and Human Services (HHS)
EXPIRED
Department of Health and Human
Services
Participating Organizations
National
Institutes of Health (NIH) (http://www.nih.gov)
Program Announcement (PA) Number: PA-09-094
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) SBIR/STTR Application Guide.
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).
IMPORTANT: A registration process in Grants.gov and eRA Commons is necessary before submission. Applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)Due
Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
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, Review,
and Anticipated Start Dates
1. Letter of Intent
B. Submitting an
Application Electronically to the NIH
C. Application
Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and
Information
Section
V. Application Review Information
1.
Criteria
2. Review and Selection Process
A. Additional
Review Criteria
B. Additional
Review Considerations
3. Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1.
Award Notices
2. Administrative and National Policy
Requirements
3.
Reporting
Section
VII. Agency Contact(s)
1.
Scientific/Research Contact(s)
2. Peer Review Contact(s)
3.
Financial/Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Background
Liver and biliary diseases affect Americans of all ages and all walks of life. Collectively liver and biliary diseases rank in the top 10 causes of mortality in the United States. Chronic liver diseases affect between 5 and 10 percent of Americans and account for 1 to 2 percent of deaths in the United States. Gallbladder disease affects an estimated 20 million Americans and causes considerable morbidity and occasional mortality. Liver cancer currently ranks 8th as a cause of cancer deaths and has been increasing markedly as a cause of cancer in the United States over the last decade. Yearly economic costs for chronic liver disease and cirrhosis are estimated to be $1.6 billion, for liver cancer $1.3 billion and for gallbladder disease $6 billion.
Liver and biliary diseases can be caused by infectious agents, inherited defects, metabolic disturbances, alcohol, toxins and environmental toxicants. The most common causes of liver diseases are chronic hepatitis C, alcohol liver disease, nonalcoholic fatty liver disease, chronic hepatitis B, autoimmune liver diseases and drug-induced liver diseases. Many of these conditions can be prevented or treated, but if not, they can lead to progressive liver injury, liver fibrosis and ultimately cirrhosis, portal hypertension, end-stage liver disease and, in some instances, liver cancer. Currently, the only therapy for end-stage liver disease is liver transplantation. More than 5000 liver transplants are done in the United States each year (including more than 500 in children). At least 17,000 persons are on a waiting list for liver transplantation and as many as 1500 die yearly while waiting. The needs and challenges in liver disease research are many.
In February 2005, the Digestive Diseases Interagency Coordinating Committee of the National Institutes of Health (NIH) released a trans-NIH Action Plan for Liver Disease Research. The text of this Action Plan is available on the NIH website at: http://liverplan.niddk.nih.gov.
The major purpose for development of the Action Plan was to identify areas of greatest scientific opportunity to serve as a stimulus to progress and help direct NIH research resources toward practical but important goals in the prevention and control of liver and biliary diseases. The Action Plan outlined a total of 214 research goals categorized into 16 areas of liver disease research. Many of these research goals are appropriate for Small Business Innovative Research Grants and represent excellent opportunities for translational research that could be conducted by a small business with expertise and interest in biomedical research. This announcement summarizes these opportunities and defines the interest of the sponsoring Institutes and Centers in funding such research.
Summary of Priority Areas
The objective of this FOA is to encourage and enable scientists at small businesses to develop and evaluate new technologies, drugs, devices, and approaches to diagnosis, management, and prevention of liver disease. Development of new technologies as well as application of existing technologies may be proposed. Studies may include use of animal models or human participants or both. If appropriate, plans for manufacturing and clinical evaluation of developed technologies, drugs, devices and innovative approaches should be included in the application. However, clinical trials beyond Phase I studies will not be considered appropriate to this announcement.
Appropriate topics for development and validation under this FOA include, but are not limited to, the following which are categorized into four major areas and which incorporate research goals from the Action Plan for Liver Disease Research:
Diagnostic Assays. A specific diagnosis can be made in most liver diseases but may require specialized testing or an invasive procedure. In some instances, diagnostic assays are not generally available and may lead to delay or mistakes in diagnosis. More accurate, commercially available tests are needed for several liver diseases and conditions.
Biomarkers and Imaging Techniques. Biomarkers and more sensitive imaging techniques may allow for non-invasive means of assessing the liver and obviate the need for liver biopsy in diagnosis, staging and grading of liver diseases.
Pharmacotherapy. Safer and more effective disease-specific as well as non-specific therapies for liver disease are needed. Understanding of pathways of liver cell injury, repair, and regeneration are likely to lead to new and innovative approaches to treat liver diseases.
Gene Therapy. Gene therapy holds enormous promise for therapy and potential cure of many inherited as well as acquired liver diseases. Advances in gene therapy could well replace liver transplantation for several liver diseases.
Liver Assist Devices. Currently there are no means of providing support to liver function in the face of liver failure or after major hepatectomy. Liver assist devices could be life-saving as a bridge to liver transplantation (while awaiting an appropriate donor liver) in a patient with primary graft non-function or acute liver failure or while awaiting the normal processes of regeneration to occur in acute liver failure or delayed regeneration after partial hepatectomy.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
1. Mechanism(s) of Support
This funding opportunity will use the Small Business Technology Transfer (STTR [R41/R42] grant mechanisms. Applications may be submitted for support as Phase I, Phase II, or Fast-Track grants as described in the SF424 (R&R) SBIR/STTR Application Guide.
Small business concerns that have received a Phase I STTR grant may apply for Phase II funding of that project. 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. STTR Phase II applications will compete with all STTR applications and will be reviewed according to the customary peer review procedures. Applications for STTR Phase II Competing Renewal grants will be accepted by only those ICs described in the current SBIR/STTR Program Descriptions and Research Topics of the NIH, CDC and FDA.
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses Just-in-Time information concepts. The modular budget format is not accepted for STTR grant applications. Applicants must complete and submit budget requests using the SF424 Research and Related (R&R) Budget component found in the application package attached to this FOA in Grants.gov/Apply. All other participating organizations, including the single, partnering research institution, must complete and submit requests using the Research & Related Subaward Budget Attachment(s) Form contained in the SF424 (R&R) application package.
2. Funds AvailableAwards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.
The SF424 (R&R) SBIR/STTR Application Guide indicates the statutory guidelines of funding support and project duration periods for Phase I and Phase II STTR awards. Phase I awards normally may not exceed $100,000 total for a period normally not to exceed 1 year. Phase II awards normally may not exceed $750,000 total for a period normally not to exceed 2 years. These award levels and project periods are statutory guidelines, not ceilings. Therefore, applicants are encouraged to propose a budget and project duration period that is reasonable and appropriate for completion of the research project. STTR Phase II Competing Renewal budgets must be submitted in accordance with participating IC-specific budget limitations described in the current SBIR/STTR Program Descriptions and Research Topics of the NIH, CDC and FDA.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
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 of STTR Phase I and
Phase II, meets all of the following criteria:
1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;
3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and
4. Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are 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. 121.3-2(a). The term "number of employees" is defined in 13 C.F.R. 121.3-2(t).
Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Office of Size Standards (http://sba.gov/size).
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 CFR 121.3 also states that control or the power to control exists when key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise. Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.
For purposes of the 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 SBAs size regulations, 13 CFR 121.106 Small Business Size Regulations.
Note regarding affiliation arising under stock options, convertible securities, and agreements to merge: In determining size, SBA considers stock options, convertible securities, and agreements to merge (including agreements in principle) to have a present effect on the power to control a concern. SBA treats such options, convertible securities, and agreements as though the rights granted have been exercised. See http://edocket.access.gpo.gov/cfr_2005/janqtr/pdf/13cfr121.103.pdf.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.
Note: An applicant organization that has been determined previously by SBA to be other than small for a size standard of not more than 500 employees or for purposes of the SBIR/STTR program, must be recertified by the SBA prior to any future SBIR/STTR awards.Any individual with the skills, knowledge,
and resources necessary to carry out the proposed research is invited to work
with his/her organization to develop an application for support. Individuals
from underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application
for projects that require a team science approach that clearly does not fit
the single-PD/PI model. Additional information on the implementation plans and
policies and procedures to formally allow more than one PD/PI on individual
research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must
be registered in the NIH eRA Commons prior to the submission of the application
(see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. Each PD/PI is responsible and accountable to the grantee organization, or as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
For a STTR application, the Project Director/Principal Investigators (PD/PIs) may be employed with the SBC or the single, partnering non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual. For projects with multiple PD/PIs, the Contact PD/PI may be from either the SBC or the single, partnering research institution.
As defined in 42 CFR 52, the PD/PI is the single individual designated by the grantee in the grant application who is responsible for the scientific and technical direction of the project. When the proposed PD/PI clearly does not have sufficient qualifications to assume this role, the application is not likely to receive a favorable evaluation.
Each PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration. In all cases, however, the PD/PIs official relationship with the grantee must entail sufficient opportunity for the PD/PI to carry out his or her responsibilities for the overall scientific and technical direction of the project. Documentation (e.g., consultant, consortium and contractual arrangements) describing the official relationship of the PD/PI with the applicant small business concern should NOT be submitted with the grant application, but a copy must be furnished upon the request of the NIH awarding component.
Following are examples of situations describing the official relationship of the PD/PI with the applicant small business organization:
2. Cost
Sharing or Matching
This
program does not require cost sharing as defined in the current NIH Grants Policy
Statement.
Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date (and any other due dates for FY2010 funding and beyond), all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016.
Original new and competing renewal applications that were submitted for due dates prior to January 25, 2009 will be permitted two resubmissions (amendments A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.
In STTR Phase I and Phase II, at least 40% of the work must be performed by the small business concern and at least 30% of the work must be performed by the single, partnering research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and F&A/indirect costs attributable to each party, unless otherwise described and justified in Item 13, Consortium/Contractual Arrangements, of the PHS398 Research Plan component of the SF424 (R&R) application forms.
Applicants may submit more than one application, provided that each application is scientifically distinct. The NIH will accept as many "different" applications as the applicant organization chooses. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process, or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this STTR funding opportunity and any other HHS FOA, including the current SBIR and STTR Parent FOAs.
Likewise,
identical or essentially identical grant applications submitted by different
organizations will not be accepted. Applicant organizations
should ascertain and assure that the materials they are submitting on behalf of
the principal investigator are the original work of the principal investigator
and have not been used elsewhere in the preparation and submission of a similar
grant application. Applications to the NIH are grouped by scientific discipline
for review by individual Scientific Review Groups and not by disease or disease
state. The reviewers can thus easily identify multiple grant applications for
essentially the same project. In these cases, application processing may be
delayed or the application(s) may be returned to the applicant without review.
It is unlawful to enter into contracts or grants requiring essentially equivalent work or effort. Essentially equivalent work or effort occurs when (1) substantially the same research is proposed for funding in more than one contract proposal or grant application submitted to the same Federal agency; (2) substantially the same research is submitted to two or more different Federal agencies for review and funding consideration; or (3) a specific research objective and the research design for accomplishing an objective are the same or closely related in two or more proposals or awards, regardless of the funding source. If there is any question concerning essentially equivalent work or effort, it must be disclosed to the soliciting agency or agencies before award.
Only one Phase II award may be made for a single SBIR/STTR project.You may submit a STTR Phase II application either before or after expiration of the Phase I budget period, unless you elect to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I grantee organization should submit a Phase II application within the first six receipt dates following the expiration of the Phase I budget period.
STTR Phase II awardees may submit a STTR Phase II Competing Renewal application for projects that require extraordinary time and effort in the R&D phase and may or may not require FDA approval for the development of such projects. Applicants are strongly encouraged to contact NIH IC program staff prior to submitting STTR Phase II Competing Renewal applications.Section IV. Application and Submission Information
To
download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR
Application Guide for completing the SF424 (R&R) forms for this FOA, use
the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions
provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.
Several additional separate actions are required before an applicant SBC can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Registered
2) Organizational/Institutional Registration in the eRA Commons
3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
To affiliate the PD/PI with the applicant small business concern:
Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.
Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and the eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.
1.
Request Application Information
Applicants must download the SF424 (R&R)
application forms and SF424 (R&R) SBIR/STTR Application Guide for this FOA
using the Apply for Grant Electronically button in this FOA or through Grants.gov/Apply.
Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.
For further assistance contact GrantsInfo: Telephone
301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2.
Content and Form of Application Submission
Prepare all STTR applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) SBIR/STTR Application Guide.
The SF424 (R&R) SBIR/STTR Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PIs assigned eRA Commons User ID). Failure to include this data field will cause the application to be rejected.
Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/ APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:
Required Components:SPECIAL INSTRUCTIONS
Applications with Multiple PDs/PIs
When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The Contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above. For STTR, the contact PD/PI may be from either the SBC or the single, partnering research institution. All funding for STTR projects goes to the small business concern, so funding for PD/PIs from other organizations must be requested via a subcontract with the small business using the Research & Related Subaward Budget Attachment(s) Form.
Information for the Contact PD/PI should be entered in Item 13 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of PD/PI. Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the Credential field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan, must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
3.
Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date:March 5, 2009 (Earliest date an application may be
submitted to Grants.gov)
Application Due Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council
Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates
apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
3.A.1.
Letter of Intent
A
letter of intent is not required for the funding opportunity.
3.B.
Submitting an Application Electronically to the NIH
To submit an application in response to this FOA, applicants may use the Apply for Grant Electronically button in this FOA
or link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow steps
1-4.
Note: Applications must only be submitted electronically.
PAPER
APPLICATIONS WILL NOT BE ACCEPTED.
3.C.
Application Processing
3.C.1 Submitting On-Time
Applications may be submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5:00 p.m. local
time(of the applicant
institution/organization) on the application due date(s). (See Section
IV.3.A. for
all dates.) If
an application is not submitted by the due date(s) and time, the application
may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered on-time:
Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.
Submission to Grants.gov is not the last step - applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been successfully submitted through Grants.gov NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons. The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays. All errors must be corrected to successfully complete the submission process. Warnings will not prevent the application from completing the submission process.
Note that the following caveats apply:
3.C.3 Viewing an Application in the eRA Commons
Once any eRA identified errors have been addressed and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR). Incomplete applications will not be reviewed.
4. Intergovernmental ReviewPD/PI Credential (e.g., Agency Login)
The NIH requires each PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) SBIR/STTR Application Guide.
All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide are to be followed, with the following requirements.
STTR Phase I applications
STTR Phase II and Phase II Competing Renewal Applications
Applicants are strongly encouraged to contact program staff prior to submitting STTR Phase II Competing Renewal applications.
STTR Fast-Track Applications
Resubmissions
Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Appendix MaterialsApplicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) SBIR/STTR Application Guide (see http://grants.nih.gov/grants/funding/424/index.htm).
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process. Phase I SBIR/STTR Appendix materials are not permitted unless specifically requested by NIH.
NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing (for example, human subject concerns, the Small Business Act provisions, etc.), this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)
(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with NIH Institute/Center (IC) program staff likely to accept assignment of their application (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/)
Section V. Application Review Information
1.
Criteria
Only the review criteria described
below will be considered in the review process.
2. Review and
Selection Process
Review Process
Applications
submitted for this funding opportunity will be assigned to the ICs for funding
consideration on the basis of established PHS referral guidelines.
Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.
As part of the scientific peer review, all applications will:
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Scored Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change 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 product, process or service? (In the case of Phase II, Fast-Track, and Phase II Competing Renewals, does the Commercialization Plan demonstrate a high probability of commercialization?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for (1) Protections for Human Subjects, and (2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment. Will the scientific environment
in which the work will be done contribute to the probability of success?
Are the institutional support, equipment and other physical resources available
to the investigators adequate for the project proposed? Will the project
benefit from unique features of the scientific environment, subject
populations, or collaborative arrangements?
Additional Review
Criteria
As
applicable for the project proposed, reviewers will consider
the
following additional items in the determination of scientific and technical
merit, but will not give separate scores for these items.
For Phase II Applications Only. When reviewing Phase II applications, 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?
For Phase I/Phase II Fast-Track Applications Only. When reviewing Phase I/Phase II Fast-Track applications, reviewers will consider the following:
1.
Does the Phase I application specify clear, appropriate, measurable goals
(milestones) that should be achieved prior to initiating Phase II?
2. 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?
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: (1) risk to subjects, (2) adequacy of protection against risks, (3) potential benefits to the subjects and others, (4) importance of the knowledge to be gained, and (5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: (1) the justification for the exemption, (2) human subjects involvement and characteristics, and (3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: (1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; (2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; (3) adequacy of veterinary care; (4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and (5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.
Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans.
Reviewers will comment on whether the following Resource Sharing Plans, or the
rationale for not sharing the following types of resources, are reasonable: 1)
Data Sharing Plan (http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm);
2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html);
and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Budget and Period of Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Selection Process
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended SBIR or STTR applications. The following will be considered in making funding decisions:
3. Anticipated Announcement and Award
Dates
Not
Applicable
1. Award Notices
After
the peer review of the application is completed, the PD/PI will be able to
access his/her Summary Statement (written critique) via the eRA Commons.
If
the application is under consideration for funding, NIH will request
"just-in-time" information from the applicant. For details,
applicants may refer to the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General.
A
formal notification in the form of a Notice of Award (NoA) will be provided to
the applicant organization. The NoA signed by the grants management officer is
the authorizing document. Once all administrative and programmatic issues have
been resolved, the NoA will be generated via email notification from the
awarding component to the grantee business official.
Selection of an application for award is
not an authorization to begin performance. Any costs incurred before receipt of
the NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See also Section
IV.5., Funding Restrictions.
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.
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. Item 3 of the Research Plan may not exceed 12 pages. That is, the
combined Phase I and Phase II plans for a Fast-Track application (for Item 3) must be contained within the
12-page limitation.
2. Administrative and National Policy Requirements
All
NIH grant and cooperative agreement awards include the NIH
Grants Policy Statement as part of the NoA.
For these terms of award, see the NIH Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General
and Part II: Terms and
Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific
Types of Grants, Grantees, and Activities.
3. Reporting
NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.
Failure to submit timely final reports may affect future funding to the organization or awards with the same principal investigator.
For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF 424 (R&R) SBIR/STTR Application Guide.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 Contact(s):
Christine L.
Densmore, M.S.
Program Director
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Rm 649
Bethesda, MD 20892-5450
Phone: (301) 402-8714
Fax: (301) 480-8300
Email: [email protected]
Edward
Doo, M.D.
Program Director
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd, Room 651
Bethesda, MD 20892-5450
Phone: (301) 451-4524
Fax: (301) 480-8300
Email: [email protected]
Jerrold
(Jerry) Heindel, Ph.D.
Scientific
Program Administrator
National
Institute of Environmental Health Sciences
Division
of Extramural Research and Training
Cellular,
Organ and Systems Pathobiology Branch
POB
12233
Research
Triangle Park, NC, 27709
Phone:
(919) 541-0781
Fax:
(919) 541-5064
Email: [email protected]
Svetlana
Radaeva, Ph.D.
Program
Director
Division
of Metabolism and Health Effects
National
Institute on Alcohol Abuse and Alcoholism
National
Institutes of Health
5635
Fishers Lane, Room 2033
Bethesda,
MD 20892-9304
Phone:
(301) 443-1189
Fax:
(301) 594-0673
Email: [email protected]
Alan
McLaughlin, Ph.D.
Director,
Division of Applied Science and Technology
National
Institute of Biomedical Imaging and Bioengineering
Two
Democracy Plaza, 200
6707 Democracy Boulevard
Bethesda, MD 20892-5477
Phone:
(301) 496-9321
Fax:
(301) 480-4973
Email: [email protected]
Jag
H. Khalsa, Ph.D.
Chief, Medical Consequences Branch
Division of Pharmacotherapies and Medical
Consequences of Drug Abuse (DPMC)
National Institute on Drug Abuse, NIH
6001 Executive Boulevard, Room 4137, MSC 9551
Bethesda, MD 20892-9551
Phone: (301) 443-2159
Fax: (301) 443-2599
Email: [email protected]
Greg Evans, PhD
Program
Director
Team
Leader, Cancer Biology/Control/Prevention
SBIR
Development Center
National
Cancer Institute
National
Institutes of Health
31
Center Drive
Building
31, Room 10A19
Bethesda,
MD 20892-2580
Phone:
301-594-8807
Fax:
301-480-4082
E-mail: [email protected]
Asad
Umar, DVM, PhD
Chief, Gastrointestinal & Other Cancers Research Group
Division of Cancer Prevention
National Cancer Institute
Bethesda, MD 20892
Phone:
301.594.7671
Fax:
301-435-6344
Email: [email protected]
2. Peer Review Contact(s):
Not
Applicable
3. Financial or Grants Management Contact(s):
Florence Danshes
Senior
Grants Management Specialist
Grants
Management Branch
National
Institute of Diabetes and Digestive and Kidney Diseases
6707
Democracy Boulevard, Room 734
Bethesda,
MD 20892
Phone:
301-594-8861
Fax: 301-480-3504
Email: [email protected]
Pamela
Clark
Grants
Management Specialist
National
Institute of Envirnmental Health Sciences
Division
of Extramural Research and Training
Grants
Management Branch
POB
12233
Research
Triangle Park, NC, 27709
Phone:
(919) 541-7629
Fax:
(919) 541-2860
Email: [email protected]
Judy
S. Fox
Chief
Grants Management Officer
National
Institute on Alcohol Abuse and Alcoholism
5635
Fishers Lane, Room 3023, MSC 9304
Bethesda,
MD 20892-9304
Phone:
301-443-4704
FAX:
301-443-3891
Email: [email protected]
Angelos
Bacas
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Boulevard, MSC 5469
Suite 900, Democracy II
Bethesda, MD 20892-5469
Phone: 301-451-4782
Email: [email protected]
Rosemary Ward
Office of Grants Administration
National Cancer Institute
6120
Executive Boulevard, EPS Room 243, MSC 7150
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular delivery)
Rockville, MD 20892 (for non-USPS delivery)
Phone: 301-496-3182
Fax: 301-496-8662
E-mail: [email protected]
Anne
Ryan
Program
Specialist
National
Cancer Institute
6130
Executive Boulevard
Suite
2025
Rockville,
MD 20852
Phone:
301 402-0910
Fax: 301-480-4109
Email: [email protected]
Section VIII. Other Information
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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