Expired RFA-CA-06-007: Innovations in Cancer Sample Preparation (SBIR/STTR)

Department of Health
and Human Services (HHS)

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EXPIRED

Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Cancer Institute (NCI), (http://www.nci.nih.gov)

Title: Innovations in Cancer Sample Preparation (SBIR/STTR)

Announcement Type
This is a reissue of RFA-CA-05-008.

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

January 26, 2006 - RFA-CA-06-007 has been reissued, see RFA-CA-07-010 and RFA-CA-07-011.

Request For Applications (RFA) Number: RFA-CA-06-007

NOTICE: This funding opportunity must be read in conjunction with the current Omnibus Solicitation of the National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications. The solicitation (see http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf [PDF] or http://grants.nih.gov/grants/funding/sbirsttr1/index.doc [MS Word] contains information about the SBIR and STTR programs, regulations governing the programs, and instructional information for submission. All of the instructions within the current SBIR/STTR Omnibus Solicitation apply. Exceptions are noted in the Executive Summary.

Catalog of Federal Domestic Assistance Numbers
93.393, 93.394, 93.395, 93.396

Key Dates
Release Date: December 16, 2004
Letters of Intent Receipt Dates: January 17, 2005; May 17, 2005; September 18, 2005
Application Receipt Dates: February 17, 2005; June 17, 2005; October 18, 2005
Peer Review Dates: June-July 2005, October-November 2005, February-March 2006
Council Review Dates: September-October 2005, January-February 2006, May-June 2006
Additional Information To Be Available Date (URL Activation Date): Not applicable.
Earliest Anticipated Start Dates: December 2005; April 2006; July 2006
Expiration Date: October 19, 2005

Due Dates for E.O. 12372
Not applicable.

Additional Overview Content

Executive Summary

The National Cancer Institute (NCI) invites applications for research projects involving the development and significant enhancement or adaptation of sample preparation methodologies and technologies, the development of assays to assess sample quality, and studies designed to elucidate the criteria by which to judge sample quality. Applications may be submitted for support as Phase I STTR (R41) or Phase I SBIR grants (R43), or Phase II STTR (2-R42) or Phase II SBIR (2-R44) grants, or the SBIR/STTR Fast-Track option (1-R42 or 1R44) as described in the SBIR/STTR Omnibus Solicitation. The National Cancer Institute intends to commit approximately $1,250,000 dollars in FY 2006 to fund eight to twelve Phase I, Phase II, and/or Fast-Track applications under the SBIR/STTR set-aside funding mechanism. An applicant may submit an unlimited number of unique applications in response to this announcement.

Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. Only U.S. small business concerns are eligible to submit SBIR/STTR applications. A small business concern is one that, on the date of award for both Phase I and Phase II agreements, meets ALL of the criteria as described in the current SBIR/STTR Omnibus Solicitation.

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. On an SBIR application, the principal investigator must have his/her primary employment (more than 50 percent) with the small business at the time of award and for the duration of the project. The PI on an STTR application may be employed with the small business concern or the participating non-profit research institution as long as s/he has 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.

Applications must be prepared using the PHS 398 research grant application instructions, available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Telecommunications for the hearing impaired is available at TTY 301-451-5936.

All of the instructions within the SBIR/STTR Omnibus Solicitation apply with the following exceptions:

Special receipt dates;
Initial review convened by the NCI Division of Extramural Activities;
Additional review considerations; and
In certain cases, larger budgets and longer project periods than statutory guidelines.

This funding opportunity will utilize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) mechanisms, but will be run in parallel with a request for applications (RFA ) of identical scientific scope (CA-06-004 , http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-06-004.html) that will utilize the exploratory/developmental research Phase I (R21) and the exploratory/developmental research Phase II (R33) grant mechanisms.

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(s) 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. Receipt and 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
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
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 development of new and/or improved cancer sample preparation methodologies and technologies, the development of assays to assess sample quality, and studies to elucidate the criteria needed to judge sample quality cover a wide range of project sizes and innovation levels. This RFA will allow the submission of applications involving Phase I, Phase II, and Fast- Track mechanisms. Phase I (R41 or R43) applicants may propose small, highly innovative feasibility studies or small, short-term exploratory studies to meet one of the RFA goals. Fast-Track applicants should propose projects that require a small feasibility study followed by a well-defined development plan. Successful completion of the Phase I feasibility study and the resulting transition to Phase II will be judged by NCI staff according to Fast-Track review criteria. Projects for which feasibility has already been established through the award of a Phase I grant (through this or another relevant RFA) may be proposed as Phase II (R42 or R44) applications. Feasibility means that some preliminary experiments have been performed and that sufficient technical data exist to support proof-of-principle of the technology/hypothesis.

This initiative is part of a broader technology development program within the NCI. That program underscores the desire of NCI to develop and integrate novel technologies focused on the molecular analysis of cancers and their micro-environment in support of cancer research, diagnosis, and treatment. In the research continuum of discovery, development, and delivery, this program thus emphasizes the link between development and delivery. This specific initiative aims to foster the development of sample preparation techniques and methodologies that are essential for effective research, technology development, and validation that will eventually lead to clinical applications.

This RFA capitalizes on both the success and intent 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 and centers. This 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. This RFA is designed to support research focused on sample preparation methods. Projects focused on the development of novel technologies may be most suitable for RFA (CA-06-005), Innovative Technologies for the Molecular Analysis of Cancer SBIR/STTR (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-06-005.html). Projects focused on evaluating emerging technologies that are ready for initial clinical or biological application in cancer research may be most suitable for RFA (CA-06-006), Application of Emerging Technologies for Cancer Research SBIR/STTR (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-06-006.html).

Background:

High quality sample preparations are the foundation for effective technology validation as well as for meaningful biological and clinical research. Sample preparation covers the spectrum from preparation of molecules to cells to tissues. Preparation of the highest quality samples can be hampered by technical issues, lack of standards by which to judge quality, and lack of standard practices. Sample preparation methods vary. Researchers often develop sample preparation methodologies in an ad hoc fashion as part of other projects. This lack of information and standardization affects the quality and comparability of data across all fields of cancer research and across all technological platforms.

Objectives and Scope:

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 developed 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.

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 RFA will support methods to assess sample quality and studies that elucidate the criteria needed to judge sample quality under different conditions. This RFA 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 or under the RFA (Innovative Technologies for Molecular Analysis of Cancer, RFACA-06-002 (http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-06-002.html) will propose projects for this RFA. However, this RFA 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.

Section II. Award Information

1. Mechanisms of Support

This funding opportunity will use the STTR (R41/R42) and SBIR (R43/R44) grant mechanism(s). Applications may be submitted for support as Phase I STTR (R41) or Phase I SBIR grants (R43), or Phase II STTR (2-R42) or Phase II SBIR (2-R44) grants, or the SBIR/STTR Fast-Track option (1-R42 and 1-R44) as described in the SBIR/STTR Omnibus Solicitation. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and the SBIR/STTR Omnibus Solicitation.

Phase II applications in response to this funding opportunity will only be accepted as competing continuations of previously funded Phase I SBIR or 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. Fast-Track applications will benefit from expedited evaluation of progress following the Phase I feasibility study for transition to Phase II funding for expanded developmental work.

The Phase I portion of the Fast-Track application must contain well-defined quantitative milestones that will be used to judge the success of the proposed research, as well as a credible plan for the pilot application of the proposed technology in Phase II.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as non-modular budget formats. Specifically if you are submitting an application budget with $100,000 total costs (direct, F&A and fee) or less, use the modular format and instructions as described in the current SBIR/STTR Omnibus Solicitation (http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf or http://grants.nih.gov/grants/funding/sbirsttr1/index.doc). Otherwise follow the instructions for non-modular budget research grant applications.

This program will run in parallel with an RFA of identical scientific scope ( CA-06-004, http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-06-004.html) that will utilize the exploratory/developmental research Phase I (R21) and the exploratory/developmental research Phase II (R33) mechanisms.

2. Funds Available

The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of funding support and project duration periods for SBIR and STTR Phase I and Phase II awards. For this funding opportunity, an applicant may request a project period of up to 2 years for Phase I, up to 3 years for Phase II, and up to 4 years for a combined Phase I/Phase II Fast-Track, of which the Phase I portion may be no more than 2 years. An applicant may request a budget for up to $100,000 in direct costs per year for Phase I and the Phase I portion of Fast-Track applications. Phase I budgets can exceed this cap to accommodate F&A/indirect costs to subcontracts to the project, but funds for such may not be rebudgeted. Budgets for Phase II and the Phase II portion of Fast-Track grant applications should be appropriate for the science proposed. Because the nature and scope of the proposed research will vary from application to application, NCI will consider budgets that exceed the statutory guidelines. Total costs include direct costs, F&A, and fee/profit.

The National Cancer Institute intends to commit approximately $1,250,000 dollars in FY 2006 to fund eight to twelve Phase I, Phase II, and/or Fast-Track applications under the SBIR/STTR set-aside funding mechanism. Although the financial plans of the NCI provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt 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 RFA will be reissued.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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 institution 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.

On an SBIR application, the principal investigator must have his/her primary employment (more than 50 percent) with the small business at the time of award and for the duration of the project. The PI on an STTR application may be employed with the small business concern or the participating non-profit research institution as long as s/he has 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.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

The NIH will accept as many "different" applications as the applicant organization chooses. However, 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 the SBIR/STTR Omnibus Solicitation.

Section IV. Application and Submission Information

1. Address to Request Application Information

Application submission instructions are contained in Part I of the SBIR/STTR Omnibus Solicitation available from the NIH Small Business Funding website http://grants.nih.gov/grants/funding/sbir.htm. 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/STTR applications (new and revised) using the most current PHS 398 research grant application forms in accordance with the instructions provided in the SBIR/STTR Omnibus Solicitation. Applications must have a D&B Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnd.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application.

Potential applicants are encouraged to contact program staff for guidance and to read the advice and information on the web sites. However, responsibility for planning, direction, and execution of the proposed research will be solely that of the applicant.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Dates: January 17, 2005; May 17, 2005; September 18, 2005
Application Receipt Dates: February 17, 2005; June 17, 2005; October 18, 2005
Peer Review Dates: June-July 2005, October-November 2005, February-March 2006
Council Review Dates: September-October 2005, January-February 2006, May-June 2006 :
Additional Information To Be Available Date (URL Activation Date): Not applicable.
Earliest Anticipated Start Dates: December 2005; April 2006; July 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research;
Name, address, and telephone number of the Principal Investigator;
Names of other key personnel;
Participating institutions; and
Number and title of this funding opportunity.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

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
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-1550
FAX: (301) 496-7807
Email: downingg@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional copies of the application and all five copies of the appendix material must be sent to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: ncirefof@dea.nci.nih.gov

Appendices should be comprised of unbound materials with separators between documents. ( Unless specifically solicited by NIH, Phase I appendices are not permitted and will not be considered in the review of the application.)

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

Personal deliveries of applications are no longer permitted.

3.C. Application Processing

Applications must be received on or before the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review. Applications will be evaluated for completeness by CSR and responsiveness by the NCI. Incomplete and non-responsive 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. 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 applicationApplications that are not funded in the competition described in this RFA may be resubmitted as amended applications for the receipt dates listed in this RFA and its future issuances, if any.Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks.

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. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3.Reporting).

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 continuation 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 continuation 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

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 principal investigator and one additional senior investigator to attend this annual meeting.

Applications may be submitted for Phase I or Phase II support, or as a combined Phase I and II (Fast-Track). The Phase II proposal must be a logical extension of previously funded Phase I SBIR/STTR research but not necessarily a Phase I project supported in response to this initiative. The total duration for a Phase I/Phase II Fast-Track application cannot exceed 4 years.

PHASE I: Demonstration of feasibility of the innovative approach. Research should be proposed with quantitative feasibility milestones that, when accomplished, would provide sufficient reason to continue the technology development in Phase II. It is expected that technology feasibility will be established. If 2 years of support are requested, the goals for the first year should be clearly stated and not be simply a reiteration of specific aims. Support for the second year will be contingent upon Institute programmatic evaluation to ensure that investigators are reaching milestones and accomplishing the goals presented.

PHASE II: Development of approach to a stage at which the innovation can be piloted for implementation. Extensive studies designed to validate the approach would be expected. Goals and milestones for each year of support should be clearly presented. Support for years 2 and 3, if requested, is dependent upon Institute programmatic review of progress and achievement of the proposed milestones.

FAST-TRACK: Applications may be submitted for combined Phase I and Phase II, Fast-Track consideration as described in the OMNIBUS SOLICITATION.

The Phase I part of Fast-Track applications must specify clear, quantitative milestones that should be achieved prior to Phase II funding. These must be presented in a section labeled Milestones at the end of the Research Plan. A discussion of the suitability of the proposed milestones for assessing success in Phase I, and a discussion of the implications of successful completion of these milestones for the proposed Phase II, should also be presented in this section. Failure to provide such information in the Phase I application and/or sufficient detail in the Phase II application may be sufficient reason for the peer review committee to exclude the Phase II from consideration. If so, a Phase I grantee may apply later for Phase II support. Such applications will be reviewed by an appropriate scientific review group convened by the NIH.

Special provisions described in this RFA pertaining to Phase I and Phase II applications also apply to Fast-Track applications.

All Phase II and Fast-Track applications must include a succinct Commercialization Plan (limited to 15 pages). The Commercialization Plan must be included as part of the Research Plan. Refer to the Phase II grant application instructions for more specific details and instructions. See http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.pdf or http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.doc.

Intellectual Property Management Plan

Certain research plans will require collaboration and coordination between investigators at different institutions, some of whom may not be NIH funding recipients and who may have pre-existing intellectual property (IP) obligations to third parties. It is anticipated that commercial embodiments of the results of such research may incorporate single inventions shared by several institutions, or multiple inventions each from a separate institution. Therefore, prior to funding, Phase II grant applicants must address how they will coordinate patent prosecution and licensing activities, if necessary to enable a licensee to access the bundle of IP needed to take a product to market on commercially viable terms. Suggested strategies include: (1) assigning IP 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/IP management/licensing officer or equivalent of the principal investigator's institution is to submit an IP management plan including at least those elements above. Alternatives to the suggested strategies, which accomplish the same goals, will be considered. IP management plans are a just-in-time requirement; it is not necessary to include the plan in the grant application, but plans will be required before a Phase II grant can be awarded.

Applicants 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.

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. Under the Small Business Act, SBIR/STTR grantees may withhold their data for four years after the end of the award. The Small Business Act provides authority for NIH to protect from disclosure and nongovernmental use all SBIR/STTR data developed from work performed under an SBIR/STTR funding agreement for a period of 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/STTR award, or by agreement between the small business concern and NIH. Applicants are encouraged to discuss their data-sharing plan with the NCI 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/.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

This announcement does not require cost sharing. See also Section III. Eligibility Information 1. A., and B.

Only the review criteria described below will be considered in the review process.

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended SBIR and STTR applications. The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review ;
Availability of funds; and
Relevance of program priorities.

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. Incomplete and/or non-responsive applications will not be reviewed.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score;
Receive a written critique; and
Receive a second level of review by the N ational Cancer Advisory Board.

The goals of NIH-supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an 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/STTR Applications

1. Significance: Does this study address an important problem? 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 proposed project have commercial potential to lead to a marketable produce or process? What may be the anticipated commercial and societal benefits of the proposed activity? Will the proposed work 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? What will be the effect of these studies on the concepts or methods that drive this field?

2. Approach: Are the conceptual 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 tactics? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Are the evaluation procedures appropriate?

3. Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

4. Investigator: Is the principal investigator capable of coordinating and managing the proposed SBIR/STTR? Is the work proposed appropriate to the experience level of the principal investigator 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?

5. Environment: Is there sufficient access to resources (e.g., equipment, facilities)? Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support?

Phase II Applications:

1. How well did the applicant demonstrate progress toward meeting the Phase I objectives, demonstrating feasibility, and providing a solid foundation for the proposed Phase II activity?

2. Did the applicant submit a concise Commercialization Plan that adequately addresses the seven areas described in the Research Plan item J?

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

Amended Applications:

In addition to the above criteria, the following criteria will be applied to revised applications.

1. Are the responses to comments from the previous SRG review adequate?

2. Are the improvements in the revised 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, and measurable goals (milestones) that should be achieved prior to initiating Phase II?

2. Did the applicant submit a concise Commercialization Plan (formerly Product Development Plan) that adequately addresses the seven areas described in the Research Plan, item J?

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. Failure to provide clear, measurable goals may be sufficient reason for the scientific review group to exclude the Phase II application from Fast-Track review.

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 to determine whether the Phase I milestones have been successfully achieved.

2.A. Additional Review Criteria:

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

Milestones: In the case of Phase I or Fast-Track applications, are appropriate and quantitative scientific milestones included that will show, when completed by the end of Phase I, whether or not the project has shown feasibility to pursue Phase II aims?

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. For all applications, is the percent effort listed for the PI appropriate for the work proposed? On applications requesting up to $100,000 direct costs, is the overall budget realistic and justified in terms of the aims and methods proposed? On applications requesting over $100,000 in direct costs, is each budget category realistic and justified in terms of the aims and methods?

Period of Support: The appropriateness of the requested period of support in relation to the proposed research.

2.C. Sharing Research Data

Data Sharing Plan: 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).

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 at http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and at http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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 Principal Investigator will also receive a written critique called a Summary Statement.

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 (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Grant Award (NGA) will be provided to the applicant organization. The NGA signed by the grants management officer is the authorizing document.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NGA 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

Principal Investigators whose proposals have been selected for award will be notified by postal mail.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, financial or grants management issues.

1. Scientific/Research Contacts:

2. Peer Review Contacts:

3. Financial or Grants Management Contacts:

Ted Williams
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service)
Telephone: 301-496-8785
Fax: 301-496-8601
Email: tw133b@nih.gov

Section VIII. Other Information

Required Federal Citations

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); and 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).

Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional Review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials, see: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. See NIH Guide Notice on Further Guidance on a Data and Safety Monitoring for Phase I and II Trials for additional information: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available: http://www.cancer.gov/clinical_trials/.

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 the scientific merit or the priority score.

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 new PHS Form 398; 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.

Public 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 public 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 RFA 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.

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 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 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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 percent of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.

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NIH Funding Opportunities and Notices