Federal Register / Vol. 63, No. 73 /Thursday, April 16, 1998 /Rules and Regulations 18835

In making its reviews of the pilot program,

the Commission should focus specific

attention on the restrictions imposed on

option contract design and strategies. The

success of risk management tools is partly

dependent upon the ability of users to tailor

contracts to meet specific business concerns.

The Commission has made some changes

from its proposed rules to provide additional

flexibility in contract design. However, the

pilot program should afford participants even

greater flexibility to negotiate specific

contract terms and strategies, subject only to

general guidelines.

In addition, the $10 million net worth

requirement necessary to trigger an

exemption from the regulations should be

scrutinized more closely. My view is that

there may be a more appropriate net worth

level at which to set exemption eligibility. I

therefore would recommend a

reconsideration of the net worth amount

within one year following the effective date

of the interim rules, if not sooner.

Finally, I believe we have made significant

progress towards transforming the November

proposal into a less complex, shorter and

more workable program. The fact that the

program is, by its terms, a pilot program,

provides the Commission and the industry

with an opportunity to address individual

situations that arise in the marketplace. To

this end, I am hopeful that the agricultural

community, the futures exchanges and others

involved in the futures industry will remain

in close contact with the Commission during

the interim period. It is important that we

maintain open lines of communication and

that the Commission is apprised of the needs

of the private sector. In this manner,

adjustments to the pilot program may be

made, as appropriate.

Dated: April 7, 1998.

David D. Spears.

Commissioner.

Concurring Remarks of Commissioner

Barbara Pedersen Holum, Interim Final

Rules, Trade Options on the Enumerated

Agricultural Commodities

I agree with and join in the action the

Commission is taking to permit exchange

trading of options on physicals on the

enumerated agricultural commodities. In

particular, I believe this important initiative

recognizes the potential of exchanges in

offering more flexible option contracts.

Exchanges in the past have demonstrated an

exceptional ability to meet the demands of

the market. I am therefore confident, now

that the prohibition is to be lifted, the

exchanges will work with the end-users to

develop option contracts with the necessary

flexibility to meet their individualized needs.

While I also join in the Commission’s

lifting of the prohibition on the offer and sale

of off-exchange trade options on the

enumerated agricultural commodities, I have

serious concerns about the extensive

regulatory provisions included in the interim

rules. Specifically, these interim rules create

a regulatory infrastructure essentially

duplicating that which already exists on the

exchanges. While the Commission has acted

to exempt other off-exchange transactions

from much of the centralized regulatory

structure, these interim rules impose new,

extensive, and costly regulatory mandates. In

my opinion, the imposition of this farreaching regulatory structure, and its

additional costs, will limit participation and

deny producers and processors the very risk

management tools that lifting the ban

envisions.

Dated: April 8, 1998.

Barbara Pedersen Holum,

Commissioner.

[FR Doc. 98–9879 Filed 4–15–98; 8:45 am]

BILLING CODE 6351–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use In Animal

Feeds; Bambermycins

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 supplement

provides for using bambermycins Type

A medicated articles to make a

bambermycins free-choice Type C

medicated feed for pasture cattle

(slaughter, stocker, and feeder) for

increased rate of weight gain.

EFFECTIVE DATE: April 16, 1998.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0217.

SUPPLEMENTARY INFORMATION: Hoechst

Roussel Vet, 30 Independence Blvd.,

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

supplemental NADA 141–034 which

provides for using 10-grams per pound

Flavomycin (bambermycins) Type A

medicated articles to make free-choice

Type C medicated feeds for pasture

cattle (slaughter, stocker, and feeder).

The Type C medicated feeds are fed to

provide 10 to 20 milligrams

bambermycins per head per day for

increased rate of weight gain. The

supplement is approved as of March 10,

1998, and the regulations are amended

by adding 21 CFR 558.95(d)(4)(iv) to

reflect the approval.

As required by 21 CFR 510.455, each

use of a Type A medicated article to

make a free-choice medicated Type C

feed requires an approved NADA or

supplemental NADA. Under section

512(m) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

360b(m)), as amended by the Animal

Drug Availability Act of 1996 (Pub. L.

104–250), free-choice medicated Type C

feeds must be manufactured in a

licensed feed mill.

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, from 9

a.m. to 4 p.m., Monday through Friday.

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

act, this supplemental approval for

food-producing animals qualifies for 3

years of marketing exclusivity beginning

March 10, 1998, because the

supplement contains substantial

evidence of the effectiveness of the drug

involved, studies of animal safety or, in

the case of food-producing animals,

human food safety studies (other than

bioequivalence or residue studies)

required for approval of the supplement

and conducted or sponsored by the

applicant. The 3 years of marketing

exclusivity applies only to the use of

bambermycins with the proprietary freechoice Type C feeds as approved in this

supplemental NADA.

The agency has determined under 21

CFR 25.33(a)(3) 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 558.95 is amended by

adding paragraph (d)(4)(iv) to read as

follows:

§ 558.95 Bambermycins.

* * * * *

(d) * * *

(4) * * *
18836 Federal Register / Vol. 63, No. 73 /Thursday, April 16, 1998 /Rules and Regulations

(iv) Use free-choice Type C medicated

feeds for pasture cattle (slaughter,

stocker, and feeder) as follows:

(a) Amount. Feed continuously to

provide 10 to 20 milligrams of

bambermycins per head per day.

(b) Indications for use. For increased

rate of weight gain.

(c) Limitations. Not for use in animals

intended for breeding. Each use in a

free-choice Type C medicated feed must

be the subject of an approved new

animal drug application (NADA) or

supplemental NADA as required by 21

CFR 510.455.

* * * * *

Dated: March 31, 1998.

Andrew J. Beaulieu,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–10033 Filed 4–15–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 806

[Docket No. 91N–0396]

Medical Devices; Reports of

Corrections and Removals; Lift of Stay

of Effective Date

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; lift of stay of effective

date.

SUMMARY: The Food and Drug

Administration (FDA) is lifting a stay of

the effective date of certain provisions

in a final rule on establishing

procedures for submission of reports of

corrections and removals of medical

devices. The Office of Management and

Budget (OMB) has approved the

collection of information requirements

contained in the final rule.

EFFECTIVE DATE: May 18, 1998.

FOR FURTHER INFORMATION CONTACT: Rosa

M. Gilmore, Center for Devices and

Radiological Health (HFZ–215), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850, 301–827–

2970.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 19, 1997 (62 FR

27183), FDA published a final rule to

establish procedures for implementing

the reports of corrections and removals

for medical devices by requiring that

manufacturers, importers, and

distributors report promptly to FDA any

corrections or removals of a device

undertaken to reduce a risk to health

posed by the device or to remedy a

violation of the Federal Food, Drug, and

Cosmetic Act caused by the device

which may present a risk to health. In

the final rule, FDA requested comments

by July 18, 1997 (62 FR 27183 at 27190),

on the collection of information

requirements contained in the final rule.

FDA reviewed and responded to four

comments received in response to this

request. In the Federal Register of

November 26, 1997 (62 FR 63182), FDA

announced that the information

collection requirements contained in the

final rule had been submitted to OMB

for approval under the Paperwork

Reduction Act of 1995 (Pub. L. 104–13).

In a separate document published on

December 24, 1997 (62 FR 67274), FDA

announced that it was staying the

effective date of the information

collection requirements pending OMB

clearance for §§ 806.10 and 806.20 (21

CFR 806.10 and 806.20).

On January 30, 1998, OMB sent FDA

a notice stating that the collection of

information requirements are approved

for use through January 31, 2001, under

OMB control number 0910–0359. FDA

announced OMB approval of the

collection of information provisions in

the Federal Register of February 17,

1998 (63 FR 7811).

Therefore, under sections 201–903 of

the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321–393) and under

authority delegated to the Commissioner

of Food and Drugs, the stay for

§§ 806.10 and 806.20 that was published

at 62 FR 67274, December 24, 1997, is

lifted and these provisions will become

effective May 18, 1998.

Dated: April 9, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–10034 Filed 4–15–98; 8:45 am]

BILLING CODE 4160–01–F

PANAMA CANAL COMMISSION

35 CFR Parts 113 and 115

RIN 3207–AA26

Vessels Carrying Dangerous Packaged

Goods Board of Local Inspectors;

Composition and Functions

AGENCY: Panama Canal Commission.

ACTION: Final rule.

SUMMARY: The Panama Canal

Commission is amending its rules in

part 113 to prohibit the loading or offloading of explosive cargo not destined

for U.S. Government use at Commission

facilities. The changes to 35 CFR part

113 are required by recent changes to

commercial ports in the Republic of

Panama which now provide a

sufficiency of safe anchorages and

facilities for the loading and unloading

of explosive cargo for cargo not

consigned to the Commission. As a

result of these changes, the Commission

is required to cease offering such

services under the Panama Canal Treaty

of 1977.

The Commission is also changing, in

part 115, the requirement that the

Administrator or his designee perform

certain appointment functions and

transferring those functions to the

Marine Operations Director. This

change makes this section consistent

with the nomenclature changes called

for by an internal reorganization at the

Commission and the changes to 35 CFR

part 115, published January 14, 1998.

DATES: Effective April 16, 1998.

FOR FURTHER INFORMATION CONTACT: John

A. Mills, Secretary, Panama Canal

Commission, 1825 I Street NW., Suite

1050, Washington, DC 20006–5402;

Telephone: (202) 634–6441; Facsimile:

(202) 634–6439; or John L. Haines, Jr.,

General Counsel, Panama Canal

Commission, Facsimile: 011–507–272–

3748.

SUPPLEMENTARY INFORMATION: The

change to 35 CFR part 115 is a result of

an internal reorganization of the Panama

Canal Commission. The Board of Local

Inspectors (BLI) has existed at the

Panama Canal pursuant to statute or

executive order since 1912, two years

before the waterway opened its doors to

world shipping. One of the BLI’s

primary functions is the investigation of

marine accidents. Since 1966, the

agency’s Marine Director has served, ex

officio, as Supervising Inspector and, in

that latter capacity, has overseen the

operations of the BLI.

As a result of this internal

reorganization, the Marine Director

(previously an active-duty or retired

U.S. Naval officer) is to be known as the

Maritime Operations Director. Duties

previously carried out by the

Supervising Inspector had been

assumed by the Administrator or his

designee. This change removes the

Administrator from the system of

appointments for a BLI chairman when

the designated Chairman is absent or

circumstances require the appointment

of a specially qualified individual to

serve on the BLI.

Because these changes are technical

or internal in nature and do not place

a burden on Canal users, the

Commission has determined to

promulgate a final rule without

opportunity for comment.