Part I Overview Information


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:

Request For Applications (RFA) Number: RFA-AG-09-008

Catalog of Federal Domestic Assistance Number(s)
93.866

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.

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) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed 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: PatmiosG@nia.nih.gov

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: Vemuri@nia.nih.gov

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.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.

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:

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: PatmiosG@nia.nih.gov

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: Vemuri@nia.nih.gov

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: ballj@nia.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of 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/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (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.


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