[Federal Register Volume 66, Number 118 (Tuesday, June 19, 2001)]
[Notices]
[Pages 32955-32958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15389]


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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

[[Page 32956]]

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,

[[Page 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 time-lines 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 time-lines 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

[[Page 32958]]

    (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: 
<a href="/cdn-cgi/l/email-protection#b0d7dcd481f0d3d4d39ed7dfc6"><span class="__cf_email__" data-cfemail="bddad1d98cfdded9de93dad2cb">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#fb81829fcabb989f98d59c948d"><span class="__cf_email__" data-cfemail="b3c9cad782f3d0d7d09dd4dcc5">[email protected]</span></a>.
  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: 
<a href="/cdn-cgi/l/email-protection#93f8ebe4a2d3f0f7f0bdf4fce5"><span class="__cf_email__" data-cfemail="1d76656a2c5d7e797e337a726b">[email protected]</span></a>.

    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


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