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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

Limited Competition: The Health and Retirement Study (U01)

Activity Code

U01 Research Project Cooperative Agreements

Announcement Type

New

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-AG-12-001

Companion FOA

None

Number of Applications

Only one application per institution is allowed, as defined in Section III. 3. Additional Information on Eligibility. Section III. 3. Additional Information on Eligibility.

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

93.866

FOA Purpose

This limited competition FOA is to continue the Health and Retirement Study (HRS) as the pre-eminent resource of publicly-available data for researchers, policy analysts and program planners who are studying and/or making major policy decisions that affect retirement, pensions, health insurance, savings and economic well-being. The purpose of this FOA is to solicit an application for the next 6-year cycle of the HRS. The goals of this next phase are to continue the steady-state longitudinal design for data collection and content; continue innovative sub-studies such as on consumption and time use; enhance content and methods on health, functioning, cognitive status, wealth, pensions, family structure, and psychosocial factors; continue to develop relevant linkages to administrative data; maintain and enhance data distribution and user support; and extend harmonization efforts with internationally comparable surveys of population aging.

Key Dates
Posted Date

April 7, 2011

Open Date (Earliest Submission Date)

May 10, 2011

Letter of Intent Due Date

May 10, 2011

Application Due Date(s)
AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October-November 2011

Advisory Council Review

January 2012

Earliest Start Date(s)

March 1, 2012

Expiration Date

June 11, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.

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

Background

The Health and Retirement Study (HRS; see at http://hrsonline.isr.umich.edu/) began in 1990 in response to the recognition by the research and public policy communities that the Baby Boom and the subsequent fertility decline, coupled with growing life expectancy, would confront America with population aging. This, in turn, would create major challenges for public sector Social Security retirement and disability and Medicare programs, and for private sector employer pensions and health insurance when the Boomers began to retire around 2010. At that time, no existing data system was adequate to provide scientific and policy researchers with the information needed to study the issues that pre-Boomers and Boomers alike would face as they grew old in an aging society. The HRS was funded in response to RFA AG-90-002 and the currently funded investigators have successfully developed the HRS into the pre-eminent resource for researchers, policy analysts and program planners who are studying and/or making major policy decisions that affect retirement, pensions, health insurance, savings and economic well-being. The HRS has a large user community of over 10,000 registered users and there have been 1,762 publications using the data to date. The study has produced valuable information about the determinants of work and retirement, the health and cognitive status of older adults both within the US and in an international comparative context, the relationship between health behaviors and outcomes, and family structure and intergenerational relations. Many findings have implications for public programs such as Medicare and Social Security. The HRS has also become a model for surveys in more than 30 countries around the world; thus, it is key to NIA initiatives on international comparative research on aging and relevant to the NIH Common Fund initiative on Global Health.

The HRS has produced 9 waves of publicly available data and the 10th wave of data collection is in process. The HRS began in 1992 as a single cohort study focusing on people ages 51-61 at baseline, and their spouses, who received longitudinal follow-up interviews at two year intervals. The HRS was augmented with additional cohorts in 1993 (AHEAD, born 1923 and earlier) and 1998, and thus transitioned into a steady state design that represents the entire US population 51 and older (N~20,000). The steady-state design calls for refreshment every six years with a new six-year birth cohort of 51-56 year olds. This was done in 2004 with the Early Baby Boomers (b. 1948-53) and in 2010 with the Mid Boomers (b. 1954-59) who were identified from a population screening done in 2004.

The HRS was designed to provide a rich longitudinal dataset for the community of scientific and policy researchers who study the health, economics and demography of aging. Over time the HRS has become a uniquely multidisciplinary study, collecting data in the domains of income, work, assets, pension plans, health insurance, family structure, disability, physical health and functioning (including biomarkers, DNA, anthropometric and physical performance data), cognitive functioning, psychosocial factors, and health care expenditures. The study has also been used as a sampling frame to support several sub-studies on dementia, consumption and time use, parents human capital investments in children, diabetes management, and internet interviewing among others. A critical feature of the HRS is the commitment to data dissemination and user support. Public use data products are made available as quickly as possible through online dissemination at http://hrsonline.isr.umich.edu/ , and the HRS creates linkages of sensitive administrative data (such as Social Security earnings and benefit records, Medicare utilization and diagnostic records, employer pension records, geographic information, and National Death Index information) to the HRS survey data set that are available as restricted data files. The HRS administers a restricted data protection protocol to ensure that sensitive data is securely stored and used only for research purpose. Another critical feature is that the design and execution of the survey have involved the active participation of a large number of scientists from a broad array of disciplines including economics, sociology, demography, psychology, and medicine from both domestic and international institutions.

Purpose

The purpose of this FOA is to solicit an application for the next six-year cycle of the HRS. The goals of this next phase are to continue the steady-state longitudinal design for data collection and content; continue innovative sub-studies such as on consumption and time use; enhance content and methods on health, functioning, cognitive status, wealth, pensions, family structure, and psychosocial factors; continue to develop relevant linkages to administrative data; maintain and enhance data distribution and user support; and extend harmonization efforts with internationally comparable surveys of population aging. Applicants are not expected to address all the scientific goals evenly and are encouraged to balance among longitudinal continuity of design and methods, scientific innovation, and other constraints.

Research Objectives

The objectives for the next 6-year cycle of the HRS are listed below. Applicants are not expected to address all the research objectives; if all research objectives are addressed, applicants are not expected to address them evenly. Applicants are encouraged to balance among these and justify their priorities and focus.

Applicants are not expected to address all the competing scientific goals and research objectives evenly. Applicants are encouraged to balance among these and justify their priorities and focus.

Applicants should provide a multidisciplinary organization and management structure appropriate for a mature yet constantly innovating study. The management structure must continue to include the active involvement of the NIA Data Monitoring Committee as described in Section VI. 2, Cooperative Agreement Terms and Conditions of Award.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

Renewal

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIA intends to commit up to $11.5 Million Direct Costs in FY2012 for one award.

Award Budget

NIA intends to award up to $11.5 Million Direct Costs in FY2012.

Award Project Period

The maximum project period is six 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

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Eligible organizations must have: 1) significant experience as social science survey and research organizations; 2) the infrastructure to design and conduct major national and longitudinal sample surveys in the social sciences; and 3) access to the identifiable information about HRS panel members in order to continue the longitudinal steady state design described above.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (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/PIs) 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 four (4) 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/Principal Investigator (PD/PI) 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 SF 424 (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 only one application per institution.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

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.

Letter of Intent

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.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Georgeanne E. Patmios
Division of Behavioral and Social Research
National Institute on Aging
7201 Wisconsin Avenue, Suite 533
Bethesda, MD 20892-9205
Telephone: 301-496-3138
Fax: 301-402-0051
Email: PatmiosG@mail.nih.gov

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 application submission. 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, with the following exceptions or additional requirements:

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 modifications:

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, with the following modifications:

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of 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 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 SF 424 (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/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Central Contractor Registration (CCR). 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIA Referral Office by email at {VemuriR@mail.nih.gov} when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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/priority 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/PIs, 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? Does the application strike the right balance between innovation and the need to maintain longitudinal consistency in the questions, measures and methods?

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? Are the plans for study design, data acquisition and data management appropriate? Are the plans and protocols for distributing and protecting data appropriate?

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/priority 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

Not Applicable

Renewals

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

Revisions

Not Applicable

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/priority score.

Applications from Foreign Organizations

Not Applicable

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) convened by the National Institute on Aging (NIA) , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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 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, CCR 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 [Part 92 is applicable when State and local Governments are eligible to apply], and other HHS, PHS, and NIH grant administration policies.

The PD(s) PI(s) will have the primary responsibility for:

The Principal Investigator will have the primary responsibility for the design and details of the study, and will retain primary responsibility for performance of the activity including analyzing and publishing results, negotiating required Restricted Use Agreements with the Centers for Medicare and Medicaid Services, Social Security Administration, Internal Revenue Service, Department of Labor, and other administrative data as required, and maintaining ownership over data collected. The awardee agrees to accept assistance from the designated NIH/NIA Program Official and Project Scientist in aspects of the scientific and technical management of the study and in coordinating with other Federal agencies.

After award, the PD/PI should work with the existing Executive Committee, made up of the study’s co- Investigators group plus experts in the scientific community and who are not connected with the study except in this capacity, to advise the PD/PI on the overall scientific and financial management of the study and on the recruitment of new investigators which is critical to the future of this already long-running study. The Executive Committee should continue to liaise with the NIA Data Monitoring Committee described below.

The Awardee will retain custody of and have primary rights to the data and software developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An NIH/NIA Project Scientist, Dr. John W.R. Phillips of the NIA Division of Behavioral and Social Research, will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. The NIH/NIA Project Scientist will assist in the following areas: refining study objectives, methodologies, and survey instruments; exploring the use of alternative sampling frames; developing record linkages with administrative files maintained by other federal agencies; coordinating the study with other surveys (nationally and internationally) of the older population in order to enhance the capacity for comparative analyses; initiating and maintaining collaborative relationships with relevant federal agencies and other groups; and analyzing and publishing the results of the study.

Additionally, an agency Program Official, Ms. Georgeanne E. Patmios of the NIA Division of Behavioral and Social Research, will be responsible for the normal scientific and programmatic stewardship of the award. The NIA Program Official will approve all major stages of the study and all new major additions/changes to content and methods. In addition, this individual will assist in initiating and maintaining collaborative relationships with relevant federal agencies. Prior approval is required by the NIA Program Official for any replacements of key personnel or other changes in subcontracts.

In order to ensure that the HRS achieved NIA assistance objectives under the cooperative agreement, NIA established and appointed members to a Data Monitoring Committee (DMC) comprised of NIA staff, study investigators, representatives from relevant federal agencies, and independent scientific experts in areas appropriate to the multidisciplinary content areas of the HRS. The NIA will retain the existing Data Monitoring Committee whose purpose is to provide expert independent advice to the NIA and HRS Principal Investigator on the successful implementation of the study. Experts, including but not limited to the Principal Investigator, co- Investigators, NIA staff, and invited independent experts, will make presentations to the DMC on scientific and administrative issues regarding the development and implementation of study aims. Both the NIA Program Official and the PI may request the DMC’s advice on specific issues. The NIA Program Official and the HRS investigators will consider the recommendations of the DMC regarding implementation of study aims as well as additions or changes to content and methods during the execution of the cooperative agreement. The DMC will report to the NIA and it will communicate specific advice to the NIA regarding funding priorities for the HRS via executive sessions of DMC meetings. The DMC will also, where appropriate, provide advice and recommendations to the study s Principal Investigator and Executive Steering Committee; this advice is not binding on the Principal Investigator who retains primary responsibility for the scientific direction and implementation of the study. New DMC Chair and members will be appointed by NIA when necessary.

Areas of Joint Responsibility include:

None; all responsibilities are divided between the awardee and NIH staff as described above.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three academic members who are not involved in the study will be convened. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, 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.

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 301-710-0267
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
National Institute on Aging (NIA)
Telephone: 301-496-3138
Email: PatmiosG@mail.nih.gov

Peer Review Contact(s)

Ramesh Vemuri, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9666
Email: VemuriR@mail.nih.gov

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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