined that this

final rule is not a ‘‘significant regulatory

action’’ under the criteria set forth in

Executive Order 12866. The PBGC

certifies that the amendments will not

have a significant economic impact on

a substantial number of small entities.

The amendments will affect only de

minimis benefits and will have an

immaterial effect on liabilities