Department of Health and Human Services
Issuing Organization
National Institute of
Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)
Participating Organizations
National Institutes of
Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of
Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)
National
Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National
Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov)
National
Cancer Institute (NCI), (http://www.nci.nih.gov)
National
Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
National
Institute of Mental Health (NIMH), (http://www.nimh.nih.gov)
Title: Characterization, Behavior and Plasticity of Pluripotent
Stem Cells (R21)
Announcement Type
This is a
reissue of PA-04-101, previously released May 4,
2004.
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 SF424 (R&R) Application Guide. APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
This FOA must be read in conjunction with the application guidelines provided 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 weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be submitted to Grants.gov by 5:00 p.m. local time (of the applicant institution/organization) on the submission date (see “Key Dates” below).
2) Applicants must complete a verification step in the eRA Commons within two business days of notification from NIH. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the Commons.
Program Announcement (PA) Number: PA-06-198
Catalog of Federal Domestic Assistance Number(s)
93.853, 93.173, 93.866,
93.929, 93.396, 93.279, 93.242
Key Dates
Release/Posted
Date: March 3, 2006
Opening
Date: May 2,
2006 (Earliest
date an application may be submitted to Grants.gov)
Letter of
Intent Receipt Date(s): Not applicable
Application
Submission Date(s): Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council
Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information
To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: July 17, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
The National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute on Aging (NIA), the National Institute of Child Health and Human Development (NICHD), the National Cancer Institute (NCI), the National Institute of Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH) invite applications for studies on the characterization, behavior and plasticity of human and non-human stem cells, regulation of their replication, differentiation, integration and function in the nervous system, and the identification and characterization of normal and tumor stem cells.
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.
Sending an Application to the NIH
C.
Application Processing
4. Intergovernmental
Review
5. Funding
Restrictions
6. Other Submission
Requirements
Section
V. Application Review Information
1. Criteria
2. Review and
Selection Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Sharing Research Data
D.
Sharing Research Resources
3. Anticipated
Announcement and Award Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative
and National Policy Requirements
3. Reporting
Section
VII. Agency 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
Stem cells appear to possess great plasticity, but the cellular mechanisms regulating their behavior and fate are not understood. If these mechanisms can be harnessed to obtain cells specifically required for therapy, diagnosis or drug discovery, it may be possible to restore function to tissues and organ systems that have been compromised by congenital disorders, developmental malfunction, age, injury, disease or drug exposure. The National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute on Aging (NIA), the National Institute of Child Health and Human Development (NICHD), the National Cancer Institute (NCI), the National Institute of Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH) invite applications for studies on the characterization, behavior and plasticity of human and non-human stem cells, regulation of their replication, differentiation, integration and function in the nervous system, and the identification and characterization of normal and tumor stem cells. An understanding of intrinsic and extrinsic signals, especially those involved in the stem cell niche, age-dependent processes and genetic factors that govern the activities of pluripotent cells is crucial in order to utilize them to develop safe and effective treatments for the restoration of function, or to prevent their transformation into tumor-generating cells. Although animal studies demonstrate that stem or progenitor cells can be derived from a variety of tissues and from hosts of different ages, the requirements and potential for differentiation of each type of pluripotent cell appear to be unique. We lack a clear understanding of the intrinsic properties that distinguish one population from another, and how these populations differ in their response to similar conditions in vitro and in vivo. This Program Announcement, which replaces PA-01-078 (Biology of Non-Human Stem Cells in the Environment of the Nervous System) and PA-02-025 (Plasticity of Human Stem Cells in the Nervous System), encourages applications to study the fundamental properties of all classes of human and non-human stem cells, and to confirm, extend, and compare the behavior of stem cells that are derived from different sources and ages or exposed to different regimes in vitro and in vivo or derived from tumors. Of high priority are studies to develop methods for identifying, isolating and characterizing specific precursor populations at intermediate stages of differentiation into neurons and glia, and their relationship to tumor-generating cells. Projects that address comparisons between different classes of human stem cells and between human and non-human stem cells would also be directly relevant to this PA.
Background
Stem cell research offers enormous potential for treating a host of congenital, developmental, psychiatric or degenerative diseases for which there are no cures. In animal studies, multipotent progenitor cells from many different sources have been reported to generate cells with neuronal or glial properties, raising expectations that they could be used to replace lost neurons and glia, repair defective circuits, and restore functions compromised by abnormal development, age, physical damage, disease or drug addiction. In addition to cell and tissue therapy, the ability to selectively produce one or more differentiated cell types at will from pluripotent stem cells would be of clinical importance in investigating the effects of drugs, environmental and genetic factors on differentiation and cell function in the human nervous system. These approaches could aid in the discovery of drugs and ultimately in the development of a variety of effective treatment strategies.
Major challenges have to be overcome before any type of stem cell can be harnessed and translated to meaningful treatments for patients. These challenges include identifying the optimal type of stem cell or stem cell derivative for specific assays and therapies for individual disorders, harvesting and growing sufficient quantities of the appropriate cell type, deciding the best therapeutic strategy for each condition to be treated, and assessing the potential side effects that may arise when such versatile cells are introduced into a patient. In addition, examples of the enormous plasticity exhibited by stem cells raise fundamental questions about the comparative potential for differentiation of precursor cells derived from different sources and different stages of development, the nature of the conditions that regulates stem cell behavior, and the genetic, molecular and cellular mechanisms that result in functional integration within the nervous system over the lifespan of the host.
Of the many types of progenitor cells competent to develop neuronal and glial features, embryonic stem (ES) cells, derived from embryos at the blastocyst stage, may have the broadest natural potential for differentiation because, during development, they normally produce all the cells of an organism. These pluripotent cell lines are characterized by nearly unlimited self-renewal and differentiation capacity. During differentiation in vitro, mouse and human ES cells express properties of mature tissues such as muscles, several classes of neurons, glia, pancreatic islet cells, cartilage and blood. When transplanted into the central nervous system (CNS), ES cells that have been coaxed along an oligodendrocytic lineage will form myelin and ensheath axons. Some improved function was reported in rodent models of demyelination and spinal cord injury that received these ES cell-derived transplants. However, how the transplanted cells contributed to the restoration of function is unclear.
Other sources of progenitors are neural stem cells that are derived from neurogenic regions in the developing and adult CNS. They integrate seamlessly into the host when transplanted into the developing nervous system, but their fate appears highly dependent upon the local environment that they encounter. This is particularly true when these cells are introduced into the adult CNS. For example, cells that can become neurons in one part of the nervous system, such as the hippocampus, generate astrocytes exclusively when placed into the spinal cord. The concept of the niche has emerged recently as an important one; yet at the present time, we have very little information on the nature of the environmental signals that regulate fate decisions of stem cells.
Of particular interest are recent reports from a number of investigators that stem cells present in adult, non-neuronal tissues appear to show surprising plasticity or versatility. For example, under specific culture conditions, bone marrow stromal cells appear to “trans-differentiate” to give rise to cells with neuronal or glial features. Following bone marrow transplantation, donor-derived cells could be found in many tissues including the CNS, skeletal muscle, liver, heart, vascular endothelia, and bone. Some of these findings have been attributed to the fusion of a donor cell with a mature host cell, giving the appearance of trans-differentiation of the donor cell to an unrelated adult phenotype. Other reports of switches in lineage cannot be explained by fusion. Perhaps most intriguing is the hypothesis that cells committed to a particular lineage may “de-differentiate” to a more pluripotent state. One of the most attractive sequelae of plasticity is the possibility of developing autologous cells for transplantation, because autologous grafts will not be rejected by the host or recipient. On the other hand, the pliable nature of stem cells raises the concern that transplanted cells could be triggered by the local environment to an undesired phenotype with unpredictable consequences. Before we can design therapies using human stem cells, we must understand how "plastic" or malleable are these different classes of cells, the signals that drive their choice of fates, and how reversible are these fates.
For unknown reasons, select populations of cells are destroyed in specific neurological disorders and diseases - dopaminergic neurons in Parkinson's Disease (PD), cholinergic neurons in Alzheimer's Disease(AD), motor neurons in Amyotrophic Lateral Sclerosis (ALS) and myelinating oligodendrocytes in Multiple Sclerosis (MS). Because there is great diversity of neurons and glia, studies to develop treatments for these and other diseases with less well defined etiologies will require the characterization and acquisition of unique populations of neurons and glia. While dopaminergic neurons are clearly the target of studies on PD, defining the specific features of the dopaminergic neurons needed to treat PD is less obvious. Each neuronal and glial phenotype is defined by a constellation of morphological, biochemical, genetic, and electro-physiological properties, and the functional significance or impact of a neuronal population depends on connectivity with appropriate afferent and efferent populations. It is necessary to determine the optimal stem cell and protocol that will produce a differentiated phenotype that best replicates the significant properties required and can replace the dysfunctional cell type. The features most commonly evaluated include morphology, biochemical and gene expression, and physiology. Less often described are quantification of protein and gene levels, acquisition and maintenance of phenotype over time, cell division and migration, and the simultaneous tracking of multiple properties in a population of cells. Least studied are the integration and functional consequences of the transplanted cells in the host, and the long-term behavior of the transplanted population. In summary, because we know little about the biology and the comparative scope for differentiation of the many different types of stem cells, it is difficult to assess realistically their potential for use in developing treatments for neurological disease and other conditions.
Recent findings demonstrate that in select regions of the avian and mammalian nervous systems, endogenous neural stem and precursor cells continue to produce new neurons and circuits throughout adulthood, and indeed over the entire lifespan, though new cell production declines with age. In the adult hippocampus, newly born neurons acquire the size and morphology of their older neighbors and establish contacts with existing circuits in the brain, a process that can take months to complete. Endogenous stem cells can replace hair cells of the inner ear following acoustic and drug-induced damage in the adult avian and amphibian nervous systems. Similarly, the sensory neurons of the olfactory epithelium are replaced on a regular basis, and especially in response to injury, from an endogenous stem cell pool. Behavior, experience and drugs such as anti-depressants have demonstrable and profound effects on the production and establishment of new neurons in the adult and the aging brain. Drug abuse, on the other hand, have been shown to inhibit neurogenesis in rodents and result in developmental deficits and cognitive dysfunctions in humans and animals. All these findings have important implications for development, learning, memory and the maintenance of a healthy nervous system that functions throughout life. New research into mechanisms that influence ongoing neurogenesis and gliogenesis will provide fundamental information on the capacity of the nervous system to adapt in response to pharmacological and behavioral therapy throughout life. The hope is that processes that regulate the native production and integration of new neurons may be deployed to repair disordered regions of the brain.
Objectives and Scope
This Funding Opportunity Announcement (FOA) is intended to promote studies of stem cell biology and the regulation and control of stem cells in the nervous system. Research efforts on characteristics that distinguish between different types of stem cells and the cellular, molecular and genetic mechanisms that influence their lineage choices are particularly relevant, as are studies that explore the long-term fates of stem cell-derived populations in animal models. Also of interest is the development of methods for isolating specific cell populations, and studies that demonstrate or enhance the safety of stem cells in treatments for neurological conditions. The following examples illustrate areas that are of high interest; other innovative projects are also encouraged.
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section II. Award Information
1. Mechanism of Support
This funding opportunity
will use the National
Institutes of Health (NIH) Exploratory/Developmental (R21) award mechanism. As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
Exploratory/developmental grant support is for new projects only; competing renewal (formerly “competing continuation”) applications will not be accepted. Up to two resubmissions (formerly “revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.
The R21 mechanism is intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These one-time awards support innovative, high impact research projects that 1) assess the feasibility of a novel area of investigation or a new experimental system, 2) include the unique and innovative use of an existing methodology to explore a new scientific area, 3) involve considerable risk but may lead to a breakthrough in a particular area, or 4) develop new technology or methodology that could have major impact in a specific research
area. Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.
This funding opportunity uses just-in-time concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).
2. Funds Available
There is no special set aside of funds for applications submitted in response to this announcement.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Direct costs are limited to $275,000 over the two years of the R21 award, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this Program Announcement funding opportunity.
Facilities and Administrative (F&A) costs requested by consortium
participants are not included in the direct cost limitation. See NOT-OD-05-004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
1.B. Eligible Individuals
Any individual with the
skills, knowledge, and resources necessary to carry out the proposed research
is invited to work with their institution to develop an application for
support. Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH programs.
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
Not applicable.
Section
IV. Application and Submission Information
Registration and Instructions for Submission via Grants.gov
To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at both:
PD/PIs should work with their institutions/organizations to make sure they are registered in the NIH Commons.
Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov/Get Started
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.
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) Application
Guide for this FOA through Grants.gov/Apply.
Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.
For further
assistance contact GrantsInfo, Telephone 301-435-0714, Email: GrantsInfo@nih.gov.
Telecommunications
for the hearing impaired: TTY 301-451-0088.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).
The SF424 (R&R) 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). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “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
PHS398
Cover Page Supplement
PHS398
Research Plan
PHS398
Checklist
PHS398 Modular Budget
Optional Components:
PHS398
Cover Letter File
R&R
Subaward Budget Attachment(s) Form
Note: While both budget components are included in
the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)
Foreign
Organizations
Several
special provisions apply to applications submitted by foreign organizations:
Proposed research should provide a unique research opportunity not available in the United States.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A.
Submission, Review, and Anticipated Start Dates
Letter of Intent Receipt
Date: Not applicable
Application Submission Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Council Review Date(s): http://grants.nih.gov/grants/funding/submissionschedule.htm
Earliest Anticipated Start Date: http://grants.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of Intent
A letter of intent
is not required for the funding opportunity.
3.B. Sending an
Application to the NIH
To submit an application
in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply 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 to Grants.gov on or after the opening date and must be submitted
no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission date(s).
(See Section IV.3.A. for all dates.) If an application is not submitted
by the submission date(s) and time, the application may be delayed in the
review process or not reviewed.
Upon receipt, applications will be transferred from Grants.gov to the
NIH Electronic Research Administration process for validation. Both the PD/PI
and the Signing Official for the organization must verify the submission via Commons within 2 business days
of notification of the NIH validation.
Upon receipt, applications will be evaluated for completeness by the
Center for Scientific Review, NIH. Incomplete applications will not be
reviewed.
The NIH will not accept any application in response to this 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 that such an application is considered a
"resubmission" for the SF424 (R&R).
There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.
4. Intergovernmental Review
This initiative is
not subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/policy.htm).
Pre-Award Costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing continuation award if
such costs: are necessary to conduct the project, and would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or competing continuation 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
The NIH requires the 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. 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 “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”
Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.
Special Requirements
Use of human embryonic stem cells (hESCs): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. All cell lines that meet these criteria and are therefore eligible for research with federal funding are identified and registered in the NIH Human Embryonic Stem Cell Registry (http://escr.nih.gov). NIH has established a website (http://stemcells.nih.gov/info/faqs.asp) that provides information in the form of answers to frequently asked questions about implementation issues for human embryonic stem cell research (see also: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-014.html). Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for funding. Each approved cell line is specifically identified by an NIH code in the Registry. It is the responsibility of the applicant to provide in the Description of their application the official NIH identifier(s) for the hESC line(s) that they will use as found in the NIH Registry (http://escr.nih.gov). Applications that do not provide this information will be returned without review.
Specific
Instructions for Modular Grant applications.
Applications
requesting direct costs in each year of $250,000 or less (excluding consortium
F&A costs), must be submitted in a modular budget format using the Modular Budget
Component provided in the SF424 (R&R) Application Package and Instructions
Guide (see specifically Section 5.4). The modular budget format simplifies the
preparation of the budget in these applications by limiting the level of
budgetary detail. Applicants request direct costs in $25,000 modules.
Application Characteristics
Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. 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.
Plan for Sharing Research Data
The
precise content of the data-sharing plan will vary, depending on the data being
collected and how the investigator is planning to share the data. Applicants
who are planning to share data may wish to describe briefly the expected
schedule for data sharing, the format of the final dataset, the documentation
to be provided, whether or not any analytic tools also will be provided,
whether or not a data-sharing agreement will be required and, if so, a brief
description of such an agreement (including the criteria for deciding who can
receive the data and whether or not any conditions will be placed on their
use), and the mode of data sharing (e.g., under their own auspices by mailing a
disk or posting data on their institutional or personal website, through a data
archive or enclave). Investigators choosing to share under their own auspices
may wish to enter into a data-sharing agreement. References to data sharing may
also be appropriate in other sections of the application.
Applicants requesting more than
$500,000 in direct costs in any year of the proposed research must include a
plan for sharing research data in their application. The funding organization
will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness
of the data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
Sharing Research
Resources
NIH policy requires that grant awardee recipients make
unique research resources readily available for research purposes to qualified
individuals within the scientific community after publication (See the NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3. “Reporting.”
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the
initial merit review, all applications will:
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, weighting them 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 high priority score. For example, an investigator may propose
to carry out important work that by its nature is not innovative but is
essential to move a field forward.
Significance: Does this study address an
important problem? 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?
Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
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?
Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?
Environment: Does the scientific
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?
2.A. Additional Review
Criteria:
In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed. See item 6 of the Research Plan component of the SF424 (R&R).
Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See item 7 of the Research Plan component of the SF424
(R&R).
Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under item 11 of the Research
Plan component of the SF424 (R&R) will be assessed.
Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.
2.B. Additional
Review Considerations
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed research
may be assessed by the reviewers. Is the percent effort listed for the PD/PI
appropriate for the work proposed? Is each budget category realistic and
justified in terms of the aims and methods?
Period of Support: The appropriateness of the
requested period of support in relation to the proposed research.
2.C. Sharing
Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
Program staff will be responsible for the administrative review of the plan for sharing research data.
2.D. Sharing
Research Resources
NIH
policy requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
Program staff will be responsible
for the administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making recommendations
about funding applications. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3., “Reporting.”
3. Anticipated Announcement and Award Dates
Not applicable
Section VI. Award Administration Information
1. Award Notices
After
the peer review of the application is completed, the PD/PI will be able to
access his or her Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and cooperative agreement awards include
the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart
A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be required to submit the PHS
Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency Contacts
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:
1. Scientific/Research Contacts:
David Owens, Ph.D.
Repair and Plasticity Cluster
National Institute of Neurological Disorders and Stroke
Neuroscience Center, Room 2204
6001 Executive Blvd.
Bethesda, MD 20892-9605
Telephone: (301) 496-1447
FAX: (301) 480-1080
Email: do47h@nih.gov
Barry J. Davis, Ph.D.
Division
of Scientific Programs
NIDCD / Suite 400C
6120
Executive Blvd., MSC 7180
Rockville, MD 20892-7180
Phone:
301-402-3464
FAX:
301-402-6251|
Email: Davisb1@nidcd.nih.gov
Bradley C
Wise, Ph.D.
Program
Director, Fundamental Neuroscience
Neuroscience
and Neuropsychology of Aging Program
National
Institute on Aging
Gateway Building, Suite 350
7201 Wisconsin Avenue MSC 9205
Bethesda, MD 20892-9205
Telephone:
(301) 496-9350
FAX:
(301) 496-1494
Email: WiseB@nia.nih.gov
Ralph M.
Nitkin, Ph.D.
Biological
Sciences and Career Development Program
National Center for Medical Rehabilitation
Research
National Institute of Child Health and Human Development
Executive Building, Room 2A03
6100
Executive Blvd,
MSC 7510
Bethesda, MD 20892-7510
Telephone:
(301) 402-4206
FAX:
(301) 402-0832
Email: rn21e@nih.gov
Neeraja
Sathyamoorthy, Ph.D.
Program
Director
Tumor
Biology & Metastasis Branch
Division
of Cancer Biology
National
Cancer Institute
6130
Executive Boulevard EPN 5036
Rockville MD 20892
Phone:
301-435-1878
Fax:
301-480-0864
Email: ns61r@nih.gov
Geraline
C. Lin, Ph.D.
Division
of Neuroscience and Behavioral Research
National
Institute on Drug Abuse
6001
Executive Boulevard
Room
4282, MSC 9555
Bethesda, MD 20892-9555
Telephone:
(301) 435-1305
FAX:
(301) 594-6043
Email: glin@nida.nih.gov
Beth-Anne
Sieber, Ph.D.
Chief,
Developmental Neurobiology Program
National
Institute of Mental Health
Division
of Neuroscience and Basic Behavioral Science
6001
Executive Boulevard, Rm 7186
Bethesda, MD 20892-9641
Phone:
(301) 443-5288
Fax:
(301) 402-4740
E-mail: bsieber@mail.nih.gov
2. Peer Review Contacts:
Not
applicable
3. Financial or Grants Management Contacts:
Michael
J. Loewe
Chief,
Grants Management Branch
National
Institute of Neurological Disorders and Stroke
6001
Executive Blvd., Suite 3290, MSC 9537
|Bethesda, MD 20892-9537
Telephone:
(301) 496-9231
FAX:
(301) 402-0219
Email: ml70m@nih.gov
Or to
Gavin Wilkom
Grants Management Branch, DER
National Institute of Neurological Disorders and Stroke
Building Number, Room Number
6001 Executive Blvd.
Bethesda, MD 20892-9605
Telephone: (301) 496-7480
FAX: (301) 402-0219
Email: gw62m@nih.gov
Sara Stone
Chief,
Grants Management Office
Division
of Extramural Activities
NIDCD / Suite 400B
6120
Executive Blvd,
MSC-7180
Bethesda, MD 20892-7180
Telephone:
(301)402-0909
FAX:
(301) 4021758
Email: stones@nidcd.nih.gov
Linda
Whipp
Grants
Management Officer
Grants
and Contracts Management Office
National
Institute on Aging
7201 Wisconsin Avenue, Suite 2N212 MSC9205
Bethesda, Maryland 20892-9205
Telephone:
(301) 496-1472
Email: WhippL@nia.nih.gov
Chris
Robey
Grants
Management Branch
National Institute of Child Health and Human Development
6100
Executive Boulevard, 8A17, MSC 7510
Bethesda, MD 20892-7510
Telephone:
(301) 435-6996
FAX:
(301) 451-5510
Email: robeyj@mail.nih.gov
Bill
Wells
Grants
Administration Branch
National
Cancer Institute
EPS Room
243
6130
Executive Boulevard
Rockville MD 20892
Phone:
301-496-8796
Email: wellsw@mail.nih.gov
Diana
Haikalis
Acting
Team Leader
Grants
Management Branch
National
Institute on Drug Abuse
6101
Executive Boulevard
Room 270
MSC 8403
Bethesda, MD 20892-8403
Telephone:
(301) 443-6710
Email: dhaikali@nida.nih.gov
Rebecca
Claycamp, CRA
Chief
Grants Management Officer
National
Institute of Mental Health
6001
Executive Boulevard, Room 6122, MSC 9605
Bethesda, MD 20892-9605
Telephone:
(301) 443-2811
FAX:
(301) 443-6885
Email: rc253d@nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients of PHS support for activities involving
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of
Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for
multi-site clinical trials involving interventions that entail potential risks
to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of scientific merit or the priority score.
Access to Research Data through the Freedom of
Information Act:
The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.
Sharing of Model Organisms:
NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
Inclusion of Women And Minorities in Clinical
Research:
It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R); and updated roles and responsibilities
of NIH staff and the extramural community. The policy continues to require for
all NIH-defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to conduct
analyses, as appropriate, to address differences by sex/gender and/or
racial/ethnic groups, including subgroups if applicable; and b) investigators
must report annual accrual and progress in conducting analyses, as appropriate,
by sex/gender and/or racial/ethnic group differences.
Inclusion of Children as Participants in Clinical
Research:
The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.
All investigators proposing research involving human subjects
should read the "NIH Policy and Guidelines" on the inclusion of
children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).
Required Education on the Protection of Human
Subject Participants:
NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.
NIH Public Access Policy:
NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service Awards,
as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.
For more information about the Policy or the
submission process please visit the NIH Public Access Policy Web site at http://PublicAccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable
Health Information:
The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).
Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR Website (http://www.hhs.gov/ocr/) provides information
on the Privacy Rule, including a complete Regulation Text and a set of decision
tools on "Am I a covered entity?" Information on the impact of the
HIPAA Privacy Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts can be
found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be
self-contained within specified page limitations. Unless otherwise specified in
an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This PA is
related to one or more of the priority areas. Potential applicants may obtain a
copy of "Healthy People 2010" at http://www.health.gov/healthypeople.
Authority and Regulations:
This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The NIH Grants Policy
Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Loan Repayment Programs:
NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of researchers
by providing the means for developing a research career unfettered by the
burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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