Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Notices 66757

voting shares of FCB Interim Bank,

Ocala, Florida.

Board of Governors of the Federal Reserve

System, November 2, 2000.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 00–28531 Filed 11–6–00; 8:45 am]

BILLING CODE 6210–01–P

FEDERAL RESERVE SYSTEM

Notice of Proposals To Engage in

Permissible Nonbanking Activities or

To Acquire Companies That Are

Engaged in Permissible Nonbanking

Activities

The companies listed in this notice

have given notice under section 4 of the

Bank Holding Company Act (12 U.S.C.

1843) (BHC Act) and Regulation Y (12

CFR Part 225) to engage de novo, or to

acquire or control voting securities or

assets of a company, including the

companies listed below, that engages

either directly or through a subsidiary or

other company, in a nonbanking activity

that is listed in § 225.28 of Regulation Y

(12 CFR 225.28) or that the Board has

determined by Order to be closely

related to banking and permissible for

bank holding companies. Unless

otherwise noted, these activities will be

conducted throughout the United States.

Each notice is available for inspection

at the Federal Reserve Bank indicated.

The notice also will be available for

inspection at the offices of the Board of

Governors. Interested persons may

express their views in writing on the

question whether the proposal complies

with the standards of section 4 of the

BHC Act. Additional information on all

bank holding companies may be

obtained from the National Information

Center website at www.ffiec.gov/nic/.

Unless otherwise noted, comments

regarding the applications must be

received at the Reserve Bank indicated

or the offices of the Board of Governors

not later than November 22, 2000.

A. Federal Reserve Bank of Atlanta

(Cynthia C. Goodwin, Vice President)

104 Marietta Street, N.W., Atlanta,

Georgia 30303–2713:

1. Covenant Bancgroup, Inc., Leeds,

Alabama; to engage de novo through its

subsidiary, Raymond James Financial

Services, St. Petersburg, Florida, in

agency transactional services for

customer investments, pursuant to

§ 225.28(b)(7) of Regulation Y.

Board of Governors of the Federal Reserve

System, November 2, 2000.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 00–28529 Filed 11–6–00; 8:45 am]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–1563]

Draft Guidance for Industry on

Carcinogenicity Study Protocol

Submissions; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Carcinogenicity

Study Protocol Submissions.’’ This

document is intended to provide

guidance on the types of information the

Center for Drug Evaluation and Research

relies on when evaluating protocols for

animal carcinogenicity studies.

DATES: Submit written comments on the

draft guidance by February 5, 2000.

General comments on agency guidance

documents are welcome at any time.

ADDRESSES: Copies of this draft

guidance for industry are available on

the Internet at http://www.fda.gov/cder/

guidance/index.htm. Submit written

requests for single copies of the draft

guidance to the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Joseph J. DeGeorge, Center for Drug

Evaluation and Research (HFD–24),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5476.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled

‘‘Carcinogenicity Study Protocol

Submissions.’’ The draft guidance

describes the kind of information the

agency relies on when evaluating

special protocols for animal

carcinogenicity studies.

The Prescription Drug User Fee Act of

1992 (PDUFA) was reauthorized in

November 1997 (PDUFA 2). In

conjunction with PDUFA 2, FDA agreed

to specific performance goals (PDUFA

goals) for activities associated with the

development and review of products in

human drug applications as defined in

section 735(1) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C.

379g(1)). The PDUFA goals for special

protocol assessment and agreement

provide that, upon request, FDA will

evaluate within 45 days certain

protocols and issues relating to the

protocols to assess whether they are

adequate to meet scientific and

regulatory requirements identified by

the sponsor. Protocols for animal

carcinogenicity studies are eligible for

this special protocol assessment. This

draft guidance is intended to facilitate

the agency’s review of animal

carcinogenicity study protocols.

This draft guidance is being issued

consistent with FDA’s good guidance

practices (65 FR 56468, September 19,

2000). The draft guidance represents the

agency’s current thinking on

carcinogenicity study protocol

submissions. It does not create or confer

any rights for or on any person and does

not operate to bind FDA or the public.

An alternative approach may be used if

such approach satisfies the

requirements of the applicable statutes

and regulations.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. 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

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

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

Friday.

Dated: October 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–28521 Filed 11–6–00; 8:45 am]

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