and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Environmental Health Sciences
(NIEHS), (http://www.niehs.nih.gov)
Title: Environmental Sensors for Personal Exposure Assessment (SBIR
[R44])
Announcement Type
This Funding Opportunity Announcement (FOA) is a
reissue of RFA-ES-07-001.
Request For Applications (RFA) Number: RFA-ES-09-005
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).
IMPORTANT: A registration process in Grants.gov and eRA Commons is necessary before submission. Applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal Domestic Assistance Number(s)
93.113
Key Dates
Release/Posted Date: February 26, 2009
Opening Date: March 25, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): March 30, 2009
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): April 28, 2009
Peer Review Date(s): June/July2009
Council Review Date(s): August 2009
Earliest Anticipated Start Date(s): October 2009
Additional Information To Be
Available Date (URL Activation Date): Not Applicable
Expiration Date: April
29, 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(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Submission, Review, and Anticipated
Start Dates
1. Letter of Intent
B. Submitting an Application
Electronically to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
and Information
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
3. Anticipated Announcement and
Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National
Policy Requirements
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)
Section VIII. Other Information - Required Federal
Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Nature of the research opportunity
Background
Substantive evidence exists to support the concept that common human diseases/dysfunctions, such as asthma, cardiovascular disease, infertility, neurodegenerative diseases and cancer, result from a complex interplay between genes and environmental factors, including chemical toxicants and biological toxins. Population studies aimed at investigating the role of gene-environment interaction in human health and disease have been hampered by the lack of precise measurement tools for assessing a person s exposure to these agents. Typically, these studies rely on exposure data derived from questionnaire and from stationary monitoring devices to assess levels of specific compounds in the general environment where a person works or lives. Less often, they include personal monitoring devices such as portable or wearable sensor badges, clothing, or backpacks to assess levels of specific compounds at the point of contact with the body, such as at the breathing zone or skin, or biomonitoring assays which assess levels of specific analytes in a sample of blood or urine.
Existing methods of human exposure assessment provide little information about changes in exposure levels over time, and most have technology problems concerning sensitivity, specificity, portability, throughput, automation, and functionality to measure multiple analytes with a single device. In addition, most of the available methods require laboratory-based analysis as opposed to in-field analysis, limiting their application in large-scale population studies. New methods are critically needed for near real-time monitoring of environmental exposures to multiple toxicants simultaneously and in a non-obtrusive manner.
A growing number of new sensing modalities have emerged from the nanotechnology and nanoengineering, medical diagnostic, and biodefense arenas. The purpose of this FOA is to promote technology development through the adaptation of existing or emerging sensing modalities to improve the assessment of personal exposure to airborne chemical and biological agents. The development, validation and use of new tools will be of tremendous benefit to the study of gene-environment interaction in human disease.
Panels of biomarkers are needed that can quantify the presence or absence of an exposure and the response to exposure in key physiologic pathways of human disease. Markers that can track response over a relevant time course are highly desirable. For the purposes of this FOA, a biomarker is an indicator of a biologic response to an environmental stressor that is objectively measured. In order to adequately define a response, multiple markers may be necessary to characterize the full response of the pathway to the stressor. A panel of markers, which includes those at the physiologic, cellular and molecular level, are likely to be more valuable than a single marker. For these projects, pathways known to be perturbed by environmental stressors and disease are of greatest interest. These include inflammation, oxidative stress, DNA damage, mitochondrial perturbations, endocrine disruption, xenobiotic biotransformation, immune activation, and epigenetic regulation. Technology that could be applied to the development of biomarkers derived from studies of genomics, proteomics, metabolomics, comparative biology, systems biology, protein-protein interaction, protein trafficking, molecular imaging, and computational or in-silico analyses. A goal of this product development program is to invest in assays that can be developed, validated and scaled up for high-throughput application to large populations quickly and efficiently.
Scientific Knowledge to be Achieved
The goal of the trans-NIH Genes and Environment Initiative is to determine the etiology of common diseases by focusing on the interaction of genetic and environmental factors that increase the risk of these diseases. The Exposure Biology component of the GEI will develop new methods to assess personal exposure to stressors in the environment and the response to these stressors in key biological pathways involved in the pathogenesis of common diseases
Objectives of This Research Program
The purpose of this funding opportunity is threefold: (1) t to develop functional, portable, self-contained, easy-to-use sensing devices for simultaneous multi-analyte measurement of point-of-contact exposures to priority environmental chemical/biological agents; (2) to develop sensors for monitoring environmental exposures in readily available biosamples; and (3) to develop and refine panels of biomarkers of biological response to priority environmental exposures. The projects supported under this FOA will adopt a product-driven approach to the development, small-scale field testing, and functional validation of new sensing technology, especially those with potential for scale up for use in large population studies as part of the GEI.
For purposes of this FOA, priority environmental exposures include:
The new tools developed through this initiative will address current limitations in personal exposure assessment by providing quantitative, precise, reliable, reproducible, mulitplexed measurement of environmental exposures with a high level of temporal resolution. Sensing devices refer to technologies that have the capacity to measure continuously in a closed format, requiring little user intervention for field deployment and data capture.
The sensors developed under this FOA should be capable of measuring simultaneously, and in near real time, multiple agents within a single exposure class (e.g., multiple types of metals, multiple size fractions of particulate matter, multiple components of diesel exhaust) or multiple agents across more than one exposure class.
This FOA will support the development of new sensing devices through the adaptation of existing or emerging technologies including, but not limited to, electrical, mechanical, chemical or optical sensing modalities. To the extent feasible and appropriate, new technologies will capitalize on the emerging properties of nanotechnology and nano-engineered devices, and integrate information technology components to create systems capable of near real-time telemetry for remote data capture and reporting to centralized, managed systems operators. The development of information technologies to support the real-time reporting of external exposure information is appropriate if such development can be completed within the context of the physical device engineering being conducted by the applicant and within the budgetary and time limitations of this solicitation.
Sensors for Measuring Point-of-Contact Exposures
This FOA focuses on the need for field-deployable or wearable sensors that provide quantitative measurement of external exposure to priority chemical and biological agents at the point of contact with the body at the nose, at the breathing zone as inhaled or exhaled breath, or on the skin. The sensing devices will address priority chemical and biological agents that have been shown to cause, or are suspected to be causative factors for, common human diseases such as respiratory disease, neurological disease, cardiovascular disease, immune disorders, and cancer.
Sensors for Measuring Internal Dose and Activity
This FOA addresses the need for accurate internal assessment of internal dose and/or activity of priority environmental exposures in real time or via continuous measurement. Measures of internal dose and activity should be developed using readily accessible biosamples (blood, urine, saliva, buccal samples or exhaled breath). The sensors should have the ability to measure single or multiple agents within a single class of exposure (e.g., pesticides, metals), or multiple agents across more than one exposure class. Throughput will be an important component of these devices to ensure utilization in future large-scale population studies.
Sensors for Measuring Biological Response Indicators
With regard to the development of biomarkers of response, three phases of research define an experimental paradigm that permits researchers to leverage existing biomarker studies and that encourages new biomarker discovery. Since this FOA is for phase II SBIR applications it is expected that applications will focus on assay refinement and validation for use in human populations.
Research may include the use of animal models to characterize response to environmental stressors in key pathways to agents of choice in target and peripheral tissues or identification and characterization of a suite of biomarkers in clinical specimens.
Research conducted under this part of the FOA could include use of technologies such as genomics, proteomics, metabolomics, and more precise quantification of DNA damage products coupled with clinical biochemistry, histology, or physiologic markers (such as pulmonary function or cardiac activity) should be considered in the assessment of patterns of response due to environmental stressors and incorporated into biomarker development.
Research could include any of the following: the study of clinical samples from persons who are exposed to environmental stressors and controls, persons who display interesting and relevant clinical manifestations of pre-clinical or clinically apparent disease, or the study of animal model systems or other cell culture systems.
Examples of research that would be relevant for the development of biomarkers of exposure portion of this FOA include, but are not limited to:
Product Development Plan
Proposed projects should be focused on coupling new technology development with assessment needs and opportunities for specific priority environmental agents. The applicant should describe (1) the criteria for selecting the analytes to be measured by the proposed technology, (2) whether a current technology exists for the detection or quantification of these analytes, and (3) how the proposed device will be an improvement over the current technology.
The Product Development Plan for phase II applications should describe how the functional validation phase will effectively assess sensor function in real-time, and relate the sensor output to environmentally and physiologically relevant values. Applicants should describe the algorithms used to relate sensor measurements to these parameters. It is expected that any devices developed through this FOA will be available for application to population studies at the end of the funding period.
As a critical aspect of the application, applicants should describe how the new sensing device or system (point of contact, internal dose, or biomarker of response) will address the following technology specifications:
The products developed under this FOA should be either entirely field-deployable or wearable devices for individual exposure assessment (point of contact, internal dose, or biomarker of response) or combined field-deployable capture devices dependent on laboratory-based analyses; provided these devices meet the above criteria. Proposals to develop exclusively laboratory-based technologies will not be considered responsive. Applicants are not required to achieve all specifications for a single device or system, but will be judged on their ability to address as many of these specifications as possible. Applicants should provide a rationale as to why a given specification cannot be met within the proposed application and what steps would be needed to address the specification.
The development of sensing devices and systems is a complex process involving engineers, basic researchers, manufacturers, end users, and information technologists. It is expected that individual applications will involve collaborations between experts in several of these core disciplines in order to cover the full spectrum of research activities needed to support the facets of technology development from conceptualization to field testing and functional assessment. Applicants should include a section within the application that identifies entities with which partnerships will be established, and their respective role on the project with regard to the identification and adaptation of existing or emerging sensing modalities, manufacture of prototype devices, and the small-scale field testing and functional validation of the prototypes. Research partners might include engineering centers with expertise in component integration, clinical or basic research networks, user-based networks, industry researchers or manufacturing centers.
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
Innovation Research (SBIR [R43]) grant mechanisms. Applications may be submitted for support as Phase II grants
as described in the SF424 (R&R) SBIR/STTR Application Guide.
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. SBIR Phase II applications will compete with all SBIR applications and will be reviewed according to the customary peer review procedures. SBIR Phase II Competing Renewal applications are not permitted under this FOA.
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses Just-in-Time information concepts. The modular budget format is not accepted for 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
The estimated amount of funds available for support of 8-10 projects awarded as a result of this announcement is $10 million for fiscal year 2009. Future year amounts will depend on annual appropriations.
Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.
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 SBIR applications. A small business concern
is one that, at the time of award of SBIR Phase I and Phase II, meets all of
the following criteria:
1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there can be no more than 49 percent participation by foreign business entities in the joint venture;
3. Is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, except in the case of a joint venture, where each entity to the venture must be 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and;
4. Has, including its affiliates, not more than 500 employees.
SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.
Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 C.F.R. 121.3-2(a). The term "number of employees" is defined in 13 C.F.R. 121.3-2(t).
Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Office of Size Standards (http://sba.gov/size).
One of the circumstances that would lead to a finding that an organization is controlling or has the power to control another organization involves sharing common office space and/or employees and/or other facilities (e.g., laboratory space). Access to special facilities or equipment in another organization is permitted (as in cases where the awardee organization has entered into a subcontractual agreement with another organization for a specific, limited portion of the research project). However, research space occupied by an SBIR awardee organization must be space that is available to and under the control of the SBIR awardee for the conduct of its portion of the proposed project.
Title 13 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 SBIR program, personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee. This is consistent with SBA’s size regulations, 13 CFR 121.106 Small Business Size Regulations.
Note regarding affiliation arising under stock options, convertible securities, and agreements to merge: In determining size, SBA considers stock options, convertible securities, and agreements to merge (including agreements in principle) to have a present effect on the power to control a concern. SBA treats such options, convertible securities, and agreements as though the rights granted have been exercised. See http://edocket.access.gpo.gov/cfr_2005/janqtr/pdf/13cfr121.103.pdf.
All SBIR grant applications will be examined with the above eligibility considerations in mind. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an SBIR award until the SBA provides a determination.
Note: An applicant organization that has been determined previously by SBA to be other than small for a size standard of not more than 500 employees or for purposes of the SBIR/STTR program, must be recertified by the SBA prior to any future SBIR/STTR awards.
1.B. Eligible Individuals
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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 (i.e., multiple PDs/PIs), may be designated on the application for projects that require a team science approach and therefore clearly do 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 electronic Research Administration (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 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. 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.
As defined in 42 CFR 52, the PD/PI is the single individual designated by the grantee in the grant application who is responsible for the scientific and technical direction of the project. When the proposed PD/PI clearly does not have sufficient qualifications to assume this role, the application is not likely to receive a favorable evaluation.
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.
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
Resubmissions: Applicants are not permitted to submit a resubmission application in response to this FOA.
Renewals. SBIR Phase II Competing Renewal applications are not permitted in response to this FOA.
Number of Applications. Applicants may submit one application.
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. 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.
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.
Several of the steps of the registration process could take four (4) 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 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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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. 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.
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.
All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan (Item 14 of the PHS398 Research Plan component of the SF424 (R&R) application), 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, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.
If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
Grantee Meeting
Applicants should include in their budget funds to travel to at least one GEI meeting during the tenure of the phase II award.
3. Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and
Anticipated Start Dates
Opening Date: March 25,
2009 (Earliest date an application
may be submitted to Grants.gov)
Letters of Intent Receipt Date: March
30 2009
Application Due Date: April 28, 2009
Peer Review Date(s): June/July2009
Council Review Date: August
2009
Earliest Anticipated Start Date: October 2009
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter
of intent that includes the following information:
Although a letter of intent is
not required, is not binding, and does not enter into the review of a
subsequent application, the information that it contains allows IC staff
to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent to:
Jerrold J. Heindel, PhD
Division of Extramural Research
and Training
National Institute of Environmental
Health Sciences
530 Davis Drive
Building 530, Room 3083
Research Triangle Park,
NC, 27713
Telephone: (919) 541-0781
Fax:
(919-541-5064
Email: [email protected]
3.B. Submitting an Application Electronically
to the NIH
To submit an application in response to this
FOA, applicants should access this FOA via 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.
In order to expedite the review, applicants are requested to notify the NIEHS Referral Office by email ([email protected]) when the application has been submitted. Please include the FOA number and title, and PD/PI name and title of the application.
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)
and responsiveness by the NIEHS. Incomplete and non-responsive applications will not be reviewed.
There will be an acknowledgement of receipt of applications
from Grants.gov and the Commonshttps://commons.era.nih.gov/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 funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application using the standard NIH, CDC, and FDA SBIR submission dates of April 5, August 5, and December 5 (or May 7, September 7, and January 7 for NIH AIDS and AIDS-related SBIR applications). That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
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
Grantee Meeting
Applicants should include in their budget funds to travel to at least one GEI meeting during the tenure of the phase II award.
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) SBIR/STTR Application Guide. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.
All application instructions outlined in the SF424 (R&R) SBIR/STTR Application Guide are to be followed, incorporating "Just-in-Time" information concepts, with the following requirements.
SBIR Phase II 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) SBIR/STTR 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.
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 (for example, human subject concerns, the Small Business Act provisions, etc.), this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.)
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with NIH institute/center (IC) program staff likely to accept assignment of their application (see Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where 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 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 (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process..
2. Review and Selection Process
Applications that are complete and responsive
to this FOA will be evaluated for scientific and technical merit
by an appropriate peer review group convened by NIEHS and 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 FOA will compete for available funds with all other recommended SBIR applications. The following will be considered in making funding decisions:
Enhanced Review Criteria
The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
All SBIR Applications
Overall Impact. Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance. Does the proposed project have commercial potential to lead to a marketable product, process or service? Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation. Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Environment. Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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?
2.A. Additional Review Criteria
As applicable for the project proposed, reviewers will consider the
following additional items in the determination of scientific and technical
merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
2.B. Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the
following items, but will not give scores for these items and should not
consider them in providing an overall impact score.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Select Agent Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans. Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:
3. Anticipated Announcement and
Award Dates
Not Applicable
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the PD/PI will be
able to access his or her Summary Statement (written critique) via the NIH
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 Section IV.5.,
Funding Restrictions.
A formal notification in the
form of a Notice of Award (NoA) will be provided to the applicant organization.
The NoA signed by the grants management officer is the authorizing document.
Once all administrative and programmatic issues have been resolved, the
NoA will be generated via email notification from the awarding component
to the grantee business official.
For Fast-Track applications, the Phase II portion
may not be funded until a Phase I final report and other documents necessary
for continuation have been received and assessed by program staff that the
Phase I milestones have been successfully achieved.
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.
Section VII. Agency Contact(s)
We encourage your inquiries concerning
this funding opportunity and welcome the opportunity to answer questions
from potential applicants. Inquiries may fall into three areas: scientific/research,
peer review, and financial or grants management issues:
1. Scientific/Research Contact(s):
Jerrold J. Heindel, PhD
Division of Extramural Research
and Training
National Institute of Environmental
Health Sciences
530 Davis Drive
Keystone Building, Room 3026
Research Triangle Park,
NC, 27713
Telephone: (919) 541-0781
Fax:
(919-541-5064
Email: [email protected]
2. Peer Review Contact(s):
Rose Anne McGee
Division of Extramural Research
and Training
National Institute of Environmental
Health Sciences
530 Davis Drive
Keystone Building, K3-03, Room 3084
Research Triangle Park,
NC, 27713
Telephone: (919) 541-0752
Email: [email protected]
3. Financial or Grants Management Contact(s):
Pam Clark
Division of Extramural Research and Training
National Institute of Environmental
Health Sciences
530 Davis Drive
Keystone Building, Room 3054
Research Triangle Park,
NC 27713
Telephone: (919 541-7629
Fax: (919) 541-2860
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 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.
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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