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)
National Human Genome Research Institute (NHGRI), (http://www.nhgri.nih.gov)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov) 

Title: Development of Advanced Genomic Characterization Technologies (SBIR [R43/R44])

Announcement Type
New

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

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 SF 424 (R&R) SBIR/STTR Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA 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 should be started at least two weeks in advance of the planned submission. See Section IV.

Request For Applications (RFA) Number: RFA-CA-07-029

Catalog of Federal Domestic Assistance Number(s)
93.392, 93.393, 93.394, 93.395, 93.396

Key Dates
Release/Posted Date: June 14, 2006
Opening Date: July 16, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): July 24, 2006
NOTE:On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): August 24, 2006
AIDS Application Submission/Receipt Date(s):Not Applicable
Peer Review Date(s): November-December, 2006
Council Review Date(s): February 2007
Earliest Anticipated Start Date(s): March 2007
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: August 25, 2006


Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

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 or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
 1. Request Application Information
 2. Content and Form of Application Submission
 3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
     1. Letter of Intent
    B. Submitting an Application Electronically 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
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
 3. Anticipated Announcement and Award Dates

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


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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


SectionI. Funding Opportunity Description


1. Research Objectives

Purpose.This funding opportunity is part of The Cancer Genome Atlas (TCGA, http://cancergenome.nih.gov/) Pilot Project recently announced by the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI) to accelerate the understanding of genomic alterations associated with the initiation and pathological progression of human cancers.  The Cancer Genome Atlas Pilot Project will explore the feasibility and benefits of a systematic effort to rigorously and comprehensively characterize molecular alterations of specific tumor types and sub-types.  In keeping with the strategic goals of TCGA initiative, the NCI and the NHGRI solicit applications for research projects proposing the development of highly innovative genomic analysis technologies for the characterization of cancer biospecimens and control tissue.  For the purposes of this FOA, the term “technology” encompasses methods and tools that enable research including, but not limited to techniques and instrumentation and/or devices.  “Genomic characterization technologies” refer to the examination of the complete transcriptome, genome and epigenome of a cell.  In particular, technologies solicited include those that are suitable for the detection of those alterations in the transcriptome, genome, or epigenome which may play a role in cancer.  Technology is distinct from databases, reagents, and tissue repositories.  Applications for the support of such resources will not be considered responsive to this FOA.

This FOA is designed both to support the development of new technologies and to demonstrate that such technologies are robust and capable of yielding reproducible measurements of cancer-associated features in the cancer genome, epigenome, and/or transcriptome with greater sensitivity and accuracy.  Significant improvement of current whole-genome, low-throughput, and low-sensitivity technologies will be also considered under this FOA.  To be considered responsive to this FOA, research plans must focus on technologies that are applicable to small samples (consisting of 1000 or fewer cells) and from samples that are flash frozen, embedded and frozen in a cryopreservation medium, such as optimal cutting temperature (OCT) compoundor paraffin embedded. 

Background.  Cancer is a complex and heterogeneous disease whose initiation and pathological progression are influenced by a variety of molecular changes (e.g. chemical alterations to nucleic acids, proteins, and other molecules).  The complete characterization of the genomic changes that distinguish any particular cancer type may therefore help to predict its pathologic behavior as well as its anticipated responsiveness to particular modes of treatment.  Such knowledge will offer the potential for a better understanding of cancer biology and aid in the accelerated discovery of new tools and biomarkers for detection, diagnosis, treatment, and prevention.  This knowledge may also lead to new targets for therapeutic development or intervention and a refined clinical understanding of patient stratification in cancer therapy.  Thus, the development of innovative or emerging technologies for molecular feature detection and characterization is crucial to the development of new directions and paradigms in cancer research.

Among the molecular alterations that occur in the pathogenesis of cancer are an increasing number of somatic mutations.  Inherited genetic variants can also contribute to cancer susceptibility.  These cancer-associated mutations provide important insights into the molecular processes underlying the development and progression of certain tumors.  Moreover, encouraging clinical results with drugs designed to directly target protein products of cancer-associated and altered genes have provided proof-of-principle that these alterations identify viable targets for drug therapy.  Given the complexity and heterogeneity of cancer, it is generally believed that only a fraction of the alterations that may be useful as characteristic markers of specific tumor types and/or potential molecular targets have been identified to date.  Consequently, one of the major hurdles in conducting a comprehensive genomic analysis of cancer will be to overcome the limitations of current technologies in analysis of complex and the heterogeneous tumor specimens as well as the various types and subtypes of cancer.  Examples of limitation include, but are not exclusive to the imprecise identification of all transcripts and variants in cancer cells, the imprecise determination of boundaries of amplified or deleted regions, etc.  Such limitations must be overcome if the identification ofall genomic alterations that contribute to cancer pathology or susceptibility is to be successful.

In 2005, the NCI and the NHGRI initiated a joint effort to pursue a 3-year pilot project to determine the feasibility of identifying and cataloging the genomic alterations associated with a small number of human cancers.  The pilot project is focused on 2-3 tumor types (at least two) to assess the technical feasibility and clinical relevance of conducting a comprehensive analysis of cancer-associated genomic alterations.  The pilot project is designed to: 1) verify whether genes or genomic regions contributing to cancer pathology or susceptibility can be identified by combining information from diverse approaches to genome analyses, and 2) whether the sequencing of selected genomic regions can be efficiently and cost-effectively achieved.  The genomic data generated by this pilot project, combined with the clinical information about the cancer samples, will provide the initial contribution to a comprehensive Web-based resource that describes the genomic “fingerprints” associated with specific cancer types.  This resource will be known as The Cancer Genome Atlas (http://cancergenome.nih.gov/).

Efforts associated with the Human Genome Project have spurred the development of technologies to rapidly sequence and interrogate the genome.  While high-throughput, cost-effective technologies to survey specific alterations in the genome exist, further improvements in genomic coverage, resolution, and sensitivity are needed.  Thus, the aim of this FOA is to stimulate the development of genomic technologies that exceed limitations imposed by current platforms.  As part of this process, a novel technology should be developed and refined to a point that it is capable of supporting large-scale, production phase analysis of clinical biospecimens.

Objectives and Scope.This funding opportunity is designed to support innovative technology platform development in support of the identification and measurement of cancer-associated alterations within the human genome, epigenome, and/or transcriptome.  New tools are needed for genome-wide analyses of molecular profiles of normal, pre-cancerous, and cancerous cells.  In particular, tools are sought that maximize resolution, throughput, and sensitivity.  Projects proposed for this FOA should be designed to identify and overcome the critical limitations of current technologies in the analysis of clinical biospecimens and the detection of specific cancer-associated features of interest.  The limitations of the current technologies arise due to the cellular heterogeneity of cancer tissue as well as the multiclonal origin of the subset of cells within the tumor.  This funding opportunity will not support research addressing mechanistic studies on genes, other regions of the genome or transcriptome, proteins or peptides, clinical correlative studies of biomarkers, or hypothesis-driven studies primarily oriented on the understanding of the roles of specific genes or gene products in cancer.

The applicants for this funding opportunity should initially plan to procure appropriate specimens for their early technology development studies, including cell lines and cancer tissues from human and/or mouse models of cancer.  At an appropriate time in the technology development process, benchmarking will be necessary.  The NCI/NHGRI have developed a set of standard biological samples/cell lines that are suitable for use in benchmarking.  Applicants should include a description of plans for performing appropriate benchmarking at an appropriate time in the development of their technology.  It will be crucial that technology platforms supported by this initiative achieve the level of performance required for the characterization of cancer samples that are complex mixtures of different cell types and even subclones of cancer cells.  Each applicant is required to submit a plan for the incorporation and application of the technology platform to the analysis of human cancer biospecimens in future years, including specific advantages to be achieved in comparison to current methods.

The purpose of this FOA is to stimulate the development of novel or profoundly improved analysis technology platformsthat would be suitable for large sample sets.  Potential applicants should consider innovations in technology platforms aimed at any of the following improvements:

Examples given below are only illustrative of the types of capabilities that are of interest for the large-scale characterization of the cancer genome, epigenome, and/or transcriptome.  This list is not intended to be all-inclusive:

This FOA will NOT support the following areas:

For the technologies proposed to be developed and/or improved, it will be important to substantiate the ultimate value and role of the technology in the analysis of clinical biospecimens and explain how this technology would support the achievement of the goals of The Cancer Genome Atlas in the future.  It is also important for applicants to discuss both the ultimate applicability of the technology as well as its dissemination to other laboratories.

The "process" of technology development can be considered to span a spectrum of stages.  Initially, it involves the development of an entirely new methodology (or the significant improvement of an existing methodology) to the point of proof of principle.  The method must then be reduced to practice.  For such a new method to have a significant impact for genomic studies in cancer, it also must be shown that it can be used efficiently and cost-effectively on a large-scale or genomic basis, which may require a further round of technology development.  This FOA solicits applications that address any of these phases of technology development, with an emphasis on the development of completely novel techniques for identifying somatic alterations to genomic DNAs in cancer.  Incremental improvement of existing methods will be considered, but such proposals should provide detailed descriptions, including explicit quantitative measures, of anticipated advances.

An important feature of any newly developed technology is the ease with which it can be disseminated to other laboratories and investigators.  Therefore, the issue of access to the inventions, or technology transfer, should be described in the grant application.

To encourage the consideration of novel approaches, applicants responding to this FOA are not required to have preliminary data (unless they propose Phase II projects).  However, the research project must be scientifically and technically sound and alternative solutions must be proposed for high risk steps in the research plan.  If no preliminary data are available, applicants are encouraged to present any other relevant information in support of the project. Phase II projects must have proper evidence of feasibility.

Collaboration with Other Organizations.Collaborations between private sector for-profit organizations and not-for-profit and academic institutions have the potential to further the goals of this FOA.  Alternatively, for-profit entities may engage into sub-contract relationships with other institutions submitting applications

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the Small Business Innovation Research (SBIR [R43/R44]) grant mechanisms. Applications may be submitted for support as Phase I, Phase II, or Fast-Track grants as described in the SF424 (R&R) SBIR/STTR Application Guide.

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

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.

2. Funds Available

The SF424 (R&R) SBIR/STTR Application Guideindicates 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 2 years may be requested for Phase II. Total costs include direct costs, Facilities & Administrative (F&A)/indirect costs, and fee.

NCI and NHGRI intend to commit approximately $2,000,000 in FY 2007 to fund up to 10 Phase I and/or Phase II applications under the SBIR set-aside funding mechanism. In addition to NIH and NHGRI, also National Institute of Environmental Health Sciences (NIEHS) will participate in this RFA. Although NIEHS does not commit any specific set-aside funds to this RFA, applications arising from this solicitation that address topics of interest to NIEHS may be considered for funding along with other unsolicited SBIR applications assigned to NIEHS.

Although the financial plans of the participating organizations 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 Title 13 Code of Federal Regulations (CFR) Part 121.103. The term "number of employees" is defined in 13 CFR 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 (SBA) 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 support.

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 CFR 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 another HHS FOA, including the current SBIR or STTR Parent FOAs.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR 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:

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

Several additional separate actions are required before an applicant SBC can submit an electronic application as follows: 

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

2) Organizational/Institutional Registration in the eRA Commons

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

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 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 301-435-0714, 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 the 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 “Frequently Asked Questions – Application Guide, 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 Attachment(s) Form

3. Submission Dates and Times

See Section IV.3.A. for details.

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

Opening Date: July 16, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): July 24, 2006
Application Submission Date(s): August 24, 2006
Peer Review Date(s): November-December, 2006
Council Review Date(s): February 2007
Earliest Anticipated Start Date(s): March 2007

3.A.1. Letter of Intent
 
Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC 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 either one of the program directors listed below:

Daniela S. Gerhard, Ph.D.

Director
Office of Cancer Genomics
Office of the Director
National Cancer Institute
Building 31, Room 10A07, MSC 2580
31 Center Drive
Bethesda, MD 20892-2580
Telephone:  (301) 451-8027
Fax:  (301) 480-4368
Email: gerhardd@mail.nih.gov

Or

Bradley A. Ozenberger, Ph.D.
Program Director, Technology Development
National Human Genome Research Institute
National Institutes of Health
Suite 4076-MSC 9305
5635 Fishers Lane
Bethesda, MD 20892-9305
Telephone: (301) 496-7531
Fax: (301) 480-2770
Email: bozenberger@mail.nih.gov

3.B. Submitting an Application Electronically 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 on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

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

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.

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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an “Introduction” describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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

5. Funding Restrictions

Capital equipment, defined as equipment whose unit costs exceed $50,000, is not allowed.  To justify any capital equipment requests; applicants must provide compelling evidence (e.g., preliminary data) that the equipment is needed.

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

Collaboration with Other Organizations. Applicants should briefly describe existing as well as planned partnerships with other organizations or state “Not Applicable” if there are no such collaborations.  Such collaborations may involve academic and non-profit domestic organizations as well as for-profit organizations.  The role of such partners should be clearly delineated, reiterating the adherence to the policies of data sharing and resource sharing.  Letters of collaboration from all collaborators and consultants should succinctly indicate institutional commitment to the program and their expertise and respective roles.  

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

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.

SBIR Phase I applications:

SBIR Phase II applications:

SBIR Fast-Track applications:

Examples of Milestones [pertinent to SBIR Phase I (R43) applications and Fast-Track (R43/R44) applications].

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.  Milestones must summarize the concrete parameters that the applicant expects to accomplish in a verifiable way and in the prescribed time frame, not general long-term potential capabilities of the technology.  Specific aims, as such, may not be regarded as milestones (unless they include appropriate quantitative end points).  In general, it is expected that the applicants provide milestones for each specific aim.  Below are examples of formats to define quantitative milestones:

 Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these 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.

Appendix Materials. The following materials may be included in the Appendix:

Up to fivepublications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project.  Do not include manuscripts submitted for publication. 

Plan for Sharing Research Data

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The 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 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 NIH. Applicants are encouraged to discuss their data-sharing plan with the Institute/Center (IC) 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 (NIH Grants Policy Statementhttp://grants.nih.gov/grants/policy/nihgps_2003/index.htm and 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 Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), 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:

The following will be considered in making funding decisions:

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.

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 as described in the FOA?  If the aims of the application are achieved, how will it improve accuracy, speed, sensitivity and costs of genomic analyses?  How will all of this be achieved using starting biomolecules from about 1000 cells?  What may be the anticipated commercial and societal benefits that may be derived from the proposed research?  What will be the effect of these studies on the concepts, methods, technologies, treatments, services, 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?  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 I Applications

In addition to the above review criteria:

1. Milestones: Are the appropriate quantitative milestones specified?  Are these milestones realistic? Will these milestones be sufficient to judge the success of the proposed research?

Phase II Applications

In addition to the above review criteria:

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

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. Milestones. Does the Phase I part of the application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II? Are these milestones realistic? Will these milestones be sufficient to judge the success of the proposed research?

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

3. Commercialization-related commitments. 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?

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 criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

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

Milestones: All Phase I and Phase I/Phase II Fast-Track applications in response to this FOA must have quantitative milestones. A Phase I or Phase I/Phase II Fast-Track application lacking quantitative milestones as determined by the NCI program staff will be returned to the applicant without review.

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers.  Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed?  Is each budget category realistic and justified in terms of the aims and methods?

Adequacy of data sharing plan (see below).

 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 FAQ #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://www.ott.nih.gov/policy/rt_guide_final.html). 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.

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 Program staff of the funding organization 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 also 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

When multiple years are involved, 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, and financial or grants management issues:

1. Scientific/Research Contacts:

Daniela S. Gerhard, Ph.D.
Director
Office of Cancer Genomics
Office of the Director
National Cancer Institute
Building 31, Room 10A07, MSC 2580
31 Center Drive
Bethesda, MD 20892-2580
Telephone:  (301) 451-8027
Fax:  (301) 480-4368
Email: gerhardd@mail.nih.gov

Or

Bradley A. Ozenberger, Ph.D.
Program Director, Technology Development
National Human Genome Research Institute
National Institutes of Health
Suite 4076-MSC 9305
5635 Fishers Lane
Bethesda, MD 20892-9305
Telephone: (301) 496-7531
Fax: (301) 480-2770
Email: bozenberger@mail.nih.gov

Or

Jerrold Heindel, Ph.D.
National Institute of Environmental Health Sciences
Division of Extramural Research and Training
POB 12233 (U.S. Postal Service Express or regular mail)
4401 Bldg, 3rd Floor (for express/courier service; non-USPS service)
79 T.W. Alexander Drive
Research Triangle Park, NC, 27709
Telephone: (919) 541-0781
Fax: (919)541-5064
Email: heindelj@niehs.nih.gov

2. Peer Review Contacts:

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 Contacts:

For awards to be administered by NCI:

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.

For awards to be administered by NHGRI:

Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute
Suite 4076 – MSC 9306
5635 Fishers Lane
Bethesda, MD  20892-9306
Telephone: (301) 435-7858
Fax: (301) 402-1951
Email: chickc@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 (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

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 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 the 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); 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 (http://publicaccess.nih.gov/publicaccess_manual.htm).

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 FOA 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 at http://www.cfda.gov/ 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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