29548 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations

individual’s annuity in order to recover

an overpayment of benefits. The

regulation also adds a provision to

explain when an actuarial adjustment in

an annuity takes effect when an annuity

is paid by electronic funds transfer

(EFT).

DATES EFFECTIVE: July 1, 1998.

ADDRESSES: Secretary to the Board,

Railroad Retirement Board, 844 North

Rush Street, Chicago, Illinois 60611.

FOR FURTHER INFORMATION CONTACT:

Michael C. Litt, Bureau of Law, Railroad

Retirement Board, 844 North Rush

Street, Chicago, Illinois 60611, (312)

751–4929, TDD (312) 751–4701.

SUPPLEMENTARY INFORMATION: Section

255.8 of the Board’s regulations (62 FR

64164) provides for recovery of an

overpayment by means of an actuarial

adjustment. In accordance with this

provision, an overpayment may be

recovered by permanently reducing the

annuity payable to the individual from

whom recovery is sought. The

calculation of the reduction is

performed using actuarial tables.

Formerly, the authority for the use of

these tables is contained in a Board

Order which is not readily available to

the public. This amendment adds

language specifying that the Board will

use the tables and interest rate adopted

in accordance with the triennial

evaluation of the railroad retirement

trust funds as required by section 15(g)

of the Railroad Retirement Act.

Previously, where an annuity is paid

by check, an actuarial reduction takes

effect, and the overpayment is

recovered, upon negotiation of the first

check which reflects the adjustment.

The amendment adds language to

provide that, in the case of an annuity

paid by electronic funds transfer, the

adjustment is effective when the first

payment reflecting the actuarially

adjusted rate is deposited.

The rule was published as a proposed

rule February 12, 1998 (63 FR 7088)

requesting comments on or before April

13, 1998. No comments were received.

The Board, with the concurrence of

the Office of Management and Budget,

has determined that this is not a

significant regulatory action for

purposes of Executive Order 12866.

Therefore, no regulatory impact analysis

is required. There are no information

collections associated with this rule.

List of Subjects in 20 CFR 255.8

Railroad employees, Railroad

retirement.

For the reasons set out in the

preamble, title 20, part 255 of the Code

of Federal Regulations is amended as

follows:

PART 255—RECOVERY OF

OVERPAYMENTS

1. The authority citation for part 255

continues to read as follows:

Authority: 45 U.S.C. 231f(b)(5); 45 U.S.C.

231(i).

2. Section 255.8 is revised to read as

follows:

§ 255.8 Recovery by adjustment in

connection with subsequent payments.

(a) Recovery of an overpayment may

be made by permanently reducing the

amount of any annuity payable to the

individual or individuals from whom

recovery is sought. This method of

recovery is called an actuarial

adjustment of the annuity. The Board

cannot require any individual to take an

actuarial adjustment in order to recover

an overpayment nor is an actuarial

adjustment available as a matter of right.

An actuarial adjustment becomes

effective and the debt is considered

recovered when, in the case of an

individual paid by electronic funds

transfer, the first annuity payment

reflecting the annuity rate after actuarial

adjustment is deposited to the account

of the overpaid individual, or, in the

case of an individual paid by check, the

first annuity check reflecting the

annuity rate after actuarial adjustment is

negotiated.

Example. An annuitant agrees to recovery

of a $5,000 overpayment by actuarial

adjustment. However, the annuitant dies

before negotiating the first annuity check

reflecting the actuarially-reduced rate. The

$5,000 is not considered recovered. If the

annuitant had negotiated the check before he

died, the $5,000 would be considered fully

recovered.

(b) In calculating any adjustment

under this section, beginning with the

first day of January after the tables and

long-term or ultimate interest rate go

into effect under section 15(g) of the

Railroad Retirement Act (the triennial

evaluation), the Board shall use those

tables and long-term or ultimate interest

rate.

Dated: May 21, 1998.

By Authority of the Board,

Beatrice Ezerski,

Secretary to the Board.

[FR Doc. 98–14326 Filed 5–29–98; 8:45 am]

BILLING CODE 7905–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 87F–0162]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of sulfosuccinic acid 4-ester

with polyethylene glycol nonylphenyl

ether, disodium salt (alcohol moiety

produced by the condensation of 1 mole

of nonylphenol and an average of 9 to

10 moles of ethylene oxide) for use as

an emulsifier in the manufacture of

polyvinyl acetate and vinyl-acrylate

copolymers intended for use in coatings

for paper and paperboard that will

contact food. This action responds to a

petition filed by American Cyanamid

Co.

DATES: The regulation is effective June

1, 1998; written objections and requests

for a hearing by July 1, 1998.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3086.

SUPPLEMENTARY INFORMATION:

I. Background

In a notice published in the Federal

Register of June 4, 1987 (52 FR 21122),

FDA announced that a food additive

petition (FAP 6B3908) had been filed by

American Cyanamid Co., One Cyanamid

Plaza, Wayne, NJ 07470. The petition

proposed to amend the food additive

regulations in § 178.3400 Emulsifiers

and/or surface-active agents (21 CFR

178.3400) to provide for the safe use of

sulfosuccinic acid 4-ester with

polyethylene glycol nonylphenyl ether,

disodium salt for use as a surfactant in

contact with food.

The agency has determined that the

data submitted in the food additive

petition provided information for a

more specific identification of the

additive as sulfosuccinic acid 4-ester

with polyethylene glycol nonylphenyl

ether, disodium salt (alcohol moiety
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29549

produced by the condensation of 1 mole

of nonylphenol and an average of 9 to

10 moles of ethylene oxide). Therefore,

FDA is using this description of the

additive in the codified section of the

final rule. The agency has also

determined that the data submitted in

the petition are adequate to support its

limited use as a surfactant in the

manufacture of polyvinyl acetate and

vinyl-acrylate copolymers intended for

use in coatings for paper and

paperboard food packaging.

Subsequent to the filing of the

petition, American Cyanamid Co. was

acquired by Cytec Industries, Inc., Five

Garret Mountain Plaza, West Paterson,

NJ 07424. As a result of this change in

ownership, FDA was informed in a

letter dated September 20, 1995, that the

petition and all related records be

amended to reflect this change in

ownership for this food additive

petition.

In its evaluation of the safety of this

additive, FDA has reviewed the safety of

the additive itself and the chemical

impurities that may be present in the

additive resulting from its

manufacturing process. Although the

additive itself has not been shown to

cause cancer, it has been found to

contain minute amounts of unreacted

ethylene oxide and minute amounts of

1,4-dioxane as impurities resulting from

its manufacture. These chemicals have

been shown to cause cancer in test

animals. Residual amounts of impurities

are commonly found as constituents of

chemical products, including food

additives.

II. Determination of Safety

Under the so-called ‘‘general safety

clause’’ of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

348(c)(3)(A)), a food additive cannot be

approved for a particular use unless a

fair evaluation of the data available to

FDA establishes that the additive is safe

for that use. FDA’s food additive

regulations (21 CFR 170.3(i)) define safe

as ‘‘a reasonable certainty in the minds

of competent scientists that the

substance is not harmful under the

intended conditions of use.’’

The food additives anticancer, or

Delaney, clause of the act (21 U.S.C.

348(c)(3)(A)) provides that no food

additive shall be deemed safe if it is

found to induce cancer when ingested

by man or animal. Importantly,

however, the Delaney clause applies to

the additive itself and not to impurities

in the additive. That is, where an

additive itself has not been shown to

cause cancer, but contains a

carcinogenic impurity, the additive is

properly evaluated under the general

safety clause using risk assessment

procedures to determine whether there

is a reasonable certainty that no harm

will result from the proposed use of the

additive (Scott v. FDA, 728 F.2d 322

(6th Cir. 1984)).

III. Safety of the Petitioned Use of the

Additive

FDA estimates that the petitioned use

of the additive, sulfosuccinic acid 4-

ester with polyethylene glycol

nonylphenyl ether, disodium salt

(alcohol moiety produced by the

condensation of 1 mole of nonylphenol

and an average of 9 to 10 moles of

ethylene oxide) as an emulsifier/

surfactant in the manufacture of

polyvinyl acetate and vinyl-acrylate

copolymers intended for use in coatings

for paper and paperboard food

packaging, will result in exposure of no

greater than 120 parts per billion (ppb)

of the additive in the daily diet (3

kilograms (kg)), or an estimated daily

intake (EDI) of 0.36 milligrams per

person per day (mg/p/d) (Refs. 1 and 2).

FDA concludes that the currently

regulated use of the additive in

adhesives (21 CFR 175.105) and the

petitioned use in polyvinyl acetate and

vinyl-acrylate copolymers intended for

use as coatings for paper and

paperboard will result in a cumulative

exposure no greater than 148 ppb, or an

EDI of 0.44 mg/p/d.

FDA does not ordinarily consider

chronic toxicological studies to be

necessary to determine the safety of an

additive whose use will result in such

low exposure levels (Ref. 3), and the

agency has not required such testing

here. However, the agency has reviewed

the available toxicological data on the

additive and concludes that the

estimated small dietary exposure

resulting from the proposed use of this

additive is safe.

FDA has evaluated the safety of this

additive under the general safety clause,

considering all available data and using

risk assessment procedures to estimate

the upper-bound limit of lifetime

human risk presented by ethylene oxide

and 1,4-dioxane, the carcinogenic

chemicals that may be present as

impurities in the additive. The risk

evaluation of ethylene oxide and 1,4-

dioxane has two aspects: (1) Assessment

of exposure to the impurities from the

petitioned use of the additive; and (2)

extrapolation of the risk observed in the

animal bioassays to the conditions of

exposure to humans.

A. Ethylene Oxide

FDA has estimated the cumulative

exposure to ethylene oxide from both

the regulated use of the additive in

adhesives and the petitioned use of the

additive as an emulsifier/surfactant in

the manufacture of polyvinyl acetate

and vinyl-acrylate copolymers intended

for use in paper and paperboard

coatings that will contact food to be no

more than 1.5 parts per trillion (pptr) in

the daily diet (3 kg) or 4.5 nanograms

(ng)/person/day (Ref. 2). The agency

used data from a carcinogenesis

bioassay on ethylene oxide conducted

by the Institute of Hygiene, University

of Mainz, Germany (Ref. 4) to estimate

the upper-bound limit of lifetime

human risk from the cumulative

exposure to this chemical resulting from

the currently regulated use and the

proposed use of the additive. The

results of the bioassay on ethylene oxide

demonstrated that ethylene oxide was

carcinogenic for female rats under the

conditions of the study. The author

reported that the rodent bioassay

showed that the test material caused

significantly increased incidence of

squamous cell carcinomas of the

forestomach and carcinomas in situ of

the glandular stomach.

Based on the agency’s estimate that

the cumulative exposure to ethylene

oxide will not exceed 4.5 ng/person/

day, FDA estimates that the upperbound limit of lifetime human risk from

the regulated and proposed uses of the

subject additive is 8.4 x 10-9 or 8.4 in

one billion (Refs. 2 and 5). Because of

the numerous conservative assumptions

used in calculating the exposure

estimate, the actual lifetime-averaged

individual exposure to ethylene oxide is

likely to be substantially less than the

estimated exposure, and therefore, the

probable lifetime human risk would be

less than the upper-bound limit of

lifetime human risk. Thus, the agency

concludes that there is a reasonable

certainty that no harm from exposure to

ethylene oxide would result from the

proposed use of the additive.

B. 1,4-Dioxane

FDA has estimated the cumulative

exposure to 1,4-dioxane from both the

regulated use of the additive in

adhesives and the petitioned use of the

additive as an emulsifier/surfactant for

paper and paperboard coatings in

contact with food to be no more than

0.15 pptr of the daily diet (3 kg), or 0.45

ng/person/day (Refs. 2 and 5). The

agency used data from a carcinogenesis

bioassay on 1,4-dioxane, conducted by

the National Cancer Institute (Ref. 6) to

estimate the upper-bound limit of

lifetime human risk from exposure to

this chemical resulting from the

regulated use of the additive in

adhesives and the proposed use of the

additive. The results of the bioassay on
29550 Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations

1,4-dioxane demonstrated that the

material was carcinogenic for female

rats under the conditions of the study.

The authors reported that the rodent

bioassay showed that the test material

caused a significantly increased

incidence of squamous cell carcinomas

and hepatocellular tumors in female

rats.

Based on the agency’s estimate that

exposure to 1,4-dioxane will not exceed

0.45 ng/person/day, FDA estimates that

the upper-bound limit of lifetime

human risk from both the regulated and

proposed uses of the subject additive is

1.6 x 10-11, or 1.6 in 100 billion (Refs.

2 and 5). Because of the numerous

conservative assumptions used in

calculating the exposure estimate, the

actual lifetime-averaged individual

exposure to 1,4-dioxane is likely to be

substantially less than the estimated

exposure, and therefore, the probable

lifetime human risk would be less than

the upper-bound limit of lifetime

human risk. Thus, the agency concludes

that there is a reasonable certainty that

no harm from exposure to 1,4-dioxane

would result from the proposed use of

the additive.

C. Need for Specifications

The agency has also considered

whether specifications are necessary to

control the amount of ethylene oxide

and 1,4-dioxane present as impurities in

the food additive. The agency finds that

specifications are not necessary for the

following reasons: (1) Because of the

low levels at which ethylene oxide and

1,4-dioxane may be expected to remain

as impurities following production of

the additive, the agency would not

expect the impurities to become

components of food at other than

extremely low levels; and (2) the upperbound limits of lifetime human risk

from exposure to ethylene oxide and

1,4-dioxane are very low, 8.4 in 1 billion

and 1.6 in 100 billion, respectively.

IV. Conclusion

FDA has evaluated data in the

petition and other relevant material.

Based on this information, the agency

concludes that the proposed use of the

additive as an emulsifier/surfactant for

use in polyvinyl acetate and vinylacrylate copolymers intended for use as

coatings for paper and paperboard food

packaging is safe, and that the additive

will achieve its intended technical

effect. Therefore, the agency concludes

that the regulations in § 178.3400

should be amended as set forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

V. Environmental Impact

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.

VI. Objections

Any person who will be adversely

affected by this regulation may at any

time on or before July 1, 1998, file with

the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

VII. Paperwork Reduction Act of 1995

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

VIII. References

The following references have been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Memorandum dated September 3, 1986,

from the Regulatory Food Chemistry Branch

(HFF–458), to the Indirect Additives Branch

(HFF–335), entitled ‘‘FAP 6B3908—

American Cyanamid Co. Undated submission

received July 18, 1986. Sulfosuccinic acid 4-

ester with polyethylene glycol nonylphenyl

ether disodium salt.’’

2. Memorandum dated June 26, 1997, from

the Division of Product Policy, Scientific

Support Branch (HFS–207), Chemistry and

Environmental Review Team (CERT), to the

Regulatory Policy Branch (HFS–206), entitled

‘‘FAP 6B3908 (MATS #223, M2.10)-Cytec

Industries, Inc. (through Keller & Heckman).

Update of exposure estimates for Aerosol A–

103. Regulatory Policy Branch (RPB) request

dated 3–31–97 and Division of Health Effects

Evaluation (DHEE) memorandum dated 3–

27–97.’’

3. Kokoski, C. J., ‘‘Regulatory Food

Additive Toxicology’’ in Chemical Safety

Regulation and Compliance, edited by F.

Homburger and J. K. Marquis, published by

S. Karger, New York, NY, pp. 24–33, 1985.

4. Dunkelburg, H., ‘‘Carcinogenicity of

Ethylene Oxide and 1,2-Propylene Oxide

Upon Intragastric Administration to Rats,’’

British Journal of Cancer, 46, pp. 924–933,

1982.

5. Memorandum dated July 16, 1997, from

the Regulatory Policy Branch (HFS–206), to

Sara H. Henry, Executive Secretary,

Quantitative Risk Assessment Committee

(HFS–308), entitled ‘‘Re-evaluate Estimation

of the Upper-Bound Lifetime Risk of

Ethylene Oxide and 1,4-Dioxane in

Sulfosuccinic Acid 4-Ester With

Polyethylene Glycol Nonylphenyl Ether,

Disodium Salt as an Emulsifier for Latex

Coatings for Food-Contact Applications:

Subject of Food Additive Petition FAP

6B3908 (Cytex Industries, Inc.)’’.

6. ‘‘Bioassay of 1,4-Dioxane for Possible

Carcinogenicity,’’ National Cancer Institute,

NCI–CG–TR–80, 1978.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

2. Section 178.3400 is amended in the

table in paragraph (c) by alphabetically

adding a new entry under the headings
Federal Register / Vol. 63, No. 104 / Monday, June 1, 1998 /Rules and Regulations 29551

‘‘List of substances’’ and ‘‘Limitations’’

to read as follows:

§ 178.3400 Emulsifiers and/or surface

active agents.

* * * * *

(c) * * *

List of substances Limitations

* * * * * * *

Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl ether,

disodium salt (alcohol moiety produced by condensation of 1 mole

nonylphenol and an average of 9–10 moles of ethylene oxide) (CAS

Reg. No. 9040–38–4).

For use only at levels not to exceed 5 percent by weight of the total

coating monomers used in the emulsion polymerization of polyvinyl

acetate and vinyl-acrylate copolymers intended for use as coatings

for paper and paperboard.

* * * * * * *

* * * * *

Dated: May 15, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14296 Filed 5–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

Animal Drugs, Feeds, and Related

Products; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

change of sponsor for an approved new

animal drug application (NADA) from

Deprenyl Animal Health, Inc., to Pfizer,

Inc.

EFFECTIVE DATE: June 1, 1998.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: Deprenyl

Animal Health, Inc., 7101 College Blvd.,

suite 580, Overland Park, KS 66210, has

informed FDA that it has transferred the

ownership of, and all rights and

interests in, the approved NADA 141–

080 (selegiline hydrochloride tablets) to

Pfizer, Inc., 235 East 42d St., New York,

NY 10017. The agency is amending 21

CFR 510.600(c)(1) and (c)(2) to remove

the sponsor name for Deprenyl Animal

Health, Inc., because the firm no longer

is the holder of any approved NADA’s.

The agency is also amending 21 CFR

520.2098 to reflect the change of

sponsor.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Parts 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 parts 510 and 520 are amended as

follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entry for ‘‘Deprenyl

Animal Health, Inc.’’; and in the table in

paragraph (c)(2) by removing the entry

for ‘‘063248’’.

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

3. The authority citation for 21 CFR

part 520 continues to read as follows:

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

§ 520.2098 [Amended]

4. Section 520.2098 Selegiline

hydrochloride tablets is amended in

paragraph (b) by removing ‘‘063248’’

and by adding in its place ‘‘000069’’.

Dated: May 12, 1998.

Andrew J. Beaulieu,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–14299 Filed 5–29–98; 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; Lufenuron

Suspension

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 Novartis

Animal Health US, Inc. The NADA

provides for subcutaneous use of

lufenuron suspension in cats for control

of flea populations.

EFFECTIVE DATE: June 1, 1998.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1612.

SUPPLEMENTARY INFORMATION: Novartis

Animal Health US, Inc., P.O. Box 26402,

Greensboro, NC 27404–6402, is the

sponsor of NADA 141–105 that provides

for the subcutaneous use of ProgramTM

(lufenuron) 10 percent sterile

suspension for cats for the control of

flea populations. The drug is limited to

use by or on the order of a licensed

veterinarian. The NADA is approved as

of March 13, 1998, and the regulations

are amended by adding § 522.1289 to

reflect the approval. The basis of