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)
Title: Application of Emerging Technology For Cancer
Research (SBIR [R43/R44])
Announcement Type
This
is a reissue of RFA-CA-07-008 (SBIR/STTR) that expired September 26, 2006.
Update: The following update relating to this announcement has been issued on March 8, 2007 (see Notice NOT-CA-07-011): This Notice announces the change, effective immediately, in the scientific contact person for this Request for Application (RFA) and for 11 other related RFAs under Innovative Technologies for Molecular Analysis of Cancer (IMAT) Program.
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 SF424 (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-07-041
Catalog of Federal Domestic Assistance Number(s)
93.392,
93.393, 93.394, 93.395, 93.396
Key Dates
Release/Posted Date: January 4,
2007
Opening Date: January 5, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters
of Intent Receipt Date(s): January 27, 2007; April 29, 2007; August 27, 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 Dates(s): February 28, 2007; May 30, 2007; September 28, 2007.
Peer Review Date(s): May/June 2007,
September/October 2007, January/February 2008.
Council Review Date(s): October 2007,
February 2008, June 2008.
Earliest Anticipated Start Date(s): September 2007, April 2008, July 2008.
Additional
Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: September 29, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
This
Funding Opportunity Announcement (FOA) solicits Small Business Innovation
Research (SBIR) grant applications from small business concerns (SBCs) for
research projects proposing the initial application of emerging molecular
biology technologies to clinical or laboratory cancer research. Technology
encompasses methods and tools that enable research, including but not limited
to, instrumentation, techniques, and devices.
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) issued by the National Cancer Institute (NCI) is to invite Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) for research projects to evaluate the usefulness of emerging molecular technologies that are ready for initial application to clinical or biological questions in cancer research. Projects should be designed to demonstrate that the technology is robust and yields reproducible measurements. Projects should also be designed to gather preliminary data to support the use of the technology in a future project(s) with a clinical or biological focus. It is expected that some refinement or adaptation of the technology may be appropriate in the initial phase of the project, but projects requiring significant technology development effort are not appropriate. In addition, applications that propose the use of commercially available technology under standard conditions, or any technology that is already commonly accepted for the proposed use, are not appropriate. (Applicants proposing projects focused on biological or clinical questions are encouraged to contact their NCI/NIH program director to discuss appropriate funding opportunities.)
This FOA is part of the broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program. The IMAT program underscores the desire of the NCI to develop and integrate novel technologies focused on the molecular analysis of cancers and their micro-environments in support of cancer research, diagnosis, and treatment. In the research continuum of discovery, development, and delivery, this program emphasizes the link between development and delivery. This specific initiative will serve as a tool to develop emerging technologies in an appropriate biological or clinical context.
The continuation of the IMAT Program consists of the following three related themes:
For each IMAT theme, parallel FOAs exist that utilize various funding mechanisms, such as R21 and R33 grant mechanisms as well as the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grant mechanisms (R41, R42, R41/R42, R43, R44, R43/R44) that are specifically intended for applicants from small business concerns. The overall goal of the IMAT program is to accelerate meritorious technology development projects by funding both feasibility and development phases. Through the use of appropriate funding mechanisms, the individual IMAT FOAs are focused either on: (1) the Phase I or high-risk exploratory portion of an investigator's scientific effort, with an emphasis on innovation; or (2) the developmental Phase II projects; or (3) projects that combine Phase I and Phase II efforts in one application. Whereas the scientific scopes within the main IMAT themes remain constant, FOAs with the focus on exploratory pilot phases and on developmental phases have distinct submission requirements.
The complete matrix of multiple IMAT FOAs, including their scopes and basic requirements, is outlined in NOT-CA-07-005. Potential applicants interested in IMAT initiatives are strongly advised to use that NIH Guide Notice as a switchboard to verify which of the closely related active FOAs might be most appropriate for them to apply to.
This FOA, RFA-CA-07-041, is designed to support applicant SBC projects through the use of SBIR grant mechanisms for Phase I, Phase II, and Fast-Track applications.
Researchers who emphasize the assessment of in vivo imaging technologies as the primary focus of their grant applications should contact the Cancer Imaging Program for information on appropriate funding opportunities. Researchers focusing on applying new bioinformatics or statistical techniques as the primary focus of their applications should consider one of the Biomedical Information Science and Technology Initiative (BISTI) opportunities.
Background
In order to reduce death and suffering due to cancer, the NCI will continue to support the development of creative methods to understand, prevent, diagnose, and treat cancer. In the past several decades, basic discovery research has revealed that cancer is a complex disease involving myriad molecular and cellular processes, and that cancers arise as the result of the gradual accumulation of genetic changes in specific cells. Identifying which subset of the genes encoded within the human genome can contribute to the development of cancer remains a challenge. Even more challenging is the subsequent understanding of the roles of RNA, proteins, and other functional products encoded by these genes. The identification and characterization of these cancer genes and their associated gene products remains a high priority in cancer research. New technologies and approaches not only address specific questions in basic research and clinical practice but are also beneficial in uncovering and developing new directions and paradigms in cancer research. Therefore, technological advances play critical role throughout the NCI's mission.
The IMAT program was originally designed in 1999 with three objectives: to focus technology development on cancer, to solicit highly innovative technology development projects, and to accelerate the rate of maturation of meritorious technologies from feasibility through development of the technology. Through solicitation, outreach, and communication with the investigator community, the IMAT program has been successful in promoting cancer-relevant applications of a diverse spectrum of new and emerging technologies. The program has focused on both the inception and development of cancer-related technologies. Some of the technologies originally generated with IMAT funding have been put in use to facilitate the acquisition of basic knowledge about cancer, which feeds the discovery pipeline. Other IMAT supported technologies have been applied to questions of clinical importance. The IMAT program has also been successful in accelerating meritorious technology development projects by minimizing the funding gap between feasibility and development phases through the use of the Fast-Track funding mechanism. This funding opportunity will support not only separate Phase I and Phase II SBIR applications, but also SBIR Fast-Track applications, as outlined in Section II.1., Mechanisms of Support.
This FOA is intended to support the development of molecular analysis tools that will not only allow for the more in depth examination of the molecular basis of cancer in general but will also provide the ability to identify those molecular characteristics of individuals that are pertinent to cancer development and prognosis. For instance, such tools are anticipated to facilitate the identification of genetic factors that influence an individual's risk of developing cancer or his/her ability to respond to adverse external/environmental factors such as radiation, carcinogens, as well as to therapeutic agents.
To better understand the neoplastic process and the molecular responses of the host to cancer, it will be critical not only to acquire relevant knowledge at the DNA level, but also to improve our understanding of the impact of aberrant genetic information on cellular functions. Current discoveries indicate that alterations in many of the cellular processes, pathways, or networks may contribute to the genesis of cancer and that these alterations could be exploited for therapeutic or preventive intervention. Therefore, it is important to invoke technologies that can detect molecular changes in the cell without preconceived ideas as to what specific markers might be the most valuable to monitor. In the discovery phase, the emphasis will be on highly multiplexed technologies that can effectively detect structural variations or functional changes in many (ultimately in all) members of the populations of DNA, RNA, or protein species present in cells. Current technologies for the multiplexed analysis of macromolecular species are at a stage where the greatest utility exists for the analysis of large numbers of relatively homogeneous cell populations that can be assayed in vitro. While many of the existing technologies have relatively sophisticated multiplexing capabilities in the assay format, none are comprehensive for any particular type of macromolecular species (DNA, RNA, or protein). Therefore, there is a need for further development to insure that the resulting technologies provide enhanced assay potential, adequate sensitivity and specificity, robust data analysis tools, and easy adaptation to the basic, preclinical, and clinical research settings.
Objectives and Scope
The purpose of this RFA is to solicit applications from small businesses interested in applying to basic, clinical, and epidemiological research emerging technologies that are suitable for the molecular analysis of cancers and their host environment. Technologies to support research in the following areas are considered to be appropriate. Examples given below are not intended to be all-inclusive but serve to illustrate the types of capabilities that are of interest.
New tools that would allow for acquisition of more complete profiles of DNA, RNA, protein, and other important biomolecules of normal, pre-cancerous, and cancerous cells are needed to support the basic discovery process by offering a more complete picture of the neoplastic phenomenon. Analogous technological advances will also be needed to examine the tumor micro-environment, including both stromal and vascular interactions. Such tools will allow more comprehensive characterization of both the variations that influence predisposition to cancer and the responses of an individual to therapeutic and preventive agents. The types of capabilities, technologies and data analysis tools that are of interest include, but are not limited to, the following examples: for:
For all technologies proposed for development, it is important to substantiate the potential value of and role for the technology in elucidating the molecular characteristics of cancer cells or cancer-relevant characteristics of the individual. It is also important for applicants to discuss the prospects for the eventual dissemination of new technologies to other laboratories or the clinic. In the case of technologies intended for use on clinical specimens or in patients, collaborations with investigators involved in the clinical research of cancer are encouraged.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. 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 small business concern (SBC) will be solely responsible for
planning, directing, and executing the proposed project. Future unsolicited,
competing renewal applications based on this project will compete with all SBIR
applications and will be reviewed according to the customary peer review
procedures. Applications that are not funded in the competition described in
this FOA may be submitted as NEW applications through Grants.gov/Apply using the standard NIH, CDC, and
FDA SBIR
submission dates of April 1, August 1, and December 1 (or January 2, May 1, and
September 1 for NIH AIDS and AIDS-related SBIR applications).
This
funding opportunity uses Just-in-Time 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 total costs per year and time periods up to 2 years for Phase I may be requested. Budgets
up to $750,000 total costs per year and up to 3 years may be
requested for Phase II. Total costs include direct costs, Facilities &
Administrative (F&A)/indirect costs, and fee.
The NCI intends to
commit approximately $1,250,000 dollars in FY 08 to fund 3 to 5 Phase I and/or Phase II
applications under the SBIR set-aside funding mechanism. Although the financial
plans of the participating organizations provide support for this program,
awards pursuant to this FOA are contingent upon the availability of funds and
the submission of a sufficient number of meritorious applications. At this
time, it is not known if competing renewal applications will be accepted and/or
if this FOA will be reissued.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
Only United States small business concerns (SBCs) are eligible to submit SBIR applications. A small business
concern is one that, at the time of award for both Phase I and Phase II SBIR
awards, meets all of the following criteria:
1. Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit.
2. Is (a) at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or (b) for SBIR only, it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States.
3. Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in 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 13 CFR 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 CFR 121.3 also states that control or the power to control exists when key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise. Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.
For purposes of the SBIR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13 CFR 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 any other 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 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: January 5, 2007 (Earliest date
an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January
27, 2007; April 29, 2007; August 27, 2007.
Application Submission/Receipt Date(s): February 28, 2007; May 30, 2007; September 28, 2007.
Peer Review Date(s): May/June 2007,
September/October 2007, January/February 2008.
Council Review Date(s): October 2007,
February 2008, June 2008.
Earliest Anticipated Start Date(s): September 2007, April 2008, July 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 Institute and
Center (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:
Gregory J. Downing, D.O., Ph.D.
Office of Technology and Industrial Relations
National Cancer Institute
Building 31, Room 10A52, MSC 2580
Bethesda, MD 20892-2580
Telephone: (301) 496-1550
Fax: (301) 496-7807
Email: downingg@mail.nih.gov
3.B. 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
All
application instructions outlined in the SF424 (R&R) SBIR/STTR Application
Guide (MS Word or PDF) are to be followed, with the following requirements.
Note: While each section of the Research Plan needs to eventually be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits.
Note also that an annual meeting of all investigators funded through this program will be held to share progress and research insights that may lead to further progress in the program. Applicants should request travel funds in their budgets for the PD/PI and one additional senior investigator to attend this annual meeting.
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:
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 expects grant recipients to 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/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.
Guidelines for Planning Intellectual Property Management
Detailed Intellectual Property Management Plans are a just-in-time requirement and do not need to be included in the grant application, but the applicants must be aware of this requirement and their Commercialization Plans must be consistent with the Guidelines below.
Certain research plans will require collaboration and coordination between investigators at different institutions/organizations, some of whom may not be NIH funding recipients and who may have pre-existing intellectual property obligations to third parties. It is anticipated that commercial embodiments of the results of such research may incorporate single inventions shared by several institutions/organizations, or multiple inventions each from a separate institution/organization. Therefore, prior to funding, Phase II SBIR grant applicants must address how they will coordinate patent prosecution and licensing activities, if necessary, to enable a licensee to access the bundle of intellectual property needed to take a product to market on commercially viable terms. Suggested strategies include: (1) assigning intellectual property rights to related inventions to an invention management firm; (2) designating one organization to take the lead on patenting and licensing related inventions; and (3) agreeing in advance that if multiple parties are to independently license related inventions, the total of stacked royalties will not exceed a predetermined percentage rate.
The technology transfer/intellectual property management/licensing officer or equivalent of the PD/PI's institution/organization will be expected to submit an intellectual property management plan if the application is selected for funding. Alternatives to the suggested strategies, which accomplish the same goals, will be considered.
The PD/PI s institution/organization should avoid exclusively licensing those inventions that are research tools unless either: (1) the field of use of the exclusive license is restricted to commercial use; or (2) the exclusive licensee will make the research tool available on reasonable terms. Applicants are directed to the NIH policy on the dissemination of biological research resources ( research tools ) at http://www.ott.nih.gov/policy/rt_guide_final.html.
Appendix Materials
The following materials may be included in the Appendix:
Up to three publications, manuscripts (accepted for publication), abstracts, patents, or other materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. For details see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
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:
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?
Phase II
Applications
In addition to the
above review criteria:
1. How well did the
applicant demonstrate progress toward meeting the Phase I objectives, demonstrating
feasibility, and providing a solid foundation for the proposed Phase II
activity?
2. Did the applicant
submit a concise Commercialization Plan that adequately addresses the specific
areas described in the SF424 (R&R) SBIR/STTR Application Guide and the
SBIR/STTR Information component?
3. Does the project
carry a high degree of commercial potential, as described in the
Commercialization Plan?
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
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?
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 expects grant recipients to 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_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding
to this funding opportunity should include a sharing research resources plan
addressing how unique research resources will be shared or explain why sharing
is not possible.
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/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:
Gregory J. Downing, D.O.,
Ph.D.
Office of Technology and Industrial Relations
National Cancer Institute
Building 31, Room 10A52, MSC 2580
Bethesda, MD 20892-2580
Telephone: (301) 496-1550
Fax: (301) 496-7807
Email: downingg@mail.nih.gov
2. Peer Review Contacts:
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC
8329
Bethesda, MD 20892-8329 (for U.S.
Postal Service express or regular delivery)
Rockville, MD 20852 (for
express/courier service)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov
3. Financial or Grants Management Contacts:
Mr. Sean Hine
Grants Management Specialist
Office of Grants Administration, NCI,
NIH
Fairview Center Bldg, Suite 300
1003 West 7th St.
Frederick, MD 21701-4106
Telephone: (301) 846-1005
Fax: (301) 846-5720
Email:
seanhine@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 sharing 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). 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.
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (HHS)
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 HHS 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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