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: National Study of Disability Trends and Dynamics (U01)

Announcement Type
New

Request For Applications (RFA) Number: RFA-AG-08-007

Catalog of Federal Domestic Assistance Number(s)
93.866

Key Dates
Release Date: November 15, 2007
Letters of Intent Receipt Date: December 20, 2007
Application Receipt Date: January 18, 2008
Peer Review Date: June/July 2008
Council Review Date: August 2008
Earliest Anticipated Start Date: September 30, 2008
Additional Information To Be Available Date (Url Activation Date): Not applicable
Expiration Date: January 19, 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

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
      1. Principal Investigator Rights and Responsibilities
      2. NIH Responsibilities
      3. Collaborative Responsibilities
      4. Arbitration Process
  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 Cooperative Agreement (U01) grant applications from applicant organizations that propose to design and conduct a longitudinal, nationally-representative survey of disability trends and dynamics among the U.S. older population residing in community and institutional settings that is linked to Centers for Medicare and Medicaid Services’ (CMS) Medicare claims records.

Background

The multiple dimensions of an individual’s health and functional ability evolve continuously over the course of later life – sometimes gradually, sometimes abruptly, sometimes uni-directional in decline, sometimes in complex patterns of decline and recovery, sometimes with a clearly dominant and identifiable health condition, sometimes with multiple precipitating conditions.  People live with and adapt to their evolving health – applying health interventions, medications, and assistive technologies, as needed; using environmental, social and family support systems, if they help; living independently to the extent they can, and relying on assistive care, both formal and informal, to the extent they need.  Nationally-representative, longitudinal data are needed to help us understand the complexity of health-related conditions as they evolve over the course of later life, and how they relate to functional ability, independence and the use of assistive care at older ages. 

To date, one of the leading resources for studying changes in health and functional status and for tracking health expenditures, Medicare service use, and the availability of personal, family and community resources for caregiving has been the National Long-Term Care Survey (NLTCS) which collected 6 waves of data in 1982, 1984, 1989, 1994, 1999 and 2004.  There are no additional waves of data collection currently planned.  The data are publicly archived at the National Archive of Computerized Data on Aging (NACDA), a component of the Inter-University Consortium for Political and Social Research (ICPSR) at the University of Michigan (see http://www.icpsr.umich.edu/NACDA/welcome.html ). 

RFA Goals

Applicants are invited to offer designs and plans for a longitudinal, nationally-representative study of disability trends and dynamics among the U.S. older population residing in community and institutional settings that is linked to CMS Medicare claims records.  Although applications are limited to a maximum period of five years, study designs should include the potential for a longer term study.  Applicants may propose completely new samples, supplements to existing samples, or may propose to conduct another wave of the NLTCS, or a successor study using the NLTCS sample.  Applicants proposing to continue the NLTCS longitudinal sample in any way are directed to the section below entitled “Special Requirements.”  Applicants are referred to two National Academy of Sciences (NAS) workshops (see http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/ConferencesAndWorkshops.htm ).  While the NAS workshops were convened to discuss the NLTCS specifically, the workshop summaries contain information that is relevant for planning new surveys or supplements to existing surveys as well.  For example, see the section below entitled “General Characteristics of Responsive Applications” which summarizes design and content issues discussed in the workshops.  Proposed studies must detail plans to make the data publicly available (see Section 6).

This solicitation is for study design and conduct of the resulting study.  It is not anticipated that final analyses will be supported by this solicitation.  Funds for analyses are permitted only for the purpose of study development, e.g. data cleaning, validation, pilot questions, etc., and should not delay or hamper public release of the data.  Significant substantive analyses are expected to be conducted under separate grant mechanisms. 

Applicants are encouraged to design a study that: 1) provides estimates of disability rates for 5 year age groups (including ages 85+), and major racial/ethnic groups within the 65+ population; 2) permits analyses of transitions among different living situations and the determinants and consequences of transitions (i.e., disability dynamics); 3) permits estimation of national disability prevalence (by age, racial/ethnic group, physical and cognitive status) that, for the purpose of trend analyses, is as comparable as possible to estimates for previous years from the National Long-Term Care Survey.  Applicants might also consider options to calibrate incidence and prevalence estimates (for analysis) to those from other relevant sources such as the National Health Interview Survey, Medicare Current Beneficiary Survey, Health and Retirement Study, etc.   Applicants will have to balance the desirability of comparability with costs and other constraints, including the development of improved measures of disability.

The broad goals of this RFA are that the awarded survey will:

1.       Facilitate the study of causes and consequences of disability and disability trends.

2.       Facilitate the analysis of disability dynamics and individual pathways to disability at the population level.

3.       Create a database infrastructure of important medical, behavioral, social and environmental risk factors for disability.

4.       Improve the measurement of disability by incorporating additional approaches beyond traditional Activities of Daily Living (ADL)/Instrumental Activities of Daily Living (IADL) measures.

5.       Facilitate the analysis of health disparities. 

6.       Facilitate the comparison of population-level intervention strategies to reduce disability.

7.       Facilitate the analysis of the long term economic impact of changes in functioning on families, personal finances, and on public programs such as Medicare and Medicaid.

8.       Consider coordination of measurement with other social science studies of the aging process.  For example, measurement of cognitive and economic status and other variables might be harmonized with measures in, e.g., the Health and Retirement Study, the Panel Study of Income Dynamics, or the Medicare Current Beneficiary Survey.

Applications are not expected to address all the competing scientific goals evenly.  Applicants are encouraged to balance among these and justify their overall priority and focus. 

General Characteristics of Responsive Applications

1.       The following options for designing a longitudinal, nationally-representative study on disability trends and dynamics among the U.S. older population were discussed at two meetings of the National Academy of Sciences (see meeting summaries at http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/ConferencesAndWorkshops.htm ). 

2.       Convenient access to the data by the scientific community is an important element of this RFA, as are state-of-the-art processes for maintaining the security of sensitive data and sample confidentiality.  Applicants must propose a plan for rapid public release of well-documented and user-friendly research files, and plans for user support and user training.  Applicants should consider successful approaches to the dissemination of large-scale survey data including confidential elements and linked administrative data or geographic detail.  Examples are NACDA or other sites that meet scientific standards of documentation, openness and access (e.g., the Health and Retirement Study, Panel Study of Income Dynamics, Wisconsin Longitudinal Study, etc.), while scrupulously safeguarding confidentiality.  The plan for dissemination of publicly-available data must be justified in the application.  Applicants are also referred to Section 6. 

3.       Prior to award, a Data Safety and Monitoring Board, whose purpose will be to monitor the study and advise NIA, will be established.  Scientific experts and representatives of relevant federal agencies will be appointed to the DSMB prior to the award by NIA. 

4.       After award, the study should appoint an advisory panel, made up of experts in the scientific community, to broadly advise the PD/PI throughout the survey design and implementation process.  Names of advisory group members should not be given in the application; rather, guidelines for how they will be selected (e.g., what substantive areas would be covered) should be briefly discussed in the application.  Potential advisory group members should not be approached until after the application has undergone peer review and the application is awarded.  If desired, funds may be requested for this activity in the application (see Section VI.2, Administrative and National Policy Requirements).  

5.       A timeline for the development of the proposed survey, data collection, and public use file production is required in the budget justification section of the application.

6.       Limited funds for analyses are permitted for the purpose of study development only, e.g. data cleaning, validation, pilot questions, preparing for future waves, etc., and substantive analyses of major outcomes should not delay or hamper public release of the data.  A timeline for making the data publicly available must be proposed.  Substantive analyses are expected to be conducted under separate grant mechanisms. 

References

Summaries of two National Academy of Sciences expert meetings on the future of the NLTCS.  http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BehavioralAndSocialResearch/ConferencesAndWorkshops.htm  

Freedman VA, Schoeni RF, Martin LG, Cornman JC.  Chronic conditions and the decline in late-life disability. Demography. 2007 Aug;44(3):459-77.

Manton KG, Gu X, Lamb VL.  Change in chronic disability from 1982 to 2004/2005 as measured by long-term changes in function and health in the U.S. elderly population.  Proc Natl Acad Sci U S A. 2006 Nov 28;103(48):18374-9. Epub 2006 Nov 13.

Freedman VA, Martin LG, Shoeni RF.  Recent trends in disability and functioning among older adults in the United States: a systematic review.  JAMA.  2002.  288(24):3137-46.

Special Requirements

Applicants who wish to propose conducting additional waves of the NLTCS or a successor study using the NLTCS sample must budget for a sub-contract with Duke University.  Due to consent agreements under which NLTCS participants were solicited in the 2004 wave, access to identifiable information about panel members is restricted to Duke University.  Therefore, Duke University has agreed to collaborate with any awardee who proposes using the NLTCS sample.  Minimally, this collaboration is for the purpose of reconsenting previous survey respondents to permit reinterview by a different institution.  Thus, Duke University collaboration is minimally required only until the reconsent process for the next wave, and any data transfers, are complete. 

When developing the informed consent procedures for the next wave of the NLTCS, applicants must consent panel members in a manner that protects their confidentiality, but that permits their identifiable information to be released from Duke University to the applicant for the purpose of conducting the proposed survey.  In addition, consent must be obtained to permit panel members’ identifiable information to be transferred to another institution at a later date, should another institution in the future (not the applicant) be authorized to continue the study.  In the Protection of Human Subjects section of the Research Plan, applicants should specify their proposed informed consent form and procedures and discuss how they propose to handle cases that decline to consent or that consent to be surveyed by the applicant but do not consent to have their identifiable information transferred to another institution at a later time. 

Applicants should not contact Duke University to negotiate directly regarding budget or scope of work.  Applicants wishing to use the NLTCS sample in any way should budget for one-year estimated funds of $862,000 in Total Costs to Duke University.  This includes an estimated $162,000 in costs to Duke University (which will negotiate necessary reconsenting agreements with Duke University’s Institutional Review Board, the Census Bureau, the Centers for Medicare and Medicaid Services, the Research Data Assistance Center (ResDAC), and the Office of Management and Budget) and an estimated $700,000 in costs to the data collection organization Duke University contracts with to obtain the NLTCS sample person’s consent for Duke University to release their records for use in subsequent rounds of the survey.  These are estimated costs only and the final budget will depend on whether or not an “opt-out” or “opt-in” approach for reconsent is used.  These total estimated costs include any data transfers required.  Depending on the design proposed, the estimated costs may or may not be merged with the full costs of the next interview wave.  In other words, if applicants propose using the same data collection agent as the one contracted by Duke University to conduct the reconsenting operation, the estimated $700,000 for reconsenting would be merged with costs for data collection, and it would be possible to combine reconsenting with the next wave of data collection.  If applicants propose another survey organization for the data collection, the estimated $700,000 would be just for the reconsenting procedure and the next wave of data collection would be done separately from the reconsenting.

Historically, the US Census Bureau has served as the data collection agency for the NLTCS.  Applicants who wish to use the Census Bureau as the data collection agency for the next interview should contact the NIA Scientific/Research Contact named in Section VII.

After a funding decision is made, and if the award requires NLTCS identifiable information, final budgets will be decided after direct negotiations among the selected awardee, Duke University, and the NIA.  Also, NIA must approve the proposed informed consent form and procedures prior to award.

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 Cooperative Agreement (U01) award mechanism.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award". NIA does not expect to reissue this FOA.  The successful applicant is encouraged to apply for competing supplements and/or competing renewals for subsequent waves of data collection/data processing using the U01 mechanism. 

2. Funds Available

The nature and scope of the proposed research will vary from application to application.  The size of the expected award is not fully determined at this time (see “Special Requirements”).  The duration of the award is 5 years.  Although the financial plans of the National Institute on Aging provides support for this program, the award pursuant to this funding opportunity is contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

The National Institute on Aging intends to commit approximately $2.4 - $3.6 million direct costs in FY2008 to fund one application.  The total cost budget over the 5 year grant period is expected to range from $12 - $18 million direct costs. 

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.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004. 

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

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 NIH Grants Policy Statement. 
The most current Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

A PD/PI may submit only one application to this FOA.   

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 on line 2 of the face page of the application form and the YES box must be checked.

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
Letters of Intent Receipt Date: December 20, 2007
Application Receipt Date: January 18, 2008
Peer Review Date(s): June/July 2008
Council Review Date: August 2008
Earliest Anticipated Start Date: September 30, 2008

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 at the beginning of this document.

The letter of intent should be sent to:

Georgeanne E. Patmios, M.A.
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, appendix material and five signed photocopies of the application in one package to:

Center for Scientific Review (CSR)
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).

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Institute on Aging.Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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 competing continuation award if such costs: are necessary to conduct the project, and 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 competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Not applicable. 

Plan for Sharing Research Data

This FOA requires a data sharing plan for the storage and dissemination of publicly-available and user-friendly data for research use.  The precise content of the data-sharing plan will vary.  Applicants are expected to describe the expected schedule for data sharing, appropriate data cleaning, file construction, the documentation to be provided, whether or not any analytic tools also will be provided, special protections for linked administrative data and data with geographic identifiers, and procedures to safeguard confidentiality.  Applicants should consider successful approaches to the dissemination of large-scale survey data such as the National Archive of Computerized Data on Aging (NACDA) or other sites that meet scientific standards of documentation, openness and access (e.g., the Health and Retirement Study, Panel Study of Income Dynamics, Wisconsin Longitudinal Study, etc.).  The plan for dissemination of publicly-available data must be justified in the application.  If a continuation of the NLTCS is proposed, the data sharing plan should describe how the 1982-2004 files will be incorporated.  Applicants should also describe their track record of producing timely and user-friendly public-use data files from prior data collection activities.

This FOA also requires that the data sharing plan describe plans to service user requests and for appropriate data user training workshops.

The data sharing policy is available at http://grants.nih.gov/grants/policy/data%5Fsharing/ .

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

Not applicable. 

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

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?

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? 

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)? Has the PD/PI successfully directed and managed large-scale, complex longitudinal studies?  Is the PD/PI a recognized leader in the scientific areas proposed?  Do the PD/PI and the proposed data collection agency have a positive record of producing and disseminating timely and user-friendly public data files?  Does the proposed data collection agency have a record of producing high quality data and achieving high response rates?

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?

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 priority score:

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 E on Human Subjects in the PHS Form 398).

Inclusion of Women and Minorities in Research: The adequacy of plans to include subjects from both genders and all racial and ethnic groups (and subgroups), as appropriate for the scientific goals of the research,  will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

2.B. Additional Review Considerations

Data Sharing Plan: Is the data sharing plan sound and innovative, in terms of quality and timeliness?

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. Sharing Research Data

This FOA requires a data sharing plan for the storage and dissemination of publicly-available and user-friendly data for research use.  Applicants are expected to describe the expected schedule for data sharing, appropriate data cleaning, file construction, the documentation to be provided, whether or not any analytic tools also will be provided, special protections for linked administrative data and data with geographic identifiers, and procedures to safeguard confidentiality.  Applicants should consider successful approaches to the dissemination of large-scale survey data such as the National Archive of Computerized Data on Aging (NACDA) or other sites that meet scientific standards of documentation, openness and access (e.g., the Health and Retirement Study, Panel Study of Income Dynamics, Wisconsin Longitudinal Study, etc.).  The plan for dissemination of publicly-available data must be justified in the application.  If a continuation of the NLTCS is proposed, the data sharing plan should describe how the 1982-2004 files will be incorporated.  Applicants should also describe their track record of producing timely and user-friendly public-use data files from prior data collection activities.

This RFA also requires that the data sharing plan describe plans to service user requests and for appropriate data user training workshops.

The data sharing policy is available at http://grants.nih.gov/grants/policy/data%5Fsharing/.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers.  However, reviewers will not factor the proposed data sharing

plan into the determination of scientific merit or the priority score.

2.D. Sharing Research Resources

Not applicable.

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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.

2. Administrative and National Policy Requirements

NIA must approve the proposed informed consent form and procedures prior to award.

A Data Safety and Monitoring Board (DSMB) whose purpose will be to monitor the study and advise NIA will be established prior to award.  The NIA will appoint independent scientific experts and representatives of relevant federal agencies to a DSMB prior to award and the final choice of membership will be the NIA’s. 

After award, the study should appoint an advisory panel, made up of experts in the scientific community and not connected with the study except in this capacity, to advise the PD/PI throughout the survey design and implementation process.  The DSMB will report to the NIA and to the study’s advisory panel.  Names of advisory group members should not be given in the application; rather, guidelines of how they will be selected (e.g., what substantive areas would be covered) should be discussed in the application.   Also, potential advisory group members should not be approached until after the application has undergone peer review.  If desired, funds may be requested for the advisory panel (Also see below, 2.A.3., Collaborative Responsibilities).

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. 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 administrative and funding instrument used for this program will be the cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2.A.1. Principal Investigator Rights and Responsibilities


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 Data Use Agreements with the Centers for Medicare and Medicaid Services and other administrative data as required, and maintaining ownership over data collected.  The awardee agrees to accept assistance from the designated NIH/NIA Project Scientist in aspects of the scientific and technical management of the study and in coordinating with other Federal agencies (see below under 2.A.2., NIH Responsibilities and 2.A.3., Collaborative Responsibilities).

After award, the PD/PI should appoint an advisory panel, made up of experts in the scientific community, to advise the PD/PI throughout the survey design and implementation process (also see below under  2.A.3., Collaborative Responsibilities). 

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NIH/NIA project scientist will provide assistance to the PD/PI and project team in coordinating survey design and operations with participating federal agencies.  If the awardee will continue the NLTCS, the NIA role will additionally include coordination among the awardee, Duke University and the contractor selected by Duke University for the purposes of reconset. 

The NIH/NIA project scientist will serve as a nonvoting member of the advisory panel appointed by the PD/PI and will provide assistance in establishing, and in providing operational support for, the federal coordinating group described under 2.A.3., Collaborative Responsibilities.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The program official will also monitor the progress of the data sharing plan. 

2.A.3. Collaborative Responsibilities

In addition to the Advisory Panel to be selected by the PD/PI, the PD/PI, the NIH/NIA Project Scientist, relevant sub-contractor organizations, and representatives of participating federal agencies will meet as a federal coordinating group at least twice during the first year of the award and at least once a year in subsequent years. Meetings of the federal group may be coordinated with meetings of the external advisory group. The federal group will exchange information on data needs, data collection, data quality, available federal resources and methodological issues.

2.A.4. Arbitration Process

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 arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Advisory Panel chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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, M.A.
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:

Not applicable

3. Financial or Grants Management Contacts:

Ms. Deborah Stauffer
Grants and Contracts Management
National Institute on Aging
Gateway Building, Suite 2N212
Bethesda, MD  20892-2292
Telephone: (301) 496-1472
Fax: (301) 402-3672
Email: StauffeD@nia.nih.gov    

Section VIII. Other Information


Required Federal Citations

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).

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 factor the plan into the determination of the scientific merit or the priority score.

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 public 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.

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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).

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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