9650 Federal Register / Vol. 66, No. 28 / Friday, February 9, 2001 / Rules and Regulations

The amount of the $485 fee attributable

to line item 1 is $71.295 (.1470 × $485

= $71.295). The amount of the fee

attributable to line item 2 is $128.3795

(.2647 × $485 = $128.3795). The amount

of the fee attributable to line item 3 is

$285.277 (.5882 × $485 = $285.277).

Amount of merchandise processing

fee eligible for drawback per line item.

The amount of merchandise processing

fee eligible for drawback for line item 1

is $70.5821 ÷ (.99 × $71.295). The

amount of fee eligible for drawback for

line item 2 is $127.0957 (.99 ×

$128.3795). The amount of fee eligible

for drawback for line item 3 is

$282.4242 (.99 × $285.277).

Amount of merchandise processing

fee eligible for drawback per unit of

merchandise. The amount of

merchandise processing fee eligible for

drawback per unit of merchandise is

calculated by dividing the amount of fee

eligible for drawback for the line item

by the number of units in the line item.

For line item 1, the amount of

merchandise processing fee eligible for

drawback per unit is $.0141 ($70.5821 ÷

5,000 = $.0141). If 1,000 widgets form

the basis of a claim for drawback under

19 U.S.C. 1313(j), the total amount of

drawback attributable to the

merchandise processing fee is $14.10

(1,000 × .0141 = $14.10). For line item

2, the amount of fee eligible for

drawback per unit is $.0212 ($127.0957

÷ 6,000 = $.0212). For line item 3, the

amount of fee eligible for drawback per

unit is $.0282 ($282.4242 ÷ 10,000 =

$.0282).

Example 2

This example illustrates the treatment

of dutiable merchandise that is exempt

from the merchandise processing fee

and duty-free merchandise that is

subject to the merchandise processing

fee.

Line item 1—700 meters of printed cloth

valued at $10 per meter (total value

$70,000) that is exempt from the

merchandise processing fee under 19

U.S.C. 58c(b)(8)(ii)(B)(iii)

Line item 2—15,000 articles valued at

$100 each (total value $1,500,000)

Line item 3—10,000 duty-free articles

valued at $50 each (total value

$500,000)

The relative value ratios are

calculated using line items 2 and 3 only,

as there is no merchandise processing

fee imposed by reason of importation on

line item 1.

Line item 2—1,500,000 ÷ 2,000,000 =

.75 (line items 2 and 3 form the total

value of the merchandise subject to

the merchandise processing fee).

Line item 3—500,000 ÷ 2,000,000 = .25

If the total merchandise processing fee

paid was $485, the amount of the fee

attributable to line item 2 is $363.75 (.75

× $485 = $363.75). The amount of the

fee attributable to line item 3 is $121.25

(.25 × $485 = $121.25).

The amount of drawback on the

merchandise processing fee attributable

to each unit of line item 2 is $.0243

($363.75 ÷ 15,000 = $.02430). The

amount of drawback on the

merchandise processing fee attributable

to each unit of line item 3 is $.0121

($121.25 ÷ 10,000 = $.0121).

If 1,000 units of line item 2 were

exported, the drawback attributable to

the merchandise processing fee is

$24.23 ($.02423 × 1,000 = $24.23).

* * * * *

Raymond W. Kelly,

Commissioner of Customs.

Approved: November 9, 2000.

John P. Simpson,

Deputy Assistant Secretary of the Treasury.

[FR Doc. 01–3358 Filed 2–8–01; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Pyrantel Pamoate Chewable Tablets

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 an abbreviated new animal

drug application (ANADA) filed by Blue

Ridge Pharmaceuticals, Inc. The

ANADA provides for use of pyrantel

pamoate chewable tablets for the

removal of certain gastrointestinal

parasites and prevention of reinfection

in puppies and dogs.

DATES: This rule is effective February 9,

2001.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0209.

SUPPLEMENTARY INFORMATION: Blue

Ridge Pharmaceuticals, Inc., 4249–105

Piedmont Pkwy., Greensboro, NC 27410,

filed ANADA 200–281 that provides for

use of WORMEXX (pyrantel pamoate)

Chewable Tablets for the removal of

certain gastrointestinal parasites and

prevention of reinfection in puppies and

dogs. Blue Ridge’s WORMEXX

Chewable Tablets is approved as a

generic copy of Farnam Co.’s D–

WORM (pyrantel pamoate) Dog

Wormer Chewable Tablets, approved

under NADA 139–191. ANADA 200–

281 is approved as of January 3, 2001,

and 21 CFR 520.2041 is amended to

reflect the approval. The basis for

approval is discussed in the freedom of

information summary.

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(d)(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 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.

§ 520.2041 [Amended]

2. Section 520.2041 Pyrantel pamoate

chewable tablets is amended in

paragraph (b) by removing ‘‘No.

017135’’ and adding in its place ‘‘Nos.

017135 and 065274’’.

Dated: January 31, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01–3415 Filed 2–8–01; 8:45 am]

BILLING CODE 4160–01–F