[Federal Register Volume 69, Number 58 (Thursday, March 25, 2004)]
[Notices]
[Pages 15440-15467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-6283]



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Part II





Department of Health and Human Services





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Centers for Disease Control and Prevention



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Health Promotion and Disease Prevention Research Centers Special 
Interest Projects Competitive Supplements; Notice

  Federal Register / Vol. 69, No. 58 / Thursday, March 25, 2004 / 
Notices  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Health Promotion and Disease Prevention Research Centers Special 
Interest Projects Competitive Supplements

    Announcement Type: Competing Supplements.
    Funding Opportunity Number: 04003-FY04 Comp Supp.
    Catalog of Federal Domestic Assistance Number: 93.135.
    Key Dates:
    Letter of Intent Deadline: May 7, 2004.
    Application Deadline: May 25, 2004.

I. Funding Opportunity Description

    Authority: This program is authorized under sections 301(a), 
317(k)(2) and 1706 [42 U.S.C. 241(a), 247b(k)(2) and 300 u-5] of the 
Public Health Service Act, as amended.
    Purpose: The purpose of the Prevention Research Centers (PRC) 
program's Special Interest Projects (SIPs) is to support supplemental 
projects in health promotion and disease prevention research that (1) 
focus on the major causes of death and disability, (2) improve public 
health practice within communities, and (3) cultivate effective state 
and local public health programs. One of the major focuses of this 
supplemental funding program is to design, test, and disseminate 
effective prevention research strategies.
    This program addresses the department-wide initiative, Steps to a 
HealthierUS, which advances the HealthierUS goal of helping Americans 
live longer, better and healthier lives by focusing on the importance 
of prevention. The Steps focus areas supported by this program are the 
following: Physical Activity and Fitness; Nutrition and Overweight; 
Cancer; Diabetes; and other areas addressed by ``Healthy People 2010,'' 
such as Access to Quality Health Services, Disability and Secondary 
Conditions, Educational and Community-Based Programs, and Health 
Communications.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center for Chronic Disease 
Prevention and Health Promotion (NCCDPHP): to support prevention 
research to develop sustainable and transferable community-based 
behavioral interventions.
    Research Objectives: Research objectives are described for each 
special interest project in section IX of this announcement.
    Recipient Activities: Awardee activities for this program are 
described for each special interest project in section IX of this 
announcement. Consistent with the nature of the cooperative agreement 
funding mechanism, awardees are expected to collaborate with CDC staff 
on research activities associated with these projects.
    CDC Activities: CDC activities for this program are described for 
each special interest project in section IX of this announcement. 
Consistent with the nature of the cooperative agreement funding 
mechanism, CDC staff is expected to be substantially involved in the 
program activities, above and beyond routine grant monitoring. This may 
include technical assistance in the design or direction of activities 
to develop research protocols.

II. Award Information

    Type of Award: Cooperative Agreement.
    Fiscal Year Funds: 2004.
    Approximate Total Funding: $18,000,000.
    Approximate Number of Awards: 26 Special Interest Projects.
    Approximate Average Award: $ Amount Varies (see each individual 
special interest project description in section IX). Before application 
submission, it is imperative that the Principal Investigator critically 
evaluate whether the proposed budget is commensurable with the scope of 
work and provide thorough justification for any amounts requested. If 
CDC's Secondary Review Panel determines that funding discrepancies 
exist for any approved SIP application, the panel will make funding 
recommendations to the CDC/NCCDPHP Director for review.
    Floor of Award Range: None.
    Ceiling of Award Range: CDC will accept and review applications 
with budgets greater than the ceiling of the award range.
    Anticipated Award Date: September 15, 2004.
    Budget Period Length: 12 months.
    Project Period Length: Projects range in length from a minimum of 1 
year to a maximum of 5 years. Throughout the project period, CDC's 
commitment to continuation of awards will be as described below.

Continuation of Funding

    Continuation of awards within an approved project period 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.

Funding Preferences

    If applicable for a particular special interest project, funding 
preference will be based on maintaining an equitable geographic 
distribution of centers and for the distribution of centers among areas 
containing a wide range of population groups.

III. Eligibility Information

    III.1. Eligible applicants: All applicants who have applied for and 
have been considered eligible for Program Announcement 04003 may submit 
an application for the special interest project competitive supplements 
announcement.
    Please note, however, only those applicants who have been selected 
as Prevention Research Centers under Program Announcement 04003 will be 
considered eligible to compete for the Special Interest Project 
supplements funding. That is, only applicants who are selected to 
receive a Notice of Grant award in September 2004 for Program 
Announcement 04003 will be considered eligible to receive funding for 
the special interest project competitive supplements.
    III.2. Cost Sharing or Matching: Matching funds are not required 
for this program.
    III.3. Other Eligibility Requirements: Submission of a Letter of 
Intent (LOI) on or before the LOI deadline.
    III.4. Individuals Eligible to Become Principal Investigators: 
Individuals with the skills, knowledge, and resources necessary to 
conduct the proposed research are invited to work with their 
institutions to develop an application. Individuals from 
underrepresented racial or 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. How to Obtain Application Forms and Form Instructions: 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

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National Institutes of Health (NIH) Web site at the following Internet 
address: http://grants.nih.gov/grants/funding/phs398/phs398.html.
    Applicants that do not have access to the Internet or have 
difficulty accessing the forms online can receive the application forms 
through the mail by contacting the CDC Procurement and Grants Office 
Technical Information Management Section (PGO-TIM) staff at (770) 488-
2700.
    IV.2. Content and Form of Submission:
    Letter of Intent (LOI): Potential applicants are required to send a 
LOI stating intent to apply for a specific SIP. The LOI will be used to 
gauge the level of interest in this program and help program prepare 
for the Special Emphasis Panel. If an LOI is not received by the LOI 
deadline, applicant will be considered ineligible for this 
announcement.
    The LOI must be written in the following format:
     Maximum number of pages: one.
     Font size: 12-point unreduced.
     Double spaced.
     Paper size: 8.5 by 11 inches.
     Page margin size: One inch.
     Printed only on one side of page.
     Written in plain language, avoiding jargon.
    The LOI must contain the following information:
     Title and number of the Special Interest Project 
applying for;
     Name, address, E-mail address, and telephone 
number of the Principal Investigator;
     Participating institution or Prevention Research 
Center.
    Application: A separate application must be submitted for each SIP. 
Applications must clearly indicate which SIP the applicant is applying 
for.
    Follow the PHS 398 application instructions for content and 
formatting of the application. For assistance with the PHS 398 
application form, contact PGO-TIM staff at (770) 488-2700, or contact 
GrantsInfo at Telephone (301) 435-0714 or E-mail: [email protected].
    Applicants' research plan should address activities to be conducted 
over the entire project period specified.
    Applicants 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. 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, go online at 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. Enter the DUNS number on line 11 of the 
face page of the PHS 398 application form.
    IV.3. Submission Dates and Times:
    LOI Deadline Date: The LOI must be received by 4 p.m. Eastern Time, 
May 7, 2004. Submit an electronic copy of the LOI to Jean Smith at e-
mail address [email protected].
    Application Deadline Date: Applications for SIPs must be received 
by CDC no later than 4 p.m. on May 25, 2004.
    Explanation of Application Deadline: Applications must be received 
in the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the 
deadline date. For applications sent via the U.S. Postal Service or 
commercial delivery service, you must ensure that the carrier 
guarantees delivery of the application by the closing date and time. If 
CDC receives an application after the deadline due to (1) carrier error 
(the carrier accepted the package with a guarantee for delivery by the 
closing date and time) or (2) significant weather delays or natural 
disasters, applicants will be given the opportunity to submit 
documentation of the carrier's guarantee. If the documentation verifies 
a carrier problem, CDC will consider the 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 an application does not meet the deadline 
above, it will not be eligible for review and will be discarded. 
Applicants will be notified if an application did not meet the 
submission requirements.
    Otherwise, CDC will not notify applicant upon receipt of 
application. For questions regarding application receipt, first contact 
the carrier. If a question persists, contact the PGO-TIM staff at (770) 
488-2700. To allow time for applications to be processed and logged, 
please wait two to three days after the application deadline before 
calling.
    IV.4. Intergovernmental Review of Applications: Executive Order 
12372 does not apply to this program.
    IV.5. Funding restrictions: Restrictions that must be taken into 
account in the budget should follow funding instructions provided for 
each special interest project in section IX. Applicants requesting 
indirect costs must include a copy of the indirect cost rate agreement. 
If the indirect cost rate is a provisional rate, the agreement should 
be less than 12 months old.
    IV.6. Other Submission Requirements:
    LOI Submission Address: Submit the LOI by e-mail to Jean Smith at 
[email protected].
    Application Submission Address: Submit the original and five copies 
of the application by mail or express delivery service to Technical 
Information Management--PA 04003, 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: Provide measures of effectiveness that will 
demonstrate the accomplishment of the objectives of the cooperative 
agreement; these measures will be an element of evaluation. Measures of 
effectiveness must relate to the performance goals stated in the 
Purpose section of this announcement. These measures must be objective, 
quantitative, and appropriate for measuring the intended outcome.
    Calculation of Scores: The reviewers will provide an overall score 
for each application with 1=highest (best) and 5=lowest by using a 1 to 
5 scale in increments of 0.1. The reviewers' scores for each 
application will then be averaged and multiplied by 100 to obtain a 
priority score for the application.

Evaluation Criteria: Non-Research SIPs

    The relative importance and applicability of any category will 
differ by the focus of the project being solicited. Specific questions 
listed below within each category serve as examples of the type of 
information the applicant may wish to address.
1. Significance
    (a) Does this project address an important public health problem?
    (b) If the aims of the project are achieved, how will public health 
be advanced from the project proposed?
    (c) To what extent will the project incorporate prior research 
findings and recommended practices?
2. Approach
    (a) Does the applicant demonstrate an understanding of the 
community and cultural contexts, and current public health and other 
literature as well as other information sources relevant to the 
proposed project?
    (b) Are the conceptual framework, design, methods, activities, and 
plans for dissemination fully developed, well integrated, and 
appropriate to achieve the aims of the project?

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    (c) Are there adequate procedures in place for recruiting the 
desired number of project participants? (if applicable)
    (d) Does the proposed approach explain areas of flexibility as well 
as procedures that would be used in responding to conditions that 
require changes in methods or focus as needed?
    (e) Does the applicant acknowledge potential problem areas and 
consider alternative tactics?
    (f) Is there an appropriate work plan and time line included?
    (g) Does the project incorporate evaluation activities, including 
measurement of progress toward achieving the stated objectives?
    (h) Does the project include appropriate community involvement in 
all phases of program development?
3. Innovation
    (a) Are the aims clear?
    (b) Is this work innovative or does it build upon previous work?
4. Staff
    (a) Is there evidence that the proposed project director has 
demonstrated knowledge, experience, and ability in planning and 
managing projects that are similar to the proposed project in 
complexity, scope, and participatory focus? (Ability includes the 
percentage of time each person will devote to each project/activity.)
    (b) Is there evidence that the proposed project staff has 
demonstrated knowledge, experience, and ability in implementing similar 
projects?
5. Environment/Collaborations
    (a) Is there evidence that the proposed project will be conducted 
through partnerships with representatives of community-based 
organizations, private and public sector institutions, State and local 
health departments, and/or academia, as appropriate?
    (b) Does the project process allow for partners to apply their 
knowledge and contribute to the project's planning, implementation, and 
evaluation?
    (c) Is there evidence of sufficient institutional support (e.g., 
space, equipment, support from senior faculty, etc.)?
    (d) Is there an appropriate degree of commitment and cooperation of 
potential partners as evidenced by letters detailing the nature and 
extent of their involvement?
6. Target Population (Gender and Minorities)
    (a) Are characteristics of the target population(s) well described?
    (b) Are there adequate plans to included both genders, minorities, 
and their subgroups as appropriate for the goals of the project?
    (c) Are the plans for recruitment and retention of project 
participants satisfactory?
7. Budget (Reviewed But Not Scored)
    The extent to which the budget is clearly explained, adequately 
justified, reasonable, sufficient for the proposed project activities, 
and consistent with the intended use of the funding.

Evaluation Criteria: Research SIPs

    The relative importance and applicability of any category will 
differ by the focus of the project being solicited. Specific questions 
listed below within each category serve as examples of the information 
the applicant may wish to address.
1. Significance
    (a) Does this project address an important public health problem?
    (b) If the aims of the study are achieved, how will scientific 
public health knowledge be advanced from the research proposed, 
considering issues such as internal validity and generalizability?
    (c) To what extent will the results of the study be useful in 
promoting the adoption of effective public health prevention and 
intervention programs and policies?
2. Approach
    (a) Does the applicant demonstrate an understanding of the 
community and cultural contexts, and current public health and other 
scientific literature and theories as well as other information sources 
relevant to the proposed project?
    (b) Are the conceptual framework, design, methods, analyses, and 
translation plan scientifically strong, well integrated, and 
appropriate to achieve the aims of the project and to ensure the 
sustainability of effective interventions?
    (c) Does the proposed approach explain areas of flexibility as well 
as procedures that would be used in responding to conditions that 
require changes in research methods or focus as needed?
    (d) Does the applicant acknowledge potential problem areas and 
consider alternative tactics?
    (e) Is there an appropriate work plan and time line included?
    (f) Does the project incorporate evaluation activities, including 
measurement of progress toward achieving the stated objectives?
    (g) does the project include appropriate community involvement in 
data collection, analyses, dissemination of results, and participation 
in sustainable program development?
3. Innovation
    (a) Are the aims clear?
    (b) Is this work innovative or does it build upon previous work?
    (c) Does the project challenge existing paradigms or develop new 
methodologies or technologies?
    (d) Does the applicant propose creative research translation 
approaches or methods?
4. Investigators
    (a) Is there evidence that the proposed project director has 
demonstrated knowledge, experience, and ability in planning and 
managing research projects that are similar to the proposed project in 
complexity, scope, and participatory focus? (Ability includes the 
percentage of time each person will devote to each project/activity.)
    (b) Is there evidence that the proposed project staff has 
demonstrated knowledge, experience, and ability in implementing the 
proposed research?
    (c) Is there evidence that prior research findings from 
investigators have been translated and adopted into public health 
practice or policy?
    (d) Is there evidence that community-based staff has demonstrated 
knowledge, experience, and ability to assist in the implementation of 
the proposed research, develops relationships with community members, 
and cultivates community participation?
5. Environment/Collaborations
    (a) Is there evidence that proposed research and translation 
activities will be conducted through partnerships with representatives 
of community-based organizations, private and public sector 
institutions, State and local health departments, and/or academia, as 
appropriate?
    (b) Does the research process allow for research partners to apply 
their knowledge and contribute to the project's planning, 
implementation, and evaluation?
    (c) Is there evidence of sufficient institutional support (e.g., 
space, equipment, support from senior faculty, etc.)?
    (d) Is there an appropriate degree of commitment and cooperation of 
potential partners as evidenced by letters detailing the nature and 
extent of their involvement?
6. Target Population (Gender and Minorities)
    (a) Are characteristics of the target population(s) well described?

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    (b) Are there adequate plans to include both genders, minorities, 
and their subgroups as appropriate for the scientific goals of the 
research?
    (c) Are the plans for recruitment and retention of research 
participants satisfactory?
    (d) To what extent has the applicant met 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; (4) a statement as to whether the plans for 
recruitment and outreach for study participants include the process of 
establishing partnerships with communities and recognition of mutual 
benefits.
7. Budget (Reviewed But Not Scored)
    The extent to which the budget is clearly explained, adequately 
justified, reasonable, sufficient for the proposed project activities, 
and consistent with the intended use of the funding.
8. 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.
9. 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 policy 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 communities and recognition of mutual benefits.
    V.2. Review and Selection Process: Applications will be reviewed 
for completeness by the Procurement and Grants Office (PGO), and for 
responsiveness by NCCDPHP. 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 will be evaluated for 
scientific and technical merit by an appropriate peer review group or 
charter study section convened by NCCDPHP in accordance with the 
appropriate 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.
     Receive a second level review by the NCCDPHP 
Internal Review Panel.
    Award Criteria: Criteria that will be used to make award decisions 
include:
     Scientific merit (as determined by peer review).
     Availability of funds.
     Programmatic priorities.
     Specific language provided within each special 
interest project description below.
    V.3. Anticipated Announcement and Award Dates: September 15, 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.
    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 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-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.
 AR-22 Research Integrity.
    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 Requirements: Funded applicants must provide CDC 
with an original plus two copies of the following reports:
    1. Interim progress report, (PHS 2590, OMB Number 0925-0001, rev. 
5/2001) no less than 90 days before the end of the budget period.
    The progress report will serve as a non-competing continuation 
application.
    It 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. Additional Requested Information.
    f. Measures of Effectiveness.
    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 financial, grants management, or budget assistance, contact: 
Lucy Picciolo, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-
2683. e-mail: [email protected].
    For Program technical assistance, contact: Margaret Kaniewski, 
Project Officer, Prevention Research Centers Office, National Center 
for Chronic Disease Prevention and Health Promotion, Centers for 
Disease Control and Prevention, 4770 Buford Highway, Northeast, MS K45, 
Atlanta, GA 30341-3724, Telephone: (770) 488-5919, e-mail address: 
[email protected].

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VIII. Other Information

    A forum for questions and answers between CDC and applicants during 
the application process will be available as a LISTSERV, a system that 
allows for creating, managing, and controlling mailing lists on a 
network or the Internet. The mailing list, which will be titled PREV-
CENTERS is a closed list available only to persons and entities 
associated with the application process for Announcement Number 04003.
    To subscribe to the LISTSERV, the applicant must send an e-mail 
message to [email protected] with the following command in the 
body of the message: subscribe PREV-CENTERS. There is no need to write 
a ``Subject'' or anything else in the message. The subscriber will then 
receive a welcome e-mail message and instructions on how to use 
commands for the LISTSERV. After the applicant is subscribed, questions 
about this announcement and the special interest projects may be sent 
to the following e-mail address: [email protected].
    Do not post confidential information on the LISTSERV because all 
members receive the messages and the replies. All confidential matters 
should be conducted through direct e-mail, paper correspondence, or 
telephone.
    Please use the PREV-CENTERS LISTSERV exclusively for posting 
questions about the application process for Announcement Number 04003. 
Questions will be accepted until the application deadline. All 
subscribers to the list will be deleted after the application due date.

IX. New Special Interest Projects (SIPs)

SIP 1-04

    Project Title: Effectiveness of population-based interventions to 
promote oral health.
    Project Description: In 2002 the Task Force on Community Preventive 
Services published a systematic review of the evidence of effectiveness 
of selected population-based interventions to prevent oral diseases and 
promote oral health, and identified gaps in knowledge for oral disease- 
or condition-specific interventions. Population-based interventions can 
bring about change by (1) providing information and education to 
communities on current issues, such as prevention of dental caries 
(tooth decay) and periodontal diseases; (2) changing laws and policies 
to improve and protect health and well-being, such as mandatory 
fluoridation laws; (3) altering the environment to enhance health and 
encourage healthy behaviors, for example, through community water 
fluoridation; (4) implementing health system changes, such as provider 
reminder systems to reduce missed prevention opportunities; and (5) 
making preventive services available in non-traditional settings, such 
as schools, worksites, and community centers. The Task Force recognized 
the need to develop and evaluate approaches that (a) influence 
environments and behavior at the individual, family, organizational, 
and community levels, and (b) consist of multiple components and 
targets of change. Applicants are encouraged to review gaps in 
knowledge for oral health promotion and disease prevention that were 
identified by the Task Force. (See Truman BI, Gooch BF, Sulemana I, et 
al. and the Task Force on Community Preventive Services. Reviews of 
Evidence on Interventions to Prevent Dental Caries, Oral and Pharyngeal 
Cancers, and Sport-Related Craniofacial Injuries. Am J Prev Med 
2002;23(1s): 21-54. Available at: http://www.thecommunityguide.org/pubs/default.htm). Applicants also are encouraged to review all 
interventions recommended by the Task Force across a range of topics 
(e.g., vaccine-preventable diseases, diabetes, physical activity) and 
levels (e.g., policy/law, health care system, worksite, and general 
population) to consider the applicability and feasibility of these 
interventions for promoting oral health. (Summaries of recommended 
interventions are available at: http://www.thecommunityguide.org/pubs/default.htm). These funds will not be used to support determinant 
research (i.e., research that examines risk factors for oral diseases).
    Consistent with CDC's priority to translate science into public 
health practice, funds will be available to support applied research on 
the effectiveness of interventions to reduce oral diseases and 
conditions and promote oral health at the community or population 
level. High priority will be placed on approaches that seek to reduce 
disparities in oral health and improve quality of life among older 
adults, the poor, and some members of racial and ethnic minority 
groups. It is expected that the applicant will build on their effective 
relationships with communities to develop investigator-initiated 
research that reflects the health priorities of the communities they 
serve and demonstrates community participation in the design, conduct, 
and interpretation of the studies.
    Project Activities: Applications should address the following:
    1. Describe a study to assess the effectiveness of a well-defined 
intervention or combination of interventions to promote oral health.
    2. Show that the interventions are innovative and well supported by 
promising findings in the health promotion literature.
    3. Describe the proposed setting and study population. Ensure that 
the study population has documented oral health needs.
    4. Describe appropriate methods to assess the effectiveness of each 
intervention or combination of interventions at the individual or 
community level, as appropriate.
    5. Provide evidence for the feasibility of the research design.
    6. Ensure the suitability of the study design for assessing 
effectiveness and consistency with design standards (i.e. concurrent or 
before-after comparison) established by the Guide to Community 
Preventive Services. (See Briss PA, Zasa S, Pappaioanou M, et al. 
Developing an Evidence-based Guide to Community Preventive Services-
methods. Am J Prev Med 2000;18(1s):35-43. Available at: http://www.thecommunityguide.org/pubs/default.htm).
    7. Include specific, measurable time-framed objectives for the 
three-year study period.
    8. Identify key project staff. For each person describe their 
demonstrated knowledge, experience, and ability in planning and 
conducting intervention research of similar complexity and scope to 
that described in this proposal.
    9. Describe the established resources and expertise available to 
the research staff for conducting intervention research in a timely 
fashion.
    10. Demonstrate that the project leverages the resources, central 
research theme, and established linkages of the Prevention Research 
Center.
    Preference will be given to applicants who:
    (1) Demonstrate experience in the area of analytical epidemiology 
or community-based studies.
    (2) Have completed earlier exploratory studies related to the 
topic(s) of interest.
    (3) Propose prospective measurement of exposure and outcome and 
concurrent comparison group(s).
    (4) Provide record of having published similar research in peer-
reviewed scientific journals.
    (5) Implement the study in settings (e.g., workplaces, senior 
centers, childcare centers) that reach at-risk populations.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 20 pages. Supporting materials included in 
the appendices should not exceed 20 pages.

[[Page 15445]]

    Availability of Funds: Approximately $1,000,000 will be available 
to fund up to four Prevention Research Centers for the first year of a 
three-year funding period. Each award will be made for no more than 
$250,000. Funding may vary and is subject to change.
    Research Status: It is expected that these projects will be non-
exempt research. CDC staff will not serve as co-investigators on these 
projects, but will provide technical assistance on activities such as 
research design, data collection and analysis, and dissemination of 
results. Applications should provide a federal wide assurance 
registration number for each performance site included in the project.

SIP 2-04

    Project Title: The feasibility of a population-based family cohort 
study to assess the impact of familial and genomic factors on 
population health
    Project Description: The purpose of this project is to fund pilot 
studies to assess the feasibility of assembling a state-based 
representative sample of newborns and their families for the purpose 
of:
    (1) Using residual newborn blood spots (leftover blood spots from 
newborn screening programs) from state programs to assess the 
prevalence of selected genetic variants of public health significance 
in the United States and among different racial/ethnic subgroups.
    (2) Using newborn blood spots to assess the relationship between 
genetic variants and selected childhood outcomes (e.g. birth defects, 
low birth weight, infant mortality, developmental disabilities) by 
linking to various state-based surveillance and information systems.
    (3) Recruiting a family cohort composed of child, parents, and 
grandparents to study the relation between genetic variation and the 
prevalence of adult health outcomes and other risk factors.
    (4) Using this family cohort to assess levels of familial risks for 
selected chronic diseases based on a core family history tool and to 
study associations between familial risks and prevalence of risk 
factors and genetic variants.
    (5) Recruiting this family cohort for a longitudinal study of 
health and disease.
    (6) Defining and studying the ethical, legal and social 
implications of using newborn blood spots to assemble a cohort for 
population-based family studies.
    An immense gap currently exists between the scientific products of 
the Human Genome Project and their application to the treatment and 
prevention of disease. The challenge for public health is to translate 
genomic research findings into information that can be used for more 
effective health policies and programs. One priority for CDC and its 
partners in the next 3-5 years is to conduct public health research to 
better understand genomic factors in the health of populations. 
Epidemiologic studies are needed of genotype prevalence, gene-disease 
associations, and gene-environment interactions to examine individual 
susceptibility to diseases related to infections, environmental 
exposures, and behaviors. Knowing which subgroups or individuals in the 
population are more likely to get sick may be useful for targeting 
behavioral or pharmaceutical interventions and reducing the population 
burden of various diseases. Understanding the population prevalence of 
the thousands of genetic variants in different population groups and 
geographic locations and their associations with health and disease is 
crucial for planning screening programs and guiding future research.
    Most discoveries of gene variants and their association with 
disease are based on studies of a few high-risk families or selected 
groups. Highly penetrant gene variants have been identified that are 
transmitted through families in recognizable mendelian patterns 
resulting in mostly rare diseases but also some common diseases like 
breast and colorectal cancer (e.g., BRCA1 and APC). Fortunately, these 
deleterious gene variants are rare in the population. For the majority 
of families, genetic susceptibility is transmitted through many low 
penetrant genes that interact with environmental factors to increase 
the risk of disease. For example, polymorphisms for genes that code for 
carcinogen metabolizing enzymes (e.g., NAT2 and MGMT) can increase the 
risk of cancer. Population-based studies are needed to estimate the 
frequency of gene variants, environmental exposures, and disease/
disability outcomes in different subgroups of the population and 
explore the interactions between gene variants and exposures that 
influence outcomes. Advantages of a cohort study design are the ability 
to study rare exposures (gene variants); establish temporal 
relationships between gene variants, environmental exposures and 
disease; and study the multiple effects of a single gene variant or 
exposure. A family-based study design will allow the study of three 
generations and common age-associated diseases such as developmental 
disabilities, heart disease, and Alzheimer's. This can be accomplished 
in a shorter time frame than following individuals from birth through 
the life stages. In addition, family-based studies can be used to 
evaluate the clinical validity (predictive value) of family medical 
history and can be used to determine the genetic etiology of certain 
traits or diseases.
    A large-scale family-based cohort study will be complex and 
resource intensive so it is important that the feasibility of this 
study design be determined first through smaller pilot studies. For 
example, there are several options and methods for identifying and 
recruiting the index child; blood spots from state newborn screening 
programs could be used as the initial sampling frame or ongoing 
population-based studies of newborns could be used as the foundation 
for developing the family cohort. Additional issues to consider are:
     The feasibility of identifying, locating, and 
contacting parents and grandparents of the index child.
     The feasibility of linking individuals with 
existing administrative databases and obtaining information from 
medical records.
     Obstacles and incentives for participation in 
research that includes DNA analysis.
     Models for community participation and public 
education about genomic studies.
     Providing informed consent and assurances of 
privacy and confidentiality.
     Options and methods for biologic specimen 
collection (DNA sources), processing, and storage.
     Methods for selecting genes (and variants) to be 
studied.
     Options for laboratory and bioinformatics 
technology for genotyping.
    Project activities: Approximately 2 to 3 pilot studies will be 
funded to address the feasibility of a collaborative family-based 
cohort study as described by the six activities numbered above. Pilot 
study activities might include the following:
    1. Identifying a random sample of approximately 10,000 newborns 
using residual newborn blood spots from state programs (options for 
sample selection and over-sampling of minority groups or infants with 
selected outcomes should be considered).
    2. Assessing the prevalence of selected genetic variants from the 
blood spots or other DNA sources.

[[Page 15446]]

    3. Linking the newborn blood spots to state-based surveillance and 
information systems.
    4. Taking a 10% sample (1000) of the blood spots and contacting the 
parents and grandparents about participating in a study.
    5. Administering a questionnaire (risk factors and personal and 
family medical history) and collecting buccal cells (cells scraped from 
the inside of the cheek) from the parents and grandparents.
    6. Obtaining health outcome information for participants from 
medical records.
    7. Following up study participants at 6 months and 1 year post-
enrollment.
    8. Analyzing the questionnaire and DNA data.
    Particular attention should be given to the ethical, legal, and 
social implications of using newborn blood spots as the basis of a 
family-based cohort study design; standardized and in-depth 
documentation of reasons for non-participation; resources and effort 
required to identify and contact parents and grandparents; ability to 
re-contact and follow the cohort over time; technological and 
laboratory issues concerning DNA collection, storage and processing; 
and the application of the processes on a much larger scale.
    Preference will be given to:
    1. Collaborations between state health departments and academic 
institutions;
    2. Applicants who are knowledgeable and experienced in 
Epidemiological and community-based research;
    3. Applicants with the capacity for doing genomics research that 
might include DNA banking, genetic-related IRB issues, and the use of 
genetic epidemiological methods.
    Project Proposal length and Supporting Materials: Proposed 
narratives are limited to 20 pages. Supporting materials included in 
the appendices should not exceed 30 pages.
    Availability of Funds: Two to three Prevention Research Centers 
will be funded at approximately $300,000-$400,000 per center per year 
for three years. Funding may vary and is subject to change. Preference 
will be given to funding applicants that will aid in providing 
geographic diversity for the feasibility studies.
    Research Status: It is expected that projects will be non-exempt 
research. CDC staff will serve as co-investigators on these projects 
and will provide technical assistance on activities such as research 
design, data collection and analysis, and dissemination of results. It 
is expected that this project will require CDC IRB approval. The CDC 
IRB will review and approve the protocol initially and on an annual 
basis until the research project is completed. Applications should 
provide a federal wide assurance registration number for each 
performance site included in the project.

SIP 3-04

    Project Title: Healthy Passages: A Community-based Longitudinal 
Study of Adolescent Health.
    Project Description: Healthy Passages is a longitudinal study 
conducted in three communities--Houston, Texas; Birmingham, Alabama; 
and Los Angeles, California. Healthy Passages will help us understand 
why some youth engage in healthful behaviors while others engage in 
risky behaviors that affect their health, education, and social well 
being. Funds are available to support implementation of the full study 
among a cohort of 1,750 fifth-grade youth in each community.
    A limited number of health risk behaviors, generally established 
during childhood and adolescence, account for the overwhelming majority 
of immediate and long-term morbidity, mortality, disability, and social 
problems among adolescents and young adults. These behaviors include 
carrying a weapon, physical fighting, attempted suicide, drinking when 
driving, and unprotected sexual intercourse. In addition, use of 
tobacco, unhealthy dietary behaviors, and physical inactivity, 
behaviors also established during childhood and adolescence, contribute 
substantially to morbidity and mortality in adulthood.
    Previous and on-going longitudinal surveys and research studies 
have made important contributions to understanding the association 
between health risk behaviors and their determinants. However, these 
studies are often limited in scope, limited in duration, or assess 
participants at infrequent intervals. In addition, although previous 
research has shown differences in health outcomes across racial and 
ethnic groups of youth, the sources of those differences have yet to be 
systematically investigated.
    The objectives of the project are as follows:
     Fund three Healthy Passages Research Centers 
(HPRC) in geographically distinct metropolitan areas to (1) establish 
and assess on a biennial basis a cohort of youth from age 10 (fifth 
grade) through age 20; and (2) identify the etiological factors, 
including individual, family, school, and community influences, that 
predict health risk behaviors and related health outcomes and are 
important for understanding disparities in health outcomes across 
racially and ethnically diverse populations.
     Implement a collaborative research study among 
the funded HPRCs for implementation of the study design, development of 
study instruments for each wave of data collection, and dissemination 
of study results through peer reviewed publications and presentations 
at scientific meetings.
     Sustain the collaboration between the funded 
HPRCs and CDC on the development and implementation of the study.
     Participate in quarterly project meetings that 
include key staff members from each HPRC and key CDC staff.
    Project Activities: Applicants should address the following project 
activities:
    1. Significance:
     Identify and justify the health risk behaviors 
and health, educational, and social outcomes to be measured.
     Identify and justify the etiologic factors 
thought to influence health risk behaviors and health, educational, and 
social outcomes. Etiologic factors should include factors at the 
individual, family, school, and community levels.
     Describe research goals, objectives, and 
research questions.
     Describe how study results can be used to 
develop effective strategies for promoting adolescent health across a 
broad range of social institutions.
     Describe how study results will be important in 
understanding disparities in health outcomes across racially and 
ethnically diverse populations.
    2. Approach:
     Describe the conceptual framework and how the 
framework incorporates health risk behaviors; health, educational, and 
social outcomes; and etiological factors.
     Describe plans for instrument development, data 
collection, data management, and data analysis.
     Describe the plans for training data collectors.
     Describe the quality assurance evaluation and 
monitoring for all research activities.
     Describe plans for data handling and storage, 
assurance of confidentiality, and linkage of data across occasions.
     Describe the potential limitations of the study.
     Identify the project work plan and timeline.
     Describe the community involvement in the 
research project.
     Provide a clear dissemination plan to work 
collaboratively with the other HPRCs and CDC to ensure that analysis 
and production of peer-reviewed papers, presentations, and reports are 
developed in a timely manner.

[[Page 15447]]

    3. Innovation:
     Describe how the proposed research builds upon 
pilot studies.
     Describe how the proposed research will 
translate into the development of effective policies and programs.
    4. Investigators:
     Describe the research team and demonstrate that 
the proposed research staff represent an interdisciplinary team of 
behavioral and social scientists, epidemiologists, and statisticians 
with the scientific training and previous scientific and practical 
experience needed to conduct the research.
     Provide evidence that the Principal Investigator 
has successfully participated in collaborative, multicenter research 
projects, longitudinal studies, and research studies related to the 
health of youth.
     Demonstrate the adequacy of the proposed staff 
to carry out all project activities (i.e., sufficient in number, 
percentage of time commitment to this and other projects, and 
qualifications).
    5. Environment and collaborations:
     Describe the involvement of community-based 
organizations and key members of the targeted population in a Community 
Advisory Committee and provide letters of support describing their role 
in the proposed research activities.
     Describe facilities and systems for data 
security and maintenance of participant confidentiality.
     Describe institutional support in terms of 
space, equipment, etc.
    6.Target population:
     Provide evidence of the ability to recruit and 
enroll 1,750 10-year-old (fifth grade) children divided between at 
least two of the three major race/ethnic groups (white, African-
American, and Hispanic).
     Provide information on the sampling strategy to 
assure appropriate representation by gender and race/ethnicity.
     Describe plans to obtain participation of 
adequate numbers of the targeted population.
     Provide a detailed plan of the expected sample 
attrition, how study participants will be tracked, and what strategies 
will be used to increase retention.
    7. Budget:
     Provide a detailed line-item budget for year 1 
that is adequately justified, sufficient for project activities, and 
consistent with the intended use of the funds.
    8. Human subjects:
     Provide evidence that the applicant complies 
with DHHS regulations regarding the protection of human subjects.
    Preference will be given to applicants who:
    1. Have extensive experience in conducting longitudinal studies 
among children and adolescents;
    2. Can demonstrate pilot studies to inform implementation of the 
longitudinal study;
    3 .Can provide a record of scientific publications from similar 
studies.
    Project Proposal Length and Supporting Materials: Proposal 
narratives are limited to 20 pages. Supporting materials included in 
appendices should include survey instruments and consent forms for year 
1 data collection, biographical sketches, and letters of support.
    Availability of Funds: Approximately $3,600,000 is available to 
fund up to three Prevention Research Centers in the first year of a 5-
year project period. Individual awards are expected to range from 
$1,100,000 to $1,300,000. Funding may vary and is subject to change.
    Research Status: Healthy Passages is non-exempt research. CDC staff 
will serve as co-investigators on these projects and will provide 
technical assistance on activities such as research design, data 
collection and analysis, and dissemination of results. Healthy Passages 
has CDC IRB approval. The CDC IRB reviews and approves the protocol on 
an annual basis until the project is completed. As applicable, 
applicants should provide a federal-wide assurance registration number.

SIP 4-04

    Project Title: Evaluation of abstinence-only and abstinence-plus 
programs to prevent HIV, STD, and pregnancy among middle school 
students.
    Project Description: Beginning in the 1990s, the prevalence of 
sexual intercourse decreased among high school students, particularly 
among males, African Americans, and whites. In addition, the number of 
adolescents using condoms at last intercourse increased. Despite these 
improvements, adolescents continue to be at risk for HIV infection, 
other sexually transmitted diseases (STD), and pregnancy. Between 1994 
and 2000, 14% of HIV cases were diagnosed among youth aged 13-24; one 
in every four cases of STD diagnosed annually in the United States 
occurs among teenagers; and in 1997, 840,000 pregnancies occurred among 
15 to 19 year olds in the United States.
    Starting in the 1990s, major legislative initiatives have funded 
both abstinence-only and abstinence-plus programs to prevent HIV, STD, 
and pregnancy among adolescents. The efficacy of both kinds of programs 
and their role in the decrease in sexual risk behaviors among youth has 
been debated. Further studies are necessary to explore the relative 
efficacy of these approaches. Funds are available to support a five-
year evaluation project to test the efficacy of an abstinence-only 
sexual risk reduction program for middle school students relative to a 
comparable abstinence-plus program and relative to standard care.
    For purposes of this announcement, abstinence-only programs 
emphasize sexual abstinence (that is, refraining from vaginal, oral, 
and anal sexual activity). Abstinence interventions should address all 
of the following elements; however, programs need not place equal 
emphasis on each of the following: (1) Teaches abstinence from sexual 
activity outside of marriage as the expected standard for all school 
age children; (2) teaches that abstinence is the only certain way to 
avoid out-of-wedlock pregnancy, STD, and other health problems; (3) 
teaches that a monogamous relationship in context of marriage is the 
expected standard of human sexual activity; (4) teaches that sexual 
activity outside of marriage is likely to have harmful effects; (5) 
teaches that bearing children out-of-wedlock is likely to have harmful 
consequences; (6) teaches young people how to avoid sexual advances and 
how alcohol and drug use increases vulnerability to sexual advances; 
(7) teaches the importance of attaining self-sufficiency before 
engaging in sexual activity; and (8) teaches the gains to be realized 
by abstaining from sexual activity. (See http://www.mchb.hrsa.gov/programs/adolescents/statefs.htm for information on Title V Abstinence 
Education criteria and for ordering information for the Title V 
guidance.)
    Abstinence-plus programs include information and skills related to 
abstinence, condom and other barrier use, and contraception. 
Abstinence-plus programs address avoiding or reducing sexual risk 
behaviors and address specific antecedents of sexual risk behaviors 
such as reducing social pressures to engage in sexual activity; or 
increasing negotiation and communication skills. Abstinence-plus 
programs, for purposes of this announcement, do not include clinically-
based programs, or programs that focus on offering clinical services to 
adolescents.
    Project Activities: Applicants should address the following:
    1. Describe a study that includes a developmental phase in which 
known, effective interventions are adapted and pilot-tested for use in 
equivalent

[[Page 15448]]

abstinence-only and abstinence-plus arms of the study, and a comparison 
or standard care intervention is specified. This study may include, but 
is not limited to: (a) Adapting existing interventions based on sound 
behavior change theory or from empirically supported interventions for 
middle school students. The proposed interventions may be adapted to 
become equivalent school-based abstinence-only and abstinence-plus 
interventions. The proposed interventions may include multiple booster 
sessions. Interventions may include innovative components such as 
parent or family involvement, youth asset development, community 
service learning, or mentoring by youth or adults. Interventions should 
be targeted toward youth in communities disproportionately affected by 
HIV, STD, or unintended pregnancy; (b) Convening panels consisting of 
individuals from participating communities, and programmatic and 
evaluation experts experienced in abstinence-only and abstinence-plus 
interventions to provide input on the content, and assessment of, the 
developed interventions; (c) Pilot-testing interventions and data 
collection instruments among youth comparable to those proposed as 
participants in the evaluation study.
    2. Describe a study that includes an evaluation phase to test the 
efficacy of these interventions relative to a standard care control or 
comparison group. This portion of the study may include, but is not 
limited to: (a) Designing and conducting a longitudinal experimental or 
quasi-experimental study with follow-up of participants for short 
period of time (e.g. minimum of 24 months), including clear 
conceptualization of the control or comparison group consisting of 
standard care in schools or a standard control intervention; (b) 
Proposing a population of middle-school students in communities 
disproportionately affected by HIV, STD, or teen pregnancy to 
participate in the study; (c) Determining the primary outcomes of the 
study that include, but are not limited to, sexual risk behaviors, 
intentions to engage in sexual risk behaviors, and biological markers 
for STD; (d) Determining secondary outcomes of the study that would 
include psychosocial outcomes (such as self-efficacy, attitudes, 
normative beliefs), and knowledge; intervening variables that may 
identify sub-populations for whom the interventions have particular 
impact; and unique outcomes appropriate to intervention components; (e) 
Outlining plans to sustain interventions in the target community that 
are found to be efficacious; and (f) Outlining plans to disseminate 
research results.
    In addition, applicants should address the following issues:
    1. Significance: Describe the extent to which the proposed research 
addresses important public health issues, and how it will advance 
knowledge about sexual risk interventions through generalizable and 
internally valid research.
    2. Approach: Describe the following: the proposed interventions to 
be adapted and the process of adaptation and consultation, including 
community input in all phases of the proposed research; the proposed 
evaluation design including a conceptual framework based on behavior 
change theory or empirical findings, and a description of the sample 
size, matching or randomization plan, statistical power, longitudinal 
data management plan, and statistical analyses; anticipated problems 
and methods used to respond to them; plans to sustain efficacious 
programs; plans to disseminate findings; and a proposed work plan and 
timeline.
    3. Innovation: Describe the following: how the proposed research 
builds upon prior research and what innovative programmatic and 
research components are proposed, including creative program adaptation 
approaches and methods.
    4. Investigators: Describe the following: experience of proposed 
staff in program adaptation and in conducting all phases of behavioral 
intervention evaluations for adolescents; experience in working with 
schools and school-based interventions; current commitments of proposed 
staff and the percent of time that each staff member will devote to the 
project; prior experience in working with community members and program 
staff and researchers who represent a broad spectrum of policy outlooks 
and programmatic approaches.
    5. Environment/Collaborations: Describe the following: experience 
in forming partnerships with community members; experience in forming 
partnerships with programmatic staff and researchers who are 
experienced with abstinence-only and abstinence-plus research; evidence 
of support for the proposed research from community, programmatic, and 
research collaborators; methods to create and maintain productive 
collaboration; institutional support including resources such as space 
and equipment; letters of support from proposed collaborators.
    6. Target Population: Describe the following: demographic 
characteristics and sexual risk behaviors among the proposed 
intervention participants, and disproportionate impact of HIV, other 
STD, or pregnancy on the proposed community; plan to include both 
genders and ethnic minorities as appropriate to the proposed research; 
plans to recruit and retain participants; plans to longitudinally link 
participants' responses; and plans to meet CDC policy requirements 
regarding the inclusion of women and ethnic and racial groups.
    7. Budget: Provide a clear budget, and provide a narrative that 
adequately justifies expenditures as reasonable, sufficient for the 
proposed project activities, and consistent with the intended use of 
the funding.
    Project Proposal Length and Supporting Material: Applications 
should not exceed 20 pages, and appendices should not exceed 30 pages; 
the appendices should include biographic sketches, position 
descriptions of staff (if needed), letters of support, proposed 
membership lists of panels, and other evidence as consistent with the 
proposal.
    Availability of Funds: Approximately $1,000,000 is available to 
fund one Prevention Research Center in the first year of a 5-year 
project. Funding may vary and is subject to change.
    Research Status: This project is anticipated to be non-exempt 
research. CDC staff will serve as co-investigators on this project and 
will provide technical assistance on activities such as research 
design, data collection and analysis, and dissemination of results. 
This project will require CDC Institutional Review Board (IRB) 
approval. The CDC IRB reviews and approves the protocol on an annual 
basis until the project is completed. As applicable, applicants should 
provide a federal-wide assurance registration number. Additional 
clearances, such as certificates of confidentiality, may also be 
needed.

SIP 5-04

    Project Title: Establishment of a Physical Activity Policy Research 
Network (PAPN)--Participating Network Center.
    Project Description: Significant improvements in public health have 
been achieved through health policy interventions in areas such as 
tobacco control and injury prevention. Currently, research is being 
conducted through the Prevention Research Centers (PRC) addressing 
physical activity. However this research has a primary focus on 
identifying environmental, social or individual correlates of 
participation in physical

[[Page 15449]]

activity where physical activity or disease endpoints are the outcome 
measures. The Physical Activity and Health Branch, Division of 
Nutrition and Physical Activity, National Center for Chronic Disease 
Prevention and Health Promotion seeks to support the creation of a 
Physical Activity Policy Research Network to foster understanding of 
the effectiveness of health policies related to increasing physical 
activity in communities. The network, which would have long-term 
sustainability for physical activity policy research, will have one 
lead center and several participating centers. This particular project 
is for the participating centers only.
    PRCs are housed within schools of public health, medicine, or 
osteopathy, which primarily work with stakeholders within those 
traditional fields of public health. This current structure poses a 
barrier to the potential non-traditional, transdisciplinary nature of 
physical activity policy research. In addition to traditional public 
health partnerships, this proposed network would establish active and 
productive collaborations with non-traditional partners including 
researchers and practitioners in political science, law, architecture, 
and urban planning and design. The network will rely on cross-
disciplinary collaboration to achieve its objectives.
    Recently, accomplishments have been made toward developing a 
framework for physical activity public health policy research. This 
framework was developed through a series of three CDC workshops that 
gathered information and opinions from national experts. During these 
workshops, the following priorities were identified as critical to 
future physical activity policy research: (1) Schools; (2) Worksites; 
(3) Parks and Public Spaces; (4) Walkability; (5) Safety and Crime; (6) 
Economic Factors; and (7) Liability. Participants also concluded that 
policy research involves more than just understanding whether or not a 
policy is effective. Policy research can involve (1) identifying 
policies that affect physical activity levels; (2) identifying 
determinants of why some policies are adopted and others are not; (3) 
research on how to implement a policy so that it is effective; and (4) 
the outcomes of policy implementation. Research is lacking on 
understanding the contribution of health policies to increasing 
community physical activity levels.
    Project Activities: Applicants should address the following:
    1. Discuss how the center would collaborate with the PAPN Lead 
Coordinating Center and CDC to advance a physical activity research 
policy agenda.
    2. Identify resources in areas relevant to public health and 
physical activity within or available to your PRC. Discuss how these 
resources could be involved in and enhanced through the proposed 
network. Discuss the potential and need for collaboration with 
community-based organizations and public health departments to enhance 
dissemination and impact of policy research.
    3. Document that your center will work with the other PAPN network 
centers in prioritizing and choosing topics for research, intervention 
or translation.
    4. Describe how your center will work with the PAPN network and 
other partners to develop evidence-based interventions that can be 
implemented in communities.
    Centers are expected to actively participate in the network and to 
identify and develop one pilot project in physical activity policy. 
Applicants should develop collaborative projects for creation and 
evaluation of physical activity policy frameworks in one or more of the 
following policy research areas:
    1. Transportation planning and urban design models that incorporate 
valid measures of active transport such as walking, bicycling, and 
other forms of physical activity.
    2. Links between transportation and urban design policies and 
community levels of physical activity.
    3. Surveillance techniques to assess and track key indicators of 
policies that promote or inhibit physical activity.
    4. Case studies of school setting within a community and the effect 
on physical activity and correlates (e.g., community, social 
interaction, transportation, health, and economic impact).
    5. Detailed review and analysis of the economic impact of smart 
growth and traditional neighborhood design as they relate to physical 
activity.
    The project results are expected to include the following:
    1. Development of a multidisciplinary physical activity policy 
research network.
    2. Satisfactory progress in each of the five areas of interest 
outlined above.
    3. Communication of progress and findings through meetings and 
publications.
    4. Plans for network sustainability and growth.
    Research results should help inform activities of CDC-funded state 
programs for promoting physical activity. Issues related to diversity, 
social equity, and health disparities should be built into the core 
policy agenda. Multiple traditional and non-traditional partnerships 
necessary for a successful project should be addressed.
    Preference will be given to applicants that document or demonstrate 
the ability to establish formal working agreements with multiple 
disciplines such as law, economics, political science, architecture, 
and urban design and that include a state health department as part of 
the project team.
    Project Proposal Length and Supporting Material: Application 
proposals should not exceed 20 pages, excluding appendices and 
supporting materials. Appendices should not exceed a total of 30 pages.
    Availability of Funds: Three to five centers will receive funding 
to be part of the physical activity policy network. Funding will be up 
to $60,000 per center, per year for a period of three years. The 
composition of the working group and the individual projects proposed 
by the sites cannot be known in advance; therefore, some sites may be 
asked to revise their scope of work so that (1) two or more sites 
collaborate on a policy research project and/or (2) policy research 
areas deemed a priority by the network and CDC are assigned to at least 
one PRC. Funding may vary and is subject to change.
    Research Status: The operations of the network itself will not 
involve research on human subjects. However, the pilot projects chosen 
may involve IRB review. CDC staff will assist network centers in making 
human subject determinations.

SIP 6-04

    Project Title: Establishment of a Physical Activity Policy Research 
Network (PAPN)--Lead Coordinating Center.
    Project Description: Significant improvements in public health have 
been achieved through health policy interventions in areas such as 
tobacco control and injury prevention. Currently, research is being 
conducted through the Prevention Research Centers (PRC) addressing 
physical activity. However this research has a primary focus on 
identifying environmental, social or individual correlates of 
participation in physical activity where physical activity or disease 
endpoints are the outcome measures. The Physical Activity and Health 
Branch, Division of Nutrition and Physical Activity, National Center 
for Chronic Disease Prevention and Health Promotion seek to support the 
creation of a Physical Activity Policy Research Network designed to 
foster advances in understanding the effectiveness of health policies 
related

[[Page 15450]]

to increasing physical activity in communities and with long-term 
sustainability for physical activity policy research. This Special 
Interest Project would provide the funding necessary for one PRC to 
take the leadership responsibility in coordinating the Physical 
Activity Policy Research Network described in SIP 5-04.
    PRCs are housed within schools of public health, medicine, or 
osteopathy, which primarily work with stakeholders within those 
traditional fields of public health. This current structure poses a 
barrier to the potential non-traditional, transdisciplinary nature of 
physical activity policy research. In addition to traditional public 
health partnerships, this proposed network would establish active and 
productive collaborations with non-traditional partners including 
researchers and practitioners in political science, law, architecture, 
urban planning and design. The network will rely on cross-discipline 
collaboration to achieve this objective.
    Recently, substantial accomplishments have been made toward 
developing a preliminary framework for physical activity public health 
policy research. This framework was developed through a series of three 
CDC workshops that gathered information and opinions from national 
experts. During these workshops, the following priorities were 
identified as critical to future physical activity policy research: (1) 
Schools; (2) Worksites; (3) Parks and Public Spaces; (4) Walkability; 
(5) Safety and Crime; (6) Economic Factors; and (7) Liability. 
Participants also concluded that policy research involves more than 
just understanding whether or not a policy is effective. Policy 
research can involve: (1) Identifying policies that affect physical 
activity levels; (2) identifying determinants of why some policies are 
adopted and others are not; (3) research on how to implement a policy 
so that it is effective; and (4) the outcomes of policy implementation. 
Research is lacking on understanding the contribution of health 
policies to increasing community physical activity levels.
    Project Activities: Applicants should address the following:
    1. Explain the organization and interaction of the Coordinating and 
Collaborating centers. Discuss the relationship with relevant CDC 
activities. Define performance expectations for the network.
    2. Explain how the proposed PAPN would draw on community 
collaborations to enhance physical activity public health policy 
research. Discuss additional partners who may have a stake in the work. 
Address the dissemination of relevant information beyond the scientific 
literature, specifically to communities.
    3. Describe how the network Coordinating Center will provide 
leadership in fostering and growing the network. Indicate how this 
growth will be assessed and monitored during the project period.
    4. Describe how the Coordinating Center will represent and promote 
the PAPN and its member centers within the PRCs and to external 
partners.
    5. Describe how the Coordinating Center will participate as a 
general member of the PAPN, including identifying established resources 
in areas relevant to public health and physical activity within or 
available to the PRC, and how you will work with the other network 
centers to prioritize topics for research and intervention development.
    6. Describe the process by which each member center's 
contributions, including individual roles and responsibilities for the 
projects and activities, will be determined.
    Preference for the Coordinating Center will be given to: Applicants 
who can document or demonstrate the ability to (1) manage multi-
discipline, multi-site initiatives and (2) establish formal working 
agreements with disciplines such as law, economics, political science, 
and architecture and urban design and that include a state health 
department as part of the project team. The Coordinating Center will be 
expected to coordinate the PAPN, document network results, and plan and 
coordinate a meeting at which the work of other network members will be 
presented. The Coordinating Center will also coordinate any activities 
undertaken with partners external to the network. Working with CDC, the 
Coordinating Center will divide the work among the members of the 
network.
    Project Proposal Length and Supporting Material: Application 
proposals should not exceed 20 pages, excluding appendices and 
supporting materials. Appendices should not exceed a total of 30 pages.
    Availability of Funds: Approximately $30,000 is available to 
support one Lead Coordinating Center per year for a three-year period. 
Applicants applying for this SIP 6-04 as the Coordinating Center must 
apply as a PAPN participating center under SIP 5-04. The applicant 
selected as the Coordinating Center will have an approximate total 
budget of $90,000 annually ($30,000 for leadership and coordination; 
$60,000 for network member activities). The composition of the working 
group and the individual projects proposed by the sites cannot be known 
in advance; therefore, some sites may be asked to revise their scope of 
work so that (1) two or more sites collaborate on a policy research 
project and/or (2) policy research areas deemed a priority by the 
network and CDC are assigned to at least one PRC. Funding may vary and 
is subject to change.
    Research Status: The operations of the network itself will not 
involve research on human subjects. However, the pilot projects chosen 
may involve IRB review. CDC staff will assist network centers in making 
human subject determinations.

SIP 7-04

    Project Title: Investigation of the role of school-based physical 
activity on indicators of academic performance among elementary school 
children
    Project Description: Schools are a natural environment for physical 
activity promotion. Most children are enrolled in schools where 
facilities and infrastructure exist to help promote physical activity. 
Recent successes in improving physical education training and delivery 
for elementary school children are examples of what is possible in 
targeting schools for physical activity programs.
    The literature on the role that physical activity may play in 
academic achievement is sparse. Academic achievement can be assessed in 
a variety of ways, including distal outcomes for standardized test 
scores, or more proximal outcomes such as acute learning, time-on-task, 
disruptive behavior, daily attendance, etc. School-based physical 
activity need not be limited to only physical education curriculum, but 
should also include multiple inputs such as environmental supports 
(equipment and infrastructure), classroom activities, after-school 
activities and intramural/interscholastic activities. The intent of 
this project is to seek to study the effects on the role physical 
activity may play in academic or classroom settings.
    Project Activities: The overall objective of this project is to 
support the design, conduct, and evaluation of an experimental 
investigation into the role that physical activity may play in academic 
performance and its associated indicators among elementary school 
children.
    Preference will be given to applicants with demonstrated experience 
in school based physical activity interventions. An adequate cross-
section of grade levels in elementary schools is desired. Applicants 
should take a broad

[[Page 15451]]

approach to defining key outcomes of interest of academic achievement 
and include both distal and proximal variables. Physical activity 
efforts should focus not only on physical education, but other 
potential exposures as well such as classroom, after-school, recess, 
and sports participation.
    It is expected that applicants/investigators will design, conduct, 
and evaluate an experimental investigation into the role that physical 
activity may play in academic performance and its associated indicators 
among elementary school children. All aspects of the design, including 
conceptualization, sample size estimation, intervention design, data 
collection and analysis, and reporting will be the responsibility of 
the applicant/investigator(s). Design characteristics should include 
the ability to evaluate a dose-response effect if one exists.
    Project Proposal Length and Supporting Material: Application 
proposals should not exceed 20 pages, excluding appendices and 
supporting materials. Appendices should not exceed a total of 30 pages.
    Availability of Funds: It is anticipated that $400,000-$450,000 per 
year for up to three years will be available to fund one Prevention 
Research Center for this project. Funding may vary and is subject to 
change.
    Research Status: It is expected that this will be non-exempt 
research. CDC staff will not serve as co-investigators on this project 
but will provide technical assistance on activities such as research 
design, data collection and analysis, and dissemination of results. As 
applicable, applications should provide a federal wide assurance 
registration number for each performance site included in the project.

SIP 8-04

    Project Title: Development of a Brief Physical Activity Assessment 
Tool for Use in Medical Settings as a Patient Chart Variable.
    Project Description: Despite recommendations for health care 
providers to counsel patients to be physically active (including 
Healthy People 2010 health objectives for the nation), there are few 
health care settings with physical activity chart variables or 
recordkeeping systems to evaluate or track patients' physical activity 
habits. Such information may be beneficial for physicians and other 
health care providers to identify patients at risk from inactivity, or 
with health conditions (e.g., obesity, hypertension, hyperlipdemia, 
cardiovascular disease, diabetes, low/abnormal bone density levels, 
etc.) that may be improved by increased participation in physical 
activity. A physical activity chart variable may also yield data that 
health plans can use to determine the economic burden of physical 
inactivity specific to their own patient population. Furthermore, a 
physical activity chart variable may serve as a catalyst for 
physicians/providers to triage patients' to obtain an in-depth physical 
activity assessment or to physical activity program. Although protocols 
are available to assist health care providers do physical activity 
assessment and counseling, these standardized procedures are perceived 
by some in the health care field to be too lengthy for use during 
routine medical care practice. Thus, there is a need for physicians and 
other health care providers to rapidly assess a patient's physical 
activity level, and at minimum, provide a patient with a recommendation 
to increase physical activity when warranted.
    The purpose of the proposed funding is to support the development 
of a ``rapid assessment'' physical activity tool that can be used as a 
chart variable. It can be incorporated into a health care system 
infrastructure to allow for the assessment and tracking of patients' 
physical activity behaviors, prompt provider recommendations to 
patients to be active, and monitoring economic factors of economic.
    Project Activities: Funding will be awarded to develop a valid and 
reliable rapid assessment tool to be used as a physical activity 
patient chart variable, with patients 18 years and older. An empirical 
or intuitive approach to item development may be used. Year 1 
activities are to (1) develop an assessment tool (chart variable), and 
(2) plan and conduct a study to determine the validity and reliability 
of the item(s)/assessment tool. Year 2 activities are to plan and 
conduct a feasibility study using the item(s)/assessment tool in 
clinical settings. These activities will result in the following study 
outcomes: (1) The PI will take the lead on the development and 
feasibility testing of a valid and reliable physical activity chart 
variable that can be used in standard medical care practice (including 
publication of scientific articles). (2) A physical activity chart 
variable will be available for use in health care settings (a) to 
monitor the physical activity behavior of patients and prompt 
recommendations for patients to increase physical activity, and (b) to 
link a physical activity chart variable to health, medical care 
utilization, and medical expenditure outcomes.
    Project Proposed Length and Supporting Materials: Application 
proposals should not exceed 15 pages excluding appendices and 
supporting materials. Appendices should not exceed a total of 10 pages.
    Availability of Funds: One PRC will be funded for this project, for 
a two-year period. Approximately $232,750 is available for the two-year 
period. It is anticipated that year one costs may be lower than year 
two costs, both years totaling to $232,750.
    Research Status: It is expected that this will be non-exempt 
research. CDC staff will not serve as co-investigators on this project 
but will provide technical assistance on activities such as research 
design, data collection and analysis, and dissemination of results. 
Applications should provide a federal wide assurance registration 
number for each performance site included in the project.

SIP 9-04

    Project Title: Investigation of Pedometers and Step Counters for 
Physical Activity Promotion.
    Project Description: Physical activity levels in the U.S. currently 
are measured with national surveys (telephone or interview) that 
require respondents to characterize their usual level of leisure time, 
occupational, household and transportation related physical activity. 
Respondents are further asked to characterize the intensity of 
participation (moderate or vigorous). Data from these national surveys 
indicate fewer than 50% of U.S. adults are currently active at levels 
thought to promote and maintain health.
    Walking is the most frequently reported source of physical activity 
among U.S. adults. Recently, community and individual physical activity 
promotion programs have emerged that rely on the accumulation of daily 
steps toward a target goal as a prime physical activity strategy. These 
programs rely on either a static daily goal (e.g., 10,000 steps each 
day) or on a progressive goal (e.g., an additional 2,000 steps each day 
from baseline). Regardless of the program, electronic pedometers and 
step counters are used to help participants monitor their daily step 
accumulation and as a behavioral tool for prompting and goal setting.
    Despite recent studies, there are few health outcomes data on which 
to base daily step recommendations. More specifically, there is a 
paucity of information on how (or if) step counters and pedometers can 
be used to promote congruence with physical activity recommendations 
based on scientific evidence of their relation to health outcomes 
(e.g., CDC/ACSM physical activity recommendations). Existing

[[Page 15452]]

step accumulation programs do not specifically promote intensity (e.g., 
at least moderate-intensity) or duration (e.g., at least 8-10 minute 
continuous bouts); both of which are central tenets of evidence-based 
public health recommendations for physical activity promotion. The 
purpose of this project is to generate scientific research to help 
understand the role that step counters and pedometers play in helping 
to promote existing physical activity recommendations.
    Project Activities: The overall objective of the project is to 
support the design, conduct, and evaluation of scientific assessments 
of the utility of electronic step counters and pedometers in helping to 
promote physical activity recommendations for adults. Investigators on 
the project, working closely with CDC staff, will design evaluation 
studies to meet this objective.
    Preference will be given to applicants who have documented skills 
in physical activity promotion programs which include step counters 
and/or pedometers. Proposals should consider aspects of both physical 
activity intensity and duration as they may relate to daily 
accumulation of steps. Aspects of the uses of electronic step counters 
and pedometers for population physical activity assessment and 
individual interventions should be considered.
    All aspects of the design, including conceptualization, sample size 
estimation, intervention design, data collection and analysis, and 
reporting will be the responsibility of the investigators. An adequate 
cross-section of a variety of settings is desirable as is diversity in 
age, gender, and race or ethnicity of the populations examined. Design 
characteristics should include the ability to evaluate a dose-response 
effect if one exists. Also of interest are behavioral aspects of 
pedometer use and potential health outcomes associated with their use 
as physical activity promotion tools.
    Project Proposal Length and Supporting Material: Application 
proposals should not exceed 20 pages, excluding appendices and 
supporting materials. Appendices should not exceed a total of 30 pages.
    Availability of Funds: It is anticipated that up to $200,000 per 
year for 3 years will be available to fund one Prevention Research 
Center. Funding may vary and is subject to change.
    Research Status: It is anticipated that this project will be non-
exempt research. Human subject research will be involved and CDC IRB 
approval will be required. CDC staff will serve as a co-investigator on 
this project and will provide technical assistance on activities such 
as research design, data collection and analysis, and dissemination of 
results. Applications should provide a federal wide assurance 
registration number for each performance site included in the project.

SIP 10-04

    Project Title: Center of Excellence in Public Health Training and 
Intervention Research Translation: WISEWOMAN and Obesity Prevention 
Programs.
    Project Description: The intent of the special interest project is 
to develop a Center of Excellence in Public Health Training and 
Intervention Research Translation. The Center will address training and 
intervention research translation needs of two CDC programs funded 
through the Division of Nutrition and Physical Activity: the WISEWOMAN 
program and the Obesity Prevention Program. The Center will begin by 
addressing the component needs of the programs described below. The 
Center will likely expand its activities in the future and serve as a 
model for other Centers of Excellence in Public Health Research 
Translation and Training.
    Little is known about effective obesity and chronic disease 
interventions, especially those interventions addressing disparities. 
The public will benefit: (1) By having services provided by a well-
trained public health professional staff in the areas of obesity, 
cardiovascular health, and other chronic diseases and (2) from the 
translation of effective preventive health programs that will meet 
their particular needs in addressing obesity, cardiovascular and other 
chronic diseases.

CDC Program Descriptions

    WISEWOMAN Program: WISEWOMAN funds 14 projects throughout the 
United States that provide low-income, underinsured, or uninsured 40 to 
64 year old women, with the knowledge, skills, and opportunities needed 
to improve diet, physical activity, and other life habits to prevent, 
delay, or control cardiovascular and other chronic diseases. The 
projects provide these services to women from various racial and ethnic 
groups who live in both urban and rural settings. More information on 
this program can be found at http://www.cdc.gov/wisewoman.
    Obesity Prevention Program: The purpose of the program is to 
prevent and control obesity and other chronic diseases by supporting 
States in the development, implementation, and evaluation of science-
based nutrition and physical activity interventions. Funds have been 
awarded to 20 states to address the obesity epidemic in the US. The 
goals of the program are to: (1) Decrease levels of obesity or reduce 
the rate of growth of obesity in communities reached through 
interventions; (2) Increase physical activity and better dietary 
behaviors in communities reached through interventions; (3) Increase 
the number of effective obesity prevention interventions using 
nutrition and physical activity that are implemented and evaluated; (4) 
Increase the number of communities that implement a nutrition and 
physical activity plan for the prevention and control of obesity and 
other chronic diseases; (5) Increase the number of state or community 
nutrition and physical activity policies, environmental supports, and/
or legislative actions that are planned, initiated, or modified for the 
prevention or control of obesity and other chronic diseases. More 
information about this program can be found at http://www.cdc.gov/nccdphp/dnpa/obesityprevention.htm.

Component 1: Center of Excellence in Public Health Training and 
Intervention Research Translation

    Objective: To develop the Center of Excellence model There is a 
need to coordinate training and translation activities into Centers for 
Excellence for both the WISEWOMAN and Obesity Prevention programs. Both 
programs address similar risk factors including obesity, poor 
nutrition, and physical inactivity. By October 2004, CDC expects to 
have recommendations for creating Centers of Excellence for WISEWOMAN. 
The awardee will focus on the development of one Center of Excellence 
based on these recommendations. The Center may become a model for 
future Centers.
    Activity 1: Review the WISEWOMAN recommendations for the 
establishment of a Center for Excellence and discuss implementation 
issues with a CDC workgroup that includes WISEWOMAN team members and 
representatives of funded states.
    Activity 2: Conduct research as necessary to further elucidate the 
recommendations made in the plan for the establishment of a Center of 
Excellence to meet both WISEWOMAN and Obesity Prevention Program needs.
    Activity 3: Develop a plan and timetable for the establishment of 
the Center of Excellence.
    Activity 4: Establish a Center of Excellence by the end of the 
third year of funding.

[[Page 15453]]

    Activity 5: Develop a monograph documenting and describing the 
development of the Center of Excellence and how coordination of 
training and translation has been achieved.
    Funding: Year 1: $105,000; Years 2-5: $130,000 annually.

Component 2: Training

    Part 1 Objective: To fund the continuation and expansion of 
Nutrition and Public Health, A Course for Community Practitioners.
    A course titled, `Nutrition and Public Health, A Course for 
Community Practitioners' (NPH) was developed and conducted for public 
health practitioners, particularly WISEWOMAN staff responsible for 
planning and implementing WISEWOMAN projects. This course was developed 
using the socioecological model and MATCH \1\, multi-level approaches 
toward community health, as theoretical models to provide public health 
practitioners with the skills necessary to address lifestyle 
intervention planning and implementation at multiple levels of 
influence. The planning and implementation of NPH will continue under 
this special interest project. More information about NPH can be 
obtained at http://www.hpdp.unc.edu/nph/.
    Activity 1: Plan and conduct NPH annually starting in fiscal Year 
2005.
    Activity 2: Make course revisions and updates based on soon to be 
completed training needs assessment, annual course evaluations, and 
input from course advisory committee and CDC.
    Activity 3: Assess the training course to determine if participant 
needs are met and the extent to which participants apply the knowledge 
in public health practice.
    Activity 4: Explore delivery and expansion options for NPH.
    Activity 5: Develop a 5 year training plan based on the 
recommendations in the soon to be completed training needs assessment.
    Activity 6: Develop and implement at least one additional training 
annually based on the soon to be completed training needs assessment 
and the 5-year training plan developed under this SIP.
    Funding: Years 1-5: $175,000 annually.
    Part 2 Objective: To fund the development and implementation of 
training for public health professionals addressing obesity prevention.
    Activity 1: Review the recommendations made in the soon to be 
completed training needs assessment for the Obesity Prevention Program.
    Activity 2: Discuss the training needs assessment with CDC staff to 
reach consensus on methods of implementing the recommendations reached 
in the assessment.
    Activity 3: Develop a five-year training plan to address the 
recommendations made in the training needs assessment with a continuous 
process for gathering CDC and state input.
    Activity 4: Plan, develop and implement training based on the five-
year plan.
    Activity 5: Assess the developed trainings to determine if 
participant needs are met and, the extent to which participants apply 
the knowledge in public health practice.
    Funding: Years 1-5: $135,000 annually.

Component 3: Translation

    Objective: This component will provide an understanding of how to 
translate efficacious interventions into the public health setting. 
WISEWOMAN has been engaged in these activities since its inception and 
CDC has been supporting the development and translation of new 
community and clinical guidelines for the prevention and control of 
obesity. The newly funded Center will evaluate current translation 
efforts for the purpose of maximizing their public health impact. A 
theoretical framework such as RE-AIM \2\ might be used. Also, the 
Center will identify other efficacious interventions that may be 
translated into the public health setting. The key components of the 
efficacious interventions will be identified and translated 
appropriately for various populations and settings including 
underserved populations, preschool and young children, families, 
worksites, community-based settings, and diverse ethnic/racial groups. 
Appropriate evaluation of interventions can assist public health 
professionals in making decisions about adopting interventions for 
implementation in their communities.

Activities

    (1) Identify efficacious studies related to improved nutrition and 
physical activity, obesity prevention and weight management for 
translation into a variety of public health settings.
    (2) Describe the key components of the intervention that relate to 
its efficacy.
    (3) Use or develop a model for translating the key components into 
public health settings.
    (4) Develop a method for assessing whether current or future 
translation activities achieve maximum public health impact to include 
the reach, efficacy, adoption, implementation, and sustainability of 
the intervention.
    (5) Develop training that provides health professionals and 
partners with the necessary skills for effective translation of 
interventions in their local settings.
    (6) Provide technical assistance to health professionals in 
translating interventions in their setting.
    (7) Continually review the literature to identify new efficacious 
studies appropriate for translation, inform CDC, and work with CDC to 
decide their relevance for WISEWOMAN and the Obesity Prevention 
Programs.
    Funding: Year 1: $195,000; Years 2-5: $260,000 annually.
    Preference will be given to applicants who:
    (1) Demonstrate understanding and experience with both WISEWOMAN 
and Obesity Prevention Programs, and
    (2) demonstrate expertise and experience in:
    (a) Developing, planning, implementing, and evaluating public 
health nutrition and obesity training in a variety of delivery modes,
    (b) Conducting and evaluating public health interventions to 
prevent and control obesity and other chronic diseases,
    (c) Evaluating revising and training to meet the needs of 
participants,
    (d) Assessing efficacy studies related to improved nutrition, 
physical activity, and other positive health behaviors to identify key 
components for translation into the public health setting,
    (e) Tailoring these key components for effectiveness in various 
populations including underserved midlife women, preschool and young 
children, families, worksites, community-based settings, various 
racial/ethnic backgrounds, and those that are financially 
disadvantaged,
    (f) Developing a method for public health translation,
    (g) Evaluating public health interventions for reach, efficacy, 
adoption, implementation, and maintenance
    (h) Ongoing assessment of training needs of public health 
professionals
    Project proposal and length: The application narrative should not 
exceed 25 pages, exclusive of appendices. The appendices should not 
exceed 15 pages.
    Availability of Funds: Year 1: Total budget of $610,000; Years 2-5: 
Total budget of $700,000 annually. Funding may vary and is subject to 
change.
    Research Status: This project will not involve human subject 
research and therefore, should not require CDC IRB approval. The CDC 
staff will serve as technical consultants.

[[Page 15454]]

    References:
    1. Simons-Morton DG, Simons-Morton BG, Parcel GS, Bunker JF: 
Influencing personal and environmental conditions for community health: 
A multilevel intervention model. Fam. Community Health 1988; 11(2): 25-
35.
    2. Glasgow RE, Vogt TM, Boles SM: Evaluating the public health 
impact of health promotion interventions: The RE-AIM framework. Am J 
Public Health. 1999; 89: 1322-1327.

SIP 11-04

    Project Title: Development and Evaluation of Messages to Address 
Safety and Adverse Event Concerns about Influenza Vaccination among 
Adults.
    Project Description: Although an effective vaccine against 
influenza is available and covered by Medicare, only two thirds of 
persons 65 and over are vaccinated each year. In addition, only one 
third of high-risk adults 18 to 65 are vaccinated. At present the 
leading reason for non-vaccination among 65 and older is concern about 
the vaccine, specifically the belief that the vaccine causes illness. 
Concern about the vaccine is also a leading reason among those 18-65. 
Funds will be available to support sound research on developing 
effective messages to reduce such concerns and overcome this barrier to 
vaccination.
    Data from Medicare's Current Beneficiary Survey have shown that 
almost half of unvaccinated seniors give reasons related to concerns 
about the vaccine for not being vaccinated, including that it causes 
disease, causes side effects, and is not effective at preventing 
influenza. About a third give as main reasons for non-vaccination 
reasons related to not knowing they should be vaccinated. Preliminary 
data from a survey of Medicare beneficiaries suggest that concerns 
about the vaccine are more prevalent among African Americans than among 
whites. African Americans are less likely to be vaccinated than whites 
(50% and 69%, respectively in 2002), and remain less likely to be 
vaccinated even after taking into account differences in demographic 
factors and access to care.
    Previous research suggests that a physician's recommendation can 
overcome patient concerns about the influenza vaccine, however not all 
patients are swayed by a provider recommendation. The type of 
information or messages needed to reduce concerns about influenza 
vaccine in general and to help convince those for whom physician 
recommendation is not sufficient to overcome concerns is unknown.
    Research is needed to identify messages and methods that will 
reduce concerns of patients about influenza vaccination, and to 
determine whether different messages are needed for racial/ethnic 
subgroups, with an emphasis on African American patients. The results 
of this project should lead to increased understanding of the kind of 
information that helps to convince people that the influenza vaccine 
does not cause illness and to identify the best channel to deliver such 
information.
    Project Activities: Applications should address the following:
    Objective 1: Message development (Year 1).
     Develop an approach to message development that 
will allow for identifying the need for different messages for 
different racial ethnic groups. A possible approach might be to conduct 
focus groups of persons who have been offered vaccination but elected 
not to be vaccinated because of concerns about the vaccine (groups 
segmented by race/ethnicity)
     Determine setting, methods, feasibility of 
message development protocol prior to implementation. The setting 
should provide access to a substantial proportion of African American 
patients.
     Identify key staff and established resources/
expertise available to conduct this project. Staff qualifications 
should be based on demonstrated knowledge of message development.
    Objective 2: Message testing/evaluation (Year 2, during influenza 
vaccination season).
     Develop an approach for testing the message 
against a control message (for example a pre and post intervention 
survey).
     Develop an approach to determining which channel 
(e.g. pamphlet, doctor, nurse, peer educator) is the most effective or 
preferred channel for receiving such information (again, for example, a 
pre and post intervention survey addressing issues such as trust of the 
information, overall satisfaction, and beliefs about the flu vaccine).
     Determine setting, methods, feasibility of 
message testing/evaluation protocol prior to implementation. The 
setting should provide access to a substantial proportion of African 
American patients.
     Identify key staff and established resources/
expertise available to conduct this project. Staff qualifications 
should be based on demonstrated knowledge of message development.
    Preference will be given to applicants who:
    1. Can demonstrate they have participated in prior research related 
to message development and evaluation.
    2. Can provide a record of publishing similar research.
    3. Can demonstrate access to working with substantial numbers of 
African American adults.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 15 pages. Supporting materials included in 
appendices should not exceed 20 pages.
    Availability of Funds: Approximately $300,000 is available to fund 
up to 2 Prevention Research Centers in the first of a 2-year project 
period. No individual award will exceed $150,000. Funding may vary and 
is subject to change.
    Research Status: It is expected that this project will be non-
exempt research. CDC staff will serve as co-investigators on these 
projects and will provide technical assistance on activities such as 
research design, data collection and analysis, and dissemination of 
results. This project will require CDC IRB approval. As applicable, 
applicants should provide a federal wide assurance number for each 
performance site included in the project.

SIP 12-04

    Project Title: Provider and public health input for vaccine policy 
decisions.
    Project Description: Vaccination is considered one of the top ten 
public health achievements in the 20th century. Despite the power of 
this prevention tool, however, vaccine coverage with all recommended 
vaccines remains below national goals for both children and adults. 
Many factors play a role in immunization uptake, but evidence has shown 
that provider recommendations and practices are very influential. 
Further, a number of evidence-based strategies for raising and 
sustaining high coverage levels among children, adolescents, and adults 
include interventions to be carried out at the provider level. State 
and public health officials are important partners to immunization 
providers, monitoring provider practices and providing technical 
assistance, particularly regarding childhood immunization.
    Implementation of recommendations for new vaccines and recommended 
strategies for vaccination requires several critical components: (1) An 
understanding of potential barriers and concerns perceived by providers 
and by state and local public health officials, (2) measurement of the 
extent of knowledge and misperceptions that

[[Page 15455]]

private and public sector staff have about new recommendations and 
strategies, and (3) the ability to test potential messages among both 
groups. Further, data from these inquiries should be collected using 
scientifically sound methods. Ample response rates to present 
generalizable results and the findings should be available for broad 
dissemination in a timely fashion.
    The purpose of this project is to develop a collaborative mechanism 
with an academic researcher to obtain such input from providers and 
state and local public health officials in a timely fashion. Based on 
prior experience, staff at CDC's National Immunization Program 
anticipate a need to carry out multiple inquiries during each year of 
the three year project period.
    This project should assist in making policy recommendations 
regarding new vaccines, strategies to improve immunization coverage, 
contingency plans to address urgent problems such as vaccine supply 
shortages. In addition, these data will be used to test and refine 
messages for immunization providers and their state and local public 
health collaborators.
    Project Activities: Applications should address the following:
    1. A multidisciplinary study team, including:
     Individuals experienced in the conduct of health 
services research specifically related to childhood and adult 
immunization.
     Individuals with experience conducting and 
analyzing quantitative and qualitative (e.g., focus groups, key 
informant interviews) studies.
     Individuals able to support necessary 
statistical analyses.
     Individuals to support research activities such 
as sampling from national databases, data collection, data entry, 
database management, and programming.
    2. A process for working with CDC staff to identify, prioritize, 
and devise timelines for multiple inquiries per year, including the 
ability to modify priorities/timelines as needed.
    3. A process for working with CDC staff (and outside public health/
researchers as appropriate) to develop and refine study objectives, 
methods, and instruments.
    4. Approaches for collecting data in areas relevant to this 
project, including:
     Awareness, agreement, and adoption of new 
recommendations and factors influencing these outcomes;
     Issues affecting private provider adoption of 
strategies designed to raise immunization coverage, such as the use of 
reminder/recall systems, Assessment, Feedback, and Information eXchange 
(AFIX), and immunization registries;
     Response to and feedback to potential 
recommendations or communications.
    Preference will be given to applicants who:
    1. Can demonstrate that they have participated in rapid (2-6 
months) assessments of provider and public health official perceptions, 
barriers, and reaction to potential recommendations, using both 
qualitative and quantitative methods.
    2. Can provide a record of publishing such research.
    3. Can demonstrate ability to obtain high response rates (50-70%) 
in such research.
    4. Can conduct a minimum of four inquiries per year during each 
year of the three-year project period.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 15 pages. Supporting materials included in 
appendices should not exceed 20 pages.
    Availability of funds: Approximately $300,000 is available to fund 
1 Prevention Research Center in the first of a 3-year project period. 
Funding may vary and is subject to change.
    Research Status: It is expected that this project will involve 
multiple components, most of which are exempt research. CDC staff will 
participate as co-investigators on project activities including 
research design, data collection and analysis, and co-authoring 
manuscripts. It is expected that this project will require CDC IRB 
approval of exempt research status. As applicable, applications should 
provide a federal wide assurance registration number for each 
performance site included in the project.
    References: Centers for Disease Control and Prevention. Ten great 
public health achievements--United States, 1900-1999. MMWR 1999; 
48:241-3.
    Task Force on Community Preventive Services. Recommendations 
regarding interventions to improve vaccination coverage in children, 
adolescents, and adults. American Journal of Preventive Medicine. 
2000;18(1S):92-96.

SIP 13-04

    Project Title: Prevention Research Centers' Healthy Aging Research 
Network (HAN)--Participating Network Center.
    Project Description: The Health Care and Aging Studies Branch, 
Division of Adult and Community Health, National Center for Chronic 
Disease Prevention and Health Promotion, CDC, is seeking to support the 
infrastructure and activities of a network formed around ``healthy 
aging.'' Of particular interest is a network that draws on the 
community collaborations characteristic of the PRCs and provides a 
framework to translate research into practice and policy.
    Consistent with the vision and mission of the PRCs, the proposed 
network will conduct the following types of activities: (1) Synthesis 
of scientific information on the determinants of healthy aging, 
intervention research, and/or translation research for programs in 
healthy aging; (2) research on the effectiveness of community-based 
interventions for which evidence is insufficient to justify a CDC 
recommendation; (3) research on mechanisms to disseminate and implement 
evidenced-based interventions into communities by public health and 
aging services network organizations; (4) evaluation of the 
implementation and effectiveness of community-based programs; and (5) 
development and dissemination of training products for the public 
health and aging networks.
    Although the core function of this special interest project is to 
provide the necessary funding to organize and operate a network of PRCs 
focused on healthy aging, the network would be expected to identify a 
topic area of focus and participate in activities that address gaps in 
the knowledge; assist in the translation of research into practice; and 
contribute to the development of evidence-based intervention that can 
be implemented into community practice.
    Project Activities: Applications should address the following:
    1. Define how the center would collaborate with the Coordinating 
Center and CDC to advance a prevention research agenda for public 
health and aging.
    2. Identify established resources in areas relevant to public 
health and aging within or available to your PRC. Discuss how these 
resources could be enhanced through the proposed network. Define the 
potential for collaboration with academic and community-based resources 
in aging.
    3. Describe how your center would contribute to facilitating the 
translation of research into practice. Discuss the areas where your 
center could play a leadership role and those areas where your 
contributions would be more of a supporting role. What other partners 
need to be involved and how do you propose to include them in 
activities?
    4. Explain how your center will work with the other HAN network 
centers in prioritizing and choosing topics for research, intervention 
or translation.

[[Page 15456]]

    5. Describe how your center will work with the HAN network and 
other partners to develop evidence-based interventions that can be 
implemented in communities.
    Preference will be given to applicants who have:
    (1) Demonstrated experience in health issues for older adults;
    (2) Experience working within a network construct; and
    (3) Basic knowledge about the organization and capacity of the 
aging services network (i.e. the formal network established through the 
Older Americans Act of 1965 which includes the U.S. Administration on 
Aging, state units on aging, local area agencies on aging, and local 
community aging service providers which provides health and social 
services to older adults).
    Project Proposal Length and Supporting Materials: Proposal 
narratives are limited to 20 pages. Supporting materials included as 
appendices should not exceed 40 pages, including publications.
    Availability of Funds: Approximately $210,000-$300,000 is available 
to support six participating network centers (ranging from $35,000-
$50,000/center) for the first year of a five-year project. Funding may 
vary and is subject to change.
    Research Status: The operations of the network itself will not 
involve research on human subjects. However, the pilot projects chosen 
may involve IRB review. CDC technical monitors will assist network 
centers in making human subject determinations.

SIP 14-04

    Project Title: Prevention Research Centers' Healthy Aging Research 
Network (HAN)--Lead Coordinating Network Center.
    Project Description: The Health Care and Aging Studies Branch, 
Division of Adult and Community Health, National Center for Chronic 
Disease Prevention and Health Promotion, CDC is seeking to support the 
infrastructure and activities of a network formed around ``healthy 
aging.'' Of particular interest is a network that draws on the 
community collaborations characteristic of the PRCs and provides a 
framework to translate research into practice. This network would serve 
as a model for a PRC-directed collaboration to address a CDC priority 
population. This Special Interest Project (SIP) would provide the 
funding necessary for one PRC to take the leadership responsibility in 
coordinating the Healthy Aging Research Network's (HAN) activities.
    Consistent with the vision and mission of the PRCs, the proposed 
network will conduct the following types of activities: (1) Synthesis 
of scientific information on the determinants of healthy aging, 
intervention research, and/or translation research for programs in 
healthy aging; (2) research on the effectiveness of community-based 
interventions for which evidence is insufficient to justify a CDC 
recommendation; (3) research on mechanisms to disseminate and implement 
evidenced-based interventions into communities by public health and 
aging services network organizations; (4) evaluation of the 
implementation and effectiveness of community-based programs; and (5) 
development and dissemination of training products for the public 
health and aging networks.
    Although the core function of this special interest project is to 
provide the necessary funding to organize and operate a network of PRCs 
focused on healthy aging, the network would be expected to identify a 
topic area of focus and participate in activities that address gaps in 
the knowledge; assist in the translation of research into practice; and 
contribute to the development of evidence-based interventions that can 
be implemented into community practice.
    Project Activities: Applications should address the following:
    1. Explain the organization and interaction of the Coordinating and 
Collaborating centers. Discuss the relationship with relevant CDC 
activities and staff. Define performance expectations for the network.
    2. Explain how the proposed HAN network would draw on community 
collaborations to enhance older consumers' ability to lead healthier 
and more satisfying lives. Discuss additional partners who may have a 
stake in the work taking place. Address the dissemination of relevant 
information beyond the scientific literature, specifically to 
communities.
    3. Describe how the HAN network would facilitate translation of 
research into practice. Provide a description of a project that would 
be developed and initiated within the first year of the project period 
related to the prior efforts of the HAN.
    4. Define how training needs in public health and aging for public 
health practitioners will be identified and addressed.
    5. Describe how the network Coordinating Center will provide 
leadership in fostering and growing the network. Indicate how this 
growth will be assessed and monitored during the project period. 
Measures may include but are not limited to: (1) The number of 
intervention and dissemination research projects that have been funded; 
or (2) the variety of governmental, foundation, and non-profit sources 
of funding.
    6. Describe how the Coordinating Center will represent and promote 
the PRC Healthy Aging Research Network and its member centers within 
the PRCs and to external partners.
    7. Describe how the Coordinating Center will participate as a 
member of the Healthy Aging Research Network including contributing to 
the facilitation of translating research into practice; identifying 
established resources in areas relevant to public health and aging 
within or available to its PRC; and how the Coordinating Center will 
work with the other network centers to prioritize topics for research 
and intervention development.
    8. Describe the process by which each member center's contributions 
including individual roles and responsibilities to the projects and 
activities of the HAN will be determined.
    Preference will be given to an applicant who:
    (1) Has demonstrated experience in health issues for older adults;
    (2) Has experience in organizing and leading a group of academic 
institutions around a common agenda or theme;
    (3) Has experience in working within a network construct;
    (4) Has letters of support from current member centers of the PRC 
Healthy Aging Research Network that define each PRC's role and 
responsibilities; and
    (5) Has basic knowledge about the organization and capacity of the 
aging services network (i.e., the formal network established through 
the Older Americans Act of 1965 which includes the U.S. Administration 
on Aging, state units on aging, local area agencies on aging, and local 
community aging service providers which provides health and social 
services to older adults).
    Project Proposal Length and Supporting Materials: Proposal 
narratives are limited to 20 pages. Supporting materials included as 
appendices should not exceed 40 pages, including publications.
    Availability of Funds: Approximately $185,000-$200,000 ($150,000 
for leadership and coordination; $35,000-$50,000 for network 
activities) is available to support one Coordinating Center for the 
first year of a five year project. Applicants must apply as a Healthy 
Aging Research Network (SIP 13-04) center to apply for the Coordinating 
Center funding. Funding may vary and is subject to change.

[[Page 15457]]

    Research Status: The operations of the network itself will not 
involve research on human subjects. However, the pilot projects chosen 
may involve IRB review. CDC staff will assist network centers in making 
human subject determinations.

SIP 15-04

    Project Title: Prevention Research Centers' Healthy Aging Research 
Network (HAN)--Defining the Public Health Role in Depression and 
Depressive Disorders for Older Adults.
    Project Description: Several areas of interest in healthy aging 
research are emerging for which no defined public health role has been 
established. Among these areas of interest are health conditions such 
as depression, dementia, Alzheimer's disease, and Parkinson's disease.
    Mental health illnesses, such as depression, can be debilitating 
for older adults. Older adults commonly have multiple chronic 
conditions. Due to physical difficulties resulting from chronic 
disease, older adults may find traveling difficult and are, therefore, 
often physically isolated from family and friends. Social isolation can 
lead to feelings of despair and depression, which when combined with 
physical inactivity, can bring about a decline in both physical and 
mental health functioning.
    Chronic illnesses, such as heart disease, stroke, diabetes, and 
cancer often co-exist with depression. Because many older adults face 
these illnesses as well as various social and economic difficulties, 
health care professionals may mistakenly conclude that depression is a 
normal consequence of these problems'an attitude often shared by 
patients themselves. These factors together contribute to the 
underdiagnosis and undertreatment of depressive disorders in older 
people.
     About 58% of those ages 65 and older believe 
that it is ``normal'' for people to be ``depressed'' as they grow 
older. It is estimated that only half of older adults who acknowledge 
mental health problems actually receive treatment from any health care 
provider.
     Major depression affects 5-10% of older adults 
who visit their primary care provider (Blazer D.G. Depression in Late 
Life: Review and Commentary. J of Gerontology: Medical Sciences. 2003; 
58A(3), pp. 249-265.).
     The prevalence of clinically significant 
depressive symptoms for community-dwelling older adults ranges from 
approximately 8% to 16% (Blazer D.G. Depression in Late Life: Review 
and Commentary. J of Gerontology: Medical Sciences. 2003; 58A(3), pp. 
249-265.).
    The identification and refinement of public health prevention 
opportunities in addressing depression and depressive disorders or the 
co-morbidities associated with depression among older adults are of 
particular interest.
    Project Activities: Applications should address the following:
    1. Describe the review team. This should include but not be limited 
to: (a) Selection of the HAN network center participants; (b) role of 
the coordinating center (applicant); and (c) selection and expertise of 
review team members and roles and responsibilities of the team members. 
Letters of support, identifying the roles and support of the project 
should be provided from all identified team members. Indicate how this 
activity relates to the mission and activities of the PRC Healthy Aging 
Network.
    2. Provide a detailed description of how the review team plans to 
conduct a systematic review of the literature. The purpose of the 
systematic literature review is to identify effective interventions for 
preventing or addressing depression or depressive disorders, and, in 
particular, those strategies that could be made available to older 
adults through the public health and aging services network. As part of 
the review, the review team should also identify strategies for 
assessing mental health in older adults, such as screening instruments 
for depressive symptoms.
    3. Describe the methods that will be employed to execute the 
review, including the databases to be searched, and potential search 
terms. Indicate how the applicant will develop or refine a conceptual 
approach to assist with defining the scope and organization of the 
review. If the framework developed by the Healthy Aging Research 
Network through SIP 13-04 is refined from other work on mental health, 
such as the Guide to Community Preventive Services, indicate how such a 
model will be applied to older adults.
    4. Describe the criteria that will be used to classify articles as 
eligible or ineligible for the review, as well as the process through 
which data will be abstracted from articles, including training of the 
reviewers and measurement of inter-rater reliability.
    5. Describe how the team will assess and define the effectiveness 
of interventions that address depression and depressive disorders for 
older adults for the public health system and the aging services 
network (i.e. the formal network established through the Older 
Americans Act of 1965 which includes the U.S. Administration on Aging, 
state units on aging, local area agencies on aging, and local community 
aging service providers which provides health and social services to 
older adults).
    6. Describe how the network would work with CDC, including the CDC 
Mental Health Workgroup and the Guide to Community Preventive Services 
(http://www.thecommunityguide.org/mental/default.htm), to frame the 
public health role and parameters for interventions and outcomes, 
including health outcomes and costs, related to depression and 
depressive disorders for older adults.
    Preference will be given to an applicant who:
    (1) Is a funded member of the PRC Healthy Aging Research Network 
through SIP 13-04;
    (2) Explicitly partners with one or more other members of the 
current PRC Healthy Aging Research Network;
    (3) Has demonstrated letters of support from contributing member 
centers of the current PRC Healthy Aging Research Network that define 
each center's role and responsibilities; and
    (4) Has demonstrated research experience in the area of depression 
and depressive disorders for older adults. The anticipated activities 
will be conducted in collaboration with staff from CDC, including 
representatives from the Division of Adult and Community Health, 
National Center for Chronic Disease Prevention and Health Promotion, 
who are members of the CDC Mental Health working group and a 
representative from the mental health chapter of the Guide to Community 
Preventive Services.
    Project Proposal Length and Supporting Materials: Proposal 
narratives are limited to 20 pages. Supporting materials included as 
appendices should not exceed 40 pages, including publications.
    Availability of Funds: Approximately $200,000 is available to 
support a project on depression and depressive disorders in older 
adults for the PRC Healthy Aging Research Network for the first year of 
a two-year project. Applicants must also apply and be funded as a 
Healthy Aging Research Network center to apply for this funding. 
Funding may vary and is subject to change.
    Research Status: The project will not involve research on human 
subjects.

SIP 16-04

    Project Title: Prevention Research Centers' Cancer Prevention and 
Control Research Network (CPCRN).
    Project Description: Funds are available for Prevention Research

[[Page 15458]]

Centers (PRCs) to become members of the Cancer Prevention and Control 
Research Network (CPCRN). The vision of the CPCRN is communities and 
researchers work together to significantly reduce the burden of cancer, 
especially among those disproportionately affected. Its mission is to 
conduct cancer prevention and control research that (1) extends the 
knowledge base, (2) addresses critical gaps, and (3) leads to adoption, 
replication, implementation and diffusion of successful programs in 
communities. This research is carried out both by each member center 
through local networks and by the CPCRN as a larger network of member 
centers following the work in the Community Guide to Preventive 
Services (Guide).
    The Guide provides public health decision makers with 
recommendations regarding population-based interventions to promote 
health and to prevent disease, injury, disability, and premature death, 
appropriate for use by communities and health care systems. The Guide 
provides an assessment of the evidence of intervention effectiveness 
and makes two types of recommendations: (1) Where the evidence is 
insufficient to recommend the adoption of an intervention, the Guide 
identifies areas for further research; and (2) where evidence of 
intervention effectiveness is sufficient, the Guide recommends adoption 
of that intervention. CDC and the National Cancer Institute are 
collaborating to develop and/or disseminate several chapters of the 
Guide related to cancer control, including the Cancer Chapter and the 
Tobacco Control Chapter. For more information on the Guide to Community 
Preventive Services, applicants may refer to http://www.thecommunityguide.org or see: Am J Prev Med 2000; 18 (1S): 18-26 
and Am J Prev Med 2000;18(1S):35-43.
    For more information about the CPCRN, see http://ukprc.uky.edu/CPCRN/home.htm. Also, please see the related Special Interest Project 
17-04 which requests proposals for a Coordinating Center for the Cancer 
Prevention and Control Network.
    Project Activities: The objective of this project is to support the 
work of the CPCRN in expanding community-based intervention research on 
cancer prevention and control and facilitating the translation of 
effective interventions into practice. This project is to establish or 
maintain the infrastructure necessary for an individual Center's local 
network and for the larger CPCRN to conduct community-based 
participatory research which will contribute to extending the knowledge 
base, addressing critical gaps in evidence for a particular 
intervention strategy, evaluate specific intervention, and leading to 
adoption, replication, implementation and diffusion of successful 
interventions in communities. Such an infrastructure would allow 
individual Centers and the larger CPCRN to compete successfully for 
research projects, including multi-center projects, from a wide variety 
of sources.
    Applicants should address the following issues:
    1. Describe how your center will contribute to vision, mission, and 
objectives of the CPCRN.
    a. Provide a description of prior research, practice and evaluation 
experiences in intervention and dissemination research (provide 
examples of your achievements in the appendices, including peer-
reviewed articles, grants received, etc).
    b. Describe your particular experiences with cancer prevention and 
control research.
    c. Describe your particular experience with community-based 
participatory research, specifically with regard to health intervention 
programs that involve partnerships with community-based organizations.
    d. Given that this center would be part of the CPCRN, describe your 
experiences of collaboration or describe how the project staff could 
collaborate with other centers in the network.
    2. Identify the key staff who will be devoted to this project.
    a. For each person describe his or her demonstrated knowledge, 
experience, and ability in planning and conducting research that is 
similar in complexity, scope and focus to the types proposed here. If 
there is a position that is yet to be filled, provide a position 
description in the appendix. Include the percentage of time each person 
will devote to project activities.
    b. Of the named staff, provide evidence of the interdisciplinary 
nature of the key center leadership and experiences in conducting and 
being funded for intervention research, community-based participatory 
research, and translation of research into practice.
    3. Provide evidence that the proposed project activities will be 
conducted through partnerships with cancer prevention and control 
experts in the community, state, and/or region.
    a. Provide evidence of links to other cancer control research and 
practice centers, such as comprehensive cancer control centers, special 
population networks, transdisciplinary tobacco use research centers, 
and the current PRC Cancer Prevention and Control Research Network.
    b. Describe the methods that will be used to maintain these 
partnerships. Provide evidence of commitment and cooperation of 
potential partners (e.g., recent letters of support, memoranda of 
understanding, and documented examples of prior collaboration).
    c. Describe the methods that will be used to establish and maintain 
new partnerships, as needed.
    d. Describe how you will involve various community representatives 
in the proposed project.
    e. Indicate the leadership responsibilities, roles, and 
relationship of community representatives to the larger CPCRN team.
    4. Provide evidence of sufficient institutional support for this 
project (e.g., support from PRC leadership, space, equipment, etc). 
Describe the established resources and expertise available to your 
staff (e.g., intervention research, health services research, 
community-based participatory research, behavioral sciences, 
statistical expertise for randomized trials, research dissemination, 
program evaluation, public health, economics, communication theory and 
practice, etc).
    5. State the proposed evaluation strategies and measures at three 
and five years that can be used to indicate the effectiveness of the 
local network and provide information needed for refinement and growth 
of the local network. Measures might include: (1) The number of 
intervention and dissemination research projects that have been funded, 
conducted and published which might be used to inform subsequent Guide 
recommendations; (2) the number of such research efforts that have been 
awarded from a variety of governmental, foundation, and non-profit 
sources; and (3) the number of collaborative research efforts that have 
been initiated between the member center and other NCI-supported cancer 
research centers/networks.
    Preference will be given to applicants who:
    1. Demonstrate the capacity to publish and/or be funded for 
community intervention research, particularly in cancer prevention and 
control.
    2. Provide evidence of successful experiences in conducting 
research on dissemination processes, dissemination of specific 
research, or community-based participatory research with underserved 
populations.
    3. Represent diverse populations and are geographically distributed 
throughout the United States.

[[Page 15459]]

    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 20 pages. Supporting materials included in 
the appendices should not exceed 30 pages. The appendices should 
include the requested materials above, including the 2-page 
biographical sketches, position descriptions of faculty and staff (if 
needed), letters of support, membership lists of community advisory 
board, etc.
    Availability of Funds: Approximately $1,500,000 is available to 
fund 5 Prevention Research Centers for the first year of a 5-year 
project period. The average award is expected to range from $300,000 to 
$350,000 per year. Budgets should include costs for travel for two 
persons to an annual meeting of the full Network. For budgetary 
purposes, use Atlanta as the site of such annual meetings. Funding may 
vary and is subject to change.
    Research Status: This project is to establish or maintain 
infrastructure of the CPCRN, and will not involve human subject 
research.

SIP 17-04

    Project Title: Coordinating Center, Prevention Research Centers' 
Cancer Prevention and Control Network.
    Project Description: Funds are available to support a Coordinating 
Center for the Prevention Research Centers' (PRC's) Cancer Prevention 
and Control Network. The Coordinating Center serves as the focal point 
for (1) guiding network discussions related to the development of 
research expertise in community interventions for cancer prevention and 
control, (2) organizing collaborative activities with network members 
and their various collaborating partners (e.g., state/local health 
departments, community groups, and cancer control research and practice 
centers), (3) facilitating linkages among network members and national/
state/local partners to ensure network objectives are being achieved, 
and (4) coordinating evaluation of network activities. For further 
detail on the objectives and activities of the Cancer Prevention and 
Control Network, please see the Special Interest Project 16-04.
    Project Activities: Applicants should address the following:
    1. Describe the proposed process for serving as the coordinating 
arm for the development of a PRC Cancer Prevention and Control Network, 
including but not limited to the following items:
    a. Description of the resources and processes that will facilitate 
linkages and activities among the Cancer Prevention and Control 
Research Network, such as coordination of conference calls and 
dissemination of information;
    b. Description of the processes through which network research 
projects would be selected and pursued by network centers or subgroups; 
and
    c. Description of the process for identifying, collecting, and 
disseminating products and results from network members.
    2. Propose an external evaluation process to indicate the 
effectiveness of the network and to provide information needed for 
refinement and growth of the network. Indicate how and when the 
evaluation results will be shared with the network members and other 
partners, including the PRC program.
    3. Identify the proposed staff who will work on coordinating center 
activities. Provide their relevant experience, a description of their 
roles, and the proportion of time each will spend on coordinating 
center activities. Examples of these personnel may include an 
administrator, project manager, and others.
    Preference will be given to applicants who demonstrate experience 
in:
    1. Coordinating and conducting multicenter research;
    2. Collaborative planning using participatory methods; and
    3. Conducting community-based intervention research, participatory 
research, dissemination research, and program evaluation.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 20 pages. Supporting materials included in 
the appendices should not exceed 30 pages; the appendices should 
include the above-requested materials, 2-page biographical sketches, 
position descriptions of staff (if needed), recent letters of support, 
membership lists of community advisory board, and other evidence as 
consistent with the proposal.
    Availability of Funds: Approximately $300,000 is available to fund 
one Prevention Research Center in the first year of a 5-year project 
period to act as the Coordinating Center. Funding may vary and is 
subject to change. Applicant must apply and receive funding as a 
Prevention Research Centers' Cancer Prevention and Control Research 
Network (SIP 16-04) to be eligible to receive Coordinating Center 
funding.
    Research Status: The Coordinating Center does not conduct research, 
but monitors the network infrastructure only. This project will not 
involve research on human subjects.

SIP 18-04

    Project Title: Trial of interventions to increase utilization of 
colorectal cancer screening and promote informed decision making about 
colorectal screening among Hispanic women and men.
    Project Description: Colorectal cancer is the second leading cause 
of cancer death in the United States. Strong scientific evidence has 
shown that screening for colorectal cancer saves lives. However, 
studies have demonstrated that most eligible persons are still not 
meeting the screening recommendations for colorectal cancer and that 
screening rates are especially low among Hispanic men and women in the 
United States. Few intervention studies have examined methods to 
increase colorectal cancer screening, or to promote informed decision 
making about colorectal cancer screening, and even fewer studies have 
focused on Hispanic persons. As such, effective intervention materials 
that are culturally appropriate and available in English and Spanish 
are needed to promote colorectal cancer screening among Hispanic 
adults.
    Informed decision making about colorectal cancer screening includes 
making informed choices between screening options. The interventions 
tested for effectiveness should target Hispanic men and women aged 50 
years older (including those who are at average risk and those who have 
a modest family history of colorectal cancer). The interventions 
developed as part of this project should be consistent with the U.S. 
Preventive Services Task Force (USPSTF) recommendations regarding 
colorectal cancer screening and informed decision-making.
    The available evidence regarding the effectiveness of specific 
client-oriented interventions and provider-oriented interventions for 
colorectal cancer screening is not currently sufficient to justify a 
Guide to Community Preventive Services recommendation (http://www.thecommunityguide.com). Where evidence is sufficient for a 
recommendation, there is a need for replication studies to examine the 
applicability of the interventions to other populations such as 
Hispanic men and women. Most studies of informed decision making for 
cancer screening have focused on prostate or breast cancer screening, 
and few studies on informed decision making for cancer screening have 
included Hispanic persons.
    This project seeks to develop and examine the effectiveness of an 
intervention to increase colorectal screening and promote informed 
decision making about colorectal cancer screening among Hispanic men 
and women (for example, Mexican

[[Page 15460]]

Americans), via a community-based intervention trial and participatory 
research methods.
    Project Activities: Applications should address the following:
    1. Explain how intervention materials will be developed and tested 
to increase routine colorectal screening and to promote informed 
decision making about colorectal cancer screening among Hispanic women 
and men.
    2. Explain how the above intervention materials will fit into an 
intervention strategy for increasing informed decisions regarding 
colorectal cancer screening.
    3. Describe how a pilot of the intervention strategy will be 
conducted, including revisions based upon the pilot.
    4. Describe how a community-based intervention trial will be 
conducted including the: background and rationale, methods (including a 
description of the intervention materials that will be developed and 
tested), sample size estimates, desired outcome measures, the plan for 
analysis, and human subjects considerations.
    5. Outline plans for engaging Hispanic community partners in all 
aspects of this study.
    6. Describe the collaborative relationships between the university, 
representatives of the community partners, the relevant state and local 
health departments, and a major provider of health care services for 
the target population.
    Preference will be given to applicants who:
    1. Demonstrate prior experience conducting community-based, 
participatory research involving Hispanic communities.
    2. Propose a community-based intervention trial that would be 
conducted by a Prevention Research Center, in partnership with a 
university medical center or other major health care provider and their 
community partners.
    3. Propose an intervention study consisting of a randomized 
preventive trial or one which has a quasi-experimental design, 
following guidelines for rigorous research identified by the Guide to 
Community Preventive Services (http://www.thecommunityguide.com).
    4. Demonstrate that research participants who have a positive 
colorectal cancer screening test will have access to follow-up care and 
treatment, as appropriate.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 20 pages. Supporting materials in appendices 
should not exceed 20 pages.
    Availability of Funds: Approximately $350,000 is available to fund 
1 Prevention Research Center in the first year of a 4-year project 
period. Funding may vary and is subject to change.
    Research Status: It is expected that the project will be non-exempt 
research. CDC staff will serve as co-investigators on this project and 
will provide technical assistance on activities such as research 
design, data collection and analysis, and dissemination of results. It 
is expected that the project will require CDC IRB approval or approval 
of deferral to the local IRB. As applicable, applications should 
provide a federal wide assurance registration number for each 
performance site included in the project.

SIP 19-04

    Project Title: Assessing the reliability and validity of core 
questions to measure colorectal cancer screening behaviors.
    Project Description: Colorectal cancer (CRC) is the second leading 
cause of cancer death. Screening has been demonstrated to be effective 
in reducing death from colorectal cancer, but the prevalence of 
colorectal cancer screening among adults is extremely low. The Task 
Force on Community Preventive Services has concluded that there is 
insufficient evidence concerning the effectiveness of interventions to 
increase screening for CRC. The recently published Institute of 
Medicine report, Fulfilling the Potential of Cancer Prevention and 
Early Detection (Curry SJ, Byers T, Hewitt M (eds.) Fulfilling the 
Potential of Cancer Prevention and Early Detection. Washington, DC: The 
National Academies Press, 2003.) called for the development, 
implementation and evaluation of ``comprehensive community-based 
programs in cancer prevention and early detection.'' Additional 
research is likely to be undertaken in the next several years to 
address the effectiveness of different types of interventions to 
increase CRC screening. Central to any program evaluation are valid and 
reliable measures of outcome.
    For measures of CRC screening behaviors, core questions recently 
have been developed by a working group of experts which was sponsored 
by the National Cancer Institute (NCI) (A manuscript describing this 
effort has been prepared and is expected to be published within the 
next year.) These core questions were based on questions that had been 
used in national surveys or in survey instruments for intervention 
studies of colorectal cancer screening. Cognitive testing was performed 
on these questions in May 2002. As the next step, the working group has 
recommended ``studies to assess the reliability and validity of the 
questions in different subgroups of the population.'' To date, this 
research has not been conducted. In other words, there is no evidence 
regarding the reliability or validity of commonly used measures of 
colorectal screening behavior.
    The establishment of reliable and valid measures of colorectal 
cancer screening behaviors would be of enormous value to a variety of 
surveillance and intervention activities. These activities would enable 
decision makers to have a greater confidence in data which are based on 
reliable and valid measures. Measures of colorectal cancer screening 
are used to evaluate the effectiveness of interventions, compare the 
effectiveness of different types of interventions with each other, and 
track changes in screening behavior over time. The value of research 
studies on intervention effectiveness and surveillance efforts are 
highly dependent on the quality of the outcome measures used.
    The purpose of this funding would be to conduct studies using the 
core questions to measure colorectal cancer screening behaviors that: 
(1) Measure the reliability or consistency of responses to questions 
following repeat administration; and/or (2) measure the validity of 
responses to the core questions. The results of the research to be 
supported through this project should contribute substantially toward 
the establishment of reliable and valid measures for colorectal cancer 
screening behavior.
    Project Activities: Applicants should address the following:
    1. Clarify the specific research question(s) to be addressed. The 
research question(s) should consider measures of reliability and 
validity of the core CRC screening behavior questions. The specific 
research question(s) may be refined depending on the method of 
administration (mail, telephone, or face-to-face) and the population to 
be included.
    2. Describe a study to address the research question to be 
addressed, including a description of the proposed population, setting 
and methods.
    3. Provide a description of prior research to justify the proposed 
study population and study approach.
    4. Provide an explanation of the basis for the proposed sample size 
and anticipated participation rates.

[[Page 15461]]

    5. Describe the estimated timetable for the study.
    6. Provide evidence of support from institutions and other 
stakeholders to carry out this research.
    7. Identify the key staff who will be devoted to the project and 
their respective roles and time commitments. For each person, describe 
their demonstrated knowledge, experience, and ability in planning and 
conducting this type of research.
    Preference will be given to applicants who:
    1. Can demonstrate that they have participated in previous research 
related to tests of the reliability or validity of outcome measures 
used in questionnaires.
    2. Have extensive experience in conducting research in community or 
clinic settings.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 15 pages. Supporting materials included in 
appendices should not exceed 20 pages.
    Availability of Funds: Approximately $250,000 is available to fund 
one Prevention Research Center in the first year of a 2-year project 
period. Funding may vary and is subject to change.
    Research Status: It is expected that this project is non-exempt 
research. CDC staff will not serve as co-investigators on this project 
but will provide technical assistance on activities such as research 
design, data collection and analysis, and dissemination of results.

SIP 20-04

    Project Title: Trial of interventions to increase utilization of 
colorectal cancer screening among women and men.
    Project Description: Colorectal cancer is the second leading cause 
of cancer death in the United States. Strong scientific evidence has 
shown that screening for colorectal cancer saves lives. However, 
studies have demonstrated that most eligible persons are still not 
meeting the screening recommendations for colorectal cancer. In 
addition, few intervention studies have examined methods to increase 
colorectal cancer screening.
    The available evidence regarding the effectiveness of specific 
client-oriented interventions and provider-oriented interventions for 
colorectal cancer screening is not currently sufficient to justify a 
Guide to Community Preventive Services recommendation (http://www.thecommunityguide.com). Where evidence is sufficient for a 
recommendation, there is a need for replication studies to examine the 
applicability of the interventions to other populations.
    This project seeks to develop and examine the effectiveness of an 
intervention to increase colorectal screening among men and women, via 
a community-based intervention trial and participatory research 
methods.
    The interventions should be tested for effectiveness that target 
men and women aged 50 years of older (including those who are at 
average risk and those who have a modest family history of colorectal 
cancer). The interventions developed as part of this project should be 
consistent with the U.S. Preventive Services Task Force (USPSTF) 
recommendations regarding colorectal cancer screening.
    Project Activities: Applications should address the following:
    1. Explain how intervention materials will be developed and tested, 
to increase routine colorectal screening among women and men.
    2. Explain how the above intervention materials will fit into an 
intervention strategy for increasing colorectal cancer screening.
    3. Describe how a pilot of the intervention strategy will be 
conducted, including revisions based upon the pilot.
    4. Describe how a community-based intervention trial will be 
conducted including the: background and rationale, methods (including a 
description of the intervention materials that will be developed and 
tested), sample size estimates, desired outcome measures, the plan for 
analysis, and human subjects considerations.
    5. For all aspects of this study, outline plans for engaging 
community partners in implementing the study.
    6. Identify a collaborative relationship between the university, 
representatives of the target population, the relevant state and local 
health departments, and a major provider of health care services for 
the target population.
    Preference will be given to applicants who:
    1. Demonstrate prior experience conducting community-based, 
participatory research involving communities.
    2. Propose a community-based intervention trial that would be 
conducted by a Prevention Research Center, in partnership with a 
university medical center or other major health care provider and 
community partners.
    3. Propose an intervention study consisting of a randomized 
preventive trial or one which has a quasi-experimental design, 
following guidelines for rigorous research identified by the Guide to 
Community Preventive Services (http://www.thecommunityguide.com).
    4. Demonstrate that research participants who have a positive 
colorectal cancer screening test will have access to follow-up care and 
treatment, as appropriate.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 20 pages. Supporting materials in appendices 
should not exceed 20 pages.
    Availability of Funds: Approximately $350,000 is available to fund 
1 Prevention Research Center in the first year of a 4-year project 
period. Funding may vary and is subject to change.
    Research Status: It is expected that the project will be non-exempt 
research. CDC staff will serve as co-investigators on this project and 
will provide technical assistance on activities such as research 
design, data collection and analysis, and dissemination of results. It 
is expected that the project will require CDC IRB approval or approval 
of deferral to the local IRB. As applicable, applications should 
provide a federal wide assurance registration number for each 
performance site included in the project.

SIP 21-04

    Project Title: Community Interventions in Non-medical Settings to 
Increase Informed Decision Making (IDM) for Prostate Cancer Screening.
    Project Description: The purpose of this project is to provide 
evidence contributing to recommendations made in The Guide to Community 
Preventive Services (Guide). The Guide provides evidence-based 
recommendations on the effectiveness of community interventions to 
promote health and prevent disease, disability and premature death. 
Guide recommendations are provided for use by communities, public 
health agencies, and health care systems. For more information see 
http://www.thecommunityguide.org or Am J Prev Med 2000; 18 (1S). In a 
recently published review of evidence on the effectiveness of community 
interventions to promote IDM for cancer screening, the Guide found 
insufficient evidence to make a recommendation about the effectiveness 
of these interventions (Am J Prev Med Jan. 2004). While the Guide found 
evidence that such interventions increased individuals' knowledge, too 
few studies examined whether the interventions resulted in individuals' 
participating in decision making at their desired levels or whether 
decisions were consistent with individuals' values and preferences. The 
Guide recommended

[[Page 15462]]

additional research focusing on participation in decision making and on 
the how to effectively incorporate individual values and preferences in 
decision making. Given the lack of research in non-medical settings and 
in diverse populations, additional research is needed on how to perform 
effective and cost-effective IDM interventions in non-clinical settings 
and on how to implement these interventions in diverse populations, 
particularly in populations that include non-white or less advantaged 
groups. Interventions for use in non-clinical settings are particularly 
needed because of the limited time primary care providers have 
available to provide preventive services. Applicants may refer to http://www.thecommunityguide.org for the Guide IDM review and 
recommendations and for copies of other relevant Guide publications.
    Evidence on the effectiveness of prostate cancer screening and on 
the balance of benefits and harms from screening is summarized by the 
U.S. Preventive Services Task Force (USPSTF) http://www.ahrq.gov/clinic/cps3dix.htm#screening. There is good evidence that prostate 
specific antigen (PSA) screening can detect early-stage prostate cancer 
but mixed and inconclusive evidence that early detection improves 
health outcomes. Screening is associated with important harms, 
including unnecessary anxiety, biopsies, and complications of treatment 
of some prostate cancers that may never have affected a patient's 
health. It is unclear whether the benefits outweigh the harms. Given 
the uncertainty regarding the balance of benefits and harms from 
prostate cancer screening, the CDC supports informed decision making as 
a public health approach to prostate cancer screening (http://www.cdc.gov/cancer/prostate/).
    The objective of this funding is to support research on the 
effectiveness of community interventions in non-medical settings to 
promote informed decision making for prostate cancer screening, 
conducted in collaboration with appropriate community and research 
partners.
    Project Activities: Applicants should address the following:
    1. How the proposed study design and methods of implementation meet 
quality criteria for inclusion in evidence reviews conducted by the 
Guide;
    2. How the research will provide evidence of the effectiveness of 
the community intervention in promoting IDM as defined by the Guide;
    3. How the information component of the proposed intervention (the 
knowledge provided) is consistent with USPSTF on prostate cancer 
screening effectiveness and on the balance of benefits and harms from 
prostate cancer screening;
    4. How the intervention will be developed and evaluated for use in 
non-clinical settings, such as workplaces or with voluntary 
associations or community organizations;
    5. How the intervention will be developed and evaluated for use 
among men from a range of diverse backgrounds, including non-white and/
or Hispanic populations and men with blue collar occupations and/or 
lower incomes;
    6. How the intervention will be developed and evaluated for effects 
on men's participation in screening decisions at their desired level;
    7. How the interventions will be developed and evaluated for 
incorporation of individuals' values and preferences in decision-
making;
    Preference will be given to proposals that demonstrate the 
following:
    1. The ability to address each of the project activities listed 
above, particularly with regard to consistency with the Guide and the 
USPSTF evidence reviews and recommendations;
    2. The applicants' abilities to successfully complete the research;
    3. A history of extramural funding for related research and of 
publications from that research;
    4. Evidence that the community interventions can be made available 
in a format that will allow them to be easily used by public health 
agencies and community groups to promote informed decision making for 
prostate cancer in community settings; and
    5. Use materials and methods previously developed and evaluated 
through formative research and piloting in the planned setting with the 
proposed populations.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 25 pages. Supporting materials included in 
the appendices should not exceed 40 pages; the appendices should 
included the materials supportive of ability to successfully conduct 
the research described above, 2-page biographical sketches, position 
descriptions of staff (if needed), any needed letters of support, and 
other evidence as consistent with the proposal.
    Availability of Funds: Approximately $1,275,000 is available to 
fund two applications ($637,500 per applicant) in the first year of a 
3-year project period. Funding may vary and is subject to change. 
Applicants must apply for and receive funding as a PRC Cancer 
Prevention and Control Research Network Center to be eligible to 
receive funding for this project. (See SIPs 16-04 and 17-04 on the 
Prevention Research Centers Cancer Prevention and Control Network).
    Research Status: CDC staff will serve as co-investigators on these 
projects and will provide technical assistance on activities such as 
research design, data collection and analysis, and co-authoring 
manuscripts. It is anticipated that these projects will need approval 
by the IRB at the recipient institution and that CDC IRB approval or 
deferral to the recipient IRB will be required. The CDC IRB reviews 
projects annually. Applicants should provide a federal wide assurance 
registration number for each performance site included in this project.

SIP 22-04

    Project Title: Validating the Educational Effectiveness of 
Professional Education on Informed Decision Making for Prostate Cancer 
Screening.
    Project Description: A key element in the Community Guide to 
Preventive Services analytic framework for interventions to promote 
informed decision making about prostate cancer screening is providers' 
knowledge, attitudes, intentions, and efficacy. For more information 
about the Community Guide, see http://www.thecommunityguide.org or Am J 
Prev Med 2000; 18 (1S). The intent of this project is to support 
methodologically sound initial evaluation studies of professional 
medical education training materials and curricula on informed decision 
making. Curricula to be evaluated should promote:
     Doctor-patient communication about prostate 
cancer screening and informed decision making
     Physician's knowledge and understanding of the 
clinical evidence related to prostate cancer screening, including the 
harms and benefits
     Physicians' skills in relating and explaining 
the current recommendations related to prostate cancer screening
     Physicians' understanding of racial, ethnic and 
cultural differences related to prostate cancer epidemiology and the 
use of medical services.
    These projects should evaluate training materials and curricula 
which have been fully developed but have not been tested to address 
initial validation questions such as: Do physicians who complete the 
professional education curriculum acquire the knowledge or 
interpersonal skills that the training

[[Page 15463]]

intends? The project may support up to two validation studies of 
comprehensive professional medical education programs through the 
Cancer Prevention and Control Research Network.
    Although prostate cancer is an important cause of death and 
disability among men in the United States, screening for prostate 
cancer is controversial. Because of the growing use of screening in 
spite of uncertainty about the balance between its harms and benefits, 
many organizations encourage informed decision making to assist men 
with understanding complex screening issues and making decisions which 
are consistent with their personal values, beliefs, and preferences.
    Informed decision making is a complex process designed to assist a 
patient with understanding the nature of prostate cancer; understanding 
the preventive service (in this case, prostate cancer screening) 
including risks, limitations, benefits, alternatives, uncertainties; 
identifying preferences and values; choosing a level of participation 
in decision making with which he is comfortable; and making (or 
deferring) a decision based on his preferences and values. The process 
of informed decision making involves, at some point, an active 
discussion between the individual and his health care provider, usually 
his primary care physician. Like their patients, physicians need to be 
prepared to be effective participants in the informed decision making 
dialogue. At the level of the individual physician, this translates 
into very practical questions about what exactly should be said during 
the clinical visit, how should relevant aspects of risk and benefit be 
communicated, or how to respond to asymptomatic men who request a 
screening test with obviously incomplete or incorrect information.
    It is well accepted that patients defer to their physicians when 
faced with complicated medical decisions. Physicians and other health 
care providers must not only understand the facts of prostate cancer 
screening but also be able to assist the patient with actively 
participating in the informed decision making process. Specific 
professional medical education and informed decision making for 
prostate cancer screening is necessary. Projects funded through this 
proposal will evaluate the effectiveness of existing professional 
education materials and programs for teaching providers the knowledge, 
interpersonal skills, and cultural sensitivity needed to participate in 
informed decision making. Training packages should include training on 
doctor-patient communication; information on the clinical evidence 
related to prostate cancer screening, including the harms and benefits; 
information on racial, ethnic and cultural differences related to 
prostate cancer epidemiology and the use of medical services; and 
specific skills training for relating and explaining the current 
recommendations related to prostate cancer screening.
    Project activities: Applications should address the following:
    1. Describe a study to assess the potential effectiveness of a 
well-defined and replicable professional education training program 
designed to promote competent physician participation in informed 
decision making for prostate cancer screening;
    2. Provide a description of prior research and examples of success 
with conducting experimental intervention research (e.g., resulting 
scientific publications in peer-reviewed journals);
    3. Provide a description of the proposed setting, methods, and 
training materials;
    4. Provide evidence for the feasibility of the training methods and 
materials;
    5. Describe how the study design is consistent with design 
standards established by the Guide to Community Preventive Services. [A 
detailed description of Community Guide standards can be found at: 
www.thecommunityguide.org];
    6. Identify the key project staff and their roles. For each person, 
describe their demonstrated knowledge, experience, and ability in 
planning and conducting research on professional education;
    7. Describe the established resources and expertise available to 
the research staff for conducting intervention research in a timely 
fashion;
    8. Provide evidence of sufficient institutional and other necessary 
support for carrying out this project.
    Preference will be given to applicants who:
    1. Have developed the educational materials and procedures to be 
used in this project;
    2. Can demonstrate that they have participated in previous research 
related to informed decision making;
    3. Can provide a record of publishing similar research;
    4. Have extensive experience in conducting intervention research in 
community or clinical settings;
    5. Are part of, or actively collaborate with a member of, the 
Cancer Prevention and Control Research Network;
    6. Develop their project using an existing professional education 
program designed specifically to address provider participation in 
informed decision making. No support will be provided for new 
development of training materials.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 15 pages. Supporting materials included in 
appendices should not exceed 30 pages. Supporting materials should 
provide information sufficient to evaluate the content and 
comprehensiveness of the training, biographical sketches of key 
investigators, position descriptions of staff (if needed), and letters 
of support from collaborators.
    Availability of Funds: Approximately $150,000 per year per project 
for up to two projects per year is available for over a three-year 
period. Funding may vary and is subject to change. The applicant funded 
through this announcement will not be eligible for funding under SIP 
23-04.
    Research Status: It is expected that this project will be exempt 
research. CDC staff will provide technical assistance but will not 
serve as co-investigators. CDC staff will not have significant input on 
project activities including study design, methods, sampling, and data 
analysis.

SIP 23-04

    Project Title: Evaluating the Effect of Professional Education on 
Provider Interventions for Informed Decision Making about Prostate 
Cancer Screening.
    Project Description: A key element in the Community Guide to 
Preventive Services analytic framework for interventions to promote 
informed decision making about prostate cancer screening is providers' 
knowledge, attitudes, intentions, and efficacy. For more information 
about the Community Guide, see www.thecommunityguide.org or Am J Prev 
Med 2000; 18 (1S).
    The objective of this project is to support methodologically sound 
research evaluating the effectiveness of professional medical education 
designed to shape health care providers' interventions with patients 
for promoting informed decision making about prostate cancer screening. 
A comprehensive program should provide, at a minimum, training on:
     Doctor-patient communication about prostate 
cancer screening and informed decision making;
     Physician's knowledge and understanding of the 
clinical evidence related to prostate cancer screening, including the 
harms and benefits;
     Physician's skills in relating and explaining 
the current

[[Page 15464]]

recommendations related to prostate cancer screening; and
     Physicians' understanding of racial, ethnic and 
cultural differences related to prostate cancer epidemiology and the 
use of medical services.
    The project will support one investigation of a comprehensive 
professional medical education program through the Cancer Prevention 
and Control Research Network. The research should be designed to 
evaluate differences in outcomes for patients who participate in 
informed decision making with trained providers compared to those who 
participate in informed decision making with providers who have not 
received the training.
    Although prostate cancer is an important cause of death and 
disability among men in the United States, screening for prostate 
cancer is controversial. Because of the growing use of screening in 
spite of uncertainty about the balance its harms and benefits, many 
organizations encourage informed decision making to assist men with 
understanding complex screening issues and making decisions which are 
consistent with their personal values, beliefs, and preferences.
    Informed decision making is a complex process designed to assist a 
patient with understanding the nature of prostate cancer; understanding 
the preventive service (in this case, prostate cancer screening) 
including risks, limitations, benefits, alternatives, and 
uncertainties; identifying preferences and values; choosing a level of 
participation in decision making with which he is comfortable; and 
making (or deferring) a decision based on his preferences and values. 
The process of informed decision making involves, at some point, an 
active discussion between the individual and his health care provider, 
usually his primary care physician. Like their patients, physicians 
need to be prepared to be effective participants in the informed 
decision making dialogue. At the level of the individual physician, 
this translates into very practical questions about what exactly should 
be said during the clinical visit, how relevant aspects of risk and 
benefit should be communicated, or how responses should be made to 
asymptomatic men who request a screening test with obviously incomplete 
or incorrect information.
    It is well accepted that patients defer to their physicians when 
faced with complicated medical decisions. Physicians and other health 
care providers must not only understand the facts of prostate cancer 
screening but also be able to assist the patient with actively 
participating in the informed decision making process. Training 
materials have been developed to assist physicians with participating 
in informed decision making, including 4 developed through DCPC 
cooperative agreements and a slide show developed by DCPC. However, 
there has been no research on the effectiveness of these materials for 
promoting decision making by improving practitioners' knowledge and 
skill.
    Projects funded through this proposal should evaluate the 
effectiveness of existing professional education materials and programs 
for enhancing competent provider participation in informed decision 
making in real-world, clinical settings. Competence should be measured 
in terms of both changed provider behavior and successful completion of 
the informed decision making process by the patient. Training packages 
should include training on doctor-patient communication; information on 
the clinical evidence related to prostate cancer screening, including 
the risks and benefits; information on racial, ethnic and cultural 
differences related to prostate cancer epidemiology and the use of 
medical services; and specific skills training for relating and 
explaining the current recommendations related to prostate cancer 
screening. Training materials and procedures used in the project should 
have received an initial evaluation demonstrating educational 
effectiveness.
    Project activities: Applications should address the following:
    1. Describe a study to assess the effectiveness of a well-defined 
and replicable professional education training program designed to 
promote competent physician participation in informed decision making 
for prostate cancer screening.
    2. Provide a description of prior research and examples of success 
with conducting experimental intervention research (e.g., resulting 
scientific publications in peer-reviewed journals);
    3. Provide a description of the proposed setting, methods, and 
training materials;
    4. Provide a summary of the initial evaluation results for the 
training methods and materials;
    5. Provide evidence for the feasibility of the research design;
    6. Describe how the study design is consistent with design 
standards established by the Guide to Community Preventive Services. [A 
detailed description of Community Guide standards can be found at: 
http://www.thecommunityguide.org];
    7. Identify the key staff who will be devoted to the project. For 
each person describe their demonstrated knowledge, experience, and 
ability in planning and conducting research on professional education;
    8. Describe the established resources and expertise available to 
the research staff for conducting intervention research in a timely 
fashion;
    9. Provide evidence of sufficient institutional and other necessary 
support for carrying out this project.
    Preference will be given to applicants who:
    1. Have developed and pre-tested the educational materials and 
procedures to be used in this project;
    2. Can demonstrate that they have participated in previous research 
related to informed decision making;
    3. Can provide a record of publishing similar research;
    4. Have extensive experience in conducting intervention research in 
community or clinical settings;
    5. Are part of, or actively collaborate with a member of the 
Prevention Research Centers' Cancer Prevention and Control Research 
Network, SIP 16-04 and SIP 17-04.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 15 pages. Supporting materials included in 
appendices should not exceed 30 pages. Supporting materials should 
provide information sufficient to evaluate the content and 
comprehensiveness of the training, biographical sketches of key 
investigators, position descriptions of staff (if needed), and letters 
of support from collaborators.
    Availability of Funds: Approximately $400,000 per year is available 
to fund one project for up to 4 years. Funding may vary and is subject 
to change. Each applicant should develop their project using an 
existing professional education. No support will be provided for new 
development of training materials. The applicant funded for this 
project will not be eligible for funding under SIP 22-04.
    Research Status: It is expected that this project will be exempt 
research. CDC staff will provide technical assistance but will not 
serve as co-investigators. CDC staff will not have significant input on 
project activities including study design, methods, sampling, and data 
analysis.

SIP 24-04

    Project Title: Analysis of ovarian cancer surgeries using state 
hospital discharge data.
    Project Description: Existing data have shown that cancer staging 
and

[[Page 15465]]

cytoreduction performed by gynecologic oncologists has a significant, 
positive impact on survival (Nguyen, et al. 1993; Mayer, et al. 1992; 
Puls et al. 1997). It is likely that these specialists perform the most 
surgeries and practice in high-volume hospitals. A recent study in 
Canada (Elit et al. 2002) used hospitalization data to evaluate the 
effect of hospital type, hospital volume, and surgical specialty on 
ovarian cancer re-operation rates and mortality rates. This study found 
that patients were less likely to have a repeat operation if the 
initial operation was done in a high-or intermediate-volume hospital, 
in a hospital with a gynecologic oncologist, or performed by a 
gynecologic oncologist, gynecologist, or high-volume surgeon. The study 
also found that the adjusted survival was improved when the initial 
surgery was done by a gynecologic oncologist. In addition, a Maryland 
study using hospital discharge data has shown that most ovarian cancer 
surgeries in that state continue to be performed in low-volume 
hospitals by low-volume surgeons (Bristow, et al., in press). 
Additional information is needed in the United States to assess what 
proportion of ovarian cancer patients are being surgically evaluated in 
low-volume hospitals and by surgeons with a low operating volume.
    CDC is committed to better understanding the current patterns of 
care in women being evaluated or treated for ovarian cancer. In the 
majority of cases, ovarian cancer is diagnosed at a late stage when 5-
year survival rates are very low. Without a screening test, 
opportunities for improving survival depend upon identification of 
modifiable factors during the diagnosis or initial treatment of ovarian 
cancer that may decrease the stage at diagnosis or increase disease 
free survival time. If a large proportion of women are receiving their 
primary surgical care from low-volume hospitals and surgeons, 
opportunities can be identified for improving initial surgical staging 
and treatment, as well as survival in these women. Women and general 
surgeons should be educated that survival from ovarian cancer is 
improved when these surgeries are performed by gynecologic oncologists 
and in high volume hospitals.
    Project Activities: Applicants should address the following:
    1. Describe a study which uses appropriate hospital discharge data 
to learn more about the medical setting where the primary surgical 
management of ovarian cancer is taking place. Activities might include:
    a. Determining and evaluating the patterns of primary surgical care 
of ovarian cancer by hospital volume and individual surgeon volume; and
    b. Assessing changes in patterns of surgical care over time.
    2. Describe the methods which will be used to obtain and analyze 
the data.
    3. Identify key staff who will be devoted to the project. Describe 
each person's demonstrated knowledge, experience, and ability in 
analyzing data for this study.
    4. Provide evidence of sufficient institutional and other necessary 
support for carrying out this project.
    5. Describe how the information gained from this study will be made 
available to improve the health and survival of persons diagnosed with 
ovarian cancer.
    Preference will be given to applicants who:
    1. Describe a project which will incorporate data from multiple 
states, as well as from rural and urban hospitals.
    2. Can provide a record of publishing similar research.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 15 pages. Supporting materials included in 
appendices should not exceed 20 pages.
    Availability of Funds: Approximately $175,000 is available to fund 
one Prevention Research Center in the first year of a 1-year project 
period. Funding may vary and is subject to change.
    Research Status: It is expected that this project will be exempt 
research. This project will involve the study of existing data that are 
publicly available for a fee. The data will be recorded in a manner in 
which the individual subjects cannot be identified, directly or though 
identifiers linked to the subjects. CDC staff will serve as co-
investigators and provide input into the design, methodology, and 
analysis of the data; however, CDC will not receive the data. It is 
expected that this project will require CDC IRB approval of exempt 
research status.

SIP 25-04

    Project Title: A Prospective Study on the Effect of Treatment on 
Health-Related Quality of Life for Men with Localized Prostate Cancer.
    Project Description: More than 220,000 men will be diagnosed with 
prostate cancer in 2003. Eighty six percent of these individuals will 
be diagnosed with localized disease. Patients with newly diagnosed, 
early stage prostate cancer have a number of treatment choices, 
including watchful waiting, surgical resection, brachytherapy, and 
external beam radiation. These treatment choices are associated with 
significant morbidity and side effects, which affects men's health-
related QOL. Currently there is no clinical consensus regarding the 
optimal medical management of early stage prostate cancer, and given 
the protracted natural history of the disease, it is not possible to 
differentiate tumors that behave aggressively from those that remain 
indolent during a man's lifetime. Lacking comparative data from 
controlled studies and divergent clinical opinions about the benefits 
and harms of each treatment option, men with prostate cancer face 
difficult choices about their care. As an important measure of health 
outcome, QOL following screening, diagnosis, and treatment for prostate 
cancer may provide important information to guide patients' decisions 
regarding available treatment choices.
    A major portion of treatment decisions take place at home, that is, 
within the context of family. However, existing studies have not 
credited family as a major player in the prostate cancer treatment 
decision making process. In this study, we hypothesize that treatment 
choices regarding prostate cancer will inevitably be influenced by 
three decision makers: the patient, their physician, and (when present) 
the patient's family or caregiver. To date, no prospective study has 
examined the influence of this ``triangle'' of decision makers on 
treatment decisions.
    While shared decision making is vital in prostate cancer, it is 
inevitable that knowledge about the myriad of outcomes that are related 
to each treatment choice (e.g., side effects, impact on chances of 
cancer recurrence, etc.), as well as preferences regarding the many 
outcomes corresponding to each treatment will differ among decision 
makers. Facilitating shared decision making among all those involved is 
likely to improve satisfaction with care and outcomes for prostate 
cancer treatment.
    The purpose of this project is to support studies that measure 
prostate cancer-specific and general health-related quality of life 
(QOL) from the perspective of the patient, their caregiver and the 
physician directing care before, during, and after treatment. The goal 
is to better understand the patient's QOL following prostate cancer 
treatment and to correlate the patient's self-reported QOL with that 
reported by the caregiver and the attending physician. The objective of 
this study is to develop a better understanding of patient, physician, 
and caregiver perceptions of the costs, benefits, and

[[Page 15466]]

QOL associated with each prostate cancer treatment option.
    Project Activities: Applicants should address the following issues:
    1. Demonstrate a conceptual framework, design, methods, and 
analyses appropriate to the aims of the project. Applicants should:
    a. Demonstrate knowledge of available treatments for prostate 
cancer and issues related to the evaluation of health-related quality 
of life and differences in perceptions of QOL.
    b. Demonstrate knowledge of recent literature and explain how the 
proposed research could further what is already known.
    c. Demonstrate access to substantial patient population and provide 
plans for patient retention.
    d. Include policies, criteria, and processes for selecting 
candidates, including special efforts to recruit minorities.
    e. Address potential problem areas and consider alternative 
tactics.
    2. Provide evidence of infrastructure suitable to their study. 
Applicants should:
    a. Describe the scientific environment in which the work will be 
conducted.
    b. Describe nature of infrastructure or partnership.
    c. Provide evidence of commitment and cooperation of potential 
partners (e.g., recent letters of support, memoranda of understanding, 
and documented examples of prior collaboration).
    3. Identify the key staff who will be devoted to this project.
    a. For each person describe their demonstrated knowledge, 
experience, and ability in planning, implementation, conducting, and 
management of research that is similar to that proposed here in 
complexity, scope and focus. If there is a position that is yet to be 
filled, provide a position description in the appendix. Include the 
percentage of time each person will devote to project activities.
    b. Of the named staff, provide evidence of the nature of their 
experience in conducting and being funded for intervention research, 
community-based participatory research, and translation of research 
into practice.
    4. Provide evidence of sufficient institutional support (e.g., 
space, equipment, etc.). Describe the established resources and 
expertise available to your member center staff (e.g., intervention 
research, health services research, community-based participatory 
research, behavioral sciences, communication theory and practice, 
etc.).
    2. Include specific, measurable, time-framed objectives for a 
three-year funding period.
    Preference will be given to applicants who:
    1. Demonstrate past publication history or literature reviews in 
this area.
    2. Demonstrate the ability to manage multi-site initiatives.
    3. Consider a national, multi-site sampling scheme.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 20 pages. Supporting materials included in 
the appendices should not exceed 30 pages. The appendices should 
include the requested materials above, including the 2-page 
biographical sketches, position descriptions of faculty and staff (if 
needed), letters of support, etc.
    Availability of Funds: Approximately $290,000 is available to fund 
one Prevention Research Center for the first year of a 3-year project 
period. Funding may vary and is subject to change.
    Research Status: It is expected that this project will be non-
exempt research. CDC staff will serve as co-investigators on this 
project and will provide technical assistance on activities such as 
research design, data collection and analysis, and dissemination of 
results. It is expected that the project will require CDC IRB approval 
and local IRB approval. As applicable, applicants should provide a 
federal wide registration number for each performance site included in 
the project.
    References.
    Sommers and Ramsey. A review of quality-of-life evaluations in 
prostate cancer. Pharmacoeconomics 16:127-40. 1999.
    Schapira MM, Lawrence WF, Katz DA, McAuliffe TL, Nattinger AB. 
Effect of treatment on quality of life among men with clinically 
localized prostate cancer. Medical Care. 39(3):243-53, 2001 Mar.
    Litwin MS et al. Urinary function and bother after radical 
prostatectomy or radiation for prostate cancer: a longitudinal 
multivariate quality of life analysis from the Cancer of the Prostate 
Strategic Urologic Research Endeavor. J Urology 164:1973-77. 2000.
    Lubeck DP et al. Changes in health-related quality of life in the 
first year after treatment for prostate cancer: results from CaPSURE. 
Urology 53:180-86. 1999.
    Lubeck DP et al. Health related quality of life differences between 
black and white men with prostate cancer: results from CaPSURE. J 
Urology 166:2281-85. 2001.

SIP 26-04

    Project Title: HIV Infection and Breastfeeding: Interventions for 
Maternal and Infant Health.
    Project Description: With levels of HIV seroprevalence in pregnant 
women in parts of sub-Saharan Africa approaching 30%, the potential 
impact of HIV/AIDS on maternal morbidity and mortality must be 
considered. Preliminary data from a study conducted in Nairobi 
indicates that HIV-infected women who breastfed experienced an increase 
in mortality as compared to HIV-infected women who did not. Not only 
are these women HIV-infected and mothers, but many may suffer from 
malnutrition and have very limited access to health care. This nexus of 
factors demands a careful examination of the impact of breastfeeding by 
HIV positive mothers on maternal morbidity and mortality.
    Many antiretroviral (ARV) regimens that administer the ARVs to 
pregnant women and neonates result in substantial reduction in vertical 
transmission at birth. However, in the absence of interventions to 
prevent postnatal infection due to HIV transmission through breast 
milk, many infants will be infected during the breastfeeding period. 
There are no safe alternatives to breastfeeding in many less developed 
countries. Many interventions for reduction of HIV transmission through 
breastfeeding are currently being explored including formula feeding 
(WHO), exclusive breastfeeding, early weaning, treatment of subclinical 
mastitis, antiretroviral treatment of the mother, antiretroviral 
prophylaxis for the infant, or enhancement of protective anti-HIV 
immunity in either mother or infant. The implications of these options 
for maternal and infant health remain unexplored.
    The purpose of this project is to support studies that explore 
interventions to reduce maternal morbidity and HIV transmission during 
breastfeeding. It would be most advantageous to link this study with an 
ongoing intervention to reduce maternal to child transmission of HIV 
(e.g. short course ZDV in late pregnancy and labor or nevirapine in 
labor).
    Project Activities: Activities that meet the objectives of the 
project may include:
    1. Describe the benefit of nutritional supplementation given to 
women during breastfeeding.
    Data would be collected prospectively on 2,000-3,000 breastfeeding 
HIV-infected mothers from delivery to at least 6 months post-partum. 
Follow-up

[[Page 15467]]

measurements would include, but not be limited to, maternal mortality, 
HIV viral load, CD4 counts, AIDS-related illness, anthropometric 
measurements, and maternal micronutrient levels.
    2. The benefit and safety of antiretroviral medications given 
either to infants or to their mothers to prevent HIV transmission 
during breastfeeding.
    Interventions to reduce HIV transmission during breastfeeding 
should be provided in the form of antiretrovirals to infants born to 
breastfeeding HIV-infected mothers who participate in the prospective 
study listed above in an effort to reduce maternal to child 
transmission of HIV. For antiretroviral drugs provided as prophylaxis 
for breastfeeding infants, issues of dosing schedule, pediatric 
formulation, safety, necessary U.S. and host country regulatory 
approvals, and sustainability need to be considered.
    3. The feasibility of exclusive breastfeeding followed by early, 
rapid breastfeeding cessation. In facilitation of this, a suitable 
alternative to formula will be used as a replacement food for breast 
milk after 6 months.
    Applications should also address the following:
    1. Identify key staff who will be devoted to the project. For each 
person describe their demonstrated knowledge, experience, and ability 
in planning and conducting intervention research that is described 
above in complexity, scope and focus.
    2. Provide evidence of sufficient institutional and other necessary 
support for carrying out this project.
    3. Describe the established resources and expertise available to 
the research staff for conducting intervention in a timely fashion.
    4. Identify specific methods that will be used to assess the 
individual components as well as the intervention components of the 
intervention.
    5. Provide evidence of feasibility of the research.
    Preference will be given to applicants who:
    1. Have obtained information on food security, acceptability of 
food supplementation, use of supplementation in pregnancy and 
postnatally, issues around sharing of supplementation with family 
members, typical weaning diets and the acceptability of early 
breastfeeding cessation.
    2. Can demonstrate that they have participated in previous research 
related to informed consent process.
    3. Have piloted a suitable informed consent process.
    4. Have experience in conducting intervention research in community 
or clinic settings.
    5. Can demonstrate ability to recruit at least 60 HIV-infected 
mothers and their infants per month.
    6. Have demonstrated clinical experience in prescribing ARV 
regimens in resource-limited settings.
    Project Proposal Length and Supporting Material: Proposal 
narratives are limited to 10 pages. Supporting materials included in 
the appendices should not exceed 35 pages.
    Availability of Funds: Up to $1,500,000 is available to support one 
Prevention Research Center for the first year of a five-year project 
period. Funding may vary and is subject to change.
    Research Status: It is expected this project will involve non-
exempt research as it will require obtaining clinical and behavioral 
information from human subjects. This project involves a protocol which 
requires IRB review by all institutions participating in the research 
project. CDC staff will serve as co-investigators on this project and 
will provide technical assistance on activities such as research 
design, data collection and analysis, and dissemination of results. The 
CDC IRB will review and approve the protocol on an annual basis until 
the project is completed. Applications should provide a federal wide 
assurance registration number for each performance site included in the 
project.

    Dated: March 15, 2004.
Edward Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-6283 Filed 3-24-04; 8:45 am]
BILLING CODE 4163-18-P