and Human Services (HHS)
EXPIRED
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 (STTR [R41/R42])
Announcement Type
Reissue: This Funding
Opportunity Announcement (FOA) is a reissue of PA-02-075.
Program Announcement (PA) Number: PA-09-007
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 8, 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
A. Cooperative Agreement Terms and
Conditions of Award
1. Project
Director/Principal Investigator (PD/PI) 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
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 Technology Transfer (STTR) 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 STTR 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.
1. Mechanism(s) of Support
This funding
opportunity will use the Small Business Technology Transfer (STTR [R41/R42]
grant mechanisms. Applications
may be submitted for support as Phase I, Phase II, or Fast-Track grants as
described in the SF424 (R&R) SBIR/STTR Application Guide. 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.
Small
business concerns that have received a Phase I STTR grant may apply for Phase
II funding of that project. The Phase II must be a logical extension of the
Phase I research but not necessarily as a Phase I project supported in response
to this funding opportunity. Phase II applications will compete with all STTR
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 STTR grant applications. Applicants must
complete and submit budget requests using the SF424 Research and Related
(R&R) Budget component found in the application package attached to this
FOA in Grants.gov/Apply.
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 STTR awards. Phase I awards normally may not exceed $100,000 total for a period normally not to exceed one year. Phase II awards normally may not exceed $750,000 total for a period normally not to exceed 2 years. These award levels and project periods are statutory guidelines, not ceilings. Therefore, applicants are encouraged to propose a budget and project duration period that is reasonable and appropriate for completion of the research project. 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. The following sponsoring ICs do not accept Phase II STTR Competing Renewals (NIEHS, NIAMS, NIGMS, NEI, NHLBI, NINR, and NCRR.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
Only United States small business concerns (SBCs) are eligible to submit STTR applications. A small business
concern is one that, at the time of award of Phase I and Phase II, meets all of the following
criteria:
1. Organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
2. In the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by business entities in the joint venture;
3. At least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States.
4. Has, including its affiliates, not more than 500 employees and meets the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 C.F.R. 121.3-2(a). The term "number of employees" is defined in 13 C.F.R. 121.3-2(t).
Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Size District Office at http://sba.gov/size.
One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an STTR awardee organization must be space that is available to and under the control of the STTR awardee for the conduct of its portion of the proposed project.
Title 13 CFR 121.3 also states that control or the power to control exists when key employees of one concern organize a new concern ... and serve as its officers, directors, principal stockholders, and/or key employees, and one concern is furnishing or will furnish the other concern with subcontracts, financial or technical assistance, and/or other facilities, whether for a fee or otherwise. Where there is indication of sharing of common employees, a determination will be made on a case-by-case basis of whether such sharing constitutes control or the power to control.
For purposes of the STTR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13 CFR 121.106 Small Business Size Regulations.
All STTR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an STTR award until the SBA provides a determination.
Note: An applicant organization that has been determined previously by SBA to be other than small for a size standard of not more than 500 employees or for purposes of the SBIR/STTR program, the organization must be recertified by the SBA prior to any future SBIR/STTR awards.
1.B. Eligible Individuals
Any
individual with the skills, knowledge, and resources necessary to carry out the
proposed research is invited to work with his/her organization to develop an
application for support. Individuals from underrepresented racial and ethnic
groups as well as individuals with disabilities are always encouraged to apply
for NIH support.
More than one PD/PI, or multiple PDs/PIs, may be designated on the application
for projects that require a team science approach that clearly does not fit
the single-PD/PI model. Additional information on the implementation plans and
policies and procedures to formally allow more than one PD/PI on individual
research projects is available at http://grants.nih.gov/grants/multi_pi . All PDs/PIs must be registered in the NIH eRA Commons prior to the submission
of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).
The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. 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 multiple PDs/PIs, 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 PD/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.
For an STTR application, the Project Director/Principal Investigators (PD/PIs) may be employed with the SBC or the participating non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual. For projects with multiple PD/PIs, the Contact PD/PI may be from either the SBC or the single partnering research institution.
When the proposed PD/PI clearly does not have sufficient qualifications to assume this role, the application is not likely to receive a favorable evaluation.
Each PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration. In all cases, however, the PD/PI’s official relationship with the grantee must entail sufficient opportunity for the PD/PI to carry out his or her responsibilities for the overall scientific and technical direction of the project. Documentation (e.g., consultant, consortium and contractual arrangements) describing the official relationship of the PD/PI with the applicant small business concern should NOT be submitted with the grant application, but a copy must be furnished upon the request of the NIH awarding component.
The following are examples of situations describing the official relationship of the PD/PI with the applicant small business organization:
2. Cost Sharing or Matching
This program does not
require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants
may submit a resubmission application, but such application must include an
Introduction addressing issues raised in the previous critique (Summary
Statement).
In STTR Phase I and Phase II, at least 40% of the work must be performed by the small business concern and at least 30% of the work must be performed by the single, partnering research institution. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and F&A/indirect costs attributable to each party, unless otherwise described and justified in Item 12, Consortium/Contractual Arrangements, of the PHS398 Research Plan component of the SF424 (R&R) application forms.
Applicants may submit more than one application, provided that each application is scientifically distinct. Applicants may not simultaneously submit identical/essentially identical applications under both this STTR funding opportunity and any other HHS FOA, including the current SBIR and STTR Parent FOAs .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 receipt 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 STTR Phase II Competing Renewal applications. The following sponsoring ICs do not accept Phase II STTR Competing Renewals (NIEHS, NIAMS, NIGMS, NEI, NHLBI, 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:
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
301-710-0267, Email: [email protected].
Telecommunications for the hearing impaired: TTY
301-451-5936.
2. Content and Form of Application Submission
Prepare all STTR applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) SBIR/STTR Application Guide.
The SF424 (R&R) SBIR/STTR Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/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
Research
& Related Subaward Budget Attachment(s) Form
PHS398
Cover Page Supplement
PHS398
Research Plan
PHS398
Checklist
SBIR/STTR
Information
Optional
Components:
PHS398
Cover Letter File
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 STTR, the contact PD/PI may be from either the SBC or the single partnering research institution. All funding for STTR projects goes to the small business 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 receipt 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 each PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
PHS398 Research Plan Component Sections
Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) 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.
STTR Phase I applications:
STTR Phase II and Phase II Competing Renewal Applications:
Applicants are strongly encouraged to contact program staff prior to submitting STTR Phase II Competing Renewal applications.
STTR Fast-Track applications:
Resubmissions:
Warning: Please be sure that you observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.
Appendix 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 initial merit review, all applications will:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended STTR applications. The following will be considered in making funding decisions:
The goals of NIH supported research are to advance our understanding of biological systems, 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 STTR
Applications
Significance: Does the proposed project have commercial potential to lead to a marketable
product, process or service? Does this study address an important problem? What
may be the anticipated commercial and societal benefits that may be derived
from the proposed research? If the aims of the application are achieved, how
will scientific knowledge or clinical practice be advanced? What will be the
effect of these studies on the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field? Does the
application lead to enabling technologies (e.g., instrumentation, software) for
further discoveries? Will the technology have a competitive advantage over
existing/alternate technologies that can meet the market needs?
Approach: Are
the conceptual or clinical framework, design, methods, and analyses adequately
developed, well-integrated, and appropriate to the aims of the project? Is the
proposed plan a sound approach for establishing technical and commercial
feasibility? 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 STTR 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 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 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.
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 principal investigator.
For details about each specific required report, see the section on Award Guidelines, Reporting Requirements, and Other Considerations, in the SF 424 (R&R) SBIR/STTR Application Guide.We encourage your inquiries
concerning this funding opportunity and welcome the opportunity to answer
questions from potential applicants. Inquiries may fall into three areas:
scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research 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: [email protected]
Dr. Gregory Milman
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases, NIH
Room 2153
6700-B Rockledge Drive
Bethesda, MD 20892-7610
Phone: 301-496-8666
Fax: 301-402-0369
Email: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
Dr. Paul Cotton
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
Mr. William Darby
Chief, Grants Management Branch
National Eye Institute, NIH
5635 Fishers Lane, Suite 1300
Bethesda, MD 20892-9300
Phone: 301-451-2020
Fax: 301-496-9997
Email: [email protected]
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: [email protected]
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: [email protected]
Mr. Brian Albertini
Chief, Grants and Contracts Management
National Institute of Nursing Research, NIH
6701 Democracy Boulevard
Room 710
One Democracy Plaza
Bethesda, MD 20892-4870
Phone: 301-594-6869
Fax: 301-402-4502
Email: [email protected]
Ms. Holly Atherton
Grants Management Specialist
National Center for Research Resources, NIH
6701 Democracy Blvd
Room 1040
Bethesda, MD 20892-4874
Phone: 301-435-0840
Fax: 301-480-3777
Email: [email protected]
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 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.
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 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 the 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); 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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