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 This draft guidance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draft guidance by May 4, 2000.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copies of the draft guidance to the Drug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:

Federal Register / Vol. 65, No. 24 / Friday, February 4, 2000 / Notices 5647

Form Number of

respondents

Responses

per

respondent

Hours per

response

Total hour

burden

Hospital Facility Data Abstract ......................................................................... 150 1 1 150

Send comments to Susan G. Queen,

Ph.D., HRSA Reports Clearance Officer,

Room 14–33, Parklawn Building, 5600

Fishers Lane, Rockville, MD 20857.

Written comments should be received

within 60 days of this notice.

Dated: January 28, 2000.

Jane Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 00–2433 Filed 2–3–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Availability of Funds for Grants for the

Community Access Program

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice of availability of funds.

SUMMARY: The Health Resources and

Services Administration (HRSA)

announces the availability of $25

million to assist communities and their

safety net providers in developing

integrated health care delivery systems

that serve the uninsured and

underinsured with greater efficiency

and improved quality of care. The $25

million in available funding has been

appropriated under the FY 2000 HHS

Appropriations Act.

In FY 2000, HRSA will provide

funding for approximately 20

communities to further their

development of integrated delivery

systems for the uninsured and

underinsured. Grants will vary in size,

based on the scope of the project and

the size of the service area.

During the first year of funding for

this program, HRSA will support

infrastructure development in

communities that have already begun to

reorganize and integrate their health

care delivery systems. FY 2000 funding

is not intended to support those

communities that have not yet begun

the planning and development of

necessary organizational structure.

Up to 100 communities may

ultimately be funded as part of this

national program targeted by the

Administration to spend $1 billion over

five years. FY 2000 funded communities

may be eligible for available FY 2001

funding (assuming continued

appropriations) to support further

infrastructure development and filling

service gaps. In addition, using the

experiences of the FY 2000 funded

communities as potential models for

adaptation, FY 2001 funding is

anticipated for support of new

communities for planning and system

development. Thus, communities that

have not yet begun the planning and

development of necessary

organizational structure should have an

opportunity to apply in FY 2001.

Over the years that the program is

funded, funds are anticipated to be

available to fill service gaps within

coordinated systems of care.

This program shares some of the same

goals of the W.K. Kellogg Foundation’s

Community Voices Program and the

Robert Wood Johnson Foundation’s

Communities in Charge Program. Thus,

CAP will take into account the

experiences of these foundations as well

as other programs that promote the

integration of services to the uninsured

and underinsured.

DATES: The timeline for application

submission, review, and award are as

follows:

February 10, 2000: Application kits

and additional guidance will be

available through the HRSA Grants

Application Center (GAC).

March 7–16, 2000: There will be a

series of six pre-application workshops

conducted across the country: Boston,

MA—March 7, 2000; Atlanta, GA—

March 8, 2000; Chicago, IL—March 9,

2000; Dallas, TX—March 14, 2000; Los

Angeles, CA—March 15, 2000; Seattle,

WA March 16, 2000.

June 1, 2000: Applications due.

July 3–17, 2000: Applications

reviewed.

August 2000: Site visits to selected

applicants.

September 2000: Grant awards

announced.

ADDRESSES: To receive a complete

application kit (i.e., application

instructions, necessary forms, and

application review criteria), contact the

HRSA GAC at: HRSA GAC, 1815 N. Fort

Meyer Drive, Suite 300, Arlington, VA

22209, Phone: 1–877-HRSA–123, Fax:

1–877-HRSA–345, E-Mail:

hrsagac@hrsa.gov

FOR FURTHER INFORMATION CONTACT: For

further information, contact the

Community Access Program Office:

Community Access Program Office,

Health Resources and Services

Administration, Parklawn Building,

Suite 9A–30, 5600 Fishers Lane,

Rockville, MD 20857, Phone: (301) 443–

0536, Fax: (301) 443–0248.

SUPPLEMENTARY INFORMATION: In 1998,

44.5 million people in the United States

did not have health insurance. Of these,

24.6 million were employed—18.7

million worked full time and 5.9 million

worked part time.

The uninsured and underinsured

often have complex medical needs,

remain outside organized systems of

care, and have insufficient resources to

obtain care. They may defer care or not

receive needed services, and they are

about half as likely to receive a routine

check-up as insured adults. The

uninsured and underinsured also rely

heavily on expensive emergency rooms,

and because they lack a routine source

of care, they often do not receive needed

follow-up services.

Many of the uninsured and

underinsured rely on the nation’s

institutions, systems, and individual

health professionals that provide a

significant volume of health care

services without regard for ability to

pay. In many communities, these

providers are struggling to care for the

increasing numbers of uninsured and

underinsured individuals. They face

many challenges such as an uneven

distribution of the burden of

uncompensated care, the fragmentation

of services for the uninsured,

insufficient numbers of certain types of

providers, reduced Medicaid revenues,

and a growing need for mental health

and substance abuse services.

While integration among these

providers is critical to serve the

uninsured and underinsured with

greater efficiency and to improve quality

of care, many of these providers are so

pressured by basic caregiving tasks, that

they need assistance to coordinate their

efforts with other providers and to

develop integrated community-based

systems of care.

The Community Access Program

Program Purpose

The purpose of this program is to

assist communities and consortia of