Research (OER)
9000 Rockville Pike
Bethesda, Maryland 20892
and Human Services (HHS)
Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www2.niddk.nih.gov)
Title: Silvio O. Conte Digestive Diseases Research
Development Centers (R24)
Announcement Type
This is a renewal of RFA-DK-01-030 which was previously released on April 1, 2001.
Request For Applications (RFA) Number: RFA-DK-06-018
Catalog of Federal Domestic Assistance Number(s)
93.848
Key Dates
Release Date: November
27, 2006
Letters of Intent
Receipt Date(s): February 22, 2007
Application Receipt
Date(s): March
22, 2007
Peer
Review Date(s): July-August,
2007
Council Review Date(s): October, 2007
Earliest Anticipated
Start Date(s): December,
2007
Additional
Information To Be Available Date (Url Activation Date): FAQs will be available on the
NIDDK website (http://www2.niddk.nih.gov ) by November 15, 2006.
Expiration Date: March 23, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
Table of Contents
Part I
Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity
Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility
Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and
Submission Information
1. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Receipt and 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
The objective of the Silvio O Conte Digestive Diseases
Research Development Centers program is to allow groups of investigators
already engaged in common thematic areas of digestive and/or liver diseases
research to benefit from shared research resources on a smaller scale than our
P30 centers program. The NIDDK recognizes that a critical mass of funded
investigators is needed to provide the research base for a large core grant,
such as a Silvio O. Conte Digestive Diseases Research Core Center grant (see RFA-DK-06-017),
but that many locations around the country support smaller groups of
NIDDK-funded investigators whose research would be enhanced, and extended, by
the existence of shared core facilities. Cores are defined as
shared resources that enhance productivity and benefit a group of investigators
working to accomplish the stated goals of the center. Cores should
increase efficiency and cost-effectiveness by eliminating unnecessary
duplication of effort and by supporting resources (e.g., costly equipment) that
might be needed by, but not fully utilized by, any one research grant or
investigator. Core facilities should increase efficiency, promote new
research directions, and foster interactions and collaborations among the
investigators they serve.
Cores may provide services (e.g., cell isolations, patient recruitment, statistical support); equipment (e.g., confocal microscope, scanning electron microscope); or other resources (e.g., use of transgenic facilities, access to batch preparation of reagents, clinical research resources) and may also support limited research activities that improve services, modify or verify techniques, or develop new technologies. Cores should promote new research directions and innovative uses of technology by providing access to techniques, equipment, services, and expertise that might not otherwise be available.
A research development center must support a minimum of six funded research projects, at least half of which are from the NIDDK. These grants comprised the base grants for the center.
The research development center may not be used to fund pilot projects, per se, but the cores can help investigators validate novel hypotheses and generate sufficient preliminary data for the submission of a research project grant. Cores may also be used judiciously by investigators not directly supported by base grants, as long as the core usage provides opportunities for new investigators, for minority investigators, and for investigators wishing to become involved in the research base of the center.
Research development centers may not request funds for an Administrative Core, Pilot and Feasibility program, Named New Investigator, or Enrichment program. See companion RFA for Silvio O. Conte Digestive Diseases Research Core Centers (RFA-DK-06-017).
The proposed Director of the center must have demonstrated the ability to organize, administer, and direct groups of scientists; must be the Principal Investigator of one of the base grants; and may also serve as a core director.
The following are examples of the research supported by the NIDDK which would be eligible to apply for a research development center: pediatric liver disease; pediatric gastroenterology; celiac disease; inflammatory bowel disease; motility disorders/irritable bowel syndrome; diarrheal diseases; pancreatitis/pancreatic disease; peptic ulcer disease/Helicobacter pylori; gene therapy of liver or digestive disorders; gastroesophageal reflux disease/Barrett’s esophagus; and gastrointestinal aspects of AIDS. This list is neither inclusive, nor exclusive, and consultation with program staff is advisable to determine the programmatic suitability of a research focus for a DDRDC.
Since these are development centers, each DDRDC is eligible for only one competing continuation, leading to a maximum of 10 years of support via this R24 mechanism. The hope is that the presence of a research development center will lead to capacity building such that these centers will become competitive for, and apply for, funding via the Silvio O. Conte Digestive Diseases Research Core Centers (P30) program.
See Section VIII, Other Information - Required Federal Citations,
for policies related to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding opportunity
will use the NIH
Resource-Related Research Project (R24) award mechanism(s).
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This funding opportunity
uses the just-in-time budget concepts. It also uses the non-modular budget
format described in the PHS 398 application instructions (see https://grants.nih.gov/grants/funding/phs398/phs398.html).
A detailed categorical budget for the "Initial Budget Period" and the
"Entire Proposed Period of Support" is to be submitted with the
application.
2. Funds Available
The NIDDK intends to commit
approximately $1.5
million in
FY 2008 to fund three or four new and/or competing
continuation applications in response to this RFA. An applicant may request a
project period of up to five years and a budget for direct costs up to $350,000 per year.
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.
Facilities and
administrative 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:
Institutions
eligible for DDRDC grants are those at which there is an ongoing, strong base
of digestive and/or liver diseases-related research, but where there is not a
Silvio O. Conte Digestive Diseases Research Core (P30) Center. Each
application for a DDRDC must propose to serve a minimum of six NIH research
grants, at least three of which must be supported by the NIDDK.
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 support.
2. Cost Sharing or Matching
This
program does not require cost sharing as defined in the most current Grants Policy
Statement found at: https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
The DDRDC Director, who is
the Principal Investigator of the R24 application, should be a scientist who
can provide effective administrative and scientific leadership for the center
and can manage a multi-component program. The Director will be
responsible for the organization and operation of the DDRDC and for
communicating with the NIDDK on scientific and operational matters. Each DDRDC
Director is required, and their administrator is strongly encouraged, to attend
an annual meeting to be held at al location to be determined by the
NIDDK. Funds for travel to this meeting should be included in the budget
for one of the cores, since an administrative core is not permitted.
Each application for a DDRDC must propose to serve a minimum of six NIH Research Project (R01), Exploratory/Development (R21), MERIT (R37), and/or Program Project (P01) grants, with no less than 10 grant-years collectively remaining in the Council-recommended project periods of those grants at the start of the DDRDC project period. A minimum of three of these grants must be supported by the NIDDK. This cohort of funded grants will be known collectively as the “base grants” for the DDRDC. Each grant counted in the base must have more than one year remaining in the Council-recommended project period at the requested start date for the DDRDC. No other mechanism or source of support will be considered in determining eligibility. While only three NIDDK grants are required, the composition of the base grant portfolio will strongly influence funding decisions by the NIDDK.
Each DDRDC will support one to three cores. Each core must be used by at least three of the base grants, and, in general, should serve as many base grant investigators as possible.
Only one DDRDC will be awarded to any single applicant organization. Principal Investigators of the base grants, however, may be located at several affiliated, or closely aligned, institutions, provided a clear plan of operation is provided describing administration structure and current interactions among the investigators. Each NIDDK base grant may only serve that purpose for one DDRDC.
If well justified, core activities and core-related research may be located at sites and institutions other than that of the DDRDC. This could be justified, for example, when the applicant institution is located in close proximity to a research institution with a well-established gnotobiotic animal facility, and it would not be logical or cost effective to duplicate the facility at the DDRDC institution. Collaboration and/or use of core facilities at nearby Silvio O. Conte Digestive Disease Core Centers are encouraged.
Section IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. 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
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
3. Submission Dates and Times
Applications must be
received on or before the receipt date described below (Section
IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated
Start Dates
Letters of Intent
Receipt Date(s): February 22,
2007
Application
Receipt Date(s): March 22, 2007
Peer Review Date: July-August, 2007
Council Review
Date(s): October, 2007
Earliest
Anticipated Start Date(s): December, 2007
3.A.1. Letter of Intent
Prospective applicants
are asked to submit a letter of intent that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
The letter of intent
is to be sent by the date listed at the beginning of this document.
The letter of intent
should be sent to:
Francisco O. Calvo,
Ph.D.Chief,
Review
Branch
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard, Room
752
Bethesda, MD 20892-5452
(for
express/courier service: Bethesda, MD 20817)
Telephone: (301)
594-8897
FAX: (301)
480-3505
Email: fc15y@nih.gov
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and three signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time of
submission, two additional copies of the application and all copies of the
appendix material must be sent to:
Francisco O. Calvo, Ph.D. Chief, Review
Branch
National
Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard, Room
752
Bethesda, MD
20892-5452
(for express/courier service: Bethesda, MD
20817)
Telephone: (301) 594-8897
FAX:
(301)
480-3505
Email: fc15y@nih.gov:
Using the RFA Label: The RFA label available in
the PHS 398 application instructions must be affixed to the bottom of the face
page of the application. Type the RFA number on the label. Failure to use this
label could result in delayed processing of the application such that it may
not reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form and
the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/labels.pdf.
3.C. Application
Processing
Applications must be received on or before the
application receipt date(s) described above (Section IV.3.A.).
If an application is received after that date, it will be returned to the
applicant without review. Upon receipt, applications will be evaluated for
completeness by the CSR and responsiveness by the NIDDK. Incomplete and non-responsive
applications will not be reviewed.
The NIH will not
accept any application in response to this funding opportunity that is
essentially the same as one currently pending initial review, unless the
applicant withdraws the pending application. However, when a previously
unfunded application, originally submitted as an investigator-initiated
application, is to be submitted in response to a funding opportunity, it is to
be prepared as a NEW application. That is, the application for the funding
opportunity must not include an Introduction describing the changes and
improvements made, and the text must not be marked to indicate the changes from
the previous unfunded version of the application.
Information on the status of an application should be
checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/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. The Grants Policy Statement can
be found at https://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing continuation award if
such costs: are necessary to conduct the project, and would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.
6. Other Submission Requirements
A DDRDC
must be an identifiable organizational unit within a single university medical
center or within a consortium. The following are NOT allowed in the
DDRDC: an Administrative Core; a Pilot and Feasibility program; a Named New
Investigator; and an Enrichment program. If these are needed, and the
research base is sufficient, then see RFA-DK-06-017 for Silvio O. Conte Digestive Diseases Research Core Centers (P30).
The DDRDCs are intended to enhance the capabilities of NIDDK-supported investigators to pursue digestive and/or liver diseases research. The manner in which the proposed DDRDC will do this must be evident from the information provided in the application. The following sections should replace the Specific Aims, Background and Significance, Preliminary Studies/Progress Report, and the Research Design and Methods sections of the traditional Research Plan in the PHS 398 application:
Plan for Sharing Research
Data
All applicants must
include a plan for sharing research data in their application. The data sharing
policy is available at https://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 expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (NIH Grants Policy Statement https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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, https://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.
The following will be
considered in making funding decisions:
2. Review and Selection Process
Applications that are
complete and responsive to the RFA will be evaluated for scientific and
technical merit by an appropriate peer review group convened by NIDDK in accordance with the review
criteria stated below.
As part of the initial
merit review, all applications will:
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? What are the strengths of the
center's research base (its breadth and depth) and the relevance and
interrelation of the separately funded research projects to the focus/theme of
the center? What is the likelihood that the DDRDC will increase
efficiency; promote new research directions and meaningful collaborations among
center investigators; facilitate interactions and collaborations among
DK-funded investigators; and prove cost-effective? In competing
continuation applications, have the benefits of the center been documented in
the forms of increased collaboration, new research directions, and cost
savings?
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? How appropriate and relevant are the proposed cores and the modes of operation (such as how usage will be prioritized)? Will researchers supported by at least three of the base grants use each core? Will the cores provide opportunities not otherwise available to the investigators; represent appropriate cost savings/cost sharing advantage; and stimulate the development of new approaches? In competing continuation applications, is the use, utility, quality control, and cost effectiveness of each core requested to continue as part of the center documented? Have cores no longer needed appropriately been discontinued in response to the changing needs of center investigators? Is there a significant list of publications arising from each core in competing continuation applications?
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? Is it likely that this support
will significantly enhance the capabilities of base grant investigators to
pursue digestive and/or liver diseases research? Is it likely that the proposed
resources, by supporting the base grants, will lead to fundamental advances
within the field, to new discoveries, and/or to new technological, clinical, or
scientific developments? In competing continuation applications, have the cores
provided new methods, techniques, and/or resources and developed ways to
support investigators in new areas of digestive and/or liver diseases research,
as appropriate to the purpose of the core and the research supported by the
center?
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)? Are the center investigators
responsible for the individual research projects willing to interact with each
other and contribute to t the overall objectives of the DDRDC? What are the
scientific and administrative leadership abilities of the proposed Director and
his/her commitment and ability to devote adequate time for the effective
management and coordination of the DDRDC cores and investigators? Are the core
directors appropriate and well-qualified?
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? What is the nature and level
of resource commitment from the applicant institution and from any other participating
institutions? Do the proposed cores appear to complement or to enhance what is
already available at the institution?
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 the Research Plan, Section E on Human Subjects in the PHS Form
398).
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 the Research Plan, Section E on Human Subjects in
the PHS Form 398).
Care and
Use of Vertebrate Animals in Research: If vertebrate animals are to
be used in the project, the five items described under Section F of the PHS
Form 398 research grant application instructions 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. The priority score should not be affected by the evaluation of the
budget.
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. https://grants.nih.gov/grants/policy/data_sharing. Since these are R24
applications for core facilities, only when a core facility stores/maintains
data that can be shared will a data sharing plan be required.
2.D. Sharing Research
Resources
NIH policy expects that
grant recipients make unique research resources readily available for research
purposes to qualified individuals within the scientific community after
publication (See the NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to
this funding opportunity should include a sharing research resources plan
addressing how unique research resources will be shared or explain why sharing
is not possible.
Program staff will be
responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable.
Section
VI. Award Administration Information
1. Award Notices
After the peer review of
the application is completed, the PD/PI will be able to access his or her
Summary Statement (written critique) via the eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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 (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
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 Notice of Award. For these terms of award, see the NIH Grants Policy
Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General
(https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).
The following Terms and
Conditions will be incorporated into the award statement and will be provided
to the Principal Investigator as well as to the appropriate institutional
official, at the time of award.
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (https://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
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:
Judith Podskalny, Ph.D.
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard,
Room 667
Bethesda, MD 20892-5450
Telephone: (301) 594-8876
FAX: (301) 480-8300
Email: jp53s@nih.gov
2. Peer Review Contacts:
Francisco O. Calvo, Ph.D.Chief, Review
Branch
National Institute of Diabetes and Digestive and Kidney
Diseases
6707 Democracy Boulevard, Room
752
Bethesda, MD 20892-5452
(for express/courier service: Bethesda, MD 20817)
Telephone:
(301)
594-8897
FAX: (301)
480-3505
Email: fc15y@nih.gov
3. Financial or Grants Management Contacts:
Michael Giza
Division
of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy
Blvd., Room
733
Bethesda, MD 20892-5453
Telephone:
(301) 594-8851
FAX: (301) 480-3504
Email: mg548o@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 (https://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (https://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, https://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 (https://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 the 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 https://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 https://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 https://grants.nih.gov/archive/archive/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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://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 new PHS Form 398; 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 (https://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 https://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 https://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 https://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) must be used for publicly accessible on-line journal
articles. Unless otherwise specified in this solicitation,
Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.
Healthy People 2010:
The Public Health
Service (PHS) is committed to achieving the health promotion and disease
prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This PA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This program is described in
the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement. The
NIH Grants Policy Statement can be found at https://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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