Federal Register / Vol. 66, No. 118 / Tuesday, June 19, 2001 / Notices 32955

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will:

a. Develop a community-based

mechanism for ongoing interaction with

the affected residents and communities.

This mechanism will include

assembling a formal community-based

assistance group to consist of

representatives from the affected

communities.

b. Interact with communities around

the Kelly Air Force Base to assess their

exposure.

c. Develop environmental health

education materials that are appropriate

for residents surrounding Kelly AFB

considering literacy levels, cultural

values, and languages spoken.

E. Application Content

Use the information in the 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. These criteria serve

as the basis for evaluating the

application; therefore, omissions or

incomplete information may affect the

rating of the application.

Narrative should be no more than 30

pages, double-spaced, printed on oneside, with 1′′ margins, and unreduced

fonts (font size 12 points) on 81⁄2′′ by 11′′

paper. The pages must be clearly

numbered, and a complete index to the

application and its appendices must be

included. The original and two copies of

the application must be submitted

unstapled and unbound.

F. Submission and Deadline

Application

Submit the original and two copies of

PHS 5161–1 (OMB Number 0937–0189).

Forms are available in the application

kit and at the following Internet address:

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

application kit.

On or before July 31, 2001, submit the

application to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

G. Evaluation Criteria

The application will be evaluated

individually against the following

criteria by an independent review group

appointed by ATSDR.

1. Proposed Program (50 Percent)

Extent to which the applicant’s

application addresses: (a) The feasibility

of the approach and the adequacy of the

design of the proposed project; (b) the

technical merit of the proposed project,

including the degree to which the

project can be expected to yield or

demonstrate results that will be useful

and desirable in furthering the program

objectives; and (c) the proposed project

schedule, including clearly established

and obtainable project objectives for

which progress toward attainment can

and will be measured.

2. Capability and Coordination Efforts

(15 Percent)

Extent to which the application has

described: (a) The capability of the

applicant’s administrative structure to

foster successful scientific and

administrative management of a

program; (b) the capability of the

applicant to demonstrate an appropriate

plan for interaction with the community

and other partners participating in the

program and (c) the suitability of

facilities and equipment available or to

be purchased for the project.

3. Program Personnel (35 Percent)

Extent to which the proposed program

staff is qualified and appropriate, and

the time allocated for them to

accomplish program activities is

adequate.

4. Budget (Not Scored)

Extent to which the budget is

reasonable, clearly justified, and

consistent with intended use of funds.

H. Other Requirements

Technical Reporting Requirements

Provide ATSDR with original plus

two copies of

1. Annual progress report;

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–7 Executive Order 12372 Review

AR–9 Paperwork Reduction Act

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2000

AR–12 Lobbying Restrictions

AR–18 Cost Recovery—ATSDR

AR–19 Third Party Agreements—

ATSDR

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 104(i)(1)(E), (7), and (15) of the

Comprehensive Environmental

Response, Compensation, and Liability

Act (CERCLA) as amended by the

Superfund Amendments and

Reauthorization Act (SARA) [42 U.S.C.

9604(i)(1)(E), (7), and (15)]. The Catalog

of Federal Domestic Assistance number

is 93.161.

J. Where to Obtain Additional

Information

A complete copy of the

announcement may be downloaded

from CDC’s home page on the Internet

at: http://www.cdc.gov. Click on

‘‘Funding’’ the ‘‘Grants and Cooperative

Agreements.’’ If you have questions after

reviewing the contents of all the

documents, business management

technical assistance may be obtained

from: Nelda Godfrey, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Announcement 01124,

Centers for Disease Control and

Prevention, 2920 Brandywine Rd., Suite

3000, Atlanta, Georgia 30341–4146,

Email address: nag9@cdc.gov,

Telephone: (770) 488–2722.

For program technical assistance,

contact: Maurice West, Environmental

Engineer, Agency for Toxic Substances

and Disease Registry, Division of Health

Assessment and Consultation, 1600

Clifton Rd., NE., Mailstop E–32, Atlanta,

Georgia 30333, Telephone: (404) 498–

0497, Fax: (404) 498–0777, Email

address: myw4@cdc.gov.

Dated: June 12, 2001.

Georgi Jones,

Director, Office of Policy and External Affairs,

Agency for Toxic Substances and Disease

Registry.

[FR Doc. 01–15355 Filed 6–18–01; 8:45 am]

BILLING CODE 4163–70–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01099]

Research on Community Cancer

Control Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for a cooperative agreement

program for Research on Community

Cancer Control. This program addresses

32956 Federal Register / Vol. 66, No. 118 / Tuesday, June 19, 2001 / Notices

the ‘‘Healthy People 2010’’ focus area of

Cancer.

The purpose of this Cooperative

Agreement is to increase the number of

evidence-based intervention studies in

the areas noted in Appendix A. This

will be accomplished through

solicitation of well-designed,

methodologically-sound studies.

B. Eligible Applicants

Applications may be submitted by

public and private nonprofit

organizations and by governments and

their agencies; that is, universities,

colleges, research institutions, hospitals,

State, and local governments or their

bona fide agents, and federally

recognized Indian tribal governments,

Indian tribes, or Indian tribal

organizations.

C. Availability of Funds

Approximately $2,900,000 is available

in FY 2001 to fund six to 13 awards. It

is expected that the awards will begin

on or about September 30, 2001 and will

be made for a 12-month budget period

within a project period of up to five

years. Funding estimates may change.

Awards can be made to applicants for

projects on breast cancer alone, cervical

cancer alone, colorectal cancer alone,

prostate cancer alone, or a combination

of these.

Breast and Cervical Cancer

Approximately $1,100,000 is available

in FY 2001 to fund two to five awards.

It is expected that the average award

will be $550,000 ranging from $200,000

to $600,000. Awards can be made to

applicants for projects on breast cancer

alone, cervical cancer alone, or breast

and cervical cancers together.

Colorectal Cancer

Approximately $850,000 is available

in FY 2001 to fund approximately two

to four awards. It is expected that the

average award will be $300,000 ranging

from $200,000 to $400,000.

Prostate Cancer

Approximately $500,000 is available

in FY 2001 to fund approximately two

to four awards. It is expected that the

average award will be $250,000 ranging

from $200,000 to $300,000.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and on

the availability of funds.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities), and CDC

will be responsible for the activities

listed under 2. (CDC Activities).

1. Recipient Activities

a. Research Activities

(1) Develop a written research

protocol according to the standards for

effective intervention research in the

Community Guide for testing the

effectiveness of an intervention. The

protocol should include hypotheses and

research questions, literature review,

study design, plans for sampling, data

collection, and quantitative data

analyses. Given the demonstrated need

for effective interventions on breast,

cervical, and colorectal cancer, recipient

is encouraged to submit a protocol that

combines two or more intervention

strategies listed in Attachment B in

which the effect of the entire

intervention is measured as well as the

independent effects of each component.

(2) Develop plans for peer-reviewed

publications that will present,

summarize, and interpret the results of

the study.

b. Administrative activities

(1) Develop a time-table listing

duration and expected completion dates

for all major activities.

(2) Submit the research protocol for

Institutional Review Board review by all

cooperating institutions participating in

the research project.

(3) Develop and submit the Office of

Management and Budget package. (See

AR–9 in Other Requirements section of

this document.)

2. CDC Activities

a. Assist in the development of

document for CDC’s required IRB

review. The CDC IRB will review and

approve the protocol initially and on at

least an annual basis until the research

project is completed.

b. Provide consultation and technical

assistance regarding the study.

c. Monitor the recipient’s performance

of project activities and attainment of

project objectives through the

provisions of technical assistance and

progress reporting.

d. Collaborate with the preparation

and publication of research findings.

E. Content

Letter of Intent (LOI)

An LOI is requested for this program.

The narrative should be no more than

two, double spaced pages, printed on

one side, with one inch margins, and

unreduced font. Your letter of intent

will be used to enable CDC to determine

level of interest in the announcement

and should include the following

information:

1. Priority area of application

2. Audience

3. Study design

4. Proposed outcomes

On or before June 29, 2001, submit the

original and two signed copies of the

LOI to the Program Technical

Assistance contact identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

Applications

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections in this

program announcement 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. Number

all pages clearly and sequentially and

include a complete table of contents to

the application and its appendices. The

original and each copy of the

application should be submitted

unstapled and unbound. Print all

materials single-spaced in a 12-point or

larger font on 8.5 by 11 paper with at

least one inch margins and printed on

one side only. All graphics, maps,

overlays, etc., should be in black and

white and meet the above criteria. The

narrative should be no more than 30

pages including budget and

justification. Applicants should also

submit appendices which should not

exceed an additional 20 pages.

1. Executive Summary

a. Provide a clear, concise one to two

page summary of the proposed study.

b. State the need for the proposed

study, the capacity of the investigators

to carry out the research, the program

announcement priority area(s)

addressed, and the study design.

Include descriptions of the

intervention(s), exposures, outcomes,

data collection procedures, and

statistical analyses.

2. Background

a. Demonstrate the need for the

research study within the context of the

priority area(s) and population(s) it is

intended to address.

b. Provide a review of relevant

research studies.

c. Present evidence for research gap(s)

the proposed project will fill.

3. Qualifications and experience

a. Provide evidence of qualifications

and experience of research team, which

should include but not be limited to a

principal investigator, co-investigator,

Federal Register / Vol. 66, No. 118 / Tuesday, June 19, 2001 / Notices 32957

statistician or investigator with

sufficient statistical background and

experienced.

b. Provide evidence of ability to

access the population selected for study

including

(1) Specific letters of support from

named collaborators

(2) Descriptions of past research with

intended collaborators

c. Identify level of effort and time

commitments for key investigators and

staff.

d. Provide resumes or curriculum

vitae in appendices.

e. Describe the necessary

qualifications, experience, and abilities

for unassigned positions.

f. Describe team structure and

methods of routine communication.

4. Work plan and timetable

a. Provide evidence of research within

priority areas.

b. Provide evidence that priority

populations as defined within this

announcement will be studied.

c. Provide specific objectives that are

time-related, measurable, and consistent

with the purpose of the cooperative

agreement.

d. Provide specific and feasible timelines specifying major milestones for the

proposed research, including a schedule

of detailed activities for the first 12

months of the project period, with

milestones for the cooperative

agreement five year project period.

e. Provide plans for feedback of

results to community.

5. Methods

a. Provide hypotheses and research

questions in the context of the

intervention strategy.

b. Describe study population(s)

c. Describe sampling protocol

d. Describe study design proposed

from standards in Community Guide

(see list in Appendix A), including:

(1) Experimental and comparison

group(s)

(2) Exposures and outcomes

(a) Validity

(b) Reliability

e. Describe data collection procedures

f. Provide a clear and appropriate plan

for statistical analyses

6. Inclusion of Women and Minorities

State the degree to which the

proposed research will meet 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.

d. A statement as to whether the plans

for recruitment and outreach for study

participants include the process of

establishing partnerships with

community(ies) and recognition of

mutual benefits.

7. Budget

The budget should be reasonable,

clearly justified, and consistent with the

intended use of funds. All budget

categories should be itemized. Budgets

should include travel for at least one

investigator to travel to Atlanta each

year for a reverse site visit. Proposed

sub-contracts should identify the name

of the contractor, if known; describe the

services to be performed; provide an

itemized budget and justification for the

estimated costs of the contract; specify

the period of performance; and describe

the method of selection. If indirect costs

are requested, a copy of the current

Indirect Cost Rate Agreement should be

included.

F. Application submission and deadline

Submit original and five copies of

PHS–398 (OMB Number 0925–0001)

(adhere to the instructions on the Errata

Instruction Sheet for PHS 398). Forms

are available in the application kit and

at the following Internet address:

www.cdc.gov/od/pgo/forminfo.htm.

On or before July 27, 2001, submit the

application to the Grants Management

Specialist identified in the Where to

Obtain Additional Information section

of this announcement.

Deadline: Applications shall be

considered as meeting the deadline if

they are either:

1. Received on or before the deadline

date; or

2. Sent on or before the deadline date

and received in time for submission to

the objective review group.

(Applicants must request a legibly

dated U.S. Postal Service postmark or

obtain a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks will

not be accepted as proof of timely

mailing.)

Late Applications: Applications that

do not meet the criteria in 1. or 2. above

are considered late applications and

will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Background (5 points)

The extent to which the applicant;

a. demonstrates the need for the

research study within the context of the

priority area(s) and population(s) it is

intended to address;

b. provides a review of relevant

research studies; and

c. presents evidence for research

gap(s) the proposed project will fill.

2. Qualifications and Experience (15

points)

The extent to which the applicant:

a. provides evidence of qualifications

and experience of research team, which

should include but not be limited to a

principal investigator, co-investigator,

statistician or investigator with

sufficient statistical background and

experienced;

b. provides evidence of ability to

access the population selected for study

including letters of support from named

collaborators;

c. identifies level of effort and time

commitments for key investigators and

staff.

3. Work Plan and Time Table (5 points)

The extent to which the applicant:

a. provides evidence of research

within priority areas;

b. provides evidence that priority

populations will be studied;

c. provides specific objectives that are

time-related, measurable, and consistent

with the purpose of the cooperative

agreement; and

d. provides specific and feasible timelines specifying major milestones for the

proposed research, including a schedule

of detailed activities for the first 12

months of the project period, with

milestones for the cooperative

agreement five year project period.

4. Methods (65 points)

The extent to which the applicant:

a. describes the hypotheses and

research questions in the context of the

intervention strategy (5 points);

b. describes the study population(s) (5

points);

c. describes sampling, including (15

points);

(1) unit of analysis (entire population

or sample)

(2) type of sample (random,

convenience, etc.)

(3) potential selection biases

(4) power calculations

d. describes study design (from list in

Appendix A), including (20 points):

(1) experimental and comparison

group(s);

(2) Exposures and outcomes

(a) Validity

32958 Federal Register / Vol. 66, No. 118 / Tuesday, June 19, 2001 / Notices

(1) Verifies by a variety of methods, if

possible, that participants were exposed

to the intervention.

(2) Provides evidence of validity in

the proposed population for existing

interventions and instruments,

including those newly developed.

(b) Reliability provides evidence that

the variables used to measure exposures

and outcomes are consistent and

reproducible.

e. describes data collection

procedures (5 points)

f. provides a clear and appropriate

plan for statistical analyses that

includes: (15 points)

(1) quantitative data analyses

(2) statistical models

(3) statistical approach to

confounding and bias

(4) statistical approach to complex

sampling (i.e., other than simple

random sampling) and sample

weighting, if relevant.

(5) discussion of other statistical

issues, such as use of repeated measures

analyses, where relevant.

5. Inclusion of Women and Minorities

(10 points)

State the degree to which the

proposed research will meet 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;

and

d. a statement as to whether the plans

for recruitment and outreach for study

participants include the process of

establishing partnerships with

community(ies) and recognition of

mutual benefits.

6. Budget (reviewed, but not scored)

The extent to which the budget is

reasonable, clearly justified, and

consistent with the intended use of

funds. All budget categories should be

itemized.

7. Human Subjects Protection (not

scored)

Does the application adequately

address the requirements of Title 45

CFR part 46 for the protection of human

subjects?

H. Other Requirements

Technical Reporting Requirements:

Provide CDC with the original plus

two copies of

1. Semiannual progress reports;

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial report and

performance report, 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 of the

announcement.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

AR–14 Accounting System

Requirements

AR–15 Proof of Non-Profit Status

AR–22 Research Integrity

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 317(k)(2), 1507 [42 U.S.C.

247b(k)(2) and 42 U.S.C. 300n–3]; and

1501 [42 U.S.C. 300k] of the Public

Health Service Act, as amended. The

Catalog of Federal Domestic Assistance

number is 93.919 for breast and cervical

cancers and 93.283 for colorectal and

prostate cancer.

J. Where to Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address—http://www.cdc.gov.

Click on ‘‘Funding’’, then ‘‘Grants and

Cooperative Agreements’’.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from:

Glynnis Taylor, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

Announcement 01099, 2920

Brandywine Road, Room 3000, Atlanta,

GA 30341–4146, Telephone number:

770–488–2752, Email address:

gld1@cdc.gov.

For program technical assistance,

contact: Rosalind Breslow,

Epidemiologist, National Center for

Chronic Disease Prevention and Health

Promotion, Centers for Disease Control

and Prevention, 4770 Buford Highway,

Mail Stop K–55, Atlanta, GA 30341–

3717, Telephone number: 770–488–

3086, Email address: zyd1@cdc.gov.

or

Katherine Wilson, Public Health

Educator, National Center for Chronic

Disease Prevention and Health

Promotion, Centers for Disease Control

and Prevention, 4770 Buford Highway,

Mail Stop K–48, Atlanta, Ga 30341–

3717, Telephone number: 770–488–

3079, Email address: kxw1@cdc.gov.

Dated: June 13, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–15389 Filed 6–18–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Advisory Council for the Elimination of

Tuberculosis: Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following council

meeting.

Name: Advisory Council for the

Elimination of Tuberculosis (ACET).

Times and Dates: 8:30 a.m.–5 p.m.,

July 12, 2001. 8:30 a.m.–12 p.m., July

13, 2001.

Place: Corporate Square Building 8,

1st Floor Conference Room, Atlanta,

Georgia 30333.

Status: Open to the public, limited

only by the space available. The meeting

room accommodates approximately 100

people.

Purpose: This council advises and

makes recommendations to the

Secretary of Health and Human

Services, the Assistant Secretary for

Health, and the Director, CDC, regarding

the elimination of tuberculosis.

Specifically, the Council makes

recommendations regarding policies,

strategies, objectives, and priorities;

addresses the development and

application of new technologies; and

reviews the extent to which progress has

been made toward eliminating

tuberculosis.

Matters to be Discussed: Agenda items

include issues pertaining to the

Tuberculosis control in low incidence

areas, Latent TB Infection, and CDC’s