Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute on Aging (NIA)
Funding Opportunity Title	Limited Competition: Alzheimer's Disease Cooperative Study (U19)
Activity Code	U19 Research Program Cooperative Agreement
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-AG-13-001
Companion FOA	None
Number of Applications	See 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 Alzheimer's Disease Cooperative Study (ADCS) as the pre-eminent Alzheimer's disease (AD) clinical trials consortium. The purpose of this FOA is to solicit the renewal application for the next 5-year cycle of the ADCS.  The goals of this next phase are to continue to advance research in the development of interventions that might be useful for treating, delaying, or preventing AD, particularly interventions that might not be developed by industry.

Posted Date	November 28, 2011
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	March 7, 2012
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June - July 2012
Advisory Council Review	October 2012
Earliest Start Date(s)	December 1, 2012
Expiration Date	March 8, 2012
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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.

Part 1. Overview Information
Part 2. Full Text of 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

Background

The Alzheimer's Disease Cooperative Study (ADCS; see http://adcs.org/) was initially funded in1991 as a cooperative agreement between the NIA and the University of California, San Diego (UCSD) in response to the need to advance research in the development of interventions that might be useful for treating patients with AD, particularly interventions that might not be developed by industry. These include testing interventions to improve cognition, slow the rate of decline, or delay the appearance of AD; developing studies for promising interventions designed to ameliorate behavioral symptoms; designing new instruments for use in clinical studies; developing novel and innovative approaches to AD clinical trial design and analysis; expanding the range of impairment level of patients studied in AD studies; and enhancing the recruitment of minority groups into AD studies. The ADCS was funded in response to RFA-AG-91-10 and the currently funded investigators have developed the ADCS into the pre-eminent AD clinical trials consortium in the U.S. There are currently 35 consortium member sites and more than 50 participating sites, as well as productive and efficient Administrative, Data, Clinical Operations, Medical, Imaging, and Biomarker Cores based at UCSD. There has been widespread sharing of assessment tools, trial methods, and data with investigators around the world.

Since 1991, the ADCS has initiated 30 research studies: 23 drug studies (Phase I-III) and 7 instrument development protocols. In addition to conducting its own studies, the ADCS provides infrastructure support to other federally funded clinical research efforts, including the Alzheimer's Disease Neuroimaging Initiative (ADNI), the Dominantly Inherited Alzheimer Network (DIAN), and investigator initiated R01 trials such as Nerve Growth Factor (NGF) gene therapy trial. The number of participants enrolled has ranged from 9 to 800 people per study with well over 7,000 participants enrolled to date. The ADCS has generated numerous publications and a number of the ADCS trials have had major public health impact. For example, the mild cognitive impairment (MCI) donepezil/vitamin E trial was the first MCI trial and the first trial to demonstrate delay of progression to AD with donepezil treatment. In addition to the MCI trial, other trial design and analysis innovations include the use of brain imaging endpoints in MCI and AD trials, endpoint analyses in AD trials, linear modeling methods, and site performance analysis. Instrument development for AD clinical trials also has been a focus of the ADCS. The ADCS has developed instruments that have been widely used by both academic and industry investigators around the world including the Modified ADAS-cog with the addition of executive functioning and delayed recall; the ADCS-ADL first Activities of Daily Living (ADL) scale specifically developed for AD; the ADCS-MCI-ADL ADL scale for MCI trials; the SIB - Severe Impairment Battery; and the ADCS-CGIC standardized Clinical Global Impression of Change scale. Currently, instruments for home-based assessment for primary prevention trials are under study including mail-in instruments, home computer instruments, and interactive voice response instruments. Data and specimens collected during ADCS studies are shared with external investigators. Data are typically shared by granting temporary access to a study-specific web portal for download of the full data set, data dictionary and supporting documents.

Purpose

The purpose of this FOA is to solicit the renewal application for the next five-year cycle of the ADCS.  The goals of this next phase are to continue to advance research in the development of interventions that might be useful for treating, delaying, or preventing AD, particularly interventions that might not be developed by industry.

Research Objectives

The objectives for the next 5-year cycle of the ADCS are listed below.  The applicants are not expected to address all the research objectives; if all research objectives are addressed, applicants are not expected to address them evenly.  The applicants are encouraged to balance among these and justify their priorities and focus.

Test interventions to improve cognition, slow the rate of decline, or delay/prevent the onset of AD.

Develop studies for promising interventions designed to ameliorate behavioral symptoms.

Design new instruments for use in clinical trials.

Develop novel and innovative approaches to AD clinical trial design.

Develop novel and innovative approaches to AD clinical trial analysis.

Expand the range of individuals studied in AD studies to include at-risk individuals and those with MCI.

Enhance the recruitment of minority groups into AD studies.

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

The applicants should provide a multidisciplinary organization and management structure appropriate for a mature yet constantly innovating clinical trials consortium.

Funding Instrument	Cooperative Agreement
Application Types Allowed	Renewal The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NIA intends to commit up to $13 Million in FY2013. Future year amounts will depend on annual appropriations and will be no more than $55 Million over 5 years.
Award Budget	Application budget is limited to $55 Million in Total Costs.
Award Project Period	The maximum period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

The applicant institution must have the facilities to support multiple cores and to coordinate research at multiple sites both nationally and internationally.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations must complete the following registrations as described in the PHS398 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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• eRA Commons

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

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

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

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.

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

It is critical that applicants follow the instructions in the PHS398 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.

Not Applicable

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

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

At the time of submission, two additional paper copies of the application and all copies of the Appendix files must be sent to:

Dr. Ramesh Vemuri
Chief, Scientific Review Branch.
National Institute on Aging
7201 Wisconsin Avenue Suite 2C212
Bethesda, Md 20892-9205
Telephone: 301-496-9696
Email: VemuriR@nia.nih.gov

All page limitations described in the PHS398 Application Guide must be followed, with the following requirements:

• The Research Strategy Section of the Overall Project Objectives is limited to 6 pages.
• The Research Strategy Section of proposed Cores is limited to 6 pages.
• Each Project Section should be a maximum of 12 pages.

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Section 1: Information for the Entire Application

Form Page 1 - Face Page: Include the number and title of this FOA in item/line 2 of the PHS 398 face page

Table of Contents: Modify PHS Form Page 3 to enable reviewers to find each component of the application easily. Number all pages consecutively. Because the first page of the application is the Title Page begin the next page with the numeral "2". Do not use lettered numbers (e.g., "2A", "2B" etc.) Use these referent numbers in the Table of Contents.

Form Pages 4 and 5 Detailed Budget for Initial Budget Period; Budget for Entire Proposed Period of Support: Prepare a detailed composite budget (across all subprojects and cores) for all requested support categories for the first year using Form Page 4 and a summary budget for the entire proposed period of support using Form Page 5 of the PHS 398 application. If applicable, provide additional budget pages for consortium/contractual arrangements

Biographical Sketches

When an investigator has a role in more than one part of the application then a complete biosketch should be placed in each section where the individual has a role. As the particular qualifications for roles may differ between cores and subprojects or between different subprojects, the selected publications and the description of qualifications for the individual may differ in the several biosketches listed.

Resources

Reviewers will use information from the Resources page to evaluate the quality of the scientific environment for the research proposed. Applicants should complete separate Resources pages for all projects and cores. Reviewers will use information from the Resources page of the Administrative Core to evaluate the quality of the overall environment for the consortium.

Section 2: Overall Program Objectives:

Specific Aims: (limited to one page):  Describe the aims of the overall project and outline how the component projects and cores will contribute to these aims.

Overall Research Strategy: limited to 6 pages.

Items 1, 2 and 3 below are to be included in the six page limit.

1. Significance: Focusing on the project as a whole address (i) the importance of the problem or critical barrier to progress in the field that the proposed project addresses, (ii) how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields, (iii) how the concepts methods, technologies, treatments, services, or preventive interventions that drive this field will be changed if the proposed aims are achieved. (One to two pages recommended).

2. Innovation: Considering the project as a whole, show how the proposed research seeks to shift current research or clinical practice paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions. Are these concepts, approaches, methodologies, instrumentation, or interventions novel to the research field or novel in a broad sense? Does the proposed work refine, or improve, or apply in a new way, the concepts, approaches, methodologies, instrumentation, or interventions proposed?(One page recommended).

3. Approach: Include the major approaches and studies involved in the application showing how the approaches of cores and individual projects complement each other or are inter-dependent. Describe the mechanisms that will ensure the coherence of the overall project and maintain a multidisciplinary focus. (Three to four pages recommended.)

Renewals: Describe findings (with citations) from the prior period of support that are of particular significance to the project as a whole. If cores included in the prior period of support are not part of the current submission describe their progress and explain why they are not included. In addition in the Statement of Overall Program Objectives show the correspondence between the structure of the renewal application and the prior application. (Note: This should also be within the 6 page limit.)

Human Subjects

List the components of the application that involve human subjects and page numbers for the relevant human subjects sections. In other words, it is requested that the applicant list all the page numbers, where human subjects are used, in sequential order.

See PHS Form 398 PHS Form 398 instructions.

Women, Minorities and Children

Describe the composition of the human subjects and the proactive plan to recruit women, minorities, and children (if appropriate). List the page numbers for the relevant Women, Minorities, and Children sections. For most NIA applications involving human participants, a justifiable exclusion for children is that the topic is not relevant to children. See PHS Form 398 instructions.

Section 3: Research Strategies for Individual Cores and Component Projects

How to organize the Layout of the Cores and Component Projects

Present information for each component project and core according to the Table of Contents

List the cores first, identifying multiple cores by consecutive letters (Core A, Core B, etc.)

List individual research projects in the application after the cores, and identify them with consecutive Arabic numbers and titles (project 1, project 2, etc.) Include the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) name, or Core Leader's (CL) name at the upper right-hand corner of each page under the PD(s)/PI(s) name. Begin each component project or core with a new PHS 398 Continuation Page. Do not use the Face Page of PHS Form 398.

Follow instructions in the PHS 398 form with the following exceptions:

Specific Aims: (1 page)

Identify which subprojects the core will assist and indicate the overall role of the core in the program project.

Research Strategy (6 pages)

Organize the Research Strategy into sections on: a. Significance; and b. Approach

Follow instructions in the PHS 398 form with the following exceptions:

Specific Aims: (limited to 1 page)

Research Strategy: (12 pages)

Following Instructions in the PHS 398 form, the Research Strategy should be organized into sections on: a. Significance; b. Innovation; and c. Approach.

All instructions in the PHS398 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 PHS398 Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered on-time is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

This initiative is not subject to intergovernmental review.

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.

Applications must be postmarked on or before the due dates in Part I. Overview Information.

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.

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

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.

For this particular announcement, note the following:

Reviewers will provide an overall impact rating to reflect their assessment of the likelihood for the ADCS renewal considered as a whole to continue to advance research in the development of interventions that might be useful for treating, delaying, or preventing AD, considering the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

They will give weight both to the merits of the individual projects and cores and to the extent to which the renewal advances the aims of the overall project. The criteria below will guide their assessment of the overall impact of the renewal application as a whole. 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.

Projects: Reviewers will provide an impact rating to reflect their assessment of the likelihood that each component project will advance research in the development of interventions for AD considering the five core review criteria below.

Cores: Overall Impact: Reviewers will provide an adjectival rating of high, moderate, or low enthusiasm. Central ("Core") Review Criteria: Reviewers will consider four of the five review criteria below in the determination of scientific and technical merit. As cores are generally resources to enable or to advance research, Innovation is not considered routinely as an independent review criterion for cores. Innovative cores may be valuable and that value will be assessed under Significance or Approach as appropriate.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the ADCS renewal 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 overall project proposed).

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

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the overall 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

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

Approach

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

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

Environment

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

As applicable for the overall 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 overall 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.

As applicable for the overall 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.

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:

• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD(s)/PI(s) 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.

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

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

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.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) 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, 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.

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

• overall management of the study through the coordinating center and should agree to work cooperatively with the cores/functions and clinical sites
• developing and implementing systems necessary for communications among the various study organizational components. The coordinating center will facilitate the design and refinement of all protocols, manuals of operations, and forms.
• all data and samples that shall be placed in the public domain and shared freely by methods and within time periods to be specified by the Steering Committee, as a fundamental purpose of this study is the establishment of an unrestricted public database.
• 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 DHHS, PHS, and NIH policies.

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

• The designated NIA Project Scientist will serve as a member of the Steering Committee and have substantial scientific/programmatic involvement during conduct of this cooperative agreement, through technical assistance, advice, and coordination above and beyond normal program stewardship of grants. The awardee agrees to accept assistance from the designated NIA Project Scientist. This person will participate, through the Steering Committee, in the monitoring of issues relating to recruitment, follow-up, and adherence to protocols and will assist in the development and/or adjustment of study protocols.
• Additionally, an agency program official or NIA program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• The Steering Committee, comprised of the PD(s)/PI(s) of the cooperative agreement, the leaders of the cores/functions and each of the clinical sites, the bioethicist, the family representative, the FDA representative, and the NIA Project Scientist will have primary responsibility for finalizing standard definitions, procedures, and measures common for all the protocols. The steering committee will meet every three to six months, or as dictated by the needs of the study. Each full member of the Steering Committee will have one vote, and all major scientific decisions will be determined by majority vote of the Steering Committee. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee. Subcommittees appointed by the Steering Committee, comprised of appropriate staff from the cores and clinical sites, will be involved in the design of protocols and manuals of operations, and in ongoing functions of the study such as preparation of publications.
• To oversee the allocation and distribution of biological specimens generated from the study, the Steering Committee will nominate members for the Resource Allocation Review Committee (RARC). This group will review applications for use of the biological specimens. The format of the application and criteria for the use of repository biological specimens will be developed by the RARC with advice and approval from the Steering Committee and made available to all potential users. Membership on this committee will rotate periodically according to a procedure developed by the RARC. Final approval of members of the RARC and final approval for disposition of samples to investigators following RARC review will be made by NIA staff. The primary governing body of the study will be the Steering Committee, which will have responsibility for the final details of study design and policy decisions and will define the rules regarding access to data and samples.

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 members will be convened. It will have three members: a designee of the Steering Committee 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 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.

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 the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

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

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

Laurie Ryan, PhD
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: ryanl@mail.nih.gov

Ramesh Vemuri, PhD
National Institute on Aging (NIA)
Telephone: 301-496-9696
Email: VemuriR@nia.nih.gov

Linda Whipp
National Institute on Aging (NIA)
Telephone: 301-496-1472
Email: WhippL@mail.nih.gov

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.

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.