Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations 41587

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

are to be submitted and are to 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. FDA will publish notice

of the objections that the agency has

received or lack thereof in the Federal

Register.

XI. References

1. Golubev, W. I., ‘‘Perfect State of

Rhodomyces dendrorhous (Phaffia

rhodozyma),’’ Yeast, 11:101–110, 1995.

2. Andrewes, A. G., H. J. Phaff, and M.

P. Starr, ‘‘Carotenoids of Phaffia

rhodozyma, a Red-Pigmented

Fermenting Yeast,’’ Phytochemistry,

15:1003–1007, 1976.

3. Johnson, E. A., D. E. Conklin, and

M. J. Lewis, ‘‘The Yeast Phaffia

rhodozyma as a Dietary Pigment Source

for Salmonids and Crustaceans,’’

Journal of the Fishers Research Board of

Canada, 34:2417–2421, 1977.

4. Johnson, C. B., memorandum

entitled ‘‘Astaxanthin from Phaffia

rhodozyma: Final Toxicology Review’’

from the Division of Health Effects

Evaluation (HFS–225) to the Division of

Petition Control (HFS–215), Center for

Food Safety and Applied Nutrition,

FDA, August 12, 1999.

List of Subjects in 21 CFR Part 73

Color additives, Cosmetics, Drugs,

Foods, Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 73 is

amended as follows:

PART 73—LISTING OF COLOR

ADDITIVES EXEMPT FROM

CERTIFICATION

1. The authority citation for 21 CFR

part 73 continues to read as follows:

Authority: 21 U.S.C. 321, 341, 342, 343,

348, 351, 352, 355, 361, 362, 371, 379e.

2. New § 73.355 is added to subpart A

to read as follows:

§ 73.355 Phaffia yeast.

(a) Identity. (1) The color additive

phaffia yeast consists of the killed, dried

cells of a nonpathogenic and

nontoxicogenic strain of the yeast

Phaffia rhodozyma.

(2) Phaffia yeast may be added to the

fish feed only as a component of a

stabilized color additive mixture. Color

additive mixtures for fish feed use made

with phaffia yeast may contain only

those diluents that are suitable and are

listed in this subpart as safe for use in

color additive mixtures for coloring

foods.

(b) Specifications. Phaffia yeast shall

conform to the following specifications

and shall be free from impurities other

than those named to the extent that such

impurities may be avoided by good

manufacturing practice:

Physical state, solid.

Lead, not more than 5 parts per

million.

Arsenic, not more than 2 parts per

million.

Mercury, not more than 1 part per

million.

Heavy metals (as Pb), not more than

10 parts per million.

Astaxanthin, not less than 0.4 percent.

(c) Uses and restrictions. Phaffia yeast

may be safely used in the feed of

salmonid fish in accordance with the

following prescribed conditions:

(1) The color additive is used to

enhance the pink to orange-red color of

the flesh of salmonid fish.

(2) The quantity of astaxanthin in

finished feed, from phaffia yeast when

used alone or in combination with other

astaxanthin color additive sources listed

in this part 73, shall not exceed 80

milligrams per kilogram (72 grams per

ton) of finished feed.

(d) Labeling requirements. (1) The

labeling of the color additive and any

premixes prepared therefrom shall bear

expiration dates for the sealed and open

container (established through generally

accepted stability testing methods),

other information required by § 70.25 of

this chapter, and adequate directions to

prepare a final product complying with

the limitations prescribed in paragraph

(c) of this section.

(2) The presence of the color additive

in finished fish feed prepared according

to paragraph (c) of this section shall be

declared in accordance with § 501.4 of

this chapter.

(3) The presence of the color additive

in salmonid fish that have been fed

feeds containing phaffia yeast shall be

declared in accordance with

§§ 101.22(b), (c), and (k)(2) and

101.100(a)(2) of this chapter.

(e) Exemption from certification.

Certification of this color additive is not

necessary for the protection of the

public health, and therefore batches

thereof are exempt from the certification

requirements of section 721(c) of the act.

Dated: June 27, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–17019 Filed 7–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

Ophthalmic and Topical Dosage Form

New Animal Drugs; Furazolidone

Aerosol Powder

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 Fort

Dodge Animal Health, a Division of

American Cyanamid Co. The

supplemental NADA provides for

removal of that portion of the approval

reflecting topical cattle use of

furazolidone aerosol powder.

DATES: This regulation is effective July

6, 2000.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

6642.

SUPPLEMENTARY INFORMATION: Fort

Dodge Animal Health, a 1Division of

American Cyanamid Co., P.O. Box 1339,

Fort Dodge, IA 50501, is the sponsor of

NADA 32–319 for Furox (furazolidone)

aerosol powder for use in dogs, horses,

ponies, and cattle. The sponsor filed a

supplemental NADA requesting removal

of topical ocular use of the product in

cattle. The supplemental NADA is

approved as of November 29, 1999, and

the regulations are amended in 21 CFR

41588 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations

524.1005(b)(1), (c)(2)(iii), and (c)(3) to

reflect the approval.

The regulations in § 524.1005(b)(1)

(21 CFR 524.1005(b)(1)) indicate that

Pfizer, Inc., is sponsor of NADA 32–319

for use of a 10 percent furazolidone

aerosol powder in dogs, horses, and

cattle. The NADA had been acquired by

Fort Dodge Animal Health, a Division of

American Cyanamid Co. At this time,

the regulation is amended in

§ 524.1005(b) to reflect the sponsor

change.

Approval of this supplemental NADA

provides for removal of a cattle use. It

does not affect the safety or

effectiveness data in the application.

Therefore, a freedom of information

summary is not required.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to

congressional review requirements in 5

U.S.C. 801–808.

List of Subjects in 21 CFR Part 524

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under the

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 524 is amended as follows:

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 524 continues to read as follows:

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

2. Section 524.1005 is amended by

revising paragraphs (b)(1) and (c)(3) and

by removing and reserving paragraph

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

§ 524.1005 Furazolidone aerosol powder.

* * * * *

(b) * * *

(1) See No. 053501 in § 510.600(c) of

this chapter for use as in paragraphs

(c)(1), (c)(2)(i), (c)(2)(ii), and (c)(3) of

this section.

* * * * *

(c) * * *

(2) * * *

(iii) [Reserved]

(3) Limitations. For topical

application in horses, ponies, and dogs:

Clean affected area thoroughly, apply

drug once or twice daily, and repeat

treatment as required. Use only as

recommended by a veterinarian in

treatment of puncture wounds, wounds

requiring surgical debridement or

suturing, those of a chronic nature

involving proud flesh, generalized and

chronic infections of the skin, and those

skin conditions associated with intense

itching. If redness, irritation, or swelling

persists or increases, discontinue use

and consult a veterinarian. Not for use

in horses intended for food.

Dated: June 15, 2000.

Andrew J. Beaulieu,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 00–16977 Filed 7–5–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 556

Tolerances for Residues of New

Animal Drugs in Food; Fenbendazole

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

Hoechst Roussel Vet. The supplemental

NADA provides for establishing

tolerances for residues of fenbendazole

in edible tissues of cattle. Also, a

tolerance for parent fenbendazole in

goat muscle is established.

DATES: This rule is effective July 6,

2000.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–130), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578.

SUPPLEMENTARY INFORMATION: Hoechst

Roussel Vet, Perryville Corporate Park

III, P.O. Box 4010, Clinton, NJ 08809–

4010, filed a supplement to NADA 128–

620 that provides for use of Safe-Guard

(fenbendazole) 10% Suspension for

Cattle and Panacur (fenbendazole)

10% Suspension for Cattle. The

supplement provides for establishing a

tolerance for parent fenbendazole in

cattle muscle. The supplement is

approved as of May 9, 2000, and the

regulations in § 556.275 (21 CFR

556.275) are amended to reflect the

approval. The basis of approval is

discussed in the freedom of information

summary.

In addition, FDA is reviewing

information in the application and it is

establishing a tolerance for parent

fenbendazole in goat muscle. The

regulations are further amended in

§ 556.275 to reflect this action.

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, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

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

Friday.

The agency has determined under 21

CFR 25.33(a)(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.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

List of Subjects in 21 CFR Part 556

Animal drugs, Foods.

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 556 is amended as follows:

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

1. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: 21 U.S.C. 342, 360b, 371.

2. Section 556.275 is amended by

adding paragraphs (b)(1)(ii) and (b)(3)(ii)

to read as follows:

§ 556.275 Fenbendazole.

* * * * *

(b) * * *

(1) * * *

(ii) Muscle. The tolerance for parent

fenbendazole (the marker residue) is 0.4

ppm.

* * * * *

(3) * * *

(ii) Muscle. The tolerance for parent

fenbendazole (the marker residue) is 0.4

ppm.

Dated: June 19, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 00–16976 Filed 7–5–00; 8:45 am]

BILLING CODE 4160–01–F