Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Aging (NIA)

Funding Opportunity Title

Limited Competition for the Renewal of the National Cell Repository for Alzheimer's Disease (NCRAD) (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-11-080  

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.866   

FOA Purpose

The National Institute on Aging invites applications to renew an ongoing NIA-supported cooperative agreement, the National Cell Repository for Alzheimer's disease.  

Key Dates
Posted Date
Letter of Intent Due Date

Not Applicable

Application Due Date(s)

February 25, 2011

AIDS Application Due Date(s)

Standard dates apply

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

February 26, 2011

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.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

 The National Institute on Aging (NIA) is requesting submission of a renewal application for a limited competition  for the National Cell Repository for Alzheimer’s Disease (NCRAD).  NCRAD was established in 1990 to recruit, collect, maintain and distribute information and biological specimens on large numbers of genetically informative, phenotypically well-characterized families having multiple individuals affected with AD. Initial efforts were focused on the recruitment of early onset, autosomal dominant families. Subsequently, NCRAD expanded its focus to also include late onset families as well as kindreds with familial non-AD dementia, such as frontotemporal dementia. In 2003, NCRAD became the repository for a large NIA sponsored genetics initiative to expand the collection of families with late onset AD (LOAD Study).  In addition, NCRAD has become the key sample repository for the Alzheimer Disease Genetic Consortium (ADGC), which has led collaborative efforts among US dementia researchers. This consortium also includes the network of NIA-funded Alzheimer's Disease Centers and the National Alzheimer's Coordinating Center (NACC). NCRAD has developed working relationships with all of these entities and future success depends on keeping the relationships together. An important aspect of NCRAD function is to continue to coordinate with NACC and to provided infrastructural support for the ADGC, and other NIA funded genetic studies such as the Late Onset Alzheimer's Disease (LOAD) Family Study, Alzheimer's Disease Neuroimaging Initiative (ADNI), and other multiple and single site studies that involve the collection and banking of biospecimens for genetic research on Alzheimer's disease.

It is expected in the next five-year funding period that NCRAD will expand its scope to ensure that the NIA will have a central biospecimen repository that will meet the needs of genetic research on Alzheimer's disease and related neurodegenerative diseases. NCRAD should be a state-of -the-art central biospecimen repository for samples (DNA,cell lines, plasma, serum, RNA, brain tissue) collected by NIA-funded studies. NCRAD will distribute data and biospecimens to qualified investigators for use in research studies following government guidelines and regulations.

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New
Renewal
The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

One award will be made

Award Budget

Direct costs should not exceed $675,000.

Award Project Period

The maximum period of support may be no more than five years.   

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

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

 Eligibilty is limited to applications from currently active NIA-funded cooperative agreements (U24) with established relationships with the National Alzheimer's Coordinating Center, the network of NIA-funded Alzheimer's Centers and the  NIA-funded Alzheimer's Disease Genetics Consortium.  

Required Registrations

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.

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Project Director/Principal Investigator)

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

 Multiple principal investigators/program directors are not allowed on NIA cooperative agreements.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

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.

Letter of Intent

Not applicable

Application Submission

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

Page Limitations

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

Research Plan

All instructions in the PHS398 Application Guide must be followed.

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 modifications:

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,

Foreign Organizations

 Not eligible

3. Submission Dates and Times

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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

The administrative and funding instrument used for this program is a cooperative agreement (U24), an assistance mechanism (rather than an acquisition mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardees is anticipated during performance of the activity.  Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient’s activity by working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility or a dominant role in the activity.  Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the collaborative aspects will be shared among the awardees and the designated NIA Program Administrators. Further details will be elaborated in the terms and conditions of the award. 

6. Other Submission Requirements and Information

Applications must be postmarkedreceived on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

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

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

Overall Impact

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

Scored Review Criteria

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

Significance

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

Investigator(s)

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

Innovation

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

Approach

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

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

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Resubmissions are not allowed.

Renewals

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

Revisions

Revisions are not allowed.

Additional Review Considerations

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

Applications from Foreign Organizations

Not applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute on Aging  (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

·       Will receive a written critique.

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  . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Aging . The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. . More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable 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 is the U24, an "assistance" mechanism (rather than an "acquisition" mechanism),in which substantial NIH scientific and/or programmatic involvement with the awardees is anticipated during performance of the activities.  Under the cooperative agreement, the NIH purpose is to support and/or stimulate the  ecipient's activities by involvement in and otherwise working jointly with the award recipients in a partnership role.  The NIH purpose 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 awardee for the project as a whole, although specific tasks and activities will be shared among the awardee, the advisory committee, and NIA Scientific Partner.

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

The awardee, as Cell Bank PD/PI, will coordinate project activities

Scientifically and administratively at the awardee institution, and will have primary responsibility for performing all scientific and fee-for-service activities.  The PI agrees to accept the close coordination, cooperation, and participation of the NIA Scientific Partner and Cell Bank Advisory Committee (CBAC) in those aspects of scientific and technical management of the project as described below.

Specifically, the PD/PI will:

Accept and implement the guidelines and procedures related to cell bank operations as approved by CBAC and NIA. 

Design protocols, oversee the provision of services and research resources to the scientific community, and work cooperatively to set project milestones, in consultation with NIA program staff and CBAC.  

Receive biomaterials and data files from the Alzheimer's Disease Centers (ADCs) the National Alzheimer's Coordinating Center (NACC) and other scientists, ascertain that proper informed consent exists for all samples, develop a unique coding system for each sample that de-identifies patient data, and distribute cells, DNA and data files to qualified researchers granted access by criteria set up by CBAC and consistent with NIH data and biomaterials sharing policies. (see below)

Define a protocol detailing the requirements for sharing of genotypic data to a central databank from scientists using cells and DNA obtained from the Indiana Cell Bank.

Maintain a log of Cell Bank usage that records the products and Services provided and the fees charged.

Prior to each non-competing renewal, submit progress reports in a standard format, as agreed upon by NIA and CBAC.  The progress report will describe the activities and accomplishments of the Cell Bank for the preceding award period, and the goals to be accomplished during the renewal period.  The progress report will include the log of Cell Bank usage.  The contents of the progress report will be used by NIA program officer, along with other information, to determine the amount of funding the Cell Bank will receive for the renewal period.

Organize and set the agenda for at least one meeting of CBAC, with additional advisors as appropriate, each year along with teleconferences as needed. The awardee will have one vote on CBAC and will accept any modification, deletion, or addition of Cell Bank activities approved by CBAC and the NIA.  The PI will be responsible for preparing within 30 days a concise summary of each CBAC meeting or teleconference for distribution to participants.

Attend and participate in ADC Director's meetings twice-yearly meetings.

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

The NIA Scientific Partner will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice, and coordination above and beyond normal stewardship.  This includes facilitating the partnership relationship between the NIA and the Cell Bank, helping to maintain the overall scientific balance in the program commensurate with emerging research opportunities, and ensuring that the activities of the Cell Bank are consistent with the scientific mission of the NIA Alzheimer's Disease Genetic Initiative.   Access to research resources maintained in the Cell Bank will be determined by the CBAC with input from NIA and consistent with NIH sharing policy (see below).  The NIA Scientific Partner shall be a non-voting member of CBAC. Other NIA staff involved with the genetics initiative may also attend meetings of CBAC.

Specifically, the NIA Scientific Partner will:

Provide relevant scientific expertise and overall knowledge.

Recruit and select the members of CBAC.  The NIA Scientific Partner with the approval of the Director, Division of Neuroscience, NIA, will also have the responsibility of replacing CBAC members that choose to leave.  The Scientific Partner will consult with the Cell Bank PI, CBAC members, other outside advisors and NIA staff when recruiting CBAC members.

Attend CBAC meetings and assist in developing operating guidelines, quality control procedures, and consistent policies for dealing with recurrent situations that require coordinated action.

Participate with other CBAC members in the group process of setting priorities and milestones, deciding optimal approaches and protocol designs, and contributing to the adjustment of protocols or approaches as warranted.

Serve as administrative liaison to NACC and the ADCs and help coordinate Cell Bank activities with those of the complimentary programs. The Scientific Partner will coordinate Cell Bank activities with the scientific mission and evolving goals of the NIA Alzheimer's Genetics Initiative, with input as required from CBAC and other NIA staff.  The Scientific Partner will also coordinate Cell Bank activities with other US and international efforts that focus on sharing research resources for genetic analyses of complex diseases.

The NIA Program Officer is responsible for normal stewardship of the Cooperative agreement and will:

Serve as program liaison between the Cell Bank and other NIA staff involved in the Genetics Initiative.

Assist in promoting and encouraging the sharing of unique research resources for genetic studies of Alzheimer's disease and other dementias of aging by the scientific community at large.

Retain the option to recommend re-allocating NIA support provided to the Cell Bank, as scientific goals evolve.

Determine the amount of support that will be awarded to the Cell Bank as a non-competing renewal.  The progress report received from the Cell Bank, along with other information, will be used to make this determination.  The criteria used for this decision will include, but not be limited to, Cell Bank productivity e.g.. number of samples banked and distributed, customer satisfaction, and successful performance of the Cell bank in providing services to the genetic research community.

Scientific Oversight - Cell Bank Advisory Committee (CBAC)

The CBAC will meet at least once each year and will oversee Cell Bank Activities to assure that the needs of the broader scientific community for research resources necessary for the genetic analysis of Alzheimer's disease and other dementias of aging are being met.  CBAC will provide oversight of the Cell Bank, and scientific advice to NIA.  CBAC members will provide scientific and operational oversight concerning both long-term developments and distribution activities at the Cell Bank.  CBAC also will consult on the incorporation of emerging genomic and genetic tools and technologies into Cell Bank activities.

The CBAC will consist of approximately 10 scientists including the Director of NACC and the NIA Scientific Partner. CBAC members will be appointed by the NIA Scientific Partner and will be selected for their broad expertise in relevant topics such as molecular biology, molecular genetics, genomics, pharmacogenomics, statistical genetics, epidemiology, bioinformatics, cell and DNA banking, and Alzheimer's genetics.  The NIA will select one member to be CBAC's chair, after considering the PI's and CBAC's recommendations.

Additional CBAC members may be added with agreement between CBAC and the NIA.  The NIA Scientific Partner will attend CBAC meetings as a non-voting member and will act as a representative of NIA.  Other NIA staff involved with the Genetics Initiative will attend the CBAC meetings to help facilitate specific discussions.  The NIA Program Official will consider CBAC opinions with regard to overall Cell Bank functioning and when making determinations for renewal funding.

Dispute Resolution

Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIA may be brought to dispute resolution.  A Dispute Resolution panel will be composed of three members   one chosen by CBAC (with NIA not voting) or by the awardee in the event of an individual disagreement, a second member selected by the NIA, and the third member with expertise in the relevant area who is selected by the two prior selected members.  This special dispute resolution procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16.

Data Sharing

Providing access to data and biomaterials collected in Alzheimer's genetic studies for qualified investigators in the wider scientific community is a guiding principle of the NIA Alzheimer's Genetics Initiative. To address the joint interests of the government in the availability of, and access to, the results of publicly funded research and in the opportunity for economic development based on these results, the NIA expects that the information to be shared will include clinical, diagnostic, and pedigree structure information, in addition to cell lines and DNA. Oversight for this process will be provided by the CBAC and the NIA.

More specifically, it is expected that the Indiana Cell Bank will: (1) establish cell lines, from which DNA will be extracted and stored, for all subjects studied from whom blood samples have been received by the Cell Bank; (2) provide data to qualified investigators related to the clinical phenotype, diagnostic criteria and pedigree structure for cell lines and DNA from the Cell bank; (3) set up mechanisms by which data and biomaterials (DNA samples, cell lines) can be made easily available to qualified investigators in the scientific community; and (4) develop a protocol, together with the NIA, for free and open sharing of these data and biomaterials.

3. Reporting

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

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

Scientific/Research Contact(s)

 Creighton H. Phelps, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: phelpsc@nia.nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

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

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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