and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute on Aging (NIA), (http://www.nia.nih.gov)
National Institute of Diabetes
and Digestive and Kidney Diseases (NIDDK), (http://www.niddk.nih.gov)
Title: Insulin Signaling and Receptor Cross-Talk (R21)
Announcement Type
This is a reissue of PA-03-156
which was previously released July 28, 2003.
Update: The following update relating to this announcement has been issued:
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-06-176
Catalog of Federal Domestic Assistance
Number(s)
93.847, 93.866
Key Dates
Release/Posted Date: March 2, 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): http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Dates: http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Council Review Dates: http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward.
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: January 23, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview Content
Executive Summary
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Institute on Aging (NIA) invite investigator-initiated research grant applications that will investigate crosstalk in insulin responses at molecular, cellular, and physiological levels. The purpose of this initiative is to stimulate novel and innovative research into the fundamental mechanism(s) of action of the insulin receptor in target tissues in the context of other cellular receptors and signaling pathways, and to broaden our understanding of how insulin signals act to regulate coordinated responses between and among insulin responsive tissues. Of particular interest is how such signaling interactions may affect the development and/or progression of diabetes and its complications.
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
Background
Diabetes currently affects an estimated 16 million Americans, and is the sixth leading cause of disease-related death in the US. With the diagnosis of approximately 800,000 new cases each year, the health and economic burden of diabetes continues to escalate. Given the magnitude of the problem and its enormous impact on patient health and welfare, there is an urgent need to define the factors contributing to diabetes onset and severity, and to identify new potential therapeutic targets. A defining feature of Diabetes Mellitus is the inappropriate regulation of serum glucose levels. Both type 1 and type 2 diabetes are associated with insulin deficiency, with type 2 diabetes further complicated by cellular resistance to insulin action. Obesity, a condition that itself is rising in prevalence, is a major risk factor for development of both insulin resistance and type 2 diabetes. While the precise relationship between obesity, type 2 diabetes, and insulin resistance remains under investigation, emerging data suggests that changes in insulin receptor regulated signaling pathways are involved.
The insulin receptor plays a dominant role in mediating insulin's effects. However, insulin target tissues also respond to hormones, growth factors and cytokines that have the potential to modify insulin responses. Receptors for many of these soluble factors initiate signals that may overlap or modulate insulin-stimulated biochemical pathways, and in this way impact the quality or quantity of the insulin response. For example, members of the growth factor, cytokine, and G-protein coupled receptor families are all expressed in various combinations in insulin responsive tissues. Stimulation of these receptors and the signaling pathways they regulate has the potential to alter the strength, duration, or character of the insulin response. Thus, signals initiated via the insulin receptor must be interpreted by cells in the context of multiple biochemical signals that arise in the complex microenvironment found in insulin-responsive tissues. Intracellular interactions between insulin dependent biochemical events and signals transduced via other signaling pathways, or "crosstalk", may occur at multiple levels, including at the level of receptor function, substrate availability, signal flow through downstream pathways, and/or integrated control of gene expression. Cross-talk also occurs between insulin-responsive tissues, with recent evidence suggesting that insulin signals elicited in one target tissue impact responses in other organs and at distant sites.
While significant progress has been made in defining the biochemistry of the insulin-response pathway, in documenting insulin-regulated changes in gene expression and in elucidating the crosstalk that occurs between insulin responsive organs, important scientific gaps remain to be explored. For example, our understanding of how a cell's complex biochemical history may modify subsequent responses to insulin, and of how multiple environmental cues regulate insulin action within and between target tissues in vivo, remains rudimentary. Information generated via these and related studies of signaling crosstalk within and between insulin-responsive tissues has the potential to provide important insights into the mechanisms that underlie diabetes pathophysiology, and may have important implications for the design of new therapeutics to treat diabetes and its complications.
Objectives and Scope
This funding opportunity solicits investigator-initiated research projects that will define the mechanistic basis of crosstalk between the insulin receptor signaling pathway and other signaling pathways, with the goal of defining how insulin action is influenced by the complex microenvironment found in insulin responsive tissues.
Appropriate topics for investigation under this funding opportunity would include, but are not limited to:
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/Development Research Grant (R21) award mechanism.
As an applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
The R21 awards are to demonstrate feasibility and to obtain preliminary data
testing innovative ideas that represent clear departure from ongoing research
interests. These grants are intended to: 1) provide initial support for new
investigators; 2) allow exploration of possible innovative new directions
for established investigators; and 3) stimulate investigators from other areas
to lend their expertise to research within the scope of this solicitation.
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: http://grants.nih.gov/grants/policy/policy.htm#gps).
Specifically, if you are submitting an application with direct costs in each
year of $250,000 or less (excluding consortium F&A costs), use the Modular
Budget Component provided in the SF424 (R&R) Application Package and Instructions
Guide (see specifically Section 5.4).
The R21 grant support is for new projects only, and will not be renewed. Continuation of projects developed under this program will be through the regular research grant (R01) program. Two resubmissions (formerly called revisions) of a previously reviewed R21 grant application may be submitted as defined in the NIH policy at http://grants.nih.gov/grants/policy/amendedapps.htm.
2. Funds Available
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. For example, you may request $100,000 in
the first year and $175,000 in the second 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. 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
N/A
This program does not require cost sharing as defined in the current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants may submit more than one application, provided
they are scientifically distinct.
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 301-710-0267, 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 (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
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
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. See http://grants1.nih.gov/grants/funding/submissionschedule.htm
for details.
Peer Review Date(s): Standard dates apply. Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
for details.
Council Review Date(s): Standard dates apply. Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
for details.
Earliest Anticipated Start Date(s): Standard dates apply. Please see http://grants.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
for details.
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.
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: 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 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
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.
All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 applications:
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
All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://grants.nih.gov/grants/policy/data_sharing. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
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 (NIH
Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
and 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.
The adequacy of the resources sharing plan and any
related data sharing plans 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, http://grants.nih.gov/grants/funding/2590/2590.htm).
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:
Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:
The goals of NIH supported research
are to advance our understanding of biological systems, to improve the control
of disease, and to enhance health. In their written critiques, reviewers will
be asked to comment on each of the following criteria in order to judge the
likelihood that the proposed research will have a substantial impact on the
pursuit of these goals. Each of these criteria will be addressed and considered
in assigning the overall score, 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.
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 and any related data sharing plans
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
N/A
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 (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:
Kristin Abraham, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 795
Bethesda, MD 20892-5460
Phone: (301) 451-8048
Fax: (301) 480-3503
Email: ka136s@nih.gov
Frank Bellino, PhD
Biology of Aging Program
National Institute on Aging
Gateway Building, Suite 2C231
Bethesda, MD 20892-9205
Phone: (301) 496-6402
Fax: (301) 402-0010
Email: fb12a@nih.gov
2. Peer Review Contacts:
N/A
3. Financial or Grants Management Contacts:
Randi Freundlich, R.D.
Grants Management Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 723
Bethesda, MD 20892-5456
Phone: (301) 594-8825
Fax: (301) 480-3504
Email: rf160d@nih.gov
Jeff Ball
Grants and Contracts Management Office
National Institute on Aging
Gateway Building, Room 2N212
Bethesda, MD 20892-9205
Phone: (301) 496-1472
Fax: (301) 402-3672
Email: jb666t@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 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
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