Expired RFA-CA-07-008: Application of Emerging Technologies for Cancer Research (SBIR [R43/R44])

Department of Health
and Human Services (HHS)

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This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.nci.nih.gov)

Title: Application of Emerging Technologies for Cancer Research (SBIR [R43/R44])

Announcement Type
This is a reissue of RFA-CA-06-006 (SBIR/STTR) that expired October 19, 2005.

Update: The following update relating to this announcement has been issued:

January 4, 2007 - This RFA has been reissued as (RFA-CA-07-041).
March 20, 2006 (NOT-CA-06-017) - NCI is amending the Financial or Grant Management Contact information (Section VII. 3.) in RFA-CA-07-008.

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) SBIR/STTR Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA, RFA-CA-07-008, must be read in conjunction with the application guidelines included with this announcement in Grants.gov Apply for Grants (hereafter called 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 submitted to Grants.gov by 5:00 p.m. local time (of the applicant institution/organization) on the submission date (see Key Dates below).

2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons. .

Request for Applications (RFA) Number: RFA-CA-07-008

Catalog of Federal Domestic Assistance Numbers
93.392, 93.393, 93.394, 93.395, 93.396

Key Dates

Release/Posted Date: January 26, 2006
Opening Date: January 26, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Dates: February 8, 2006; April 26, 2006; August 28, 2006
Application Submission Dates: February 22, 2006; May 26, 2006; September 26, 2006
AIDS Application Submission Dates: Not Applicable
Peer Review Dates: June/July 2006; October/November 2006; February/March 2007
Council Review Dates: September/October 2006; January/February 2007; May/June 2007
Earliest Anticipated Start Dates: September 2006; February 2007; June 2007
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: September 27, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

This Funding Opportunity Announcement (FOA) solicits Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) for research projects proposing the initial application of emerging molecular biology technologies to clinical or laboratory cancer research. Technology encompasses methods and tools that enable research, including but not limited to, instrumentation, techniques, and devices.
Contingent upon the availability of funds and the submission of a sufficient number of meritorious applications, the National Cancer Institute (NCI) intends to commit approximately $1,250,000 in Fiscal Year 2007 to fund 3-5 Phase I and/or Phase II SBIR applications responding to this FOA.
This FOA will utilize the SBIR (R43/R44) grant mechanisms for Phase I, Phase II, and Fast-Track applications and runs in parallel with FOAs of identical or related scientific scope that solicit applications under the Small Business Technology Transfer (STTR [R41/R42]) grant mechanisms (RFA-CA-07-009) and R21 Exploratory/Developmental and R33 Exploratory/Developmental Phase 2 grant mechanisms (RFA-CA-07-002).
Budgets up to $100,000 in total costs per year and time periods up to 2 years may be requested for Phase I; project duration periods of up to 3 years and budgets for Phase II applications of up to $750,000 total costs per year will be considered, but should be appropriate for the scope of research proposed.
Eligible organizations: Only United States SBCs are eligible to submit SBIR applications. A SBC is one that, on the date of award for both Phase I and Phase II SBIR funding agreements, meets ALL of the criteria as described in Section III.
Eligible individuals: Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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 programs. On an SBIR application, the Project Director/Principal Investigator (PD/PI) must have his/her primary employment (more than 50%) with the SBC at the time of award and for the duration of the project.
Generally, consultative or other arrangements between SBCs and other organizations, including other for-profit organizations and universities or other non-profit organizations, are permitted, but the SBC must serve as the applicant and grantee organization.
Only domestic SBCs that have obtained a Phase I SBIR grant are eligible to apply for Phase II SBIR funding. The objective of Phase II the principal R&D phase is to continue the research efforts initiated in Phase I. Funding for Phase II is based on the results of Phase I (e.g., feasibility demonstration) and the scientific and technical merit and commercial potential of the Phase II application. A Phase I SBIR award must have been received in order to obtain a Phase II SBIR award. A Phase II SBIR award may be issued by a Federal agency other than the one that made the Phase I SBIR award.
The NIH Fast-Track application is now a single application consisting of Phase I and Phase II activities. See Section IV.6. and the SF424 (R&R) SBIR/STTR Application Guide.
Applicant SBCs may submit more than one application, provided each application is scientifically distinct.
See Section IV.1 for application materials. The SF424 (R&R) SBIR/STTR Application Guide for this FOA is located at these Web sites:

For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites: SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
Telecommunications for the hearing impaired is available at: TTY (301) 451-5936.
Special receipt/submission dates are listed under Key Dates.
Initial merit review convened by the Division of Extramural Activities, NCI.

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 of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
A. Submission, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
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
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources

Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact
2. Peer Review Contact
3. Financial/Grants Management Contact

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The purpose of this Funding Opportunity Announcement (FOA) issued by the National Cancer Institute (NCI) is to invite Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) for research projects proposing the initial application of emerging molecular biology technologies to clinical or laboratory cancer research. Technology encompasses methods and tools that enable research, including but not limited to, instrumentation, techniques, and devices. Technology is distinct from resources such as databases, reagents, and tissue repositories. Applications for support of such resources will not be considered responsive to this FOA. Technologies solicited include but are not necessarily limited to, those that are suitable for the detection of alterations and instabilities of genomic DNA; measurement of the expression of genes and gene products, including proteins; analysis and detection of gene and/or cellular products, including post-translational modification and function of proteins; identification and characterization of exogenous infectious agents in cancer; and assaying the function of major signal transduction networks involved in cancer. Developing technologies would include those that will support molecular analysis in vitro, in situ, or in vivo in discovery processes as well as in pre-clinical models and clinical research.

This funding opportunity is part of a broader technology development program within the NCI, which underscores the desire of the NCI to develop and integrate novel and emerging technologies in the support of cancer research, diagnosis, and treatment. In the research continuum of discovery, development, and delivery, this program accelerates development and delivery. This specific FOA initiative will serve as the discovery tool of the larger program by soliciting and funding highly innovative, high risk, and cancer-relevant technology development projects associated with the molecular analysis of cancer. This initiative capitalizes on the success of the original NCI sponsored Innovative Molecular Analysis Technologies (IMAT) program in bringing together a multi-disciplinary group of scientists and engineers to work on cancer and the expansion of interest in technology development across the NCI and other NIH Institutes and Centers (ICs). The continuation of the IMAT program consists of the following three initiatives: Innovative Technologies for the Molecular Analysis of Cancer; Innovations in Cancer Sample Preparation; and Application of Emerging Technologies for Cancer Research. For each IMAT initiative, parallel funding opportunities, which utilize the SBIR (R43/R44) and the Small Business Technology Transfer (STTR [R41/R42]) grant mechanisms, exist for applicants from the small business research community.

This FOA, RFA-CA-07-008, is designed to support applicant SBC projects through the use of SBIR grant mechanisms for Phase I, Phase II, and Fast-Track applications. Applications should emphasize research projects centered on the evaluation of emerging technologies that are ready for testing of their utility in basic and/or clinical cancer research. SBIR applications pertinent to technologies developed or adapted for sample preparation methodology may be most suitable for RFA-CA-07-010, Innovations in Cancer Sample Preparation, whereas RFA-CA-07-011 solicits applications for the same purpose and title under the STTR grant mechanisms. SBIR research projects centered on inception of new technologies may be most suitable for RFA-CA-07-006, Innovative Technologies for Molecular Analysis of Cancer, whereas RFA-CA-07-007 solicits applications for the same purpose and title under the STTR grant mechanisms. Researchers who emphasize the assessment of in vivo imaging technologies as the primary focus of their grant applications should contact the Cancer Imaging Program for information on appropriate funding opportunities. Researchers focusing on applying new bioinformatics or statistical techniques as the primary focus of their applications should consider one of the Biomedical Information Science and Technology Initiative (BISTI) opportunities.

Background

In order to reduce death and suffering due to cancer, the NCI will continue to support the development of creative methods to understand, prevent, diagnose, and treat cancer. In the past several decades, basic discovery research has revealed that cancer is a complex disease involving myriad molecular and cellular processes, and that cancers arise as the result of the gradual accumulation of genetic changes in specific cells. Identifying which subset of the genes encoded within the human genome can contribute to the development of cancer remains a challenge. Even more challenging is the subsequent understanding of the roles of RNA, proteins, and other functional products encoded by these genes. The identification and characterization of these cancer genes and their associated gene products remains a high priority in cancer research. New technologies and approaches not only address specific questions in basic research and clinical practice but are also beneficial in uncovering and developing new directions and paradigms in cancer research. Therefore, technological advances play critical role throughout the NCI's mission.

The IMAT program was originally designed in 1999 with three objectives: to focus technology development on cancer, to solicit highly innovative technology development projects, and to accelerate the rate of maturation of meritorious technologies from feasibility through development of the technology. Through solicitation, outreach, and communication with the investigator community, the IMAT program has been successful in promoting cancer-relevant applications of a diverse spectrum of new and emerging technologies. The program has focused on both the inception and development of cancer-related technologies. Some of the technologies originally generated with IMAT funding have been put in use to facilitate the acquisition of basic knowledge about cancer, which feeds the discovery pipeline. Other IMAT supported technologies have been applied to questions of clinical importance. The IMAT program has also been successful in accelerating meritorious technology development projects by minimizing the funding gap between feasibility and development phases through the use of the Fast-Track funding mechanism. This funding opportunity will support not only separate Phase I and Phase II SBIR applications, but also SBIR Fast-Track applications, as outlined in Section II.1., Mechanisms of Support.

This FOA is intended to support the development of molecular analysis tools that will not only allow for the more in depth examination of the molecular basis of cancer in general, but will also provide the ability to identify those molecular characteristics of individuals that are pertinent to cancer development and prognosis. For instance, such tools are anticipated to facilitate the identification of genetic factors that influence an individual's risk of developing cancer or his/her ability to respond to adverse external/environmental factors such as radiation, carcinogens, as well as to therapeutic agents.

To better understand the neoplastic process and the molecular responses of the host to cancer, it will be critical not only to acquire relevant knowledge at the DNA level but also to improve our understanding of the impact of aberrant genetic information on cellular functions. Current discoveries indicate that alterations in many of the cellular processes, pathways, or networks may contribute to the genesis of cancer and that these alterations could be exploited for therapeutic or preventive intervention. Therefore, it is important to invoke technologies that can detect molecular changes in the cell without preconceived ideas as to what specific markers might be the most valuable to monitor. In the discovery phase, the emphasis will be on highly multiplexed technologies that can effectively detect structural variations or functional changes in many (ultimately in all) members of the populations of DNA, RNA, or protein species present in cells. Current technologies for the multiplexed analysis of macromolecular species are at a stage where the greatest utility exists for the analysis of large numbers of relatively homogeneous cell populations that can be assayed in vitro. While many of the existing technologies have relatively sophisticated multiplexing capabilities in the assay format, none are comprehensive for any particular type of macromolecular species (DNA, RNA, or protein). Therefore, there is a need for further development to insure that the resulting technologies provide enhanced assay potential, adequate sensitivity and specificity, robust data analysis tools, and easy adaptation to the basic, preclinical, and clinical research settings.

Objectives and Scope

The purpose of this RFA is to solicit applications from small businesses interested in applying to basic, clinical, and epidemiological research emerging technologies that are suitable for the molecular analysis of cancers and their host environment. Technologies to support research in the following areas are considered to be appropriate. Examples given below are not intended to be all-inclusive but serve to illustrate the types of capabilities that are of interest.

New tools that would allow for acquisition of more complete profiles of DNA, RNA, protein, and other important biomolecules of normal, pre-cancerous, and cancerous cells are needed to support the basic discovery process by offering a more complete picture of the neoplastic phenomenon. Analogous technological advances will also be needed to examine the tumor micro-environment, including both stromal and vascular interactions. Such tools will allow more comprehensive characterization of both the variations that influence predisposition to cancer and the responses of an individual to therapeutic and preventive agents. The types of capabilities, technologies and data analysis tools that are of interest include, but are not limited to, the following examples:

Scanning for and identification of the sites of chromosomal aberrations, mutations, and polymorphisms that reflect inherited abnormalities as well as somatic alterations associated with aging and/or resulting from exposure to environmental mutagenic factors, such as oxidative stress, ionizing or ultraviolet radiation, and carcinogens. Particular interest is in the development of scalable tools that can be applied across whole genomes, for example to detect rare abnormalities in mixed populations of normal and abnormal cells;
Technologies for detection and characterization of foreign nucleic acid sequences, such as DNA of as yet uncharacterized exogenous infectious agents, that might be present in human cancer cells;
Highly specific and sensitive detection of mutations in defined genomic sites;
Assessing the status/functionality of DNA repair machinery (nucleotide excision repair, base excision repair, mismatch repair, and recombinational) repair in the context of cancer susceptibility and sensitivity to anticancer drugs;
Massively parallel analysis of the expression of genes that would overcome limitations of the existing multiplexed gene expression technologies;
Detection of expression of proteins and their posttranslational modifications, including technologies suitable for expansion to profiling of all proteins expressed in cells, detecting rare protein variants in mixed populations, and detecting proteins modified (adducted) by carcinogens or anticancer drugs;
Monitoring the function of specific proteins and cellular metabolic or signaling pathways, including such aspects as examination of ligand-protein and protein-protein complexes and technologies for simultaneous monitoring of functions of all members of a class of proteins or a complete metabolic or signaling pathway;
Molecular imaging technologies, contrast approaches, gene amplification techniques, and related tools suitable for examining expression and/or function of biomolecules at the cellular level;
Technologies to elucidate structural modifications of macromolecules that may be indicative of and critical to the neoplastic transformation process;
Development of biocompatible molecular and cellular labels and technologies and approaches to enable their faster and more accurate delivery to cells and to specific cellular compartments, and
Development of high-throughput, quantitative assays for epigenetic alterations linked to abnormal gene expression, e.g., DNA methylation at particular promoters and/or histone acetylation and chromatin remodeling at such sites..

For all technologies proposed for development, it is important to substantiate the potential value of and role for the technology in elucidating the molecular characteristics of cancer cells or cancer-relevant characteristics of the individual. It is also important for applicants to discuss the prospects for the eventual dissemination of new technologies to other laboratories or the clinic. In the case of technologies intended for use on clinical specimens or in patients, collaborations with investigators involved in the clinical research of cancer are encouraged.

See Section VIII, Other Information - Required Federal Citations for policies related to this announcement.

Section II. Award Information

1. Mechanisms of Support

This FOA (RFA-CA-07-008) will utilize the SBIR (R43/R44) grant mechanisms for Phase I, Phase II, and Fast-Track applications and runs in parallel with FOAs of identical or related scientific scope that solicit applications under the Small Business Technology Transfer (STTR [R41/R42]) grant mechanisms (RFA-CA-07-009) and R21 Exploratory/Developmental and R33 Exploratory/Developmental Phase 2 grant mechanisms (RFA-CA-07-002).

Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS FOA, including the current Parent SBIR and STTR FOAs.

Phase II applications in response to this funding opportunity will only be accepted as competing renewals (formerly competing continuations ) of previously funded Phase I SBIR awards. The Phase II must be a logical extension of the Phase I research but not necessarily as a Phase I project supported in response to this funding opportunity.

The applicant SBC will be solely responsible for planning, directing, and executing the proposed project. Future unsolicited, competing renewal applications based on this project will compete with all SBIR applications and will be reviewed according to the customary peer review procedures. Applications that are not funded in the competition described in this FOA may be submitted as NEW applications through Grants.gov/Apply using the standard NIH, CDC, and FDA SBIR submission dates of April 1, August 1, and December 1 (or January 2, May 1, and September 1 for NIH AIDS and AIDS-related SBIR applications). The NIH allows up to two resubmission (formerly revised/amended ) applications without a time line for submitting the first and second resubmissions. See NOT-OD-03-041, May 7, 2003.

This funding opportunity uses just-in-time concepts. The modular budget format is no longer accepted for SBIR grant applications. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget component found in the application package attached to this FOA in Grants.gov/Apply.

The Phase I application will emphasize the innovative, high-risk nature and high potential impact of the proposed research and be conceptual in nature, with no preliminary data required. In addition to the concept and discussion of the proposed technology that is common to all Phase I applications, the application must also include a brief section describing the potential use and impact of the proposed technology. The specifics of the Phase I application are described in Section IV.2., Content and Form of Application Submission.

2. Funds Available

The SF424 (R&R) SBIR/STTR Application Guide indicates the statutory guidelines of funding support and project duration periods for Phase I and Phase II SBIR awards. For this funding opportunity, budgets up to $100,000 total costs per year and time periods up to 2 years for Phase I may be requested. Budgets up to $750,000 total costs per year and up to 3 years may be requested for Phase II. Total costs include direct costs, facilities and administrative (F&A)/indirect costs, and fee.

The NCI intends to commit approximately $1,250,000 in Fiscal Year 2007 to fund three to five (3-5) Phase I and/or Phase II applications under the SBIR set-aside funding mechanism. Although the NCI’s financial plans provide support for this program, awards pursuant to this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. At this time, it is not known if competing renewal applications will be accepted and/or if this FOA will be reissued.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Only United States small business concerns (SBCs) are eligible to submit SBIR applications. A small business concern is one that, at the time of award for both Phase I and Phase II SBIR awards, meets all of the following criteria:

1. Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit.

2. Is (a) at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or (b) for SBIR only, it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States.

3. Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns are generally considered to be affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.

Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 C.F.R. 121.103. The term "number of employees" is defined in 13 C.F.R. 121.106.

A business concern may be in the form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative. Further information may be obtained at http://sba.gov/size, or by contacting the Small Business Administration's Government Contracting Area Office or Office of Size Standards.

One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an SBIR awardee organization must be space that is available to and under the control of the SBIR awardee for the conduct of its portion of the proposed project.

Title 13 C.F.R. 121.3 also states that control or the power to control exists when key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise. Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.

For purposes of the SBIR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13 C.F.R. 121.106 Small Business Size Regulations.

All SBIR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an SBIR award until the SBA provides a determination.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their 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 programs.

Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. Primary employment means that more than one half of the PD/PI’s time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization. Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.

As defined in 42 C.F.R. Part 52, the PD/PI is the single individual designated by the grantee in the grant application who is responsible for the scientific and technical direction of the project. When the proposed PD/PI clearly does not have sufficient qualifications to assume this role, the application is not likely to receive a favorable evaluation.

If the application has the likelihood for funding, the awarding component will require documentation to verify the eligibility of the PD/PI, if at the time of submission of the application, the PD/PI is a less-than-full-time employee of the small business concern, is concurrently employed by another organization, or gives the appearance of being concurrently employed by another organization, whether for a paid or unpaid position.

If the PD/PI is employed or appears to be employed by an organization other than the applicant organization in a capacity such as Research Fellow, Consultant, Adjunct Professor, Clinical Professor, Clinical Research Professor, or Associate, a letter must be provided by each employing organization confirming that, if an SBIR grant is awarded to the applicant small business concern, the PD/PI is or will become a less-than-half-time employee of such organization and will remain so for the duration of the SBIR project. If the PD/PI is employed by a university, such a letter must be provided by the Dean's office or equivalent; for other organizations, the letter must be signed by a corporate official.

This requirement applies also to those individuals engaged currently as the PD/PI on an active SBIR project. All current employment and all other appointments of the PD/PI must be identified in his or her Biographical Sketch required as part of the application. Be certain that correct beginning and ending dates are indicated for each employment record listed.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

The NIH will accept as many "different" applications as the applicant organization chooses. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS FOA, including the current Parent SBIR and STTR FOAs.

Section IV. Application and Submission Information

Registration and Instructions for Submission via Grants.gov

To download an Application Package and Application Guide 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 both:

Grants.gov (http://www.grants.gov/GetStarted) and
NIH eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organization/Institutional Registration in Grants.gov/Get Started

Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
Direct questions regarding Grants.gov registration to:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email support@grants.gov

2) Organization/Institutional Registration in the eRA Commons

To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
Direct questions regarding the Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email commons@od.nih.gov

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

The individual designated as the PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
The PD/PI must hold a PD/PI account in the Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
This registration/affiliation must be done by the Signing Official (SO) or their designee who is already registered in the Commons.
Both the PD/PI and SO need separate accounts in the NIH eRA Commons since both are required to verify the application.

Note that if a PD/PI is also an NIH 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 institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) SBIR/STTR 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 GrantsInfo: Telephone 301-710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all SBIR applications using the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR Application Guide (MS Word or PDF) instructions. The SF424 (R&R) SBIR/STTR Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s 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, required 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
SBIR/STTR Information

Optional Components:

PHS398 Cover Letter File
Research & Related Subaward Budget Form

3. Submission Dates and Time

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: January 26, 2006 (Earliest date an application may be submitted to grants.gov)
Letters of Intent Receipt Dates: February 8, 2006; April 26, 2006; August 28, 2006
Application Submission Dates: February 22, 2006; May 26, 2006; September 26, 2006
AIDS Submission Dates: Not Applicable
Peer Review Dates: June/July 2006; October/November 2006; February/March 2007
Council Review Dates: September/October 2006; January/February 2007; May/June 2007
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Earliest Anticipated Start Dates: September 2006; February 2007; June 2007

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research;
Name, address, and telephone number of the PD/PI;
Names of other key personnel;
Participating institutions; and
Number and title of this funding opportunity.

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 NCI 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:

Gregory J. Downing, D.O., Ph.D.
Office of Technology and Industrial Relations
National Cancer Institute
Building 31, Room 10A52, MSC 2580
Bethesda, MD 20892-2580
Telephone: (301) 496-1550
Fax: (301) 496-7807
Email: downingg@mail.nih.gov

3.B. Sending an Application to the NIH

Applications in response to this FOA may only be submitted to Grants.gov through Grants.gov/Apply.
PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted to Grants.gov on or after the opening date and must be submitted no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission dates described in Section IV.3.A. If an application is not received by that date, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be transferred from Grants.gov to the NIH Electronic Research Administration process for validation. Both the PD/PI and the Signing Official for the organization must verify the submission via Commons within two business days of notification of the NIH validation.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons . Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing renewal award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide (MS Word or PDF) are to be followed, with the following requirements.

Note: While each section of the Research Plan needs to eventually be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan 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.

Note also that an annual meeting of all investigators funded through this program will be held to share progress and research insights that may lead to further progress in the program. Applicants should request travel funds in their budgets for the PD/PI and one additional senior investigator to attend this annual meeting.

SBIR Phase I applications:

Although preliminary data are not required, they may be included.
Items 2-5 of the Research Plan component may not exceed 15 pages, including tables, graphs, figures, diagrams, and charts.
Introduction (required for a resubmission application) is limited to one page.
The Biographical Sketch is limited to a maximum of 4 pages for each senior/key person. (This includes the table at the top of the first page.)
There is no further limitation on the total number of pages for the entire Phase I application; however, applicants are encouraged to be succinct.

Applicants must include a specific section of no more than two pages labeled Milestones as part of and at the end of the PHS 398 Research Plan. Milestones should be well described, quantitative, and scientifically justified and not be simply a restatement of the specific aims. Discuss the milestones as means of judging the success of Phase I as well as providing proof of principle for a future Phase II. Specific aims may not be regarded as milestones (unless they include quantitative end points). The specific aims describe the goals and intended path of the research. Quantitative milestones are a way of determining whether an applicant has successfully reached the specified goal. In most cases, applicants should provide a milestone for each specific aim. Milestones should be clearly stated and presented in a quantitative manner, such as numerical specifications of sensitivity and specificity or a count of some desired kind of newly discovered molecule, etc. Several examples of quantitative milestones follow:
Detection of one cancer cell in 10⁶ normal blood cells;
Identification of 10 new cancer-associated cDNAs;
Detection of substance x at a concentration of 1 pmol/mL in serum;
Cost of new technology is 10 percent that of the current technology;
Detection of one mutated gene in the presence of 10³ normal genes;
Demonstration that the technology gives the same result in 95 out of 100 assays; and
Demonstration that the technology is capable of detecting 25,000 different polypeptides from a cell or tissue type.

If 2 years of support are requested, the goals/milestones for the first year should be clearly stated. Support for the second year will be contingent upon Institute programmatic evaluation of the progress to ensure that investigators are reaching milestones and accomplishing their proposed first year goals

SBIR Phase II applications:

Items 2-5 of the Research Plan component may not exceed 25 pages, including tables, graphs, figures, diagrams, and charts.
Introduction (required for a resubmission application) is limited to three (3) pages.
The Biographical Sketch is limited to a maximum of four (4) pages for each senior/key person. (This includes the table at the top of the first page.)
The Phase II application must present a Commercialization Plan (maximum 15 pages) that addresses specific points as described in the SF424 (R&R) SBIR/STTR Application Guide and the SBIR/STTR Information component. In the Commercialization Plan, the applicants must briefly outline how they will manage intellectual property issues and acknowledge that a full Intellectual Property Management Plan will be submitted on just-in-time basis if their application is selected for funding (see guidelines below).
There is no further limitation on the total number of pages for the entire Phase II application; however, applicants are encouraged to be succinct.
Extensive studies designed to validate the approach would be expected. Goals and milestones for each year of support should be clearly presented. Support for years 2 and 3, if requested, is dependent upon Institute programmatic review of progress and achievement of the proposed milestones.
An applicant may not apply for Phase II without having successfully completed a Phase I SBIR project. Phase II applications must present detailed account in support of the feasibility of the technologies or approaches that are proposed for further development beyond the completion of Phase I studies. The applicants will also have the added burden of demonstrating the innovation of the particular technology or approach. Proof of feasibility of the investigation must be mainly based on the work performed as part of Phase I studies. Sufficient technical data must exist to support proof of principle of the technology/hypothesis.

SBIR Fast-Track applications:

Unlike in the past where Fast-Track applicants were required to submit two separate applications (one for Phase I and one for Phase II), the NIH Fast-Track application is now a single application consisting of Phase I and Phase II activities. See the SF424 (R&R) SBIR/STTR Application Guide.
The Phase I portion of a Fast-Track must specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II work.
The Fast-Track application must present a Commercialization Plan (maximum 15 pages) that addresses specific points as described in the SF424 (R&R) SBIR/STTR Application Guide.
Introduction (required for a resubmission application) is limited to three (3) pages.
Items 2-5 of the Research Plan may not exceed 25 pages. That is, the combined Phase I and Phase II plans for Fast-Track applications (for Items 2-5) must be contained within the 25-page limitation.
The Phase I portion of the Fast-Track application must contain well-defined quantitative milestones that will be used to judge the success of the proposed research project, as well as a credible plan for the pilot application of the proposed technology in Phase II. The Fast-Track must have a section labeled "Milestones" at the end of the Research Plan for Phase I R41/R43. In addition, as is required for all Phase II applications, the Phase II portion of a Fast-Track application must present a Commercialization Plan (maximum 15 pages) that addresses specific points. (See 5.7.1 Commercialization Plan in the SF424R&R application instructions). In the Commercialization Plan, the applicants must briefly outline how they will manage intellectual property issues and acknowledge that a full Intellectual Property Management Plan will be submitted on just-in-time basis if their application is selected for funding (see guidelines below).
Special provisions described in this FOA pertaining to Phase I and Phase II applications apply also to Fast-Track applications.

Guidelines for Planning Intellectual Property Management

Detailed Intellectual Property Management Plans are a just-in-time requirement and do not need to be included in the grant application, but the applicants must be aware of this requirement and their Commercialization Plans must be consistent with the Guidelines below.

Certain research plans will require collaboration and coordination between investigators at different institutions/organizations, some of whom may not be NIH funding recipients and who may have pre-existing intellectual property obligations to third parties. It is anticipated that commercial embodiments of the results of such research may incorporate single inventions shared by several institutions/organizations, or multiple inventions each from a separate institution/organization. Therefore, prior to funding, Phase II SBIR grant applicants must address how they will coordinate patent prosecution and licensing activities, if necessary, to enable a licensee to access the bundle of intellectual property needed to take a product to market on commercially viable terms. Suggested strategies include: (1) assigning intellectual property rights to related inventions to an invention management firm; (2) designating one organization to take the lead on patenting and licensing related inventions; and (3) agreeing in advance that if multiple parties are to independently license related inventions, the total of stacked royalties will not exceed a predetermined percentage rate.

The technology transfer/intellectual property management/licensing officer or equivalent of the PD/PI's institution/organization is to submit an intellectual property management plan. Alternatives to the suggested strategies, which accomplish the same goals, will be considered.

The PD/PI’s institution/organization should avoid exclusively licensing those inventions that are research tools unless either: (1) the field of use of the exclusive license is restricted to commercial use; or (2) the exclusive licensee will make the research tool available on reasonable terms. Applicants are directed to the NIH policy on the dissemination of biological research resources ( research tools ) at http://www.ott.nih.gov/policy/rt_guide_final.html.

Plan for Sharing Research Data

Applicants requesting $500,000 or more in direct costs in any year should include a brief one paragraph description of how final research data will be shared, or explain why data-sharing is not possible. The specific nature of the data to be collected will determine whether or not the final dataset may be shared. If the final data are not amenable to sharing, for example, if they are proprietary, this must be explained in the application. The Small Business Act requires the NIH to protect from disclosure and nongovernmental use all SBIR and STTR data developed from work performed under an SBIR and STTR funding agreement for a period of four (4) years after the closeout of either a Phase I or Phase II grant unless NIH obtains permission from the awardee to disclose these data. The data rights protection period lapses only upon expiration of the protection period applicable to the SBIR and STTR award, or by agreement between the small business concern and the NIH. Applicants are encouraged to discuss their data-sharing plan with the NIH Institute/Center staff likely to accept assignment of their application.

The reasonableness of the data sharing plan or the rationale for not sharing research data may 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. For more information on data sharing, see http://grants.nih.gov/grants/policy/data_sharing/ and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm. (See FAQ #13.)

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). 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 NCI program staff 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). 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 this funding opportunity will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score;
Receive a written critique; and
Receive a second level of review by the National Cancer Advisory Board.

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended SBIR applications. The following will be considered in making funding decisions:

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

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

Significance
Approach
Innovation
Investigator
Environment
Additional Review Criteria

The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score.

All SBIR Applications

Significance: Does the proposed project have commercial potential to lead to a marketable product, process, or service? Does this study address an important problem? What may be the anticipated commercial and societal benefits that may be derived from the proposed research? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, and/or preventative interventions that drive this field? Does the application lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are the milestones and evaluation procedures appropriate?

Innovation: Are the aims original and innovative? 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?

Investigator: Is the PD/PI appropriately trained and capable of coordinating and managing the proposed SBIR project? Are the investigators well suited to carry out this work? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Is the work proposed appropriate to the experience level of the PD/PI and other researchers, including consultants and subcontractors (if any)? Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed?

Environment: Is there sufficient access to resources (e.g., equipment, facilities)? Does the scientific and technological environment in which the work will be done 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?

Phase II Applications
In addition to the above review criteria:

1. How well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?

2. Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in the SF424 (R&R) SBIR/STTR Application Guide and the SBIR/STTR Information Component?

3. Does the project carry a high degree of commercial potential, as described in the Commercialization Plan?

Resubmission Applications (formerly amended applications)

In addition to the above criteria, the following criteria will be applied to resubmission applications.

1. Are the responses to comments from the previous scientific review group adequate?

2. Are the improvements in the resubmission application appropriate?

Phase I/Phase II Fast-Track Application Review Criteria

For Phase I/Phase II Fast Track applications, the following criteria also will be applied:

1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II?

2. Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in the SF424 (R&R) SBIR/STTR Application Guide and the SBIR/STTR Information Component?

3. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/ STTR funding sources that would enhance the likelihood for commercialization?

4. Does the project carry a high degree of commercial potential, as described in the Commercialization Plan?

Phase I and Phase II Fast-Track applications that satisfy all of the review criteria will receive a single rating.

For Fast-Track applications, the Phase II portion may not be funded until a Phase I final report and other documents necessary for continuation have been received and assessed by program staff that the Phase I milestones have been successfully achieved. Items 2-5 of the Research Plan may not exceed 25 pages. That is, the combined Phase I and Phase II plans for a Fast-track application (for items 2-5) must be contained within the 25-page limitation.

2.A. Additional Review Criteria

In addition to the above general criteria, the following items will be considered in the determination of scientific merit and the priority score:

A Phase I or Phase I/Phase II FastTrack application lacking quantitative milestones as determined by the NCI program staff will be returned to the applicant without review.

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, 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 effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

2.C. Sharing Research Data

The reasonableness of the data sharing plan or the rationale for not sharing research data may 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. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm See FAQs #13.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

NCI program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by NCI program staff when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

3. Anticipated Announcement and Award Dates
Not Applicable

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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 is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Section IV.5., Funding Restrictions.

2. Administrative and National Policy Requirements

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.

3. Reporting

Awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, financial or grants management issues:

1. Scientific/Research Contact:

2. Peer Review Contact:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular delivery)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

3. Financial or Grants Management Contact:

Ted Williams
Office of Grants Administration
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8785
Fax: (301) 496-8601
E-mail: williate@mail.nih.gov.

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with 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.

Human Subjects Protection:
Federal regulations (45CFR46) 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).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.

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NIH Funding Opportunities and Notices