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 Eye Institute (NEI), (http://www.nei.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov/)

Title: Countermeasures against Chemical Threats (CounterACT) Small Business Innovation Research (SBIR/U44) Awards for Therapeutics Development

Announcement Type
New

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 SF 424 (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).

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 5:00 p.m. local time (of the applicant institution/organization) on the receipt  date (see “Key Dates” below).

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

Request For Applications (RFA) Number: RFA-NS-06-006

Catalog of Federal Domestic Assistance Number(s)
93.867 (NEI), 93.856 (NIAID), 93.846 (NIAMS), 93.113 (NIEHS), 93.859 (NIGMS), 93.853 (NINDS)

Key Dates   
Release/Posted Date: January 4, 2006
Opening Date:  February 11, 2006 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): March 10, 2006
Application Receipt Dates(s): April 11, 2006
Peer Review Date(s): July-August 2006 
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 30, 2006
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: April 12, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary  

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 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. Receipt, 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
   A. Cooperative Agreement Terms and Conditions of Award
     1. Project Director/Principal Investigator Rights and Responsibilities
     2. NIH Responsibilities
     3. Collaborative Responsibilities
     4. Arbitration Process
 3. Reporting

Section VII. Agency Contact(s)
 1. Scientific/Research Contact(s)
 2. Peer Review Contact(s)
 3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The purpose of this research program is to support small business awards on the development of new and improved therapeutics to prevent or mitigate the toxic effects from exposure to chemical threats.  Chemical threat agents are toxic chemicals that could be used in a terrorist attack against civilians, or chemicals that could be released at toxic levels by accident or natural disaster.  Applications for Small Business  Innovation Research (SBIR) cooperative agreements (U44s) are being solicited in this Funding Opportunity Announcement (FOA).

Background

The increased risk of a terrorist attack in the United States involving chemical agents has created new challenges for many departments and agencies across the federal government.  Within the Department of Health and Human Services (DHHS), the National Institutes of Health (NIH) is taking a leadership role in pursuing the development of new and improved medical countermeasures designed to prevent, diagnose, and treat the conditions caused by potential and existing chemical agents of terrorism. In addition, many of the same chemicals posing a threat as terrorist agents may also be released from transportation and storage facilities by industrial accidents or during a natural disaster.  The NIH is developing a comprehensive Countermeasures Against Chemical Threats (CounterACT) Research Network that includes CounterACT Research Centers of Excellence, individual research projects, SBIRs, contracts and other programs (see http://www.ninds.nih.gov/ funding/research/counterterrorism/index.htm).  The network will conduct basic, translational, and clinical research aimed at the discovery and/or identification of better therapeutic and diagnostic medical countermeasures against chemical threat agents, and their movement through the regulatory process.  The overarching goal of this research program is to enhance our diagnostic and treatment response capabilities during an emergency.   The SBIR program described in this FOA is part of this overall larger effort, and is designed to support small business concerns, specifically for development of therapeutics.  To ensure that research is focused on the development of new and improved therapeutics and their movement through the regulatory process, these SBIRs will be funded as cooperative agreement U44s (SBIR Phase II and Fast-Track) with substantial involvement by NIH staff.  Each U44 will be part of the CounterACT Research Network which will facilitate interactions with regulatory and public health organizations.  The U44 Project Director/Principal Investigator (PD/PI) and collaborators will be members of the research network.   The CounterACT program at NIH is part of the larger biodefense program coordinated by the National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov/) that includes biological and radiation/nuclear threats.

Objectives

The primary objective of this SBIR program FOA is to develop safe and effective therapeutics to prevent or mitigate the toxic effects of chemical threat agents.  Highest priority will be given to research that is clearly aimed at rapid advancement of candidate therapeutics techniques through the regulatory process, so that they can be used to enhance the medical response capabilities of the United States. 

Higher Priority Chemical Threats

The civilian chemical threat spectrum now includes chemical warfare agents, toxic industrial chemicals, toxins and other chemicals.  Categories of higher priority chemical threats that will be supported by the CounterACT program include:

Applicants are urged to contact the program officials listed in this FOA to determine whether their proposed threat agent or countermeasure is of high enough programmatic priority to be considered for funding under the CounterACT program.

Scope of Research

This SBIR program FOA will only support basic or translational research that is clearly relevant to the development of new or improved therapeutics that will enhance our medical response capabilities during an emergency.  New therapeutics that have no practical use during a mass casualty situation will not be considered under this program FOA. The categories of research supported under this program FOA include:

Special consideration will be given to research relevant to people who are particularly vulnerable, including the young, the elderly, and individuals with pre-existing medical conditions.  Clinical research, including trials, will be supported but will depend on the nature and scope of the proposed project and the potential for advanced development.  All applicants are strongly encouraged to confer with NIH staff and with  U.S. Food and Drug Administration (FDA) staff as soon as an appropriate product candidate or medical approach is identified. Information on FDA processes, requirements, and contacts can be found at the following Web sites: http://www.fda.gov/cder/about/smallbiz/default.htm; http://www.fda.gov/cber/manufacturer.htm; and http://www.fda.gov/cdrh/devadvice.

Some examples of research projects that could be supported by this FOA are listed below.  This list only presents some examples of research that could be supported; investigators are encouraged to contact the program officials listed in this FOA to determine if their proposed research will be responsive.  Research may include but is not limited to:

Special Biosafety Certification

Special biosafety certifications may be required to conduct research with some chemical threat agents, e.g., nerve agents.  Therefore, when applicable, applicants will be encouraged to collaborate with laboratories that are certified to work with restricted chemical agents, such as the NIH-supported facility at the U.S. Army’s Institute of Chemical Defense.  Applicants are encouraged to contact the National Institute of Neurological Disorders and Stroke (NINDS) program official listed in this FOA for further information on working with restricted chemical agents.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This FOA (RFA-NS-06-006) will use the SBIR cooperative agreement (U44) grant mechanism. Applications may be submitted for support as Phase II or Fast-Track grants as described in the SF424 (R&R) SBIR/STTR Application Guide.

Applicants may not simultaneously submit identical/essentially identical applications under both this funding opportunity and another HHS FOA, including the current SBIR or STTR Parent FOAs.

Only SBCs that have obtained a Phase I SBIR grant are eligible to apply for SBIR Phase II funding.  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 SBIR 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 NEW applications through Grants.gov/Apply using the standard NIH, CDC, and FDA SBIR receipt dates of April 1, August 1, and December 1 (or January 2, May 1, and September 1 for NIH AIDS and AIDS-related SBIR applications).

This funding opportunity uses just-in-time concepts. The modular budget format is no longer accepted for SBIR 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.

The NIH SBIR “U44is a cooperative agreement award mechanism. Under the U44 mechanism, the PD/PI retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the PD/PI, as described in Section VI.2.A., "Cooperative Agreement Terms and Conditions of Award.”

2. Funds Available

The SF424 (R&R) SBIR/STTR Application Guide indicates the statutory guidelines of funding support and project duration periods for Phase I and Phase II SBIR awards.  For this funding opportunity, budgets up to $300,000 total costs per year and time periods up to 2 years for Phase I may be requested. A Phase I award can only be made under this FOA if it is part of a Fast-Track Project. Phase II applicants may request  project periods of up to 3 years and budgets up to $750,000 total costs per year, or up to $1 million per year if studies required for Investigational New Drug (IND) filing with the FDA  Total costs include direct costs, Facilities and Administrative (F&A)/indirect costs, and fee.

The NIH components participating in this FOA  intend to commit approximately $2.5 million  in Fiscal Year 2006 to fund 3-5 Phase I and/or Phase II applications under the SBIR set-aside funding mechanism. Although the financial plans of these NIH components  provide support for this program, awards pursuant to this FOA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if competing renewal applications will be accepted and/or if this FOA will be reissued.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Only United States small business concerns (SBCs) are eligible to submit SBIR applications. A small business concern is one that, at the time of the award for both Phase I and Phase II SBIR 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 (a) at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or (b) for SBIR only, it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States.

3. Has, including its affiliates, an average number of employees for the preceding 12 months not exceeding 500, and meets the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns are generally considered to be affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.

Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 C.F.R. 121.103. The term "number of employees" is defined in 13 C.F.R. 121.106.

A business concern may be in the form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative. Further information may be obtained at http://sba.gov/size, or by contacting the Small Business Administration's Government Contracting Area Office or Office of Size Standards.

One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an SBIR awardee organization must be space that is available to and under the control of the SBIR 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 SBIR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13 C.F.R. 121.106 – Small Business Size Regulations.

All SBIR 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 SBIR 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.

Under the SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and during the conduct of the proposed project. Primary employment means that more than one half of the PD/PI’s time is spent in the employ of the small business concern. Primary employment with a small business concern precludes full-time employment at another organization. Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.

As defined in 42 C.F.R. 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.

If the application has the likelihood for funding, the awarding component will require documentation to verify the eligibility of the PD/PI, if at the time of submission of the application, the PD/PI is a less-than-full-time employee of the small business concern, is concurrently employed by another organization, or gives the appearance of being concurrently employed by another organization, whether for a paid or unpaid position.

If the PD/PI is employed or appears to be employed by an organization other than the applicant organization in a capacity such as Research Fellow, Consultant, Adjunct Professor, Clinical Professor, Clinical Research Professor, or Associate, a letter must be provided by each employing organization confirming that, if an SBIR grant is awarded to the applicant small business concern, the PD/PI is or will become a less-than-half-time employee of such organization and will remain so for the duration of the SBIR project. If the PD/PI is employed by a university, such a letter must be provided by the Dean's office or equivalent; for other organizations, the letter must be signed by a corporate official.

This requirement applies also to those individuals engaged currently as the PD/PI on an active SBIR project. All current employment and all other appointments of the PD/PI must be identified in his or her “Biographical Sketch” required as part of the application. Be certain that correct beginning and ending dates are indicated for each employment record listed.

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

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

Milestones

This FOA supports basic and translational research (see Section I).  Since the need for new and improved therapeutics is time-sensitive, priority will be given to those projects that are translational in nature, with a new therapy that has already been identified that needs further development.  Each CounterACT U44 application must include a clearly stated project timeline that includes practical achievable goals and project milestones.  Milestones toward therapeutic intervention are goals that create go/no-go decision points in the project, including quantitative success criteria.  Some awards may be contingent upon pre-award negotiations between the applicant and the NIH whereby milestones are reviewed and refined.  Progress towards proposed milestones will be a major factor in the review and continued funding of Type 5 non-competing annual applications.

If a specific new therapy has not yet been identified, basic research should clearly be relevant to the discovery of a new therapy.  The proposal should describe in detail how the proposed research will lead to the development of a novel therapeutic product, and it should present milestones related to achieving that goal, some of which may be future plans outside the scope of the current research proposal.

Any collaborators, consultants, or subcontractors should be identified, no matter when during the conduct of the activity the proposed interaction occurs. It is not required that an Investigational New Drug (IND) or Investigational Device Exemption (IDE) is achieved during the first project period, but the plan to complete pre-clinical development should be presented in the application. Since translational research is intrinsically interdisciplinary, this plan will often involve cooperation among basic researchers and clinicians, and may include the participation of private-sector companies and voluntary organizations.

Consultation with NINDS Program Staff

Due to the unique requirements of this FOA, applicants are strongly encouraged to consult with NIH Program Staff as plans for an application are being developed. This early contact will provide an opportunity to clarify the applicant's understanding of program goals and guidelines, including the scope of projects within the program and the requirement that project objectives be milestone-driven.

Section IV. Application and Submission Information

Registration and Instructions for Submission via Grants.gov

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, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons.

Several additional separate actions are required before an applicant SBC can submit an application through Grants.gov. See "Preparing for Electronic Submission" at http://era.nih.gov/ElectronicReceipt/preparing.htm.

Several of the steps of the registration process could take up to two weeks. Therefore, applicants should immediately check with their business official to determine whether their small business is already registered in both Grants.gov and the Commons.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

Prepare all SBIR applications using the SF424 (R&R) application forms and the 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 FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget

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

Optional Components:

PHS398 Cover Letter File
Research & Related Subaward Budget Form

3. Submission Dates and Times

See Section IV.3.A. for details.

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

Opening Date: February 11, 2006
Letter of Intent Receipt Date: March 10, 2006
Application Receipt Date: April 11, 2006
Peer Review Date: July-August 2006
Council Review Date: September 2006
Earliest Anticipated Start Date: September 30, 2006

3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

David A. Jett, Ph.D.
Technology Development
National Institute of Neurological Disorders and Stroke, NIH
6001 Executive Boulevard
NSC, Room 2177, MSC 9527  
Bethesda, MD 20892-9527
Telephone: (301) 496-6035
Fax: (301) 402-1501
Email: jettd@ninds.nih.gov

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 February 11, 2006 (i.e., the Opening Date on Grants.gov) and must be submitted no later than 5:00 p.m. local time (of the applicant institution/organization) on the application receipt date identified in 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 , NIH. Incomplete applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.  

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

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 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.

SBIR Phase II applications:

SBIR 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. The Small Business Act requires NIH to protect from disclosure and nongovernmental use all SBIR and Small Business Technology Transfer (STTR) data developed from work performed under an SBIR and STTR funding agreement for a period of 4 years after the closeout of either a Phase I or Phase II grant unless NIH obtains permission from the awardee to disclose these data. The data rights protection period lapses only upon expiration of the protection period applicable to the SBIR and 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/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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

Prior to peer review, applications will be examined by NIH Program Staff to determine if they are responsive to this FOA. Applications that are not responsive will be withdrawn from further consideration. 

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

2. Review and Selection Process

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIH Center for Scientific Review in accordance with the review criteria stated below.

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

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended SBIR 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 SBIR 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 SBIR? Are the investigators well suited to carry out this work? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Is the work proposed appropriate to the experience level of the  PD/PI and other researchers, including consultants and subcontractors (if any)? Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed?

Environment: Is there sufficient access to resources (e.g., equipment, facilities)? Does the scientific and technological environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

Phase II Applications

In addition to the above review criteria:

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

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

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

Resubmission Applications (formerly “amended” applications)

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

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

2. Are the improvements in the resubmission application appropriate?

Phase I/Phase II Fast-Track Application Review Criteria

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

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

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

3. To what extent was the applicant able to obtain letters of interest, additional funding commitments, and/or resources from the private sector or non-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 limitation.

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:

Phase I Exploratory/Developmental Projects (included in Fast-Track applications):

1. The likelihood that completion of the exploratory/developmental research objectives will assist with translation of basic observations into one or more new therapies for the chemical threat(s) under study.

2. The adequacy of the plan for how the project, if successful, will be used to initiate the process of therapeutic development, including, when appropriate, the adequacy of proposed interdisciplinary collaborations.

Phase II Translational Research Projects:

1. The adequacy of proposed project milestones, and the feasibility of achieving them.

2. The potential usefulness of the proposed countermeasure(s) for enhancing the response capabilities of medical personnel during a terrorist attack, accident, or natural disaster. 

3. Appropriate plans for the rigorous management and quality control of research data or materials from human subjects.

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/archive/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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the 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.”

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.  

The following Terms and Conditions will be incorporated into the NoA and will be provided to the PD/PI and the appropriate institutional official at the time of award.

 2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U44, an "assistance" mechanism (rather than an "acquisition" mechanism such as a contract), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility reside with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined above.

2.A.1. Project Director/Principal Investigator (PD/PI) Rights and Responsibilities

The PD/PI will have the primary responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.

Awardees are responsible for identifying specific milestones toward therapeutic development that will be achieved during the project period.

Awardees agree to participate in the overall coordination of the NIH CounterACT Research Network activities.  This participation may include collaboration and consultation with other CounterACT research awardees, and the sharing of information, data, and research materials.

It is understood that some information developed under the cooperative agreement will be proprietary and cannot be shared immediately without damaging the commercialization potential of the technology. Applicants should describe their plans for managing the intellectual property concerns in the context of the Research Network activities and other opportunities for information sharing.

The PD/PI will retain custody of, and have primary rights to, information developed under the cooperative agreement, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. Publication and copyright agreements and the requirements for financial status reports, retention of records, and terminal progress reports will be as stated in the NIH Grants Policy Statement.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Each project will have the support of one or more Project Scientists from NIH program staff who are assigned an administrative role for the therapeutic(s) being studied and have expertise in the implementation of the CounterACT research program.

The NIH Project Scientists will have substantial scientific-programmatic involvement during conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants.

NIH Project Scientists will be responsible for assessing the progress of the projects toward the accomplishment of specified milestones, and for recommending if further funds should be released to the project.

The NIH Project Scientists will facilitate the establishment of contacts and collaborations between awardees of the CounterACT research program and other persons or organizations whose participation will assist with the accomplishment of project goals.  These persons or organizations may include the FDA, disease voluntary organizations, pharmaceutical companies, or research organizations that can provide essential services on contract.

An important part of the research network is the coordination of research efforts across different funding mechanisms and research structures, and coordination among efforts aimed at different neurological disorders.  NIH Project Scientists will have the primary responsibility for this overall coordination.

The program director will be named on the NoA and will be responsible for normal program stewardship of the award, and may also serve as a Project Scientist.

2.A.3. Collaborative Responsibilities
Not Applicable

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

When multiple years are involved, 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 Contacts:

For questions concerning the overall CounterACT program or questions related to the mission of the National Institute of Neurological Disorders and Stroke (NINDS) and its role in the CounterACT program:

David A. Jett, Ph.D.
Technology Development
National Institute of Neurological Disorders and Stroke, NIH
6001 Executive Boulevard
NSC, Room 2177, MSC 9527  
Bethesda, MD 20892-9527
Telephone: (301) 496-6035
Fax: (301) 402-1501
Email: jettd@ninds.nih.gov

For questions related to the mission of the National Eye Institute (NEI) and its role in the CounterACT program:

Dr Ralph J. Helmsen
Vision Research Program
National Eye Institute, NIH
5635 Fishers LN., MSC 9300
Suite 1300
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
Fax: (301) 402-0528
Email: rh27v@nih.gov

For questions related to the mission of the National Institute of Allergy and Infectious Diseases (NIAID) and its role in the CounterACT program:

Ernest T. Takafuji, M.D., M.P.H.
Asst. Director for Biodefense Research
National Institute of Allergy and Infectious Diseases, NIH
6610 Rockledge Dr.
Rm. 4091
Bethesda, MD 20892-6615
Telephone: (301) 451-4416
Fax: (301) 480-1432
Email: ETakafuji@niaid.nih.gov

For questions related to the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and its role in the CounterACT program:

Alan N. Moshell, M.D.
Director, Skin Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH
One Democracy Plaza
6701 Democracy Blvd., Suite 800
Bethesda, Maryland 20892-4872
Telephone: 301-594-5017
Fax: 301-480-4543
Email: moshella@ep.niams.nih.gov

For questions related to the mission of the National Institute of Environmental Health Sciences (NIEHS) and its role in the CounterACT program:

Dennis Lang, Ph.D.
Deputy Director Division of Extramural Research and Training
National Institute of Environmental Health Sciences, NIH
P.O. Box 12233, MD EC20
Research Triangle Park, NC 27709
Telephone: (919) 541-7729
Fax: (919) 541-2843
Email: DL73v@nih.gov

For questions related to the mission of the National Institute of General Medical Sciences (NIGMS) and its role in the CounterACT program:

Richard T. Okita, Ph.D.
Division of Pharmacology, Physiology, & Biological Chemistry
National Institute of General Medical Sciences, NIH
45 Center Drive
Room 2AS-49A
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
Fax: (301) 480-2802
Email: okitar@nigms.nih.gov

2. Peer Review Contacts:
Not Applicable
 
3. Financial or Grants Management Contacts:

Denise Chatman
Grants Management Specialist
National Institute of Neurological Disorders and Stroke, NIH
NSC 3257
6001 Executive Blvd.
Bethesda, MD 20892-9537
Telephone: (301) 496-5707
Fax: (301) 402-0219
Email: chatmand@ninds.nih.gov

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 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.. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” ; 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); and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

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

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

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

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

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

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

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

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

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

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

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

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% 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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