United States Department of Health and Human Services (HHS)
Participating
Organizations
Centers for Disease Control and Prevention (CDC), at http://www.cdc.gov/
Components of
Participating Organizations
National Center for Chronic Disease
Prevention and Health Promotion (NCCDPHP/CDC), at http://www.cdc.gov/nccdphp/
Title: Health Promotion and Disease Prevention Research Centers: Special Interest Project Competitive Supplements (U48)
The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement may differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then applicants will be directed elsewhere for that information.
Authority: Awards are made under the authorization of Public Health Service Act, Section 1706, 42 U.S.C. 300u-5, as amended; Section 2(d), Public Law 98-551.
Announcement
Type:
This is a
supplement to Program Announcement 04003 which was released on March 27, 2003.
Instructions for Submission of Electronic Research Applications:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance may be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)
A registration process is necessary before submission, and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Standard Time on the application submission receipt date (see “Key Dates” below.)
2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.
Funding Opportunity Announcement (FOA) Number: RFA-DP-07-002
Catalog of Federal Domestic Assistance Number(s):
93.135
Key
Dates
Release/Posted
Date: February 28, 2007
Letter of Intent Receipt Date: March 19, 2007
Application Submission Receipt Date: April 17, 2007
Peer Review Date: June 2007
Secondary Review Date: Week of July 9, 2007
Earliest
Anticipated Start Date: September 30, 2007
Expiration
Date: April 18, 2007
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
Executive Summary
Funding Opportunity Announcement Glossary: FOA Glossary Terminology
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Investigators
2.Cost Sharing or Matching
3.Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Request Application Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of
Intent
B. Submitting an
Application to CDC
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review
Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research
Resources
3. Anticipated Announcement and Award
Dates
Section VI. Award Administration
Information
1. Award Notices
2. Administrative and National Policy
Requirements
A. Cooperative Agreement
1. Recipient Rights and Responsibilities
2. HHS/CDC Responsibilities
3.
Collaborative Responsibilities
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management
Contact(s)
4. General Questions Contact(s)
Section VIII. Other Information
- Required Federal Citations
IX. Special Interest Projects (SIP) Descriptions
1. Title
2. Project
Description and Objectives
3. Project
Activities
4. Additional
Review Criteria and Funding Preferences
5. Project Proposal
Length and Supporting Material
6. Availability of
Funds
7. Research Status
8. Award
Administration
9. References
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This RFA addresses “Healthy People 2010” priority areas of cancer, nutrition and overweight, physical fitness and activity, disability and secondary conditions, and public health infrastructure and is in alignment with NCCDPHP performance goal to support prevention research to develop sustainable and transferable community-based behavioral interventions. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.
This program also 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 initiative envisions a healthy, strong U.S. population supported by a health care system in which diseases are prevented when possible, controlled when necessary, and treated when appropriate. This funding opportunity supports the Steps focus areas of obesity and physical fitness.
Nature of the Research Opportunity
This RFA builds upon the infrastructure of the Prevention Research Centers (PRC) program and solicits applications in the form of cooperative agreements to support supplemental health promotion and disease prevention research projects 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. CDC will use the FY07 Special Interest Projects (SIP) mechanism to provide supplemental funding to PRCs to design, test, and disseminate effective prevention research strategies in the areas of cancer, epilepsy, adolescent health, nutrition, and physical activity.
Background
As the US population ages and health care costs increase, prevention becomes even more critical to the national health care agenda. Many chronic diseases, injuries, and some infectious diseases are caused by behavioral and environmental factors that can be changed. Prevention research is critical to helping people change risk factors in their lives and their communities. The gaps between research findings and their translation into public health programs, practice, and policy must be eliminated so that new knowledge is effectively applied in states and communities throughout the country.
In 1984 Congress authorized HHS to create a network of academic health centers to conduct applied public health research. CDC was selected to administer the PRC program and to provide leadership, technical assistance, and oversight. Today, the PRCs comprise a national network of 33 academic-based research centers that are committed to community-based participatory research and to the translation of research into programs and policies. The PRC infrastructure and their various research projects are supported by CDC and guided by community committees. The consortium of academic, public health, and community partners engages in community-based prevention research, research translation, and education to address the leading causes of death and disability. The combined research portfolio for the 33 PRCs includes nearly 500 projects across the country.
The partnerships and expertise each PRC builds strengthens its competitiveness for additional funding by federal agencies and private foundations. The SIP mechanism, created in 1993, allow the PRCs to compete for research projects sponsored by CDC organizational units and other HHS agencies that want to utilize their resources to fund research that promotes better public health practice in specific areas. Typically, SIPs are funded for a minimum of one year and $100,000; however, there are many SIPs that are multi-year endeavors to which several million dollars are dedicated. The SIP mechanism is designed to maximize the expertise and resources offered by each center and the PRC network as a whole.
Scientific Knowledge to be achieved through this Funding Opportunity
This RFA is expected to fund research that will expand our knowledge and understanding in the areas of cancer, epilepsy, adolescent health, nutrition, and physical activity. Each SIP has specific activities and anticipated outcomes. Section IX. Special Interest Projects (SIP) Descriptions of this announcement lists each SIP and provides a complete description of the project.
Cancer Special Interest Projects 1-4
Epilepsy Special Interest Projects 5-6
Adolescent Health Special Interest Project 7
Nutrition Special Interest Project 8
Physical Activity Special Interest Projects 9-11
Experimental Approach and Research Objectives
The research objectives of the SIPs are in alignment with the following performance goal for NCCDPHP: To support prevention research to develop sustainable and transferable community-based behavioral interventions. The experimental approach and research objectives for each SIP are detailed in Section IX. Special Interest Projects (SIP) Descriptions of this announcement.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section II. Award
Information
1. Mechanism(s) of Support
This funding opportunity will use the U48 activity code. The HHS/CDC U48 is a cooperative agreement assistance instrument. Under the cooperative agreement assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project with HHS/CDC staff substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.
2. Funds Available
The participating Center, Institute and Office (CIO) NCCDPHP intends to commit approximately $2,390,000 in FY07 to fund approximately 15 cooperative agreements ranging in total costs, direct and indirect, from $60,000, to $550,000 in response to this FOA. Because the nature and scope of the proposed research will vary by SIP, and from application to application, it is anticipated that the funding amount and duration of each award will vary.
The anticipated start date for each SIP is September 30, 2007. The project period will vary by SIP and is detailed in Section IX. Special Interest Projects (SIP) Description of this announcement. Following is a list of the SIPs with the project period and total funding amount (direct and indirect) for the first 12-month budget period:
Cancer
SIP 1: General Practitioners’ Ovarian Cancer Screening and Testing Practices and Awareness of Published Guidelines (2-years, $350,000)
SIP 2: Assessing the Needs of Ovarian Cancer Caregivers (2-years, $210,000)
SIP 3: Intervention to Increase Screening for Cervical Cancer in Women of Mexican Descent - Phase 3 (2-years, $550,000)
SIP 4: Impact of Cultural and Socioeconomic Factors on Post-treatment Surveillance among African Americans with Colorectal Cancer (2-years, $250,000)
Epilepsy
SIP 5: Managing Epilepsy Well (MEW) -- Network for Epilepsy Self-management Intervention Research -- Coordinating Center (2-years, $150,000)
SIP 6: Managing Epilepsy Well (MEW) -- Network for Epilepsy Self-management Intervention Research -- Collaborating Center (2-years, $280,000 to fund four projects at $70,000 each)
Adolescent Health
SIP 7: Urban Stressors and Problem Behaviors among Adolescents in High Risk Urban Environments (2-years, $100,000)
Nutrition
SIP 8: Understanding Motivators and Barriers for Changing Sugar-sweetened Beverage Intake in the Home Environment of Overweight Youth (2-years, $150,000)
Physical Activity
SIP 9: Expansion of the Physical Activity Policy Research Network (PAPRN) – Coordinating Center (2-years, $130,000)
SIP 10: Expansion of the Physical Activity Policy Research Network (PAPRN) – Collaborating Center (2-years, $120,000 to fund two projects at $60,000 each)
SIP 11: Implementation and Evaluation of Interventions in the Built Environment to Improve Public Health (2-years, $100,000)
All estimated funding amounts are subject to availability of funds.
CDC will accept and review applications with budgets greater than the ceiling amount.
Although the financial plans of the CIO are to provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.
Section III. Eligibility Information
1.
Eligible Applicants
1.A. Eligible Institutions
Only applicants who have applied for and have been selected as PRCs under CDC Program Announcement 04003 are eligible to compete for the SIP supplemental funding. Competition is limited to PRCs funded under PA 04003 because they are uniquely positioned to perform, oversee, and coordinate community-based participatory research that promotes the field of prevention research due to their established relationships with community partners. The supplemental projects in this RFA complement ongoing prevention research projects being conducted as part of the CDC Prevention Research Program.
1. B. Eligible Investigators
Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research as the Project
Director/Principal Investigator (PD/PI) is invited to work with his/her
organization to develop an application for support.
2. Cost Sharing or
Matching
Cost
sharing, matching funds, or cost participation are not required under this
program.
The most current HHS Grants Policy Statement is available at: HHS GPS
3. Other-Special Eligibility Criteria
A PRC may apply for multiple SIPs; however, a separate application must be submitted for each SIP. A PRC may submit only one application per SIP.
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.
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.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at the following:
PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
Several additional actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.
1.
Request Application Information
Applicants must
download the SF424 (R&R) application forms and SF424 (R&R) Application
Guide for this FOA through Grants.gov/Apply.
Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA); although some of the "Attachment" files may
be useable for more than one FOA.
For further assistance, contact PGO TIMS: Telephone 770-488-2700,
Email: PGOTIM@cdc.gov
HHS/CDC Telecommunications for the hearing impaired:
TTY 770-488-2783.
2.
Content and Form of Application Submission
Prepare all
applications using the SF424 (R&R) application forms and in accordance with
the SF424 (R&R) Application Guide (MS
Word or PDF).
The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, mandatory and optional. A completed application in response to this FOA will include the following components:
Required
Components:
SF424
(R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398
Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional
Components:
PHS398 Cover
Letter File
Research & Related Sub award Budget Attachment(s)
Form
Note: While both budget
components are included in the SF424 (R&R) forms package, the CDC U48 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS
398 Modular Budget.)
3. Submission Dates and
Times
3. A. Submission,
Review and Anticipated Start Dates
Letter of Intent
Receipt Date: March 19, 2007
Application
Submission Receipt Date: April 17, 2007
Peer
Review Date: June 2007
Secondary
Review Date: Week of July 9, 2007
Earliest
Anticipated Start Date: September 30, 2007
3.A.1. Letter of
Intent
Prospective applicants are asked to submit a letter of intent
that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A
The letter of intent should be sent to:
Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
Centers for Disease Control and
Prevention
U.S. Department of Health and Human
Services
Koger
Center-Williams Building, MS K-92
2877
Brandywine Road
Atlanta,
GA 30341
Telephone:
(770) 488-8390
FAX:
(770) 488-8046
Email: bjc4@cdc.gov
3. B. Submitting an Application to CDC
If the instructions in this announcement differ in any way from the 424 R&R instructions, follow the instructions in this announcement.
To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov. Applicants will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application.
All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Standard Time on the deadline date. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If HHS/CDC receives your submission after closing because of : (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline.
This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.
Otherwise, HHS/CDC will not notify you upon receipt of
your paper submission. If you have a question about the receipt of your
application, first contact your courier. If you still have a question, contact
the PGO-TIMS staff at: (770) 488-2700. Before calling, please wait two to
three days after the submission deadline. This will allow time for HHS/CDC to
process and log submissions.
If submitting a paper application, it must be prepared
using the 424 R&R instructions for preparing a research grant application.
Submit a signed, typewritten original of the application and all appendices,
including the checklist, and three signed photocopy(s) to the
following address:
Technical Information Management Section – DP07-002
CDC, Procurements and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Phone: (770) 488-2700
3. C. Application Processing
HHS/CDC must receive applications on or before 5:00 P.M. Eastern Standard Time
on the application submission date(s) described above (Section IV.3.A.). If
HHS/CDC receives an application after that submission date and time, the
application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
Upon receipt, applications will be evaluated for completeness and responsiveness by NCCDPHP and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.
There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons.
4. Intergovernmental Review
Executive Order 12372 does not apply to this program.
All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
6. Other Submission
Requirements
The application
must clearly indicate which SIP you are applying for. Please refer to the
individual SIP description in Section IX. Special Interest Projects (SIP) Descriptions
of this announcement.
Awardees upon acceptance of Notice of Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI. "Award Administration Information”.
If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately.
Applicants’ research plan(s) should address activities they will conduct over the entire project period.
The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.
Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a. PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments. If your research plan exceeds the page limitation specified in Section IX. Special Interest Projects (SIP) Descriptions of this announcement under Project Proposal Length and Supporting Material of the SIP description, your application may be considered unresponsive and ineligible for review.
The following materials may be included in the Appendix: Publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.
Do not to use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements. Please refer to Section IX. Special Interest Projects (SIP) Descriptions of this announcement under Project Proposal Length and Supporting Material of the SIP description.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not the awardee will place any conditions on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.
All
applicants must include a plan for sharing research data in their application. The
HHS/CDC data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. All investigators
responding to this funding opportunity should include a description of how
final research data will be shared, or explain why data sharing is not
possible.
The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers; however, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Sharing Research Resources
HHS policy requires that grant award recipients make unique
research resources readily available for research purposes to qualified
individuals within the scientific community after publication (see the HHS
Grants Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs). Investigators responding to this funding opportunity
should include a plan for sharing research resources addressing how unique
research resources will be shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any related data
sharing plans will be considered by the HHS/CDC Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590,http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Section V. Application Review Information
1.
Criteria
Only
the review criteria described below will be considered in the review process:
2.
Review and Selection Process
Applications
that are complete and responsive to the FOA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by NCCDPHP in
accordance with the review criteria stated below.
As part of the
initial merit review, all applications will:
The goals of HHS/CDC-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness. In their written comments, reviewers evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals. Each of the following criteria will be addressed by the reviewers and considered in their assignment of the overall score, weighting them as appropriate for each application.
Note that an application does
not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high priority score. For example, an
investigator may propose to carry out important work that by its nature is not
innovative but is essential to move a field forward.
Significance: Does this study address an
important problem? If the applicant achieves the aims of the application, how
will it advance scientific knowledge or clinical practice? What will be the
effect of these studies on the concepts, methods, technologies, treatments, or
preventative interventions that drive this field?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?
Environment: Does the scientific environment in which the applicant will do the work contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria
In addition to
the above criteria, the following items will be considered in the determination
of scientific merit and the priority score:
Individual SIP Preferences: Does the applicant adequately address the additional review criteria detailed in the SIP they are applying for? Please refer to Section IX. Special Interest Projects (SIP) Descriptions of this announcement under Additional Review Criteria and Funding Preferences of the SIP description for any additional review criteria that may apply to an individual SIP.
Protection of Human Subjects from Research Risk: When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research. [see the Research Plan, Section 2, item 8 on Human Subjects in the SF424 (R&R)] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Inclusion of Women and Minorities in Research:
Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research? This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits (see Section 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research:
If applicants plan to use vertebrate
animals in the project, HHS/CDC will assess the five items described under Section
2, item 12 Vertebrate Animals of the Research Plan component of the SF424
(R&R). Additional HHS/CDC Requirements under AR-3 Animal Subjects
Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Biohazards: If applicants propose the applicant has proposed materials
or procedures that are potentially hazardous to research personnel and/or the
environment, HHS/CDC will determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget and
Period of Support: The reasonableness of the proposed budget and the appropriateness
of the requested period of support in relation to the proposed research may be
assessed by the reviewers. Is the number of person months listed for the effort
of the PD/PI appropriate for the work proposed? Is each budget category
realistic and justified in terms of the aims and methods? The evaluation of
the budget should not effect the priority score.
2.C. Sharing Research Data
Data
Sharing Plan: HHS/CDC will assess the reasonableness of the data sharing plan; however,
reviewers will not factor the proposed data sharing plan into the determination
of scientific merit or the priority score. The presence of a data sharing plan
will be part of the terms and conditions of the award. The funding organization
will be responsible for monitoring the data sharing policy.
2.D. Sharing Research Resources
HHS policy requires that recipients of grant awards
make unique research resources readily available for research purposes to
qualified individuals within the scientific community after publication.
Please see http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.
Investigators responding to this funding opportunity should include a plan on sharing
research resources.
The
adequacy of the resources sharing plan will be considered by Program staff of
the funding organization when making recommendations about funding
applications. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each non-competing Grant Progress Report (HHS/PHS
2590 http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting .
3. Anticipated
Announcement and Award Dates
HHS/CDC
expects to announce awards in September 2007.
Section
VI. Award Administration Information
1.
Award Notices
After the peer
review of the application is completed, the applicant organization will receive
a written critique called a “Summary Statement.” The applicant
organization and the PD/PI will be able to access the Summary Statement via the
eRA Commons.
HHS/CDC will contact those applicants under consideration for funding for additional information.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the Grants Management Officer (GMO) is the authorizing document. HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application.
Selection of the application for award is not an authorization to begin performance. Any cost incurred before receipt of the NoA is at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.
2. Administrative and National Policy Requirements
The Code of
Federal Regulations 45 CFR Part 74 and Part 92 have details about requirements.
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.
Additional requirements are available Section VIII. Other Information of this
document or on the HHS/CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
These will be incorporated into the NoA by reference.
The
following terms and conditions will be incorporated into the NoA and will be
provided to the appropriate institutional official and a courteous copy to the
PD/PI at the time of award.
The
following terms of award are in addition to, and not in lieu of, otherwise
applicable Office of Management and Budget (OMB) administrative guidelines, HHS
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS grant administration policies.
The administrative and funding instrument used for
this program will be the cooperative agreement U48 an "assistance" instrument
(rather than an "acquisition" instrument), in which substantial HHS/CDC
programmatic involvement with the awardees is anticipated during the
performance of the activities. Under the cooperative agreement, the HHS/CDC
purpose is to support and stimulate the recipients' activities by involvement
in and otherwise working jointly with the award recipients in a partnership
role; it is not to assume direction, prime responsibility, or a dominant role
in the activities. Consistent with this concept,
the dominant role and prime responsibility resides with the awardees for the
project as a whole, although specific tasks and activities may be shared among
the awardees and the HHS/CDC may share specific tasks and activities, as
defined above.
2.A.1. Recipient Rights and Responsibilities
The Recipient will have the dominant role and primary responsibility for the project.
Recipient
Organization will retain custody of and have primary rights to the information,
data and software developed under this award, subject to U.S. Government rights
of access consistent with current HHS policies.
2.A.2. HHS/CDC Responsibilities
An HHS/CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. Each SIP lists specific HHS/CDC responsibilities. Please refer to Section IX. Special Interest Projects (SIP) Descriptions of the announcement under Award Administration of the individual SIP description.
Additionally, an HHS/CDC agency program official or CIO program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA.
2. A.3. Collaborative Responsibilities
Each SIP has specific collaborative responsibilities. Please refer to Section IX. Special Interest Projects (SIP) Descriptions of the announcement under Award Administration of the individual SIP description.
3. Reporting
Recipient
Organization must provide HHS/CDC with an original, plus two hard copies of the following
reports:
1. Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHSCDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.
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.
Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this FOA.
Although the financial plans of the HHS/CDC CIO provide support for this program, awards pursuant to this funding opportunity are contingent upon 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.
HHS/CDC encourages your inquiries concerning this FOA and welcomes
the opportunity to answer questions from potential applicants. Inquiries can
fall into three areas: scientific/research, peer review, and financial or
grants management issues:
1.
Scientific/Research Contacts:
Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
Centers for Disease Control and Prevention
U.S. Department of Health and Human
Services
Koger
Center-Williams Building, MS K-92
2877
Brandywine Road
Atlanta,
GA 30341
Telephone:
(770) 488-8390
Email: bjc4@cdc.gov
2. Peer Review
Contacts:
Juliana Cyril, PhD, MPH
Scientific
Review Service
Office of
Public Health Research
Centers for Disease Control and Prevention
U.S. Department of Health
and Human Services
1600 Clifton Road NE, MS D-72
Atlanta, GA 30333
Telephone: (404) 639-4639
Email: jcyril@cdc.gov
3. Financial or
Grants Management Contacts:
Lucy Picciolo
Procurement and Grants Office
Center for Disease Control and
Prevention
U.S. Department of Health and Human Services
2920
Brandywine Road, Room 3000
Atlanta, GA 30341
Telephone:
(770) 488-2777
Email: LPicciolo@cdc.gov
4.
General Questions Contacts:
Technical Information
Management Section
CDC
Procurement and Grants Office
U.S. Department of Health and
Human Services
2920
Brandywine Road
Atlanta, GA 30341
Telephone:
(770) 488-2700
Email: PGOTIM@cdc.gov
Section VIII. Other Information
Required
Federal Citations
Human Subjects Protection
Federal regulations (45
CFR Part 46) require that applications and proposals involving human subjects
must be evaluated with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to be gained
(http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found
on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Use of Animals in
Research
Recipients of PHS
support for activities involving live, vertebrate animals must comply with the PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable. Additional HHS/CDC Requirements under AR-3 Animal Subjects
Requirements can be found at http://www.cdc.gov/od/pgo/funding/ARs.htm.
Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
It is the policy of the Centers for Disease Control and
Prevention (CDC) and the Agency for Toxic Substances and Disease Registry
(ATSDR) to ensure that individuals of both sexes and the various racial and
ethnic groups will be included in CDC/ATSDR-supported research projects
involving human subjects, whenever feasible and appropriate. Racial and ethnic
groups are those defined in OMB Directive No. 15 and include American Indian or
Alaska Native, Asian, Black or African American, Hispanic or Latino, Native
Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial
and ethnic minority populations are appropriately represented in applications
for research involving human subjects. Where clear and compelling rationale
exist that inclusion is inappropriate or not feasible, this situation must be
explained as part of the application. This policy does not apply to research
studies when the investigator cannot control the race, ethnicity, and/or sex of
subjects. Further guidance to this policy is contained in the Federal Register,
Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.
Inclusion Of Persons Under The Age Of 21 In Research
The policy of CDC is that persons under the age of 21 must be included in all
human subjects research that is conducted or supported by CDC, unless there are
scientific and ethical reasons not to include them. This policy applies to all
CDC-conducted or CDC-supported research involving human subjects, including
research that is otherwise exempt in accordance with Sections 101(b) and 401(b)
of 45 C.F.R. Part 46, HHS Policy for the Protection of
Human Subjects. Therefore, proposals for research involving human
subjects must include a description of plans for including persons under the
age of 21. If persons under the age of 21 will be excluded from the research,
the application or proposal must present an acceptable justification for the
exclusion.
In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.
The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.
Paperwork Reduction Act Requirements
Under the
Paperwork Reduction Act, projects that involve the collection of information
from 10 or more individuals and funded by a grant or a cooperative agreement
will be subject to review and approval by the Office of Management and Budget
(OMB).
Smoke-Free Workplace Requirements
HHS/CDC strongly encourages all
recipients to provide a smoke-free workplace and to promote abstinence from all
tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities that receive Federal funds in which education,
library, day care, health care, or early childhood development services are
provided to children.
In addition no part of HHS/CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.
Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation
It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.
Recipients of HHS/CDC grants and
cooperative agreements need to be careful to prevent CDC funds from being used
to influence or promote pending legislation. With respect to conferences,
public events, publications, and "grassroots" activities that relate
to specific legislation, recipients of HHS/CDC funds should give close
attention to isolating and separating the appropriate use of HHS/CDC funds from
non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful
not to give the appearance that HHS/CDC funds are being used to carry out activities
in a manner that is prohibited under Federal law.
Accounting
System Requirements
The services of a certified public
accountant licensed by the State Board of Accountancy or the equivalent must be
retained throughout the project as a part of the recipient's staff or as a
consultant to the recipient's accounting personnel. These services may include
the design, implementation, and maintenance of an accounting system that will
record receipts and expenditures of Federal funds in accordance with accounting
principles, Federal regulations, and terms of the cooperative agreement or
grant.
Capability Assessment
It may be necessary to conduct an
on-site evaluation of some applicant organization's financial management
capabilities prior to or immediately following the award of the grant or
cooperative agreement. Independent audit statements from a Certified Public
Accountant (CPA) for the preceding two fiscal years may also be required.
Research
Integrity
The signature of the institution official on the face page
of the application submitted under this Funding Opportunity Announcement is
certifying compliance with the Department of Health and Human Services (HHS)
regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE
POLICIES ON RESEARCH MISCONDUCT.
The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the HHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).
For example:
Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [Page 28389] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.
Health Insurance Portability and
Accountability Act Requirements
Recipients of this grant award should
note that pursuant to the Standards for Privacy of Individually Identifiable
Health Information promulgated under the Health Insurance Portability and
Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may
disclose protected health information to public health authorities authorized
by law to collect or receive such information for the purpose of preventing or
controlling disease, injury, or disability, including, but not limited to, the
reporting of disease, injury, vital events such as birth or death, and the
conduct of public health surveillance, public health investigations, and public
health interventions. The definition of a public health authority includes a
person or entity acting under a grant of authority from or contract with such
public agency. HHS/CDC considers this project a public health activity
consistent with the Standards for Privacy of Individually Identifiable Health
Information and HHS/CDC will provide successful recipients a specific grant of
public health authority for the purposes of this project.
Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the HHS/CDC data sharing agreement will be released as follows:
April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) www.4.law.cornell.edu/uscode/5/5/552/html
Applications must include a copy of the applicant's Data Release Plan. Applicants should provide HHS/CDC with appropriate documentation on the reliability of the data. Applications submitted without the required Plan may be ineligible for award. Award will be made when reviewing officials have approved an acceptable Plan. The successful applicant and the Program Manager will determine the documentation format. HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.
Conference Disclaimer and Use of Logos
Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:
“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) . The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”
Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003). Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer. It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.
Section IX. Special Interest Project (SIP) Descriptions
Cancer
SIP 1: General Practitioners’ Ovarian Cancer Screening and Testing Practices and Awareness of Published Guidelines
Project Description and Objectives: The purpose of this project is to evaluate physicians’ self-reported ovarian cancer screening and testing practices, determine physician awareness of the published guidelines regarding the lack of evidence for routine ovarian cancer screening, and assess physicians’ adherence to published guidelines on ovarian cancer screening among a nationally representative sample of practicing primary care physicians and gynecologists.
Numerous medical organizations, advocacy groups, and governmental organizations have developed cancer screening guidelines including the U.S Preventive Services Task Force (USPSTF), the American Cancer Society (ACS), the American College of Obstetricians and Gynecologist (ACOG), the American College of Physicians-American Society of Internal Medicine (ACP-ASIM), and the Canadian Task Force on Preventative Health. These various organizations have generally achieved consensus on many screening guidelines such as breast, cervical, and colorectal cancer; however, they often have a broad, sometimes conflicting set of recommendations for other cancer sites.1 Among the organizations making statements about ovarian cancer screening, they generally agree that there is not enough evidence to recommend routine screening with the currently available procedures (transvaginal ultrasound, cancer antigen (CA) -125, pelvic examinations, or various combinations of the three). However, there currently is some variation among the different groups especially with regard to certain high-risk populations who often present a challenge to physicians making clinical decisions.1
Despite the strong governmental and private support to publish and disseminate the various evidence-based cancer screening recommendations, several studies show that primary care physicians do not always comply with them.2-6 More specifically, anecdotal evidence and some small descriptive cross-sectional studies have suggested that patients may be screened for ovarian cancer more frequently than the evidence-based guidelines recommend.7,8 Besides the often fragmented recommendations by the various organizations, other physician-related factors for non-compliance include forgetfulness, disagreement with recommendations, perceptions of guidelines, clinical practice experience, and influence of colleagues.4,9 Additionally, determinants of cancer screening decision-making with regard to conflicting or unclear guidelines include patient factors such as anxiety, expectations and family history.9
Lastly, most of the existing body of literature has focused on the determinants of cancer screening decisions associated with adherence or non-adherence to commonly recommended guidelines (e.g. USPSTF grade A and B recommendations such as breast and cervical cancer screening). There is little, if any research dealing with factors associated with adopting the “neutral” or “negative” (USPSTF grade C, D and I) recommendations. Clearly clinical decisions involve more complex considerations than scientific, population-based evidence alone. It is important that public health researchers understand the additional factors involved in making decisions at the individual patient/provider level, as well as the penetration of the guidelines related to ovarian cancer in clinical practice, so that a more focused dissemination of the guidelines can be achieved.
Project Activities: Applications submitted in response to this SIP should present information that address the activities listed below:
Additional Review Criteria and Funding Preferences: In addition to the standard review criteria used to evaluated the scientific and technical merit of applications (Significance, Approach, Innovation, Investigators, and Environment), the following additional review criteria specific to this SIP will be considered in the review process:
1. Access to a population of nationally-representative practicing primary care physicians and gynecologists.
2. Sound study design and previous experience in survey administration including the development and piloting of survey questions.
3. Previous experience with successfully completed projects with similar design including dissemination of results through publications.
4. The project team includes expertise on issues related to the early detection and diagnosis of ovarian cancer.
Project Proposal Length and Supporting Material: Proposal narratives are limited to 20 pages. Supporting material included as appendices is limited to ten attachments. The appendices should include materials that show evidence of the applicant’s ability to successfully conduct the proposed project, and other evidence deemed necessary to support the contents of the proposal.
Availability of Funds: Approximately $350,000 is available to fund one PRC 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 will be non-exempt research. It is anticipated that this project will require local IRB approval. Applicants should provide a federal-wide assurance registration number for each performance site included in the project.
Award Administration: CDC Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. CDC staff will serve as consultants on this project and provide technical assistance related to ovarian cancer screening and diagnostic practices. CDC staff is expected to consult on the design, methodology, analysis of the data, and will co-author manuscripts.
References:
1. Zoorob R, Anderson R, Cefalu C, Sidani M. Cancer screening guidelines. Am Fam Physician 2001 Mar 15;63(6):1101-12.
2. Hamblin J, Connor PD. Cancer screening guideline preference surveys: physicians’ perceptions of the American Cancer Society. Tenn Med 1998 Jan;91(1):17-20.
3. Holland-Barkis P, Forjuoh SN, Couchman GR, Capen C, Rascoe TG, Reis MD. Primary care physicians’ awareness and adherence to cervical cancer screening guidelines in Texas. Prev Med 2006 Feb;42(2):140-5.
4. McPhee SJ, Bird JA. Implementation of cancer prevention guidelines in clinical practice. J Gen Intern Med 1990 Sep;5(5 Suppl):S116-S122.
5. Selinger HA, Goldfarb NI, Perkel RL, Carlson BL. Physician compliance with mammography guidelines: a retrospective chart review. Fam Med 1989 Jan;21(1):56-8.
6. Young JM, Ward JE. Strategies to improve cancer screening in general practice: are guidelines the answer? Fam Pract 1999 Feb;16(1):66-70.
7. MacDonald DJ, Sarna L, Uman GC, Grant M, Weitzel JN. Cancer screening and risk-reducing behaviors of women seeking genetic cancer risk assessment for breast and ovarian cancers. Oncol Nurs Forum 2006 Mar;33(2):E27-E35.
8. McGinley PJ, Kilpatrick ES. Tumour markers: their use and misuse by clinicians. Ann Clin Biochem 2003 nov;40(Pt 6):643-7.
9. Tudiver F, Brown JB, Medved W, Herbert C, Ritvo P, Guibert R, et al. Making decisions about cancer screening when the guidelines are unclear of conflicting. J Fam Pract 2001 Aug;50(8)”682-7.
SIP 2: Assessing the Needs of Ovarian Cancer Caregivers
Project Description and Objectives: The Centers for Disease Control and Prevention (CDC) is interested in efforts that aim to identify and address the needs of cancer survivors, including the caregivers of those diagnosed with cancer. The purpose of this project is to conduct research to better understand the unmet needs of caregivers of ovarian cancer survivors. This includes a clarification of the needs of caregivers by phases of cancer survivorship (i.e., diagnosis/ treatment, long term survival, end of life, and bereavement). This project would use formative research methodology to identify important but unmet caregiver needs, paying close attention to those that may be addressed and met through future interventions.
Previous research has found that caregivers commonly experience unmet mental, physical, social, and economic needs that lead to poor quality of life and high levels of distress1 and that caregivers are especially likely to suffer when caring for a patient with illness that is advanced, debilitating, and terminal.2 Ovarian cancer is the most deadly of the female gynecologic cancers. Most women with ovarian cancer are diagnosed at late stages of the disease, when chances of survival are low, and a combination of invasive surgeries and aggressive chemotherapy treatments are prescribed, leaving patients physically and emotionally debilitated. The low probabilities of survival, debilitating effects of treatment, and emotional aftermath of an ovarian cancer diagnosis present a gravely unique situation for caregivers of ovarian cancer patients, but little research has focused on the unmet needs of this group of caregivers.
This project is expected to examine the needs of ovarian cancer caregivers, clarifying the types of needs by phase of cancer survivorship (i.e., diagnosis/treatment, long term survival, end of life, and bereavement) by using formative research methodology to identify important but unmet caregiver needs. Closest attention should be paid to identifying needs that could be addressed and met through future interventions (e.g., social support needs through support groups; informational needs through educational resources). By focusing on the identification of modifiable unmet needs, this study has potential to add to the literature in a way that could guide future efforts to improve caregivers’ quality of life. It is believed that through the use of formative research, this study will serve to identify important but unmet needs, generate hypotheses for future research, and guide future efforts in intervention that may improve the quality of life of ovarian cancer caregivers, as well as caregivers of persons with other cancers or diseases.
Project Activities: Applications submitted in response to this SIP should present information that address the activities listed below:
1. Describe the study design and methods used to gather information on the met and un-met needs of ovarian cancer caregivers at different stages of survivorship. For example, a series of focus groups comprised of individuals providing care to ovarian cancer patients at various stages could be used to accomplish the goals of this project.
2. Describe plans for gaining access to and recruiting a sufficient sample of ovarian cancer caregivers who are currently caring for patients in one of the four phases of cancer survivorship (i.e., diagnosis/treatment, long term survival, end of life, and bereavement). It may be necessary to use different methods for gaining access to caregivers at different stages of survivorship.
3. Describe plans for determining participant eligibility and methods used to recruit participants. Include proposed strategies for dealing with insufficient numbers of eligible participants and high refusal rates.
4. Describe detailed plans for developing study materials and carrying out proposed activities.
5. Describe which research questions will be used to guide the project and how data will be collected to address the research questions. Examples of the questions of interest include, but are not limited to:
6. Describe the types of caregiver needs (e.g., informational, financial, emotional) that will be addressed by the research.
7. Describe how findings may be used to guide future research and interventions for cancer caregivers.
8. Describe how data will be stored and analyzed.
9. Provide a detailed timeline for completing the proposed activities within the 2-year project period.
10. Identify key staff and describe the qualifications of all individuals who will be involved in the design and execution of this project.
11. Describe how the results from this project will be disseminated.
Additional Review Criteria and Funding Preferences: In addition to the standard review criteria used to evaluate the scientific and technical merit of applications (Significance, Approach, Innovation, Investigators, and Environment), the following additional review criteria specific to this SIP will be considered in the review process:
1. Research experience in the topic areas of social support and/or caregiving, especially in the context of cancer or other chronic diseases or disabilities.
2. Sound study design and evidence of experience conducting formative research.
3. Ability to recruit sufficient numbers of caregivers of ovarian cancer patients at each stage of survivorship (diagnosis/treatment, long term survival, end of life, and bereavement).
4. Plans for including, but not limiting study participation to, groups with known cancer outcome disparities.
5. Demonstrated support from agencies, medical facilities, registries, or other groups that will be used to identify eligible participants and conduct the research.
6. Previous experience with successfully completed projects with similar design including dissemination of results through publications.
Project Proposal Length and Supporting Material: Proposal narratives are limited to 20 pages. Supporting material included as appendices is limited to ten attachments. The appendices should include materials that show evidence of the applicant’s ability to successfully conduct the proposed project, letters of support, and other evidence deemed necessary to support the contents of the proposal.
Availability of Funds: Approximately $210,000 is available to fund one PRC in the first year of a 2-year project period. Approximately $235,000 is available in the second year. Funding may vary and is subject to change.
Research Status: It is expected that this project will be non-exempt research and will require local IRB approval. Applicants should provide a federal-wide assurance registration number for each performance site included in the project.
Award Administration: CDC Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. CDC staff will serve as consultants on this project and provide technical assistance related to ovarian cancer, public health priorities in cancer survivorship, and participant recruitment. CDC staff is expected to consult on the design, methodology, analysis of the data, dissemination of results, and will co-author manuscripts.
References:
1. Sales, E. (2003) Family burden and quality of life. Quality of Life Research 12 Suppl 1:33-41.
2. Schumacher, K. L., Dodd, M. J., Paul, S. M. (1993) The stress process in family caregivers of persons receiving chemotherapy. Research in Nursing & Health 16(6):395-404.
SIP 3: Intervention to Increase Screening for Cervical Cancer in Women of Mexican Descent - Phase 3
Project Description and Objectives: This SIP encompasses Phase 3 of a larger research study, to increase screening for cervical cancer among women of Mexican descent who are rarely or never screened. From its inception, this project has included a Lay Health Worker Advisory Committee (LHWAC) made up of promotoras or managers of promotoras.
The research study has four phases of research. In Phase 1, formative research was conducted to better understand why women of Mexican heritage do not participate in cervical cancer screening programs. Results from Phase 1 were discussed with the LHWAC in Phase 2 with the objective of developing or adapting an intervention and its delivery process. In keeping with current dissemination and implementation research, this intervention was designed with future implementation in mind.1,2 An intervention prototype, AMIGAS, was developed which includes a flip chart, video, and Promotora Instruction Guide. The Guide contains lesson plans, games, posters, resource sheet, educational pieces for the educational session, checklists, and appointments cards. Currently the primary components are seen as the flip chart, video, and resource sheet. Some Phase 2 activities are waiting OMB approval, but are expected to be concluded by the time of award for this SIP.
This SIP is soliciting applications to test an intervention prototype (develope