27844 Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 /Rules and Regulations

hour period.’’ Children 5 to 9 years of

age: Oral dosage is dibasic sodium

phosphate 0.86 to 1.89 g and monobasic

sodium phosphate 2.2 to 5.05 g (5 to 10

mL dibasic sodium phosphate/

monobasic sodium phosphate oral

solution) as a single daily dose. ‘‘Do not

take more than 10 mL (2 teaspoonfuls)

in a 24-hour period.’’ Children under 5

years of age: ask a doctor.

(c) After June 22, 1998, for package

size limitation and September 18, 1998,

for labeling in accord with paragraph (b)

of this section, any such OTC drug

product initially introduced or initially

delivered for introduction into interstate

commerce, or any such drug product

that is repackaged or relabeled after

these dates regardless of the date the

product was manufactured, initially

introduced, or initially delivered for

introduction into interstate commerce,

that is not in compliance with this

section is subject to regulatory action.

Dated: April 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–12053 Filed 5–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

Animal Drugs, Feeds, and Related

Products; Change of Sponsor Name

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

change of sponsor name from Protiva, a

unit of Monsanto, to Monsanto Co.

EFFECTIVE DATE: May 21, 1998.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: Protiva, a

unit of Monsanto has informed FDA of

a change of sponsor name to Monsanto

Co. Accordingly, FDA is amending 21

CFR 510.600(c)(1) and (c)(2) to reflect

the change of sponsor name.

List of Subjects in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

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 510 is amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entry for ‘‘Protiva, A Unit

of Monsanto Co.’’ and by alphabetically

adding a new entry for ‘‘Monsanto Co.,

800 North Lindbergh Blvd., St. Louis,

MO 63167’’ and in the table in

paragraph (c)(2) in the entry for

‘‘059945’’ by removing the sponsor

name ‘‘Protiva, A Division of Monsanto

Co.’’ and adding in its place ‘‘Monsanto

Co.’’

Dated: May 8, 1998.

Andrew J. Beaulieu,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–13162 Filed 5–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 558

Animal Drugs, Feeds, and Related

Products; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect a

change of sponsor for 96 new animal

drug applications (NADA’s) and 4

abbreviated animal drug applications

(ANADA’s) from Hoffmann-La Roche,

Inc., to Roche Vitamins, Inc.

EFFECTIVE DATE: May 21, 1998.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: HoffmannLa Roche, Inc., Nutley, NJ 07110, has

informed FDA that it has transferred the

ownership of and all rights and interests

in approved NADA’s and ANADA’s to

Roche Vitamins, Inc., 45 Waterview

Blvd., Parsippany, NJ 07054–1298.

Accordingly, the agency is amending

the regulations in 21 CFR parts 510 and

558 to reflect the change of sponsor. The

agency is also amending the regulations

in § 510.600(c)(1) and (c)(2) by removing

Hoffmann-La Roche, Inc., because the

sponsor no longer sponsors any

approved new animal drugs, and by

alphabetically adding an entry for Roche

Vitamins, Inc.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

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 parts 510 and 558 are amended as

follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

2. Section 510.600 is amended in the

table in paragraph (c)(1) by removing

the entry for ‘‘Hoffmann-La Roche,

Inc.,’’ and by alphabetically adding an

entry for ‘‘Roche Vitamins, Inc.,’’ and in

the table in paragraph (c)(2) by

removing the entry for ‘‘000004’’ and by

numerically adding an entry for

‘‘063238’’ to read as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *
Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 /Rules and Regulations 27845

Firm name and address Drug labeler code

* * * * * * *

Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 07054–1298 063238

* * * * * * *

(2) * * *

Drug labeler code Firm name and address

* * * * * * *

063238 Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 07054–1298

* * * * * * *

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

The authority citation for 21 CFR part

558 continues to read as follows:

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

§ 558.58 [Amended]

3. Section 558.58 Amprolium and

ethopabate is amended in the table in

paragraph (d)(1)(iii), under the

‘‘Limitations’’ column in the entries for

‘‘Bacitracin 4 to 50’’, ‘‘Bacitracin 5 to 35

plus roxarsone 34 (0.00375%)’’, and

‘‘Bacitracin 10 to 50 plus roxarsone 15.4

to 45.4 (0.0017% to 0.005%)’’ by

removing ‘‘000004 and 046573’’ and

adding in its place ‘‘046573 and

063238’’, and under the ‘‘Sponsor’’

column by removing ‘‘000004’’

wherever it appears and adding in its

place ‘‘063238’’.

§ 558.78 [Amended]

4. Section 558.78 Bacitracin zinc is

amended in paragraph (a)(2), in the

table in paragraph (d)(1), under the

‘‘Sponsor’’ column, and in paragraph

(d)(2)(ii) by removing ‘‘000004’’

wherever it appears and adding in its

place ‘‘063238’’.

§ 558.95 [Amended]

5. Section 558.95 Bambermycins is

amended in paragraph (d)(1)(xi)(b) and

(d)(1)(xii)(b) by removing ‘‘Nos. 012799

and 000004’’ and adding in its place

‘‘Nos. 012799 and 063238’’.

§ 558.120 [Amended]

6. Section 558.120 Carbarsone (not

U.S.P.) is amended in paragraph

(d)(1)(iii)(b) by removing ‘‘Nos. 000004

and 046573’’ and adding in its place

‘‘Nos. 046573 and 063238’’.

§ 558.128 [Amended]

7. Section 558.128 Chlortetracycline is

amended in paragraph (a)(1) by

removing ‘‘000004’’ and adding in its

place ‘‘063238’’, and in the table in

paragraph (d)(1), under the ‘‘Sponsors’’

column, by removing ‘‘000004’’

wherever it appears and adding in its

place ‘‘063238’’.

§ 558.145 [Amended]

8. Section 558.145 Chlortetracycline,

procaine penicillin, and sulfamethazine

is amended in paragraph (a)(1) by

removing ‘‘000004 and 046573’’ and

adding in its place ‘‘046573 and

063238’’, and in paragraph (a)(2) by

removing ‘‘000004’’ and adding in its

place ‘‘063238’’.

§ 558.175 [Amended]

9. Section 558.175 Clopidol is

amended in paragraph (d)(1)(iii)(b) and

(d)(1)(iv)(b) by removing ‘‘Nos. 000004

and 046573’’ and adding in its place

‘‘Nos. 046573 and 063238’’.

§ 558.195 [Amended]

10. Section 558.195 Decoquinate is

amended in the table in paragraph (d) in

the entry for ‘‘27.2 (0.003 pct.),

Roxarsone 11 to 45 (0.0012–0.005 pct.)

plus Bacitracin 12 to 50’’ under the

‘‘Limitations’’ column by removing

‘‘Nos. 000004, 011716, and 046573’’ and

adding in its place ‘‘Nos. 011716,

046573, and 063238’’.

§ 558.305 [Amended]

11. Section 558.305 Laidlomycin

propionate potassium is amended in

paragraph (a) by removing ‘‘000004’’

and adding in its place ‘‘063238’’.

§ 558.311 [Amended]

12. Section 558.311 Lasalocid is

amended in paragraphs (b)(2), (b)(3),

(b)(4), (b)(5), (b)(6), and (b)(7) by

removing ‘‘000004’’ and adding in its

place ‘‘063238’’; in the table in

paragraph (e)(1)(v) under the

‘‘Limitations’’column by removing

‘‘000004’’ and adding in its place

‘‘063238’’ and under the ‘‘Sponsors’’

column by removing ‘‘000007’’ and

adding in its place ‘‘063238’’; and in

paragraphs (e)(2)(v) and (e)(3)(v) by

removing ‘‘000004’’ and adding in its

place ‘‘063238’’.

§ 558.340 [Amended]

13. Section 558.340 Maduramicin

ammonium is amended in paragraph (a)

by removing ‘‘000004’’ and adding in its

place ‘‘063238’’.

§ 558.342 [Amended]

14. Section 558.342 Melengestrol

acetate is amended in paragraph

(d)(3)(ii) by removing ‘‘000004’’ and

adding in its place ‘‘063238’’, and in

paragraph (d)(6)(ii) by removing ‘‘Nos.

000004, 000009, and 000986’’, and

adding in its place ‘‘Nos. 000009,

000986, and 063238’’.

§ 558.355 [Amended]

15. Section 558.355 Monensin is

amended in paragraphs (b)(8), (b)(9),

(f)(1)(iv)(b), (f)(1)(v)(b), (f)(1)(xiv)(b),

(f)(1)(xv)(b) by removing ‘‘000004’’ and

adding in its place ‘‘063238’’, and in

paragraph (f)(1)(xvi)(b) by removing

‘‘Nos. 000004 and 046573’’ and adding

in its place ‘‘Nos. 046573 and 063238’’.

§ 558.515 [Amended]

16. Section 558.515 Robenidine

hydrochloride is amended in paragraphs

(a) and (d)(1)(vi)(b) by removing

‘‘000004’’ and adding in its place

‘‘063238’’.
27846 Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 /Rules and Regulations

§ 558.550 [Amended]

17. Section 558.550 Salinomycin is

amended in paragraphs (a)(1),

(d)(1)(vii)(c), (d)(1)(xv)(c), and

(d)(1)(xvi)(c) by removing ‘‘000004’’ and

adding in its place ‘‘063238’’, and in

paragraph (d)(1)(ix)(c) by removing

‘‘Nos. 000004 and 046573’’ and adding

in its place ‘‘Nos. 046573 and 063238’’.

§ 558.575 [Amended]

18. Section 558.575

Sulfadimethoxine, ormetoprim is

amended in paragraphs (a)(1) and (a)(2)

by removing ‘‘000004’’ and adding in its

place ‘‘063238’’.

§ 558.582 [Amended]

19. Section 558.582 Sulfamerazine is

amended in paragraph (a) by removing

‘‘000004’’ and adding in its place

‘‘063238’’.

§ 558.600 [Amended]

20. Section 558.600 Tiamulin is

amended in paragraph (c)(4)(ii) by

removing ‘‘000004 and 046573’’ and

adding in its place ‘‘046573 and

063238’’.

Dated: May 8, 1998.

Andrew J. Beaulieu,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–13161 Filed 5–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Office of Foreign Assets Control

31 CFR Part 537

Burmese Sanctions Regulations

AGENCY: Office of Foreign Assets

Control, Treasury.

ACTION: Final rule.

SUMMARY: The Office of Foreign Assets

Control of the U.S. Department of the

Treasury is issuing the Burmese

Sanctions Regulations to implement

Executive Order 13047 of May 20, 1997,

‘‘Prohibiting New Investment in

Burma.’’

EFFECTIVE DATE: May 21, 1998.

FOR FURTHER INFORMATION CONTACT:

Steven I. Pinter, Chief of Licensing, tel.:

202/622–2480, or William B. Hoffman,

Chief Counsel, tel.: 202/622–2410,

Office of Foreign Assets Control,

Department of the Treasury,

Washington, DC 20220.

SUPPLEMENTARY INFORMATION:

Electronic Availability

This document is available as an

electronic file on The Federal Bulletin

Board the day of publication in the

Federal Register. By modem, dial 202/

512–1387 and type ‘‘/GO FAC,’’ or call

202/512–1530 for disk or paper copies.

This file is available for downloading

without charge in WordPerfect 5.1,

ASCII, and Adobe AcrobatR readable

(*.PDF) formats. For Internet access, the

address for use with the World Wide

Web (Home Page), Telnet, or FTP

protocol is: fedbbs.access.gpo.gov. The

document is also accessible for

downloading in ASCII format without

charge from Treasury’s Electronic

Library (‘‘TEL’’) in the ‘‘Business, Trade

and Labor Mall’’ of the FedWorld

bulletin board. By modem, dial 703/

321–3339, and select self–expanding file

‘‘T11FR00.EXE’’ in TEL. For Internet

access, use one of the following

protocols: Telnet = fedworld.gov

(192.239.93.3); World Wide Web (Home

Page) = http://www.fedworld.gov; FTP

= ftp.fedworld.gov (192.239.92.205).

Additional information concerning the

programs of the Office of Foreign Assets

Control is available for downloading

from the Office’s Internet Home Page:

http://www.ustreas.gov/treasury/

services/fac/fac.html, or in fax form

through the Office’s 24–hour fax–on–

demand service: call 202/622–0077

using a fax machine, fax modem, or

(within the United States) a touch–tone

telephone.

Background

On May 20, 1997, the President issued

Executive Order 13047 (the ‘‘Order’’),

effective at 12:01 a.m. EDT on May 21,

1997, certifying to Congress under

section 570(b) of the Foreign

Operations, Export Financing, and

Related Programs Appropriations Act,

1997, (Public Law 104–208) (the ‘‘Act’’)

that the Government of Burma has

committed large–scale repression of the

Democratic opposition in Burma after

September 30, 1996, thereby invoking

the prohibition on new investment in

Burma by U.S. persons, contained in

that section. The President also declared

a national emergency to deal with the

threat posed to the national security and

foreign policy of the United States by

the actions and policies of the

Government of Burma, invoking the

authority, inter alia, of the International

Emergency Economic Powers Act (50

U.S.C. 1701–1706). The Order

authorizes the Secretary of the Treasury,

in consultation with the Secretary of

State, to take such actions, including the

promulgation of rules and regulations,

as may be necessary to carry out the

purposes of the Order. In

implementation of the Order, the

Treasury Department is issuing the

Burmese Sanctions Regulations, 31 CFR

part 537 (the ‘‘Regulations’’).

Section 537.201 of the Regulations

implements section 1 of the Order, and

prohibits new investment in Burma by

U.S. persons. The term new investment,

defined in section 4(d) of the Order,

means any of the following activities, if

such an activity is undertaken pursuant

to an agreement, or pursuant to the

exercise of rights under such an

agreement, that is entered into with the

Government of Burma or a

nongovernmental entity in Burma on or

after May 21, 1997:

(1) the entry into a contract that

includes the economic development of

resources located in Burma;

(2) the entry into a contract providing

for the general supervision and

guarantee of another person’s

performance of a contract that includes

the economic development of resources

located in Burma;

(3) the purchase of a share of

ownership, including an equity interest,

in the economic development of

resources located in Burma; or

(4) the entry into a contract providing

for the participation in royalties,

earnings, or profits in the economic

development of resources located in

Burma, without regard to the form of the

participation.

Section 537.202 of the Regulations

implements section 2(a) of the Order

and prohibits any approval or other

facilitation by a United States person,

wherever located, of a transaction by a

foreign person where the transaction

would constitute prohibited new

investment in Burma if engaged in by a

United States person or within the

United States.

Section 537.203 of the Regulations

implements section 2(b) of the Order

and prohibits any transaction by a U.S.

person or within the United States that

evades or avoids, or that has the

purpose of evading or avoiding, or

attempts to violate, any of the

prohibitions set forth in the Order.

The prohibitions contained in these

sections are subject to the exemption

contained in section 3 of the Order,

implemented in § 537.204 of the

Regulations, which excludes from the

new investment and facilitation

prohibitions the entry into or

performance or financing of a contract

to sell or purchase goods, services, or

technology. This exemption, however,

does not apply where the entry into

such a contract on or after the effective

date of the Order is for the general

supervision and guarantee of another

person’s performance of a contract for

the economic development of resources

located in Burma; or where such