Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Cancer Institute (NCI)
Funding Opportunity Title	Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) Revision to Enhance the Collection of Cervical Cancer Screening Data (U54)
Activity Code	U54 Specialized Center- Cooperative Agreements
Announcement Type	New
Related Notices	RFA-CA-11-003
Funding Opportunity Announcement (FOA) Number	RFA-CA-14-001
Companion Funding Opportunity	None
Number of Applications	Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.393; 93.394; 93.399
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) invites revision applications from investigators with active PROSPR research center (U54) awards funded under RFA-CA-11-003 that are focused on screening for colorectal or breast cancers. This FOA solicits revision applications from these centers to expand the scope of their research activities to include screening for cervical cancer. The sole PROSPR center that is currently focused on cervical cancer is not eligible to apply for the revision award. The PROSPR Statistical Coordinating Center is also not eligible. Revision applications are expected to concentrate primarily on the collection of multilevel cervical cancer screening process data for submission to the PROSPR central data repository, but should also document expertise and capacity for participation in multicenter collaborative projects utilizing these data.

Posted Date	November 4, 2013
Letter of Intent Due Date(s)	December 13, 2013
Application Due Date(s)	January 13, 2014
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	February-March 2014
Advisory Council Review	May 2014
Earliest Start Date	July 2014
Expiration Date	January 14, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. See NOT-OD-13-075 and  NIH’s Applying Electronically website for more information.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Population-based Research Optimizing Screening through Personalized Regimens (PROSPR, RFA-CA-11-003) is a research program of the National Cancer Instititute (NCI) designed to improve the cancer screening process. Currently, the PROSPR program supports coordinated, multidisciplinary, multilevel research to evaluate screening processes for breast, colorectal, and cervical cancers in routine clinical practice in the U.S. The emphasis of this program is on addressing all key aspects of these processes (recruitment, screening procedure, positive screen evaluation, diagnosis, and referral for treatment). The goal is to improve the effectiveness and efficiency of screening for these three cancers through a comprehensive understanding of the various factors involved at the patient, provider, facility, and health care system levels. The existing PROSPR network includes three research centers (U54 awards) for breast cancer screening and three research centers (U54 awards) for colorectal cancer screening but only one research center (U54 award) focused on screening for cervical cancer. Therefore, additional research efforts relevant to screening for cervical cancer are warranted.

The purpose of this Funding Opportunity Announcment (FOA) is to expand PROSPR's activities related to screening women for cervical cancer. The FOA solicits revision applications specifically from the existing PROSPR centers that are focused on breast or colorectal cancer to expand their research scope by including cervical cancer. The sole PROSPR center that is currently focused on cervical cancer is not eligible to apply for these revision awards. The PROSPR Statistical Coordinating Center is also not eligible.

Eligible PROSPR center awardees interested in competing for these revision awards must be able to collect cervical cancer screening process data and submit these data to the PROSPR central data repository. They need also to plan for participation in multicenter, collaborative projects that will utilize these cervical cancer data.

Definitions

In the context of this FOA, several key terms are used as defined below.

• PROSPR research centers: the existing centers funded by the PROSPR U54 parent FOA (RFA-CA-11-003); these centers are currently focused on colorectal cancer screening (3), breast cancer screening (3), and cervical cancer screening (1).
• Collaborative Projects: research projects that utilize data and/or expertise from multiple PROSPR research centers; these were were referred to in the parent FOA (RFA-CA-11-003) as "trans-network projects" and will subsequently be referred to in this FOA as "collaborative projects."
• Cervical Cancer Unit: the additional unit to be proposed in this FOA; this unit will be part of an existing PROSPR research center and will include both the Cervical Cancer Screening Process Documentation and the Cervical Cancer Research components.
• Clinical Provider Network: the clinicians and their organizational structures who together deliver cancer screening, diagnosis, and treatment. (Also see http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-11-003.html "Key Definitions Used in the FOA.")

Cervical cancer is responsible for a relatively small number of deaths in U.S. women, largely due to widespread adoption of Pap testing in the 1950s and its continued uptake. Nevertheless, the impact of cervical cancer screening on the U.S. health care system and women in general is far-reaching. For the past several decades, practitioners typically have initiated Pap screening of average-risk women soon after the time of sexual debut and have continued to screen until the sixth or seventh decade of life. Advances in our understanding of the relationship of human papilloma virus (HPV) and cervical cancer have led researchers to conclude, however, that persistent HPV infection increases risk of cervical cancer and that HPV testing is likely to be of benefit in the screening process. Research also has demonstrated that positive Pap tests rarely lead to a cervical cancer diagnosis in young women, but that the invasive procedures that typically follow positive Pap tests can result in adverse pregnancy outcomes such as increased risk of pre-term delivery. Rates of cervical cancer are higher among women from recent immigrant groups in the U.S., such as women from Latin America and Asia. Rates of cervical cancer incidence also are higher in low-resource communities, as lack of resources reduces the opportunity for early detection and treatment, and thus cure.

The landscape of cervical cancer prevention is changing rapidly in the U.S. With the advent and acceptance of HPV testing and vaccination, coupled with evidence indicating that annual screening is no more beneficial than screening at longer intervals among average-risk women, the U.S. Preventive Services Task Force (USPSTF) released new cervical cancer screening recommendations in 2012. New practices recommended by the USPSTF, as well as other prominent organizations, include less-frequent screening, restriction of screening for average-risk women to ages 21 to 65, use of either Pap or co-testing (that is, Pap and HPV screening) for women 30 years of age and older, and the option of longer screening intervals if co-test results are negative.

While the new guidelines are intended to improve cervical cancer screening experiences for women and also reduce burden on the U.S. health care system, several clinical and health services delivery questions surrounding cervical cancer screening remain, including: acceptance of the guidelines by both women and practitioners, particularly those that call for less-frequent screening; management of patients with conflicting Pap and HPV screen results; and the viability of specimen self-collection methods, especially for women who reside in low-resource areas. HPV vaccination of girls, adolescent females, and young adult women also introduces important questions about optimal strategies for cervical cancer screening, as many individuals who were vaccinated when the first vaccine was approved for use in the U.S. in 2006 are now approaching or are already older than age 21. Because screening performance may differ in vaccinated populations, additional cervical cancer screening data from existing PROSPR research centers would provide a resource in which to integrate vaccination surveillance efforts, such that the joint impact of screening and vaccination could be evaluated in different health care settings.

Applications for adding Cervical Cancer Units to existing PROSPR research centers are being solicited because of the need to examine the cervical cancer screening process across multiple health care settings, in different regions of the U.S., and in high-risk populations that are not well-represented in the single cervical PROSPR research center. The challenges to the successful completion of the screening process and, consequently, the design of interventions to enhance that process are likely to be different in different populations, and a thorough understanding of the screening process requires comparisons across multiple settings. These comparisons are not possible under PROSPR’s current structure, with only one cervical research center. Because the existing breast and colorectal PROSPR research centers have the capacity to address these gaps, this FOA has been structured as a limited competition in order to take advantage of the existing infrastructure, working relationships between PROSPR investigators, and an established set of core data elements, in order to allow for a more rapid start-up and to maximize the productivity of the network within the 2-year funding period. A 2-year funding period was chosen to align with the duration of the parent awards, and to collect data during this period of rapid change in cervical cancer screening in the U. S. Because the priority is to document what is happening during this 2-year period, single-center research projects will not be funded as part of the competitive revision; this is in contrast to the parent awards, which did include support for three single-center projects at each research center (RFA-CA-11-003).

Eligible PROSPR research centers competing for the revision awards under this FOA must have the capacity to collect high-quality, multilevel cervical cancer screening process data. They also must plan for the use of the data to be collected in collaborative multicenter research projects. These future projects are expected to focus on the identification of factors associated with successful completion of the screening process and better long-term outcomes. These factors will need to be addressed in a systemic way at the levels of patients, providers, facilities, and health care systems. Specific collaborative projects are not to be proposed in the revision applications but the applicants must have appropriate expertise and research capacities for such studies.

Applicants responding to this FOA must be able to collect all required multilevel data elements related to the cervical cancer screening process. (For the list of these required data elements, see Section IV. Content and Form of Application Submission.) It is understood that other data elements not listed may need to be developed in accordance with the evolving needs of the network. Additionally, as required by the Terms and Conditions of the parent awards (listed in RFA-CA-11-003), applicants must be able to elucidate the size and basic demographic characteristics of the underlying population eligible for cervical cancer screening. The collection of individual, patient-level data on all screened women is required; collection of patient-level data on unscreened women is not required but is highly desirable.

To facilitate research to examine which factors are associated with the best outcomes, patients must be linked to detailed cancer information from a geographically defined cancer registry (SEER - http://seer.cancer.gov; or a North American Association of Central Cancer Registry gold-certified State Cancer Registry http://www.cdc.gov/cancer/npcr/about.htm; http://www.naaccr.org/Certification/CertificationLevels.aspx).

The types of research questions that could be addressed in collaborative projects for which applicants must have expertise and research capabilities include, but are not limited to:

• Frequency of use of different screening regimens (e.g., Pap only, co-testing, reflex testing) in different health care settings and high-risk populations;
• Overuse (outside of recommended age range and/or at a shorter interval than recommended) and underuse of screening;
• Comparative effectiveness of different screening regimens;
• Use and effectiveness of screening among HPV-vaccinated versus HPV-unvaccinated women; and
• Predictors of appropriate follow-up care following a positive screening examination.

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	Revision The OER Glossary and the PHS 398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NCI intends to commit $1.3 M in FY 2014 and $2.6 M over the entire 2-year budget period to fund two awards.
Award Budget	The budget may not exceed $650,000 in total costs per year.
Award Project Period	Applicants may request support for up to two (2) years, not to exceed the remaining number of years on the parent grant. The parent grant must be active during the entire project period proposed in the Revision application.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Eligible applicants are limited to the institutions that are awardees of the existing PROSPR research centers that are focused on breast or colorectal cancer.

The FOA solicits revision applications specifically from the existing PROSPR centers that are focused on breast or colorectal cancer to expand their research scope by including cervical cancer. The sole PROSPR center that is currently focused on cervical cancer is not eligible to apply for these revision awards. The PROSPR Statistical Coordinating Center is also not eligible.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the PHS 398 Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS 398 Application Guide.

Revision applications must be submitted by the same contact PD/PI as the parent PROSPR U54 award but applicants may add a new PD/PI if desired. It is expected that the senior leadership will include an investigator with expertise in cervical cancer screening to lead this effort. It is recommended that such an investigator be a PD/PI.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS 398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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 IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

V. Paul Doria-Rose, D.V.M., Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute (NCI)
9609 Medical Center Drive, Room 3E438
Bethesda, MD 20892-9762 (US Postal Service)
Rockville, MD 20850 (non-USPS deliveries)
Telephone: 240-276-6904
Email: [email protected]

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Referral Officer
Division of Extramural Activities
National Cancer Institute
Telephone: (240) 276-6390
Fax: (240) 276-7682
Email: [email protected]

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed, in addition to the following page limitations to the Research Strategy section of each component of the application.

• Overall: 6 pages
• Cervical Cancer Screening Process Documentation : 12 pages
• Cervical Cancer Research: 6 pages

The following section supplements the instructions found in the PHS 398 Application Guide, and should be used for preparing a multi-component application.

The application must consist of the following components:

• Overall: required
• Cervical Cancer Screening Process Documentation: required
• Cervical Cancer Research: required

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Applicants must have a demonstrated commitment from their Clinical Provider Network (as defined in the parent PROSPR FOA (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-11-003.html) to provide cervical cancer screening process data for utilization in PROSPR collaborative projects. Furthermore, applicants must have the infrastructure to store and process these data, and to securely transmit the data to the PROSPR Statistical Coordinating Center.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: Summarize the overall goals of your current PROSPR center and outline the overall goals of the proposed cervical cancer-focused enhancements.

Research Strategy: Provide an overview of the proposed cervical screening-focused enhancements to the PROSPR research center. This new Cervical Cancer Unit must include two structural and functional components dedicated to:

• Documentation of cervical cancer screening process; and
• Cervical cancer research.

As part of this section, describe the following elements:

• How will the Cervical Cancer Unit be integrated into the existing breast/colorectal PROSPR research center? How will the governance structure of the research center be modified to accommodate the study of two different types of cancer screening, and how will additional center staff with the relevant cervical cancer expertise be incorporated?
• What are the expertise and experience of the research team in conducting multilevel, multidisciplinary cervical cancer screening research?
• What is the defined population to be studied? Specify age range; proportion of the population falling into specific racial/ethnic or other groups known to be at increased risk of developing cervical cancer; other inclusion/exclusion criteria; and any other unique population characteristics that are of particular interest for the study of the cervical cancer screening process. Describe retention in your study population (e.g., for integrated health care delivery systems, what proportion of members disenroll within 1, 3, and 5 years?; for geographically defined catchment areas, what are annual rates of in- and out-migration?). How complete is the capture of diagnostic and treatment data for women with positive screening examinations?
• What is the makeup of the Clinical Provider Network that delivers cervical cancer screening services to the study population? What proportion of screening exams are performed in primary care as compared to specialty care or other settings? Where and how are women referred for follow-up testing following an abnormal finding at a screening examination? What practice- and/or system-level support tools are in place to promote attendance at screening and to ensure that women with abnormal screening examinations receive appropriate follow-up testing and treatment?

Resource Sharing Plan:Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan under Overall component (but do not complete corresponding sections under other components).

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Cervical Cancer Screening Process Documentation)

All instructions in the PHS 398 Application Guide must be followed

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Cervical Cancer Screening Process Documentation )

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Cervical Cancer Screening Process Documentation)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Cervical Cancer Screening Process Documentation)

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support (Cervical Cancer Screening Process Documentation )

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Cervical Cancer Screening Process Documentation )

All instructions in the PHS 398 Application Guide must be followed

Resources (Cervical Cancer Screening Process Documentation )

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Cervical Cancer Screening Process Documentation)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: Outline your aims to collect and link multilevel cervical cancer screening process data from multiple sources within your defined population, and to securely transmit a set of standardized data elements to the PROSPR Statistical Coordinating Center.

Research Strategy: Provide a comprehensive description of data sources and strategies for collecting and linking multilevel cervical cancer screening process data from these sources. Address the following elements:

• Describe the study team, with particular attention to their qualifications and experience in collecting cervical cancer screening process data.
• Provide evidence of the Clinical Provider Network's ability to actively participate in and support the collection of comprehensive, multilevel cervical cancer screening process data by your PROSPR research center. How will Clinical Provider Network and research center staff interact to ensure efficient, timely, and complete capture of the relevant clinical data for research purposes?
• Document your center's capacity to prospectively collect and submit the following data elements (all elements are required unless otherwise noted):
  • Patient level: age, race, ethnicity, type of health insurance coverage, socioeconomic status (optional), educational attainment (optional), HPV vaccination status, timing and type(s) of testing for cervical cancer, indication for test(s) (i.e. for screening versus diagnostic purposes), follow-up test(s) performed following a positive screening examination and their results, treatment(s) performed, diagnosis of cervical intraepithelial neoplasia (CIN), cancer diagnosis (as determined via linkage to a high-quality cancer registry);
  • Provider level: medical specialty of the referring and performing provider, provider type of the referring and performing provider (e.g. physician, nurse practitioner, physician assistant), years in practice;
  • Practice/Facility level: practice type (e.g. academic medical center, federally qualified health center (FQHC), HMO, etc.), practice size (i.e., number of FTE clinicians; types of clinicians in the practice); facility location, facility type (e.g. OB/gynecologist office, primary care clinic), number and types of providers performing cervical cancer screening; type and features of EMR system used to support screening activities;
  • Health system level: size and level of integration of medical system, presence and type of organizational factors to support the screening process (e.g., use of HEDIS measures; performance measurement and reporting to clinicians; use of incentives), presence of processes to support informed decision making;
  • Health policy level: ability to identify in detail at multiple points in the screening process the types and extent of patient health insurance coverage and out-of-pocket expenditures (e.g., deductibles, copays, self-pay) for cervical cancer screening, follow-up, and diagnostic testing services, so that the impact of the Affordable Care Act on cervical cancer screening delivery can be assessed.
• In addition to prospective data collection during the funding period, describe your center's ability to provide retrospective cervical cancer screening process data elements listed above. While provision of retrospective data is not required, it is strongly encouraged when available.
• Describe your plans to process, store, and securely transmit data elements to the PROSPR Statistical Coordinating Center.
• Applicants are expected to take advantage of emerging technologies relevant to the cervical cancer screening process (e.g. patient/provider reminder systems found in electronic health records) as well as new opportunities reflecting recently enacted health policy initiatives, such as new coverage models created through the Affordable Care Act.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Do not complete for this component but address the corresponding item for the "Overall".

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions, as noted.

Face Page (Cervical Cancer Research)

All instructions in the PHS 398 Application Guide must be followed

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells (Cervical Cancer Research)

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents (Cervical Cancer Research)

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period (Cervical Cancer Research)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instruction:

The budget request for the Cervical Cancer Research component must include $40,000 in each year of funding to be earmarked for future cervical screening-related collaborative projects. Note that the activation of these funds will be possible only for projects selected and approved by the PROSPR Steering Committee. In addition to this collaborative project fund, the budget for this component may include modest additional support for reseach staff to participate in the development of these collaborative projects, through interaction with the PROSPR Cervical Cancer Working Group and the PROSPR Steering Committee.

Budget for Entire Proposed Period of Support (Cervical Cancer Research)

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch (Cervical Cancer Research)

All instructions in the PHS 398 Application Guide must be followed.

Resources (Cervical Cancer Research)

All instructions in the PHS 398 Application Guide must be followed.

Research Plan (Cervical Cancer Research)

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Specific Aims: Outline your aims to engage actively in collaborative research projects with other PROSPR research centers.

Research Strategy: While the emphasis of this FOA is to fund centers with demonstrated capacity to collect and submit standardized, high-quality cervical cancer screening process data, the investigator responsible for overall leadership of the PROSPR cervical enhancement award, and his/her study team members, are expected to be actively engaged in conceptualizing and prioritizing collaborative research projects related to the cervical cancer screening process. To that end, applicants should describe their center's vision for types of cervical cancer research that could be undertaken within the PROSPR network that take advantage of the variability between the centers' patient populations, geographic locations, and health care settings. Specific research projects should NOT be proposed. However, applicants should demonstrate a clear understanding of key questions to be addressed in the rapidly changing landscape of cervical cancer screening and prevention and suggest ways in which the PROSPR network could be leveraged to address these questions.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS 398 Application Guide, with the following modification:

Do not complete for this component but address the corresponding item for the "Overall".

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide.

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in

NOT-OD-13-030.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

This FOA is designed to expand the scientific scope of some of the existing PROSPR centers by adding components focused on cervical cancer to two of the PROSPR centers that are currently focused on other cancer types. The main priority is the capacity of the applicants centers to collect and submit comprehensive, multilevel cervical cancer screening process data. This capacity will be emphasized in assessing the merit of the applications. The PROSPR centers proposing an additional focus on cervical cancer are also expected to participate as full scientific partners in PROSPR collaborative projects related to this cancer. Therefore, secondary priorities that should also be evaluated include the expertise of the research teams in cervical cancer screening and the likelihood that the proposed new Cervical Cancer Units will be able to conduct meaningful, rigorous research that is relevant to improving the screening process for cervical cancer.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific for this FOA: To what degree will the inclusion of the proposed cervical cancer activities in the applicant's PROSPR center enhance the PROSPR network's capacity to conduct high-quality, multilevel, multidisciplinary research concerning the cervical cancer screening process? How likely is the proposed Cervical Cancer Research component to significantly contribute to collaborative projects and, thereby, lead to knowledge that can be used to improve the cervical cancer screening process?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific for this FOA: Is the PROSPR cervical cancer team led by (a) recognized or emerging leader(s) in the evaluation of cervical cancer screening in the context of routine clinical practice? How well does the expertise of the team match the needs of cervical cancer research to be performed under this FOA? Does the research team have a history of successful collaborations in this area of research? Does the application demonstrate a knowledge of and vision for key research questions related to improving the process and outcomes of cervical cancer screening that are well-suited to being addressed within the PROSPR network?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific for this FOA: Does the applicant sufficiently address emerging technologies relevant to the successful completion of the cervical cancer screening process? Do the proposed data collection elements and key research questions adequately reflect recently enacted health policy initiatives?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Specific for this FOA: Does the proposed PROSPR Cervical Cancer Unit have the capacity to collect required data elements at the patient, provider, facility, and health system level? Are the data sources sufficient? Are the plans and capabilities to process and code the data sufficient to ensure the timely capture of high-quality, standardized data for submission to the PROSPR Statistical Coordinating Center? What is the potential of the proposed PROSPR Cervical Cancer Unit in terms of the ability to contribute retrospective data that will increase the scope of research that could be done by the PROSPR network? Can the proposed PROSPR Cervical Cancer Unit collect individual, patient-level data on all women eligible for screening in their study population (i.e., both in women who are screened and those who are not)? Are the proposed cervical cancer screening-focused enhancements well-integrated with the existing PROSPR research center activities, such that the work can be efficiently completed during the 2-year funding period?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific for this FOA: How strong is the support of the Clinical Provider Network in terms of ensuring that investigators will have adequate access to the relevant clinical data? If the proposed goals include targeting a high risk population, how strong is the evidence that this population is large enough and includes a significantly high proportion of women at increased risk of cervical cancer? If applicants propose to explore a unique health care environment, can this environment significantly enhance the likelihood that the research by the PROSPR network will improve the cervical cancer screening process? Does the targeted patient population include a significant portion of women at increased risk of cervical cancer and/or a unique health care environment that will enhance the capacity of the PROSPR network to conduct research to improve the cervical cancer screening process? Are the applicants' PROSPR center facilities sufficient for secure storage and transmission of cervical cancer screening process data to the PROSPR Statistical Coordinating Center?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Cancer Institute, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

The terms and conditions of the original award also apply to these revisions, with the following additional provisions:

• Each PROSPR research center that is awarded a revision award under this FOA to collect cervical cancer screening process data will have the right for additional representation on the PROSPR Steering Committee. For awardees under this FOA, two representatives from the Cervical Cancer Unit of the PROSPR research center (the overall cervical lead for the PROSPR research center and one other designated senior investigator) may be named to the Steering Committee; collectively these representatives will have one vote on the Steering Committee.
• Awardees are expected to interact with the currently funded cervical PROSPR research center in order to develop and prioritize collaborative projects. In addition, they are expected to develop and participate in collaborative projects which consider the screening process more broadly across breast, colorectal, and cervical cancer.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY: 301-451-5936
Email: [email protected]

V. Paul Doria-Rose
National Cancer Institute (NCI)
Telephone: 240-276-6904
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Carol Perry 
National Cancer Institute (NCI)
Telephone: 240-276- 6282
Email: [email protected]

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.