Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Notices 11097

Board of Governors of the Federal Reserve

System, February 23, 1995.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 95-4973 Filed 2-28-95; 8:45 am]

BILLING CODE 6210-01-F

Harrison Bankshares, Inc.; Notice of

Application to Engage de novo in

Permissible Nonbanking Activities

The company listed in this notice has

filed an application under § 225.23(a)(1)

of the Board’s Regulation Y (12 CFR

225.23(a)(1)) for the Board’s approval

under section 4(c)(8) of the Bank

Holding Company Act (12 U.S.C.

1843(c)(8)) and § 225.21(a) of Regulation

Y (12 CFR 225.21(a)) to commence or to

engage de novo, either directly or

through a subsidiary, in a nonbanking

activity that is listed in § 225.25 of

Regulation Y as closely related to

banking and permissible for bank

holding companies. Unless otherwise

noted, such activities will be conducted

throughout the United States.

The application is available for

immediate inspection at the Federal

Reserve Bank indicated. Once the

application has been accepted for

processing, it will also be available for

inspection at the offices of the Board of

Governors. Interested persons may

express their views in writing on the

question whether consummation of the

proposal can ‘‘reasonably be expected to

produce benefits to the public, such as

greater convenience, increased

competition, or gains in efficiency, that

outweigh possible adverse effects, such

as undue concentration of resources,

decreased or unfair competition,

conflicts of interests, or unsound

banking practices.’’ Any request for a

hearing on this question must be

accompanied by a statement of the

reasons a written presentation would

not suffice in lieu of a hearing,

identifying specifically any questions of

fact that are in dispute, summarizing the

evidence that would be presented at a

hearing, and indicating how the party

commenting would be aggrieved by

approval of the proposal.

Comments regarding the application

must be received at the Reserve Bank

indicated or the offices of the Board of

Governors not later than March 15,

1995.

A. Federal Reserve Bank of

Richmond (Lloyd W. Bostian, Jr., Senior

Vice President) 701 East Byrd Street,

Richmond, Virginia 23261:

1. Harrison Bankshares, Inc., Lost

Creek, West Virginia; to engage de novo

through Harrison Mortgages, Inc., Lost

Creek, West Virginia; in originating

mortgage loans, pursuant to §

225.25(b)(1) of the Board’s Regulation Y.

Board of Governors of the Federal Reserve

System, February 23, 1995.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 95–4974 Filed 2–28–95; 8:45 am]

BILLING CODE 6210–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 94D–0401]

Revised Bioequivalence Guideline;

Draft; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guideline entitled

‘‘Bioequivalence Guideline (Draft)

1994’’ prepared by the Center for

Veterinary Medicine (CVM). The draft

guideline, which is a revision of the

1990 version, covers general

considerations, blood level studies,

pharmacologic end-points, clinical endpoints, and human food safety. The

draft guideline is intended to assist

sponsors of new animal drug

applications in the submission of data to

support approval of these applications.

DATES: Written comments by May 30,

1995.

ADDRESSES: Submit written requests for

single copies of the draft guideline

entitled ‘‘Bioequivalence Guideline

(Draft) 1994’’ to the Communications

and Education Branch (HFV–12), Center

for Veterinary Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1756.

Send two self-addressed adhesive labels

to assist that office in processing your

requests. Submit written comments on

the draft 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 draft 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:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of the draft

guideline entitled ‘‘Bioequivalence

Guideline (Draft) 1994.’’ The draft is

based on an April 1990 bioequivalence

guideline and a consensus of reports

from panel presentations at the 1993

Veterinary Drug Bioequivalence

Workshop held in Rockville, MD. Major

new topics addressed in the draft

guideline include: Bioequivalence

overdose studies, testing for multiple

strength solid oral dosage forms, assay

considerations, area under the curve

and maximum blood concentration as

pivotal parameters, and blood level

studies with good laboratory practice

tissue residue depletion for generic

products for food animals.

Guidelines are generally issued under

§§ 10.85(d) and 10.90(b) (21 CFR

10.85(d) and 10.90(b)), which provide

for the use of guidelines to establish

procedures or standards of general

applicability that are not legal

requirements but that are acceptable to

FDA. The agency is now in the process

of considering whether to revise

§§ 10.85(d) and 10.90(b). Therefore, if

the agency issues this guideline in final

form, it would not be issued under the

authority of §§ 10.85(d) and 10.90(b),

and would not create or confer any

rights, privileges, or benefits for or on

any person, nor would it operate to bind

FDA in any way. 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, on or before

May 30, 1995, submit to the Dockets

Management Branch (address above)

written comments on the draft

guideline. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The draft

guideline and received comments may

be seen in the office above between 9

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

Friday.

Received comments will be

considered to determine whether further

amendments to, or revisions of, the draft

guideline are warranted.

Dated: February 23, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–4962 Filed 2–28–95; 8:45 am]

BILLING CODE 4160–01–F