29352 Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 /Rules and Regulations

the product in cats 6 weeks of age or

greater and 1.5 pounds of body weight

or greater. This supplemental NADA

approval provides for 5.75, 11.5, and

23.0 milligram tablets, given orally,

once a month, for the prevention of

heartworm disease caused by Dirofilaria

immitis and the removal of adult

Toxocara cati (roundworm) and

Ancylostoma tubaeforme (hookworm)

infections in cats 6 weeks of age or

greater and 1.5 pounds body weight or

greater. The supplemental NADA is

approved as of April 13, 1998, and the

regulations are amended in 21 CFR

520.1445 by revising paragraph (a) and

the heading of paragraph (c) and by

adding paragraph (d) to reflect the

approval for cats. The basis for approval

is discussed in the freedom of

information summary.

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 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.

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

Federal Food, Drug, and Cosmetic Act

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

approval qualifies for 3 years of

marketing exclusivity beginning April

13, 1998, because the application

contains substantial evidence of

effectiveness of the drug involved and

studies of animal safety required for

approval and conducted or sponsored

by the applicant.

The agency has determined under 21

CFR 25.33(d)(1) 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 520

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 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

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

2. Section 520.1445 is amended by

revising paragraph (a) and the heading

of paragraph (c) and by adding

paragraph (d) to read as follows:

§ 520.1445 Milbemycin oxime tablets.

(a) Specifications—(1) Dogs. Each

tablet contains 2.3, 5.75, 11.5, or 23.0

milligrams of milbemycin oxime.

(2) Cats. Each tablet contains 5.75,

11.5, or 23.0 milligrams of milbemycin

oxime.

* * * * *

(c) Conditions of use in dogs. * * *

(d) Conditions of use in cats—(l)

Amount. 0.91 milligram per pound of

body weight (2.0 milligrams per

kilogram).

(2) Indications for use. For prevention

of heartworm disease caused by

Dirofilaria immitis and the removal of

adult Toxocara cati (roundworm) and

Ancylostoma tubaeforme (hookworm)

infections in cats 6 weeks of age or

greater and 1.5 pounds body weight or

greater.

(3) Limitations. Do not use in kittens

less than 6 weeks of age or 1.5 pounds

body weight. Administer once a month.

Federal law restricts this drug to use by

or on the order of a licensed

veterinarian.

Dated: May 11, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–14182 Filed 5–28–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Guaifenesin

Injection

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 an abbreviated new animal

drug application (ANADA) filed by

Phoenix Scientific, Inc. The ANADA

provides for intravenous use of

guaifenesin injection in horses as a

skeletal muscle relaxant.

EFFECTIVE DATE: May 29, 1998.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center For Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Place,

Rockville, MD 20855, 301–827–0209.

SUPPLEMENTARY INFORMATION: Phoenix

Scientific, Inc., 3915 South 48th St.

Terrace, P.O. Box 6457, St. Joseph, MO

64506–0457, filed ANADA 200–230 that

provides for intravenous use of

guaifenesin injection in horses as a

skeletal muscle relaxant.

Approval of Phoenix Scientific, Inc.’s,

ANADA 200–230 for guaifenesin

injection is as a generic copy of Summit

Hill Laboratories’ NADA 48–854 for

Gecolate (guaifenesin) Injection. The

ANADA is approved as of April 8, 1998,

and the regulations are amended in 21

CFR 522.1086(b) to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

In addition, paragraph (c) is

redesignated as paragraph (d) and

paragraph (c) is reserved.

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 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 agency has determined under 21

CFR 25.33(d)(1) 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 522

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 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

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

§ 522.1086 [Amended]

2. Section 522.1086 Guaifenesin

injection is amended in paragraph (b) by

removing ‘‘No. 037990’’ and adding in

its place ‘‘Nos. 037990 and 059130’’, by

redesignating paragraph (c) as paragraph

(d), and by reserving paragraph (c).
Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 /Rules and Regulations 29353

Dated: May 12, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–14183 Filed 5–28–98; 8:45 am]

BILLING CODE 4160–01–F

PENSION BENEFIT GUARANTY

CORPORATION

29 CFR Part 4022, 4041, 4050

RIN: 1212–AA87

PBGC Recoupment and

Reimbursement of Benefit

Overpayments and Underpayments

AGENCY: Pension Benefit Guaranty

Corporation.

ACTION: Final rule.

SUMMARY: The Pension Benefit Guaranty

Corporation is amending its regulation

governing recoupment of benefit

overpayments in trusteed plans to stop

the reduction of monthly benefits under

its actuarial recoupment method once

the amount of the benefit overpayment

is repaid. The amendment also makes

other related changes.

EFFECTIVE DATE: May 29, 1998.

FOR FURTHER INFORMATION CONTACT:

Harold J. Ashner, Assistant General

Counsel, or James L. Beller, Attorney,

Office of the General Counsel, PBGC,

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: On

December 18, 1997, the PBGC published

a proposed rule in the Federal Register

(62 FR 66319) amending its benefit

payments regulation to provide that

recoupment will cease when the amount

of the overpayment is repaid. The

amendment also gives the PBGC

flexibility to waive recoupment of de

minimis amounts and to accept

repayment ahead of the recoupment

schedule, and modifies the rules

governing calculation of net

overpayments and underpayments.

The PBGC received comments on the

proposed rule from two commenters:

the American Association of Retired

Persons (‘‘AARP’’) and the Association

of Former Pan Am Employees, Inc.

(‘‘AFPAE’’). AARP supported the

proposed regulation and commended

the PBGC for its action. AFPAE, which

also commended the PBGC for

proposing changes, recommended a

number of revisions.

The final regulation follows the

proposed regulation with the following

modifications:

• As requested by AFPAE, the final

rule clarifies that in determining

whether the net overpayment has been

fully repaid, interest on the net

overpayment is disregarded.

• In response to an inquiry in a

pending case in which participants

received both underpayments and

overpayments, the final regulation

provides that the PBGC will always pay

interest on underpayments to the extent

they exceed overpayments. In addition,

for months beginning after May 29,

1998, the PBGC will pay interest at the

applicable federal mid-term rate. For

earlier months, the PBGC will continue

to pay interest using the immediate

annuity rate established for lump sum

valuations.

• Consistent with an AFPAE

suggestion, the final regulation provides

that the PBGC generally will not seek

recovery from the estate of a participant

who dies post-termination. (The existing

regulation precludes recovery from the

estate only for a participant who dies

after the PBGC initiates recoupment.)

• For administrative convenience, the

final regulation provides that the PBGC

will not collect any final partial

monthly installment.

• AFPAE expressed concerns about

the provision allowing repayment ahead

of the recoupment schedule, arguing

that, because the PBGC charges no

interest under the recoupment schedule,

early repayment will never be

advantageous to the participant. The

PBGC will discontinue its current

practice of routinely offering a lump

sum repayment option as part of its

recoupment notice. However, the PBGC

will retain the early repayment option

for those participants who, for whatever

reason, want to eliminate debt. As

suggested by AFPAE, the PBGC intends

to explain to those participants who ask

about the early repayment option that

there may be financial disadvantages to

early repayment.

The PBGC has carefully considered

AFPAE’s other comments and has

decided not to adopt them.

• AFPAE suggested that the PBGC not

seek recoupment from a surviving

beneficiary unless recoupment has been

initiated before the participant’s death.

AFPAE offered no reason why the

PBGC’s recoupment rules should

distinguish in this manner between a

survivorship benefit and the underlying

benefit from which the survivorship

benefit derives. The regulation

minimizes hardship in the case of

recoupment from a survivorship benefit

because the monthly recoupment

amount is reduced in proportion to any

other applicable reduction in the

deceased participant’s benefit (e.g., a

50% reduction under a joint and

survivor annuity) and is generally

capped at 10% of the survivorship

payment.

• AFPAE suggested that the PBGC

eliminate its discretion to recover

overpayments by methods other than

recoupment. The regulation provides

that the PBGC will normally exercise its

discretion only where net benefits paid

exceed plan entitlements (e.g., where a

participant entitled to $1,200 per month

as the full plan benefit and $1,000 per

month under Title IV has received

clearly erroneous payments of $5,000

per month). Any further limitation on

the PBGC’s discretion could result in

unacceptably large losses in particular

cases.

• AFPAE suggested that recoupment

be permitted only if (1) the participant

is notified of the possibility of

recoupment no later than 30 days after

the PBGC makes a final decision to seek

an involuntary termination, and (2)

recoupment begins no more than one

year after the termination date. This

suggestion is impracticable. The PBGC

often encounters significant delays in

obtaining the participant information

needed to provide notice and the benefit

and asset information needed to

complete the complex and timeconsuming process of determining final

benefit entitlements. The PBGC will

continue to provide notice to

participants, and to initiate

recoupments, as soon as possible.

• In response to the provision in the

proposed rule giving the PBGC

discretion to waive de minimis

amounts, AFPAE suggested that the

regulation specify a dollar threshold

under which recoupment is

automatically waived. The PBGC has

decided to retain the discretion

provided in the proposed rule in order

to allow maximum flexibility. After

gaining experience under the de

minimis waiver provision, the PBGC

may decide to specify a fixed dollar

threshold in the regulation.

• AFPAE suggested broadening the

scope of the recoupment and

reimbursement regulation to cover

underpayments made before the plan

termination date. The Title IV singleemployer insurance program does not

cover pre-termination underpayments.

These underpayments represent a claim

on plan assets that are satisfied before

those assets are used to satisfy Title IV

benefits under the allocation rules of

ERISA section 4044 and 29 CFR Part

4044. Thus, to the extent assets are

available, pre-termination

underpayments are fully reimbursed.

AFPAE made several other comments

suggesting revisions to the benefit