76930 Federal Register / Vol. 65, No. 237 / Friday, December 8, 2000 / Rules and Regulations

(ii) A responsible person from your

firm must sign and date the notification

letter.

(iii) You must submit the notification

letter to the Center for Veterinary

Medicine, Division of Animal Feeds

(HFV–220), 7500 Standish Pl.,

Rockville, MD 20855, prior to beginning

your first distribution.

(iv) You must notify the Center for

Veterinary Medicine at the above

address within 30 days of any change in

name or business address.

(2) If you are a distributor who ships

an animal feed containing a VFD drug

to another consignee-distributor in the

absence of a valid VFD, you must obtain

an ‘‘acknowledgment letter,’’ as defined

in § 558.3(b)(11), from the consigneedistributor. The letter must include a

statement affirming that the consigneedistributor has complied with

‘‘distributor notification’’ requirements

of paragraph (d)(1) of this section.

(e) What are the additional

recordkeeping requirements if I am a

distributor?

(1) You must keep records of receipt

and distribution of all medicated animal

feed containing a VFD drug.

(2) You must keep these records for 2

years from date of receipt and

distribution.

(3) You must make records available

for inspection and copying by FDA.

(f) What cautionary statements are

required for VFD drugs and animal

feeds containing VFD drugs? All

labeling and advertising must

prominently and conspicuously display

the following cautionary statement:

‘‘Caution: Federal law limits this drug to

use under the professional supervision

of a licensed veterinarian. Animal feed

bearing or containing this veterinary

feed directive drug shall be fed to

animals only by or upon a lawful

veterinary feed directive issued by a

licensed veterinarian in the course of

the veterinarian’s professional practice.’’

§ 558.618 [Amended]

8. Section 558.618 Tilmicosin is

amended by removing paragraph (d)(4).

Dated: November 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–31151 Filed 12–7–00; 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; Moxidectin

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is updating the

animal drug regulations to correctly

reflect the tolerance for moxidectin in

cow’s milk. This document amends the

regulations to state the correct tolerance

is 40 parts per billion (ppb). This action

is being taken to improve the accuracy

of the agency’s regulations. Changes to

a current format are also being made.

DATES: This rule is effective December 8,

2000.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for

Veterinary Medicine (HFV–135), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

7578.

SUPPLEMENTARY INFORMATION:

Moxidectin solution is approved for

topical use in cattle for the treatment

and control of infections and

infestations of certain internal and

external parasites. When the November

2, 1999, approval of the use of

moxidectin in lactating dairy cows was

published in the Federal Register of

June 9, 2000 (65 FR 36616), the

tolerance for parent moxidectin in the

milk of cattle was incorrectly listed. At

this time, the regulations are being

amended in 21 CFR 556.426 to state the

correct tolerance is 40 ppb and,

editorially, to reflect current format.

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 556.426 is amended by

revising paragraph (b) to read as follows:

§ 556.426 Moxidectin.

* * * * *

(b) Tolerances—(1) Cattle—(i) Liver

(the target tissue). The tolerance for

parent moxidectin (the marker residue)

is 200 parts per billion (ppb).

(ii) Muscle. The tolerance for parent

moxidectin (the marker residue) is 50

ppb.

(iii) Milk. The tolerance for parent

moxidectin (the marker residue in cattle

milk) is 40 ppb.

(2) [Reserved]

Dated: November 29, 2000.

David R. Newkirk,

Acting Deputy Director, Office of New Animal

Drug Evaluation, Center for Veterinary

Medicine.

[FR Doc. 00–31248 Filed 12–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 876

[Docket No. 00P–1343]

Medical Device; Exemption From

Premarket Notification; Class II

Devices; Barium Enema Retention

Catheters and Tips With or Without a

Bag

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is publishing an

order granting a petition requesting

exemption from the premarket

notification requirements for barium

enema retention catheters and tips with

or without a bag with certain

limitations. This rule will exempt from

premarket notification barium enema

retention catheters and tips with or

without a bag. FDA is publishing this

order in accordance with procedures

established by the Food and Drug

Administration Modernization Act of

1997 (FDAMA).

DATES: This rule is effective December 8,

2000.