Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
National Institute of Environmental Health Sciences (NIEHS)  (http://www.niehs.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID), (http://www3.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (http://www.niams.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov/
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov/
National Eye Institute (NEI), (http://www.nei.nih.gov)
National Institute of General Medical Sciences (NIGMS), (http://www.nigms.nih.gov/
National Heart, Lung, and Blood Institute (NHLBI), (http://www.nhlbi.nih.gov/index.htm)
National Institute of Nursing Research (NINR), (http://www.ninr.nih.gov/)
National Center for Research Resources (NCRR), (http://www.ncrr.nih.gov/

Title:  Innovative Toxicity Assays of Pollutants, Therapeutics, and Drugs (SBIR [R43/R44])

Announcement Type
Reissue: This Funding Opportunity Announcement (FOA) is a reissue of PA-02-075.

Program Announcement (PA) Number: PA-09-006

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) 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 applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.113., 93.847, 93.848, 93.849, 93.361, 93.173, 93.859, 93.837, 93.867, 93.846 , 93.389

Key Dates
Release/Posted Date: October 7, 2008
Opening Date:  November 5, 2008 (Earliest date an application may be submitted to Grants.gov)
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date(s):  Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm  
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward 
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: September 8, 2009

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. Submission, Review, and Anticipated Start Dates
         1. Letter of Intent
     B. Submitting an Application Electronically to the NIH
     C. Application Processing      
 4. Intergovernmental Review
 5. Funding Restrictions
 6. Other Submission Requirements and Information

Section V. Application Review Information
 1. Criteria
 2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Resource Sharing Plan(s)    
 3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
 1. Award Notices
 2. Administrative and National Policy Requirements
 3. Reporting

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

Recent advances in science and technology areas such as cancer biology, cell biology, molecular biology, systems biology, biomarkers, combinatorial chemistry, genomics, tissue engineering, bioinformatics and high throughput screening technology provide unprecedented opportunities for discovery of new disease prevention/intervention/treatment entities and understanding of both the useful and potential adverse biological effects of environmental agents and chemicals.  It is expected that research focused on the discovery and validation of new targets and agents that affect these targets will result in new chemical and biological agents with the potential for clinical benefit, and  will identify how exposures to these and other substances in the home and workplace may be contributing to or causing injury or disease. Before new agents can be assessed and used in humans, pre-clinical safety assessments must be conducted.  Similar safety assessments should also be made prior to exposure of the public to new chemicals and products introduced into the workplace, home, foods, water, or air. Current practices and procedures for safety assessments are costly, time consuming and utilize large amounts of compound and large numbers of animals.  Thus,  there are enormous potential benefits to applying advances in science and technology to develop new safety assessment tools and integrated strategies that can be used to evaluate whether and how new agents and other chemical entities perturb key toxicity pathways that can lead or contribute to disease and injury.  Such tools and strategies can be used to quickly assess large numbers of compounds, as well as analogs in a chemical series.

This FOA encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to develop, standardize, and validate new and innovative assays, integrated strategies, or batteries of assays that determine or predict specific organ toxicities (e.g., ocular, dermal, hematotoxicity, cardiotoxicity, gastrointestinal toxicity, hepatotoxicity, nephrotoxicity, ototoxicity, olfactory loss, bladder toxicity, neurotoxicity, pulmonary toxicity, endocrine toxicity, and pancreatic beta cell toxicity), resulting from both  acute and chronic exposures. In addition, this FOA encourages the development, standardization, and validation of new models of arthritis, convulsion, infection and shock.  New approaches for high throughput toxicity screening that involves the use of molecular endpoints, computer modeling, proteomics, genomics and epigenomics are also encouraged. This includes the creation of experimental and computational systems replicating major organ systems for high throughput and high data content screening of pharmaceuticals and potential environmental chemicals including ionizing radiation.

The development, validation and use of such improved safety assessment assays would allow for more scientifically-based and cost efficient evaluations of potential drug candidates, consumer products and environmental agents, thereby increasing the ability of regulatory agencies to protect humans from adverse effects, and would assist in the evaluation of human sensitivity to drugs and environmental agents with potential adverse health effects.

Background

Recent advances in all branches of medical sciences provide new insight into the underlying mechanisms in a variety of diseases and suggest new targets and approaches to therapy.  Drug discovery can now be focused on targeting key regulatory pathways or specific macromolecules relevant to the disease state.  For example, key growth regulatory pathways and mutations in genes predisposing for specific disease states are being identified at an increasing rate using new techniques and bioinformatics tools. New technologies in chemistry that allow facile synthesis of millions of new chemicals and high resolution structures of important target proteins are becoming available.  These advances taken together and coupled with high throughput screening methods allow for the identification of large numbers of agents that could be considered for clinical evaluation.  Translation of these new technological discoveries and innovations into clinical benefit through these newly discovered agents is essential; however, the later stages in this drug development process are lengthy and costly.  Obviously, new methods are needed to decide which of the multitude of new agents should ultimately move forward to clinical trials.  Similarly, it is important to understand the potential adverse health effects that may result from human exposure to the thousands of chemicals in the home, workplace, and environment, and whether these substances may be contributing to or causing human diseases or injuries.

Investigations focusing on the toxicity of potential cancer, AIDS or other drugs or biologicals designed to reduce the incidence or severity of disease to healthy organs in intact experimental animals are the final steps in the preclinical stages of new drug development.  Data generated from these studies on each new drug are evaluated in light of potential human toxicity and form a major portion of the information required by the Food and Drug Administration (FDA) for an Investigational New Drug (IND) application.  Preclinical toxicology studies are generally conducted in two animal species with the following objectives: to define the Maximum Tolerated Dose (MTD), Dose Limiting Toxicities (DLTs), schedule-dependency of toxicity, reversibility of adverse effects, and a safe clinical Starting Dose (SD).  The animal studies required to obtain such information for an IND application have significant limitations, both in terms of cost and time requirements as well as prediction of problems to be encountered when agents are administered to humans.  For example, since animal studies are very expensive and time-consuming, it is generally impractical to evaluate numerous analogs of a chemical series or large numbers of possible candidates from a high throughput screening program.  Another concern is the lack of information gained from animal toxicology studies in regard to molecular mechanisms for observed toxicities.  It cannot be determined if toxicities of new agents designed to attack a key molecular target are related to actions of inhibition of that target or to other unknown aspects of the drug's action in various organs.

In addition to assays that will be important to drug development and testing, these scientific advances provide opportunities to develop new and innovative tests to determine the safety or toxicity of environmental chemicals. The National Institute of Environmental Health Sciences (NIEHS) has been directed by Congress to develop and validate alternatives for acute and chronic toxicity testing that will reduce or eliminate the use of animals.  In addition, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Toxicology Program (NTP) Interagency Center for the Validation of Alternative Toxicological Methods (NICEATM) indicated in their five year plan (2008-2012) that the development and validation of alternative tests for ocular, dermal, reproductive and developmental toxicity, carcinogenicity, immunotoxicity, as well as biologics, pyrogen and endocrine disruptor testing and acute and chronic toxicity tests were all high priority needs.

The mission of the NTP, an interagency program located at NIEHS, is to evaluate agents of public health concern by developing and applying tools of modern toxicology and molecular biology.  Currently, the NTP tests chemicals of environmental or occupational concern using study designs similar to that used in preclinical toxicology studies, including 30- and 90-day toxicity studies, two-year bioassay to determine the chronic toxicity and carcinogenic potential of chemicals, two-generation studies to determine reproductive toxicity and in utero exposure to determine developmental toxicity. The goal of the NTP is consistent with the goal of the other NIH Institutes participating in this FOA: to develop new and novel alternative toxicity tests that could replace or reduce the use of animals in toxicity testing and to provide mechanistic information on a potentially hazardous environmental agent that would aid in intervention/prevention efforts.

The NTP has recently partnered with the National Human Genome Research Institute’s NIH Chemical Genomics Center and the U.S. Environmental Protection Agency’s National Center for Computational Toxicology to establish a HTS program to screen for mechanistic targets active within cellular pathways critical to carcinogenicity, reproductive and developmental toxicity, genotoxicity, neurotoxicity, and immunotoxicity. The U.S. EPA is also developing a two tiered approach for the identification of endocrine disrupting chemicals.  Thus, there is interest and commitment across the NIH and U.S. EPA to be proactive in stimulating the reduction of animals in toxicity testing and the development of new approaches including in vitro and computational models to identify cellular targets that would be predictive of tissue injury (e.g., biomarkers).

New technologies to improve toxicology from an observation-based to a mechanism-based science are emerging, but as yet none has been validated and accepted for common use.  These new technologies will be highly valuable when combined with other approaches to develop a total toxicological profile of specific organ toxicity and molecular mechanisms responsible for this toxicity.

Objectives and Scope

The goals of this FOA are the discovery, development and validation of new assays, batteries of assays and procedures to determine quickly and economically toxicological profiles of potential therapeutic drugs and environmental agents.  It is expected that a molecular definition of toxicity in the affected organ, tissue or cell would be a component of the procedure.  Approaches for new toxicity assays of pollutants, therapeutics, and drugs in response to this initiative are broad and are determined by the creativity of the applicant. 

Genetically modified animals or cell lines, various non-mammalian organisms, in vitro assays utilizing primary mammalian cells including stem cells (human cells are of particular interest), 3D tissue models, tissue slices, isolated organs, sub-cellular fractions or purified enzymes could be utilized. Computer modeling utilizing existing biological and toxicological databases would also be appropriate.  Genomic and proteomic technology could be exploited to profile total gene activity or protein expression and thereby establish the “normalcy” of the cell system being used as well as define the extent and mechanism of toxicity.  Molecular endpoints to evaluate toxicity and high throughput toxicity screening could be used to help decide which agent of a chemical series should be pursued, to allow exploration of toxicity at an earlier stage in drug development, to define the toxicity profile of agents selected for clinical trial or to define the toxicity profile of agents for which there is significant environmental exposure. The creation of experimental and computational systems replicating major organ systems such as skin, lungs and G.I. tract, metabolism and clearance systems (liver and kidney) and target organ (respiratory, nervous, and reproductive) systems for high throughput and high data content screening of pharmaceuticals and potential environmental toxicants including ionizing radiation is also encouraged.  Applicants should keep in mind that a single assay may not be sufficient and a battery of mechanism-based assays that provide an integrated approach may be needed to determine tissue or organ system toxicity. This includes development of virtual tissue systems that can be integrated into a “virtual human” to improve predictive toxicology and pharmacology. Development of 3-dimensional organ models for toxicity evaluation is also encouraged. Applicants should also design assays so they can distinguish the lack of potential for toxicity, and not only severe toxicity but gradations in toxicity.

Applicants should be aware of the activities of NICEATM and ICCVAM (http://iccvam.niehs.nih.gov). NICEATM-ICCVAM have prepared documents and instructions relating to the validation and regulatory acceptance of alternative test methods that will be helpful in writing the application and in proper validation of the methods/tests proposed.  It is critical to discuss the potential applicability of the proposed test system or testing strategy to regulatory safety assessments and decision-making. Applicants preparing applications are strongly urged to contact NICEATM staff prior to submission for guidance on validation study design. Failure to work with ICCVAM prior to submission may mean loss of time and money as well as a delay in the validation and acceptance of the assay for use by regulatory agencies.

Summary

The overall objective of this FOA is to provide a flexible funding mechanism within the SBIR program with regard to budgets and time of funding to support the research activities required to develop and validate innovative toxicity assays of pollutants, therapeutics, and drugs by small businesses.

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 Small Business Innovation Research (SBIR [R43/R44] 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. Applications for Phase II Competing Renewal grants may be submitted for those ICs that included these opportunities in the SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. The following sponsoring  ICs do not accept Phase II SBIR renewals: NIEHS, NIAMS, NIGMS,NINR, and NCRR.

Small business concerns that have received a Phase I SBIR grant may apply for Phase II funding of that project. The Phase II must be a logical extension of the Phase I research but not necessarily as a Phase I project supported in response to this funding opportunity. Phase II applications will compete with all SBIR applications and will be reviewed according to the customary peer review procedures

The applicant small business concern (SBC) will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses “Just-in-Time” information concepts. The modular budget format is not accepted for 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.

2. Funds Available

Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received.

The SF424 (R&R) SBIR/STTR Application Guide indicates the statutory guidelines of funding support and project duration periods for Phase I and Phase II SBIR awards. Phase I awards normally may not exceed $100,000 total for a period normally not to exceed 6 months. Phase II awards normally may not exceed $750,000 total for a period normally not to exceed 2 years. These award levels and project periods are statutory guidelines, not ceilings. Therefore, applicants are encouraged to propose a budget and project duration period that is reasonable and appropriate for completion of the research project.

Phase II competing renewal budgets must be submitted in accordance with participating IC-specific budget limitations described in the SBIR/STTR Program Descriptions and Research Topics.

NIH grants policies as described in the http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering the multiple PD/PI option, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

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. For projects with multiple PD/PIs, at least one must meet the primary employment requirement. That individual will serve as the Contact PD/PI. 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.

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 Contact PD/PI, if at the time of submission of the application, the Contact 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 Contact 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 Contact 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 Contact 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.

All current employment and all other appointments of the Contact 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

Applicants may submit a resubmission application, but such application must include an Introduction addressing issues raised in the previous critique (Summary Statement).

Applicants may submit more than one application, provided that each application is scientifically distinct. Applicants may not simultaneously submit identical/essentially identical applications under both this SBIR funding opportunity and any other HHS FOA, including the current SBIR and STTR Parent FOAs. The NIH will accept as many "different" applications as the applicant organization chooses. However, the NIH will not accept similar grant applications with essentially the same research focus from the same applicant organization. This includes derivative or multiple applications that propose to develop a single product, process or service that, with non-substantive modifications, can be applied to a variety of purposes. Likewise, identical or essentially identical grant applications submitted by different organizations will not be accepted.  Applicant organizations should ascertain and assure that the materials they are submitting on behalf of the principal investigator are the original work of the principal investigator and have not been used elsewhere in the preparation and submission of a similar grant application. Applications to the NIH are grouped by scientific discipline for review by individual Scientific Review Groups and not by disease or disease state. The reviewers can thus easily identify multiple grant applications for essentially the same project. In these cases, application processing may be delayed or the application(s) may be returned to the applicant without review. 

It is unlawful to enter into contracts or grants requiring essentially equivalent work or effort. “Essentially equivalent work or effort” occurs when (1) substantially the same research is proposed for funding in more than one contract proposal or grant application submitted to the same Federal agency; (2) substantially the same research is submitted to two or more different Federal agencies for review and funding consideration; or (3) a specific research objective and the research design for accomplishing an objective are the same or closely related in two or more proposals or awards, regardless of the funding source. If there is any question concerning essentially equivalent work or effort, it must be disclosed to the soliciting agency or agencies before award.

Only one Phase II award may be made for a single SBIR/STTR project.

You may submit a Phase II application either before or after expiration of the Phase I budget period, unless you elect to submit a Phase I and Phase II application concurrently under the Fast-Track procedure. To maintain eligibility to seek Phase II support, a Phase I grantee organization should submit a Phase II application within the first six due dates following the expiration of the Phase I budget period.

Phase II awardees may submit a Phase II competing renewal application for projects that require extraordinary time and effort in the R&D phase and may or may not require FDA approval for the development of such projects.  Applicants are strongly encouraged to contact NIH IC program staff included in Section VII of this announcement prior to submitting SBIR Phase II Competing Renewal applications. The following sponsoring  ICs do not accept Phase II SBIR renewals: NIEHS, NIAMS, NIGMS,NINR, and NCRR.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

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

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

Several additional separate actions are required before an applicant SBC can submit an electronic application, as follows:  

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

To affiliate the PD/PI with the applicant small business concern:

  1. PD/PI gives Commons user ID and email address to the administrator of the applicant organization/institution. (The email address must be the one that is contained in the Personal Profile for the PD/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."

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations. 

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR Application Guide for this FOA using the “Apply for Grant Electronically” button in this FOA or through Grants.gov/Apply.

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

For further assistance contact GrantsInfo -- Telephone 301-435-0714, 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 in accordance with the SF424 (R&R) SBIR/STTR Application Guide.

The SF424 (R&R) SBIR/STTR Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Failure to include this data field will cause the application to be rejected.

Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application 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 Attachment(s) Form

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project (see Section III.1.B). The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above. For SBIR, the contact PD/PI must be employed by the small business.  All funding for SBIR projects goes to the small business awardee, so funding for PD/PIs from other organizations must be requested via a subcontract with the small business using the Research & Related Subaward Budget Attachment(s) Form. 

Information for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (Section 14 of the Research Plan Component in the SF424 (R&R)), must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Grant Award (NGA).

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: November 5, 2008  (Earliest date an application may be submitted to Grants.gov)
Application Due Date(s):  Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Due Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward  

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants may use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/applicants/apply_for_grants.jsp  and follow Steps 1-4. Note:  Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review (CSR).  Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

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).

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 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 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 and Information

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. While each section of the Research Plan component needs to be uploaded separately as an attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits.

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

SBIR Phase I Applications:

SBIR Phase II and Phase II Competing Renewal Applications:

Applicants are strongly encouraged to contact program staff prior to submitting SBIR Phase II Competing Renewal applications.

SBIR Fast-Track Applications:

Resubmissions:

Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Appendix Materials 

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process. Phase I SBIR/STTR Appendix materials are not permitted unless specifically requested by NIH.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible (for example human subject concerns, the Small Business Innovation Development Act provisions, etc.). Applicants are encouraged to discuss data-sharing plans with their NIH program contact (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)

(b) Sharing Model Organisms: Regardless of the amount requested, all applications in which the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible (see Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.)

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (e.g., blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (NOT-OD-07-088) and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

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 on the basis of established PHS referral guidelines to the ICs for funding consideration.

Applications that are complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below.  

As part of the scientific peer review, all applications will:

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, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious 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? Are the milestones and evaluation procedures appropriate? Does the applicant acknowledge potential problem areas and consider alternative tactics? For applications designating multiple PD/PIs, is the leadership approach, including he designated roles and responsibilities governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PD/PIs?

Innovation: Is the project original and innovative? For example: 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(s): Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI(s) and other researchers, including consultants and subcontractors (if any)? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)? Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed?

Environment: Do(es) 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? Is there sufficient access to resources (e.g., equipment, facilities)?

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?

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.

Phase II Competing Renewal Applications

In addition to the above review criteria described under “All SBIR Applications,” the following items will be applied to ALL Phase II competing renewal applications in the determination of scientific merit and the rating.

1. 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?  

2. 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 rating:

Resubmission Applications: Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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 adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R).

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 and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

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/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.

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

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

2. Administrative and National Policy Requirements

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

3. Reporting

NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.

Financial Status Report (OMB 269, http://www.whitehouse.gov/omb/grants/grants_forms.html)

Final Progress Report

Final Invention Statement and Certification (HHS 568)

Annual Invention Utilization Reports

Final Cash Transaction Report (PSC 272, http://www.dpm.psc.gov/Reports.aspx)

Phase II Data Collection Requirement for Government Tech-Net Database  (http://technet.sba.gov)

Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.

For details about each specific required report, see the section on “Award Guidelines, Reporting Requirements, and Other Considerations,” in the SF 424 (R&R) SBIR/STTR Application Guide.

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Jerrold J. Heindel, Ph.D.
Scientific Program Administrator
National Institute of Environmental Health Sciences
Division of Extramural Research and Training
Cellular, Organs and Systems Toxicology Branch
P.O. Box 12233
Research Triangle Park, NC 27709

For Express Mail:
79 T.W. Alexander Drive
4401 Research Commons, 3rd Floor
Phone: (919) 541-0781
Fax: (919) 541-5064
Email: heindelj@niehs.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:  
gm16s@nih.gov

Carl C. Baker, M.D. Ph.D.
Program Director, Skin Diseases Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
One Democracy Plaza
6701 Democracy Blvd., Room 888
Bethesda, Maryland 20892-4872
Telephone: 301-435-1240
Fax: 301-480-4543
Email: BakerC@mail.nih.gov

Dr. Roger Miller
Program Director
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: millerr@nidcd.nih.gov

Dr. Marva Moxey-Mims
Director, Pediatric Nephrology & Renal Centers Programs
Director, Applied Kidney SBIR Program
National Institute of Diabetes and Digestive and Kidney Diseases
Kidney & Urology Branch
6707 Democracy Blvd.
Bethesda, MD 20817
Phone:301-594-7717
Fax: 301-480-3510
Email:
mm726k@nih.gov

Jerome R. Wujek, Ph.D.
Research Resources Officer
Division of Extramural Research
National Eye Institute
National Institutes of Health
5635 Fishers Lane, Suite 13000
Bethesda, MD 20892-9300
Rockville, MD 20852 (for express/courier delivery)
Telephone: (301) 451-2020
Fax: (301) 402-0528
E-mail: wujekjer@mail.nih.gov

Richard Okita, Ph.D.
Program Director
Pharmacology, Physiology & Biological Chemistry Division,
National Institute of General Medical Sciences
45 Center Drive/2AS49A
Phone: 301-594-3827
Fax: 301.480.2802
Email: okitar@nigms.nih.gov

Bishow B. Adhikari, Ph.D.
Program Director
National Heart, Lung, and Blood Institute, NIH
6701 Rockledge Drive, Room 8186, MSC 7956
Bethesda, MD 20892-7956
(For express mail, zip: 20817)
Tel: 301-435-0504
FAX: 301-480-7404
Email:
adhikarb@mail.nih.gov

Program Director
Office of Extramural Programs
National Institute of Nursing Research, NIH
6701 Democracy Blvd, Room 710
One Democracy Plaza
Bethesda, MD 20892
Phone: 301-402-6423
Fax:     301-480-8260
Email: 
pc272a@nih.gov

Dr. Amy L. Swain
Program Officer
National Center for Research Resources
6701 Democracy Blvd., MSC 4874
Bethesda, MD  20879-4874
Telephone:  (301) 435-0752
FAX: 301-402-3659
Email: swaina@mail.nih.gov

2. Peer Review Contacts:

Not Applicable

3. Financial or Grants Management Contacts:

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: dolby@niehs.nih.gov

Mr. Michael Wright
Grants Management Specialist
National Institute of Allergy and Infectious Diseases, NIH
6700B Rockledge Dr, Rm 2249
Bethesda, MD 20892-7614
Phone: 301-451-2688
Fax: 301-493-0597
Email: mawright@mail.nih.gov

Mr. Erik (Timothy) Edgerton
Grants Management Specialist
National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH
6701 Democracy Blvd. Suite 800
Bethesda, Maryland  20892
Phone:  301-594-3968
Fax:      301-480-5450
Email:   edgertont@mail.nih.gov


Mr. Christopher P. Myers
Grants Management Officer
National Institute on Deafness and Other Communication Disorders, NIH
45 Center Drive, MSC 6402
Bldg 45 Room 4AN44
Bethesda MD 20895-6402
Phone: 301-435-0713
Fax:     301-451-5365
Email:  myersc@nidcd.nih.gov  

Ms. Randi Freundlich
Grants Management Specialist
The National Institute of Diabetes and Digestive and Kidney Diseases, NIH
Office Grants & Contracts Management
6701 Democracy Blvd.
Bethesda, MD 20817
Phone: 594-5974
Fax: 402-4502
Email: freundlichr@mail.nih.gov

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: wwd@nei.nih.gov 

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: 301-594-5136
Fax: 301-480-2554
Email: molnarp@nigms.nih.gov

Mr. Robert Vinson
Robert Vinson, Jr.
Section Chief, DBDR Team
NHLBI, DERA, Office of Grants Management
Rockledge Centre Two, Suite 7044
6701 Rockledge Drive, MSC 7926
Bethesda, Maryland  20892-7926
Telephone:  (301) 435-0169
Fax:  (301) 451-5462
Email: rv7g@nih.gov 

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:
albertib2@mail.nih.gov

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:   athertoh@mail.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 (45 CFR 46) 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 institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

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.

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.

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 Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS 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. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 FOA 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. 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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