39028 Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 /Rules and Regulations

functions or duties, participates in the

investment activities of such investment

adviser, provided that such employee

has been performing such functions and

duties for or on behalf of the investment

adviser, or substantially similar

functions or duties for or on behalf of

another company for at least 12 months.

(2) The term company has the same

meaning as in section 202(a)(5) of the

Act (15 U.S.C. 80b–2(a)(5)), but does not

include a company that is required to be

registered under the Investment

Company Act of 1940 but is not

registered.

(3) The term private investment

company means a company that would

be defined as an investment company

under section 3(a) of the Investment

Company Act of 1940 (15 U.S.C. 80a–

3(a)) but for the exception provided

from that definition by section 3(c)(1) of

such Act (15 U.S.C. 80a–3(c)(1)).

(4) The term executive officer means

the president, any vice president in

charge of a principal business unit,

division or function (such as sales,

administration or finance), any other

officer who performs a policy-making

function, or any other person who

performs similar policy-making

functions, for the investment adviser.

Dated: July 15, 1998.

By the Commission.

Margaret H. McFarland,

Deputy Secretary.

[FR Doc. 98–19373 Filed 7–20–98; 8:45 am]

BILLING CODE 8010–01–P

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 Nitarsone

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 nitarsone Type A

medicated articles to make combination

drug Type C medicated turkey feeds

used as an aid in the prevention of

blackhead, and for increased rate of

weight gain and improved feed

efficiency.

EFFECTIVE DATE: July 21, 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

141–088 that provides for combining

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

or 75 grams per pound (g/lb) bacitracin

methylene disalicylate) and Histostat

(227 g/lb nitarsone) Type A medicated

articles to make Type C medicated feeds

for growing turkeys containing 4 to 50

g per ton bacitracin methylene

disalicylate and 0.01875 percent

nitarsone. The Type C medicated turkey

feed is used as an aid in the prevention

of blackhead, and for increased rate of

weight gain and improved feed

efficiency in growing turkeys. The

NADA is approved as of June 17, 1998,

and §§ 558.76(d)(3) and 558.369(d) (21

CFR 558.76(d)(3) and 558.369(d)) are

amended to add new entries to reflect

the approval. The basis for approval is

discussed in the freedom of information

summary.

Also, due to enactment of the Generic

Animal Drug and Patent Term

Restoration Act in 1988, National

Academy of Science/National Research

Council (NAS/NRC) NADA’s are no

longer approved. Therefore, the text of

§ 558.369(c) NAS/NRC status is

removed and the paragraph reserved.

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.

This approval is for use of single

ingredient Type A medicated articles to

make combination drug Type C

medicated feeds. One ingredient,

nitarsone, is a Category II drug as

defined in 21 CFR 558.3(b)(1)(ii). Prior

to enactment of the Animal Drug

Availability Act of 1996 (Pub. L. 104–

250) (ADAA), an approved medicated

feed application (MFA) was required for

feed mills to make Type C medicated

feeds from Category II drugs. The ADAA

revised the Federal Food, Drug, and

Cosmetic Act to replace the requirement

for MFA’s with that for feed mill

licenses. Use of Type A medicated

articles to make Type C medicated feeds

as in this NADA is limited to licensed

feed mills.

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)(xvi) to read as

follows:

§ 558.76 Bacitracin methylene disalicylate.

* * * * *

(d) * * *

(3) * * *

(xvi) Nitarsone alone or in

combination as in § 558.369.

3. Section 558.369 is amended by

removing paragraph (c) and reserving it,

by revising the introductory text of

paragraph (d), by redesignating

paragraphs (d)(1), (d)(2), and (d)(3) as

paragraphs (d)(1)(i), (d)(1)(ii), and

(d)(1)(iii), respectively, by adding a

heading to paragraph (d)(1), and by

adding new paragraph (d)(2), to read as

follows:

§ 558.369 Nitarsone.

* * * * *

(c) [Reserved]

(d) Conditions of use. It is used as

follows:

(1) Chickens and turkeys.

* * * * *

(2) Turkeys—(i) Amount. Nitarsone

0.01875 percent, plus bacitracin

methylene disalicylate 4 to 50 grams per

ton.

(ii) Indications for use. As an aid in

the prevention of blackhead, and for

increased rate of weight gain and

improved feed efficiency.

(iii) Limitations. For growing turkeys.

Feed continuously as sole ration. Early

medication is essential to prevent

spread of disease. Adequate drinking

water must be provided near feeders at

all times. Overdosage or lack of water

may result in leg weakness or paralysis.

The drug is not effective in preventing
Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 /Rules and Regulations 39029

blackhead in birds infected more than 4

or 5 days. Discontinue use 5 days before

slaughtering animals for human

consumption to allow elimination of the

drug from edible tissues. The drug is

dangerous for ducks, geese, and dogs.

Use as sole source of arsenic.

Dated: July 9, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–19315 Filed 7–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF LABOR

Occupational Safety and Health

Administration

29 CFR Parts 1910, 1915, and 1926

[Docket No. H–049b]

RIN 1218–AA05

Respirator Cartridge and Canister

Change-Out Schedules; Notice of

Public Meeting

AGENCY: Occupational Safety and Health

Administration (OSHA), Labor.

ACTION: Final rule; notice of a public

meeting.

SUMMARY: This document announces a

public meeting of an inter-agency work

group sponsored by the Occupational

Safety and Health Administration

(OSHA) to discuss available information

on respirator cartridge and canister

change-out schedules. Employers are

required to develop or adopt such

schedules by the revised Respiratory

Protection standard published in the

Federal Register on January 8, 1998,

and the Maritime and Construction

industry respiratory protection

standards, which now cross-reference

the General Industry respiratory

protection standard. In addition to

OSHA, representatives of the National

Institute for Occupational Safety and

Health (NIOSH) and the Environmental

Protection Agency (EPA) are

participating in the work group and will

attend the public meeting. Public

participation is encouraged.

DATES: The work group public meeting

will be held on August 6, 1998. The

public meeting will begin at 9:00 A.M.

and end about 5:00 P.M., with a onehour lunch period at about noon.

ADDRESSES: The work group public

meeting will be held in the Department

of Labor Auditorium at the Frances

Perkins Building, U.S. Department of

Labor, 200 Constitution Avenue, NW,

Washington, DC 20210.

FOR FURTHER INFORMATION CONTACT:

Bonnie Friedman, Director, OSHA

Office of Public Affairs, Room N–3647,

U.S. Department of Labor, 200

Constitution Avenue, NW, Washington,

DC 20210; Telephone (202) 219–8148.

SUPPLEMENTARY INFORMATION: On

January 8, 1998, OSHA published a

revised Respiratory Protection standard,

29 CFR 1910.134, (63 FR 1152). All

provisions of the new standard take

effect on or before October 5, l998.

Paragraph (d)(3)(iii) of the standard

specifies that, under certain

circumstances, employers must

implement a change-out schedule, based

on objective data, for respirator canisters

and cartridges used to reduce exposures

to gases and vapors. Change schedules

establish the time periods for replacing

cartridges and canisters before a toxic

substance might break through and

overexpose an employee. OSHA is

sponsoring an inter-agency work group

to discuss available relevant data for

compliance with 29 CFR

1910.134(d)(3)(iii).

The first meeting of the work group

will be held on August 6, 1998. It will

be open to the public. Representatives of

NIOSH and EPA who are experienced in

developing change-out schedules and

analyzing data sources on contaminant

breakthrough will attend the work group

meeting.

Agenda

The agenda for the work group public

meeting is as follows:

(1) Welcome and introduction of the

inter-agency work group.

(2) Public submissions of relevant

information and comment to OSHA.

(3) Question and answer session.

(4) Closing remarks.

Public Participation

The meeting will be open to the

public. Because of the limited amount of

seating available, space will be assigned

on a first-come, first-served basis. All

individuals who plan to attend should

contact Theresa Berry by July 30, 1998,

at the OSHA Office of Public Affairs,

Room N–3647, U.S. Department of

Labor, 200 Constitution Avenue, NW,

Washington, DC 20210; Telephone (202)

219–8148. Individuals with disabilities

who plan to attend should contact

Theresa Berry no later than July 30,

1998 to obtain appropriate

accommodations.

Those attendees who plan to make a

presentation are requested to submit a

copy of their presentation to Theresa

Berry by July 30, 1998. OSHA will make

copies of submissions available at the

public meeting and also in a docket

available to the public (Docket # H–

049b).

This document was prepared under

the direction of Charles N. Jeffress,

Assistant Secretary of Labor for

Occupational Safety and Health, U.S.

Department of Labor, 200 Constitution

Avenue, NW, Washington, D.C., 20210.

Signed at Washington, D.C. this 15th day

of July, 1998.

Charles N. Jeffress,

Assistant Secretary of Labor for Occupational

Safety and Health.

[FR Doc. 98–19347 Filed 7–20–98; 8:45 am]

BILLING CODE 4510–26–P

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD11–98–010]

Drawbridge Operation Regulations;

Honker Cut, San Joaquin County, CA,

Eightmile Road Bridge

AGENCY: Coast Guard, DOT.

ACTION: Notice of temporary deviation

from regulations.

SUMMARY: Notice is hereby given that

the Coast Guard has issued a temporary

deviation to the regulations governing

the opening of the Eightmile Road swing

bridge over Honker Cut between Empire

Tract and King Island at Stockton, CA.

The deviation specifies that the bridge

need not be opened for vessels from

12:01 a.m., September 1, 1998 until

11:59 p.m., October 23, 1998. The

purpose of this deviation is to allow San

Joaquin County and its contractors paint

the bridge. During this work, this bridge

will have scaffolding and tarpaulins

installed, which prevent the bridge from

opening.

DATES: The effective period of the

deviation is 12:01 a.m. September 1,

1998 to 11:59 p.m., October 23, 1998.

FOR FURTHER INFORMATION CONTACT: Mr.

Jerry Olmes, Bridge Administrator,

Eleventh Coast Guard District, Building

50–6 Coast Guard Island, Alameda, CA

94501–5100, telephone (510) 437–3515.

SUPPLEMENTARY INFORMATION: The Coast

Guard anticipates that the economic

consequences of this deviation will be

minimal. The bridge opens on average

only 6 times per year. If mariners

require an opening, they have alternate

routes available via Little Connection

Slough or King Island Cut, two miles

east and west of Honker Cut,

respectively.

This deviation from the normal

operating regulations in 33 CFR 117.161

is authorized in accordance with the

provisions of 33 CFR 117.35.