Federal Register / Vol. 60, No. 59 / Tuesday, March 28, 1995 / Notices 15933

to § 225.25(b)(1) of the Board’s

Regulation Y.

Board of Governors of the Federal Reserve

System, March 22, 1995.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 95–7521 Filed 3–27–95; 8:45 am]

BILLING CODE 6210–01–F

Otis Truman Arnold, et al.; Change in

Bank Control Notices; Acquisitions of

Shares of Banks or Bank Holding

Companies

The notificants listed below have

applied under the Change in Bank

Control Act (12 U.S.C. 1817(j)) and §

225.41 of the Board’s Regulation Y (12

CFR 225.41) to acquire a bank or bank

holding company. The factors that are

considered in acting on the notices are

set forth in paragraph 7 of the Act (12

U.S.C. 1817(j)(7)).

The notices are available for

immediate inspection at the Federal

Reserve Bank indicated. Once the

notices have been accepted for

processing, they will also be available

for inspection at the offices of the Board

of Governors. Interested persons may

express their views in writing to the

Reserve Bank indicated for that notice

or to the offices of the Board of

Governors. Comments must be received

not later than April 11, 1995.

A. Federal Reserve Bank of Dallas

(Genie D. Short, Vice President) 2200

North Pearl Street, Dallas, Texas 75201-

2272:

1. Otis Truman and Anita Ray

Arnold, both of Texarkana, Texas; to

acquire a total of 49.1 percent of the

voting shares of New Boston

Bancshares, Inc., New Boston, Texas,

and thereby indirectly acquire First

National Bank of New Boston, New

Boston, Texas.

B. Federal Reserve Bank of San

Francisco (Kenneth R. Binning,

Director, Bank Holding Company) 101

Market Street, San Francisco, California

94105:

1. James Lester Ryan, Orinda,

California; to acquire an additional 2.32

percent, for a total of 10.65 percent, of

the voting shares of BWC Corp., Walnut

Creek, California, and thereby indirectly

acquire Bank of Walnut Creek, Walnut

Creek, California.

Board of Governors of the Federal Reserve

System, March 22, 1995.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 95–7519 Filed 3–27–95; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Board of Scientific Counselors,

National Institute for Occupational

Safety and Health; Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC),

announces the following committee

meeting.

Name: Board of Scientific Counselors,

National Institute for Occupational Safety

and Health (BSC, NIOSH).

Time and Date: 10 a.m.–5 p.m., April 12,

1995.

Place: The Washington Court Hotel, Ash

Room, 525 New Jersey Avenue, NW,

Washington, DC 20001

Status: Closed 10 a.m.–12 noon; Open 1

p.m.–5 p.m.

Purpose: The Board reviews research

activities to provide guidance on the quality,

timeliness, and efficacy of the Institute’s

programs.

Matters To Be Discussed: The agenda will

include personnel and organizational issues

relating to the reorganization of NIOSH. The

meeting will convene in closed session from

10 a.m. to 12 noon to discuss subject matter

relating solely to the internal personnel rules

and practices of NIOSH. This portion of the

meeting will be closed to the public in

accordance with the provisions set forth in

section 552b(c)(2), title 5 U.S.C., and the

Determination of the Associate Director for

Management and Operations, CDC, pursuant

to Pub. L. 92–463. The open portion of the

meeting will include a report from the

Director of NIOSH, a toxicology report, an

extramural report, and future activities of the

Board.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Richard A. Lemen, Ph.D., Executive

Secretary, BSC, NIOSH, and Deputy Director,

NIOSH, CDC, 1600 Clifton Road NE.,

Mailstop D–35, Atlanta, Georgia 30333,

telephone 404/639–3773.

Dated: March 22, 1995.

Jack Jackson,

Associate Director for Management and

Operations, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 95–7579 Filed 3–27–95; 8:45 am]

BILLING CODE 4163–19–M

Food and Drug Administration

[Docket No. 94D–0407]

Miscellaneous Compliance Policy

Guides; Revocation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revocation of two compliance policy

guides (CPG’s) because they are

outdated. This action is being taken to

ensure that FDA’s CPG’s are accurate

and current.

DATES: Effective March 28, 1995.

FOR FURTHER INFORMATION CONTACT:

Judith A. Gushee, Center for Veterinary

Medicine (HFV–236), Food and Drug

Administration, 7500 Standish Place,

Rockville, MD 20855, 301–594–1785.

SUPPLEMENTARY INFORMATION: FDA is

revoking the following CPG’s because

they are outdated:

(1) CPG 7126.06 ‘‘State Analysis of

Animal Feed for Protein, Fat, and Fiber

Content,’’ and

(2) CPG 7126.14 ‘‘Protein in Animal

Feeds.’’

These CPG’s were intended to assist

the States in enforcing their

requirements for guaranteed analysis

labeling claims when their regulatory

authority was insufficient. However,

State regulatory authority is sufficient,

and the States have not required use of

these CPG’s for a number of years.

Futhermore, if FDA regulatory action is

required, the agency has ample

authority. Therefore, FDA is revoking

CPG’s 7126.06 and 7126.14 because they

are outdated.

Dated: March 13, 1995.

Gary Dykstra,

Acting Associate Commissioner for

Regulatory Affairs.

[FR Doc. 95–7615 Filed 3–27–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 94D–0356]

Protocol Development for Clinical

Effectiveness and Target Animal

Safety Trials; Availability of Guideline

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the guideline entitled,

‘‘Protocol Development Guideline for

Clinical Effectiveness and Target

Animal Safety Trials’’ prepared by the

Center for Veterinary Medicine (CVM).

This guideline describes a suggested

systematic approach to be followed

when designing and reporting

effectiveness and target animal safety

studies that are conducted to provide

data to support animal drug approvals.

DATES: Written comments may be

submitted at any time.
15934 Federal Register / Vol. 60, No. 59 / Tuesday, March 28, 1995 / Notices

ADDRESSES: Submit written requests for

single copies of the guideline entitled,

‘‘Protocol Development Guideline for

Clinical Effectiveness and Target

Animal Safety Trials’’ to the

Communications and Education Branch

(HFV–12), Center for Veterinary

Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1755.

Send two self-addressed adhesive labels

to assist that office in processing your

requests. Submit written comments on

the guideline to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857. Requests and comments should

be identified with the docket number

found in brackets in the heading of this

document. A copy of the guideline and

received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Larry Ventura, Center for Veterinary

Medicine (HFV–130), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1647.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of the

guideline entitled, ‘‘Protocol

Development Guideline for Clinical

Effectiveness and Target Animal Safety

Trials’’ prepared by CVM. The guideline

is intended to be used by clinical

investigators, study monitors, and

sponsors, when designing investigations

of effectiveness and target animal safety

for animal drug approval and may be

used when submitting the final reports

of these trials. This guideline was

written in response to a request by the

animal health industry for guidance on

facilitating protocol development and

expediting CVM’s review of the

submitted protocols, and it should help

sponsors to include all essential

components of the study in the protocol.

More uniform reports should allow a

systematic, orderly review of the data by

CVM. The goals of the protocol

development guideline are to:

1. Suggest a uniform system for

writing study protocols,

2. Provide a reference of essential

items that should be considered for

inclusion in a study protocol,

3. Facilitate the development of

complete study protocol(s) by the

author(s),

4. Design more user friendly protocols

for investigator(s),

5. Enable FDA reviewers to evaluate

study protocols more quickly and

convey their comments in terms more

easily understood by the sponsor, and

6. Reduce the number of essential

revisions of study protocols.

The guideline offers a complete

outline of the components necessary for

a well-designed study so that CVM and

industry have a common reference

point. This uniform approach will

facilitate the drafting of study reports by

the sponsor and their subsequent review

by CVM. The contents of this guideline

are neither all inclusive nor will all

items listed be applicable to all study

protocols. It is the responsibility of the

sponsor to ensure that the essential

components of a study are included in

their protocol. Guidelines state

procedures or practices that may be

useful to the persons to whom they are

directed, but are not legal requirements.

A person may follow the guideline or

may choose to follow alternate

procedures or practices. If a person

chooses to use alternate procedures or

practices, that person may wish to

discuss the matter further with the

agency to prevent an expenditure of

money and effort on activities that may

later be determined to be unacceptable

to FDA.

Guidelines are generally issued under

§§ 10.85(a) and 10.90(b)(21 CFR 10.85(a)

and 10.90(b)). The agency is now in the

process of revising §§ 10.85(a) and

10.90(b). Therefore, this guideline is not

being issued under the authority of

§§ 10.85(a) and 10.90(b). A guideline

does not bind the agency, and it does

not create or confer any rights,

privileges, or benefits for or on any

person. When a guideline states a

requirement imposed by statute or

regulation, however, the requirement is

law and its force and effect are not

changed in any way by virtue of its

inclusion in the guideline.

Interested persons may, at any time,

submit written comments on the

guideline to the Dockets Management

Branch (address above). FDA will

consider these comments in

determining whether further

amendments to, or revisions of, the

document are warranted. Two copies of

any comments should be submitted,

except that individuals may submit one

copy, identified with the docket number

found in brackets in the heading of this

document. The guideline and received

comments may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday, at the

Dockets Management Branch.

Dated: March 16, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–7513 Filed 3–27–95; 8:45 am]

BILLING CODE 4160–01–F

Industry and Consumer Exchange

Meeting Concerning FDA and APHIS

Activities on a Potential Agreement

With the European Union Related to

Human and Animal Drug and

Biological Product Information; Notice

of Public Meeting

AGENCIES: Food and Drug

Administration, HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) and Animal and

Plant Health Inspection Service (APHIS)

are cosponsoring a public meeting with

all persons interested in a potential

agreement with the European Union

that would facilitate the harmonization

of good manufacturing practices

(GMP’s) and quality controls for human

and animal drug and biological products

and associated compliance and

enforcement activities, and provide for

the exchange and use of such

information by the respective regulatory

authorities. Such an agreement would

enhance the goals of harmonizing the

monitoring and enforcement standards

of the GMP’s and would facilitate

international trade.

DATES: The industry and consumer

exchange meeting will be held on

Friday, March 31, 1995, 9 a.m. to 12 m.

ADDRESSES: The industry and consumer

exchange meeting will be held at the

Hubert H. Humphrey Bldg., Humphrey

Auditorium, 200 Independence Ave.

SW., Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Walter M. Batts, Office of Health Affairs

(HFY–50), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–4480

(Fax 301–443–0235).

Those persons interested in attending

this meeting should Fax their

registration, including name, firm, or

organization name, address, and

telephone number to Nathaniel L.

Geary, Office of External Affairs, Food

and Drug Administration (301–443–

5153) or telephone 301–443–6776.

There is no registration fee, but advance

registration is requested. Additionally, if

there are any individuals that wish to

make a presentation at this meeting,

advance notice is required.

SUPPLEMENTARY INFORMATION: The

purpose of the public meeting is to

provide information concerning FDA

and APHIS activities with the European

Union related to human and animal

drug and biological product GMP’s and

quality controls, as well as to provide an

opportunity to hear and address

concerns from persons involved in these

industries and persons representing

consumer and other interests.