Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations 31623

List of Subjects in 15 CFR Part 705

Administrative practice and

procedure, Business and industry,

Classified information, Confidential

business information, Imports,

Investigations, National Security.

For the reasons set forth in the

preamble, part 705 of Subchapter A,

National Security Industrial Base

Regulations is amended as follows:

PART 705—[AMENDED]

1. The authority citation for 15 CFR

part 705 is revised to read as follows:

Authority: Section 232 of the Trade

Expansion Act of 1962, as amended (19

U.S.C. 1862) and Reorg. Plan No. 3 of 1979

(44 FR 69273, December 3, 1979).

2. Section 705.3 is amended by

designating the existing text as

paragraph (a) and by adding a new

paragraph (b), as follows:

§ 705.3 Commencing an investigation.

(a) * * *

(b) The Secretary shall immediately

provide notice to the Secretary of

Defense of any investigation initiated

under this part.

§ 705.5 [Amended]

3. In § 705.5(a), the reference to

‘‘Office of Industrial Resource

Administration’’ is revised to read

‘‘Office of Strategic Industries and

Economic Security.’’

4. Section 705.7 is amended by

revising paragraph (d) to read as

follows:

§ 705.7 Conduct of an investigation.

* * * * *

(d) The Department shall, as part of an

investigation, seek information and

advice from, and consult with,

appropriate officers of the United States

or their designees, as shall be

determined. The Department shall also

consult with the Secretary of Defense

regarding the methodological and policy

questions raised in the investigation.

Upon the request of the Secretary, the

Secretary of Defense shall provide the

Secretary with an assessment of the

defense requirements of the article in

question. Communications received

from agencies of the U.S. government or

foreign governments will not be made

available for public inspection.

* * * * *

§§ 705.7 and 705.8 [Amended]

5. In §§ 705.7(b) and 705.8(b)(6), the

references to room number ‘‘H–4886’’

are revised to read ‘‘H–4525’’.

6. Section 705.10 is revised to read as

follows:

§ 705.10 Report of an investigation and

recommendation.

(a) When an investigation conducted

pursuant to this part is completed, a

report of the investigation shall be

promptly prepared.

(b) The Secretary shall report to the

President the findings of the

investigation and a recommendation for

action or inaction within 270 days after

beginning an investigation under this

part.

(c) An Executive Summary of the

Secretary’s report to the President of an

investigation, excluding any classified

or proprietary information, shall be

published in the Federal Register.

Copies of the full report, excluding any

classified or proprietary information,

will be available for public inspection

and copying in the Bureau of Export

Administration Freedom of Information

Records Inspection Facility, Room H–

4525, U.S. Department of Commerce,

14th Street, N.W., Washington, D.C.

20230; tel. (202) 482–5653.

7. A new section 705.11 is added to

read as follows:

§ 705.11 Determination by the President

and adjustment of imports.

(a) Upon the submission of a report to

the President by the Secretary under

§ 705.10(b) of this part, in which the

Department has found that an article is

being imported into the United States in

such quantities or under such

circumstances as to threaten to impair

the national security, the President is

required by Section 232(c) of the Trade

Expansion Act of 1962, as amended (19

U.S.C. 1862(c)) to take the following

action

(1) Within 90 days after receiving the

report from the Secretary, the President

shall determine:

(i) Whether the President concurs

with the Department’s finding; and

(ii) If the President concurs, the

nature and duration of the action that

must be taken to adjust the imports of

the article and its derivatives so that the

such imports will not threaten to impair

the national security.

(2) If the President determines to take

action under this section, such action

must be taken no later than fifteen (15)

days after making the determination.

(3) By no later than thirty (30) days

after making the determinations under

paragraph (a)(1) of this section, the

President shall submit to the Congress a

written statement of the reasons why the

President has decided to take action, or

refused to take action.

(b) If the action taken by the President

under this section is the negotiation of

an agreement to limit or restrict the

importation into the United States of the

article in question, and either no such

agreement is entered into within 180

days after making the determination to

take action, or an executed agreement is

not being carried out or is ineffective in

eliminating the threat to the national

security, the President shall either:

(1) Take such other action as deemed

necessary to adjust the imports of the

article so that such imports will not

threaten to impair the national security.

Notice of any such additional action

taken shall be published in the Federal

Register; or

(2) Not take any additional action.

This determination and the reasons on

which it is based, shall be published in

the Federal Register.

8. A new section 705.12 is added to

read as follows:

§ 705.12 Disposition of an investigation

and report to the Congress.

(a) Upon the disposition of each

request, application, or motion made

under this part, a report of such

disposition shall be submitted by the

Secretary to the Congress and published

in the Federal Register.

(b) As required by Section 232(e) of

the Trade Expansion Act of 1962, as

amended (19 U.S.C. 1862(c)), the

President shall submit to the Congress

an annual report on the operation of this

part.

Dated: June 5, 1998.

Iain S. Baird,

Deputy Assistant Secretary for Export

Administration.

[FR Doc. 98–15411 Filed 6–9–98; 8:45 am]

BILLING CODE 3510–JT–P

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 a

change of sponsor name from

Boehringer Ingelheim Animal Health,

Inc., to Boehringer Ingelheim

Vetmedica, Inc.

EFFECTIVE DATE: June 10, 1998.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug
31624 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION:

Boehringer Ingelheim Animal Health,

Inc., 2621 North Belt Hwy., St. Joseph,

MO 65406, has informed FDA of a

change of sponsor name to Boehringer

Ingelheim Vetmedica, Inc. Accordingly,

the agency 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 ‘‘Boehringer

Ingelheim Animal Health, Inc.’’ and by

alphabetically adding a new entry for

‘‘Boehringer Ingelheim Vetmedica,

Inc.’’; and in the table in paragraph

(c)(2) in the entry for ‘‘000010’’ by

removing the sponsor name ‘‘Boehringer

Ingelheim Animal Health, Inc.’’ and

adding in its place ‘‘Boehringer

Ingelheim Vetmedica, Inc.’’

Dated: May 22, 1998.

Andrew J. Beaulieu,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–15481 Filed 6–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Fenbendazole Paste

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 supplemental new animal

drug application (NADA) filed by

Hoechst Roussel Vet. The supplemental

NADA provides for expanding the

indications to include treatment of

encysted mucosal cyathostome (small

strongyle) larvae including early third

stage (hypobiotic), late third stage, and

fourth stage larvae.

EFFECTIVE DATE: June 10, 1998.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1612.

SUPPLEMENTARY INFORMATION: Hoechst

Roussel Vet, 30 Independence Blvd.,

P.O. Box 4915, Warren, NJ 07059, filed

supplemental NADA 120–648 that

provides for oral administration of

Panacur and Safe-Guard

(fenbendazole l0 percent) paste to

horses. The product is currently

approved for use concomitantly with an

approved form of trichlorfon.

Trichlorfon is approved for the

treatment of stomach bots

(Gasterophilus spp.) in horses. The

supplemental NADA provides for

expanding the indications to include

treatment of encysted mucosal

cyathostome (small strongyle) larvae

including early third stage (hypobiotic),

late third stage, and fourth stage larvae

when administered at 10 milligrams per

kilogram per day for 5 consecutive days.

The supplemental NADA is approved as

of April 20, 1998, and the regulations

are amended in 21 CFR

520.905c(d)(1)(iii) 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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

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

Friday.

Under section 512(c)(2)(F)(iii) of the

Federal Food, Drug, and Cosmetic Act,

this approval for nonfood-producing

animals qualifies for 3 years of

marketing exclusivity beginning April

20, 1998, because the supplemental

application contains substantial

evidence of the effectiveness of the drug

involved, or any studies of animal

safety, required for approval of the

application and conducted or sponsored

by the applicant.

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.

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.

2. Section 520.905c is amended by

adding paragraph (d)(1)(iii) to read as

follows:

§ 520.905c Fenbendazole paste.

* * * * *

(d) * * *

(1) * * *

(iii)(a) Amount. 4.6 milligrams per

pound of body weight (10 milligrams

per kilogram) daily for 5 consecutive

days.

(b) Indications for use. For treatment

of encysted mucosal cyathostome (small

strongyle) larvae including early third

stage (hypobiotic), late third stage, and

fourth stage larvae in horses.

(c) Limitations. (Consult your

veterinarian for assistance in the

diagnosis, treatment, and control of

encysted mucosal cyathostomes). Do not

use in horses intended for food.

* * * * *

Dated: May 27, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–15480 Filed 6–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

24 CFR Part 982

[Docket No. FR–4054–C–03]

RIN 2577–AB63

Section 8 Certificate and Voucher

Programs Conforming Rule;

Correction

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.