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.