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 (http://www.nci.nih.gov)
Title: Exfoliated Cells and Circulating DNA in Cancer Detection and Diagnosis (SBIR [R43/R44])
Announcement Type
This
funding opportunity announcement (FOA) is a reissue of RFA-CA-06-001,
which was previously released June 9, 2004, and now is divided into separate
FOAs for SBIR and STTR funding mechanisms.
NOTICE: Applications submitted in response to this 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 applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Request For
Applications (RFA) Number: RFA-CA-07-027
Catalog of Federal Domestic Assistance Number(s)
93.393, 93.394
Key Dates
Release/Posted
Date: July 28, 2006
Opening
Date: July 28, 2006 (Earliest date an application may be submitted to
Grants.gov).
Letters of Intent Receipt Date(s):
August 26, 2006; December 29, 2006; April 23, 2007
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): September 26, 2006; January 29, 2007;
May 23, 2007
Peer Review Date(s): February/March 2007; June/July 2007;
September/October, 2007
Council Review Date(s): May/June 2007; September/October 2007;
February/March 2008
Earliest Anticipated Start Date(s): July 2007; September 2007; April 2008
Additional Information To Be Available Date (URL Activation Date): Not
Applicable
Expiration Date: May 24, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
The NCI solicits grant applications aimed at the development of novel technologies for capturing, enriching, and preserving exfoliated abnormal cells from body fluids or effusions as well as methods for concentrating the tumor-derived sub-cellular material for use in biomarker studies. In body fluids, such as sputum, exfoliated tumor cells are a minor component compared to normal cells. As a result, the detection of exfoliated abnormal cells by routine cytopathology is often limited by the small number of atypical cells present in a given specimen. New enrichment methods are necessary to facilitate the detection of small numbers of exfoliated tumor cells and tumor-derived sub-cellular materials in biological fluids.
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
The purpose of this Funding Opportunity Announcement (FOA) is to develop novel technologies for capturing, enriching, and preserving exfoliated abnormal tumor cells and macromolecules in body fluids or effusions and to develop methods for concentrating the content of such specimens that originated from tumor or a pre-neoplastic lesion for biomarker studies. In the context of this FOA, the term exfoliation denotes not only the whole tumor cells, but also cellular materials, such as DNA and proteins.
In body fluids, such as sputum, the number of exfoliated tumor cells is often small compared to the number of non-neoplastic cells. Because few atypical cells may be present in the specimen, the detection of exfoliated abnormal cells by routine cytopathology is often limited. Another difficulty pertains to separating dysplastic cells from non-specific and degenerating cells. Furthermore, exfoliated tumor cells and their sub-cellular components are accompanied by normal cells, bacteria, cellular debris, and other interfering matter which make molecular analysis difficult without physical separation of the neoplastic cells. Thus, the development of efficient enrichment methods is necessary to enable the routine detection of small numbers of exfoliated cells and small amounts of cellular materials in biological fluids for molecular analysis.
Enriched abnormal exfoliated cells and biomolecules will enable genomic, proteomic, and epigenomic analyses to detect cancer-specific alterations in expressed genes, protein/peptide profiles, and epigenetic markers. The ability to carry out such enrichment and analyses in a routine way using body fluids may lead to improvements in cancer detection. For example, analysis of tumor markers enriched from urine specimens may facilitate the detection of bladder cancer.
The long-term goal of this initiative is to facilitate the development of panels of well-characterized biomarkers derived from exfoliated cells that can be sampled in the clinical setting. These methodologies will be tested and validated in future population-based clinical trials, and integrated into a comprehensive information system that will be developed under the Early Detection Research Network (EDRN).
NOTE ON SELECTION OF MOST APPROPRIATE FOA:
In addition to this FOA, the Circulating Cells and DNA in Cancer Detection initiative comprises two other FOAs of identical scientific scope. SBC applicants planning projects that have potential for commercializable products or services are also encouraged to consider a parallel FOA that solicit applications under the STTR mechanism (RFA-CA-07-028). Another FOA of a similar scientific scope (PA-06-499) using the NIH R21 funding mechanism will be appropriate for exploratory projects not involving SBC and with no immediate commercialization plans.
Please refer to the NIH Guide Notice NOT-CA-06-034 (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-06-034.html) for the cross-comparison and the outline of the characteristics and requirements for all three partner FOAs.
Background
More than 80 percent of human tumors originate from epithelial cells, often at a mucosal surface, and are clonal in origin (e.g., colon, lung, prostate, oral cavity, esophagus, stomach, uterine cervix, bladder). Their development often becomes apparent when tumor cells exfoliate spontaneously into sputum, urine, or even into various effusions. The molecular and genetic abnormalities within these exfoliated cells could be used to detect and identify precancerous lesions or very early stage cancer if highly sensitive technologies were clinically available to identify the few abnormal cells among millions of normal cells. Polymerase chain reaction (PCR)-allows for the analysis of DNA from rare neoplastic cells in body fluids. For example, detection of widespread microsatellite instability (MSI), monitored as expansion or elimination of marker elements of repetitive DNA may be applicable to exfoliated cells from a variety of tumors. Mutations in cancer relevant genes have been detected using the stools of patients with colorectal cancer (ras), in the urine of patients with bladder cancer (p53), and in the sputum of patients with lung cancer (p53). As these assays are complex and technically challenging, they depend on the development of novel technologies for isolating and enriching cells or subcellular materials/biomolecules of interest.
Abnormal exfoliated cells can be routinely identified by cytological examination of brushings and fluids, for instance, from bronchi, pancreatic ducts, voided urine, and effusions. Currently, fluids are usually processed by centrifugation or membrane filtration. However, the ability to detect abnormal exfoliated cells, including cancer cells, by routine cytopathological examination is limited by the very small number of abnormal cells compared to the number of normal cells. In addition, differences between abnormal and normal cells in terms of cellular and nuclear morphology may be minimal. This situation is common of cytological examinations of urine cytology, in which many low-grade papillary lesions are often missed. New PCR-based methods may substantially enhance detection sensitivity, but current technologies for isolating exfoliated cells and their components tend to be too cumbersome and/or specialized for routine use in the clinic.
The cellular and molecular changes that eventually lead to tumor emergence may be progressing over a number of years in an apparently random manner. The progressive accumulation of genetic and epigenetic aberrations gives rise to precancerous cell populations and, finally, to the clonal selection of subpopulations with the malignant phenotype. The progression of preneoplastic changes to cancer often requires extended time. For example, it takes on average 15 to 20 years for a small adenomatous polyp to become malignant. Nevertheless, prior to the appearance of a morphologically identifiable precancerous or cancerous lesion, numerous genetic and molecular alterations would have already occurred. The stochastic nature of molecular events in different cells confers genetic heterogeneity. The resulting abnormalities increase the chances for the selection of aggressive phenotypes but also offer a window of opportunity to detect precancerous and/or early malignant cells based on aberrant status of specific genetic and/or molecular biomarkers associated with the progression of the neoplastic process.
Identification of the neoplastic lesions before they reach advanced stages should increase the chances for a complete eradication of these lesions by allowing an earlier therapeutic intervention . This principle has been well-demonstrated in cervical neoplasia, in which early detection of dysplastic exfoliated cells can result in a 70 percent or greater reduction in the cervical cancer mortality. For this reason, intensive efforts focus on the identification and characterization of molecular and genetic biomarkers of future malignancy. The small size of precancerous lesions and their cellular and genetic heterogeneity, however, pose significant methodological challenges in the early detection of such abnormalities.
Most importantly, cancer screening assays using biological fluids must be able to detect a small number of abnormal cells/biomolecules among a large number of their normal counterparts. Approaches to detect and analyze precancerous and cancerous cells and their aberrant component in biologic fluids, depend upon: (i) the type of biological fluid (e.g., sputum, bronchial washing cervical brushing, voided urine, etc.); and (ii) the form of analysis to be performed (e.g., cytopathological analysis, morphometric analysis, molecular biomarkers for specific receptors or genetic changes, fluorescence in situ hybridization [FISH]- or PCR-based analyses). All of these approaches require an enrichment of atypical epithelial cells or their respective biomolecules. The cell enrichment methods currently used rely primarily on various centrifugation techniques (e.g., cytospin, density gradient cell fractionation) and/or on antibody-based selection combined with mechanical separation (flow-assisted cell sorting [FACS], magnetic-assisted cell sorting [MACS], etc.). One type of enrichment operation can be sequentially added to another to improve the yield and degree of enrichment. Nonetheless, one needs enrichment factors of 1 to 10,000 or 1 to million to ensure adequate sensitivity and/or specificity required for detecting precancerous cells in body fluids.
Analogous enrichment must be accomplished if abnormal biomolecules derived from preneoplastic and neoplastic cells are to be analyzed. Quite often, stored plasma or serum samples are the only patient biospecimens that are available for analysis. Whereas such samples from normal/healthy individuals typically contain only very small amounts of DNA, increased amounts of extracellular DNA have been found in plasma or serum samples from cancer patients. This circulating DNA appears to correspond to chromatin fragments released into plasma from dying tumor cells. Circulating DNA has been shown to reflect the characteristics of the tumor DNA, including molecular changes, such as methylation, point mutations, and microsatellite instability. Hence, circulating DNA offers a valuable source of biomarkers that can be used for early detection of cancer and during the follow-up of the disease. To utilize this potential, however, technologies need to be developed that would be capable of isolating circulating DNA from typical biospecimens in quantities sufficient for the analysis of biomarkers.
Goals and Scope
The primary purpose of this initiative is to encourage the development of high-throughput technologies to facilitate the isolation and enrichment of exfoliated cells and subcellular materials. In pursuit of these goals, the NCI solicits SBIR applications that are focused on at least one of the following areas:
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 Department of Health and Human Services (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.
This funding opportunity uses Just-in-Time
information 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 Guide indicates the statutory guidelines of funding support
and project duration periods for Phase I and Phase II SBIR awards. For this
funding opportunity, budgets up to $100,000 in total
costs per year and time periods up to one year for Phase I may be requested. Budgets up to $ 600,000 total costs per year and up to 4 years may be
requested for Phase II. Total costs include direct costs, Facilities &
Administrative (F&A)/indirect costs, and fee.
The NCI intends to
commit approximately $1,000,000 in FY 2007 to fund up to 3-5 awards under the SBIR set-aside funding mechanism. Although the financial plans of NCI
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 Title 13 Code of Federal Regulations (CFR) 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, 13C.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 his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
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 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 eRA 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: 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
28, 2006 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s):
August 26, 2006; December 29, 2006; April 23, 2007
Application Submission/Receipt Date(s): September 26, 2006; January 29,
2007; May 23, 2007
Peer Review Date(s): February/March 2007; June/July 2007;
September/October, 2007
Council Review Date(s): May/June 2007; September/October 2007;
February/March 2008
Earliest Anticipated Start Date(s): July 2007; September 2007; April 2008
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 NCI
staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of
intent should be sent to:
Dr.
Padma Maruvada
Division of Cancer Prevention
National Cancer Institute
6130 Executive Plaza North #3144
Executive Blvd
Bethesda, MD 20892
Telephone: (301) 496-3893
Fax: (301) 402-8990
Email: maruvadp@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
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
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:
Guidelines for 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 a specific 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.
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 component needs to eventually be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits.
Plan for Sharing
Research Data
Applicants requesting $500,000 or more in direct
costs in any year should include a brief one paragraph description of how final
research data will be shared, or explain why data-sharing is not possible. The
specific nature of the data to be collected will determine whether or not the
final dataset may be shared. If the final data are not amenable to sharing, for
example, if they are proprietary, this must be explained in the application.
The Small Business Act requires 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.
Appendix Materials
The following materials may be included in the Appendix:
Phase I applications: 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.
Phase II and Fast-Track applications: Up to ten publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication.
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 National
Cancer Institute in accordance with the review criteria stated below.
As part of the
initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended SBIR applications. The following will be considered in making funding decisions:
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? What may be the anticipated commercial
and societal benefits that may be derived from the proposed research? If the
aims of the application are achieved, how will scientific knowledge or clinical
practice be advanced? What will be the effect of these studies on the concepts,
methods, technologies, treatments, services, 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?
In
addition to the above criteria, the following criteria will be applied:
Resubmission Applications (formerly amended applications)
In addition to the above criteria, the following criteria will be applied to resubmission applications.
1. Are the responses to comments from the previous scientific review group adequate?
2.
Are the improvements in the resubmission application appropriate?
Phase
I Applications
In addition to the above review criteria, the following criteria will be applied to Phase I applications:
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, the following criteria will be applied to Phase II applications:
1.
How well did the applicant demonstrate progress toward meeting the Phase I
objectives, demonstrating feasibility, and providing a solid foundation for the
proposed Phase II activity?
2. Did the applicant
submit a concise Commercialization Plan that adequately addresses the specific
areas described in the SF424 (R&R) SBIR/STTR Application Guide and the
SBIR/STTR Information component?
3. Does the project
carry a high degree of commercial potential, as described in the
Commercialization Plan?
Phase
I/Phase II Fast-Track Application Review Criteria
For
Phase I/Phase II Fast Track applications, the following criteria also will be
applied:
1. Does the Phase
I application specify clear, appropriate, measurable goals (milestones) that
should be achieved prior to initiating Phase II?
2. Did the
applicant submit a concise Commercialization Plan that adequately addresses the
specific areas described in the SF424 (R&R) SBIR/STTR Application Guide and
the SBIR/STTR Information component?
3. To
what extent was the applicant able to obtain letters of interest, additional
funding commitments, and/or resources from the private sector or non-SBIR/STTR
funding sources that would enhance the likelihood for commercialization?
4.. Does the project carry a high
degree of commercial potential, as described in the Commercialization Plan?
Phase
I and Phase II Fast-Track applications that satisfy all of the review criteria
will receive a single rating.
For
Fast-Track applications, the Phase II portion may not be funded until a Phase I
final report and other documents necessary for continuation have been received
and assessed by program staff that the Phase I milestones have been
successfully achieved. Items 2-5 of the Research Plan may not exceed 25 pages.
That is, the combined Phase I and Phase II plans for a Fast-Track application
(for Items 2-5) must be contained within the 25-page limitation.
2.A.
Additional Review Criteria
In addition to the above 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: The reasonableness
of the proposed budget and the requested period of support in relation to the
proposed research may be assessed by the reviewers. Is the effort listed for
the PD/PI appropriate for the work proposed? Is each budget category realistic
and justified in terms of the aims and methods?
Period of Support: The appropriateness of the
requested period of support in relation to the proposed research.
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:
Dr. Padma Maruvada
Division of Cancer
Prevention
National Cancer Institute
6130 Executive Plaza North
#3144
Executive Blvd
Bethesda, MD 20892
Telephone: (301) 496-3893
Fax: (301) 402-8990
Email: maruvadp@mail.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 mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov
3. Financial or Grants
Management Contacts:
Ted Williams
Office of Grants Administration
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8785
Fax: (301) 496-8601
E-mail: williate@mail.nih.gov.
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (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. For publications listed in the
appendix and/or Progress report, internet addresses (URLs) must be used
for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet
addresses (URLs) should not be used to provide any other information necessary for 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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