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

NIA Program Project Applications (P01)

Activity Code
P01 Research Program Projects
Announcement Type

New

Related Notices

  • July 2, 2013 - This PAR has been expired and reissued as PAR-13-258.
  • April 24, 2013 - See Notice NOT-AG-13-008. Notice of Correction to Advisory Council Review Dates and Earliest Start Dates.
  • April 19, 2012 - See Notice NOT-AG-12-008. National Institute on Aging (NIA): Introducing a September 25 submission date for Program Project Application Resubmissions (P01).

Funding Opportunity Announcement (FOA) Number

PAR -11-066

Companion FOA

PAR -10-284, National Institute on Aging:Revision Requests for Active Program Projects (P01)

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 the submission of investigator-initiated  program project (P01) applications. The applications may address scientific areas relevant to the NIA mission.    Each P01 submitted in response to this FOA must include at least three related research projects that share a common central theme, focus, and/overall objective.

Key Dates
Posted Date
Letter of Intent Due Date

Not applicable

Application Due Date(s)

January 25, 2011, January 25, 2012, January 25, 2013; May 25, 2011, May 25, 2012, May 25, 2013

AIDS Application Due Date(s)

May 7, 2011, May 7, 2012, May 7, 2013 and September 7, 2011, September 7, 2012, September 7, 2013

Scientific Merit Review

June – July 2011, June – July 2012, June – July 2013; October - November 2011, October - November 2012, October - November 2013

Advisory Council Review

October 2011, October 2012, October 2013; January 2011, January 2012,January 2013

Earliest Start Date(s)

December 2011, December 2012, December 2013; April 2011, April 2012, April 2013

Expiration Date

(Now Expired July 2, 2013 per issuance of PAR-13-258) , Originally September 8, 2013

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: As part of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, seehttp://grants.nih.gov/grants/guide/notice-files/NOT-OD-06-035.html. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html).

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

1. Research Objectives

Background

The National Institute on Aging (NIA) invites applications for Program Project Grant (P01) awards in areas relevant to its mission. These include: Genetic, biological, clinical, behavioral, social, and economic research related to the aging process, diseases and conditions associated with aging, and other special problems and needs of older Americans.

Program project awards represent synergistic research programs that are designed to achieve results that cannot be attained by investigators working independently. They consist of at least three subprojects and an administrative core all of which are active through all years of the program project.

Purpose

This Funding Opportunity Announcement (FOA), issued by the NIA, invites Program Project applications (P01) that address the mission of NIA as outlined in the Background section above. This FOA continues the Program Project funding opportunity as previously detailed and structured in http://www.nia.nih.gov/GrantsAndTraining/Policies/ProgramProjectPoliciesandGuidelines.htm . Investigators are encouraged to visit the NIA website for additional information about the research mission and high-priority research areas of the NIA at http://www.nia.nih.gov/GrantsAndTraining/PrioritiesandPrograms/ )

The purpose of Program Project (P01) grants is to support integrated, multiproject research programs that have a well-defined, central research focus or objective. The P01 is a confederation of interrelated research projects, each capable of standing on its own scientific merit but complementing one another.  The P01 application must include a minimum of three individual research projects that contribute to the program objective.  Each individual research project should reflect a distinct, separate, scientifically meritorious research effort led by an independent investigator, the project leader. In addition, the individual projects should be clearly interrelated and synergistic so that the research ideas, efforts, and outcomes of the program as a whole will offer a distinct advantage over pursuing the individual projects separately.  The program project must also include an administrative core to manage day-to-day activities across the program project, communications among project and core leaders, contractual activities (if any), and other overall program project activities, such as leadership meetings.

In addition to individual research projects, applicants may propose one or more shared resource cores if needed for the proposed research. Each shared resource core must be utilized by two or more projects within the program. New cores may be proposed and/or existing cores may be augmented to support the proposed research.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission

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

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.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

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

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.

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. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

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.

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:

Ramesh Vemuri, PhD.
Chief, Scientific Review Branch
National Institute on Aging
National Institutes of Health
7201 Wisconsin Avenue, Suite 2C-212
Bethesda, MD 20892 (For Fedex use, MD 20814)
VermuriR@mail.nih.gov

Page Limitations

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

Research Plan

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

How to Organize the Application

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 subprojects and cores. Reviewers will use information from the Resources page of the Administrative Core to evaluate the quality of the overall environment for the program project.

Section 2: Overall Program Objectives:

Introduction (resubmission applications only):

Provide an overview of major changes in the application (limited to one page).  If subprojects or cores have been deleted or added indicate that here and explain the changes under significance (below).

Specific Aims: (limited to one page):  Describe the aims of the overall program project and outline how the different subprojects 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 program 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).

New Applications: Follow the instructions above.

Renewals: Identify and justify any changes in research emphasis and level of funds requested. If the structure of subprojects and cores has changed identify the cores and subprojects consecutively (numbers/subprojects, letters/cores) according to how they are arranged in the current application. Show the correspondence to the prior structure.

Resubmissions: Follow PHS 398 instructions to mark changes in the text from the prior version. If the structure of subprojects and cores has changed identify the cores and subprojects consecutively (numbers/subprojects, letters/cores) according to how they are arranged in the current application. Show the correspondence to the prior structure.

2. Innovation: Considering the program 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 subprojects complement each other or are inter-dependent. Describe the mechanisms that will ensure the coherence of the project and maintain a multidisciplinary focus. (Three to four pages recommended.)

Competing Renewals: Describe findings (with citations) from the prior period of support that are of particular significance to the program project as a whole. If subprojects or 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. Identify and justify any substantive differences in approaches from the prior period of support.

Human Subjects

Describe the general principles and policies that will apply to human subjects.

List the components of the application that involve human subjects and page numbers for the relevant human subjects sections.

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 Subprojects

How to organize the Layout of the Cores and Subprojects

Present information for each component subproject 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 subprojects in the application after the cores, and identify them with consecutive Arabic numbers and titles (Subproject 1, Subproject 2, etc.) Include the subproject leader's (PL) name, or Core leader's (CL) name at the upper right-hand corner of each page under the PI's name. Begin each subproject or core with a new PHS 398 Continuation Page. Do not use the Face Page of PHS Form 398.

For renewals and resubmissions list the cores and subprojects as for a new program project. In addition in the Statement of Overall Program Objectives show the correspondence between the structure of the renewal or resubmission application and the prior application.

How to Organize Cores:

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

Introduction: (Resubmission applications only) (1 page)

Resubmissions: The Introduction should be a summary response to the global concerns expressed about the core.

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

How to Organize Subprojects:

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

Introduction: (Resubmission applications only) (limited to 1 page)

The Introduction should be a summary response to the global concerns expressed about the subproject.

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.

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  PHS 398 Application Guide)

Appendix

Submit one appendix for the program project as a whole.

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, with the following modifications:

Foreign Organizations

Applications from foreign institutions are not eligible, but individual foreign subprojects within the P01 are acceptable.

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.

To be eligible for award as a P01 the application must have at least three scored subprojects active throughout the project period. The overall program director must be project leader on one of the funded subprojects.

6. Other Submission Requirements and Information

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

A P01 application must propose at least three subprojects and an administrative core. The subprojects and core most be proposed as active throughout the project period of the award. The overall program director of the program project must also be proposed as project leader of one or more of the subprojects. Additional subprojects and cores may be proposed as appropriate to the goals of the program project

Requests of $500,000 or more for direct costs in any year

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.

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 - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the overall program 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 - Overall

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 overall program projectt 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? What is the added value to scientific knowledge, technical capability, and/or clinical practice of the program project considered as a whole compared to the separate impact of the individual subprojects? How important is the program project structure to the prospects for success of the individual subprojects?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the program projectt? 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? How compelling are the program project’s principal investigator’s skills, research record and prior leadership experience? Has the program project principal investigator devoted sufficient effort to accomplish the goals of the program project? Do the investigators on the separate subprojects and cores show evidence of collaborating to advance the goals of the overall program 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? How much does combining the different cores and subprojects into a single overall program project enhance innovation or increase the originality of the proposed work?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the program 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? Do  the different approaches taken in the cores and subprojects create a synergy that itself enables new knowledge and/or clinically relevant findings? Are the approaches of the different subprojects consistent? Do they provide additive value beyond their individual strengths?

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? Does the environment encourage collaborative work among the project investigators?

Additional Review Criteria - Overall

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

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 project.

Renewals

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

Revisions

Not applicable

Additional Review Considerations - Overall

As applicable for the program 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.

Subprojects

Scored Review Criteria - Subprojects

Overall Impact:  

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

Central Review Criteria: Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 subproject that by its nature is not innovative may be essential to advance a field.

Significance:

Does the subproject address an important problem or a critical barrier to progress in the field? If the aims 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 investigators, collaborators, and other researchers well suited to the subproject? 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 subproject is collaborative, 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 subproject? Are potential problems, alternative strategies, and benchmarks for success presented? If the subproject is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the subproject 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 subproject proposed? Will the subproject benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the subproject proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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 subproject 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 Human Subjects 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.

Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), 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 subproject.

Renewal Applications: When reviewing a Renewal application (formerly called a competing continuation application); the committee will consider the progress made in the last funding period.

Revision Applications: Not applicable.

Additional Review Considerations

As applicable for the subproject proposed, reviewers will address 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.

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

Select Agents 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).

Applications from Foreign Organizations: Reviewers will assess whether the subproject presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Cores

Overall Impact:

Reviewers will provide an adjectival rating of high, moderate, or low enthusiasm

Central Review Criteria: Reviewers will consider each of the four 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.

Significance:

Does the core address an important problem or a critical barrier to progress in the field? If the aims 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? What is the value of the core to the overall program project and to the individual subprojects? Can the core support at least two subprojects?

Investigator(s):

 Are the investigators, collaborators, and other researchers well suited to the core? 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 core is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the core? Administrative Core: Do the core leader’s administrative, management, and leadership capabilities provide for the following activities: Internal quality control of ongoing research; Management of day-to-day program activities: Management of contractual agreements; Fair, effective communications and cooperation among program leaders and/or program investigators; Resolution of disputes; Development of scientific meetings; Allocation of funds. Scientific Core: Are the skills of the core leader and key personnel appropriate to manage the core?

Approach:

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

If the core 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?

Administrative Core: Are the operational plan and organizational structure well justified? Is the core adequate to support and encourage optimal interactions among participants of the overall program? Scientific Cores: Are the methodologies used in the core and the resources of the core most appropriate to the needs of the subprojects? Do they fully address these needs?

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 proposed core? Will the core benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? Does the environment enhance integration of the cores and subprojects? Does it facilitate interactions between cores and subprojects?

Additional Review Criteria

As applicable for the core proposed, reviewers will consider the following additional items in the determination of scientific and technical merit.

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 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 Human Subjects 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.

Resubmission Applications: When reviewing a Resubmission application (formerly called an amended application), 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 core.

Renewal Applications: When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

Revision Applications: Not applicable

Additional Review Considerations

As applicable for the core proposed, reviewers will address each of the following items.

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

Select Agents 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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html)

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened bythe 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:

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 appropriate national Advisory Council or Board . 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

Not Applicable.

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)

Robin A. Barr, D.Phil
National Institute on Aging (NIA)
Telephone: 301-496-9322
Email:BarrR@mail.nih.gov

Peer Review Contact(s)

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

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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