and Human Services (HHS)
EXPIRED
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
(STTR [R41/R42])
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-07-030
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: June 24,
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
Section I. 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) compound or 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 of all 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 intended to stimulate the development of novel or profoundly improved analysis technology platforms that 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
Technology Transfer (STTR [R41/R42]) 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 STTR 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 STTR 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 STTR submission dates of April 1, August 1, and December 1
(or January 2, May 1, and September 1 for NIH AIDS and AIDS-related STTR
applications).
This funding opportunity uses
just-in-time concepts. The modular budget format is no longer accepted for STTR
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 Guide indicates the statutory guidelines of funding support and project duration periods for Phase I and Phase II STTR
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 $1,000,000 in FY 2007 to fund up to five
Phase I and/or Phase II applications under the STTR 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 STTR 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 STTR applications. A small business concern is one that, at
the time of award for both Phase I and Phase II STTR 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 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 STTR awardee organization must be space that is available to and under the control of the STTR 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 STTR 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 STTR 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 STTR 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.
For a STTR application, the Project Director/Principal
Investigator (PD/PI) may be employed with the SBC or the participating
non-profit research institution as long as s/he has a formal appointment with
or commitment to the applicant SBC, which is characterized by an official
relationship between the SBC and that individual.
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.
The PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration. In all cases, however, the PD/PI’s official relationship with the grantee must entail sufficient opportunity for the PD/PI to carry out his or her responsibilities for the overall scientific and technical direction of the project. Documentation (e.g., consultant, consortium and contractual arrangements) describing the official relationship of the PD/PI with the applicant small business concern should NOT be submitted with the grant application, but a copy must be furnished upon the request of the NIH awarding component.
The following are examples of situations describing the official relationship of the PD/PI with the applicant small business organization:
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
In STTR Phase I and Phase II, at least 40% of the work
must be performed by the small business concern and at least 30% of the work
must be performed by the single, partnering research institution. The basis
for determining the percentage of work to be performed by each of the
cooperative parties will be the total of direct and F&A/indirect costs
attributable to each party, unless otherwise described and justified in Item
12, Consortium/Contractual Arrangements, of the PHS398 Research Plan
component of the SF424 (R&R) application forms.
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
301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Prepare all STTR 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
Research & Related Subaward
Budget Attachment(s) Form
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
SBIR/STTR Information
Optional Components:
PHS398 Cover Letter File
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/Receipt 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: [email protected]
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: [email protected]
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.
STTR Phase I applications:
STTR Phase II applications:
STTR Fast-Track applications:
Examples of Milestones [pertinent to STTR Phase I (R41) applications and Fast-Track (R41/R42) 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 five publications, 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 Statement http://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 STTR 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 STTR? 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.
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: [email protected]
And/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: [email protected]
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:
[email protected]
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: [email protected]
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: [email protected].
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:
[email protected]
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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