25936 Federal Register / Vol. 65, No. 87 / Thursday, May 4, 2000 / Notices

have appropriate training and

experience in the field of autism, other

developmental disabilities, and

surveillance activities, as evidenced by

publications, presentations, or other

materials that document prior work.

Demonstration of the ability to provide

adequate facilities and other necessary

resources to carry out all proposed

activities.

5. Budget (Not Scored)

The extent to which the budget is

reasonable, clearly justified, and

consistent with the stated objectives and

proposed activities.

6. Human Subjects Requirements (Not

Scored)

The extent to which the applicant

complies with the Department of Health

and Human Services regulation (45 CFR

part 46) on the protection of human

subjects.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Semi-annual reports, no more than

30 days after the end of the report

period;

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial status and

performance reports, no more than 90

days after the end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I in the

application kit.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–7 Executive Order 12372 Review

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301 and 317 of the Public

Health Service Act, [42 U.S.C. sections

241 and 247b, as amended]. The Catalog

of Federal Domestic Assistance number

is 93.283.

J. Where To Obtain Additional

Information

This and other documents may be

downloaded through the CDC homepage

on the Internet at http://www.cdc.gov

(click on funding).

Please refer to Program

Announcement 00107 when you request

information. For business management

technical assistance, please contact:

Mattie B. Jackson, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

2920 Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone

number: 770/488–2718, Email address:

mij3@cdc.gov.

For program technical assistance,

contact: Tom Horne, Principal

Management Officer, Developmental

Disabilities Branch, National Center for

Environmental Health, Centers for

Disease Control and Prevention (F–15),

4770 Buford Hwy, NE, Atlanta, GA

30341, Telephone: 770/488–7364, Email

address: tjh1@cdc.gov.

Dated: April 28, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–11092 Filed 5–3–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00103]

C. Everett Koop Community Health

Information Center—A National Model

for Physician-Based Community

Health Information Centers; Notice of

Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a grant program entitled ‘‘C.

Everett Koop Community Health

Information Center—A National Model

for Physician-based Community Health

Information Centers.’’

CDC is committed to achieving the

health promotion and disease

prevention objectives of ‘‘Healthy

People 2010’’ a national activity to

reduce morbidity and mortality and

improve the quality of life. This

program addresses the ‘‘Healthy People

2010’’ focus area of Health

Communication.

For the conference copy of ‘‘Healthy

People 2010,’’ visit the internet site:

http://www.health.gov/healthypeople.

The purpose of the program is to

strengthen the C. Everett Koop

Community Health Information Center

(CHIC) by (1) conducting a follow-up

evaluation of CHIC as an effective model

for other community health information

centers, (2) disseminating the results of

the evaluation to professional medical

societies nationwide, and (3) conducting

a final assessment of the dissemination

and use of the model in other

communities.

B. Eligible Applicants

Assistance will be provided only to

the C. Everett Koop Community Health

Information Center, Philadelphia

College of Physicians, Philadelphia, PA.

No other applications are solicited. The

sole source justification is based on

congressional language in fiscal year

2000 CDC Appropriation, which

provides earmarked funding for the C.

Everett Koop Community Health

Information Center in Philadelphia, PA.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement, contract

loan, or any other form.

C. Availability of Funds

Approximately $200,000 is available

in FY 2000 to fund the C. Everett Koop

Community Health Information Center.

It is expected that the award will begin

on or about September 30, 2000, and

will be made for a 12-month budget

period within a project period of three

years. Funding estimates may change.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the following:

1. Strengthening the CHIC program by

fully implementing the

recommendations of the 1999

evaluation related to (a) marketing,

promotion, and visibility, (b) resources,

and (c) accessibility (See attachment I

for recommendations).

2. Encouraging community

involvement by developing a network of

partners in providing current, complete,

and comprehensive health information,

and in increasing awareness of the

availability of information resources.

3. After the recommendations have

been fully implemented, developing a

Federal Register / Vol. 65, No. 87 / Thursday, May 4, 2000 / Notices 25937

plan for a follow-up evaluation of the

CHIC program.

4. Establishing an advisory committee

to plan for the dissemination of the

evaluation results nationwide.

5. Analyzing data, implementing

recommendations from the follow-up

evaluation, disseminating the evaluation

results to similar medical societies

nationwide, and a followup assessment

of the dissemination of and use of the

model in other communities in years

two and three.

E. Application Content

Application

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out your program

plan. The narrative should be no more

than 20 double-spaced pages, printed on

one side, with one inch margins, and

unreduced font.

F. Submission and Deadline

Submit the original and two copies of

the application PHS Form 398 (OMB

Number 0925–0001) (adhere to the

instructions on the Errata Instruction

Sheet for PHS 398). Forms are available

at the following Internet address:

www.cdc.gov/. Forms, or in the

application kit. On or before June 1,

2000, submit the application to the

Grants Management Specialist

identified in the ‘‘Where to Obtain

Additional Information’’ section of this

announcement.

Deadline: The application shall be

considered as meeting the deadline

above if it is either:

(a) Received on or before the deadline

date; or

(b) Sent on or before the deadline

date.

(Applicant must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or the U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing.)

Late Applications: Applications

which do not meet the criteria in (a) or

(b) above are considered late

applications, will not be considered,

and will be returned to the applicant.

G. Evaluation Criteria

The application will be evaluated by

an objective review panel based on the

following criteria:

Background (10 Points)

The extent to which the applicant

demonstrates an understanding of the

current literature and theories relevant

to the proposed activities.

Program Plan (40 Points)

1. The extent to which the overall

program plan has clear objectives that

are specific, measurable, and realistic.

(10 points)

2. The extent to which the proposed

program activities are well-specified,

achievable, time-phased, and consistent

with the proposed objectives. (10

points)

3. The extent to which the proposed

research methods (e.g., data collection,

outcome measures, data analyses, etc.)

are clear and appropriate, have

scientific merit, and are consistent with

proposed objectives and activities. (10

points)

4. The degree to which the applicant

has met the CDC policy requirements

regarding the inclusion of women,

ethnic and racial groups in the proposed

research. This includes:

a. The proposed plan for the inclusion

of both sexes and racial and ethnic

minority populations for appropriate

representation.

b. The proposed justification when

representation is limited or absent.

c. A statement as to whether the

design of the study is adequate to

measure differences when warranted.

(10 points).

Evaluation Plan (20 Points)

The quality of the plan to evaluate the

overall project as well as specific

program activities in regard to progress,

efficacy, and cost benefits.

Collaborations (20 Points)

1. The extent to which the applicant

has described a plan for establishing

and gathering input from an advisory

committee that includes experts with

expertise critical to the success of the

project. (10 points)

2. The extent to which the applicant

has described a plan for establishing

collaborative relationships with

appropriate organizations, individuals,

federal, state, and local health and

education agencies to implement and

evaluate the proposed activities. (10

points)

Management and Staffing Plan (10

Points)

The extent to which the applicant

demonstrates the scientific expertise

and capacity to carry out the program

objectives and specific project plan.

Budget (Not Scored)

The extent to which the budget and

justification are consistent with program

objectives and purpose.

Human Subjects (Not Scored)

If the proposed project involves

human subjects, whether or not exempt

from the Department of Health and

Human Services (DHHS) regulations,

the extent to which adequate procedures

are described for the protection of

human subjects.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Progress reports (annual);

2. Financial status report, not more

than 90 days after the end of the budget

period; and

3. Final financial status and

performance reports, no more than 90

days after the end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment II in the

application kit.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–7 Executive Order 12372 Review

AR–8 Public Health System Reporting

Requirements

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301(a), 317(k)(2) and 1706 [42

U.S.C. 241(a), 247(k)(2) and 300u–5] of

the Public Health Services Act, as

amended. The Catalog of Federal

Domestic Assistance number is 93.135.

J. Where To Obtain Additional

Information

This announcement and other CDC

program announcements can be found

on the CDC home page Internet—http:/

/www.cdc.gov. Click on ‘‘Funding’’ then

‘‘Grants and Cooperative Agreements.’’

To obtain additional information

contact: Cynthia Collins, Grants

Management Specialist, Grants

25938 Federal Register / Vol. 65, No. 87 / Thursday, May 4, 2000 / Notices

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (Centers for

Disease Control), 2920 Brandywine

Road, Room 3000, Atlanta, GA 30341–

4146, Telephone (770) 488–2757, E-mail

address:coc9@cdc.gov.

For program technical assistance,

contact: Elijah West, National Center for

Chronic Disease Prevention and Health

Promotion, Centers for Disease Control

and Prevention (CDC), 4770 Buford

Highway, NE., Mailstop K–44, Atlanta,

GA 30341–3724, Telephone 404–488–

5549, E-mail address:ejw1@cdc.gov.

Dated: April 28, 2000.

Henry S. Cassell, III,

Acting Director, Procurement and Grants

Office, Center for Disease Control And

Prevention (CDC).

[FR Doc. 00–11094 Filed 5–3–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1220]

The Future of the International

Conference on Harmonization of

Technical Requirements for the

Registration of Pharmaceuticals for

Human Use (ICH); Notice of Public

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public meeting entitled ‘‘The Future of

the International Conference on

Harmonization of Technical

Requirements for the Registration of

Pharmaceuticals for Human Use’’ to

solicit information and receive

comments on the future of the ICH. The

purpose of the meeting is to solicit

public input prior to the next Steering

Committee meeting in Brussels,

Belgium, July 2000, at which discussion

of the future of the ICH will be

continued.

DATES: The public meeting will be held

on May 16, 2000, from 10 a.m. to 2 p.m.

Registration must be received by May 9,

2000. Written and electronic comments

regarding the public meeting must be

submitted by May 20, 2000.

ADDRESSES: The public meeting will be

held in the Center for Drug Evaluation

and Research, Advisory Committee

Conference Room, 5630 Fishers Lane,

rm. 1066, Rockville, MD 20857.

Written submissions must be sent to

the Dockets Management Branch, Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Two copies of any written 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. Electronic submissions must

be sent to the Dockets Management

Branch at http://www.fda.gov/scripts/

oc/dockets/comments/

commentsmain.cfm.

FOR FURTHER INFORMATION CONTACT:

Kimberly L. Topper, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–7001, FAX 301–827–6801, or

e-mail: Topperk@cder.fda.gov.

Registration: There is no registration

fee for this public meeting, but

registration by May 9, 2000, is required.

Participation is limited to the first 140

registrants due to limited space. FDA

employees are required to register to

attend the meeting. Interested persons

may register with the contact person via

e-mail at: topperk@cder.fda.gov or fax

301–827–6801 and provide the

following information: Name, affiliation,

address, phone, fax, and e-mail address.

Interested persons may also register by

mail with the contact person (address

above).

SUPPLEMENTARY INFORMATION:

I. Background

The ICH was established in 1990 as a

joint regulatory/industry project to

improve, through harmonization, the

efficiency of the process for developing

and registering new medicinal products

in Europe, Japan, and the United States

without compromising the regulatory

obligations of safety and effectiveness.

In recent years, many important

initiatives have been undertaken by

regulatory authorities and industry

associations to promote international

harmonization of regulatory

requirements. FDA has participated in

many meetings designed to enhance

harmonization and is committed to

seeking scientifically based harmonized

technical procedures for pharmaceutical

development. One of the goals of

harmonization is to identify and then

reduce differences in technical

requirements for medical product

development among regulatory

agencies. The ICH was organized to

provide an opportunity for

harmonization initiatives to be

developed with input from both

regulatory and industry representatives.

The ICH is concerned with

harmonization among the following

three regions: The European Union,

Japan, and the United States. The six

ICH sponsors are the European

Commission, the European Federation

of Pharmaceutical Industries

Associations, the Japanese Ministry of

Health and Welfare, the Japanese

Pharmaceutical Manufacturers

Association, FDA, and the

Pharmaceutical Research and

Manufacturers of America. The ICH

Secretariat, which coordinates the

preparation of documentation, is

provided by the International

Federation of Pharmaceutical

Manufacturers Associations (IFPMA).

The ICH Steering Committee includes

representatives from each of the ICH

sponsors and the IFPMA, as well as

observers from the World Health

Organization, the Canadian

Therapeutics Products Programme, and

the European Free Trade Area. The ICH

process has achieved significant

harmonization of the technical

requirements for the approval of

pharmaceuticals for human use in the

three ICH regions. The current ICH

process and structure can be found on

the Internet at http://www.ifpma.org/

ich1.html.

The ICH will present the Common

Technical Document and other

significant achievements at the ICH 5

Conference in San Diego in November

2000. In preparing for this meeting, the

ICH Steering Committee is evaluating

the future direction for the ICH,

including structure, processes, work

program, and global cooperation. FDA is

soliciting public input at this time to

assist the agency in these deliberations.

II. Issues To Be Discussed at the Public

Meeting

The issues to be discussed include the

following: (1) Administrative and

technical issues, (2) future participation,

(3) global cooperation, and (4) new topic

areas.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending at the public

meeting. Oral presentations from the

public will be scheduled between

approximately 10:30 a.m. and 2 p.m.

Time allotted for oral presentations may

be limited to 10 minutes. Those desiring

to make oral presentations should notify

the contact person by May 9, 2000, and

submit: A brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses, phone number, fax, and email of proposed participants, and an

indication of the approximate time

requested to make their presentation.