and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute on Aging (NIA) |
|
Funding Opportunity Title |
National Institute on Aging: Revision Requests for Active Alzheimer's Disease Centers (P50) |
Activity Code |
P50 Specialized Center |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PA-12-170 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.866 |
Funding Opportunity Purpose |
The National Institute on Aging invites Revision applications (formerly called competing supplements) to ongoing NIA-supported Alzheimer's Disease Centers (P50) in order to expand the scope of the existing award. Revision applications should include proposal of a new core or project. Revision applications may not request support beyond the end date of the Parent P50 award. |
Posted Date |
April 20, 2012 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
June 19, 2012 for the first receipt date and Standard dates apply thereafter |
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 |
(Now Expired August 23, 2013 per NOT-AG-13-018), Originally May 8, 2015 |
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.
Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.
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
The National Institute on Aging (NIA) invites current NIA Alzheimer's Disease Center directors to submit revision applications to expand the scope of the current award. The proposed topic must both be related to the current focus of the Center and be relevant to the mission of the Center Program and the National Institute on Aging. The revision may propose to create new cores and/or projects. Revision applications should be submitted as appropriate to the science being proposed. So, for example, if two different ideas are being considered then they should be submitted as two different revisions. On the other hand, if a single concept spans several cores or projects then that concept should be submitted as a single revision. Projects may focus on areas such as preclinical etiology, genetics, pathogenesis, epidemiology, diagnosis, therapeutic interventions including small scale clinical trials, patient management, and caregiver issues. Projects that are translational, focusing on drug discovery or preclinical drug development for AD or other neurodegenerative diseases are also encouraged. These may focus on: validation of new therapeutic targets, development of new assays or animal models, screening of candidate compounds or acquisition of preliminary preclinical efficacy data. A project should be similar in quality to small R01 grants and subprojects of program project grants. A core would augment or enhance the present capabilities of investigators using center resources to make possible new activities at the center itself as well as for other grants affiliated with the center. There should be a detailed discussion of the project(s) that will use resources of an additional core. Some examples of research support that core components could provide are: (1) development of tools and/or technologies used for therapy development; (2) imaging; (3) tissue and/or cell culture facilities; (4) complex instrumentation, e.g., electron microscopy, mass spectrometry, electrophysiology; (5) sequencing or microarray facilities; (6) transgenic animal or cell preparation; (7) genetics; and (8) caregiving.
A revision application may be submitted only after the Parent P50 project has been funded.
Funding Instrument |
Grant |
Application Types Allowed |
New Revisions The OER Glossary and the PHS398 Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. |
Award Budget |
Application budgets are not limited, but need to reflect actual needs of the proposed project. |
Award Project Period |
The maximum period of support is limited by the time remaining on the Parent award and 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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign 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.
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.
This FOA is limited to Directors of currently funded NIA Alzheimer's Disease Research Centers. Multiple principle investigators/program directors are not allowed on NIA Alzheimer's Disease Center grants (P50).
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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.
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.
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:
Ramesh Vemuri. Ph.D.
National Institute on Aging
7201 Wisconsin Avenue, Room 2C-212
Bethesda, MD 20892-9205
Tel.: 301-496-9666
Email: [email protected]
All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
Introduction to the Entire Revision Application
Note that a single Introduction to the entire application is allowed whether or not the revision application is requesting multiple new cores and/or projects or a single core or new project.
Note on Resubmissions: Follow PHS 398 instructions to mark changes in the text from the prior version. If the structure of cores and projects has changed identify the cores and projects consecutively (numbers/projects, letters/cores) according to how they are arranged in the current application. Show the correspondence to the prior structure.
Resubmitted Revisions: Introduction (1 page): Provide an overview of major changes in the application. If cores or projects have been deleted or added indicate that here and explain the changes under Significance (below).
All Applications: Introduction (1 page): The Introduction should provide an overview of how the revision relates to the funded award. Identify whether new projects and cores are being proposed. Revision applications must contain at least one core or project which should be new in order to be accepted. Revision applications that contain only changes to projects or cores will not be accepted for review. However, if a new project requires a minor change in an existing core so it can better support the new project, this will be allowable.
Specific Aims (1 page): Describe how the aims of the revision application extend the aims of the Center.
Research Strategy (12 pages):
1. Significance: Focusing on the revision as a whole address (i) the importance of the problem or critical barrier to progress in the field that the proposed revision addresses, (ii) how the revision will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields, (iii) how the outcomes of the Center will be enhanced by the proposed work on this revision. (One to two pages recommended).
2. Innovation: Considering the revision 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 in the parent grant? (One page recommended.)
3. Approach: Describe progress on the funded award that is relevant to the aims of the revision and any overall change in approach or new approach proposed in the revision application. Show how the approaches of proposed projects and cores complement each other and the parent grant. Describe the mechanisms that will ensure the coherence of the overall Center and maintain a multidisciplinary focus. (Three to four pages recommended.)
How to Organize Projects:
Introduction (Resubmitted revisions only) (1 page): The introduction should be a summary response to the global concerns expressed about the project.
Specific Aims (1 Page): Follow instructions in the PHS 398 form.
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.
How to Organize Cores
Introduction (Resubmitted revisions only) (1 page): The Introduction should be a summary response to the global concerns expressed about the core.
Specific Aims (1 page): Identify which Center projects or other research project grants the core will assist and indicate the overall role of the core both in the revision and in the parent center.
Research Strategy (6 pages): Organize the Research Strategy into sections on: a. Significance; and b. Approach
Note on Resubmitted revisions (Projects and Cores): All changes in the Specific Aims and in the Research Strategy must be clearly marked by bracketing, indenting, or changing type font, unless the changes are so extensive that they include most of the text. Deleted sections should be described but not marked as deletions. This exception should be explained in the overall Introduction. Changes should not be underlined or shaded and should meet the 12-page or six page limit.
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.
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
Not applicable.
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.
Applications must be received 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.
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 requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS398 Application Guide.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:
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
revision considered as a whole to exert a sustained, powerful influence on the
research field(s) involved, considering the following five core 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 revision advances the aims of the parent center grant. The criteria below will guide their assessment of the overall impact of the revision 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 project will exert a sustained, powerful influence on the research field involved 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 revision 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 core or 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 revision address an important problem or a critical barrier to progress in the field? If the aims of the core or 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 work proposed? 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 revision 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 revision?
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 revision?
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 revision 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 core or 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 core or project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the Center.
Renewals
Not applicable.
Revisions
For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the Center. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.
As applicable for the research 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 and (assignments will be shown in the eRA Commons) in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned 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:
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.
Not Applicable.
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: [email protected]
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: [email protected]
Creighton Phelps, PhD
National Institute on Aging
Tel.: 301-496-9350
Email: [email protected]
Ramesh Vemuri, Ph.D.
National Institute on Aging
Tel.: 301-402-7700
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Ms. Deborah Stauffer
National Institute on Aging
Tel.: 301-496-1472
Email: [email protected]
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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