Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title

Regional and International Differences in Health and Longevity at Older Ages (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PA-13-125

Companion Funding Opportunity

PA-13-123, R03 Small Grant Program
PA-13-124, R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.866

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages Research Project Grant (R01) applications from institutions/organizations proposing to advance knowledge on the reasons behind the divergent trends that have been observed in health and longevity at older ages, both across industrialized nations and across geographical areas in the United States.  This FOA is intended to capitalize on provocative findings in the literature which have been insufficiently understood and addressed.  This FOA is also intended to capitalize on NIA’s investment in the development of cross-nationally comparable datasets that can be harnessed to study these research questions; these include the Health and Retirement Study (HRS), the English Longitudinal Study on Ageing (ELSA),  the Survey of Health, Ageing and Retirement in Europe (SHARE), and the Human Mortality Data Base.  Applications proposing secondary analysis, new data collection, calibration of measures across studies, development of innovative survey measures, and linkages to administrative sources are encouraged.  Applications are not restricted to projects using the NIA-supported datasets above and may propose research using any relevant data.

Key Dates
Posted Date

February 21, 2013

Open Date (Earliest Submission Date)

May 5, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply.

Advisory Council Review

Standard dates apply.

Earliest Start Date

Standard dates apply.

Expiration Date

September 8, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

This Funding Opportunity Announcement (FOA) encourages Research Project Grant (R01) applications from institutions/organizations proposing to advance knowledge on the reasons behind the divergent trends that have been observed in health and longevity at older ages, both across industrialized nations and across geographical areas in the United States.  This FOA is intended to capitalize on provocative findings in the literature which have been insufficiently understood and addressed.  This FOA is also intended to capitalize on NIA’s investment in the development of cross-nationally comparable datasets that can be harnessed to study these research questions; these include the Health and Retirement Study (HRS), the English Longitudinal Study on Ageing (ELSA),  the Survey of Health, Ageing and Retirement in Europe (SHARE), and the Human Mortality Data Base.  Applications proposing secondary analysis, new data collection, calibration of measures across studies, development of innovative survey measures, and linkages to administrative sources are encouraged.  Applications are not restricted to projects using the NIA-supported datasets above and may propose research using any relevant data.   

Background

Life expectancy at birth in the United States has improved dramatically over the past century. Also, throughout the second half of the century, advances in medicine—particularly in the treatment of heart disease and stroke—along with healthier lifestyles, better access to health care, and better overall health before age 65 combined to produce impressive improvements in life expectancy above age 65.  Yet U.S. life expectancy (at birth and at older ages) -- especially for women – has  lagged behind other wealthy  nations since 1980.   And evidence from cross-national research indicates that older Americans get sicker sooner compared to older Europeans.  Within the United States, similar disparities in health and longevity are observed across geographical areas. 

The recent availability of longitudinal data expressly designed to be cross-nationally comparable has begun to prompt research inquiry into the underlying dynamics of, and reasons for, these differences in health and longevity at older ages.  For example, research using the Health and Retirement Study (HRS), English Longitudinal Study of Ageing (ELSA) and the National Health and Nutrition Study (NHANES), indicates that older white non-Hispanic U.S. adults aged 55-64 are less healthy than their English counterparts for a range of diseases including diabetes, hypertension, heart disease, myocardial infarction, stroke, lung disease, and cancer (Banks et al., 2006).  This analysis also controlled for education and a standard set of comparably-measured behavioral risk factors (smoking, overweight, obesity, and alcohol drinking), which explained little of these health differences.  In addition, analysis of biomeasures from ELSA and NHANES showed that the differences between the U.S. and England and across SES groups within each country are not due to biases in self-reported disease or screening rates, because biological markers of disease (although they have not been calibrated against one another) exhibit exactly the same patterns.  Finally, the results showed that these differences are not solely driven by the bottom of the SES distribution, and that for many diseases, the top of the SES distribution (which in the U.S. has near universal health insurance coverage) is less healthy in the United States as well.  Surprisingly, English lower SES individuals have better health than high SES U.S. individuals.  This is a provocative finding, that U.S. residents in late middle-age are much less healthy than their English counterparts and that these differences exist at all points of the SES distribution.  Possible explanations include survival advantages among U.S. adults with chronic illness, behavioral differences in risk factors not (or imperfectly) measured in these studies, psychosocial factors, the obesity epidemic (which is more advanced in the U.S.), differences in health care systems, social policy contexts other than medical care (e.g., social retirement benefits, unemployment compensation, sick pay, housing policies, transportation options, social integration, etc.), how health influences wealth (e.g., in the U.S., major health events lead to wealth depletion), measurement differences across studies, quality and comparability of biospecimen assays, etc.

A subsequent analysis using data from the HRS, ELSA, and the Survey of Health, Ageing and Retirement in Europe (SHARE) found similar results (Avendano, 2009).  American adults ages 50-74 of all wealth levels reported worse health than did European adults at comparable wealth levels. Indeed, on many measures England was shown to have worse health than other European countries. Similar to the paper discussed above, this analysis excluded U.S. minorities, indicating that the worse health of Americans compared with Europeans cannot be attributed to racial disparities within the United States.  And, similar to the U.S.-U.K. results, this analysis also found that the disparities were only partially explained by differences in a standard set of behavioral factors.  Finally, while poor Americans were at particularly worse health compared with their English or other European counterparts in this analysis, even well-off Americans reported health comparable to substantially poorer Europeans – suggesting that access to and quality of health care is unlikely to be  the full explanation. 

Cross-national analyses provide insight into potential causal explanations for observed differences in health and longevity because institutional factors vary (e.g., universal health care in England at all ages vs. universal health care after age 65 in the U.S.).  However, comparative analyses can also be done within the U.S. where there is also variation.  Extensive research has focused on health disparities within the U.S. and many investigations have documented the consistent gap in measures of mortality and functional health by race, income, social class, education, community characteristics, insurance coverage, health care access and utilization, quality of care, etc. Less has been done exploiting the internal variations by geography in the U.S.  Using data from the U.S. Bureau of the Census and the National Center for Health Statistics, researchers have divided the U.S. into eight subgroups based on a number of sociodemographic and geographical variables (such as location of county of residence, race and income), which they termed the “eight Americas” (Murray, 2006).  They found disparities in mortality across the “eight Americas” that are enormous by international standards and that cannot be explained by race, income or basic health-care access and utilization alone.   A related analysis looked at trends in U.S. county mortality and cross-county mortality disparities from 1961-1999, including the contributions of specific diseases to county level mortality trends (Ezzati, 2008).  This study found that there was a steady increase in mortality inequality across the U.S. counties between 1983 and 1999, resulting from stagnation or increase in mortality among the worst-off segment of the population, and that female mortality increased in a large number of counties, primarily because of chronic diseases related to smoking, overweight and obesity, and high blood pressure.  Other examples of U.S. geographic disparities in health include scholarship on the “stroke belt”.  While no consensus has been reached to explain geographic differences in stroke mortality, recent research suggests that both early life exposures and adult residence independently contribute to stroke mortality risk (Glymour, 2009).  

A recent National Academy of Sciences panel determined, based on available evidence, that past smoking rates are a major reason for shorter lifespans in the U.S. compared to other high-income countries, and that obesity rates in the U.S. also appear to be a significant factor.  The summary report from the National Research Council, which also identified research gaps, is entitled "Explaining Divergent Levels of Longevity in High Income Countries" (NRC, 2011) and is available at http://www.nap.edu/catalog.php?record_id=13089.  A volume of background scientific papers is entitled "International Differences in Mortality at Older Ages: Dimensions and Sources" (NRC, 2011) and is available at http://www.nap.edu/catalog.php?record_id=12945.

Research Scope

Applications are encouraged that pursue possible explanations for the divergent trends that have been observed in health and longevity at older ages, both across industrialized/high life expectancy nations and across the U.S. by geographic area.  Research projects are not restricted to using NIA-supported datasets and may propose research using any relevant data.  Applicants are encouraged to consult the aforementioned National Research Council consensus report entitled “Explaining Divergent Levels of Longevity in High Income Countries” and a companion volume of scientific papers written or invited by the NRC consensus report committee, entitled “International Differences in Mortality at Older Ages:  Dimensions and Sources” (see References below).  These reports discuss potential explanations for the observed divergent trends that have been observed in longevity and health at older ages across high-income countries; discuss internal heterogeneity in the U.S.; present the available cross-national harmonized data useful for analysis; and raise many interesting and provocative hypotheses for future research.  Following a previous Funding Opportunity Announcement (RFA-AG-11-004), the National Institute on Aging funded seven research projects exploring the extent and determinants of international and U.S. regional differences in health and longevity at older ages.  These projects are described at this website: http://www.nia.nih.gov/research/announcements/2012/12/updates-selected-rfas.

Applications submitted to this Funding Opportunity Announcement should advance beyond the NAS reports and existing projects to assess determinants of trends and of international and interregional differences, quantify the contributions of particular determinants, and point the way to likely policy or systemic changes that can improve population health measurably in the United States. In order to make existing studies more suitable for comparative analyses of health status and longevity in middle aged adults, applications that propose secondary analysis, new data collection, calibration of measures across studies, and/or linkages to administrative data sources are appropriate. These represent example approaches and topics only. Other approaches and topics are welcome.

•   The prevalence of a condition is a function of its incidence, duration, and survival. These three parts have not been adequately differentiated in the comparative analysis of major chronic conditions. Do Americans have a higher prevalence of major conditions because they have a higher incidence of a condition, are more likely to have it diagnosed earlier or at all, or experience better survival from it?

•   The cross-national studies discussed above found that differences were not explained by behavioral risk factors.  Applicants are encouraged to conduct investigations of the adequacy and comparability of the behavioral risk factors measured in these studies and consider whether a fuller set of risk factors and would offer additional explanatory power.  Also, these studies do not include data on past differences in risk factors, or may not adequately measure cumulative exposure over the life course.  Behavioral risk factors of interest include:  physical activity, exercise, diet, eating patterns, tobacco/smoking, alcohol, drug use and abuse, obesity, sleep duration, sleep quality, time use, etc.  Environmental exposures and risk factors are also of interest. Studies that quantify the contribution of risk factors and conditions to observed differences (as, for example, Preston and Stokes, 2011, did for obesity) are encouraged.

•   Smoking behavior has been hypothesized to account for a significant portion of the mortality differential among countries.  Recent methodological research estimating the number of deaths attributable to smoking has shown that the ranking of the U.S. in international comparisons of longevity is heavily affected by the smoking history of American men and women (Preston, 2009).  When the mortality profiles of a set of industrialized countries were adjusted by removing the effect of smoking, the relative position of both U.S. women and men significantly improved.  Related analysis suggests that because of reductions in smoking that have already occurred or can be reliably projected, U.S. mortality is likely to decline much faster than is commonly anticipated (Wang and Preston, 2009).  Applicants are encouraged to study the effect of smoking and cohort smoking histories as a potential explanation for the U.S.’s international standing in health and longevity.

•   Psychosocial factors such as social support, social integration, stress, well-being, etc. have not adequately been studied as potential explanations for observed health and longevity differences.  Applicants are encouraged to develop better measures of psychosocial factors for incorporation into the above-mentioned NIA-funded cross-national surveys of the older population, and investigate their potential explanatory power. 

•   Available cross-national comparative data do not include much information on early life factors.  Applicants are encouraged to gather retrospective data (both recall data and information from administrative records including vital statistics) from older cohorts in ongoing studies.

•   Social policy contexts differ between the U.S. and Europe and it has been hypothesized that contextual factors may have causal effects in producing the observed health disadvantages in the U.S.  Studies of the effect of contextual factors including retirement benefits, unemployment compensation, sick pay, working conditions, housing policies, transportation options, social integration etc. are encouraged. 

•   Despite its huge policy implications, the role of health and long-term care systems in international variations in disease prevalence and mortality is only beginning to be understood. The cross-national, longitudinal studies of older people referenced in this FOA, which have frequent follow-up via biomarkers and linked data on medical records, should be further exploited to shed light on differences in the way medical systems interface with patients, and how such differences may have survival and disability implications. Applicants are also encouraged to take advantage of available natural experiments in medical care as they occur internationally.

•   Applicants are encouraged to calibrate the biomeasure assays (e.g., assays of CRP, cholesterol, etc.) and self-reported physical performance measures across datasets used for comparative analyses. 

References:

Avendano, M., Glymour, M.M., Banks, J. and Mackenbach, J.P.  (2009) Health Disadvantage in U.S. Adults Aged 50 to 74 Years: A Comparison of the Health of Rich and Poor Americans with that of Europeans.  American Journal of Public Health 99/3:540-47.

Banks, J., Marmot, M., Oldfield, Z. and Smith, J.P. (2006) Disease and Disadvantage in the United States and England.  Journal of the American Medical Association 295:2037-45.

Banks J, Muriel A, Smith JP. (2010) Disease prevalence, disease incidence, and mortality in the United States and in England.  Demography. 2010;47 Suppl:S211-31.

Ezzati, M., Friedman, A.B., Kulkarni, S.C., and Murray, C.J.L. (2008) The Reversal of Fortunes: Trends in County Mortality and Cross-County Mortality Disparities in the United States.  PLoS Med 5(/4): e66:557-68.

Glymour, M., Avendano, M., and Berkman, L.F.  (2007)  Is the ‘Stroke Belt’ worn from childhood?  Risk of first stroke and state of residence in childhood and adulthood.  Stroke 38: 2415-21.

Glymour, M., Kosheleva, A., and Boden-Albala, B. (2009)  Birth and Adult Residence in the Stroke Belt Independently Predict Stroke Mortality.  Neurology 73: 1858-1865

Murray, C.J.L., Kulkarni, S.C., Michaud, C., Tomijima, N.,  Bulzacchelli, M.T., Iandiorio, T.J.,  and Ezzati, M. (2006)  Eight Americas: Investigating Mortality Disparities across Races, Counties, and Race-Counties in the United States.  PLoS Med 3(9):1513-24.

National Research Council. Explaining Divergent Levels of Longevity in High-Income Countries . Washington, DC: The National Academies Press, 2011.  Authors:

Eileen M. Crimmins, Samuel H. Preston, and Barney Cohen, Editors; Panel on Understanding Divergent Trends in Longevity in High-Income Countries; National Research Council (http://www.nap.edu/catalog.php?record_id=13089  )

National Research Council. International Differences in Mortality at Older Ages: Dimensions and Sources. Washington, DC: The National Academies Press, 2011.  Authors:

Eileen M. Crimmins, Samuel H. Preston, and Barney Cohen, Editors; Panel on Understanding Divergent Trends in Longevity in High-Income Countries; National Research Council  (http://www.nap.edu/catalog.php?record_id=12945  )

Preston, SH and A Stokes (2011) Contribution fo Obesity to International Differences in Life Expectancy.  Amer J Public Health 101: 2137-2143.

Wang, H and Preston, SH. (2009) Forecasting United States Mortality Using Cohort Smoking Histories.  PNAS 106(2): 393-398.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period.  The maximum project period is 5 years.

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


Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization 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.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. 

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

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.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.   

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.   

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.   

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. 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.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Georgeanne E. Patmios, M.A.
National Institute on Aging (NIA)
Telephone: 301-496-3138
Email: PatmiosG@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Lesa McQueen, M.Sc.
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: McQueenL@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

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 Part 52 and 45 CFR Parts 74 and 92.


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