Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www. nih.gov )

Components of Participating Organizations
National Institute on Aging (NIA) (http://www.nia.nih.gov )

Title:  Nathan Shock Centers Of Excellence in Basic Biology of Aging (P30)

Announcement Type
This Funding Opportunity Announcement (FOA) is a reissue of RFA-AG-04-010.

Request for Applications (RFA) Number: RFA-AG-10-009

Update: The following update relating to this announcement has been issued:

Catalog of Federal Domestic Assistance Number(s)
93.866

Key Dates
Release Date: October 1, 2009
Letters of Intent Receipt Date: November 12, 2009
Application Receipt Date: December 11, 2009
Peer Review Date: February 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 1, 2010
Additional Information to Be Available Date (Url Activation Date): N/A
Expiration Date: December 12, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose. The National Institute on Aging (NIA) invites applications for support of Centers, known as Nathan Shock Centers of Excellence in Basic Biology of Aging. These Center grants will provide funding for research and training activities that belong within the areas supported by the Division of Aging Biology of the NIA (http://www.nia.nih.gov/ResearchInformation/ExtramuralPrograms/BiologyOfAging/ ).  They are intended for institutions that can demonstrate a substantial current investment in and commitment to research on the basic biology of aging, but they are not intended to support the Principal Investigator’s research directly, nor clinical research or clinical trials.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review and Anticipated Start Dates
         1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
   D.  Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact
2. Peer Review Contact
3. Financial/ Grants Management Contact

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The goal of this program is to enhance the ability of institutions with well-developed programs in basic research on aging biology to further the utilization of state-of-the-art research resources to provide the strongest environment for the conduct of research on aging biology at their Institutions, their geographical neighborhood, and the Nation at large. Thus, this Funding Opportunity Announcement is intended to: 1) enhance the quality of research in the basic biology of aging, 2) facilitate the planning and coordination of aging biology research activities, 3) provide support and a suitable environment for investigators new to aging biology research to acquire research skills and experience at institutions that have demonstrated commitment to, and expertise in, basic biology of aging research, and 4) to develop potential regional and/or national resource Centers.  Thus, each application must include at least:  1) a core to support administrative functions, including an advisory committee (not to be named in the application). Optionally, this core may also be in charge of organizing outreach activities including courses, lectures and symposia, 2) a research development core in charge of supporting pilot/feasibility projects, and providing temporary salary support for investigators just entering the field of biology of aging research, to a point where they can compete for independent support, and 3) at least two research core activities such as animal facilities, pathology, integrated physiology, comparative biology, molecular/cell biology, informatics, etc. which must be utilized by three or more projects on aging research that are already funded.  Each core must be directed by an appropriately qualified investigator.

Administrative/Program Enrichment Core. This core is required for the administrative management of the overall Center, as well as support for the required outside advisory panel. The Administrator (if one is used) will assist the Principal Investigator (Director) in managing the Center, addressing issues of fiscal management and compliance with institutional, DHHS, NIH and NIA policies.  In addition, each Center must establish an advisory panel of experts from outside the institution.  This panel should not be named, nor should potential members be contacted, until after the review process is completed, and awards are made.  This panel must be convened at least once during the fourth year of funding, and must provide a written evaluation of the progress of the Center to both the Center and the NIA no later than January, 2014.  Additional use of this advisory panel shall be at the discretion of the Center Director.

This core should present a plan (but not an actual agreement) on how it will collaborate with other funded Nathan Shock Centers, and promote the dissemination of research findings and availability of materials, reagents and other resources generated by the Center, through the development of a joint informative and interactive web site.

Funds should be requested to permit travel by the Director and one other senior staff to the annual meeting of Nathan Shock Center Directors and NIA staff. Currently, these meetings are held as part of the Annual AGE meeting. Additional elements of this core, including outreach activities, courses on the biology of aging, seminar program, conferences, etc., are encouraged, but they are optional.

Research Development Core. The Research Development Core will provide support for career development of junior faculty and other investigators who wish to change career direction towards basic aging research in the form of pilot projects.  It may also serve as a resource for pursuing an exciting new finding beyond the limits that existing support allows.  Interdisciplinary activities that focus resources from a variety of fields on understanding biological processes of aging are encouraged. The request for Research Development Core support must contain 1) a plan for the selection of faculty to be supported, 2) a general plan for the career development of individuals who will be selected for these positions, 3) a plan for review and selection of pilot projects to be pursued, and 4) a list of senior faculty who will participate in research career development, along with their curriculum vitae and current research support.  The institution must be able to demonstrate adequate resources for the support of the research efforts of proposed junior investigators, and a plan for monitoring their progress and development toward independence.

The budget for each pilot project, including salary for the investigator, may not exceed $50,000 per year (direct cost), and the total budget for pilot projects under this core is expected to not exceed $100,000 per year (direct cost).  Pilot projects funded must receive prior approval from NIA staff, and should be described briefly in the annual progress reports.

This core may also provide temporary salary support, not to exceed 24 months, and research supplies for faculty in specified areas of research complementary to ongoing activities of the group.  No more than three faculty may receive salary support through this core at any one time, including salary on pilot projects.  It must be clearly described how any requested salary support in this core will enhance the existing program. Funds may also be requested for salary support for the director of the Research Development Core, who will be responsible for coordinating all activities within said core.

The Research Development Core may also be used to encourage the career development of other faculty through the use of research core resources, even though their salary support is provided from other sources.  This may include investigators from other institutions, including, but not limited to, investigators from other Shock Centers. Finally, this core may include a specific plan for support of research by and training of students or faculty from underrepresented ethnic groups or with disabilities, or from disadvantaged backgrounds.

Research Resource Cores. These cores will provide support for personnel, equipment, supplies and limited renovation costs needed to develop new, or improve existing resources, that foster shared use and collaborative research.  Because a supply of appropriate animal models that are free of disease is essential for many areas of research on biological aging, support may be requested for the development and maintenance of animal resources (both classical and new animal models) to meet this need.   Personnel and equipment costs for integrated physiology and/or pathology studies may also be requested.  To gain insight into the mechanisms of aging through understanding the underlying intrinsic biology, a variety of molecular/cellular biology capabilities might be required, and can be supported through these cores.  Research Resource cores must support at least 3 ongoing basic research projects. Further examples include, but are not limited to:

Centers are encouraged to develop resources that will also be available for collaborative research projects with investigators from other institutions, including but not limited to other Shock Centers.  A plan must be presented to describe how such access to Center resources will be managed, so as not to overwhelm the personnel and resources of the Center. The requirement that resources support at least three basic research projects may be partially met by projects at institutions other than the grantee institution.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH P30 (Center Core grant) mechanism. This mechanism supports shared resources and facilities for categorical research by a number of investigators from different disciplines who provide a multidisciplinary approach to a joint research effort or from the same discipline who focus on a common problem. The core grant is integrated with the Center’s component projects or program project though funded independently from them. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). 

2. Funds Available

The estimated amount of funds available for support of up to 5 projects awarded as a result of this announcement is $ 4 million for fiscal year 2010. The expected direct cost amount for individual awards should not exceed $ 800,000, and should be commensurate with the work proposed. Applications with budget requests exceeding this amount will not be reviewed. Applications should be for 5 years, and future year amounts will depend on annual appropriations.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NIA provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

NIH grants policies as described in the NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applications may represent a single institution or a set of institutions with demonstrable geographic and academic proximity. To be eligible, an institution or a consortium must also have at least 12 funded research grants for biomedical research on the basic biology of aging, granted either by the Division of Aging Biology of the National Institute on Aging or by other public or private agencies and foundations. In the latter case, a clear demonstration that the project is directly related to the goals and mission of the Division of Aging Biology of the National Institute on Aging must be provided. For this purpose, each research project in a Program project grant counts as one grant.

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

Resubmissions.  Resubmissions are not allowed. Therefore, each application must be submitted as a new application, and while previous comments from reviewers can be used to improve a previously unfunded application, a response to the reviewer’s critiques cannot be included as part of the new application.

Renewals. Renewal applications are permitted in response to this FOA

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: November 12, 2009
Application Receipt Date: December 11, 2009
Peer Review Date: February 2010
Council Review Date: May 2010

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Felipe Sierra, Ph. D.
Division of Aging Biology
National Institute on Aging
7201 Wisconsin Ave
Room 2C231
Bethesda, MD 20892
Telephone: (301) 496-6402
FAX: (301) 402-0010
Email: Sierraf@nia.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 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)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Dr. Ramesh Vemuri
Scientific Review Branch
National Institute on Aging
7201 Wisconsin Ave., Room 2C212
Bethesda, MD 20892
Telephone: (301) 402-7700
FAX: (301) 402-0066
Email: Vemuri@nia.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.  Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute Incomplete and/or non-responsive applications will not be reviewed.

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

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

6. Other Submission Requirements and Information

Successful applicants will be expected to request funds to permit travel by the Director and one other senior staff to the annual meeting of Nathan Shock Center Directors and NIA staff. Currently, these meetings are held as part of the Annual AGE meeting.

Applicants for competitive renewal should fully document progress made during previous period of support.

Research Plan Page Limitations

The entire length of the research plan is limited to 30 pages. Applicants can distribute these pages as they see fit. A possible recommendation is:

o Limit the general overview, excluding information on supported research on the basic biology of aging available at the Institution, to 10 pages.

o The narrative description of the required cores (Administrative plus Research Development) might be presented in 8 pages.

o The description of all Research Resource Cores could use the remaining 12 pages.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIA and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The following will be considered in making funding decisions:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

NIH considers the following in evaluating Center grant applications:

In addition to the review criteria below, the following components of the application will be evaluated:

1)     Overall value of the program

2)     Cohesiveness and synergy

3)     Resources and environment

4)     Principal Investigator

5)     Required cores (administrative/program enrichment and research development cores)

6)     Additional research cores

7)     Progress report (renewals only)

The Center as an integrated whole will be evaluated with the following criteria:

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 six core review criteria, and additional review criteria (as applicable for the project proposed). 

Core Review Criteria.  Reviewers will consider each of the six review criteria below in the determination of scientific and technical merit.  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. 

Investigator(s). 

Innovation.  

Approach. 

Environment. 

 Coordination and cohesiveness. 

In addition to the above review criteria, the following criteria will be applied to applications in the determination of scientific merit and the impact/priority score. Not all additional criteria are applicable to every application, depending on the number and extent of proposed cores.

1) Overall

Significance. 

Investigator(s). 

Innovation.  

Approach. 

Environment. 

2) Required Cores

Significance. 

Investigator(s).  Do the proposed core director(s) have the qualifications, experience, scientific leadership and commitment required to successfully perform the functions proposed?

Approach. 

3) Additional Research Cores

Significance. 

Investigator(s).  Does each of the core directors have the qualifications, experience, scientific leadership and commitment required to perform the duties proposed?

Approach. 

Additional Review Criteria.  As applicable for the project 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.

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.

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.

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.

Additional Review Considerations.  As applicable for the project 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. All applications must request 5 years of support.

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).

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

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

3. Reporting

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.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Felipe Sierra, Ph. D.
Division of Aging Biology
National Institute on Aging
7201 Wisconsin Ave
Room 2C231
Bethesda, MD 20892
Telephone: (301) 496-6402
FAX: (301) 402-0010
Email: Sierraf@nia.nih.gov

2. Peer Review Contacts:

Dr. Ramesh Vemuri
Scientific Review Branch
National Institute on Aging
7201 Wisconsin Ave. , Room 2C212
Bethesda, MD 20892
Telephone: (301) 402-7700
FAX: (301) 402-0066
Email: Vemuri@nia.nih.gov

3. Financial or Grants Management Contacts:

Pamela Adewunmi
Grants and Contracts Management Branch
7201 Wisconsin Ave., Room 2N212
Bethesda, MD 20892-9205
Telephone: (301) 402-7737
Fax: (301) 402-3672
E-Mail: adewunmp@nia.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.