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: Centers on the Demography and Economics of Aging (P30)

Announcement Type
This is a reissuance of RFA-AG-04-001

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-AG-09-005

Catalog of Federal Domestic Assistance Number(s)
93.866

Key Dates
Release Date:  June 10, 2008
Letters of Intent Receipt Date: September 30, 2008   
Application Receipt Date: October 30, 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: October 31, 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 and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements 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

This funding opportunity announcement (FOA) solicits Research and Development Center (P30) grant applications in the areas of demography and economics of aging, including relevant interdisciplinary areas rooted in population-based social science research.  NIA invites both new teams of investigators and continuing centers (funded under RFA-AG-04-001) to apply.  The purpose of these center grants is to support:  the infrastructure and pilot data necessary for research and program development in selected illustrative areas (described under Illustrative Topic Areas); research projects in selected illustrative areas (described under Illustrative Topic Areas); the development of innovative national and international networks of researchers; the recruitment of new researchers into the field; the development and enhanced sharing of specialized databases and the rapid application of research results from these databases; and the development of statistical data enclaves for the analysis of large-scale, often-longitudinal, databases with linked administrative data and increasingly, with linked biological and genetic information.  Center grant applications must include two mandatory cores and may choose among four optional cores, while staying within the maximum allowable direct costs for the overall Center application (see Section II.2 “Funds Available” for maximum allowable direct costs).

Background

Many important scientific research findings in the demography and economics of health and aging have been made possible by interdisciplinary interactions and collaborations (across institutions and internationally) with allied scientific fields such as anthropology, biology, genetics, psychology, neuroscience/neuropsychology, epidemiology; health services, behavioral economics, medicine and public health.   In addition, the ability to link datasets, to collect biological and genetic data in population-based social science surveys, to combine raw data from different data collections, and to develop internet-based surveys have, and can, lead to innovative research designs and the ability to answer new substantive questions while raising the need to protect confidentiality and to develop new methods for sharing data.  Progress in research on population aging can be accelerated and significantly enhanced by the widespread collaboration of investigators at multiple institutions, by the recruitment of talented researchers new to aging, and by the creation of innovative networks of researchers.  This said, the focus of this FOA is on demography and economics; applicants are encouraged to integrate disciplines while maintaining a population-based, social science approach. 

The NIA has supported the development of major data collection efforts in areas such as long term care, retirement and economic status, and the dynamics of health and functional change in the very old (see Publicly Available Databases for Aging-Related Secondary Analyses in the Behavioral and Social Sciences at http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/Resources.htm  ).  However, use of these and other datasets requires considerable investment prior to conducting any sophisticated research.  Efficiency is increased, and costs of individual research projects can be reduced, when several researchers at the same institution can make use of centralized data files staffed by knowledgeable data managers.  Also, there is a growing demand from the federal government and the policy community for timely and appropriately synthesized research findings from these datasets. 

A P30 grant is intended to support shared resources and facilities for categorical research by a number of investigators from different disciplines who provide a multidisciplinary approach to a joint research effort, or from the same discipline who focus on a common research problem. The common research problem for this FOA is demographic and economic population-based research on aging, which may be informed by psychological, biological and other fields as appropriate.  Within demographic and/or economic population-based research on aging, the P30 award provides support to a variety of research-related activities organized around one or more common themes or areas of interest, which should be specified in the application.  Applicants are encouraged to collaborate with other Demography and Economics of Aging Centers as well as other NIA-funded Centers programs such as the ROYBAL Centers for Translational Research on Aging, the Resource Centers for Minority Aging Research, and the National Archive of Computerized Data on Aging. More information on these Centers programs is available from the NIH Scientific/Research Contact named in Section VII.

Applicants may therefore address a variety of topic areas within the stated theme of the proposed Center, and examples of these topic areas are listed below.  They are not intended to be prescriptive; applicants may redefine these areas, merging and combining topics according to their own perspectives of the future course of the population sciences related to aging.  Comparative international research is encouraged. 

Illustrative Topic Areas

A. Demography of Aging

Studies of the causes and consequences of population aging in the US and other societies.  Implications for elderly health, well-being and future social support of changes (and trends) in marital status, family and household size, household structure and migration patterns.  Analyses of the factors that trigger movement of the elderly through various living arrangements and the functional and health-related outcomes associated with residential options available to older persons.  Forecasting life and active life expectancy, and health, medical services and long-term care usage.  Research to explain the diverging trends in and implications of longevity improvements among high-income countries.  The relationships among neighborhoods, social capital and health and well-being of the elderly.  Analyses of features of neighborhoods and their effect on health-related behaviors.  The impact of social networks on health, behaviors, well-being, and a variety of social phenomena.  Analyses of the causes and behavioral consequences of the increase in the proportion of elderly living alone.  The impact of socioeconomic and health factors over the life course on health and well-being at older ages.  Cohort analyses of outcomes such as morbidity, mortality, functional status, and economic well-being, focusing on social and cultural experiences across generations.  Analyses of how the elderly spend and experience their time, and how their activities relate to their health and functional status.  The development of new multi-level methodologies for the analysis of complex longitudinal data. 

The demographic aspects of heritability, genetic variants, and familial aggregation of disease and longevity.  Incorporation of genetic, biological, and disease variables into demographic models and age-specific mortality rates in human and non-human populations.  The social roles of the elderly in nature.  Biological mediators of the relationship between socio-economic status and health, and between social influences and health outcomes.

B.  Trends in Chronic Disease and Disability, and Burden of Illness

Investigation of the factors underlying the decline of disability in the older population.  Analyses of determinants of transitions between levels of functioning at older ages.   Determination and quantification of the causal factors underlying  trends in disability prevalence and dynamics. Improved conceptualization and measurement of disability beyond ADL and IADL.  International comparative analyses of disability in countries with different institutional and family structures.  Effects of state and federal regulatory and reimbursement policies on long-term care, rehabilitation, home health care, and acute care on the health and functioning of the older population.

Measurement of the magnitude and socio-economic consequences of burden of illness in the older population. Dementia, Alzheimer’s Disease, and HIV/AIDS are of special interest.  Improved analysis and methodology to allocate and impute burden of illness, given the importance of comorbidity in the older population. This may also include modeling risk factor trajectories and trends in non-communicable disease, disability and mortality in developed and developing countries, with emphasis on aging populations.

C. Satellite Non-Market Accounts Relevant to Population Aging

The development of satellite national accounts that measure the non-market value of health (National Health Accounts), well being (National Well Being Accounts), and household production.  Studies that develop unique data sources to produce these types of non-market accounts (such as time-use data, measures of utility from time-use, the market value of home production, etc) are also encouraged.

D. Health, Work and Retirement

The direct effects of retirement wealth, health, disability, and family structure on retirement, as well as the interaction and dynamic development of these factors.  Models that integrate these factors into a comprehensive framework are encouraged, particularly models that consider the impact of health and health investments on savings, consumption, and retirement.  Research on the behavioral aspects of demand for insurance against old age risks (such as reverse mortgages, long-term care insurance, and annuities).  Research on the development of innovative interventions (e.g., using behavioral economics approaches) that translate findings from behavioral research to improve retirement wealth adequacy and well-being.  Research using cross-national, harmonized samples such as the Health and Retirement Study (HRS), the English Longitudinal Study of Aging (ELSA), the Survey of Health, Ageing and Retirement in Europe (SHARE), and the Study on Global Aging and Adult Health (SAGE) are encouraged to gain a better understanding of the institutional differences and underlying causes of variation in retirement and health outcomes across countries.

E. Social Insurance Systems

The development of models to forecast future costs and benefits of the Social Security, Medicare and Medicaid programs as well as research that develops key factors that contribute to the forecasting of these programs.  The impact of population aging, health care cost growth, programmatic changes, and uncertainty on social insurance forecasts.   Research that validates existing frameworks and can decompose the impact of key factors on forecasts.  The impact of technological changes on cost growth and health.  Research is also encouraged on the impact of these programs on future health and mortality.

F. Medicare

Research to identify causes of excess Medicare cost growth, to learn how to reduce geographic variation of Medicare usage, and to understand the relationship between Medicare spending and health status.   Forecasting the influence of the impact of medical interventions on future lifetime health care costs. Estimation of the impact of changes in the functional status and other characteristics of the older population on Medicare and other health care costs. Evaluations and simulations of the impact of changes in federal policies.

G.   Population Perspectives on Psychological and Cognitive Development and Aging

Interdisciplinary research on cognitive functioning and psychological well-being over the life course from a demographic or economic perspective.  Examples include behavioral economics; neuroeconomics; and research on population patterns of cognitive or psychological health and their consequences.  Incorporation of new genetic perspectives is encouraged.

H. Early and Mid-Life Determinants of Late-Life Health and Well-Being

Research that examines the influence of early life experiences and characteristics (e.g. childhood health, socioeconomic status, environment, exposure to infectious disease, heritable traits) on morbidity and mortality in later life.  The incorporation of new genetic perspectives is encouraged.  Analyses of datasets uniquely positioned for such studies, such as the National Longitudinal Mortality Study, are encouraged.  Comparative work in this area is also encouraged, for example using cross-national, harmonized samples such as the Health and Retirement Study (HRS), the English Longitudinal Study of Aging (ELSA), the Survey of Health, Ageing and Retirement in Europe (SHARE), and the Study on Global Aging and Adult Health (SAGE).  

I. Race, Ethnicity and Socioeconomic Status

Elucidation of the reciprocal causation between SES, race and ethnicity, health and morbidity across the life course.  Improved understanding of the degree to which socioeconomic status (SES) produces differences in health outcomes over the life course (with a focus on late-life outcomes), and the mechanisms involved.  Identification and quantification of the SES, social and environmental factors which have the greatest implications for health outcomes in specific population sub-groups.  Identification of the effects of variability of SES over the life course for specific SES categories as well as for specific population groups.  Studies of the interaction between health and the accumulation of stress in diverse populations.  Identification of SES and racial/ethnic differences in response to social stressors.  Comparative cross-national approaches to understanding these issues is encouraged.  The topics listed under “F. Medicare” are also relevant here. 

J. HIV/AIDS

Research on the changing age distribution of HIV/AIDS in the US.  Studies of the social environment and sources of support for long-term HIV-infected adults, and how aging influences the illness experiences of these long-term survivors. Analyses of the relationships among social environments, individual behaviors, and the incidence and prevalence of HIV/AIDS in older populations.  Studies of the demographic consequences of HIV/AIDS, especially in low-income countries.    Studies of the social, economic, comorbid and other health risks and consequences of HIV/AIDS for older persons as parents and relatives of HIV infected adults, especially in developing countries.

K. The Macroeconomic Impact of Population Aging

The relationship between population aging and economic growth (in developed and developing countries) and the effect of demographic change on savings, investment, and international capital flows.  The influence of aging populations on labor supply and other key macroeconomic variables such as real wages and interest rates.  Research that examines the influence on the age structure of a country or countries on migratory flows.  Analyses of the effect of institutional arrangements on the macroeconomic consequences of aging.

Resources

Applicants are referred to summaries of various scientific workshops sponsored by the NIA Behavioral and Social Research Program available at http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/ConferencesAndWorkshops.htm  . 

Applicants are referred to various publications of the National Academy of Sciences, sponsored by the NIA Behavioral and Social Research Program.  A list of these is available at http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/Resources.htm and searchable versions of these NAS publication are available at www.nap.edu.  

Descriptions of NIA-supported publicly available databases suitable for secondary analysis of the above-mentioned research areas are available at http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/Resources.htm .

Information on NIA’s Strategic Directions for Research on Aging is available at http://www.nia.nih.gov/AboutNIA/StrategicDirections/ .

Description of a Center

The center grant for this FOA minimally consists of two required cores:  (A) an administrative and research support core, which will provide coordination, research planning, logistical, and centralized data and technical support, and (B) a program development core providing for small scale pilot studies related to program development or methodological innovation.  In addition, an application may request funding for (C) an external innovative national or international network core, (D) an external research support and dissemination core, (E) a statistical data enclave core, and (F) a coordinating center function.  Each proposed Center should focus on one or more scientific themes or areas of interest directly relevant to population aging.

See Section II.2 “Funds Available” for maximum allowable direct costs.  Each institution should decide on an optimal mix of topical foci and cores, and within cores, of specific core functions and levels of effort.  For each Core, any overlap with activities funded or proposed through NICHD center grants must be clearly specified.

A.  Administrative and Research Support Core (MANDATORY)

The Administrative and Research Support core manages the activities of the Center and provides shared resources such as datasets.  The application must name a Center Director who will provide the overall scientific management and coordination of the Center.  The Center Director must be an experienced researcher with appropriate experience in research on population aging.  The objective of this core is to:

1.  Plan, coordinate, review and manage the Center's activities.

2.  Develop, review, and monitor pilot projects.

3.  Purchase and provide facilities or services such as centralized data libraries, including the purchase of hardware such as workstations, high capacity storage devices (hardware or equipment purchases may not exceed 15 percent of requested funding), and data files; development of user-friendly data files; salary for data managers; and cost effective data processing for the Institution's research and training on population aging.  Facilities and services should have the potential for general use at the institution, and must not be for the sole use of any single project.  Any overlap with activities funded or proposed through NICHD center grants must be clearly specified.  Salary support may be requested for the scientific director, core technical staff, consultants, and advisors. Travel funds may be requested for researchers to attend scientific meetings, for training of technical and scientific staff, for new program development, and for travel related to outreach and network functions.

4.  Manage the Advisory Committee (see SPECIAL REQUIREMENTS).

B.  Program Development Core (MANDATORY)

The objective of this support is to allow the institution to develop sufficient preliminary information to permit the submission of applications for peer-reviewed research or career development projects.  The objective is that most of the pilot projects supported will not be terminal projects or analyses, but will lead to R03, R21 or R01 NIH applications, the majority of which will be on aging-relevant topics.  To this end, the Center application must request funds to initiate small-scale pilot research that is consistent with the theme of the Center grant and that will lead to new program development. Population-based social science research (primarily demographic and economic) must be the foundation of pilot projects proposed, but may be informed by psychological, biological and other interdisciplinary fields as appropriate.  Pilot projects to develop potential intervention studies are encouraged.  Pilots could be implemented by both junior and established investigators at the Center institution or at outside institutions, or in association with academic partners.  Funds may be requested for:

1.  Small-scale projects, which may include pilot or feasibility projects.  These small-scale projects (in the range of $15,000 to $75,000 direct costs) are ordinarily limited to two years but may be extended with appropriate justification.  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.  Interdisciplinary pilots should include a discussion of relevance to the demography or economics of aging.  Provision should be made in the Administrative and Research Support 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. 

2.  Optional salary support for (a) new faculty development in demography of aging; (b) increasing the critical mass of the scientific research staff; and (c) the development of new program areas and methodologies.  The total annual salary support cannot exceed $84,000 in direct costs (salary and fringe benefits) from the Center grant, and the institution is expected to supplement any such salary costs with funds from other sources.  As a target, it is expected that scientists supported through this mechanism will either compete successfully for grant support or receive substantial support from the institution by the end of the third year.

C.  External Innovative Network Core (OPTIONAL)

This optional core differs from the new program development core in that it explicitly is for the development of networks beyond the applicant institution's boundaries, including internationally; hence the designation, external. Funds may be requested for:

1.  The development of innovative research networks on the topics listed in the ILLUSTRATIVE TOPIC AREAS section, and consistent with the Center's goals, that will serve to enhance research not only at the institution, but more generally within the field, as well as in relation to other relevant disciplines.  Such networks might include workshops, collaboration on pilot projects, harmonization of international data collection efforts, and the development of common research resources. 

2.  Outreach activities that will encourage and nurture the development of minority researchers. 

3.  Technical assistance activities intended to support users of large NIA funded databases who are outside the NIA Demography Centers

D.  External Research Resources Support and Dissemination Core (OPTIONAL)

This optional core differs from Core A in that its objective is the communication and dissemination of research resources, findings and new concepts and techniques within and beyond the institution.  Applicants are encouraged to propose innovative and creative methods of dissemination. Funds may be requested for, but are not limited to:

1.  The dissemination of new methodologies and important databases to the larger scientific community.  Encouragement is given for the development, support, and sharing of user-friendly databases and specific analytic methodologies both within the institution, and nationally to appropriate researchers.  Such dissemination might include, e.g., research and training workshops, development of user-friendly extract files with imputed variables, newsletters, and electronic bulletin boards providing technical support.  The value-added components to any on-going activities should be clearly specified.

2.  The timely dissemination of well-synthesized research results to the Federal government, scientific community, and policy making community.  Strong encouragement is given for the dissemination of research results from NIA-sponsored databases on the topics listed above under ILLUSTRATIVE TOPIC AREAS.  Such dissemination might include briefings, training seminars, working paper series, and research briefs, and newsletters. 

E.  Statistical Data Enclave Core (OPTIONAL)

Demographic and economic aging research depends heavily on large-scale, often-longitudinal, databases with complex, deeply-described phenotypes that are linked to administrative (e.g., CMS and SSA) data, geographic data (especially, small area), and, increasingly, biological and genetic data.  There is therefore potential for deductive disclosure and risks to confidentiality and privacy resulting from merging of such data.  Increased public and legislative sensitivity, including the HIPAA Privacy Rule, have also affected the environment for this type of research.  Increased emphases on cross-national research must deal with international laws on confidentiality and transmission of health data (especially biological and genetic data) across borders. Funds may be requested for, but are not limited to:

1.  Development of leading-edge analytic methods; development of new statistical techniques to mask individual identities in microdata while maintaining the maximum research value of the data; and methodological research on the merits and drawbacks of various identity masking strategies.  Development of methodology for linking administrative, biologic and genetic data with longitudinal data sources and distributing the linked files.

2.  Statistical analyses of disclosure risk.

3.  Establishing a secure data enclave for analysis of longitudinal data with sensitive linked administrative records and/or biological/genetic data.

F.  Coordinating Center Function (OPTIONAL)

Applicants are encouraged to apply for the coordinating center function in order to promote collaboration and networking among the NIA Demography Centers.  See Section II.2 “Funds Available” for additional instructions.  Coordinating Center functions may include, but are not limited to: establishing a multi-center website; coordinating conferences: arranging annual meetings: preparing research briefs of center research findings of benefit to all NIA Demography Centers; sponsoring multi-center activities or workshops, including travel to workshops; and developing a standardized reporting template for use by P30s funded through this FOA that will facilitate the reporting of aggregated information to NIA Program Officials on Centers’ results, productivity, and plans (individually and collaboratively).  This information will be used by NIA for program evaluation and reporting purposes.  Regarding productivity/output measures, the collection and reporting of the following information, for projects that can trace their lineage to Center-funded pilot projects or other activities, is strongly encouraged:  publication counts, new investigators attracted to aging research, and grant applications submitted to and/or funded by NIA and other agencies/organizations. 

Special Requirements

Advisory Committee

The Administrative and Research Support 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.   Pilot studies should be judged in terms of their basis in population-based social science research, especially in demography and economics; interdisciplinary projects are appropriate as long as they are rooted in population-based social science research.  Members of the Advisory Committee should NOT be named in the application; instead areas of expertise should be listed.  The Administrative Core budget should reflect the costs associated with communicating with and convening the Advisory Committee. 

Collaboration with Coordinating Center

It is expected that NIA will fund one Coordinating Center (CC) for the Demography and Economics of Aging (P30) Centers program.  The functions of the CC are described above (Optional Core F).  Applicants should commit to cooperate fully with the CC in its efforts to e.g., establish a multi-center website, coordinate conferences/workshops, arrange annual meetings, prepare research briefs, and respond to NIA Program Officials on behalf of the Centers program, etc.  It is expected that the CC will request that all awarded Centers follow a standardized reporting template when preparing the annual Non-Competing Continuation Grant Progress Report (PHS 2590); awarded P30s should commit to submitting their PHS 2590s following the standardized format developed by the CC. 

Annual Meeting

Demography Center (P30) Principal Investigators and Core leaders will be required to attend an annual meeting held at the Population Association of America, or at another site agreed to by the PIs and the NIA.  The travel budget of the Administrative and Research Support core should therefore reflect appropriate allocation for this activity.  Funds should be requested for the PI and one additional key person (e.g., the co-director, a Core leader, the Center Administrator, etc.)

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). In addition, the NIA Program Official will review pilot projects for a statement discussing their relevance to the goals of the Center. 

Applications must be complete at the time of submission.  NIA will not accept additional application materials after submission.

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 8-13 projects awarded as a result of this announcement is $4.4 million Direct 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.  Maximum allowable Direct Costs that may be requested for the overall Center in year one are $525,000 (for Cores A, B, C, D, and E).  A 3% per annum inflation increase is allowable in subsequent years.  Funds of up to $120,000 Direct Costs may be requested for the Coordinating Center function (Core F) above the $525,000 Direct Cost limit 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:

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the 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 submit only one application in response to this FOA.

Multiple PD/PIs are not permitted.

A Center on Demography (P30) grant requires substantial pre-existing research activity on population aging at the institution.  A minimum of at least two peer-reviewed and externally funded, currently active research projects that are rooted in population-based social science research in demography or economics that are directly relevant to aging is required.  Ideally, applicant institutions will have a substantial base.  Sub-projects on NIA P01 grants may be counted as individual projects.  Although two peer-reviewed and externally funded, currently active grants is the minimum requirement, considerable weight will be given to significant research activity in demography and economics of health and aging.

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: September 30, 2008
Application Receipt Date: October 30, 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 research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

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.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.  This includes previous unsuccessful P30 applications.

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.)

Awards made in response to this FOA will include Terms and Conditions prohibiting the expenditure of funds on pilot projects until administrative approval is granted by the NIA Grants Management Office which will be communicated via the Notice of Award (NoA).  See also Section I.1 “Special Requirements.”  See also Section IV.5, “Funding Restrictions.”

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

The information in Item 4 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 renewal application to result in significant continuing advancement . 

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 submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application.  Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (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 high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?   

Is there potential for significant scientific progress in the specific areas or themes addressed by the application?  Does the overall strategy for developing research in population-based social science research, in the demography and economics of health and aging generally and specifically within the areas or themes proposed, have potential for significant scientific progress?  Is there scientific merit in the proposed pilot or new program development projects?  Will the support and maintenance functions proposed, for e.g., databases and methodologies, provide value to the institution's researchers?  Will scientific value and public good result from any proposed external outreach and network building activities?

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?     Is the Administrative and Research Support Core’s Advisory Committee pilot project review process adequate to assess the scientific merit of proposed pilot or program development projects?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?    Is the funded research ongoing at the institution, and at the administrative components of the institution(s) proposed for interdisciplinary collaboration, adequate and directly rooted in population-based social science research, especially in the demography and economics of health and aging?  Has there been successful training activity in the area of population aging (including the recruitment and training of junior investigators)?  Is there evidence of concrete commitment of the institution's administration to develop and support research and training on population aging (e.g., provision of new resources, co-funding or new positions)?

For applications proposing the optional Coordinating Center (CC) Core (Core F), the following criteria will be used.  Coordinating Center (CC) Cores will be scored separately from the parent Demography and Economics of Aging (P30) Center application, and the score for the Coordinating Center (CC) will NOT be considered in determining the overall scientific merit of these P30 applications.

Significance: How well does the proposed CC address the coordination and communication needs of the Demography and Economics of Aging Center program? If the aims of the application are achieved, how will the proposed CC bring added value to the scientific activities and accomplishments of this program? 

Approach: Is the proposed organization adequately developed, well integrated, well reasoned, and appropriate to the aims of the CC?

Innovation: Is the approach to the coordinating functions effective?

Investigators: Is the leadership structure appropriate for the proposed CC?  Is the proposed team experienced in the coordination of multi-site activities or research collaborations?

Environment: Does the technologic and scientific environment in which the work will be done contribute to the probability of success? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the 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 gender 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.

Pilot projects must receive administrative approval from the NIA Grants Management Office before funds may be expended.  This administrative approval will be communicated via the Notice of Award (NoA) (or Revisions thereof).  See also Section I.1 “Special Requirements.”

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.

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 Branch
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:

Lesa McQueen
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Avenue, MSC 9205 (use 20814 for express mail)
Gateway Building, Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-1472
FAX:  (301) 402-3672
E-mail: Lesa_McQueen@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/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.

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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