Source: http://grants2.nih.gov/grants/guide/pa-files/PA-06-018.html
Timestamp: 2014-08-02 07:16:36
Document Index: 712169039

Matched Legal Cases: ['art 121', 'art2', 'art6', 'art4', 'art4', 'art9']

National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/) Title: Development of PET and SPECT Ligands for Brain Imaging (STTR [R41/R42]) Announcement Type This FOA is a reissue of PA-05-122 released June 14, 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 (R&R) forms and the Grants.gov SBIR/STTR Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT. This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov Apply for Grants (hereafter called Grants.gov/Apply). A registration process is necessary before submission and should be started at least two weeks in advance of the planned submission. See Section IV. Two steps are required for on time submission: 1) The application must be submitted to Grants.gov by 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 the Commons. Program Announcement (PA) Number: PA-06-018 Catalog of Federal Domestic Assistance Number(s) 93.242, 93.173, 93.279, 93.866, 93.853 Key Dates Release Date: October 17, 2005 Letter of Intent Receipt Date(s): Not Applicable Application Submission Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#SBIR for details
Peer Review Dates: Standard dates apply; please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details Council Review Dates: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details Earliest Anticipated Start Date: Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details
Due Dates for E.O. 12372 Not Applicable Additional Overview Content Executive Summary This initiative is intended to stimulate the commercial development of novel radioligands for positron emission tomography (PET) and single photon emission computed tomography (SPECT) imaging in human brain, and to incorporate pilot or clinical feasibility evaluation in pre-clinical studies, model development, or clinical studies. The NIH institutes listed in this FOA are specifically interested in the development of radioligands for molecular targets (e.g., receptors, cell adhesion molecules, intracellular messengers, and disease related proteins) that are of broad interest to the scientific community. These radiotracers will be used for neuroimaging as well as potential biological markers and surrogate endpoints for translational and clinical research, drug discovery and development, and clinical trials. Also appropriate for this FOA are applications proposing research and development of new technologies for radiotracer development. This PA will utilize the STTR (R41/R42) mechanisms, and runs in parallel to two FOAs of similar scientific intent: PA-06-017, Development of PET and SPECT Ligands for Brain Imaging (SBIR) that will utilize the R43/R44 grant mechanisms. PA-03-112, Development and Application of PET and SPECT Ligands for Brain Imaging Studies (Phased Innovation Award), that will utilize the exploratory/developmental (R21, R33) grant mechanisms. Budgets up to $ 250,000 total costs per year and time periods up to 2 years for Phase I may be requested. Budgets up to $ 450,000 total costs per year and up to 3 years may be requested for Phase II. No funds have been specifically set aside for this program; the number of awards and the amount of funds provided for awards have not been predetermined. Only United States SBCs are eligible to submit SBIR applications. A SBC is one that, on the date of award for both Phase I and Phase II funding agreements, meets ALL of the criteria as described in Section III. I.A. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. Applicant SBCs may submit more than one application, provided each application is scientifically distinct. See Section IV.1 for application materials. The application instructions for this Funding Opportunity Announcement (FOA) are located at the following links:
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 or Matching 3. Other - Special Eligibility Criteria Section IV. Application and Submission Information 1. Request Application Information 2. Content and Form of Application Submission 3. Submission Dates and Times A. Submission 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 A. Additional Review Criteria B. Additional Review Considerations C. Sharing Research Data D. Sharing Research Resources 3. Anticipated Announcement and Award Dates Section VI. Award Administration Information 1. Award Notices 2. Administrative and National Policy Requirements 3. Reporting Section VII. Agency Contact(s) 1. Scientific/Research Contact(s) 2. Peer Review Contact(s) 3. Financial/ Grants Management Contact(s) Section VIII. Other Information - Required Federal Citations Part II - Full Text of Announcement
1. Research Objectives Tremendous opportunities exist for the application of PET and SPECT imaging in studies of the pathophysiology and treatment of brain disorders, but relatively few radioligands are currently available for functional imaging of target molecules implicated in normal brain function and in brain and behavioral disorders. This initiative is intended to stimulate the development of radioligands for molecular targets (e.g., receptors, cell adhesion molecules, intracellular messengers, and disease related proteins) that are of broad interest to the scientific community. The widespread availability and use of these radioligands are expected to: 1) accelerate research on identifying and characterizing the neural circuits and pathways implicated in the pathophysiology of brain disorders, and 2) facilitate the identification of new therapeutic targets and the development of new compounds as potential therapeutic agents. Exploratory studies on the identification of novel targets or the identification of base compounds for specific molecular targets are not appropriate topics for this initiative. Molecular targets for which radioligands are needed, and for which research and development is encouraged under this FOA include, but are not limited to, those listed below: Receptors: adenosine; adrenergic: alpha 1, alpha 2; cannabinoid: CB1, CB2; corticotropin releasing hormone: CRH R1, CRH R2; dopamine: D1, D3, D4, D5, & low affinity DA receptors; estrogen; GABA A subunits; GABA ion channel; GABA B; glutaminergic; glycine site; metabotropic glutamate subtypes; muscarinic subunits; neurokinin receptors: NK1, NK2, NK3; nicotinic receptor subunits: alpha 7 & alpha 4 beta 2; NMDA subunits; opioid receptors: mu, delta, kappa; serotonin: 5-HT1A, 5-HT1B, 5-HT1D, 5-HT2A, 5-HT2C, 5-HT6, 5-HT7; sigma ligand; substance P; voltage gated ion channels: Ca, Na, K – M current proteins Transporters: vesicular ACh; GABA glutamate; NET; SERT Enzymes: choline acetyltransferase; dopamine beta-hydroxylase; GABA transaminase; glutamic acid decarboxylase; glutaminergic; phosphodiesterases; tyrosine hydroxylase Intracellular targets: amyloid deposition; diacylglycerol; gene expression markers; lipid metabolism; neuroinflammatory markers: cytokines, COX inhibitors; synthases; peptidases; phosphatases; phospholipases; protein kinases; stem cells Development of selective hormone receptor radioligands (e.g., for estrogen receptor ß, corticosteroid hormone receptors, and thyroid receptors) for basic research including novel tools and approaches to visualize activation of steroid hormone receptors in brain imaging studies across the lifespan. The following objectives would make appropriate topics for proposed Phase I or Phase II projects. This list is not meant to be all-inclusive. Lead compound identification/development and syntheses of chemicals with suitable binding affinity, biodistribution, pharmacokinetics, and physio-chemical properties allowing radiochemical synthesis Pre-clinical studies, including: initial pharmacology and toxicology to screen out compounds that are unlikely to be promising candidates for PET or SPECT imaging; radiolabeling procedures; in vitro and ex vivo autoradiography; in vivo imaging including micro PET (rodent and/or primate); and studies of pharmacological specificity, biodistribution, and pharmacokinetics Model development for quantitation, including development and evaluation of pharmacokinetic models and use of animal models of gradient of binding sites/enzymes to assess sensitivity to changes Determination of toxicology/pathology (FDA approvable) for submission of and Radioactive Drug Research Committee (RDRC) or Investigational New Drug (IND) application IND application development and submission to the FDA prior to pilot human studies Pilot human imaging studies with normal controls, pharmacological challenges with analyses of radiometabolites under the auspices of IRB approval (i.e., RDRC or IND development and submission) Clinical studies in patient/disease population or experimental manipulations See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement. Section II. Award Information
1. Mechanism(s) of Support This funding opportunity will use the STTR (R41/R42) grant mechanism(s). Applications may be submitted for support as Phase I, Phase II, or Fast-Track grants as described in the SF424 (R&R) SBIR/STTR Application Guide (MS Word or PDF). This FOA runs in parallel with two FOAs of similar scientific intent: PA-06-017, which utilizes the R41/R42 grant mechanisms, and PA-03-112, which utilizes the exploratory/developmental (R21, R33) grant mechanisms.
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. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Future unsolicited, competing-continuation applications based on this project will compete with all STTR applications and will be reviewed according to the customary peer review procedures. 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 Research and Related budget component found in the application package attached to this announcement in Grants.gov Apply. 2. Funds Available The SF424 (R&R) SBIR/STTR Application Guide (MS Word or PDF) indicates the statutory guidelines of funding support and project duration periods for STTR Phase I and Phase II awards. For this funding opportunity, budgets up to $250,000 total costs per year and time periods up to 2 years for Phase I may be requested. Budgets up to $450,000 total costs per year and up to 3 years may be requested for Phase II. Total costs include direct costs, F&A, and fee/profit. Applicants must provide thorough justification for such deviations in the grant application; this information will be evaluated during the peer review process and again by NIH staff prior to making an award. 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 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 (SBA) Government Contracting Area Office or Office of Size Standards. One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an STTR awardee organization must be space that is available to and under the control of the STTR awardee for the conduct of its portion of the proposed project. Title 13 C.F.R. 121.3 also states that control or the power to control exists when “key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise.” Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control. For purposes of the STTR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13C.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. 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 principal investigator’s official relationship with the grantee must entail sufficient opportunity for the principal investigator 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 principal investigator 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: PD/PI with a full-time, university appointment may also have appointments with other organizations (with or without salary) and still appropriately consider his or her commitment to the university to be “full-time,” consistent with the personnel policies and procedures of the university applied on a routine basis. The PD/PI’s commitment to the university and other organizations (including the applicant small business concern) cannot exceed 100% of his or her total professional effort. PD/PI with a full-time, 12-month appointment with a small business concern would be considered to have a commitment to the applicant organization of 100% of his or her total professional effort.
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 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 the “Contractual Arrangements” portion of the Research Plan section of the application. 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. Likewise, identical or essentially identical grant applications submitted by different applicant organizations will not be accepted. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and another HHS FOA, including the SBIR or STTR Parent FOAs (see Small Business Funding Opportunities web page). Section IV. Application and Submission Information
To download an Application Package and Instructions for completing the SF424 Research and Related (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that site. A one-time registration is required for institutions at both: Grants.gov (http://www.grants.gov/GetStarted) and at eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm) PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons. Several additional separate actions are required before an applicant SBC can submit an application through Grants.gov. See "Preparing for Electronic Submission" at http://era.nih.gov/ElectronicReceipt/preparing.htm. Several of the steps of the registration process could take up to two weeks. Therefore, applicants should immediately check with their business official to determine whether their small business is already registered in both Grants.gov and the Commons. Note: The STTR applicant organization must officially affiliate the PD/PI with the small business concern in the Commons if the PD/PI is not an employee of the small business concern. Following are the steps to affiliate a PD/PI to the applicant organization/institution: 1) PD/PI gives Commons user ID and email address to the administrator of the applicant institution. (The email address must be the one that is contained in the Personal Profile for the PI.) 2) Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the Accounts Administrator.) 3) Administrator selects "Administration" tab and then "Accounts" tab. 4) Administrator selects "Create Affiliation" tab. 5) Administrator enters the Commons User ID and Email address into the appropriate fields and clicks "Submit." Note: The account cannot have any other roles attached to it other than the PD/PI. 1. Request Application Information Applicants must download the SF424 (R&R) application forms and instructions for this FOA through the Grants.gov Apply http://www.grants.gov/Apply Web site. 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) 435-0714, Email: GrantsInfo@nih.gov. 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) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this announcement in Grants.gov Apply will include all applicable components, required and optional. A completed application in response to this announcement 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 Subaward Budget Form PHS398 Cover Page SupplementPHS398 Research PlanPHS398 ChecklistSBIR/STTR Information Optional Components: PHS398 Cover Letter File 3. Submission Dates and Times See Section IV.3.A for details. 3.A. Submission, Review and Anticipated Start Dates Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm AIDS application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm Council Review Date: http://grants.nih.gov/grants/funding/submissionschedule.htm Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm 3.A.1. Letter of Intent A letter of intent is not required for the funding opportunity. 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 November 7, 2005 (i.e., the Open Date on Grants.gov) and must be submitted no later than 8:00 p.m. Eastern Time on the application submission date described above (Section IV.3.A.). If an application is not submitted 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 2 business days of notification of the NIH validation. Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR), NIH. Incomplete applications will not be reviewed. The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an Introduction addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R). 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. 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 (http://grants.nih.gov/grants/policy/policy.htm). 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 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. STTR Phase I applications: Although preliminary data are not required, they may be included. Items 2-5 of the Research Plan component may not exceed 15 pages, including tables, graphs, figures, diagrams, and charts. “Introduction” (required for a resubmission application) is limited to one page.
2. Review and Selection Process Applications submitted for this funding opportunity will be assigned to the Institutes/Centers (ICs) on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. 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 Receive a second level of review by an appropriate national advisory council or board. 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: Scientific merit of the proposed project as determined by peer review Availability of funds Relevance to program priorities 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. Significance Approach Innovation Investigator Environment Additional Review Criteria 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, or preventative interventions that drive this field? Does the application lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs? Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are the milestones and evaluation procedures appropriate? Innovation: Are the aims original and innovative? Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Investigator: Is the PD/PI appropriately trained and capable of coordinating and managing the proposed STTR? Are the investigators and 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 (MS Word or PDF) 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 “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, 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 (MS Word or PDF) and the SBIR/STTR Information component? 3. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-SBIR/STTR funding sources that would enhance the likelihood for commercialization? 4. Does the project carry a high degree of commercial potential, as described in the Commercialization Plan? Phase I and Phase II Fast-Track applications that satisfy all of the review criteria will receive a single rating. For Fast-Track applications, the Phase II portion may not be funded until a Phase I final report and other documents necessary for continuation have been received and assessed by program staff that the Phase I milestones have been successfully achieved. Items 2-5 of the Research Plan may not exceed 25 pages. That is, the combined Phase I and Phase II plans for a Fast-track application (for items 2-5) must be contained within the 25-page limit. 2.A. Additional Review Criteria: In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score: Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See item 6 of the Research Plan component of the SF424 (R&R). Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See item 7 of the Research Plan component of the SF424 (R&R). Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) will be assessed. Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate. 2.B. Additional Review Considerations Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods? Period of Support: The appropriateness of the requested period of support in relation to the proposed research. 2.C. Sharing Research Data The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm. (See FAQ #13.) 2.D. Sharing Research Resources NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible. Program staff will be responsible for the administrative review of the plan for sharing research resources. The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting. 3. Anticipated Announcement and Award Dates Not applicable
1. Award Notices Summary Statements: Effective October 1, 2005 NIH will no longer send hard copies of the Summary Statements. Summary Statements will be accessible electronically, see NOT-OD-05-075 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-075.html. 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 Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions. 2. Administrative and National Policy Requirements All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of 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 NoA and will be provided to the Principal Investigator and the appropriate institutional official at the time of award. 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, and financial or grants management issues: 1. Scientific/Research Contacts: Margaret Grabb, Ph.D.
Email: mgrabb@mail.nih.gov Daofen Chen, Ph.D. |Program Director, System and Cognitive Neuroscience National Institute of Neurological Disorders and Stroke 6001 Executive Boulevard, Room 2175, MSC 9523 Bethesda, MD 20892-9523 Telephone: (301) 496-1917 FAX: (301) 402-1501 Email: dc342b@nih.gov Susan Molchan, M.D. Program Director, Alzheimer's Disease Clinical Trials Neuroscience and Neuropsychology of Aging Program National Institute on Aging Gateway Bldg., Suite 350 7201 Wisconsin Ave. Bethesda, MD 20892-9205 Telephone: (301)496-9350 FAX: (301)496-1494 Email: molchans@mail.nih.gov Lynn Luethke, Ph.D. Division of Scientific Programs |National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C Bethesda, MD 20892-7180 Telephone: (301) 402-3458 Email: luethkel@nidcd.nih.gov
|National Institute on Drug Abuse 6001 Executive Boulevard, Room 4275, MSC 9555 Bethesda, MD 20892-9555 Telephone: 301-435-1304 Email: rr82u@nih.gov