and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National
Institute on Aging (NIA) (http://www.nia.nih.gov)
Title: Roybal Centers for Translational
Research on Aging (P30)
Announcement
Type
This is a reissue of RFA-AG-04-007
Update: The following update relating to this announcement has been issued:
Key Dates
Release Date: June 11, 2008
Letters
of Intent Receipt Date: October
1, 2008
Application Receipt Date: October 31, 2008
Peer
Review Date: February/March
2009
Council
Review Date: May 2009
Earliest Anticipated Start Date: July 2009
Additional Information To Be
Available Date (Url Activation Date): N/A
Expiration
Date: November 1, 2008
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 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, Review and
Anticipated Start Dates
1.
Letter of Intent
B. Sending an Application to
the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information
Section V. Application Review
Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Resource Sharing Plan(s)
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 intention of this
Funding Opportunity Announcement (FOA) is to solicit NIH Research and
Development Core Center Grant (P30) applications for the Roybal Centers for
Translation Research on Aging. The Roybal Center program was authorized
by Congress in 1993 and named for former House Select Committee on Aging Chair
Edward R. Roybal. The program is intended to move or
translate promising social and behavioral basic research findings
into programs and practices that will improve the lives of older people and the
capacity of institutions to adapt to societal aging. This FOA defines
translation as work that moves basic research findings closer to
practical application in improving the health and well being of older
populations.
NIA has long been the primary sponsor of research in the basic social and behavioral sciences on the processes of aging at both the individual and societal levels. This long-term investment in research has generated a large body of knowledge about how people change over the adult life course (both physically and in such areas as cognition, motivation, personality, and memory), on the inter-relationships between older people and social institutions, and on the economic impact of both changing age-composition of the population and public/private programs that serve older populations. For many years, the NIA Behavioral and Social Research (BSR) Program has supported research at both (i) the population level, on the antecedents and impact of changing social, demographic, economic, and health characteristics of the older population, and (ii) the individual level, on the bio-psychosocial processes linking health and behavior, cognitive functioning, human factors, and integrative approaches to the study of social, psychological, contextual/environmental, genetic, and physiological influences on health and well-being over the life course. As recent years have seen an explosion of fundamental insights in the basic social and behavioral sciences, translating this knowledge into practical advances to benefit the health and well being of older Americans has increasingly become a priority for the NIA. This FOA encourages applications that focus on the translation of basic behavioral and social research in aging with the goal of improving the health, productivity, or well being of older populations. It is anticipated that Center investigators will use the Center resources to develop and pilot new and innovative ideas, and will then submit applications for P01s, R01s, or SBIRs to more fully implement ideas developed and piloted in the Roybal Centers. Investigators who have already effectively piloted their ideas should consider applying through these mechanisms.
A. Specific Objectives
The theme of a proposed Roybal Center program should be organized to accelerate the process of translating basic behavioral and social science research theories, methodologies, and findings about aging processes into practical outcomes and new technologies that would improve the lives of middle-aged and older people. Translational research under this FOA is intended for behavioral and social science studies with research results relevant for:
The focus on investigating a practical problem will require applicants to show familiarity with the practical domain or environment being investigated as well as with relevant aspects of aging research. Such familiarity may be achieved by collaboration with specialists in the domain or community, or by prior experience in applying aging research successfully to this domain. Because practical problems will likely benefit from cross-disciplinary attention, applications that reflect broad-based expertise are particularly encouraged.
B. NIA's Behavioral and Social Research (BSR) Program's "Areas of Emphasis"
The BSR Program is particularly interested in, but does not require, applications that address one or more of the "areas of emphasis." BSR's areas of emphasis include:
(a) Aging Minds
(b) Increasing Health Expectancy
(c) Health, Work, and Retirement
(d) Intervention and Behavior Change
(e) The Burden of Illness and the Efficiency of Health Systems
(f) Health Disparities
(g) Genetics, Behavior, and the Social Environment
More information about NIA BSR program interests is available on the program website: http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/
C. Examples of Areas of Concentration
Below are examples of potential areas of concentration for proposed Centers. These ideas are intended to be illustrative only, as applications are welcome from all domains that would increase our understanding of the processes of technological innovation and translation of basic research to practical outcomes, in the areas of individual and population aging. Applications are strongly encouraged to focus on a single topic area, but are also encouraged to propose the use of multidisciplinary and interdisciplinary approaches to translation.
D. Center Components
Each Center Grant (P30) must consist of: (a) a management and administrative core and (b) a pilot core.
Although the Center grant is primarily designed to support a research Center at a specific institution, some Centers may wish to make research resources available to the larger scientific community or galvanize scientists at several academic institutions. Consortium arrangements are permissible, provided that the applicant institution meets the eligibility requirements. Centers are also encouraged to collaborate with other NIA-funded Centers, including the Resource Centers (and Coordinating Center) for Minority Aging Research (RCMAR) (see http://www.rcmar.ucla.edu/) and the Centers on the Demography and Economics of Aging (see http://agingcenters.org/ ). Additional information about these Centers is available from the program staff listed under INQUIRIES.
(a) Management and Administrative Core
The Management and Administrative Core is central to each Center. Required activities of this core are:
Additionally, this core may include the following activities:
(b) Pilot Core
The Center application must request funds to initiate small-scale (up to $100,000 Direct Costs) pilot research that is consistent with the theme of the Center grant. Pilots can support research to: 1) move a basic research finding towards its ultimate translation, 2) conduct additional basic research needed to allow a specific step(s) in the translation process to advance (i.e. back-translation), or 3) support the development of preliminary data to produce a new grant application to translate basic research into a program or product (such as an SBIR/STTR application). The eligible groups for such pilots include, but are not limited to, junior, underrepresented and established investigators at the Center institutions or at outside institutions, or in association with academic and/or corporate partners. The pilot core can increase or decrease in relative size over the course of the funding period as the number of pilot projects varies. While pilot projects may be proposed for one to three years' duration, it is expected that most will be funded for one year. The application must describe the proposed use of program development funds for two, and only two, pilot projects in each of the first two years of the proposed center. Adequate detail should be provided in order to allow for the evaluation of the scientific value and significance of the proposed activities. Provision should be made in the Management and Administrative Core for the institutional review of new projects (including human subjects review). The description of all pilot projects, and any results must be reported in the Center's annual progress report to the NIA.
Special Requirements
Advisory Committee
The Management and Administrative Core should include an Advisory Committee that oversees the functioning of the Center and assists the Director in making the scientific and administrative decisions relating to the Center, including the allocation of funds for pilot studies. The application must describe a plan for the Center to develop, identify, review and monitor pilot projects in a manner consistent with the overall goals of the Center. Members of the Advisory Committee should NOT be named in the application; instead areas of expertise should be listed. The Management and Administrative Core budget should reflect the costs associated with communicating with and convening the Advisory Committee.
Annual Meeting
Roybal Center Principal Investigators and Core leaders will be required to attend annual meetings in the first, second and third years of the project and the travel budget should therefore reflect appropriate allocation for this activity. The meetings will be held at the NIH in Bethesda, MD, or at another site agreed to by the Principal Investigators and the NIA. The purpose of the meetings is to have investigators working in the same general area share information about translational research methods and findings. Applicants should include a statement in the application indicating a willingness to participate in such meetings and to cooperate with other researchers in the exchange of data, materials, and ideas.
Approval of Pilot Projects
NIA policy requires that the specific aims of any pilot project, in addition to the pilot project budget, Curriculum Vitae of the pilot investigator, and IRB approvals, must be submitted to the NIA Program Official for administrative approval by the NIA Grants and Contracts Management Office before funds may be expended. This administrative approval will be communicated via the Notice of Grant Award (NoA).
See Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section
II. Award Information
1. Mechanism of Support
This funding
opportunity will use the Research and
Development Center (P30) award mechanism(s).
The
Project Director/Principal Investigator (PD/PI) will be solely responsible for
planning, directing, and executing the proposed project.
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
2. Funds Available
The
estimated amount of funds available for support of 8-12 projects
awarded as a result of this announcement is $3.0 million Direct Costs
(estimated at $3.6 million Total Costs) for fiscal year 2009. An applicant may request a
project period of up to 5 years. Future
year amounts will depend on annual appropriations.
NIA expects to fund Centers of different sizes. $300,000 is the maximum allowable Direct Cost that may be requested in year one.
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.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following
organizations/institutions are eligible to apply:
Note that foreign organizations are not eligible to apply for P30 grants.
1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her 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 current NIH
Grants Policy Statement.
3. Other-Special Eligibility Criteria
Applicants are not
permitted to submit a resubmission application in response to this FOA.
Renewal applications will be permitted for this FOA.
Applicants may only submit only one application in response to this FOA.
Multiple PD/PIs are not permitted.
An Edward R. Roybal Center Grant (P30) requires relevant pre-existing research activity at the institution. Ideally, applicant institutions will be able to draw from a substantial base of relevant research.
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 in item (box) 2 only of the
face page of the application form and the YES box must be checked.
See
Section IV.6 Other Submission Requirements for additional
instructions.
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
Letter
of Intent Receipt Date: October 1, 2008
Application Receipt Date: October 31, 2008
Peer Review Date: February March, 2009
Council Review Date: May 2009
Earliest
Anticipated Start Date: July 2009
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
in Section IV.3.A.
The
letter of intent should be sent to:
Georgeanne E. Patmios
Behavioral
and Social Research Program
National
Institute on Aging
7201
Wisconsin Avenue, MSC 9205
Gateway Building, Suite 533
Bethesda, MD 20892-9205 (use 20814 for express mail)
Telephone:
(301) 496-3138
Fax:
(301) 402-0051
Email:
[email protected]
3.B. Sending an
Application to the NIH
Applications must be
prepared using the forms 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:
Ramesh Vemuri, Ph.D.
Chief,
Scientific Review Office
National
Institute on Aging
Gateway Building, Room 2C212
Bethesda, MD 20892-9205 (use 20814 for express mail)
Telephone:
(301) 496-9666
FAX:
(301) 402-0066
E-mail: [email protected]
3.C. Application Processing
Applications must be received on or before the
application receipt date) described above (Section
IV.3.A.). If an application is received after that date, the application
may be delayed in the review process or not reviewed. Upon receipt,
applications will be evaluated for completeness by the CSR and for
responsiveness by the reviewing Institute. Incomplete and/or
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 NIH Grants
Policy Statement.
Pre-award costs
are allowable. A grantee may, at its own risk and without NIH prior approval,
incur obligations and expenditures to cover costs up to 90 days before the
beginning date of the initial budget period of a new or renewal award if such costs: 1) are
necessary to conduct the project, and 2) would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or renewal 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 and Information
Research Plan Page Limitations
All Applications
Center applications must follow the Public Health Service Grant Application (revised PHS Form 398) instructions at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-028.html but for the following exceptions:
Applications must be complete upon submission; no additional materials will be accepted after the receipt date.
Renewal Applications
This information will be used by reviewers to assess the degree to which original Specific Aims and RFA objectives have been met, and the potential of the competing renewal application to result in significant continuing progress.
New Applications
New applicants should use the 10 page overview section to describe preliminary studies and ongoing work relevant to the Center application.
Appendix Materials
All paper PHS 398 applications must provide appendix material on CD only, Include five identical CDs in the same package with the application. (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.)
Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.
Resource Sharing Plan(s)NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.
(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.
(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.
(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.
Resource sharing should be discussed as Item 17 of the Research Plan in each Core.
Section V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications that are complete and responsive to
the FOA will be evaluated for scientific and technical merit by
an appropriate peer review group convened by the National
Institute on Aging and in accordance
with NIH peer review procedures (http://grants1.nih.gov/grants/peer/),
using the review criteria stated below.
As part of the scientific peer review, all applications will:
The following will be considered in making funding decisions:
The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as appropriate
for each application. Note that an application does not need to be strong in
all categories to be judged likely to have major scientific impact and thus
deserve a meritorious 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? Regarding the Pilot Core, what is the quality,
innovativeness and importance of the proposed pilot studies?
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? Do the investigators document an intention to collaborate
with commercial, non-profit or governmental interests to support and expand
Center research? Is this commitment demonstrated by letters of support
regarding new collaborations and/or evidence of past partnerships? Do
proposed collaborative activities increase the opportunities for research and
translation? Is the proposed Advisory Committee process for developing,
soliciting, reviewing, selecting, monitoring and evaluating pilot projects
adequate?
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? Does the project propose truly new
solutions or incremental changes to existing solutions?
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 duties and percent efforts of administrative staff of the Center adequate,
in terms of their qualifications and contributions to the specialized needs and
conduct of the Center’s theme?
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? Does the institutional environment
have significant ongoing research activity that is relevant to the theme of the
proposed Center? Does the environment facilitate the ability to translate
a body of basic research into significant practical outcomes? Does the
administrative structure maximize the Center’s capability to take
advantage of research opportunities?
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 rating:
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 on Human Subjects in the PHS 398 instructions).
Inclusion of Women and Minorities in Research: The adequacy
of plans to include subjects from both genders and all racial and ethnic groups
(and subgroups), 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 on Human
Subjects in the PHS 398 instructions).
Care and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five points described in
the Vertebrate Animals section of the Research Plan 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.
Resource Sharing Plan(s)
When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.
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.
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.
Approval
of Pilot Projects
NIA policy requires that the specific aims of any pilot project, in addition to the pilot project budget, Curriculum Vitae of the pilot investigator, and IRB approvals, must be submitted to the NIA Program Official for administrative approval by the NIA Grants and Contracts Management Office before funds may be expended. This administrative approval will be communicated via the Notice of Grant Award (NoA).
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 Non-Competing Continuation Grant Progress Report (PHS
2590) annually and financial statements as required in the NIH Grants Policy Statement.
Awardees
will be required to submit the annual Non-Competing Continuation Grant Progress
Report (PHS 2590) following a standardized reporting template that will be
developed by the NIA Program Official and distributed upon award. The
purpose of this standardized template is to facilitate the annual reporting of
aggregated information to the NIA Program Official for program evaluation and
reporting purposes.
A final
progress report, invention statement, and Financial Status Report are required
when an award is relinquished when a recipient changes institutions or when an
award is terminated.
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:
Georgeanne E. Patmios
Behavioral
and Social Research Program
National
Institute on Aging
7201
Wisconsin Avenue, MSC 9205
Gateway Building, Suite 533
Bethesda, MD 20892-9205 (use 20814 for express mail)
Telephone:
(301) 496-3138
Fax:
(301) 402-0051
Email: [email protected]
2. Peer Review Contacts:
Ramesh
Vemuri, Ph.D.
Chief,
Scientific Review Office
National
Institute on Aging
7201
Wisconsin Avenue, MSC 9205
Gateway Building, Suite 2C212
Bethesda, MD 20892-9205 (use 20814 for express mail)
Telephone:
(301) 496-9666
FAX:
(301) 402-0066
E-mail: [email protected]
3. Financial or Grants Management Contacts:
Jeff Ball
Grants Management Specialist
Grants & Contracts Management Office
NIH, DHHS
National Institute on Aging (NIA)
7201 Wisconsin Avenue, Gateway Bldg, Suite 2N212
Bethesda, MD 20892-9205 overnight mail use 20814
Ph (301) 402-7732, Fax (301) 402-3672
E-mail: [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.
Policy
for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data repository,
or provide an appropriate explanation why submission to the repository is not
possible. Data repository management (submission and access) is governed by the
Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide
Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/.
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.
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 Requirement:
In
accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html)
investigators must submit or have submitted for them their final, peer-reviewed
manuscripts that arise from NIH funds and are accepted for publication as of
April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly
available no later than 12 months after publication. As of May 27, 2008,
investigators must include the PubMed Central reference number when citing an
article in NIH applications, proposals, and progress reports that fall under
the policy, and was authored or co-authored by the investigator or arose from
the investigator’s NIH award. For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.
Standards
for Privacy of Individually Identifiable Health Information:
The Department
of Health and Human Services (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 FOA is related to one or more of the
priority areas. Potential applicants may obtain a copy of "Healthy People
2010" at http://www.health.gov/healthypeople.
Authority and
Regulations:
This program is
described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 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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