and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes of
Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Institute of
Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www.niddk.nih.gov)
Title: Obesity Nutrition Research Centers (P30)
Announcement Type
New
Request For Applications (RFA) Number: RFA-DK-07-001
Catalog of Federal Domestic Assistance Number(s)
93.848
Key Dates
Release Date: December
21, 2006
Letters of Intent
Receipt Date(s): May 25, 2007
Application Receipt
Date(s): June
22, 2007
Peer
Review Date(s): October-November
2007
Council Review Date(s): January 2008
Earliest Anticipated
Start Date(s): April
2008
Expiration Date: June 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) invites
applications for Obesity and Nutrition Research Centers (ONRC). The ONRCs are
core centers (P30) that are part of an integrated program of obesity and
nutrition-research support provided by NIDDK.
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 Obesity Nutrition Research Center is to bring together clinical and basic science investigators from relevant disciplines to enhance and extend the effectiveness of research related to the field of obesity, eating disorders, and energy regulation, with clinical and/or translational applications in these areas. A Core Center must be an identifiable unit within a university or medical center or a consortium of cooperating institutions, including an affiliated university. An existing program of excellence in biomedical basic and clinical research in the areas of obesity, eating disorders, and energy regulation is required. The research must be in the form of research project grants (R01), program project grants (P01), or other peer-reviewed research that is already funded by NIH, other Federal Agencies, or non-federal groups at the time of submission of the Center grant application. It is required that at least fifty percent of the obesity, eating disorders, and energy regulation research comprising the research base be supported by Federal Agencies. Close cooperation, communication, and collaboration among all involved personnel of various professional disciplines are ultimate objectives.
The research base related to obesity can include a focus on behavior, physical activity, energy metabolism, body composition, cell biology, or nutrient metabolism. Other nutritional sciences research may be included if the investigators make use of the same core services as justified by the research base related to obesity. It would be highly desirable that the Principal Investigator, as well as the applicant institution, have a commitment to the treatment and prevention of obesity. Applicants should consult with NIDDK staff concerning plans for the development of the Center and the organization of the application.
The Obesity Nutrition Research Centers are based on the core concept. Four to six cores are usually included in a Center. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in the Center to accomplish the stated goals of the Center. Examples of such resources include biostatistics, imaging, biotechnology, and instrumentation facilities. It is appropriate and may be beneficial to have one or more central themes around which core center research investigations are focused.
Centers are encouraged to include a clinical component. This clinical component can exist as a stand alone core or part of another core such as the administrative core. Besides leading to a better understanding of disease etiology and natural history of disease, clinical components might provide biostatistics support; enhance clinical study design; foster collaboration among researchers; aid in recruitment of subjects for clinical studies; support epidemiological studies; or provide modest funding for tissue, DNA, or serum storage. In addition, a clinical component may more effectively address NIH policies concerning issues of children, women, and ethnic minority participation in clinical studies. The availability of a clinic population with adequate representation of women and minorities that can be readily utilized by investigators will play a major role in attracting investigators to the field of obesity research and will serve as a resource in the design of pilot and feasibility projects.
Two other types of activities should also be supported with Center funding: a Pilot and Feasibility (P/F) program and an Enrichment program. The P/F program provides modest support for new initiatives or feasibility research studies. This program is directed at new investigators, at investigators established in other research disciplines with expertise that may be applied to obesity research, and, occasionally, at investigators already working in the obesity related fields who wish to make a substantial change in the direction of their work. In addition, temporary salary support for one Named New Investigator in a specified area of research with a defined P/F study may be requested for up to 24 months, with subsequent individuals to be named by the Center Director and approved by the Center's External Advisory Board and the NIDDK. The Core Center grant may include limited funds for program enrichment such as seminars, visiting scientists, consultants, and workshops.
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 Core Center
(P30) 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 http://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
participating IC, the National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK) intends to commit approximately 2,000,000 dollars in FY 2008 to fund two new and/or competing continuation grants 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 750,000 dollars 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 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 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 support.
2. Cost Sharing or Matching
There is no cost sharing,
matching, or cost participation required for this application. The most current Grants Policy
Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
The ONRC Director, who is the Principal Investigator of the
P30 application and Director of the Administrative Core, should be a scientist
who can provide effective administrative and scientific leadership and can
demonstrate proficiency in managing a large, multi-component project. The
Director will be responsible for the organization and operation of the ONRC and
for communication with the NIDDK on scientific and operational matters. Center
Directors are required, and their administrators are strongly encouraged, to
attend an annual meeting to be held at a location to be determined by the
NIDDK. Funds for travel to this meeting should be included in the budget for
the Administrative Core of the Center. An applicant can only submit one
application under this announcement.
Applications for ONRC grants require an existing program of excellence in research in the areas of basic and clinical research related to obesity, eating disorders, and energy regulation. To justify Core Center support, the ONRC must serve a strong research base that has a consistent and outstanding record in NIH and other peer-reviewed funding. The research base grants must be summarized in accordance with the Administrative Guidelines for NIDDK Obesity and Nutrition Research Centers (ONRC) found at http://www2.niddk.nih.gov/NR/rdonlyres/DDD8C1AB-52E9-4ABA-BCE0-F47E6CAFD8D1/0/Centers_ONRC_Guidelines.pdf
At least 50 percent of the obesity, eating disorders, and energy regulation research comprising the research base must be supported by Federal Agencies. The initial review group will determine the significance and quality of the research base.
Scientific personnel and institutional resources capable of supporting the research base must be available. In addition, the institution and pertinent departments must show a strong commitment to support the Center. Such commitment may be provided as dedicated space, staff recruitment, salary support for investigators, dedicated and shared equipment, or other financial support for the proposed Center.
Each core unit proposed for funding under the ONRC must be utilized by a minimum of two federally funded research projects. A detailed description of each core unit proposed as part of the Center must be provided, with a detailed budget and budget justification. A Core director must be named for each core proposed. The description of each core should include a rationale, indicating how it will support the Center’s research effort in a cost-effective manner. Facilities must be available for the primary needs of the ONRC because funds for new construction are not available from the P30.
Promoting interdisciplinary and multidisciplinary collaboration among scientists working within a Center is a major goal of the ONRC Program. Each Center application should describe how continuing and new interactions will be fostered and encouraged by the ONRC.
Another goal of the ONRC is to attract scientists to the
fields of obesity and related disorders. Therefore, a Pilot and Feasibility
(P/F) program will be supported to provide modest support for new initiatives
or feasibility research studies. Further, the ONRC may include limited funds to
support an Enrichment Program such as seminars, visiting scientists,
consultants, and workshops. For the purpose of this RFA, the NIDDK will not
support more than one ONRC grant (P30) in an applicant institution.
Section
IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at http://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: [email protected].
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.
The ONRC
Guidelines provide more detailed information on the Centers and on preparing
the application. The guidelines are accessible at http://www2.niddk.nih.gov/NR/rdonlyres/DDD8C1AB-52E9-4ABA-BCE0-F47E6CAFD8D1/0/Centers_ONRC_Guidelines.pdf or from the program
director listed below under Scientific/Research Contact (Section VII.1).
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): May 25, 2007
Application
Receipt Date(s): June 22, 2007
Peer Review
Date(s): October-November 2007
Council Review
Date(s): January 2008
Earliest
Anticipated Start Date(s): April 2008
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: [email protected]
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 http://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: [email protected]
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: http://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 http://grants.nih.gov/grants/policy/policy.htm.
Pre-award costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing continuation award if
such costs: are necessary to conduct the project, and would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
An ONRC
must be an identifiable organizational unit within a university or medical
center or a consortium of cooperating institutions, including an affiliated
university. The overall goal of an ONRC is to bring together, on a cooperative
bases basic science and clinical investigators to enhance the effectiveness of
their research. This goal is achieved using the P30 center grant mechanism,
which provides support for shared resources, termed “cores,” that
enhance productivity and benefit a group of investigators working to accomplish
the stated goals of the ONRC. Thus, the purpose of the ONRC is to provide the
capability for accomplishments greater than those that would be possible by
individual research project grant support alone.
To qualify for an ONRC grant, the applicant institution must already have a substantial base of ongoing, independently supported, peer-reviewed research projects related to obesity, eating disorders, and energy regulation. This currently funded research bases provides the major support for a group of investigators who would benefit from shared resources. The body of research described as the research bases includes only currently funded, peer reviewed research grants awarded to the applicant institution/consortium. These may be federally or privately funded awards; training grants and fellowship awards are not considered part of the research base. At lease 50 percent of the obesity, eating disorders and energy regulation research comprising the research base must be supported by Federal Agencies.
The research base must exist prior to the submission of an application and it is the most important element considered during the peer review process. Focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity are all considerations in judging the adequacy of the research base. Although collaborations with investigators outside the applicant institution/consortium are encouraged, the research base includes ONLY support for the investigators at the applicant institution/consortium.
Applicants should consult with NIDDK staff concerning plans for the development of an ONRC and the organization of the proposed Center.
Additional
application instructions are available in the Obesity Nutrition Research Center
Guidelines available on the internet at http://www2.niddk.nih.gov/NR/rdonlyres/DDD8C1AB-52E9-4ABA-BCE0-F47E6CAFD8D1/0/Centers_ONRC_Guidelines.pdf or from the Program Director
listed below under Scientific/Research Contacts (Section VII.1).
Plan for Sharing Research
Data
NA
Since these are P30
applications to set up core services to support other research projects, these
cores will not maintain data that can be shared.
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 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.
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?
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?
• What are the strengths of the Center's research base (its breadth and depth) and the relevance and interrelation of these separately funded research projects to the central theme(s) or focus of the Center? What is the likelihood for meaningful collaborations among Center investigators? Does the research base to be supported by the Center show evidence of a strong and consistent record of productivity and peer-reviewed funding in the center-related research areas?
• How appropriate and relevant are the proposed Cores and their modes of operation (such as how request for services will be prioritized)? What is the potential for Core contribution to ongoing research? Are facilities available for the core? Is the necessary technical and analytical expertise available to run the Core? Are appropriate quality control measures established for the operations of each core? Is there evidence of the ability to monitor use and utility of the cores? Are there at least two users identified for each core? Is there a description of the efforts to be made (for new applications or for new cores in competing continuation applications) and efforts made (for existing cores in competing continuation applications) to increase the number of core users, and thus enhance the core’s productivity and cost effectiveness? Do competing continuation applications document the past use, utility, quality control, cost effectiveness, and proposed future use of each core for which continuation is requested? Also, in competing continuation applications, is there a significant list of publications arising from the cores?
• Is there a clinical component to the Center and is it appropriate to the research theme of the Center? What are the potential for and the past efforts of the clinical component to develop specialized services relevant to the Center? Are the services to be offered, the personnel requested to run the services, and specialized services to be provided appropriate to the Center?
•Are Pilot and Feasibility (P&F) studies submitted for evaluation as part of the review of the P&F program? Are the P&F applicants eligible and is there an adequate selection process by which the individual studies were selected? For competing continuation applications, are data supplied on the success of previously funded P&F projects in obtaining outside support? Do the P&F projects propose reasonable hypothesis and are the P&F projects feasible and related to the focus of the ONRC?
• Are the Center investigators responsible for the individual research projects willing to interact with each other and contribute to the overall objectives of the Core Center? What are the scientific and administrative leadership abilities of the proposed Center Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the program? Are the individuals selected to be Core Directors, Associate Directors or other core key personnel appropriate for their roles? Are there appropriate criteria for inclusion of individuals as center members and associate members? Is appropriate administrative organization proposed for the following:(a) Coordination of ongoing research between the separately funded projects and the Center, including mechanisms for internal monitoring;(b) Establishment and maintenance of internal communication and cooperation among the Center investigators;(c) Mechanism for selecting and replacing professional or technical personnel within the Core Center;(d) Mechanism for reviewing the use of and administering funds for the P&F program;(e) Management capabilities that include fiscal administration, procurement, property and personnel management, planning, budgeting, and other appropriate capabilities? If requested, does the Named New Investigator appear well qualified and appropriate for support?
• Is there institutional commitment to the program, including lines of accountability regarding management of the Center grant and the institution's contribution to the management capabilities of the Center? Is there clear potential for interaction with scientists from other departments and institutions? Is there efficient and effective use and/or planned use of the limited enrichment funds, including the contribution of these activities in enhancing the objectives of the Center.
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
Since these are P30
applications to set up core services to support other research projects, these
cores will not maintain data that can be shared.
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 http://grants.nih.gov/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 (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 (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 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:
Carolyn W. Miles, Ph.D.
Division
of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Disease
6707
Democracy Boulevard, Room 665
Bethesda, MD 20892-5450
Telephone:
(301) 451-3759
FAX:
(301) 480-8300
Email: [email protected]
2. Peer Review Contacts:
Francisco O. Calvo, Ph.D.
Division
of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707
Democracy Boulevard, Room 752
Bethesda, MD 20892-5452
Telephone:
(301) 594-8885
FAX:
(301) 480-3505
Email: [email protected]
3. Financial or Grants Management Contacts:
Ms. Sharon Bourque
Division
of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707
Democracy Boulevard, Room 719
Bethesda, MD 20892-5456
Telephone:
(301) 594-8846
FAX:
(301) 480-3504
Email: [email protected]
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects
Protection:
Federal regulations (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 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 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 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 (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. 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 RFA is related to one or more of the priority
areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This program is described in
the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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