[Federal Register Volume 69, Number 48 (Thursday, March 11, 2004)]
[Notices]
[Pages 11625-11631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5433]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Participatory Research on Community Interventions To Increase the 
Utilization of Effective Cancer Preventive and Treatment Services

    Announcement Type: New.
    Funding Opportunity Number: PA 04087.
    Catalog of Federal Domestic Assistance Number: 93.945.
    Key Dates:
    Letter of Intent Deadline: March 26, 2004.
    Application Deadline: May 10, 2004.
    Executive Summary: None.

I. Funding Opportunity Description

    Authority: Public Health Service Act, sections 301(a) and 
317(k)(2), as amended.

    Purpose: The Centers for Disease Control and Prevention (CDC) 
announces the availability of fiscal year (FY) 2004 funds for a grant 
program from the National Center for Chronic Disease Prevention and 
Health Promotion (NCCDPHP) Division of Cancer Prevention and Control 
(DCPC) and the Public Health Practice Program Office (PHPPO) Office of 
Science and Extramural Research. This announcement supports research to 
evaluate the effectiveness of community interventions to increase the 
use by health plans, health insurers, and/or health care providers of 
evidence-based cancer screening and treatment services in the following 
three areas: (1) To increase provision of colorectal cancer screening; 
(2) to increase use of shared decision making for prostate cancer 
screening; or (3) to increase use of systematically developed 
guidelines for the diagnosis and treatment of ovarian cancer. 
Applicants may submit separate applications for one or more of the 
three above areas of research. Findings from the funded projects will 
contribute to reductions in cancer morbidity and mortality, 
improvements in the quality of life for cancer patients, and increases 
in the use of public health and prevention research in everyday health 
practice.
    This program announcement addresses the United States Department of 
Health and Human Services (DHHS) Strategic Plan Goal to improve the 
quality of health care services; the HealthierUS Initiative 
``Prevention: Getting Preventive Screening; and ``Healthy People 2010'' 
focus areas of Cancer, Access to Quality Health Services, Educational 
and Community-Based Programs, and Public Health Infrastructure.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for NCCDPHP: Support prevention research to 
develop sustainable and transferable community-based behavioral 
interventions: The following performance goal will be in alignment with 
PHPPO: Strengthen the public health infrastructure by stimulating 
extramural prevention research to discover how to apply the latest 
biomedical research at the local level and how to supply frontline 
public health workers with evidence of what works.
    Research Objectives: The specific research objective for this 
program announcement is to stimulate investigator-initiated, 
participatory research to evaluate the effectiveness of community 
interventions to: (1) Increase provision of colorectal cancer 
screening; (2) increase use of shared decision making for prostate 
cancer screening; or (3) increase use of systematically developed 
guidelines for the diagnosis and treatment of ovarian cancer.
    This objective addresses research gaps identified in recent reviews 
conducted by the Institute of Medicine (IOM), the Cochrane Effective 
Practice and Organization of Care group, and the Agency for Healthcare 
Research and Quality (AHRQ). In Fulfilling the Potential of Cancer 
Prevention and Early Detection, the IOM identified the possibility of 
substantial near term reductions in cancer incidence and mortality if 
health plans, health care providers, and health insurers implemented 
evidence-based cancer screening services. The report also illustrated 
problems for insurers, plans, providers and patients that result from 
implementing new screening technologies when evidence on the balance of 
benefits and harms from screening is uncertain. In Ensuring Quality 
Cancer Care, the IOM concluded that for many cancer patients, a wide 
gap exists between patients' experiences with cancer care and the 
evidence-based quality diagnostic and treatment services that are 
recommended. In The Unequal Burden of Cancer, the IOM provided evidence 
that the cancer burden was greater and the provision of services was 
less for many racial, ethnic and underserved populations.
    Although a Cochrane systematic review of research on the 
effectiveness of interventions to change health care systems or health 
care provider practices found that some interventions are effective in 
certain circumstances, a recent systematic review for AHRQ that focused 
specifically on interventions to increase the use of evidence-based 
cancer control practices found that evidence was insufficient to make 
recommendations. In addition, interventions found to be efficacious in 
research may not be translated into practice because the research often 
does not involve the communities of interest in the research and does 
not address community needs. Therefore, additional research is needed 
on the effectiveness of community interventions to increase use of 
evidence-based cancer screening and treatment services. This research 
should also involve the affected communities of health plans, 
providers, and insurers in the research process to increase the 
likelihood that resulting interventions can be adopted into practice.
    Activities: Awardee activities for this program are as follows:
    (1) Conduct studies to evaluate the effectiveness of community 
interventions to increase use of evidence-based cancer screening and 
treatment services, specifically to:
    (a) Increase provision of colorectal cancer screening.
    (b) Increase use of shared decision making for prostate cancer 
screening.
    (c) Increase utilization of systematically developed guidelines for 
the diagnosis and treatment of ovarian cancer.
    (2) Involve the affected communities, i.e., health plans, health 
care providers, and health insurers in the research process.
    For purposes of this announcement the following definitions are 
used:
    Community refers to health plans, health care providers, and/or 
health insurers, i.e., the people, organizations or networks (including 
faith-based) that would be affected by the community interventions and/
or that would implement such interventions. The investigator for each 
research proposal must define the relevant community or communities 
using a set of tangible criteria. The criteria can include a common 
interest, identity, or characteristic. These communities need not be 
defined geographically.
    Community interventions can include any of a variety of activities 
implemented to change health system or

[[Page 11626]]

health care provider behavior to increase the use of evidence-based 
cancer screening and treatment services. These may include, but are not 
limited to, changes in insurance coverage, incentives, health care 
provider training, reminders to providers or patients, audits and 
feedback, opinion leaders, academic detailing, role modeling, or 
standardized performance measures, e.g., the Health Employer Data and 
Information Set provided at: http://www.ncqa.org/communications/publications/hedispub.htm).
    Participatory research involves collaboration with the community 
being studied, at least in formulating the research questions and in 
interpreting and applying the findings, and possibly also in developing 
study methods and interventions and/or analyzing data, according to the 
community's interests, time, and expertise. The community or 
communities that are to be involved, as participants in the research 
process must be explicitly identified. This announcement is not limited 
to any particular model of participatory research. Applicants should 
also consult guidelines on participatory research, such as those 
provided at: http://www.ihpr.ubc.ca/guidelines.html and the campus-
community partnership principles at: http://futurehealth.ucsf.edu/ccph/principles.html#principles.
    Effectiveness of community interventions means that the community 
intervention in an intervention group results in a measurable and 
statistically significant increase in the use of evidence-based 
colorectal screening services, shared decision making for prostate 
cancer screening, or evidence-based diagnostic and treatment services 
for ovarian cancer. Effectiveness is determined when comparing the 
intervention group to the comparison group or groups.
    Evidence-based colorectal cancer screening services include only 
tests evaluated and recommended by the U.S. Preventive Services Task 
Force (USPSTF). Such tests are performed in the absence of symptoms or 
signs in order to identify cancer at an early stage or to identify 
precursor lesions. The USPSTF has found evidence that these tests are 
effective in reducing mortality and that the balance of risks and 
benefits is positive.
    Shared decision making for prostate cancer screening, for purposes 
of this announcement, refers only to definitions provided in the Guide 
to Community Preventive Services recommendations on the effectiveness 
of community interventions to increase the use of informed decision 
making for cancer screening and in the U.S. Preventive Services Task 
Force recommendations on shared decision making. Shared decision making 
occurs when a patient and his health care provider discuss screening in 
a clinical setting and decide together whether to screen or not. For 
shared decision making to occur, the patient must understand the nature 
and risks of the cancer, the screening test(s) and treatments and their 
likely consequences, including risks (harms), limitations, benefits, 
alternatives, and uncertainties. Further, the patient must consider his 
or her preferences as appropriate, participate in decision making at a 
personally desirable level, and either make a decision consistent with 
his or her preferences and values or elect to defer the decision to a 
later time. For prostate cancer screening, shared decision making must 
include making patients aware of the following from the USPSTF: There 
is good evidence that Prostate Specific Antigen screening can detect 
early-stage prostate cancer, but there is mixed and inconclusive 
evidence that early detection improves health outcomes; screening is 
associated with important harms, including frequent false-positive 
results and unnecessary anxiety, biopsies, and potential complications 
of treatment of some cancers that may never affect or have affected a 
patient's health; and evidence is insufficient to determine whether the 
benefits outweigh the harms.
    Systematically developed guidelines for the diagnosis and treatment 
of ovarian cancer include only diagnostic and treatment services for 
ovarian cancer recommended by a National Institutes of Health (NIH) 
consensus panel or by a review group for the National Cancer Institute 
Physician Data Query System. These guidelines include referral to a 
gynecologic oncologist.
    Health care involves the care, services, and supplies related to 
the health of an individual. Health care includes preventive, 
diagnostic, therapeutic, rehabilitative, maintenance, or palliative 
care, and counseling, among other services. Health care also includes 
the sale and dispensing of prescription drugs or devices.
    Health plans are individual or group plans that provide or pay the 
cost of health care. This includes private and public health plans, and 
includes, for example, health maintenance organizations, preferred 
provider organizations, long term care and health insurance companies, 
employee health benefit plans, and any other plan that provides or pays 
for the costs of health care.
    Health care provider is a person who is trained and licensed to 
give health care, or a place licensed to give health care. Doctors, 
nurses, hospitals, skilled nursing facilities, some assisted living 
facilities, and certain kinds of home health agencies are examples of 
health care providers.
    Health insurers/Health insurance--Insurance against financial 
losses resulting from health issues, preventing, diagnosing and/or 
treating disease, sickness or accidental bodily injury, as well as from 
therapeutic, rehabilitative, maintenance, or palliative care.

II. Award Information

    Type of Award: Grant.
    Fiscal Year Funds: 2004.
    Approximate Total Funding: $650,000 for Colorectal Cancer, 650,000 
for Ovarian Cancer, 650,000 for Prostate Cancer, $1,950,000 Total.
    Approximate Number of Awards: At least three total, including a 
minimum of one for colorectal cancer, one for ovarian cancer, and one 
for prostate cancer.
    Approximate Average Award: $650,000 (This amount is for the first 
12-month budget period, and includes both direct and indirect costs.).
    Floor of Award Range: None.
    Ceiling of Award Range: $650,000.
    Anticipated Award Date: September 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: Four years.
    Throughout the project period, CDC's commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal Government.

III. Eligibility Information

III.1. Eligible applicants

    Applications may be submitted by the following entities:
     Public nonprofit organizations.
     Private nonprofit organizations.
     Universities.
     Colleges.
     Research institutions.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Others

    CDC requires that you submit a Letter of Intent (LOI) if you intend 
to apply to this Program Announcement. If CDC does not receive your LOI 
by the LOI deadline specified under IV.3. Submission Dates and Times, 
your

[[Page 11627]]

application will not be entered into the review process. You will be 
notified that your application did not meet the submission 
requirements.
    If you request a funding amount greater than the ceiling of the 
award range, your application will be considered non-responsive, and 
will not be entered into the review process. You will be notified that 
your application did not meet the submission requirements.
    If your application is incomplete, it will not be entered into the 
review process. You will be notified that your application did not meet 
submission requirements.
    If your application does not include a plan for measures of 
effectiveness to demonstrate the accomplishment of the various 
identified objectives of the grant, as noted in the review criteria 
below, it will not be entered into the review process. You will be 
notified that your application did not meet submission requirements.
    In addition, if your application does not meet the following three 
eligibility criteria, it will not be entered into the review process 
and you will be notified that your application did not meet submission 
requirements:
    1. The principal investigator or co-principal investigator must 
have conducted five or more years of competitively funded peer reviewed 
research community interventions with health plans, health insurers, 
and/or health care providers, and have published the findings from that 
research in peer reviewed journals within the last three years.
    2. The applicant's project team must include significant expertise 
in research in the area of evidence-based cancer preventive or 
treatment services relevant to the project that will be conducted.
    a. For applications related to colorectal cancer, the project team 
must have significant experience in researching or promoting the use of 
cancer screening.
    b. For applications related to prostate cancer, the project team 
must have significant experience in researching or promoting shared 
decision making for cancer screening.
    c. For applications related to ovarian cancer, the project team 
must have significant experience in researching or providing diagnosis 
and treatment of ovarian cancer.
    Such expertise must be evidenced by a history of competitively 
funded peer reviewed research in that area and publication of the 
outcomes from this research in peer reviewed journals.
    3. The applicant must demonstrate an effective and well-defined 
working relationship between the research organization and the 
partnering communities of health care providers, insurers, or plans. 
One source of documentation of this relationship must be provided in 
the form of Letters of Support from each partnering community, briefly 
describing the working relationship.
Documentation of Eligibility
    Evidence of meeting the three additional eligibility criteria 
stated above must be provided as a separate appendix to the 
application, labeled ``Documentation of Eligibility,'' and the location 
of the appendix must be identified in the table of contents. This 
appendix should broadly summarize the additional eligibility criteria 
listed above including institutional affiliations, and experience and 
expertise as they relate to the application. However, this appendix 
should not reiterate or itemize specific details included in the 
Biographical Sketch provided for each of the key personnel.
    These eligibility criteria are to ensure that the proposed research 
will be of significant quality. Proposed research must meet the 
rigorous methodological guidelines required of the research to be 
included in evidence reviews conducted by the USPSTF, AHRQ, and the 
Guide to Community Preventive Services. Furthermore, proposed research 
should contribute to strong evidence on the effectiveness of 
interventions to increase the use of evidence-based cancer control 
practices.
    Individuals Eligible to Become Principal Investigators: Any 
individual with the skills, knowledge, and resources necessary to carry 
out the proposed research, and who meets the eligibility criteria 
specified above for the principal investigator or co-principal 
investigator, is invited to work with his or her eligible applicant 
institution to develop an application for support. Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for CDC programs.

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant, or loan.

IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity, use application form PHS 398 
(OMB number 0925-0001 rev. 5/2001). Forms and instructions are 
available in an interactive format on the CDC Web site, at the 
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm
    Forms and instructions are also available in an interactive format 
on the National Institutes of Health (NIH) Web site at the following 
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.

IV.2. Content and Form of Application Submission

    Letter of Intent (LOI): CDC requires that you submit an LOI if you 
intend to apply to this Program Announcement. If you fail to submit an 
LOI, any subsequent application will not be entered into the review 
process. Although the LOI is not binding, and does not enter into the 
review of your subsequent application, it will be used to gauge the 
level of interest in this program, and to allow CDC to plan the 
application review.
    Your LOI must be written in the following format:
     Maximum number of pages: Three pages
     Font size: 12-point unreduced
     Single spaced
     Paper size: 8.5 by 11 inches
     Page margin size: One inch
     Printed only on one side of page
     Written in plain language, avoid jargon
    Your LOI must contain the following information:
Page 1

     Descriptive title of the proposed research
     Name, address, E-mail address, and telephone 
number of the Principal Investigator
     Names of other key personnel
     Participating institutions
     Number and title of this Program Announcement 
(PA)

Pages 2-3

     A non-binding summary of the proposed project, 
which will be used in planning for peer review of the

[[Page 11628]]

applications. The summary should include information about the area of 
research interest (colorectal cancer screening, prostate cancer shared 
decision making, or researching or providing diagnosis and treatment of 
ovarian cancer), the communities with which the investigators will 
collaborate, the community intervention(s), and the basic study design.
    Application: Follow the PHS 398 application instructions for 
content and formatting of your application. For further assistance with 
the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or 
contact GrantsInfo, Telephone (301)435-0714, E-mail: 
[email protected].
    Your research plan should address activities to be conducted over 
the entire project period. It should also describe an effective and 
well-defined working relationship between the researchers and the 
partnering community or communities (of health care providers, 
insurers, or plans) in which these partnering communities are active 
participants with the researcher in the research process. The research 
application should also include a clear statement of the roles of the 
community participants. In addition, be sure to address the criteria 
that will be used to review your application. These criteria are listed 
at V. Application Review Information.
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. Your DUNS number must be entered 
on line 11 of the face page of the PHS 398 application form. The DUNS 
number is a nine-digit identification number, which uniquely identifies 
business entities. Obtaining a DUNS number is easy and there is no 
charge. To obtain a DUNS number, access http://www.dunandbradstreet.com 
or call 1-866-705-5711. For more information, see the CDC web site at: 
http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
    This PA uses just-in-time concepts. It also uses the modular 
budgeting as well as non-modular budgeting formats. See http://grants.nih.gov/grants/funding/modular/modular.htm for additional 
guidance on modular budgets. Specifically, if you are submitting an 
application with direct costs in each year of $250,000 or less, use the 
modular budget format. Otherwise, follow the instructions for non-
modular budget research grant applications.
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section VI.2. 
Administrative and National Policy Requirements.

IV.3. Submission Dates and Times

    LOI Deadline Date: March 26, 2004.
    Application Deadline Date: May 10, 2004.
    Explanation of Deadlines: LOIs or Applications must be received in 
the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the 
deadline date. If you send your LOI or application by the United States 
Postal Service or commercial delivery service, you must ensure that the 
carrier will be able to guarantee delivery of the LOI or application by 
the closing date and time. If CDC receives your LOI or application 
after closing due to: (1) Carrier error, when the carrier accepted the 
package with a guarantee for delivery by the closing date and time, or 
(2) significant weather delays or natural disasters, you will be given 
the opportunity to submit documentation of the carriers guarantee. If 
the documentation verifies a carrier problem, CDC will consider the LOI 
or application as having been received by the deadline.
    This announcement is the definitive guide on application submission 
address and deadline. It supersedes information provided in the 
application instructions. If your application does not meet the 
deadline above, it will not be eligible for review, and will be 
discarded. You will be notified that your application did not meet the 
submission requirements.
    CDC will not notify you upon receipt of your LOI or application. If 
you have a question about the receipt of your LOI or application, first 
contact your courier. If you still have a question, contact the PGO-TIM 
staff at: 770-488-2700. Before calling, please wait two to three days 
after the LOI or application deadline. This will allow time for LOIs or 
applications to be processed and logged.

IV.4. Intergovernmental Review of Applications

    Executive Order 12372 does not apply to this program.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
     Construction costs and pieces of equipment 
costing more than $10,000.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement should be less than 12 
months of age.
    Awards will not allow reimbursement of pre-award costs.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail or delivery 
service to: Technical Information Management--PA 04087, CDC 
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    LOI's may not be submitted electronically at this time.
    Application Submission Address: Submit the original and five hard 
copies of your application by express mail or delivery service to: 
Technical Information Management--PA 04087, CDC Procurement 
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    The goals of CDC-supported research are to advance the 
understanding of biological systems, improve the control and prevention 
of disease and injury, and enhance health. In their written comments, 
reviewers will be asked to evaluate the application in order to judge 
the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals.
    The scientific review group will address and consider each of the 
following criteria in assigning the application's overall score, 
weighting them as appropriate for each application. The application 
does not need to be strong in all categories to be judged likely to 
have major scientific impact and thus deserve a high priority score. 
For example, an investigator may propose to carry out important work 
that by its nature is not innovative, but is essential to move a field 
forward.
    The criteria are as follows:
    Measures of Effectiveness: You are required to provide measures of 
effectiveness that will demonstrate the accomplishment of the various 
identified objectives of the grant. Measures of effectiveness must 
relate to the performance goals stated in the ``Purpose'' section of 
this announcement. Measures must be objective and quantitative, and 
must measure the intended outcome. These measures of effectiveness must 
be submitted with the application and will be an element of evaluation.
    Significance: Does this study address an important problem? If the 
aims of the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of these studies on the

[[Page 11629]]

concepts or methods that drive this field?
    Approach: Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project? Does the applicant acknowledge potential problem 
areas and consider alternative methods?
    Innovation: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?
    Investigator: Is the investigator appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers? 
Does the principal investigator have significant and successful 
experience in conducting community intervention research with health 
plans, health insurers, and/or health care providers? Does the project 
team have expertise in research in the area of evidence-based cancer 
preventive or treatment services in which the project will be conducted 
(in increasing cancer screening use, for colorectal cancer projects; in 
shared decision making for cancer screening, for prostate projects; and 
in diagnosis and treatment of ovarian cancer, for ovarian cancer 
projects)?
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support?
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
    1. Study design and methods used for the proposed community 
intervention research must be of sufficient quality to qualify for 
inclusion in evidence-based reviews conducted for the Guide to 
Community Preventive Services. Those quality criteria are described in 
an early Community Guide publication in the American Journal of 
Preventive Medicine.
    2. Proposed screening tests, informed decision making 
interventions, treatments, and diagnostic services, must be consistent 
with systematic reviews, recommendations and definitions, as noted in 
the definitions section above.
    3. The applicant must demonstrate an effective and well-defined 
working relationship between the researchers and the partnering 
community or communities (of health care providers, or one or more 
insurers or plans) in which these partnering communities are active 
participants with the researchers in the research process. Reviewers 
will refer to both the research plan of the application and Letters of 
Support (Section III.3.) from the community.
    4. The development, implementation, and maintenance of an annual 
information-exchange program between the institutional researchers and 
the community members (even if the institutional researchers are also 
community members) is required. This information-exchange program must 
describe the project's current level of community input and 
involvement, its progress in accomplishing its objectives, and a 
summary of the relevant findings the research has produced. 
Documentation of this program must be in the form of annual reports 
that use plain language, as specified by Section 508 of the Workforce 
Rehabilitation Act, are easily comprehendible, and readily accessible 
to Community Members. Applicant's budgets must reflect the cost 
required for their information-exchange program.
    (5) The proposed research must be judged by the reviewers as likely 
to have a substantial impact on the pursuit of the project's goals.
    Protection of Human Subjects from Research Risks: Does the 
application adequately address the requirements of Title 45 CFR part 46 
for the protection of human subjects? This will not be scored; however, 
an application can be disapproved if the research risks are 
sufficiently serious and protection against risks is so inadequate as 
to make the entire application unacceptable.
    Inclusion of Women and Minorities in Research: Does the application 
adequately address the CDC Policy requirements regarding the inclusion 
of women, ethnic, and racial groups in the proposed research? This 
includes: (1) The proposed plan for the inclusion of both sexes and 
racial and ethnic minority populations for appropriate representation; 
(2) The proposed justification when representation is limited or 
absent; (3) A statement as to whether the design of the study is 
adequate to measure differences when warranted; and (4) 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.
    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO), and for responsiveness by PHPPO. Incomplete 
applications and applications that are non-responsive to the 
eligibility criteria will not advance through the review process. 
Applicants will be notified that their application did not meet 
submission requirements.
    Applications that are complete and responsive to the Program 
Announcement will be evaluated for scientific and technical merit by an 
appropriate peer review group or charter study section convened by 
PHPPO in accordance with Department of Health and Human Services 
requirements, and according to the review criteria listed above. As 
part of the initial merit review, all applications may:
     Undergo a process in which only those 
applications deemed to have the highest scientific merit, generally the 
top half of the applications under review, will be discussed and 
assigned a priority score.
     Receive a written critique summarizing the 
discussion of the review panel.
     Receive a second level review by the Secondary 
Review Panel to be appointed by CDC.
    Award Criteria: Criteria that will be used to make award decisions 
include:
     Scientific merit (as determined by peer review)
     Availability of funds
     Programmatic priorities
     Recommendations by the Secondary Review Panel

V.3. Anticipated Announcement and Award Dates

    September 1, 2004.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA) 
from the CDC Procurement and Grants Office. The NGA shall be the only 
binding, authorizing document between the recipient and CDC. The NGA 
will be signed by an authorized Grants Management Officer, and mailed 
to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92
    For more information on the Code of Federal Regulations, see the 
National

[[Page 11630]]

Archives and Records Administration at the following Internet address: 
http://www.access.gpo.gov/nara/cfr/cfr-table-search.html
    The following additional requirements apply to this project:
     AR-1 Human Subjects Requirements
     AR-2 Requirements for Inclusion of Women and 
Racial and Ethnic Minorities in Research
     AR-6 Patient Care
     AR-8 Public Health System Reporting Requirements
     AR-10 Smoke-Free Workplace Requirements
     AR-11 Healthy People 2010
     AR-12 Lobbying Restrictions
     AR-13 Prohibition on Use of CDC Funds for 
Certain Gun Control Activities
     AR-14 Accounting System Requirements
     AR-15 Proof of Non-Profit Status
     AR-16 Security Clearance Requirement
     AR-22 Research Integrity
     AR-23 States and Faith-Based Organizations
     AR-24 Health Insurance Portability and 
Accountability Act Requirements
     AR-25 Release and Sharing of Data
    Additional information on these requirements can be found on the 
CDC web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

VI.3. Reporting

    If awarded, you must provide CDC with an original, plus two hard 
copies of the following reports:
    1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC Web site) no less than 90 days 
before the end of the budget period. This annual progress report will 
serve as your non-competing continuation application, and must contain 
the following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Measures of Effectiveness Progress Report.
    f. Annual Report from Information-Exchange Program.
    g. Additional Requested Information.
    2. Financial status report no more than 90 days after the end of 
the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    These reports must be mailed to the Grants Management Specialist 
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
    For scientific/research issues, contact: Ralph Coates, Ph.D., 
Extramural Project Officer, Centers for Disease Control and Prevention, 
NCCDPHP/DCPC/OD, 4770 Buford Highway, NE, MS K-52, Atlanta, GA 30341-
3717, Telephone: 770-488-3003, E-mail: [email protected].
    For questions about peer review, contact: Joan Karr, Ph.D., 
Scientific Review Administrator, Centers for Disease Control and 
Prevention, PHPPO/OD/ESA, 4770 Buford Highway, NE (MS K-38), Atlanta, 
GA 30341, Telephone number: 770-488-2597, Fax: 770-488-8200, E-mail 
address: [email protected].
    For financial, grants management, or budget assistance, contact: 
Sharon Robertson, Grants Management Specialist, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-
488-2748, E-mail: [email protected].

VIII. Other Information

References

    1. Curry SJ, Byers T, Hewitt M (eds). Fulfilling the potential 
of cancer prevention and early detection. Institute of Medicine. 
National Academy Press, Washington, DC, 2003. Available at: http://www.iom.edu/report.asp?id=5402.
    2. Hewitt M, Simone JV (eds). Ensuring quality cancer care. 
Institute of Medicine. National Academy Press, Washington, DC, 1999. 
Available at: http://www.iom.edu/report.asp?id=5593.
    3. Haynes MA, Smedley BD, (eds). The Unequal Burden of Cancer. 
National Academy Press, Washington, DC, 1999. Available at: http://books.nap.edu/catalog/6377.html.
    4. U.S. Department of Health and Human Services. Strategic Plan. 
Draft 14, October 2003. Available at: http://www.aspe.hhs.gov/hhsplan/.
    5. Executive Office of the President and the U.S. Department of 
Health and Human Services. HealthierUS Initiative. Prevention: Get 
Preventive Screening. Available at: http://www.healthierus.gov/.
    6. U.S. Department of Health and Human Services. ``Healthy 
People 2010.'' Washington, DC: U.S. Government Printing Office, 
2000. Available at: http://www.health.gov/healthypeople.
    7. Grimshaw JM, Shirran L, Thomas R, et al. Changing provider 
behavior: an overview of systematic reviews of interventions. 
Medical Care 2001; 39(8 Suppl 2):112-45.
    8. Ellis P, Robineson P, Ciliska D, et al. Diffusion and 
dissemination of evidence-based cancer control interventions. 
Evidence Report/Technology Assessment Number 79. (Prepared by Oregon 
Health and Science University under Contract No. 290-97-0017.) AHRQ 
Publication No. 03-E033 Rockville, MD: Agency for Healthcare 
Research and Quality. May 2003. Available at: http://www.ahrq.gov/clinic/tp/cancontp.htm.
    9. Glasgow RE, Bull SS, Gillett C, et al. Behavior change in 
health care settings. A review of recent reports with an emphasis on 
external validity. American Journal of Preventive Medicine 
2002;23:62-9.
    10. Glasgow RE, Lichtenstein E, Marcus AC. Why don't we see more 
translation of health promotion research to practice? Rethinking the 
efficacy-to-effectiveness transition. American Journal of Public 
Health 2003;93:1261-67.
    11. U.S. Preventive Services Task Force. Guide to Clinical 
Preventive Services. Available at: http://www.ahrq.gov/clinic/cps3dix.htm
    12. Ovarian cancer: screening, treatment, and followup. NIH 
Consensus Statement 1994 Apr 5-7;12(3)1-30. Available at: http://consensus.nih.gov/cons/096/096_intro.htm
    13. NIH Consensus Development Panel on Ovarian Cancer. Ovarian 
cancer: Screening, treatment, and follow-up. JAMA 1995;273(6):491-7.
    14. PDQ (Physician Data Query System) of the National Cancer 
Institute, National Institutes of Health, Bethesda, MD. Available 
at: http://www.nci.nih.gov/cancerinfo/pdq/adulttreatment
    15. Ovarian cancer: screening, treatment, and followup. NIH 
Consensus Statement 1994 Apr 5-7;12(3) p. 15. Available at: http://consensus.nih.gov/cons/096/096_intro.htm
    16. U.S. Preventive Services Task Force. Colorectal Cancer--
Screening. Summary of Recommendations. Supporting Documents. Release 
date: July, 2002. Available at: http://www.ahrq.gov/clinic/uspstf/uspscolo.htm
    17. Briss P, Rimer B, Reilley B, et al. Promoting Informed 
Decision Making About Cancer Screening: What Can Communities and 
Health Systems Accomplish? Conceptual Background and a Systematic 
Review. American Journal of Preventive Medicine 2004; 26(1): 67-90. 
Available at: http://www.thecommunityguide.org/cancer/default.htm
    18. Sheridan SL, Harris RP, Woolf SH, for the Shared 
Decisionmaking Workgroup, Third U.S. Preventive Services Task Force. 
Current methods of the U.S. Preventive Services Task Force: A review 
of the process. Shared decision making about screening and 
chemoprevention. A suggested approach from the U.S. Preventive 
Services Task Force. American Journal of Preventive Medicine 
2004;26(1):67-80. Available at: http://www.ahrq.gov/clinic/3rduspstf/shared/sharedba.htm
    19. U.S. Preventive Services Task Force. Prostate Cancer--
Screening. Summary of Recommendations. Supporting Documents. Release 
date: December, 2002. Available at:

[[Page 11631]]

http://www.ahrq.gov/clinic/uspstf/uspsprca.htm
    20. National Institutes of Health (NIH). Final NIH Statement on 
Sharing Research Data. February 26, 2003. Notice: NOT-OD-03-032. 
Available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
    21. Section 504 of the Rehabilitation Act, 29 U.S.C. 794d. 
Workforce Investment Act of 1998. Available at: http://www.usdoj.gov/crt/508/508law.html
    22. Briss P, Zaza S, Pappaioanou M, et al. Developing an 
evidence-based Guide to Community Preventive Services. American 
Journal of Preventive Medicine 2000; 18(1S): 35-44. Available at: 
http://www.thecommunityguide.org/pubs/default.htm

    Dated: March 4, 2004.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 04-5433 Filed 3-10-04; 8:45 am]
BILLING CODE 4163-18-P [FEDREG][VOL]*[/VOL][NO]*[/NO][DATE]*[/
DATE][NOTICES]