41584 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations

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.

XI. 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. Renstrom, B., G. Borch, O. M.

Skulberg, and S. Liaaen-Jensen, ‘‘Optical

Purity of (3S,3′S)-Astaxanthin from

Haematococcus pluvialis,’’

Phytochemistry, 20:2561–2564, 1981.

2. Sommer, T. R., W. T. Potts, and N.

M. Morrissy, ‘‘Utilization of Microalgal

Astaxanthin by Rainbow Trout

(Oncorhynchus mykiss),’’ Aquaculture,

94:79–88, 1991.

3. Kitahara, T., ‘‘Carotenoids in the

Pacific Salmon During the Marine

Period,’’ Comprehensive Biochemistry

and Physiology, 78B:859–862, 1984.

4. Mori, T., K. Makabe, K. Yamaguchi,

S. Konosu, and S. Arai, ‘‘Comparison

Between Krill Astaxanthin Diester and

Synthesized Free Astaxanthin

Supplemented to Diets in Their

Absorption and Deposition by Juvenile

Coho Salmon (Oncorhynchus kisutch),’’

Comprehensive Biochemistry and

Physiology, 93B:255–258, 1989.

5. Johnson, C. B., Memorandum

entitled ‘‘Haematococcus pluvialis

Algae Meal for Use in Feed for

Salmonids: 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. Section 73.185 is added to subpart

A to read as follows:

§ 73.185 Haematococcus algae meal.

(a) Identity. (1) The color additive

haematococcus algae meal consists of

the comminuted and dried cells of the

alga Haematococcus pluvialis.

(2) Haematococcus algae meal 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 haematococcus

algae meal 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. Haematococcus

algae meal 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 1.5 percent.

(c) Uses and restrictions.

Haematococcus algae meal 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 haematococcus algae

meal 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 haematococcus algae

meal 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. 00–17018 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 73

[Docket No. 97C–0466]

Listing of Color Additives Exempt

From Certification; Phaffia Yeast

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

color additive regulations to provide for

the safe use of phaffia yeast as a color

additive in the feed of salmonid fish to

enhance the color of their flesh. This

action is in response to a petition filed

by Archer Daniels Midland Co.

DATES: This rule is effective August 8,

2000; except as to any provisions that

may be stayed by the filing of proper

objections. Submit written objections

and requests for a hearing by August 7,

2000.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Aydin O ̈rstan, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3076.

SUPPLEMENTARY INFORMATION:

I. Introduction

In a notice published in the Federal

Register of November 19, 1997 (62 FR

61823), FDA announced that a color

additive petition (CAP 8C0252) had

been filed by Archer Daniels Midland

Co., P.O. Box 1470, Decatur, IL 62525.

The petition proposed to amend the

color additive regulations to provide for

the safe use of astaxanthin from Phaffia

Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations 41585

rhodozyma as a color additive in

salmonid fish feeds. During its review of

the petition, the agency determined that

the subject color additive is more

accurately described as a dried

preparation of the yeast P. rhodozyma

that contains astaxanthin. Therefore, the

agency is establishing phaffia yeast as

the common or usual name of the color

additive.

II. Identity, Technical Effect, and

Specifications

Phaffia yeast consists of the cells of

the yeast P. rhodozyma that are

produced by pure culture fermentation

and subsequently killed by heat and

dried. P. rhodozyma is the asexual form

of the yeast species Xanthophyllomyces

dendrorhous (Ref. 1). The major

components of phaffia yeast are

proteins, carbohydrates, and lipids

produced by the yeast cells. The

primary coloring substance in phaffia

yeast is astaxanthin (3,3′-dihydroxy-β,βcarotene-4,4′-dione) (Ref. 2). One

published (Ref. 3) and several

unpublished studies included in the

petition showed that phaffia yeast

satisfactorily pigmented the flesh of the

fish when it was fed to salmonid fish.

In a final rule published in the

Federal Register of April 13, 1995 (60

FR 18736), the agency listed astaxanthin

in § 73.35 (21 CFR 73.35) for use in the

feed of salmonid fish. In the preamble

to that rule, the agency stated that the

new regulation for astaxanthin did not

specify the source of astaxanthin or the

manufacturing process, because the

agency had made its safety

determination for astaxanthin based on

the chemical similarity of synthetic

astaxanthin to astaxanthin from natural

sources. The agency concluded that any

source could be used to produce the

color additive as long as the astaxanthin

meets the identity, specifications, and

stability requirements defined in

§ 73.35, and it is manufactured in

accordance with good manufacturing

practice. Furthermore, the agency stated

in the astaxanthin rule that the

specifications were listed to convey the

fact that FDA had evaluated only a

particular form of the color additive.

The agency also stated that it was

concerned that deleterious materials not

found in the habitat of salmonids may

be included in fish feed from biomass

products that contain only a small

amount of astaxanthin with the rest of

the material being residues from the

producing organisms. Thus, the agency

said that interested parties should

submit information in the form of a new

color additive petition if they wish to

market a biomass product containing

astaxanthin.

Phaffia yeast is a biomass product that

contains a relatively small amount of

astaxanthin with the rest of the material

being proteins, carbohydrates, and

lipids. In addition, the petitioner

indicated that phaffia yeast would not

meet the specifications in § 73.35(b) for

solubility in chloroform, absorption

maximum wavelength, and residue on

ignition, because some of the yeast

components in phaffia yeast would

interfere with the test methods.

Furthermore, the petitioner specified

the astaxanthin content of phaffia yeast

to be not less than 0.4 percent, whereas

the corresponding specification for

astaxanthin in § 73.35(b) is not less than

96 percent. Therefore, the petitioner

requested that a new regulation be

established for phaffia yeast as a source

of astaxanthin. The agency agrees with

the petitioner that a new regulation is

necessary to list phaffia yeast.

During the fish feeding studies,

phaffia yeast was mixed with fish feed

in such quantities that the amount of

astaxanthin in finished feeds did not

exceed 80 milligrams per kilogram. The

agency based its safety determination on

this amount of astaxanthin and the

petitioner requested that this level be

specified in the listing regulation.

However, the agency notes that

astaxanthin in the feed of farm-raised

salmonid fish may come not only from

phaffia yeast, but also from the use of

the color additive astaxanthin meeting

the specifications of § 73.35 and other

color additives that are sources of

astaxanthin the agency may list in the

future. Therefore, newly added

§ 73.355(c)(2) (21 CFR 73.355(c)(2))

requires that the quantity of astaxanthin

in finished feed, from phaffia yeast

when used alone or in combination with

other astaxanthin color additive sources

listed in part 73 (21 CFR part 73), shall

not exceed 80 milligrams per kilogram

(72 grams per ton) of finished feed.

III. Safety Evaluation

In evaluating the safety of the use of

phaffia yeast in fish feed, the agency

considered: (1) The safety of astaxanthin

in phaffia yeast to humans and fish, and

(2) the safety of the other components in

phaffia yeast to humans and fish.

A. Safety of Astaxanthin

Astaxanthin is the principal pigment

that imparts the pink or red coloring

characteristic of the flesh of wild

salmonids (Ref. 3). These fish obtain

astaxanthin from the crustaceans that

constitute a significant portion of their

diet. A similar flesh color may be

obtained in aquacultured salmonids by

feeding them a diet supplemented with

astaxanthin. In the final rule of April 13,

1995, the agency concluded that

astaxanthin was safe for use in the feed

of salmonid fish. This conclusion was

based on the following facts: (1) The

petitioned use of astaxanthin would

result in deposition of a very small

amount of astaxanthin in salmonid

flesh; (2) astaxanthin that was the

subject of the final rule of April 13,

1995, differed from astaxanthin present

in the flesh of wild salmon only in its

optical isomeric distribution; (3) human

exposure to astaxanthin from

consumption of aquacultured salmon

fed synthetic astaxanthin is comparable

to the exposure to astaxanthin from wild

salmon. In addition, the results of the

toxicity studies submitted by the

petitioner supported the conclusion that

there was reasonable certainty of no

harm from the petitioned use of

astaxanthin.

In the final rule of April 13, 1995, the

facts upon which the agency concluded

that astaxanthin was safe for use in the

feed of salmonid fish are similar to the

facts upon which the agency is basing

its conclusion that astaxanthin from the

petitioned use of phaffia yeast is safe for

use in the feed of salmonid fish. During

the review of the present petition, the

agency determined that astaxanthin

from phaffia yeast differed from

astaxanthin present in the flesh of wild

salmon only in its optical isomeric

distribution and that the petitioned use

of astaxanthin would result in

deposition of a very small amount of

astaxanthin in salmonid flesh.

Furthermore, the agency determined

that the astaxanthin from phaffia yeast

will substitute for the fish feed uses of

astaxanthin listed in § 73.35, and that

the petitioned use of phaffia yeast will

not increase the estimated daily intake

of astaxanthin in humans, which is

comparable to the exposure to

astaxanthin from wild salmon.

Therefore, the agency concludes that

astaxanthin from the petitioned use of

phaffia yeast is safe for use in the feed

of salmonid fish.

B. Safety of the Producing Organism

The yeast P. rhodozyma naturally

produces astaxanthin (Refs. 2 and 3).

The parent strain of P. rhodozyma used

by the petitioner was originally obtained

from a natural source. From this parent

strain a new strain that produces more

astaxanthin was derived using classical

mutagenesis (nonrecombinant

deoxyribonucleic acid (DNA))

techniques.

Based on the data in the petition and

other relevant material, the agency

determined that: (1) consumers will not

be directly exposed to phaffia yeast, but

to astaxanthin remaining in fish that

41586 Federal Register / Vol. 65, No. 130 / Thursday, July 6, 2000 / Rules and Regulations

have consumed the yeast in their diet;

(2) there is no evidence that any

constituents other than astaxanthin will

accumulate in fish maintained on diets

supplemented with phaffia yeast; (3) the

results of studies during which rats and

fish were fed phaffia yeast and bacterial

mutagenicity tests did not reveal any

adverse effects on these organisms,

indicating the absence of toxic

impurities in the yeast; (4) a literature

search uncovered no reports of

pathogenicity or toxicogenicity of P.

rhodozyma; and (5) various yeasts are

commonly used as feed in fish

aquaculture with no deleterious effects

on fish health. Based on this

information, FDA concludes that the

petitioned use of P. rhodozyma is safe

(Ref. 4).

IV. Stability of Astaxanthin in Phaffia

Yeast

Based on the results of stability

studies of phaffia yeast submitted by the

petitioner, FDA concludes that to

minimize chemical changes that would

result in loss of color of astaxanthin,

phaffia yeast must be added to fish feed

only in the form of a stabilized color

additive mixture. Therefore, newly

added § 73.355(a)(2) requires that

phaffia yeast be added to fish feed only

as a component of a stabilized color

additive mixture.

V. Labeling Requirements

All color additives, in accordance

with § 70.25 (21 CFR 70.25), require

sufficient information to assure their

safe use and to allow a determination of

compliance with any limitations

imposed by the agency in other

applicable regulations. Therefore, the

labeling of the color additive, phaffia

yeast, and any mixture prepared

therefrom, is subject to the requirements

of § 70.25.

According to § 70.25(a)(4), an

expiration date for a color additive must

be stated on its label if stability data

require it. FDA finds that because of the

instability of astaxanthin in phaffia

yeast, an expiration date must be stated

on the label of sealed and open

containers, in accordance with

§ 70.25(a)(4). FDA also finds that

declaration of the expiration date

constitutes a material fact that must be

disclosed on the label of the color

additive mixture under sections 201(n)

and 403(a)(1) of the Federal Food, Drug,

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

321(n) and 343(a)(1)) because failure to

do so would constitute a failure to

reveal facts material in light of the

representations made on the label and

material with respect to consequences

which may result from the use of the

color additive. The use of phaffia yeast

requires the declaration of expiration

dates because astaxanthin in phaffia

yeast can decompose to products that

would not be coloring agents and thus

would not affect the color of salmonid

flesh.

In addition to the requirements for

labeling the color additive or color

additive mixture, the ingredient list on

fish feed, to which phaffia yeast is

added, must identify the presence of the

color additive under 21 CFR 501.4. New

§ 73.355(d)(2) references § 501.4 to

ensure that the presence of phaffia yeast

as a color additive in the fish feed will

be declared on the ingredient label.

Finally, the presence of the color

additive must be declared on the label

of any food, including salmonid fish,

containing added phaffia yeast and food

containing such salmonid fish as an

ingredient. Section 101.22(b) (21 CFR

101.22(b)) requires a food that bears or

contains artificial coloring, such as

salmon artificially colored with phaffia

yeast, to bear labeling even though such

food is not in package form. Section

101.22 requires that label statements of

artificial coloring be ‘‘likely to be read

by the ordinary person under customary

conditions of purchase and use of such

food.’’

Furthermore, § 101.22(k)(2) requires,

in the statement of ingredients for a food

to which any coloring has been added,

and for which the coloring is not subject

to certification, a declaration that makes

it clear that a color additive has been

used in the food. In addition, the

presence of a color additive must be

declared on any bulk container of food

containing a color additive that is held

at a retail establishment under the

provisions in § 101.100(a)(2) (21 CFR

101.100(a)(2)). The ingredient label

would prevent economic fraud in

salmonid fish containing added phaffia

yeast because the ingredient label would

notify the consumer that the fish is

artificially colored. Without such

ingredient labeling, food comprising

salmonid fish with added phaffia yeast

would be deemed to be misbranded

under section 403(k) of the act, which

states that: A food shall be deemed to

be misbranded ‘‘If it bears or contains

any artificial flavoring, artificial

coloring, or chemical preservative,

unless it bears labeling stating that fact

* * *.’’

Therefore, in accordance with

§§ 101.22(b), (c), and (k)(2), and

101.100(a)(2), labeling on any salmonid

fish containing phaffia yeast is required

to declare the presence of the color

additive or color additive mixture. New

§ 73.355(d)(3) references §§ 101.22(b),

(c), and (k)(2), and 101.100(a)(2) to

ensure that, at the retail level, the

presence of phaffia yeast as a color

additive in the fish will be declared, and

that the labeling of the bulk fish

container, including a list of

ingredients, will be displayed on the

container or on a counter card with

similar information. In the future, the

agency also intends to propose to amend

§ 73.35(d)(3) to include references to

§ 101.22(b) and (c).

VI. Conclusion

Based on the data in the petition and

other relevant material, FDA concludes

that the petitioned use of phaffia yeast

as a color additive in fish feed to color

the flesh of salmonid fish is safe, the

additive will achieve its intended

technical effect, and therefore, part 73

should be amended as set forth below.

In addition, based upon the factors

listed in 21 CFR 71.20(b), the agency

concludes that certification of phaffia

yeast is not necessary for the protection

of the public health.

VII. Inspection of Documents

In accordance with § 71.15 (21 CFR

71.15), 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 § 71.15, the agency will

delete from the documents any

materials that are not available for

public disclosure before making the

documents available for inspection.

VIII. Environmental Impact

The agency has previously considered

the environmental effects of this rule as

announced in the notice of filing for

CAP 8C0252 (November 19, 1997, 62 FR

61823). No new information or

comments have been received that

would affect the agency’s previous

determination that there is no

significant impact on the human

environment and that an environmental

impact statement is not required.

IX. 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.

X. Objections

Any person who will be adversely

affected by this regulation may at any

time file with the Dockets Management

Branch (address above) written

objections by August 7, 2000. Each

objection shall be separately numbered,

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