38750 Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 /Rules and Regulations

(2) Beef cattle and nonlactating dairy

cattle—(i) Amount. 1.1 to 2.2 milligrams

per kilogram of body weight (0.5 to 1

milligram per pound, 1 to 2 milliliters

per 100 pounds), once a day as a single

dose or divided into 2 doses

administered at 12-hour intervals for up

to 3 days.

(ii) Indications for use. For control of

pyrexia associated with bovine

respiratory disease and endotoxemia.

Also indicated for control of

inflammation in endotoxemia.

(iii) Limitations. Do not slaughter for

food use within 4 days of last treatment.

Not for use in lactating or dry dairy

cows. A withdrawal period has not been

established for use in preruminating

calves. Do not use in calves to be

processed for veal. Do not use in bulls

intended for breeding as reproductive

effects in this class of cattle have not

been studied. Federal law restricts this

drug to use by or on the order of a

licensed veterinarian.

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

3. The authority citation for 21 CFR

part 556 continues to read as follows:

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

4. Section 556.286 is added to subpart

B to read as follows:

§ 556.286 Flunixin meglumine.

(a) Acceptable daily intake (ADI). The

ADI for total residues of flunixin is 0.72

micrograms per kilogram of body weight

per day.

(b) Tolerances. For residues of parent

flunixin free acid of 0.125 part per

million (ppm) in cattle liver (target

tissue) and 0.025 ppm in cattle muscle

are established.

Dated: July 9, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–19176 Filed 7–17–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Bacitracin Methylene

Disalicylate and Zoalene

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 new animal drug

application (NADA) filed by Alpharma

Inc. The NADA provides for using

approved bacitracin methylene

disalicylate and zoalene Type A

medicated articles to make Type C

medicated turkey feeds.

EFFECTIVE DATE: July 20, 1998.

FOR FURTHER INFORMATION CONTACT:

Charles J. Andres, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1600.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, is sponsor of NADA

141–085 which provides for combining

approved BMD (10, 25, 30, 40, 50, 60,

or 75 gram per pound (g/lb) bacitracin

methylene disalicylate), and Zoamix

(113.5 g/lb zoalene) Type A medicated

articles to make Type C medicated feeds

for growing turkeys containing 4 to 50

g per ton (g/t) bacitracin methylene

disalicylate and 113.5 to 170.3 g/t

zoalene. The Type C medicated turkey

feed is used for prevention and control

of coccidiosis, and for increased rate of

weight gain and improved feed

efficiency. The NADA is approved as of

June 3, 1998, and the regulations are

amended in 21 CFR 558.76(d)(3) by

adding paragraph (d)(3)(xv), and in 21

CFR 558.680(c), in the table, in item (iii)

by adding an entry 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.

FDA has determined under 21 CFR

25.33(a)(2) 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 558

Animal drugs, Animal feeds.

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

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

2. Section 558.76 is amended by

adding paragraph (d)(3)(xv) to read as

follows:

§ 558.76 Bacitracin methylene disalicylate.

* * * * *

(d) * * *

(3) * * *

(xv) Zoalene alone or in combination

as in § 558.680.

3. Section 558.680 is amended in the

table in paragraph (c)(1) in item (iii) by

alphabetically adding an entry for

‘‘Bacitracin methylene disalicylate 4–

50’’ to read as follows:

§ 558.680 Zoalene.

* * * * *

(c) * * *

(1) * * *

Zoalene in grams/ton Combination in grams/ton Indications for use Limitations

* * * * * * *

(iii) 113.5–170.3 (0.0125–

0.01875%)
Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 /Rules and Regulations 38751

Zoalene in grams/ton Combination in grams/ton Indications for use Limitations

Bacitracin methylene disalicylate

4–50.

Turkeys; prevention and control of

coccidiosis, and increased rate

of weight gain and improved

feed efficiency.

For turkeys grown for meat purposes only, not to be fed to laying birds, feed continuously as

sole ration until 14 to 16 weeks

of age.

* * * * * * *

* * * * *

Dated: July 9, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–19177 Filed 7–17–98; 8:45 am]

BILLING CODE 4160–01–F

INTERNATIONAL DEVELOPMENT

COOPERATION AGENCY

Agency for International Development

22 CFR Part 228

RIN 0412–AA37

Rules on Source, Origin and

Nationality for Commodities and

Services Financed by USAID:

Miscellaneous Amendments

AGENCY: United States Agency for

International Development (USAID),

IDCA.

ACTION: Final rule.

SUMMARY: USAID is amending its

regulation on source, origin and

nationality for commodities and

services financed by USAID by revising

two rules, one on system determinations

for commodities and one on ocean

transportation eligibility, and by

clarifying waiver provisions.

The final rule amends the coverage on

systems determinations to allow

components of a commodity system to

be shipped to a cooperating country

without first being shipped to and

assembled in an eligible country. This

should reduce the cost of these

transactions by reducing unnecessary

shipments. The rules on eligibility of

transshipments are amended to require

that suppliers obtain a determination

from USAID that direct service on U.S.

a flag vessel is not available before

transshipment from a U.S. flag to a nonU.S. flag vessel will be eligible for

USAID financing. This will ensure

compliance with Cargo Preference

requirements that direct U.S. flag

service be used when available.

DATES: Effective September 18, 1998.

FOR FURTHER INFORMATION CONTACT:

Kathleen O’Hara, Office of Procurement,

Policy Division (M/OP/P) USAID,

Washington, DC 20523–. Telephone:

(202) 712–4759, facsimile: (202) 216–

3395, e-mail address: kohara@usaid.gov.

SUPPLEMENTARY INFORMATION: The

regulation at 22 CFR part 228 was

published as a final rule September 15,

1996 (61 FR 53615). After operating

under the regulation for a year a few

areas have been identified that need

some additional coverage or

clarification. USAID published a

proposed rule to amend 22 CFR part 228

on January 23, 1998 (63 FR 3506). The

only comment received was from the

American Maritime Congress which

affirmed its support for the revisions to

the ocean transportation eligibility

policy. The rule is being amended as

proposed.

List of Subjects in 22 CFR Part 228

Administrative practice and

procedure, Commodity procurement,

Grant programs—foreign relations.

Accordingly 22 CFR part 228 is

amended as follows:

PART 228—[AMENDED]

1. The authority citation continues to

read as follows:

Authority: Sec. 621, Pub. L. 87–195, 75

Stat. 445 (22 U.S.C. 2381), as amended; E.O.

12163, Sept. 29, 1979, 44 FR 56673; 3 CFR

1979 Comp., p. 435.

2. In § 228.11, paragraph (e) is revised

as follows:

§ 228.11 Source and origin of

commodities.

* * * * *

(e) Systems determination. When a

system consisting of more than one

produced commodity is procured as a

single separately priced item, USAID

may determine that the system itself

shall be considered a produced

commodity. When a determination is

made to treat a system as a produced

commodity, component commodities

which originate from other than an

authorized source country may be

shipped directly to, and the system

assembled in, the cooperating country,

unless USAID specifically determines

that assembly and shipment take place

in an authorized source country.

Transportation costs must still meet the

requirements in subpart C of this part in

order for them to be eligible for USAID

financing. USAID, or the importer in the

case of a Commodity Import Program,

shall inform the supplier of any system

determination.

* * * * *

3. Section 228.21 is amended by

adding a sentence at the end of

paragraph (a) and revising paragraph

(c)(4) as follows:

§ 228.21 Ocean transportation.

(a) * * * USAID’s policy on

implementation of the Cargo Preference

Act is in USAID’s Automated Directives

System, Chapter 315.

* * * * *

(c)* * *

(4) USAID will finance costs incurred

on vessels under flag registry of any

Geographic Code 935 country if the

costs are part of the total cost on a

through bill of lading that is paid to a

carrier for initial carriage on a vessel

which is eligible in accordance with

paragraphs (c)(1), (2) or (3) of this

section; provided that for shipments

originating on a U.S. flag vessel with

transshipment to a non-U.S. flag vessel,

the supplier must obtain a

determination that direct serve on a U.S.

flag vessel is not available from USAID’s

Office of Procurement, Transportation

Division, 1300 Pennsylvania Avenue

NW., Washington, DC 20523–7900.

4. Section 228.51, paragraph (a) is

amended by revising the introductory

paragraph and paragraph (a)(1) as

follows:

§ 228.51 Commodities.

(a) Waiver criteria. Any waiver must

be based upon one of the criteria listed

in this section. Waivers to Geographic

Code 899 or Code 935 which are

justified under paragraph (a)(2) or (3) of

this section may only be authorized on

a case-by-case basis. A waiver may be

authorized when:

(1) A commodity required for

assistance is of a type that is not

produced in or available for purchase in