Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices 5645

and regulations to become a bank

holding company and/or to acquire the

assets or the ownership of, control of, or

the power to vote shares of a bank or

bank holding company and all of the

banks and nonbanking companies

owned by the bank holding company,

including the companies listed below.

The applications listed below, as well

as other related filings required by the

Board, are available for immediate

inspection at the Federal Reserve Bank

indicated. The application also will be

available for inspection at the offices of

the Board of Governors. Interested

persons may express their views in

writing on the standards enumerated in

the BHC Act (12 U.S.C. 1842(c)). If the

proposal also involves the acquisition of

a nonbanking company, the review also

includes whether the acquisition of the

nonbanking company complies with the

standards in section 4 of the BHC Act

(12 U.S.C. 1843). Unless otherwise

noted, nonbanking activities will be

conducted throughout the United States.

Unless otherwise noted, comments

regarding each of these applications

must be received at the Reserve Bank

indicated or the offices of the Board of

Governors not later than February 28,

2000.

A. Federal Reserve Bank of Chicago

(Phillip Jackson, Applications Officer)

230 South LaSalle Street, Chicago,

Illinois 60690–1414:

1. Old Kent Financial Corporation,

Grand Rapids, Michigan; to merge with

Grand Premier Financial, Inc.,

Wauconda, Illinois, and thereby

indirectly acquire Grand National Bank,

Wauconda, Illinois.

Board of Governors of the Federal Reserve

System, January 31, 2000.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 00–2454 Filed 2–3–00; 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.

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 February 18, 2000.

A. Federal Reserve Bank of

Minneapolis (JoAnne F. Lewellen,

Assistant Vice President) 250 Marquette

Avenue, Minneapolis, Minnesota

55480–2171:

1. Dakota Bancshares, Inc., Mendota

Heights, Minnesota; and its subsidiary,

Olivia Bancorporation, Inc., Olivia,

Minnesota; to engage de novo through

their subsidiary, American State

Insurance Agency, Inc., Olivia,

Minnesota, in general insurance agency

activities in a place where the bank

holding company has a lending office

and that has a population not exceeding

5,000, pursuant to § 225.28(b)(11)(iii) of

Regulation Y.

Board of Governors of the Federal Reserve

System, January 31, 2000.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 00–2453 Filed 2–3–00; 8:45 am]

BILLING CODE 6210–01–P

FEDERAL RESERVE SYSTEM

Sunshine Act Meeting

AGENCY HOLDING THE MEETING: Board of

Governors of the Federal Reserve

System .

TIME AND DATE: 10:00 a.m., Wednesday,

February 9, 2000.

PLACE: Marriner S. Eccles Federal

Reserve Board Building, 20th and C

Streets, N.W., Washington, D.C. 20551.

STATUS: Closed.

MATTERS TO BE CONSIDERED: 

1. Personnel actions (appointments,

promotions, assignments, reassignments, and

salary actions) involving individual Federal

Reserve System employees.

2. Any matters carried forward from a

previously announced meeting.

CONTACT PERSON FOR MORE INFORMATION:

Lynn S. Fox, Assistant to the Board;

202–452–3204.

SUPPLEMENTARY INFORMATION: You may

call 202–452–3206 beginning at

approximately 5 p.m. two business days

before the meeting for a recorded

announcement of bank and bank

holding company applications

scheduled for the meeting; or you may

contact the Board’s Web site at http://

www.federalreserve.gov for an

electronic announcement that not only

lists applications, but also indicates

procedural and other information about

the meeting.

Dated: February 2, 2000.

Robert deV. Frierson,

Associate Secretary of the Board.

[FR Doc. 00–2680 Filed 2–2–00; 1:19 pm]

BILLING CODE 6210–01–P

FEDERAL RETIREMENT THRIFT

INVESTMENT BOARD

Sunshine Act Meeting

TIME AND DATE: 10 a.m. (EST), February

14, 2000.

PLACE: 4th Floor, Conference Room

4506, 1250 H Street, N.W., Washington,

D.C.

STATUS: Open.

MATTERS TO BE CONSIDERED: 

1. Approval of the minutes of the January

10, 2000, Board member meeting.

2. Thrift Savings Plan activity report by the

Executive Director.

3. Labor Department audit briefing.

4. Investment policy review.

CONTACT PERSON FOR MORE INFORMATION:

Thomas J. Trabucco, Director, Office of

External Affairs, (202) 942–1640.

Dated: February 1, 2000.

Elizabeth S. Woodruff,

Secretary to the Board, Federal Retirement

Thrift Investment Board.

[FR Doc. 00–2679 Filed 2–2–00; 1:19 pm]

BILLING CODE 6760–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–0087]

Draft Guidance for Industry on IND

Meetings for Human Drugs and

Biologics; Chemistry, Manufacturing,

and Controls Information; 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

5646 Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices

industry entitled ‘‘IND Meetings for

Human Drugs and Biologics; Chemistry,

Manufacturing, and Controls

Information.’’ This draft guidance

provides recommendations to industry

on formal meetings between sponsors of

investigational new drug applications

(IND’s) and the Center for Drug

Evaluation and Research (CDER) or

Center for Biologics Evaluation and

Research (CBER) on chemistry,

manufacturing, and controls (CMC)

information.

DATES: Submit written comments on the

draft guidance by May 4, 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, or http://

www.fda.gov/cber/guidelines.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; or to the

Office of Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, 1401 Rockville Pike,

Rockville, MD 20852–1488, FAX: 888–

CBERFAX or 301–827–3844. Send one

self-addressed adhesive label to assist

the 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:

Stephen K. Moore, Center for Drug

Evaluation and Research (HFD–

501), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

6430; or

Robert A. Yetter, Center for Biologics

Evaluation and Research (HFM–10),

Bldg. N29B, 8800 Rockville Pike,

Bethesda, MD 20892, 301–827–

0373.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘IND

Meetings for Human Drugs and

Biologics; Chemistry, Manufacturing,

and Controls Information.’’ This draft

guidance covers three kinds of meetings

held between sponsors and the agency:

(1) Pre-IND, (2) end-of-phase 2, and (3)

pre-new drug application or prebiologics license application. These

meetings address questions and

scientific issues that arise during the

course of clinical investigations, aid in

the resolution of problems, and facilitate

evaluation of the drug. The meetings

often coincide with critical points in the

drug development and/or regulatory

process. This draft guidance is intended

to assist in making these meetings on

CMC information more efficient and

effective by providing information on

the: (1) Purpose, (2) meeting request (3)

information package, (4) format, and (5)

focus of the meeting.

This Level 1 draft guidance is being

issued consistent with FDA’s good

guidance practices (62 FR 8961,

February 27, 1997). The draft guidance

represents the agency’s current thinking

on ‘‘IND Meetings for Human Drugs and

Biologics; Chemistry, Manufacturing,

and Controls Information.’’ 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, regulations, or both.

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: January 24, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–2436 Filed 2–3–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources And Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995,

Public Law 104–13), the Health

Resources and Services Administration

(HRSA) publishes periodic summaries

of proposed projects being developed

for submission to OMB under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited on: (a) whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project: Loan Information

System Records for the DHHS and

DHUD Hospital Mortgage Insurance,

Guarantee, and Direct Loan Programs

(OMB 0915–0174)—Extension

The Division of Facilities Loans

within the Health Resources and

Services Administration monitors

outstanding direct and guaranteed loans

made under Section 621 of Title VI and

Section 1601 of Title XVI of the Public

Health Service Act, as well as loans

insured under the Section 242 Hospital

Mortgage Insurance Program of the

National Housing Act. These programs

were designed to aid construction and

modernization of health care facilities

by increasing the access of facilities to

capital through the assumption of the

mortgage credit risk by the Federal

Government.

Operating statistics and financial

information are collected annually from

hospitals with mortgages that are

insured under these programs. The

information is used to monitor the

financial stability of the hospitals to

protect the Federal investment in these

facilities. The form used for the data

collection is the Hospital Facility Data

Abstract. No changes in the form are

proposed.

The estimated response burden is as

follows: