This notice has expired. Check the NIH Guide for active opportunities and notices.

EXPIRED

Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Cancer Institute (NCI/NIH), (http://www.cancer.gov/)
National Eye Institute (NEI/NIH), (http://www.nei.nih.gov/)
National Heart, Lung, and Blood Institute (NHLBI/NIH), (http://www.nhlbi.nih.gov/index.htm)
National Human Genome Research Institute (NHGRI/NIH), (http://www.genome.gov/)
National Institute on Aging (NIA/NIH), (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA/NIH), (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID/NIH), (http://www3.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS/NIH), (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB/NIH), (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD/NIH), (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD/NIH), (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR/NIH), (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK/NIH), (http://www.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA/NIH), (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS/NIH), (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS/NIH), (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH/NIH), (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS/NIH), (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR/NIH), (http://www.ninr.nih.gov/)
National Library of Medicine (NLM/NIH), (http://www.nlm.nih.gov/)
National Center for Complementary and Alternative Medicine (NCCAM/NIH), (http://nccam.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD/NIH), (http://ncmhd.nih.gov/)
National Center for Research Resources (NCRR/NIH), (http://www.ncrr.nih.gov/)

Title: Small Business Technology Transfer Program Parent Announcement (STTR [R41/R42]): Electronic Submission of Grant Applications through Grants.gov

Announcement Type
New

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 Application Instruction 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 8:00 p.m. Eastern Time on the submission date (see Key Dates below).

2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.

This FOA is for ONLY the standard NIH STTR submission date of December 1, 2005 and, for AIDS/AIDS-related applications, for the January 2, 2006 date.

Program Announcement (PA) Number: PA-06-007

Catalog of Federal Domestic Assistance Number(s)

93.113, 93.114, 93.115, 93.118, 93.121, 93.135, 93.136, 93.143, 93.161, 93.172, 93.173, 93.184, 93.185, 93.197, 93.206, 93.208, 93.213, 93.233, 93.242, 93.268, 93.273, 93.279, 93.283, 93.286, 93.307, 93.361, 93.389, 93.393, 93.394, 93.395, 93.396, 93.399, 93.837, 93.838, 93.839, 93.846, 93.847, 93.848, 93.849, 93.853, 93.855, 93.856, 93.859, 93.865, 93.866, 93.867, 93.879, 93.941, 93.942, 93.943, 93.947, 93.978

Key Dates

Release Date: October 17, 2005
Letters of Intent Receipt Date: Not applicable.
Application Submission Date: December 1, 2005
AIDS Application Submission Date: January 2, 2006
Peer Review Date(s): February-March, 2006
Council Review Date(s): May-June, 2006
Earliest Anticipated Start Date: July 2006
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: January 4, 2006

Due Dates for E.O. 12372
Not applicable

Additional Overview Content

Executive Summary

The purpose of this FOA from NIH is to invite eligible United States small business concerns (SBCs) to submit STTR Phase I, Phase II, and Fast-Track grant applications through Grants.gov. (CDC and FDA do not accept STTR grant applications).

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, 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 Contacts
1. Scientific/Research and Financial/Grants Management Contacts
2. Peer Review Contacts

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives
See NIH, CDC, and FDA SBIR/STTR Program Descriptions and Research Topics.

The research topics shown in the solicitation cited above represent program areas that may be of interest to applicant small business concerns in the development of projects that have potential for commercialization. Small business concerns are encouraged to submit STTR grant applications in these areas.

In addition to the general research areas described in the NIH, CDC, and FDA SBIR/STTR Program Descriptions and Research Topics (http://grants.nih.gov/grants/funding/sbirsttr1/2005-2_SBIR-STTR-topics.doc), some HHS awarding components have identified additional, specific STTR funding opportunities of potential interest to SBCs, as listed in the RFA, PA, PAR, and PAS announcements below. If you know of other FOAs with SF424 (R&R) requirements, but do not find them listed below, please search for those in Grants.gov/FIND as a separate FOA.

Applicants interested in these specific opportunities listed in the table below must use the application package from this parent STTR FOA in Grants.gov/FIND (i.e., PA-06-007) to apply. If applicable, applicants should then reference one of the opportunities below in the Cover Letter component of the SF424 (R&R) Application package to be considered under the specific funding opportunity.

Additional Research Topics

Issuing Organization

Title

PA-03-123

NHLBI

DEVELOPMENT OF DIAGNOSTIC SCREENING TEST FOR SALT SENSITIVITY (SBIR/STTR)

PA-03-129

NIAAA

COMPETING CONTINUATION AWARDS OF SBIR/STTR PHASE II GRANTS FOR PHARMACOLOGICAL AGENTS AND BIOMARKERS FOR ALCOHOLISM AND ALCOHOL-RELATED DISEASES

PA-03-154

NIDA

SBIR/STTR PHASE II COMPETING CONTINUATION AWARDS (NIDA)

PA-04-028

NHLBI

COMPETING CONTINUATION AWARDS OF SBIR PHASE II GRANTS FOR HEART, LUNG, BLOOD, AND SLEEP DISORDERS

PA-04-059

NHLBI

SBIR/STTR TECHNOLOGIES FOR MONITORING AND PERFORMING RESUSCITATION

PA-04-089

NCRR

NEW TECHNOLOGY FOR PROTEOMICS AND GLYCOMICS (SBIR/STTR)

PA-04-156

NHLBI

BIOENGINEERING APPROACHES TO ENERGY BALANCE AND OBESITY (SBIR/STTR)

PA-05-014

NHGRI

Molecular Libraries Screening Instrumentation SBIR/STTR

PA-05-087

NIDCR

Drug Delivery Systems for Orofacial Disease (SBIR/STTR)

PA-05-044

NHLBI

Directed Stem Cell Differentiation for Cell Based Therapies for Heart, Lung, Blood, and Aging Diseases (SBIR/STTR)

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 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 (MS Word or PDF).

A parallel funding opportunity announcement of identical scientific scope (PA-06-006) utilizes the SBIR (R43/R44) grant mechanisms. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and another Department of Health and Human Services (HHS) funding opportunity announcement, including the HHS SBIR Parent FOA (PA-06-006).

Phase II applications in response to this funding opportunity will only be accepted as competing renewals (formerly competing continuations ) of previously funded Phase I STTR awards. The Phase II must be a logical extension of the Phase I research but not necessarily as a Phase I project supported in response to this funding opportunity.

The applicant SBC will be solely responsible for planning, directing, and executing the proposed project. Future unsolicited, competing renewal applications based on this project will compete with all STTR applications and will be reviewed according to the customary peer review procedures. Applications that are not funded in the competition described in this FOA may be submitted as RESUBMISSION applications through Grants.gov Apply using the standard NIH STTR submission dates of April 1, August 1, and December 1 (or January 2, May 1, or September 1 for AIDS and AIDS-related STTR applications).

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 detailed budget requests using the SF424 (R&R) 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.

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 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 SBC, which is characterized by an official relationship between the SBC and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration. In all cases, however, the PD/PI’s official relationship with the grantee must entail sufficient opportunity for the PD/PI to carry out his or her responsibilities for the overall scientific and technical direction of the project. Documentation (e.g., consultant, consortium and contractual arrangements) describing the official relationship of the PD/PI with the applicant small business concern should NOT be submitted with the grant application, but a copy must be furnished upon the request of the NIH awarding component.

The following are examples of situations describing the official relationship of the PD/PI with the applicant small business organization:

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

In STTR Phase I and Phase II, at least 40% of the work must be performed by the small business concern and at least 30% of the work must be performed by the single, partnering research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and F&A/indirect costs attributable to each party, unless otherwise described and justified in the Contractual Arrangements portion of the Research Plan section of the application.

The NIH will accept as many "different" applications as the applicant organization (SBC) chooses. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non-substantive modifications, can be applied to a variety of purposes. Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and another HHS funding opportunity, including the HHS parent SBIR (PA-06-006).

Section IV. Application and Submission Information

Registration and Instructions for Submission via Grants.gov

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:

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 for more details.

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 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) 710-0267, Email: [email protected].

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all STTR applications using the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR Application Guide (MS Word or PDF) instructions.

The SF424 (R&R) 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 Budget
Research & Related Subaward Budget Form

PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
SBIR/STTR Information

Optional Components:

PHS398 Cover Letter File

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates

Letter of Intent Receipt Date: A letter of intent is not required for this funding opportunity.
Application Submission Date: December 1, 2005
AIDS Application Submission Date: January 2, 2006
Peer Review Date: February-March, 2006
Council Review Date: April-May, 2006
Earliest Anticipated Start Date: July 2006

3.A.1. Letter of Intent
A letter of intent is not required for this 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.

Pre-Award Costs are allowable. A grantee organization may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing renewal award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide (MS Word or PDF) are to be followed, with the following requirements.

Note: While each section of the Research Plan needs to eventually be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits.

STTR Phase I applications:

There is no further limitation on the total number of pages for the entire Phase I application; however, applicants are encouraged to be succinct.

STTR Phase II applications:

STTR Fast-Track applications

Plan for Sharing Research Data

Applicants requesting $500,000 or more in direct costs in any year should include a brief one paragraph description of how final research data will be shared, or explain why data-sharing is not possible. The specific nature of the data to be collected will determine whether or not the final dataset may be shared. If the final data are not amenable to sharing, for example, if they are proprietary, this must be explained in the application. Under the Small Business Act, STTR grantees may withhold their data for four years after the end of the award. The Small Business Act provides authority for NIH to protect from disclosure and nongovernmental use all STTR data developed from work performed under an STTR funding agreement for a period of 4 years after the closeout of either a Phase I or Phase II grant unless NIH obtains permission from the awardee to disclose these data. The data rights protection period lapses only upon expiration of the protection period applicable to the STTR award, or by agreement between the small business concern and NIH. Applicants are encouraged to discuss their data-sharing plan with the Institute/Center staff likely to accept assignment of their application.

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. For more information on data sharing see http://grants.nih.gov/grants/policy/data_sharing/ and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm. (See FAQ #13.)

Sharing Research Resources

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

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590. See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

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

2. Review and Selection Process

Applications 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:

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

The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score.

All STTR Applications

Significance: Does the proposed project have commercial potential to lead to a marketable product, process or service? Does this study address an important problem? What may be the anticipated commercial and societal benefits that may be derived from the proposed research? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, 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)?

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 resubmission applications.

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

2. Are the improvements in the resubmission application appropriate?

Phase I/Phase II Fast-Track Application Review Criteria

For Phase I/Phase II Fast Track applications, the following criteria also will be applied:

1. Does the Phase I application specify clear, appropriate, measurable goals (milestones) that should be achieved prior to initiating Phase II?

2. Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in the SF424 (R&R) SBIR/STTR Application Guide (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.

Type 2 (Renewal) Phase II Competing Continuation Applications

In addition to the above review criteria described under ALL STTR applications, the following items will be applied to ALL Type 2 Competing Continuation (Renewal) Phase II applications in the determination of scientific merit and the priority score.

1. Does the activity as proposed address issues related to Federal regulatory approval processes?


2. Did the applicant submit a concise Commercialization Plan that adequately addresses the specific areas described in 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?

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 PD/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

Section VI. Award Administration Information

1. Award Notices

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 Grant Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (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).

3. Reporting

Awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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 and Financial/Grants Management Contacts:

Scientific/Research and Financial/Grants Management contacts for this program announcement are listed below.

Awarding Component

Scientific/Research Contact

Financial/Grants Mgmt. Contact

National Institute on Aging
http://www.nia.nih.gov

Dr. Michael-David A.R.R. Kerns
National Institute on Aging, NIH
Gateway Building, Suite 2C218
7201 Wisconsin Ave., MSC 9205
Bethesda, MD 20892-9205
Phone: 301-496-9322,
Fax: 301-402-2945
Email: [email protected]

Ms. Linda Whipp
Grants Management Officer
National Institute on Aging, NIH
Gateway Building, Room 2N212
7201 Wisconsin Ave., MSC 9205
Bethesda, MD 20892
Phone: 301-496-1472,
Fax: 301-402-3672
Email: [email protected]

National Institute on Alcohol Abuse and Alcoholism
http://www.niaaa.nih.gov

Dr. Karen P. Peterson
Acting Chief, Research Policy and Special Projects Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism, NIH
Room 2017
5635 Fishers Lane
Bethesda, MD 20892
Phone: 301-451-3883
Fax: 301-443-6077
Email: [email protected]

Ms. Judy Fox
Chief, Grants Management Branch
Office of Scientific Affairs
National Institute on Alcohol Abuse and Alcoholism, NIH
Room 3023
5635 Fishers Lane
Bethesda, MD 20892
Phone: 301-443-4704
Fax: 301-443-3891
Email: [email protected]

National Institute of Allergy and Infectious Diseases
http://www.niaid.nih.gov

Dr. Gregory Milman
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases, NIH
Room 2153
6700-B Rockledge Drive
Bethesda, MD 20892-7610
Phone: 301-496-8666
Fax: 301-402-0369
Email: [email protected]

Ms. Mary Kirker
Grants Management Officer
National Institute of Allergy and Infectious Diseases, NIH
Building 6700B - 6700B Rockledge Dr, Room 2115
6700B Rockledge Dr
Bethesda, MD 20892-7610
Phone: 301-496-7075
Fax: 301-480-3780
Email: [email protected]

National Institute of Arthritis and Musculoskeletal and Skin Diseases
http://www.niams.nih.gov/

Dr. Cheryl Kitt
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH
One Democracy Plz
6701 Democracy Blvd. Suite 800
Bethesda, MD 20892
Phone: 301-594-2463
Fax: 301-480-4543
Email: [email protected]

Ms. Melinda Nelson
Chief Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH
6701 Democracy Blvd. Suite 800
Bethesda, Maryland 20892
Phone: 301-435-5278
Fax: 301-480-5450
Email: [email protected]

National Institute of Biomedical Imaging and Bioengineering
http://www.nibib.nih.gov/

Mr. Todd Merchak
Program Director
National Institute of Biomedical Imaging and Bioengineering, NIH
Two Democracy Plz
6707 Democracy Blvd Suite 200
Bethesda, MD 20892-5477
Phone: 301-496-8592
Fax: 301-480-1614
Email: [email protected]

Ms. Florence Turska
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Blvd. Suite 900
Bethesda, MD 20892-5469
Phone: 301-496-9314
Fax: 301-480-4974
Email: [email protected]

National Cancer Institute
http://www.nci.nih.gov or
http://www.cancer.gov

Mr. Michael Weingarten
Program Manager
National Cancer Institute, NIH
31 Center Drive|
Room 10A52
Bethesda, MD 20892
Phone: 301- 496-1550
Fax: 301- 496-7807
Email: [email protected]

Mr. Ted Williams
Grants Management Specialist
National Cancer Institute, NIH
6120 Executive Blvd
Room. 243
Bethesda, MD 20892
Phone: 301-496-8785
Fax: 301-496-8601
Email: [email protected]

National Institute of Child Health and Human Development
http://www.nichd.nih.gov

Dr. Louis A. Quatrano
Program Director, BSRE
National Center for Medical Rehabilitation Research
National Institute of Child Health and Human Development, NIH
6100 Executive Boulevard,
Room 2A03
Bethesda, MD 20892-7510
Phone: 301-402-4221
Fax: 301-402-0832
Email: [email protected]

Ms. Annette Hanopole
Chief Grants Management Officer
National Institute of Child Health and Human Development, NIH
6100 Executive Boulevard
Room 8A01
Bethesda, MD 20892-7510
Phone: 301- 496-1304
Fax: 301- 451-5510
Email: [email protected]

National Institute on Drug Abuse
http://www.nida.nih.gov

Dr. Cathrine Sasek
National Institute on Drug Abuse, NIH
6001 Executive Boulevard
Room 5230, MSC 9591
Bethesda, Maryland 20892-9591
Phone: 301-443-6071
|Fax: 301-443-6277
Email: [email protected]

Ms. Diana Haikalis
Grants Management Specialist
National Institute on Drug Abuse, NIH
6001 Executive Boulevard,
Room 3119, MSC 9591
Bethesda, Maryland 20892-9591
Phone: 301-443-6710
Fax: 301-594-6849
Email: [email protected]

National Institute on Deafness and Other Communication Disorders
http://www.nidcd.nih.gov

Dr. Lynn E. Luethke
Program Director, Hearing Program
National Institute on Deafness and Other Communication Disorders, NIH
6120 Executive Blvd., 400-C
Rockville, MD 20852
Phone: 301-402-3458
Fax: 301-402-6251
Email: [email protected]

Mr. Christopher P. Myers
Lead Grants Management Specialist
National Institute on Deafness and Other Communication Disorders, NIH
45 Center Drive, MSC 6402
Bldg 45 Room 4AN44
Bethesda MD 20895-6402
Phone: 301-402-0909
Fax: 301-402-1758
Email: [email protected]

National Institute of Dental and Craniofacial Research
http://www.nidcr.nih.gov

Dr. Rosemarie Hunziker
Director, Technology Development and Industrial Relations
Center for Biotechnology and Innovation
National Institute of Dental and Craniofacial Research, NIH
Building 45, Room 4AN 24K
Bethesda, MD 20892-6402
Phone: 301-451-3888
Fax: 301-480-8318
Email: [email protected]

Ms. Mary Daley
Chief Grants Management Officer
National Institute of Dental and Craniofacial Research, NIH
Building 45, Room 4AN-44B
45 Center Drive
Bethesda, MD 20892-6402
P hone: 301-594-4808
Fax: 301-480-3562
Email: [email protected]

National Institute of Diabetes and Digestive and Kidney Diseases
http://www.niddk.nih.gov

Dr. Sanford A. Garfield
P rogram Director
National Institute for Diabetes and Digestive and Kidney Diseases, NIH
6707 Democracy Blvd.Rm. 685
Bethesda, MD 20892-5460
Phone: 301-594-8803
Fax: 301-402-6271
Email: [email protected]

Ms. Helen Y. Ling
Senior Grants Management Specialist
National Institute of Diabetes and Digestive and Kidney Diseases, NIH
2 Democracy Plaza
6707 Democracy Blvd, Room 732
Bethesda, MD 20892-5456
Phone: 301-594-8857
Fax: 301-480-3504
Email: [email protected]

National Institute of Environmental Health Sciences
http://www.niehs.nih.gov

Dr. Jerrold J. Heindel
Program Director
National Institute of Environmental Health Sciences, NIH
POB 121233 (EC-23)
Research Triangle Park, NC 27709
Phone: 919-541-0781
Fax: 919-541-5064
Email: [email protected]

Mr. Dwight Dolby
Grants Management Specialist
National Institute of Environmental Health Sciences, NIH
Research Triangle Park, NC 27709
Phone: 919-541-7824
Fax: 919-541-2860
Email: [email protected]

National Eye Institute
http://www.nei.nih.gov

Dr. Ralph Helmsen
Research Resources Officer
National Eye Institute, NIH
5635 Fishers Lane, Suite
1300Bethesda, MD 20892-9300
Phone: 301-451-2020
Fax: 301-402-0528
Email: [email protected]

Mr. William Darby
Chief, Grants Management Branch
National Eye Institute, NIH
5635 Fishers Lane
Suite 1300
Bethesda, MD 20892-9300
Phone: 301-451-2020
Fax: 301-496-9997
Email: [email protected]

National Institute of General Medical Sciences
http://www.nigms.nih.gov/

Dr. Peter Preusch
Program Director
Pharmacology, Physiology, and Biological Chemistry Division
National Institute of General
Medical Sciences, NIH
45 Center Drive
Bethesda, Maryland, 20892-6200
Phone: 301-594-3827
Fax: 301-480-2802
Email: [email protected]

Ms. Patrice Molnar
Grants Management Specialist
National Institute of General
Medical Sciences, NIH
Natcher Building, Rm. 2AN-38C
45 Center Drive MSC 6200
Bethesda, MD 20892-6200
Phone: 301-534-5136
Fax: 301-480-2554
Email:[email protected]

National Heart, Lung, and Blood Institute
http://www.nhlbi.nih.gov

Ms. Susan Pucie
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute, NIH
6701 Rockledge Dr
Two Rockledge Ctr, Room 10166
Bethesda, MD 20892-7950
Phone: 301-435-0079
Fax: 301-480-0867
Email: [email protected]

Ms. Suzanne White
Grants Management Officer
National Heart, Lung, and Blood Institute, NIH
6701 Rockledge Drive, Room 7160
Bethesda, MD 20892-7926
Phone: 301-435-0144
Fax: 301-480-3310
Email: [email protected]

National Human Genome Research Institute
http://www.genome.gov

Dr. Bettie J. Graham
Program Director
National Human Genome Research Institute, NIH
Suite 4076
5635 Fishers Lane
Rockville, MD 20852
Phone: 301-496-7531
FAX: 301-480-2770
Email: [email protected]

Ms. Cheryl Chick
Chief Grants Management Officer
National Human Genome Research Institute, NIH
5635 Fishers Lane Ste. 4076
Rockville, MD 20852
Phone: 301-435-7858
FAX: 301-402-1951
Email: [email protected]

National Institute of Mental Health
http://www.nimh.nih.gov

Dr. Michael F. Huerta
Associate Director
National Institute of Mental Health, NIH
6001 Executive Blvd. Room 7202
Bethesda, MD 20892-9645
Phone: 301-443-3563
Fax: 301-443-1731
Email: [email protected]

Ms. Rebecca Claycamp
Chief Grants Management Officer
National Institute of Mental Health, NIH
6001 Executive Boulevard
Room 6122
Bethesda, Maryland 20892-9605
Phone: 301-443-2811
Fax: 301-443-6885
Email: [email protected]

National Institute of Neurological Disorders and Stroke
http://www.ninds.nih.gov

Dr. Randall Stewart
Technology Development
National Institute of Neurological Disorders and Stroke, NIH
6001 Executive Blvd., Room 2135
Bethesda, MD 20892-9523
Phone: 301-496-1917
Fax: 301-402-1501
Email: [email protected]

Mr. Mike Loewe
Grants Management Officer
National Institute of Neurological Disorders and Stroke, NIH
6001 Executive Boulevard, Room 3266
Bethesda, MD 20892
Phone: 301-496-5707
Fax: 301-402-0219
Email: [email protected]

National Institute of Nursing Research
http://www.ninr.nih.gov

Dr. Yvonne Bryan
Program Director
Office of Extramural Programs
National Institute of Nursing Research, NIH
6701 Democracy Blvd, Room 710
One Democracy Plaza
Bethesda, MD 20892
Phone: 301-594-6908
Fax: 301-480-8260
Email: [email protected]

Mr. Brian Albertini
Chief, Grants and Contracts Management
National Institute of Nursing Research, NIH
6701 Democracy Boulevard
Room 710
One Democracy Plaza
Bethesda, MD 20892-4870
Phone: 301-594-6869
Fax: 301-402-4502
Email: [email protected]

National Center for Research Resources
http://www.ncrr.nih.gov

Dr. Louise E. Ramm
Deputy Director
National Center for Research Resources, NIH
6701 Democracy Blvd
Suite 902
Bethesda, MD 20892-4874
Phone: 301-435-0879
Fax: 301-480-3658
Email: [email protected]

Ms. Holly Atherton
Grants Management Specialist
National Center for Research Resources, NIH
6701 Democracy Blvd
Room 1040
Bethesda, MD 20892-4874
Phone: 301-435-0840
Fax: 301-480-3777
Email: [email protected]

National Center for Complementary and Alternative Medicine
http://www.nccam.nih.gov/

Dr. Carol Pontzer
Program Officer
National Center for Complementary and Alternative Medicine, NIH
6707 Democracy Blvd.
Suite 401, MSC 5475
Bethesda, MD 20892-5475
Phone: 301-496-7498
Fax: 301-480-3621
Email: [email protected]

Mr. George Tucker, M.B.A.
Grants Management Officer
Complementary and Alternative Medicine, NIH
6707 Democracy Blvd.
Suite 401, MSC 5475
Bethesda, MD 20892-5475
Phone: 301-594-8853
Fax: 301-480-1552
Email: [email protected]

National Center on Minority Health and Health Disparities
http://www.ncmhd.nih.gov

Mr. Vincent A. Thomas, Jr., MSW, MPA
National Center on Minority Health and Health Disparities, NIH
6707 Democracy Blvd.
Suite 800, MSC 5465
Bethesda, MD 20892-5465
Phone: 301-402-2516
Fax: 301-480-4049
Email: [email protected]

Mr. Bryan Clark, MBA
Grants Management Officer
National Center on Minority Health and Health Disparities, NIH
6707 Democracy Blvd.
Suite 800, MSC 5465
Bethesda, MD 20892-5465
Phone: 301-594-8412
Fax: 301-480-4049
Email: [email protected]

National Library of Medicine
http://www.nlm.nih.gov

Dr. Charles Friedman
National Library of Medicine, NIH
RKL1 - One Rockledge Ctr
Room 301
6705 Rockledge Dr
Bethesda, MD 20892
Phone: 301-496-4882
Fax: 301-402-2952
Email: [email protected]

Mr. Dwight Mowery
Grants Management Officer
National Library of Medicine, NIH
RKL1 - One Rockledge Ctr
Room 301
6705 Rockledge Dr
Bethesda, MD 20892
Phone: 301-496-4221
Fax: 301-402-0421
Email: [email protected]

2. Peer Review Contacts:
Not applicable

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://www.nih.gov/about/publicaccess/ and view the Policy or other Resources and Tools including the Authors' Manual (http://www.nih.gov/about/publicaccess/publicaccess_Manual.htm).

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.


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NIH Funding Opportunities and Notices



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