21282 Federal Register / Vol. 66, No. 83 / Monday, April 30, 2001 / Rules and Regulations

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 25.24(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 Subject 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.

§ 520.1660d [Amended]

2. Section 520.1660d Oxytetracycline

hydrochloride soluble powder is

amended in the sixth sentence in

paragraphs (d)(1)(ii)(A)(3),

(d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3) by

removing ‘‘046573’’; in the last sentence

in paragraphs (d)(1)(ii)(A)(3),

(d)(1)(ii)(B)(3), and (d)(1)(ii)(C)(3) by

removing ‘‘No. 053389’’ and by adding

in its place ‘‘Nos. 046573 and 053389’’;

and in the fourth sentence in paragraph

(d)(1)(iii)(C) by removing ‘‘Nos. 046573

and 057561’’ and by adding in its place

‘‘No. 057561 and zero days those

products sponsored by No. 046573.’’

Dated: April 16, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01–10621 Filed 4–27–01; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 520, 522, and 556

Animal Drugs, Feeds, and Related

Products; Sarafloxacin for Poultry;

Withdrawal of Approval of NADAs

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations by removing the

portions reflecting approval of two new

animal drug applications (NADAs) for

which the sponsor has requested

withdrawal of approval. The NADAs

provide for use of sarafloxacin to treat

poultry. In a notice published elsewhere

in this issue of the Federal Register,

FDA is withdrawing approval of two

NADAs sponsored by Abbott

Laboratories.

DATES: This rule is effective April 30,

2001.

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–

0159.

SUPPLEMENTARY INFORMATION: In a notice

published elsewhere in this issue of the

Federal Register, FDA is withdrawing

approval of two NADAs held by Abbott

Laboratories, North Chicago, IL 60064.

The NADAs provide for use of

sarafloxacin to treat poultry. NADA

141–017 provides for the use of

SaraFlox (sarafloxacin hydrochloride)

WSP and is under § 520.2095 (21 CFR

520.2095) and NADA 141–018 provides

for the use of SaraFlox (sarafloxacin

hydrochloride) Injection and is under

§ 522.2095 (21 CFR 522.2095). Relevant

information concerning tolerances for

residues of sarafloxacin in edible tissues

of poultry is under § 556.594 (21 CFR

556.594).

Abbott Laboratories requested

withdrawal of approval in response to

safety questions raised by FDA

regarding the products.

No other NADAs for use of

sarafloxacin have been approved.

Therefore, in accordance with the notice

of withdrawal of approvals, FDA is

amending the regulations to remove

§§ 520.2095, 522.2095, and 556.594

effective April 30, 2001.

The agency has determined under 21

CFR 25.33(g) 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

21 CFR Parts 520 and 522

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Food and

Drug Administration and redelegated to

the Center for Veterinary Medicine, 21

CFR parts 520, 522, and 556 are

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.

§ 520.2095 [Removed]

2. Section 520.2095 Sarafloxacin

soluble powder is removed.

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

3. The authority citation for 21 CFR

part 522 continues to read as follows:

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

§ 522.2095 [Removed]

4. Section 522.2095 Sarafloxacin

solution for injection is removed.

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

5. The authority citation for 21 CFR

part 556 continues to read as follows:

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

§ 556.594 [Removed]

6. Section 556.594 Sarafloxacin is

removed.

Dated: April 17, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01–10069 Filed 4–27–01; 8:45 am]

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