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: Innovations in Cancer Sample Preparation (STTR [R41/R42])
Announcement
Type
This is
a reissue of SBIR/STTR RFA-CA-06-007 that
expired October 19, 2005.
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, RFA-CA-07-011, must be read in conjunction with the application guidelines included with this announcement in Grants.gov Apply for Grants (hereafter called Grants.gov/Apply).
A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be submitted to Grants.gov by 5:00 p.m. local time (of the applicant institution/organization) on the submission date (see Key Dates below).
2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.
Request for Applications (RFA) Number: RFA-CA-07-011
Catalog
of Federal Domestic Assistance Numbers
93.392,
93.393, 93.394, 93.395, 93.396
Key Dates
Release/Posted
Date: January 26, 2006
Opening Date: January 26, 2006 (Earliest date an application may be submitted
to Grants.gov)
Letters of
Intent Receipt Dates: February 8, 2006; April 26, 2006; August 28, 2006
Application Submission Dates: February 22, 2006; May 26, 2006; September 26, 2006
AIDS Application Submission Dates: Not Applicable
Peer Review
Dates: June/July 2006; October/November 2006; February/March 2007
Council Review Dates: September/October 2006; January/February 2007; May/June
2007
Earliest Anticipated Start Dates: September 2006; February 2007; June 2007
Additional Information To Be Available Date (URL Activation Date): Not
Applicable
Expiration Date: September 27, 2006
Due Dates
for E.O. 12372
Not
Applicable.
Additional Overview Content
Executive Summary
This Funding Opportunity Announcement (FOA) solicits Small Business Technology Transfer (STTR) grant applications from small business concerns (SBCs) for research projects proposing the development of novel sample preparation technologies suitable for the molecular analysis of cancer cells and their host environment. Technology encompasses methods and tools that enable research, including but not limited to, instrumentation, techniques, and devices.
Table of Contents
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
A. Submission, Review and Anticipated Start
Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Merit Review Criteria
A. Additional Review Criteria
B. Additional Review Considerations
C. Sharing Research Data
D. Sharing Research Resources
Section VI. Award Administration Information
1. Award Notices
2. Administrative Requirements
3. Reporting
Section VII. Agency Contacts
1. Scientific/Research Contact
2. Peer Review Contact
3. Financial/Grants Management Contact
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Purpose
The purpose of this Funding Opportunity Announcement (FOA) issued by the National Cancer Institute (NCI) is to invite Small Business Technology Transfer (STTR) grant applications from small business concerns (SBCs) for research projects proposing the development of novel sample preparation technologies suitable for the molecular analysis of cancer cells and their host environment. Technology encompasses methods and tools that enable research, including but not limited to, instrumentation, techniques, and devices. Technology is distinct from resources such as databases, reagents, and tissue repositories. Applications for support of such resources will not be considered responsive to this FOA. Technologies solicited include, but are not necessarily limited to, those that are suitable for the detection of alterations and instabilities of genomic DNA; measurement of the expression of genes and gene products, including proteins; analysis and detection of gene and/or cellular products, including post-translational modification and function of proteins; identification and characterization of exogenous infectious agents in cancer; and assaying the function of major signal transduction networks involved in cancer. Developing technologies would include those that will support molecular analysis in vitro, in situ, or in vivo in discovery processes as well as in pre-clinical models and clinical research.
This funding opportunity is part of a broader technology development program within the NCI, which underscores the desire of the NCI to develop and integrate novel and emerging technologies in the support of cancer research, diagnosis, and treatment. In the research continuum of discovery, development, and delivery, this program accelerates development and delivery. This specific initiative will serve as the discovery tool of the larger program by soliciting and funding highly innovative, high risk, and cancer-relevant technology development projects associated with the molecular analysis of cancer. This initiative capitalizes on the success of the original NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) program in bringing together a multi-disciplinary group of scientists and engineers to work on cancer and the expansion of interest in technology development across the NCI and other NIH institutes. The continuation of the IMAT program consists of the following three initiatives: Innovative Technologies for the Molecular Analysis of Cancer; Innovations in Cancer Sample Preparation; and Application of Emerging Technologies for Cancer Research. For each IMAT initiative, parallel funding opportunities, which utilize the STTR (R41/R42) and the Small Business Innovation Research (SBIR [R43/R44]) grant mechanisms, exist for applicants from the small business research community.
This FOA, RFA-CA-07-011, is designed to support applicant SBC projects through the use of STTR grant mechanisms for Phase I, Phase II, and Fast-Track applications. Applications must focus on novel technologies and approaches pertinent to sample preparation methodologies. STTR research projects centered on inception and early stage development of new technologies may be most suitable for RFA-CA-07-007, Innovative Technologies for Molecular Analysis of Cancer, whereas RFA-CA-07-006 solicits applications for the same purpose and title under the SBIR grant mechanisms. STTR research projects to evaluate emerging technologies that are ready for initial testing of their utility in basic and/or clinical cancer research may be most suitable for RFA-CA-07-009, Application of Emerging Technologies for Cancer Research, whereas RFA-CA-07-008 solicits applications for the same purpose and title under the SBIR grant mechanisms. Researchers who emphasize the assessment of in vivo imaging technologies as the primary focus of their grant applications should contact the Cancer Imaging Program for information on appropriate funding opportunities. Researchers focusing on applying new bioinformatics or statistical techniques as the primary focus of their applications should consider one of the Biomedical Information Science and Technology Initiative (BISTI) opportunities.
Background
In order to reduce death and suffering due to cancer, the NCI will continue to support the development of creative methods to understand, prevent, diagnose, and treat cancer. In the past several decades, basic discovery research has revealed that cancer is a complex disease involving myriad molecular and cellular processes, and that cancers arise as the result of the gradual accumulation of genetic changes in specific cells. Identifying which subset of the genes encoded within the human genome can contribute to the development of cancer remains a challenge. Even more challenging is the subsequent understanding of the roles of RNA, proteins, and other functional products encoded by these genes. The identification and characterization of these cancer genes and their associated gene products remains a high priority in cancer research. New technologies and approaches not only address specific questions in basic research and clinical practice but are also beneficial in uncovering and developing new directions and paradigms in cancer research. Therefore, technological advances play critical role throughout the NCI's mission.
The IMAT program was originally designed in 1999 with three objectives: to focus technology development on cancer, to solicit highly innovative technology development projects, and to accelerate the rate of maturation of meritorious technologies from feasibility through development of the technology. Through solicitation, outreach, and communication with the investigator community, the IMAT program has been successful in promoting cancer-relevant applications of a diverse spectrum of new and emerging technologies. The program has focused on both the inception and development of cancer-related technologies. Some of the technologies originally generated with IMAT funding have been put in use to facilitate the acquisition of basic knowledge about cancer, which feeds the discovery pipeline. Other IMAT supported technologies have been applied to questions of clinical importance. The IMAT program has also been successful in accelerating meritorious technology development projects by minimizing the funding gap between feasibility and development phases through the use of the Fast-Track funding mechanism. This funding opportunity will support not only separate Phase I and Phase II STTR applications, but also STTR 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 funding opportunity is to solicit applications from individuals and groups interested in developing novel sample preparation technologies suitable for the molecular analysis of cancer cells and their host environment. Sample preparation methods and technologies may be developed for sample collection, processing, isolation, storage, purification, preservation, and, in the case of stored tissues, reversal of adverse events resulting from storage and preservation. Methods may be for preparation of molecules, fluids, tissues, or any other samples necessary for cancer research. Researchers may propose to develop methods to isolate cells or sub-cellular components, such as classes of molecules, organelles, or sub-cellular structures. They may propose to isolate specific classes of molecules, such as membrane-bound proteins. They may also propose studies to determine the effects of collecting, processing, and storage on molecular components of interest in stored specimens. The goal is to develop products and methodologies that maximize the quality and utility of samples for research and, in the case of human specimens, maximize the quality of the samples for research and clinical needs without compromising patient care. Methods and technologies for measuring and monitoring changes in biomolecule properties and their detectability in response to specimen handling variables are encouraged.
Sample preparation methods may impact the results or interpretation of biological studies. Investigators may apply different methods of sample preparation using the same measurement technology. In many cases of measuring biological response, no gold standard exists by which to compare research results obtained from the different sample preparation methods. There is a need for methods to assess the quality of samples prepared using different methodologies. This funding opportunity will support methods to assess sample quality and studies that elucidate the criteria needed to judge sample quality under different conditions. This funding opportunity will also support the development of technologies to make these assessments, such as the development of sample reference materials that can be used to calibrate the effectiveness of new fixatives or new detection methodologies.
It is expected that many investigators who developed successful cancer sample preparation techniques under previous IMAT initiatives (i.e., with R21, but not R33, grant award funds from RFA-CA-06-002, RFA-CA-06-003, RFA-CA-06-004, RFA-CA-05-002, RFA-CA-05-003, and/or RFA-CA-05-004) will propose projects for this funding opportunity. However, this funding opportunity is not limited to techniques developed under the IMAT program. Investigators are encouraged to use any sample preparation methodologies or techniques relevant to cancer.
For all projects proposed, it will be important to substantiate the ultimate value of the innovation for analyzing samples, optimizing analysis, and/or evaluating sample quality for the purpose of research and eventually clinical applications. Also of importance is the potential for ultimately transferring knowledge, technologies, and/or methodologies to other laboratories or the clinic. In the case of technologies intended for use on clinical specimens or in patients, applications from or 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.
This FOA (RFA-CA-07-009) will utilize the STTR (R41/R42) grant mechanisms for Phase I, Phase II, and Fast-Track applications and runs in parallel with FOAs of identical or related scientific scope that solicit applications under the Small Business Innovation Research (SBIR [R43/R44]) grant mechanisms (RFA-CA-07-010) and R21 Exploratory/Developmental and R33 Exploratory/Developmental Phase 2 grant mechanisms (RFA-CA-07-003).
Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any another HHS FOA, including the current Parent STTR and SBIR FOAs.
Phase
II applications in response to this funding opportunity will only be accepted
as competing renewals (formerly competing continuations ) of previously funded
Phase I STTR awards. The Phase II must be a logical extension of the Phase I
research but not necessarily as a Phase I project supported in response to this
funding opportunity.
The
applicant SBC will be solely responsible for planning, directing, and executing
the proposed project. Future unsolicited, competing renewal applications based
on this project will compete with all STTR and other applications, as
appropriate, 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 STTR submission
dates of April 1, August 1, and December 1 (or January 2, May 1, and September
1 for NIH AIDS and AIDS-related STTR applications). The NIH allows
up to two resubmission (formerly revised/amended ) applications without a time
line for submitting the first and second resubmissions. See NOT-OD-03-041,
May 7, 2003.
This
funding opportunity uses just-in-time concepts. The modular budget format is no
longer accepted for STTR grant applications. Applicants must complete and
submit budget requests using the SF424 Research and Related (R&R) Budget
component found in the application package attached to this FOA in Grants.gov/Apply.
2. Funds
Available
The SF424 (R&R) SBIR/STTR Application Guide indicates the statutory guidelines of funding support and project duration periods for Phase I and Phase II STTR awards. For this funding opportunity, budgets up to $100,000 total costs per year and time periods up to 2 years for Phase I may be requested. Budgets up to $750,000 total costs per year and up to 3 years may be requested for Phase II. Total costs include direct costs, facilities and administrative (F&A)/indirect costs, and fee.
The NCI intends to commit approximately $1,000,000 in Fiscal Year 2007 to fund three to five (3-5) Phase I and/or Phase II applications under the STTR set-aside funding mechanism. Although the NCI’s financial plans provide support for this program, awards pursuant to this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. At this time, it is not known if competing renewal applications will be accepted and/or if this FOA will be reissued.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
Only United States small business concerns (SBCs) are eligible to submit STTR applications. A small business concern is one that, at the time of award for both Phase I and Phase II STTR awards, meets all of the following criteria:
1. Is independently owned and operated, is not dominant in the field of operation in which it is proposing, has a place of business in the United States and operates primarily within the United States or makes a significant contribution to the US economy, and is organized for profit.
2. Is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States.
3. Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns are generally considered to be affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 C.F.R. 121.103. The term "number of employees" is defined in 13 C.F.R. 121.106.
A business concern may be in the form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative. Further information may be obtained at http://sba.gov/size, or by contacting the Small Business Administration's Government Contracting Area Office or Office of Size Standards.
One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an STTR awardee organization must be space that is available to and under the control of the STTR awardee for the conduct of its portion of the proposed project.
Title 13 C.F.R. 121.3 also states that control or the power to control exists when key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise. Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.
For purposes of the STTR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13 C.F.R. 121.106 Small Business Size Regulations.
All STTR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an STTR award until the SBA provides a determination.
1.B. Eligible Individuals
Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with their organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH programs.
For a STTR
application, the Project Director/Principal Investigator (PD/PI) may be
employed with the SBC or the participating non-profit research institution as
long as s/he has a formal appointment with or commitment to the applicant SBC.
As defined in 42 CFR 52, the PD/PI is the single individual designated by the grantee in the grant application who is responsible for the scientific and technical direction of the project. When the proposed PD/PI clearly does not have sufficient qualifications to assume this role, the application is not likely to receive a favorable evaluation.
The PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration. In all cases, however, the PD/PI s official relationship with the grantee must entail sufficient opportunity for the PD/PI to carry out his or her responsibilities for the overall scientific and technical direction of the project. Documentation (e.g., consultant, consortium and contractual arrangements) describing the official relationship of the PD/PI with the applicant small business concern should NOT be submitted with the grant application, but a copy must be furnished upon the request of the NIH awarding component.
The following are examples of situations describing the official relationship of the PD/PI with the applicant small business organization:
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3.
Other-Special Eligibility Criteria
In STTR Phase I and Phase II, at least 40% of the work must be performed by the small business concern and at least 30% of the work must be performed by the single, partnering research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and F&A/indirect costs attributable to each party, unless otherwise described and justified in Item 12, Consortium/Contractual Arrangements, of the PHS398 Research Plan component of the SF424 (R&R) application forms.
The NIH will accept as many "different" applications as the applicant organization chooses. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and any other HHS FOA, including the current Parent STTR and SBIR FOAs.
Section IV. Application and Submission Information
Registration and Instructions for Submission via Grants.gov
To download an Application
Package and Application Guide for completing the SF424 (R&R) forms for this
FOA, link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organization/Institutional Registration in Grants.gov/Get Started
2) Organization/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 the SF424 (R&R) SBIR/STTR Application
Guide for this FOA through Grants.gov/Apply.
Note:
Only the forms package directly attached to a specific FOA can be used. You
will not be able to use any other SF424 (R&R) forms (e.g., sample forms,
forms from another FOA), although some of the "Attachment" files may
be useable for more than one FOA.
For further
assistance contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2.
Content and Form of Application Submission
Prepare all STTR applications using the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR Application Guide (MS Word or PDF) instructions. The SF424 (R&R) SBIR/STTR Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424
(R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research
& Related Other Project Information
Research
& Related Senior/Key Person
Research
& Related Budget
Research
& Related Subaward Budget Form
PHS398 Cover
Page Supplement
PHS398
Research Plan
PHS398
Checklist
SBIR/STTR Information
Optional Components:
PHS398 Cover Letter File
3. Submission Dates and Time
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening
Date: January 26, 2006 (Earliest date an application may be submitted to
grants.gov)
Letters of
Intent Receipt Dates: February 8, 2006; April 26, 2006; August 28, 2006
Application Submission Dates: February 22, 2006; May 26, 2006; September 26, 2006
AIDS Submission Dates: Not Applicable
Peer Review
Dates: June/July 2006; October/November 2006; February/March 2007
Council Review Dates: September/October 2006; January/February 2007; May/June
2007
Additional Information To Be Available Date (URL Activation Date): Not
Applicable
Earliest Anticipated Start Dates: September 2006; February 2007; June 2007
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A.
The letter of intent should be sent to:
Gregory
J. Downing, D.O., Ph.D.
Office of Technology and Industrial Relations
National Cancer Institute
Building 31, Room 10A52, MSC 2580
Bethesda, MD 20892-2580
Telephone: (301) 496-1550
Fax: (301) 496-7807
Email: [email protected]
3.B. Sending an Application to the NIH
Applications
in response to this FOA may only be submitted to Grants.gov through Grants.gov/Apply.
PAPER
APPLICATIONS WILL NOT BE ACCEPTED.
3.C. Application Processing
Applications may be submitted to Grants.gov on or after the opening date and must be submitted no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission dates described in Section IV.3.A. If an application is not received by that date, the application may be delayed in the review process or not reviewed.
Upon receipt, applications will be transferred from
Grants.gov to the NIH Electronic Research Administration process for
validation. Both the PD/PI and the Signing Official for the organization must
verify the submission via Commons within two business days of notification of the NIH validation.
Upon receipt, applications will be
evaluated for completeness by the Center for Scientific Review, NIH. Incomplete
applications will not be reviewed.
The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application.
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
4.
Intergovernmental Review
This
initiative is not subject to intergovernmental
review.
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.
STTR Phase I applications:
STTR Phase II applications:
STTR Fast-Track applications:
Guidelines for Planning Intellectual Property Management
Detailed Intellectual Property Management Plans are a just-in-time requirement and do not need to be included in the grant application, but the applicants must be aware of this requirement and their Commercialization Plans must be consistent with the Guidelines below.
Certain research plans will require collaboration and coordination between investigators at different institutions/organizations, some of whom may not be NIH funding recipients and who may have pre-existing intellectual property obligations to third parties. It is anticipated that commercial embodiments of the results of such research may incorporate single inventions shared by several institutions/organizations, or multiple inventions each from a separate institution/organization. Therefore, prior to funding, Phase II STTR 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 have 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://ott.od.nih.gov/policy/RT_guide_final.html.
Plan for Sharing Research Data
Applicants
requesting $500,000 or more in direct costs in any year should include a brief
one paragraph description of how final research data will be shared, or explain
why data-sharing is not possible. The specific nature of the data to be
collected will determine whether or not the final dataset may be shared. If the
final data are not amenable to sharing, for example, if they are proprietary,
this must be explained in the application. The Small Business Act requires the NIH
to protect from disclosure and nongovernmental use all STTR and STTR data
developed from work performed under an STTR 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 STTR and STTR award, or by agreement between the small
business concern and the NIH. Applicants are encouraged to discuss their
data-sharing plan with the NIH Institute/Center staff likely to accept
assignment of their application.
The reasonableness
of the data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
For more information on data sharing, see http://grants.nih.gov/grants/policy/data_sharing/ and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(See FAQ #13.)
Sharing Research
Resources
NIH policy requires
that grant awardee recipients make unique research resources readily available
for research purposes to qualified individuals within the scientific community
after publication (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to
this funding opportunity should include a plan for sharing research resources
addressing how unique research resources will be shared or explain why sharing
is not possible.
The adequacy of
the resources sharing plan and any related data sharing plans will be
considered by NCI program staff when making recommendations about funding
applications. The effectiveness of the resource sharing will be evaluated as
part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590).
See Section VI.3.,
Reporting.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to this funding opportunity will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended STTR 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 STTR
Applications
Significance: Does the proposed project
have commercial potential to lead to a marketable product, process, or service?
Does this study address an important problem? What may be the anticipated
commercial and societal benefits that may be derived from the proposed
research? If the aims of the application are achieved, how will scientific
knowledge or clinical practice be advanced? What will be the effect of these
studies on the concepts, methods, technologies, treatments, services, and/or
preventative interventions that drive this field? Does the application lead to
enabling technologies (e.g., instrumentation, software) for further
discoveries? Will the technology have a competitive advantage over
existing/alternate technologies that can meet the market needs?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed,
well-integrated, and appropriate to the aims of the project? Is the proposed
plan a sound approach for establishing technical and commercial feasibility?
Does the applicant acknowledge potential problem areas and consider alternative
strategies? Are the milestones and evaluation procedures appropriate?
Innovation: Are the aims original and
innovative? Does the project challenge existing paradigms or clinical practice;
address an innovative hypothesis or critical barrier to progress in the field?
Does the project develop or employ novel concepts, approaches, methodologies,
tools, or technologies for this area?
Investigator: Is the PD/PI appropriately
trained and capable of coordinating and managing the proposed STTR project? Are
the investigators well suited to carry out this work? Does the investigative
team bring complementary and integrated expertise to the project (if
applicable)? Is the work proposed appropriate to the experience level of the PD/PI
and other researchers, including consultants and subcontractors (if any)? Are
the relationships of the key personnel to the small business and to other
institutions appropriate for the work proposed?
Environment: Is there sufficient access to
resources (e.g., equipment, facilities)? Does the scientific and technological
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
Phase II
Applications
In addition to the
above review criteria:
1. How well did the
applicant demonstrate progress toward meeting the Phase I objectives,
demonstrating feasibility, and providing a solid foundation for the proposed
Phase II activity?
2. Did the
applicant submit a concise Commercialization Plan that adequately addresses the
specific areas described in the SF424 (R&R) SBIR/STTR Application
Guide and the SBIR/STTR Information Component?
3. Does the project
carry a high degree of commercial potential, as described in the
Commercialization Plan?
Resubmission
Applications (formerly revised/amended applications)
In
addition to the above criteria, the following criteria will be applied to
resubmission applications.
1. Are the responses
to comments from the previous scientific review group adequate?
2. Are the
improvements in the resubmission application appropriate?
Phase I/Phase II Fast-Track Application Review Criteria
For
Phase I/Phase II Fast Track applications, the following criteria also will be
applied:
1. Does the Phase
I application specify clear, appropriate, measurable goals (milestones) that
should be achieved prior to initiating Phase II?
2. Did the applicant
submit a concise Commercialization Plan that adequately addresses the specific
areas described in the SF424 (R&R) SBIR/STTR Application
Guide and the SBIR/STTR Information Component?
3. To what extent
was the applicant able to obtain letters of interest, additional funding
commitments, and/or resources from the private sector or non-STTR/ STTR funding
sources that would enhance the likelihood for commercialization?
4. Does the project
carry a high degree of commercial potential, as described in the
Commercialization Plan?
Phase
I and Phase II Fast-Track applications that satisfy all of the review criteria
will receive a single rating.
For Fast-Track
applications, the Phase II portion may not be funded until a Phase I final
report and other documents necessary for continuation have been received and
assessed by program staff that the Phase I milestones have been successfully
achieved. Items 2-5 of the Research Plan may not exceed 25 pages. That
is, the combined Phase I and Phase II plans for a Fast-track application (for items
2-5) must be contained within the 25-page limitation.
2.A. Additional Review Criteria
In addition to the above general criteria, the following items will be considered in the determination of scientific merit and the priority score:
A Phase I or Phase I/Phase II FastTrack application lacking quantitative milestones as determined by the NCI program staff will be returned to the applicant without review.
Protection of Human Subjects from Research Risk: The involvement of human subjects
and protections from research risk relating to their participation in the
proposed research will be assessed. See item 6 of the Research Plan component
of the SF424 (R&R).
Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See item 7 of the Research Plan component of the SF424
(R&R).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to be used in the project,
the five items described under item 11 of the Research Plan component of the
SF424 (R&R) will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?
2.C. Sharing Research Data
The
reasonableness of the data sharing plan or the rationale for not sharing
research data may be assessed by the reviewers. However, reviewers will not factor
the proposed data sharing plan into the determination of scientific merit or
the priority score. The funding organization will be responsible for monitoring
the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm See FAQs #13.
2.D. Sharing Research Resources
NIH
policy requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to
this funding opportunity should include a sharing research resources plan
addressing how unique research resources will be shared or explain why sharing
is not possible.
NCI program staff
will be responsible for the administrative review of the plan for sharing
research resources.
The adequacy of
the resources sharing plan will be considered by NCI program staff when making
recommendations about funding applications. Program staff may negotiate
modifications of the data and resource sharing plans with the awardee before
recommending funding of an application. The final version of the data and
resource sharing plans negotiated by both will become a condition of the award of
the grant. The effectiveness of the resource sharing will be evaluated as part
of the administrative review of each Non-Competing Grant Progress Report (PHS 2590).
See Section VI.3., Reporting.
3.
Anticipated Announcement and Award Dates
Not
Applicable
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General.
A formal
notification in the form of a Notice of Award (NoA) will be provided to the
applicant organization. The NoA signed by the grants management officer is the
authorizing document. Once all administrative and programmatic issues have been
resolved, the NoA will be generated via email notification from the awarding
component to the grantee business official.
Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Section IV.5.,
Funding Restrictions.
2.
Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.
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, financial or grants management issues:
1. Scientific/Research Contact:
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: [email protected]
2. Peer Review Contact:
Referral
Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329 (for U.S. Postal Service express or regular delivery)
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
Fax: (301) 402-0275
Email: [email protected]
3. Financial or Grants Management Contact:
Ted Williams
Office of Grants Administration
National Cancer Institute
National Institutes of Health
6120 Executive Blvd., EPS Suite 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 496-8785
Fax: (301) 496-8601
E-mail: [email protected].
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals
must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving
human subjects must be evaluated with reference to the risks to the subjects,
the adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials,
including physiologic toxicity and dose-finding studies (Phase I); efficacy
studies (Phase II); efficacy, effectiveness and comparative trials (Phase III).
Monitoring should be commensurate with risk. The establishment of data and
safety monitoring boards (DSMBs) is required for multi-site clinical trials
involving interventions that entail potential risks to the participants (NIH
Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct
costs in any single year are expected to include a plan for data sharing or
state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their institutions on issues related to
institutional policies and local IRB rules, as well as local, State and Federal
laws and regulations, including the Privacy Rule. Reviewers will consider the
data sharing plan but will not factor the plan into the determination of
scientific merit or the priority score.
Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide access to research data through the Freedom of Information Act (FOIA)
under some circumstances. Data that are (1) first produced in a project that is
supported in whole or in part with Federal funds and (2) cited publicly and
officially by a Federal agency in support of an action that has the force and
effect of law (i.e., a regulation) may be accessed through FOIA. It is
important for applicants to understand the basic scope of this amendment. NIH
has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important
research resources including the sharing of model organisms for biomedical
research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
Beginning October 1, 2004, all investigators submitting an NIH application or
contract proposal are expected to include in the application/proposal a
description of a specific plan for sharing and distributing unique model
organism research resources generated using NIH funding or state why such
sharing is restricted or not possible. This will permit other researchers to
benefit from the resources developed with public funding. The inclusion of a
model organism sharing plan is not subject to a cost threshold in any year and
is expected to be included in all applications where the development of model
organisms is anticipated.
Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their
sub-populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided indicating
that inclusion is inappropriate with respect to the health of the subjects or
the purpose of the research. This policy results from the NIH Revitalization
Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing
clinical research should read the "NIH Guidelines for Inclusion of Women
and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all clinical research, conducted or supported by the
NIH, unless there are scientific and ethical reasons not to include them.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript
submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For more information about the Policy or the submission process, please
visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view
the Policy or other Resources and Tools, including the Authors' Manual.
Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to
the "Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR Website (http://www.hhs.gov/ocr/) provides
information on the Privacy Rule, including a complete Regulation Text and a set
of decision tools on "Am I a covered entity?" Information on the
impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH solicitation,
Internet addresses (URLs) should not be used to provide information necessary
to the review because reviewers are under no obligation to view the Internet
sites. Furthermore, we caution reviewers that their anonymity may be
compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This PA is related to one or more
of the priority areas. Potential applicants may obtain a copy of "Healthy
People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This program is described in the Catalog of Federal Domestic
Assistance and is not subject to the intergovernmental review requirements
of Executive Order 12372 or Health Systems Agency review. Awards are made under
the authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and
45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified
health professionals who have made a commitment to pursue a research career
involving clinical, pediatric, contraception, infertility, and health
disparities related areas. The LRP is an important component of NIH's efforts
to recruit and retain the next generation of researchers by providing the means
for developing a research career unfettered by the burden of student loan debt.
Note that an NIH grant is not required for eligibility and concurrent career
award and LRP applications are encouraged. The periods of career award and LRP
award may overlap providing the LRP recipient with the required commitment of
time and effort, as LRP awardees must commit at least 50% of their time (at
least 20 hours per week based on a 40 hour week) for two years to the research.
For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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