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
This Funding Opportunity Announcement
(FOA) is developed as part of the American Recovery & Reinvestment Act of
2009 (Recovery Act). All NIH Institutes and Centers with funding authority will
participate with the NIH Office of the Director in this initiative. This FOA
will be administered by the Office of the Director of the NIH (http://www.nih.gov). Awards will be administered
by the participating Institutes and Centers.
Title: Recovery Act Limited
Competition: NIH Director’s Opportunity for Research in Five Thematic Areas
(RC4)
Announcement
Type
New
Update: The following update relating to this announcement has been issued:
Request for
Applications (RFA) Number: RFA-OD-10-005
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).
A registration process
is necessary before submission and applicants are highly encouraged to start
the process at least four (4) weeks prior to the grant submission date. See Section IV.
Catalog of Federal
Domestic Assistance Number(s)
93.701
Key Dates
Release/Posted Date:
December 28, 2009
Opening
Date: February 15, 2010 (Earliest date an application may be submitted to
Grants.gov)
Letters of Intent Receipt Date: February 15, 2010
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: March 15, 2010
AIDS Application Due Date: Not applicable
Peer Review Date(s): June/July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date: August 31, 2010
Additional Information To Be Available Date (Activation
Date): Not
Applicable
Expiration Date: March 16, 2010
Due Dates for
E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
The NIH has received
new funds for Fiscal Years (FYs) 2009 and 2010 as part of the American Recovery
& Reinvestment Act of 2009 ( Recovery Act or ARRA ). This is one of a
number of NIH initiatives related to the Recovery Act. These are listed at the
following site: http://grants.nih.gov/recovery/.
Under the Recovery Act,
the NIH has established a program entitled NIH Director’s Opportunity for
Research in Five Thematic Areas . This program will support projects that
address research endeavors in specific areas that will benefit from significant
three-year funds without the expectation of continued NIH funding beyond this
period. The research supported by the program should have high short-term impact,
and a high likelihood of enabling growth and investment in biomedical research
and development, public health, and health care delivery.
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section
III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section
VIII. Other Information - Required Federal Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The
mission of the NIH is science in pursuit of fundamental knowledge about the
nature and behavior of living systems and the application of that knowledge to
extend healthy life and reduce the burdens of illness and disability. To that
end, the NIH, through extramural grants programs of its Institutes and Centers,
supports a broad range of biomedical research. Previous research has enormously
increased our understanding of the molecular, cellular and behavioral bases of
disease and our approaches to health care. The most recent advances in
technology and science create numerous opportunities for the public and private
sectors to accelerate discoveries for the prevention, diagnosis and treatment
of disease. The high complexity of the technologies and data systems required for
this type of research, and the requirements for large interdisciplinary teams
significantly limit progress and prevent private sector investments and
expansions.
Through
investments of ARRA funds in FY2009, the NIH has the unprecedented opportunity
to expand, accelerate and jumpstart research programs in meeting emerging biomedical
and behavioral research needs. In FY2010, we continue to extend this
opportunity to fuel additional research in addressing new challenges. The
purpose of this program is to support high impact ideas in five broad thematic
areas that lend themselves to short-term funding, and may lay the foundation
for new fields of investigation. Applicants may propose to address either a
specific disease- or technology-related research question relevant to one or
more of the participating Institutes and Centers, or propose the creation of a
unique infrastructure/resource designed to accelerate scientific progress in
the future. This FOA is designed to provide investigators and institutions with
the opportunity to address these unique challenges by engaging in new avenues
of research where progress would produce a significant impact on growth and
investment on biomedical or behavioral science and/or health research.
Note: Applicants to the Program
must clearly specify the thematic area that their research addresses in the
Project Summary/Abstract Component of the application. Applicants must also
clearly articulate how the proposed studies would significantly extend our
understanding of biomedical or behavioral science and/or health as it relates
to the thematic area.
2. Scope
and Specific Requirements
Scope. This grants program is aimed at research endeavors
that address one or more of the following five thematic areas:
Note: For the purpose of this FOA the definition of comparative
effectiveness research (CER) will adhere to that adopted by the Federal
Coordinating Council given at http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf
(see in particular pages 5 and 16). The term comparative refers to
comparisons of interventions and strategies to prevent, diagnose, treat, and
monitor health conditions. The term effectiveness refers to applicability to
real-world needs and decisions faced by patients, clinicians, and other
decision makers within real-world settings, i.e. not the ideal settings
created in efficacy investigations. CER investigations compare two or more
interventions and strategies that are currently available to practicing
clinicians (i.e., not innovative or experimental drugs, devices, or approaches
that might more typically be part of an FDA-regulated efficacy study). These
interventions and strategies can include medications, procedures, medical and
assistive devices and technologies, diagnostic testing, behavioral change, and
delivery system strategies. As examples, CER investigations could:
For
examples of CER topics and approaches a 2009 Institute of Medicine Panel
consider to be of high national priority, applicants are also encouraged to
consult the Panel’s report at http://www.iom.edu/Reports/2009/ComparativeEffectivenessResearchPriorities.aspx.
Requirements. Projects submitted in response to this FOA are
expected to demonstrate the following:
A
detailed statement addressing the scope and the requirements should be included
as part of the application Research Plan and in summary form in the Letter of
Intent.
Only
projects with a scientific scope that requires an annual budget greater than
$500,000 in total costs are expected to be considered.
The
award provides three years of support to applicant organizations that can
demonstrate the need for a significant short-term stimulus investment on a well
defined project that is ready for deployment and implementation and that meets
the goals of the Recovery
Act.
Key
resources and data acquired with the support of this FOA will be expected to be
shared rapidly with the public and the scientific community as described under
the NIH Policy for Sharing of Data and the NIH Policy for Sharing Data Obtained
in NIH Supported or Conducted Genome-Wide Association Studies (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).
Timeline. Applicants should construct the project timeline to
include critical milestones, measurable outcomes, and mid-term and end of
project results to be publicly shared as expeditiously as possible. Awards will
be made for a three-year budget period.
See Section VIII, Other Information - Required Federal
Citations, for laws and policies related to this
announcement.
Section
II. Award Information
1. Mechanism of Support
This FOA will
use the RC4 award mechanism. The Project
Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts (see SF424 (R&R)
Application Guide).
2. Funds Available
This
initiative is supported by funds provided to the NIH under the American
Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law
111-5. Contingent upon the
submission of a sufficient number of scientifically meritorious applications,
approximately $80 million of ARRA funds will be obligated by September 30, 2010
to support requests submitted in response to this FOA.
Only applications for
projects that require $500,000 or more in total costs per year are expected to
be considered for funding. The total cost amount for individual awards will
vary and should be commensurate with the scope and complexity of the project.
However, the duration of the awards issued under this FOA will be limited to
three years.
The purpose of the Recovery
Act is to stimulate the American economy through job preservation and creation,
infrastructure investment, energy efficiency and science, and other means.
Consistent with these goals, with the exception of projects submitted to
address topics identified as included in the Focusing on Global Health
theme, domestic (United States) institutions/organizations planning to submit
applications that include foreign components should be aware that requested
funding for any foreign component should not exceed 10% of the total requested
direct costs or $25,000 per year (aggregate total for a subcontract or multiple
subcontracts), whichever is
less. Projects in
response to the Focusing on Global Health theme could propose a larger foreign
component. NIH will consider these requests in the context of the research
being proposed and its potential for critically advancing research in global
health.
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
The
following organizations/institutions are eligible to apply. Consistent with the
purposes of the Recovery Act (in particular, to preserve and create jobs and
promote economic recovery in the United States, and to provide investments
needed to increase economic efficiency by spurring technological advances in
science and health), applicants must be a domestic (United States)
institution/organization. The United States
institution/organization must be located in the 50 states, territories and
possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the
Pacific Islands, or District of Columbia. NIH
encourages applications from all interested organizations/institutions,
including those from Institutional
Development Award (IDeA) states and Academic
Research Enhancement Award (AREA)-eligible institutions. Foreign organizations/institutions are not permitted
as the applicant organization.
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 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. When considering the multiple PD/PI option, please be aware that the
structure and governance of the PD/PI leadership team as well as the knowledge,
skills and experience of the individual PDs/PIs will be factored into the
assessment of the overall scientific merit of the application. Multiple
PDs/PIs on a project share the authority and responsibility for leading and
directing the project, intellectually and logistically. Each PD/PI is
responsible and accountable to the grantee organization, or, as appropriate, to
a collaborating organization, for the proper conduct of the project or program,
including the submission of required reports. For further information on
multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.
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
Number of Applications. Applicants may submit more
than one application, provided each application is scientifically distinct.
Resubmissions. Resubmission
applications are not permitted in response to this FOA.
Renewals. Renewal applications are not
permitted in response to this FOA.
Section IV. Application and Submission Information
To
download a current SF424 (R&R) Application Package and SF424 (R&R)
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.
Registration:
Appropriate
registrations with Grants.gov and eRA Commons must be completed on or before
the due date in order to successfully submit an application. 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 organization/institution is already registered with both Grants.gov and the Commons.
All registrations must be complete by the submission deadline for the
application to be considered on-time (see 3.C.1 for more information about
on-time submission).
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 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.
Both the PDs/PI(s) and
AOR/SO need separate accounts in the NIH eRA Commons since both are authorized
to view the application image.
Note: The registration process is not
sequential. Applicants should begin the registration processes for both
Grants.gov and eRA Commons as soon as their organization has obtained a DUNS
number. Only one DUNS number is required and the same DUNS number must be
referenced when completing Grants.gov registration, eRA Commons registration
and the SF424 (R&R) forms.
1. Request Application Information
Applicants must
download the SF424 (R&R) application forms and the 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 301-710-0267; Email: GrantsInfo@nih.gov.
Telecommunications for the hearing impaired: TTY:
(301) 451-5936
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 for this FOA
through Grants.gov/Apply.
The SF424 (R&R)
Application Guide is critical to submitting a complete and accurate application
to NIH. Some fields within the SF424 (R&R) application components, although
not marked as mandatory, are necessary for processing (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 Frequently Asked Questions
Application Guide, Electronic
Submission of Grant Applications.
The SF424 (R&R)
application has several components. 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
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Research & Related Budget
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, the Research
Plan section and Multiple PD/PI Leadership Plan 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).
Applications Involving a
Single Institution
When all PDs/PIs are
within a single institution, follow the instructions contained in the SF424
(R&R) Application Guide.
Applications Involving
Multiple Institutions
When
multiple institutions are involved, one institution must be designated as the
prime institution and funding for the other institution(s) must be requested
via a subcontract to be administered by the prime institution. When submitting
a detailed budget, the prime institution should submit its budget using the
Research & Related Budget component. All other institutions should have
their individual budgets attached separately to the Research & Related
Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R)
Application Guide for further instruction regarding the use of the subaward
budget form.
3.
Submission Dates and Times
See Section IV.3.A. for details.
3.A. Submission, Review, and Anticipated Start Dates
Opening Date: February 15, 2010 (Earliest date an application may be submitted
to Grants.gov)
Letters of Intent Receipt Date: February 15, 2010
Application Due
Date: March 15, 2010
AIDS Application
Due Date: Not applicable
Peer Review Date(s): June/July 2010
Council Review
Date(s): August 2010
Earliest
Anticipated Start Date: August 31, 2010
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 and plan for the potential review workload.
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:
Cathleen Cooper, Ph.D.
Chief,
Oncology 1: Basic Translational (OBT) IRG
NIH/Center
for Scientific Review
6701
Rockledge Drive, Rm
6196
Bethesda, MD 20892 (20817 for courier delivery)
Phone:
301-443-4512
Fax:
301-480-0287
Email: cooperc@csr.nih.gov
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. 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.
3.C.
Application Processing
3.C.1 Submitting
On-Time
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. (See Section IV.3.A. for all dates.) If an application is not submitted
by the due date and time, the application may be delayed in the review process
or not reviewed.
All
applications must meet the following criteria to be considered on-time :
Please
visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues
threaten your ability to submit on time.
Submission to Grants.gov is not the last step applicants must follow
their application through to the eRA Commons to check for errors and warnings
and view their assembled application!
3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings
IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.
Once an application package has been
successfully submitted through Grants.gov,
NIH provides applicants a two day error
correction window to correct any eRA identified errors or warnings before a
final assembled application is created in the eRA Commons. The standard error
correction window is two (2) business days, beginning the day after the
submission deadline and excluding weekends and standard federal holidays. All
errors must be corrected to successfully complete the submission process.
Warnings will not prevent the application from completing the submission
process.
Please note that the following
caveats apply:
3.C.3 Viewing
an Application in the eRA Commons
Once any eRA identified 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 assembled application before
it automatically moves forward to NIH for further processing.
Upon receipt, applications will be evaluated for
completeness by the CSR and responsiveness by the OD consistent with the intent
of this FOA. Incomplete and/or non-responsive applications will not be
reviewed.
There
will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO
receives the Grants.gov acknowledgments. The AOR/SO and the 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 the
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, or previously solicited through ARRA-related opportunities, is to
be submitted in response to this funding opportunity, it is to be prepared as a
NEW application. That is, the application for this 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, as indicated in the NIH Grants Policy Statement.
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. In addition, ARRA
awards are subject to Standard
Terms and Conditions for ARRA Awards consistent
with NOT-OD-09-080, NOT-OD-09-120,
and NOT-OD-10-003.
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 award if such
costs: 1) are necessary to conduct the project, and 2) 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 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
PD/PI Credential (e.g., Agency Login)
The
NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the PROFILE
Project Director/Principal Investigator section, Credential log-in field
of the Research & Related Senior/Key Person Profile component.
Organizational DUNS
The
applicant organization must include its DUNS number in its Organization Profile
in the eRA Commons. This DUNS number must match the DUNS number provided at CCR
registration with Grants.gov. For
additional information, see Frequently Asked Questions Application Guide, Electronic
Submission of Grant Applications.
Special Instructions for PHS398 Research Plan Component (Section
5.5 of SF424 (R&R) Application)
Research Strategy
Page Limitation: The Research Strategy is limited to a total of 12 pages
PHS398 Research Plan
Component Sections
Item
Number and Title |
Instructions |
1. Introduction to Application |
Omit (N/A: Resubmissions and Revisions not
allowable) |
2. Specific Aims |
One page maximum.
Separate PDF attachment |
3. Research Strategy |
Limited to 12 pages. Attach the 12- page
Research Strategy as a single PDF document. Figures and illustrations may be
included but must fit within the 12-page limit. Do not include links to Web
sites for further information. Do not include animations. |
Excluded
from the 12-page Research Strategy limitation are the following items:
Organize
the Research Strategy in the specified order using the instructions provided
below. Start each section with the appropriate section heading (i.e. Research
Area, Opportunity and Potential Impact, Approach, Timeline, Milestones, Expected
Measurable Outcomes and Deliverables, and Long Term Sustainability Plan.)
Preliminary
data are not required but may be included, if necessary to demonstrate the
feasibility of the proposed studies. The presentation must be clear and
particularly compelling. No detailed scientific plan should be provided, but
timelines must be presented.
Special
Instructions for Other Project Information (Section 4.4 of SF424 (R&R)
Application)
Item 7. Project Summary/Abstract:
Follow instructions in the SF424 (R&R) Application Guide. Begin this
section by stating the thematic area that this application addresses.
Item 9.
Bibliography and Literature Cited: Limited to one page. Each reference must include names of
all authors (in the same sequence in which they appear in the publication), the
article and journal title, book title, volume number, page numbers, and year of
publication. When citing articles that fall under the Public Access Policy,
provide the NIH Manuscript Submission reference number or the PubMed Central
(PMC) reference number for each article. If the PMCID is not yet available,
indicate "PMC Journal - In Process."
Continue
with the instructions in the SF424 (R&R) Application Guide.
Special
Instructions for Senior/Key Person Profile (Expanded) Component (Section 4.5 of
SF424 (R&R) Application)
Biographical
Sketches: Each
biographical sketch is limited to two pages. The number of publications cited
in each biosketch is limited to ten or fewer items. Individuals should cite
their most relevant publications and those that highlight the significance of
past accomplishments.
Appendix Materials
Applicants must follow
the specific instructions on Appendix materials as described in the SF424 (R&R)
Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).
Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.
Do not use the Appendix to circumvent the page limitations.
An application that does not comply with the required page limitations may be
delayed in the review process.
No
supplemental/update information will be accepted.
NIH
considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value and further the
advancement of the research. When resources have been developed with NIH funds
and the associated research findings published or provided to NIH, it is
important that they be made readily available for research purposes to
qualified individuals within the scientific community. If the final data/resources are not amenable to sharing,
this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).
(a) Data Sharing Plan: Regardless of the
amount requested, applicants under this FOA 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 their NIH program contact
(see Data-Sharing
Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.)
(b) Sharing Model Organisms: Regardless of
the amount requested, all applications 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 NIH
Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested,
applicants seeking funding for a genome-wide association study are
expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why
submission to the repository is not possible. A genome-wide association
study is defined as any study of genetic variation across the entire genome
that is designed to identify genetic associations with observable traits (e.g.,
blood pressure or weight) or the presence or absence of a disease or
condition. For further information see Policy for Sharing of Data
Obtained in NIH Supported or Conducted Genome-Wide Association Studies (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
Review Process
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.
Applications
that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review
groups convened by the Center for Scientific Review and in accordance with NIH
peer review procedures (http://grants1.nih.gov/grants/peer/), using
the review criteria stated below.
As part of the scientific peer review, all applications will:
Overall Impact. Reviewers will provide an overall impact/priority
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).
Scored 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 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, technological
advances, technical capability, clinical practice, and/or health 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, technological developments, 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?
Are
the milestones set appropriately and could they be reached reasonably over the
timeline? Are the expected measurable outcomes and results well described, and will they
meaningfully fulfill the research opportunities
in one or more of the five research themes?
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? Have the physical facilities,
services and institutional requirements been carefully considered? Is there
evidence of strong, institutional support and commitment to the rapid and
efficient deployment of the new proposed infrastructure?
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. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
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/priority score.
Select Agents 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:
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.
Selection Process
Applications
submitted in response to this FOA will compete for available funds with all
other recommended applications submitted in response to this FOA. The following will be
considered in making funding decisions:
Appeals will not be
permitted. See NOT-OD-09-054,
Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of
Appeals Process.
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. In addition, as part of just-in-time
information for those Recovery Act awards, for any modular budget application, a detailed budget will be required
prior to award.
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.
The terms of the NoA
will reference the requirements of the Recovery Act.
In addition to the standard NIH terms of award, all awards will
be subject to the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be
found in the following document: Standard
Terms and Conditions for AARA Awards.
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.
2. Administrative and National Policy Requirements
All NIH grant
and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General and Part
II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions
for Specific Types of Grants, Grantees, and Activities.
3.
Reporting
Awardees will be
required to submit the Non-Competing
Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants
Policy Statement.
In addition, grantees must comply with the requirements set forth in the
Recovery Act, including, but not limited to, the reporting requirements
described in Section 1512 of the Act, as well as applicable OMB guidance
regarding the use of Recovery Act funds. As noted above, grantees must also
comply with the HHS Standard Terms and Conditions for Recovery Act
awards. The full text of these terms approved for NIH awards can be found
in the following document: Standard
Terms and Conditions for AARA Awards.
Recovery Act-related
reporting requirements will be incorporated as a special term of award.
A final progress report, invention statement, and
Financial Status Report are required when an award is relinquished when a
recipient changes institutions or when an award is terminated. Until such time
as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269
FSR.
This
funding announcement is subject to restrictions on oral conversations during
the period of time commencing with the submission of a formal application[1] by an individual or entity and ending with the award of the competitive funds.
Federal officials may not participate in oral communications initiated by any
person or entity concerning a pending application for a Recovery Act
competitive grant or other competitive form of Federal financial assistance,
whether or not the initiating party is a federally registered lobbyist[1] . This restriction applies unless:
(i) the
communication is purely logistical;
(ii) the
communication is made at a widely attended gathering;
(iii) the
communication is to or from a Federal agency official and another Federal
Government employee;
(iv) the
communication is to or from a Federal agency official and an elected chief
executive of a state, local or tribal government, or to or from a Federal
agency official and the Presiding Officer or Majority Leader in each chamber of
a state legislature; or
(v) the
communication is initiated by the Federal agency official.
For
additional information see http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf
We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research (program), peer review, and financial or
grants management issues:
Awarding
Component |
Scientific/Research
Contact(s): |
Financial/Grants
Management Contact(s): |
| National Institute on Aging (NIA) http://www.nia.nih.gov |
Chyren Hunter, Ph.D. Deputy Director, Division of Extramural Activities NIA, NIH Gateway Building, Room 2C218 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Phone: 301-496-9322 Fax: 301-402-2945 Email: Hunterc@nia.nih.gov |
Linda Whipp Grants Management Officer NIA, NIH Gateway Building, Suite 2N212 Bethesda, MD 20892-2292 Phone: 301-496-1472 Fax: 301-402-3672 Email: whippL@mail.nih.gov |
| National Institute on Alcohol Abuse and
Alcoholism (NIAAA) http://www.niaaa.nih.gov |
Abraham P. Bautista, Ph.D. Director, Office of Extramural Activities NIAAA, NIH 5635 Fishers Lane, Room 2089 Bethesda MD 20892-9304 Phone: 301-443-9737 Fax: 301-443-6077 Email: bautista@mail.nih.gov |
Judy Fox Chief, Grants Management Branch NIAAA, NIH 5635 Fishers Lane, Room 3023, MSC 9304 Bethesda, MD 20892-9304 Phone: 301-443-4704 Fax: 301-443-3891 Email: jfox@mail.nih.gov |
| National Institute of Allergy and
Infectious Diseases (NIAID) http://www3.niaid.nih.gov/ |
Dr. Patricia Haggerty Associate Director, Division of Extramural Activities NIAID, NIH 6700B Rockledge Dr. Rm 2139 Bethesda, MD 20892 Phone: 301-451-2615 Email: haggertp@nih.gov |
Mary Kirker Chief, Grants Management Branch NIAID, NIH 6700-B Rockledge Drive, Rm 2115 Bethesda, MD 20892-7614 Phone: 301-402-6400 Fax: 301-493-0597 Email: mk35h@nih.gov |
| National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS) http://www.niams.nih.gov/ |
Hung Tseng PhD Director Extracellular Matrix Biology and Disease Program NIAMS, NIH One Democracy Plaza, Room 886 6701 Democracy Boulevard Bethesda, MD 20892-4872 Phone: 301-496-0810 Email: tsengh@mail.nih.gov |
Gail B. Hamilton Senior Grants Management Officer NIAMS, NIH 6701 Democracy Blvd., Suite 800, Room 844 Bethesda, MD 20892-4872 Phone: 301-594-3506 Fax: 301-480-5450 Email: hamiltog@mail.nih.gov |
| National Institute of Biomedical Imaging
and Bioengineering (NIBIB) http://www.nibib.nih.gov/ |
Grace C.Y. Peng, Ph.D. Program Director NIBIB, NIH 6707 Democracy Blvd., Suite 200, MSC 5469 Bethesda, MD 20892 Phone: 301-451-4778 Email: penggr@mail.nih.gov |
Chris A. Darby Grants Management Specialist NIBIB, NIH 6707 Democracy Blvd., MSC 5469 Suite 900, Democracy II Bethesda, MD 20892-5469 Phone: 301-451-4786 Fax: 301-451-5735 Email: DavisCh@mail.nih.gov |
| National Cancer Institute (NCI) http://www.nci.nih.gov or http://www.cancer.gov |
Jerry S. H. Lee, Ph.D. Special Assistant and Program Director Office of the Deputy Director NCI, NIH 31 Center Drive, Room 11A30C, MSC 2590 Bethesda, MD 20892-2590 Phone: 301-496-1045 FAX: 301-480-2889 Email: leejerry@mail.nih.gov |
Ms. Crystal Wolfrey Office of Grants Administration NCI, NIH 6120 Executive Boulevard, EPS Suite 243, MSC 7150 Bethesda, MD 20892-7340 Phone: 301-496-8634 Fax: 301-496-8601 E-mail: crystal.wolfrey@nih.gov |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) http://www.nichd.nih.gov |
Dennis A. Twombly, Ph.D. Extramural Training Officer Acting Deputy Director, Office of Extramural Policy NICHD, NIH 6100 Executive Boulevard, Room 2C01 Bethesda, Maryland 20892-7510 Phone: 301-451-3371 FAX: 301-480-2400 Email: dtwombly@mail.nih.gov |
Bryan S. Clark, M.B.A. Chief Grants Management Officer NICHD, NIH 6100 Executive Boulevard Room 8A01, MSC 7510 Bethesda, MD 20892 Phone: 301-435-6975 Fax: 301-402-0915 Email: clarkb1@mail.nih.gov |
| National Institute on Drug Abuse (NIDA) http://www.nida.nih.gov |
Christine Colvis, PhD NIDA, NIH Director, Program Integration Neuroscience Center, Rm 5261 6001 Executive Blvd. Bethesda, MD 20892 Phone: 301-443-6480 Email: ccolvis@nida.nih.gov |
Carol Alderson Office of Management Grants Management Branch NIDA, NIH 6001 Executive Boulevard, 5th Floor, MSC 9560 Bethesda, MD 20892-9560 Phone: 301-933-6196 Fax: 301-594-6869 Email: ca10h@nih.gov |
| National Institute on Deafness and Other
Communication Disorders (NIDCD) http://www.nidcd.nih.gov/ |
Gordon B. Hughes, M.D. Program Director, Clinical Trials Division of Scientific Programs NIDCD, NIH 6120 Executive Blvd., EPS-400C MSC 7180 Bethesda, MD 20892-7180 Phone: 301-435-4085 Fax: 301-402-6251 Email: hughesg@nidcd.nih.gov |
Christopher Myers Chief, Grants Management Branch Division of Extramural Activities NIDCD, NIH Executive Plaza South, Room 400B 6120 Executive Blvd., MSC 7180 Bethesda, MD 20892-7180 Phone: 301-435-0713 Fax: 301-451-5365 Email: myersc@mail.nih.gov |
| National Institute of Dental and
Craniofacial Research (NIDCR) http://www.nidcr.nih.gov |
Lillian Shum, PhD Chief, Integrative Biology and Infectious Diseases Branch Division of Extramural Research NIDCR, NIH 6701 Democracy Blvd., Rm. 624 Bethesda, MD 20892-4878 Phone: 301-594-0618 Fax: 301-480-8319 Email: ShumL@mail.nih.gov |
Ms. Mary Greenwood Chief Grants Management Officer NIDCR, NIH 6701 Democracy Blvd. Room 658, MSC 4878 Bethesda, MD 20892-4878 Phone: 301-594-4808 Fax: 301-480-3562 Email: md74u@nih.gov |
| National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK) http://www.niddk.nih.gov |
Philip F. Smith, Ph.D. Deputy Director Division of Diabetes, Endocrinology, and Metabolic Diseases Co-Director, Office of Obesity Research NIDDK, NIH 6707 Democracy Blvd., Rm 689 MSC 5460 Bethesda, MD 20892-5460 Phone: 301.594.8816 Fax: 301.480.3503 Email: ps56z@nih.gov |
Elizabeth Gutierrez Grants Specialist Grants Management Branch Division of Extramural Activities NIDDK, NIH 6707 Democracy Blvd, Room 712B Bethesda, MD 20817 Phone: 301-594-8844 Email: gutierrezel@mail.nih.gov |
| National Institute of Environmental Health
Sciences (NIEHS) http://www.niehs.nih.gov |
NIEHS Scientific Program Contacts http://www.niehs.nih.gov/funding/grants/contacts.cfm |
Dorothy Duke Chief, Grants Management Division of Extramural Research and Training NIEHS, NIH 111 TW Alexander Drive, Mail Drop K3-13 Keystone Building, Room 3044 Research Triangle Park, NC 27709-2233 Phone: 919-541-2749 Fax: 919-541-2860 Email: duke3@niehs.nih.gov |
| National Eye Institute (NEI) http://www.nei.nih.gov |
Lisa A.Neuhold, Ph.D. Division of Extramural Research NEI, NIH 5635 Fishers Lane, Suite 1300, MSC 9300 Bethesda, MD 20892 Phone: 301-451-2020 Fax: 301-402-0528 Email: lneuhold@mail.nih.gov |
Mr. William W. Darby Division of Extramural Research NEI, NIH 5635 Fishers Lane, Suite 1300, MSC 9300 Bethesda, MD 20892-9300 Phone: 301-451-2020 Fax: 301-496-9997 Email: wwd@nei.nih.gov |
| National Institute of General Medical
Sciences (NIGMS) http://www.nigms.nih.gov/ |
Peter C. Preusch, Ph.D. Biophysics Branch Chief Division of Cell Biology and Biophysics NIGMS, NIH 45 Center Drive, MSC 6200 Bethesda, MD 0892-6200 Phone: 301-594-1158 FAX: 301-480-2004 Email: preuschp@mail.nih.gov |
Grace Olascoaga Chief Grants Management Officer NIGMS, NIH 45 Center Drive MSC 6200 Room 2AN.32 Bethesda, MD 20892-6200 Phone: 301-594-5520 Fax: 301-480-1969 Email: olascoag@nigms.nih.gov |
| National Heart, Lung, and Blood Institute
(NHLBI) http://www.nhlbi.nih.gov |
Division of Cardiovascular Sciences Stephen S. Goldman, Ph.D. NHLBI, NIH 6701 Rockledge Drive Bethesda, MD 20892-7956 Phone: 301-435-0560 Email: goldmans@nhlbi.nih.gov Division of Lung Diseases James Kiley, Ph.D. NHLBI, NIH 6701 Rockledge Drive Bethesda, MD 20892-7956 Phone: 301-435-0233 Email: kileyj@nhlbi.nih.gov Division of Blood Diseases and Resources Henry Chang, M.D. NHLBI, NIH 6701 Rockledge Drive Bethesda, MD 20892-7956 Phone: 301-435-0067 Email: changh@nhlbi.nih.gov |
Tony Agresti Grants Management Specialist NHLBI, NIH 6701 Rockledge Drive, MSC 7926 Bethesda, MD 20982 Phone: 301-435-0186 Email: agrestia@nhlbi.nih.gov |
| National Human Genome Research Institute
(NHGRI) http://www.genome.gov |
Joseph Campbell NHGRI, NIH 5635 Fishers Lane Suite 4076, MSC 9305 Bethesda, MD 20892-9305 Phone: 301-443-6811 Fax: 301-480-2770 Email: JOSEPHCAMPBELLARRA@mail.nih.gov |
Cheryl Chick Chief Grants Management Officer Grants Administration Branch NHGRI, NIH 5635 Fishers Lane, Ste. 3058 Bethesda, MD 20892-9307 Phone: 301-435-7858 Fax: 301-451-5434 Email: ChickC@mail.nih.gov |
| National Institute of Mental Health (NIMH) http://www.nimh.nih.gov |
Jean G. Noronha, Ph.D. Division of Extramural Activities NIMH, NIH 6001 Executive Blvd, Room 6147, MSC 9609, Bethesda, MD 20892-9609 Phone: 301-443-3367 Fax: 301-443-4720 Email: jnoronha@mail.nih.gov |
Ms. Rebecca Claycamp Chief Grants Management Officer NIMH, NIH 6001 Executive Boulevard Room 6122 Bethesda, MD 20892-9605 Phone: 301-443-2811 Fax: 301-443-6885 Email: rclaycam@mail.nih.gov |
| National Institute of Neurological
Disorders and Stroke (NINDS) http://www.ninds.nih.gov/ |
Emmeline Edwards, Ph.D. Deputy Director for Extramural Research NINDS, NIH NSC 3305 6001 Executive Boulevard Bethesda, MD 20892-9531 Phone: 301-496-9248 Email: edwardse@ninds.nih.gov |
Tijuana Decoster, MPA Chief Grants Management Officer NINDS, NIH NSC 3258 6001 Executive Blvd Bethesda, MD 20892-9537 Phone: 301-496-9231 Email: decostert@mail.nih.gov |
| National Institute of Nursing Research
(NINR) http://www.ninr.nih.gov |
Linda S. Weglicki, PhD, RN Health Scientist Administrator Division of Extramural Activities NINR, NIH 6701 Democracy Blvd, Rm. 710 One Democracy Plaza Bethesda, MD 20892-4870 Phone: 301-594-6908 Email: weglickils@mail.nih.gov |
Ron Wertz Grants Management Specialist NINR, NIH 6701 Democracy Blvd, Rm. 710 One Democracy Plaza Bethesda, MD 20892-4870 Phone: 301-594-2807 Fax: 301-402-4502 Email: WertzR@mail.nih.gov |
| National Center for Complementary and Alternative Medicine (NCCAM) http://nccam.nih.gov/ |
Craig Hopp Program Officer NCCAM, NIH 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892 Phone: 301-496-5825 Fax: 301-480-1587 Email: hoppdc@mail.nih.gov |
George A. Tucker, M.B.A. Director, Office of Grants Management Chief Grants Management Officer NCCAM, NIH Phone: 301-594-9102 Fax: 301-480-1552 E-mail: tuckerg@mail.nih.gov |
| National Center on Minority Health and Health Disparities (NCMHD) http://www.ncmhd.nih.gov |
Francisco S. Sy, MD, DrPH Director Division of Extramural Activities & Scientific Programs NCMHD, NIH 6707 Democracy Blvd., Suite 800, MSC 5465 Bethesda, MD 20892-5465 Phone: 301-402-1366 FAX: 301-480-4049 Email: syf@mail.nih.gov |
Priscilla Grant, J.D., C.R.A. Chief Grants Management Officer NCMHD, NIH 6707 Democracy Boulevard, Suite 800 Bethesda, MD 20892-5465 Phone: 301-594-8412 Fax: 301-480-4049 Email: pg38h@nih.gov |
| National Center for Research Resources (NCRR) http://www.ncrr.nih.gov |
Heng Xie, M.D., M.P.H., Ph.D. Supervisory Medical Officer Division for Clinical Research Resources NCRR, NIH 6701 Democracy Blvd., Democracy I, Rm. 908 Bethesda MD 20892-4874 Phone: 301-443-8063 Fax: 301-480-3661 E-mail: XieHe@mail.nih.gov |
Molly Puente, Ph.D. Grants Management Specialist NCRR, NIH 6701 Democracy Blvd., Room 1035 Phone: 301-402-6737 Fax: 301-480-3777 Email: puentem@mail.nih.gov |
| National Library of Medicine (NLM) http://www.nlm.nih.gov |
Dr. Valerie Florance NLM Extramural Programs, NIH 6705 Rockledge Drive Rockledge 1, Suite 301 Bethesda, MD 20892 Phone: 301-496-4621 Fax: 301-402-2952 Email: florancev@mail.nih.gov |
Dwight Mowery NLM Extramural Programs, NIH 6705 Rockledge Drive Rockledge 1, Suite 301 Bethesda, MD 20892 Phone: 301-496-4221 Fax: 301-402-0421 Email: moweryd@mail.nih.gov |
| John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) http://www.fic.nih.gov/ |
Kenneth Bridbord, M.D. Division of International Training & Research FIC, NIH 31 Center Drive, Room B2C39 Bethesda, MD 20892-2220 Phone: 301-496-1653 Fax: 301-402-0779 Email: bridbork@mail.nih.gov |
Bruce R. Butrum Chief Grants Management Officer Office of the Director FIC, NIH Building 31, Room B2C29 31 Center Drive Bethesda, MD 20892-2220 Phone: 301-496-1670 Fax: 301-594-1211 E-mail: butrumb@nih.gov |
Peer
Review Contact(s):
Cathleen
Cooper, Ph.D.
Chief,
Oncology 1: Basic Translational (OBT) IRG
NIH/Center
for Scientific Review
6701
Rockledge Drive, Rm
6196
Bethesda, MD 20892 (20817 for courier delivery)
Phone:
301-443-4512
Fax:
301-480-0287
Email: cooperc@csr.nih.gov
Section VIII. Other Information
The American Recovery And
Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf
Standard
Terms and Conditions for Recovery Act Awards: The full text of these terms approved for
NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf
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.
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-09-116.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 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 Sections 301 and 405 of the PHS Act, as
amended (42 USC 241 and 284) and are subject to 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/.
[1]Formal application includes the preliminary application and letter of intent phases of the program.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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