2914 Federal Register / Vol. 61, No. 20 / Tuesday, January 30, 1996 / Rules and Regulations

alteration or processing (subheading

9813.00.05, Harmonized Tariff Schedule

of the United States) and is

subsequently exported to Canada or

Mexico, duty shall be assessed on the

good on the basis of its condition at the

time of its importation into the United

States. Such duty shall be paid no later

than 60 calendar days after either the

date of exportation or the date of entry

into a duty-deferral program of Canada

or Mexico, except that, upon filing of a

proper claim under paragraph (a)(3) of

this section, the duty shall be waived or

reduced in an amount that does not

exceed the lesser of the total amount of

duty payable on the good under this

section or the total amount of customs

duties paid to Canada or Mexico.

Example. Company A imports glassware

under subheading 9813.00.05, HTSUS. The

glassware is from France and would be

dutiable under a regular consumption entry

at $6,000. Company A alters the glassware by

etching hotel logos on the glassware. Two

weeks later, Company A sells the glassware

to Company B, a Mexican company, and

ships the glassware to Mexico. Company B

enters the glassware and is assessed duties in

an amount equivalent to US$6,200 and

claims NAFTA preferential tariff treatment.

Company B provides a copy of the Mexican

landing certificate to Company A showing

that the US$6,200 equivalent in duties was

assessed but not yet paid to Mexico. If

Mexico ultimately denies Company B’s

NAFTA claim and the Mexican duty

payment becomes final, Company A, upon

submission to Customs of a proper claim

under paragraph (a)(3) of this section, is

entitled to a waiver of the full $6,000 in U.S.

duty.

(c) Recordkeeping requirements. If a

person intends to claim a waiver or

reduction of duty on goods under this

section, that person shall maintain

records concerning the value of all

involved goods or materials at the time

of their importation into the United

States and concerning the value of the

goods at the time of their exportation to

Canada or Mexico or entry into a dutydeferral program of Canada or Mexico,

and if a person files a claim under this

section for a waiver or reduction of duty

on goods exported to Canada or Mexico

or entered into a Canadian or Mexican

duty-deferral program, that person shall

maintain evidence of exportation or

entry into a Canadian or Mexican dutydeferral program and satisfactory

evidence of the amount of any customs

duties paid to Canada or Mexico on the

good (see § 181.47(c)). Failure to

maintain adequate records will result in

denial of the claim for waiver or

reduction of duty.

(d) Failure to file proper claim. If the

person identified in paragraph

(a)(2)(iii)(A) of this section fails to file

a proper claim within the 60-day period

specified in this section, that person, or

the FTZ operator pursuant to paragraph

(a)(2)(iii)(A)(3) of this section, will be

liable for payment of the full duties

assessed under this section and without

any waiver or reduction thereof.

(e) Subsequent claims for preferential

tariff treatment. If a claim for a refund

of duties is allowed by the Canadian or

Mexican customs administration under

Article 502(3) of the NAFTA or under

any other circumstance after duties have

been waived or reduced under this

section, Customs may reliquidate the

entry filed under this section pursuant

to 19 U.S.C. 1508(b)(2)(B)(iii) even after

liquidation of the entry has become

final.

George J. Weise,

Commissioner of Customs.

Approved: January 24, 1996.

John P. Simpson,

Deputy Assistant Secretary of the Treasury.

[FR Doc. 96–1677 Filed 1–29–96; 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;

Oxytetracycline Hydrochloride Soluble

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 an abbreviated new animal

drug application (ANADA) filed by

Phoenix Scientific, Inc. The ANADA

provides for the use of a generic

oxytetracycline hydrochloride soluble

powder administered orally in drinking

water for either control or control and

treatment of certain diseases of

chickens, turkeys, swine, cattle, and

sheep.

EFFECTIVE DATE: January 30, 1996.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Phoenix

Scientific, Inc., 3915 South 48th St. Ter.,

P.O. Box 6457, St. Joseph, MO 64506–

0457, filed ANADA 200–146 which

provides for use of oxytetracycline

hydrochloride soluble powder in the

drinking water of chickens, turkeys,

swine, cattle, and sheep. The medicated

drinking water is used as follows: (1)

Chickens for control of infectious

synovitis caused by Mycoplasma

synoviae, chronic respiratory disease

and air sac infections caused by

Mycoplasma gallisepticum and

Escherichia coli, and fowl cholera

caused by Pasteurella multocida; (2)

turkeys for control of hexamitiasis

caused by Hexamita meleagridis,

infectious synovitis caused by M.

synoviae, and complicating bacterial

organisms associated with blue comb

(transmissible enteritis; coronaviral

enteritis); (3) swine for control and

treatment of bacterial enteritis caused by

E. coli and Salmonella choleraesuis and

bacterial pneumonia caused by P.

multocida; (4) breeding swine for

control and treatment of leptospirosis

(reducing the incidence of abortions and

shedding of leptospira) caused by

Leptospira pomona; (5) calves, beef

cattle, and nonlactating dairy cattle for

control and treatment of bacterial

enteritis caused by E. coli and bacterial

pneumonia (shipping fever complex)

caused by P. multocida; and (6) sheep

for control and treatment of bacterial

enteritis caused by E. coli and bacterial

pneumonia (shipping fever complex)

caused by P. multocida.

ANADA 200–146 for Phoenix

Scientific’s oxytetracycline

hydrochloride soluble powder is

approved as a generic copy of Pfizer’s

Terramycin Soluble Powder which is

covered by NADA 8–622. The ANADA

is approved as of December 7, 1995, and

the regulations in 21 CFR 520.1660d are

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 part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 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, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857,

between 9 a.m. and 4 p.m., Monday

through Friday.

The agency has determined under 21

CFR 25.24(d)(1)(i) 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.

List of Subjects in 21 CFR Part 520

Animal drugs.
Federal Register / Vol. 61, No. 20 / Tuesday, January 30, 1996 / Rules and Regulations 2915

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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 520.1660d is amended by

adding new paragraphs (a)(7) and (b)(5)

to read as follows:

§ 520.1660d Oxytetracycline hydrochloride

soluble powder.

(a) * * *

(7) Each 18.14 grams of powder

contains 1 gram of OTC HCl (pail: 2 lb).

(b) * * *

(5) No. 059130 for use of OTC HCl

concentration in paragraph (a)(7) of this

section in chickens, turkeys, swine,

cattle, and sheep.

* * * * *

Dated: January 3, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–1741 Filed 1–29–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF STATE

22 CFR Part 31

[Public Notice 2298]

Repeal of Certain Tort and Property

Damage Claims Regulations

AGENCY: Office of the Legal Adviser,

Department of State.

ACTION: Direct final rule.

SUMMARY: The Department of State will

repeal 22 CFR part 31, which contains

regulations implementing the Federal

Tort Claims Act (FTCA) with respect to

the Department (subparts A and B), the

State Department’s independent

authority to pay tort claims arising in

foreign countries (subpart C), and

certain claims against the International

Boundary and Water Commission,

United States and Mexico (IBWC)

(subpart D).

DATES: This rule is effective May 13,

1996, unless significant adverse

comments are received on or before

March 8, 1996.

If significant adverse comments are

received, the State Department will

publish a document in the Federal

Register before May 13, 1996

withdrawing this rule.

ADDRESSES: Interested persons are

invited to submit comments to the

Office of International Claims and

Investment Disputes, Office of the Legal

Adviser, Suite 203, South Building,

2430 E Street NW., Washington, DC

20037–2800.

FOR FURTHER INFORMATION CONTACT:

Stephen D. McCreary, Attorney-Adviser,

Office of International Claims and

Investment Disputes, Office of the Legal

Adviser, Suite 203, South Building,

2430 E Street NW., Washington, DC

20037–2800; telephone (202) 776–8440.

SUPPLEMENTARY INFORMATION: The State

Department regulations implementing

the Federal Tort Claims Act are a

combination of substantive provisions

largely drawn from the Department of

Justice FTCA regulations in 28 CFR part

14, which apply to tort claims against

all government agencies, and procedural

provisions drawn from the State

Department’s internal Foreign Affairs

Manual. The State Department FTCA

regulations in subparts A and B of part

31 add little additional information, and

are thus duplicative and unnecessary.

Section 2672 of the FTCA (28 U.S.C.

2672) provides that claims are to be

considered in accordance with

regulations issued by the Attorney

General. Section 14.11 of the Justice

Department regulations authorize

agencies to issue supplementary FTCA

regulations, but do not require that they

do so. The State Department has

concluded that it need not maintain

supplementary FTCA regulations.

Claims against the Department of

State should continue to be submitted

directly to the office, bureau, division,

or Foreign Service establishment out of

whose activities the claim arises, if

known; or if not known, to the Assistant

Legal Adviser for International Claims

and Investment Disputes, L/CID,

Department of State, Washington, DC

20520.

Subpart C of part 31 concerns the

Department’s independent authority to

pay tort claims arising overseas, and has

no counterpart in the Justice

Department’s FTCA regulations.

However, subpart C is a single

paragraph which provides little

information beyond that already

available in the statute (22 U.S.C.

2669(f)). Thus, the Department has

concluded that subpart C may be

deleted.

The regulations in subpart D of part

31 regarding claims against the

International Boundary and Water

Commission, United States and Mexico,

have not been used in many years, and

in any case essential repeat the

provisions of the underlying statute.

Repeal of these regulations has been

coordinated with the Legal Adviser’s

Office of the IBWC, United States

Section. The State Department and the

IBWC, United States Section, have

concluded that it is appropriate to

delete subpart D.

Implemention of this rule as a direct

final rule, with provision for

postpromulgation comments, is based

on the ‘‘good cause’’ exception to the

Administrative Procedures Act found at

5 U.S.C. 553(b)(B). Repeal of these

regulations is expected to be

noncontroversial, and therefore unlikely

to engender public comment. Thus,

provision for prepromulgation notice

and comment is considered

unnecessary. Written comments are

invited from the public on or before

March 8, 1996. Unless the State

Department receives on or before that

date significant comments adverse to

repeal of these regulations, and

publishes a notice in the Federal

Register before May 13, 1996,

withdrawing this rule, this rule becomes

effective on May 13, 1996.

Repeal of these regulations by this

rule is not expected to have a significant

impact on a substantial number of small

entities under the criteria of the

Regulatory Flexibility Act. This rule

does not impose a Federal regulatory

mandate on state, local, or tribal

government entities under the

Unfunded Mandates Act (P.L. 104–4)

because it repeals regulations which

themselves created no such mandate.

This rule has been reviewed as required

by Executive Order 12778 and is in

compliance therewith. This rule is

exempt from review under Executive

Order 12866, but has been reviewed to

ensure consistency with its overall

policies and purposes. This rule does

not contain a new or amended

information requirement subject to the

Paperwork Reduction Act of 1980.

List of Subjects in 22 CFR Part 31

Claims.

PART 31—[REMOVED]

Accordingly, under the authority of

22 U.S.C. 2651a(4), 22 CFR part 31 is

removed.

Dated: December 8, 1995.

Jamison Selby Borek,

Deputy Legal Adviser.

[FR Doc. 96–1531 Filed 1–29–96; 8:45 am]

BILLING CODE 4710–08–M