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
NIH Basic Behavioral and Social Science Opportunity Network (OppNet http://oppnet.nih.gov/) and its member institutes, centers and offices:
Fogarty International Center (http://www.fic.nih.gov/)
National Cancer Institute (NCI) (http://www.cancer.gov/)
National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/)
National Center on Minority Health and Health Disparities (NCMHD) (http://ncmhd.nih.gov/ )
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov/)
National Eye Institute (NEI) (http://www.nei.nih.gov/ )
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/index.htm)
National Human Genome Research Institute (NHGRI) (http://www.genome.gov/)
National Institute on Aging (NIA) (http://www.nia.nih.gov/)
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (http://www.niaaa.nih.gov/)
National Institute of Allergy and Infectious Diseases (NIAID) (http://www3.niaid.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (http://www.niams.nih.gov/)
National Institute of Biomedical Imaging and Bioengineering (NIBIB) (http://www.nibib.nih.gov/)
National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/)
National Institute on Deafness and Other Communication Disorders (NIDCD) (http://www.nidcd.nih.gov/)
National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (http://www2.niddk.nih.gov/)
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov/)
National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov/)
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/)
National Institute of Nursing Research (NINR) (http://www.ninr.nih.gov/)
National Library of Medicine (NLM) (http://www.nlm.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR) (http://obssr.od.nih.gov)
Office of Dietary Supplements (ODS) (http://dietary-supplements.info.nih.gov/)
Office of Disease Prevention (ODP) (http://prevention.nih.gov/)
Office of Research on Women’s Health (ORWH) (http://orwh.od.nih.gov/)

Title:  Recovery Act Limited Competition: NIH Basic Behavioral and Social Science Opportunity Network (OppNet) Short-term Mentored Career Development Awards in the Basic Behavioral and Social Sciences for Mid-career  and Senior Investigators (K18)

Announcement Type
New

Request for Applications (RFA) Number: RFA-OD-10-003  

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

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.701  

Key Dates
Release/Posted Date: January 5, 2010
Opening Date:   January 16, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 20, 2010.
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Due Date(s):  February 18, 2010
AIDS Application Due Date(s): Not Applicable
Peer Review Date(s): June/July 2010 
Council Review Date(s): August 2010
Earliest Anticipated Start Date(s): August 31, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: February 19, 2010

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II 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 - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Background:

The National Institutes of Health (NIH) Basic Behavioral and Social Sciences Opportunity Network (OppNet) has identified a gap in career development funding opportunities for mid-career and senior level investigators. Specifically, a program is needed that provides the flexibility to allow these established investigators the support and protected time to obtain the necessary training and research experience to expand their already productive research programs to explore new directions in basic behavioral and social sciences research (b-BSSR).

OppNet is a new NIH-wide initiative to accelerate and expand basic behavioral and social sciences research. The mission of OppNet is to pursue opportunities for strengthening basic behavioral and social sciences research at the NIH while innovating beyond existing investments.  Twenty-four NIH Institutes and Centers and four program offices in the NIH Office of the Director will collaborate on new research initiatives supported through a shared OppNet-specific funds over an initial 5-year period.

Inaugural OppNet activities will be supported with up to $10 million in Recovery Act funds during FY 2010. In keeping with the Recovery Act’s goals, initial OppNet activities will focus on short-term research and/or training.  These activities will strive to strengthen basic behavioral and social science within existing research programs and develop capacity for interdisciplinary research.  During its first year, OppNet will develop a plan for targeted multi-year programs to advance priority areas within the basic behavioral and social sciences. A NIH plans to use regularly appropriated resources to support OppNet during FY 2011 – FY 2014; corresponding opportunities will be announced during that time frame.

The mission to support basic behavioral and social sciences is shared across NIH Institutes and Centers, and OppNet will be a means to enhance existing NIH efforts by integrating them and ensuring that new opportunities in relevant and complementary scientific areas are addressed. OppNet will identify common NIH Institute and Center interests in the basic behavioral and social sciences and support new research through targeted initiatives.  OppNet will target those b-BSSR challenges that are best met collectively, drawing on the expertise of all NIH Institutes and Centers. Additional information about OppNet goals, mission, and structure, can be found on the NIH Web site at http://oppnet.nih.gov

Purpose and Objectives:

As part of the Recovery Act, the NIH OppNet invites applications for short-term mentored career development (K18) awards  of up to 1 year duration, aimed at established, mid-career and senior investigators who seek an intense, mentored career development experience which will substantially improve their ability to pursue future research in the basic behavioral and social sciences. The intent of this FOA is to provide candidates with protected time to achieve a shift in the focus of their research direction in the basic behavioral and socials sciences, or to substantially enrich a current b-BSSR research program through the introduction of tools, theories or approaches from another discipline or area of science. Two categories of candidates are targeted: (a) biomedical or clinical researchers with little experience in basic behavioral and social sciences research seeking training with a well established b-BSSR investigator in order to explore the introduction of b-BSSR into their research programs; and (b) investigators in the basic or applied behavioral and social sciences who wish to build new components or domains of b-BSSR into their research programs.  Illustrative examples include but are not limited to: A psychologist seeking training in econometrics in order to expand a research program on basic mechanisms of decision-making; A clinical epidemiologist seeking training in social network dynamics to better understand the spread of health behaviors in populations; A demographer seeking training in psychoneuroimmunology in order to understand the mechanisms whereby sociodemographic factors get “under the skin” to impact health disparities; An ethologist seeking training in neuroscience to facilitate examination of how patterns of maternal care result in epigenetic changes in brain regions and brain structure.

This FOA is not intended as a substitute for research project support.  It is expected that either the candidate or the mentor has sufficient research funding to support the proposed project.  It is not a requirement that the candidate or the proposed mentor receive their primary funding through the NIH. 

Candidates must hold the rank of Associate Professor or Professor, or their equivalent in non-academic settings, and propose a mentored career development and career enhancement program, along with a research project, to be conducted in a different department within their home institution or different institutional setting from the location where they hold their primary appointment. The host mentoring laboratory/research program is expected to demonstrate appropriate research and resources to provide a new research direction for the candidate.  In most cases, the candidate and the proposed host laboratory/research program will not have any previous research collaborations, but candidates may propose such arrangements with justification as to why this program will facilitate career development that could not be achieved solely through a research grant mechanism. Candidates may propose an experience at a location which is geographically and physically separate from the candidate organization but this separation is not required or preferred. Departmental and School administrators for the Departments and Schools of the candidates should describe any institutional commitments the candidate will maintain during the period of the research career enhancement and any special provisions which will be made to provide appropriate release time.  In particular, the administration should demonstrate their commitment to the candidate’s separation from current responsibilities during the sabbatical period.

Candidates should also describe any clinical, administrative, research, or grant related commitments they intend to maintain during the period of the award, and arrangements which will be made to provide protected release time. Candidates may propose a career development program of a minimum of three months and up to one year in duration and are expected to devote between 25% and 50% of total annual effort to this career enhancement program.

Research Scope

The priority of OppNet is to build upon the existing body of knowledge about the nature of behavior and social systems by supporting initiatives that focus on basic mechanisms of behavior and social processes that are relevant to the missions and public health challenges addressed by multiple NIH institutes, centers, and offices (ICOs). Basic behavioral and social science research includes research on behavioral and social processes, interactions between biology, behavior and social processes, and research on methodology and measurement as described below.

(A). Research on behavioral and social processes

Research on behavioral and social processes involves the study of human or animal functioning at the level of the individual, small group, institution, organization, community, or population. At the individual level, this research may involve the study of behavioral factors such as cognition, memory, language, perception, personality, emotion, motivation, and others. At higher levels of aggregation, it includes the study of social variables such as the structure and dynamics of small groups (e.g. couples, families, work groups, etc.); institutions and organizations (e.g. schools, religious organizations, etc.); communities (defined by geography or common interest); and larger demographic, political, economic, and cultural systems. Research on behavioral and social processes also includes the study of the interactions within and between these two levels of aggregation, such as the influence of sociocultural factors on cognitive processes or emotional responses. Finally, this research also includes the study of environmental factors (both natural and human created) such as climate, noise, environmental hazards, residential and other built environments and their effects on behavioral and social functioning.

Examples of research topics include, but are not limited to, the following:

(B). Interactions between biology, behavior and social processes

The study of the interactions of biological factors with behavioral or social variables and how they affect each other (i.e., the study of bi-directional multilevel relationships). Examples of research topics include, but are not limited to, the following:

(C). Research on methodology and measurement in the behavioral and social sciences

Research on methodology and measurement encompasses the development of new approaches to research design, data collection, measurement, and data analysis. This research is designed to develop research tools that could be used in the behavioral and social sciences or in biomedical research or their interaction.

Examples of research topics include, but are not limited to, the following:

For the full definition of b-BSSR please see the NIH Office of Behavioral and Social Sciences Research (OBSSR) web site (http://obssr.od.nih.gov/about_obssr/BSSR_CC/BSSR_definition/definition.aspx).

This inaugural OppNet initiative will be supported in fiscal year 2010 as part of the American Recovery and Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5.

Relevance to OppNet Goals: Required Components of Responsive Applications

Research projects and training activities proposed in response to this FOA are expected to have a well defined impact on our understanding of basic mechanisms of behavior or social processes, as articulated in the research objectives and scope.  Candidates should consult the NIH definition of basic behavioral and social sciences research, to determine the appropriateness of their research aims and training goals to the intent of this announcement. Candidates should clearly articulate how the proposed training plan will enhance their capacity in b-BSSR research. In addition, applications must include an explicit discussion of the potential for the proposed research to advance the goals of OppNet. The proposed project must be relevant to building the collective body of knowledge about the nature of behavior and social systems and to deepening our understanding of basic mechanisms of behavioral and social processes.  The potential of the proposed research and training activities to advance the candidate’s contributions to the targeted domain of basic social and behavioral sciences and to produce knowledge and/or tools of potential relevance to multiple domains of health- and lifecourse-related research should be clearly articulated.

Applications involving human and/or animal populations are encouraged.  Relevance to individual and social human behavior should be discussed in the Research Strategy section of the application.

It is hoped that a benefit of this award to the goals of the NIH will be the stimulation of innovative, new projects in the basic behavioral and social sciences that ultimately lead to significant advances in health- and lifecourse-related research.

Applicants are advised that answers to frequently asked questions regarding this funding opportunity announcement will be posted at:  http://oppnet.nih.gov.

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the K18 award mechanism.  The candidate Project Director/Principal Investigator (PD/PI) and his/her mentor are jointly responsible for planning, directing, and executing the proposed project and career enhancement activities.  

This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide). It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).

The candidate should follow the instructions for budget information described in this FOA as well as in PHS 398 Career Development Award Supplemental form Section 7.4.6 of the R&R 424 instructions, and budget justification information.

2. Funds Available

This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 (“Recovery Act” or “ARRA”), Public Law 111-5. NIH’s OppNet has designated $2 million in FY2010 to fund approximately 10-20 grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.

Budget proposals are limited to $20,000 in direct costs for research development support to cover career enhancement training experiences, such as tuition and fees for short-term courses, consultant fees, travel to scientific meetings, and research related costs, primarily supplies and technical services but not living expenses.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Salary: The total salary provided by the award will be prorated based on a full-time, 12-month staff appointment and the support period requested, up to the maximum legislated salary level.  The total project period for an application submitted in response to this funding opportunity shall be between three and twelve months. All candidates must devote a minimum of 25 % but no greater than 50 % of full-time professional effort to conducting the b-BSSR research and career development plan described in the application. For information regarding NIH policy in determining full-time professional effort for career awards, see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html .

Research Development Support: This program will provide up to $20,000 in direct costs for research development support to cover career enhancement training experiences, such as tuition and fees for short-term courses, consultant fees, travel to scientific meetings, and research related costs, primarily supplies and technical services. 

The candidate’s institution may supplement the salary received from the K18 award to a level consistent with the institution’s salary scale.  Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the conduct of the K18 program.  No PHS funds may be used for supplementation.

Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed.

Indirect Costs: These costs, also known as Facilities and Administrative (F&A) costs, will be reimbursed at eight percent (8%) of modified total direct costs.

This program is supported by funds provided to the NIH under the Recovery Act.  The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means.  Consistent with these goals, domestic (United States) institutions/organizations planning to submit applications that include foreign components should be aware that requested funding for any foreign component should not exceed 10% of the total requested direct costs or $25,000 per year (aggregate total for a subcontract or multiple subcontracts), whichever is less.

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

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization. The United States institution/organization must be located in the 50 states, territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. NIH encourages applications from all interested organizations/institutions, including those from Institutional Development Award (IDeA) states and Academic Research Enhancement Award (AREA)-eligible institutions. Foreign organizations/institutions are not permitted as the applicant organization.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the 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.

Project Director/Principal Investigator (PD/PI): This award is intended for mid-career and senior investigators holding a research or health professional doctorate who are at the academic rank of Associate Professor or Professor, or the equivalent in nonacademic settings, who have established records of independent research who seek an intense, mentored career development experience which will substantially improve their ability to pursue future research in the basic behavioral and social sciences. Targeted candidates include: (a) biomedical or clinical researchers with little experience in basic behavioral and social sciences research who seek training with a well established b-BSSR investigator in order to explore the introduction of b-BSSR into their research programs; and (b) investigators in the basic or applied behavioral and social sciences who wish to build new components or domains of b-BSSR into their research programs.

Candidates must identify one or more mentors with extensive research experience in an appropriate domain or discipline, who are well-qualified and willing to sponsor the short term research career development experience. It is expected that the proposed career development plan will represent a novel extension of the research of the candidate. In most cases, the candidate and the proposed host laboratory/research program will not have any previous research collaborations, but candidates may propose such arrangements with justification as to why this program will facilitate career development that could not be achieved solely through a research grant mechanism.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Candidates may submit only one application in response to this FOA.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. The K18 is not renewable and may not be transferred to another individual.  Due to the short-term nature of the award, it may not be transferred to another institution.

Candidates to this program may not concurrently apply for any other PHS award that duplicates the provisions of the award. Candidates may not currently be Principal Investigators on any other K series grant award.

Each short term career enhancement program in the basic behavioral and social sciences must be tailored to meet the individual needs of the candidate. The candidate and mentor are jointly responsible for the preparation of the career development plan. The sponsoring institution must demonstrate a commitment to provide the environment and resources needed for the candidate to perform the activities included in the career enhancement program that maximize the use of relevant research and educational resources and propose qualified investigators as mentors.

A Resources Format page (PHS 398) for the host laboratory/research program must be included in the application.

Candidates for the K18 award are likely to have been principal investigators on NIH research or career development awards.  The research and career development experience proposed in the K18 must achieve a shift in focus or substantially enrich a current research program through the introduction of tools, theories or approaches from another discipline or area of science.

Section IV. Application and Submission Information


To download a current SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application.  Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:  

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

·         The individual(s) designated as PDs/PIs on the application must be registered also in the NIH eRA Commons. In the case of multiple PDs/PIs, all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to the submission of the application.

Both the PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Candidates must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

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

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are necessary for processing (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
SF424 (R&R) Detailed Budget
PHS398 Cover Letter
PHS398 Cover Page Supplement
PHS398 Career Development Award Supplemental Form
PHS398 Checklist

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: January 16, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): January 20, 2009
Application Due Date(s): February 18, 2010
Peer Review Date(s): June/July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date(s): August 31, 2010

3.A.1. Letter of Intent

Prospective candidates 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 and plan for the potential review workload.

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:

William N. Elwood, PhD
Office of Behavioral and Social Sciences Research
Office of the Director
National Institutes of Health
US Department of Health and Human Services
31 Center Drive, Suite B1-C19 (MSC 2027)
Bethesda, MD  20892-2027
Telephone: (301) 402-0116
Fax: 301-402-1150
Email: william.elwood@nih.hhs.gov 

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp  and follow Steps 1-4. Note:  Applications must only be submitted electronicallyAll attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used. PAPER APPLICATIONS WILL NOT BE ACCEPTED. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used. 

3.C. Application Processing

3.C.1 Submitting On-Time

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed.

All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov,

NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and/or non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commonshttps://commons.era.nih.gov/commons/. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

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.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review, as indicated in the NIH Grants Policy Statement.

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.

Salary support: The salary requested for the candidate must be consistent with both the established salary structure for full-time staff appointments and with salaries actually provided by the sponsoring institution from its own funds to other staff members of equivalent qualifications, rank and responsibilities in the applicant department.  The candidate is required to devote between 25% and 50% of his or her total annual effort to this career enhancement program for a period of three to twelve months.

Research Development Support: The research development support costs may not exceed $20,000 and must be justified and be consistent with the project proposed and the proportion of time spent in research and career enhancement activities. Salary for ancillary personnel support, such as mentors, secretarial, and administrative assistants is not allowed.

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 the NIH Grants Policy Statement).

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD(s)/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

Cover Letter

The PHS398 cover letter must include the list of referees (including name, department affiliation, and institution.

PHS 398 Career Development Award Supplemental Form Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide (See Supplementary Instructions for Research Career Awards, Part I.7.5) are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

The following information must be included in the application:

Candidate:

Career Enhancement/Development Plan:

Research Plan:

Training in the Responsible Conduct of Research:

Statement(s) by Mentor(s)/Consultant(s)/Collaborator(s):

Environment and Institutional Commitment to the Candidate:

Letters of Reference:

Budget for the Entire Proposed Period of Support:

Appendix Materials

Candidates must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm). Also see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Do not use the Appendix to circumvent the page limitations. An application that does not comply with the required page limitations may be delayed in the review process.  

No supplemental/update information will be accepted.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the 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 the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) Data Sharing Plan: Not Applicable.

(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 (e.g., 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 (go to 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

Review Process

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. 

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CSR 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:

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

The overall goal of NIH-supported career development programs is to help ensure that diverse pools of highly trained scientists are available in adequate numbers and in appropriate research areas to address the Nation’s biomedical, behavioral, and clinical research needs.  The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to receive a high impact/priority score. These criteria are listed in logical order and not in order of priority.

Candidate:

Career Enhancement/Development Plan:

Research Plan

Mentor/Co-Mentor(s), Consultant(s), and Collaborator(s)

Environment and Institutional Commitment

2.A. 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.

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.

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, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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.

2.B. 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.

Training in the Responsible Conduct of Research: Reviewers will evaluate plans for instruction in responsible conduct of research as well as the past record of instruction in responsible conduct of research, where applicable.  Reviewers will specifically address the five Instructional Components (Format, Subject Matter, and Frequency of instruction as detailed in NOT-OD-10-019.  The review of this consideration will be guided by the principles set forth in NOT-OD-10-019.  Plans and past record will be rated as ACCEPTABLE or UNACCEPTABLE.

 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:

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.

Selection Process

Applications submitted in response to this FOA will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

Appeals will not be permitted.  See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.

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 NIH 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.

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards.  The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

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 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  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

A. Evaluation: In carrying out its stewardship of human resource-related programs, the NIH may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

B. Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution.

All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

Usually, funds budgeted in an NIH supported research grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. The awarding component will give consideration to approval for the use of released funds only under unusual circumstances. Any proposed retention of funds released as a result of a career award must receive prior written approval of the NIH awarding component.

C. Leave Policies: Leave to another institution, including a foreign laboratory, may be permitted if the proposed experience is directly related to the purpose of the award. Only local institutional approval is required if such leave does not exceed 3 months. For longer periods, prior written approval of the NIH funding component is required. Details on the process for submission of prior approval requests can be founds in the NIHGPS (rev. 12/03), Requests for Prior Approval, at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600130.

A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave.

Leave without award support may not exceed 12 months. Such leave requires the prior written approval of the NIH component Institute or Center and will be granted only in unusual situations.

Support from other sources is permissible during the period of leave without award support. Such leave does not reduce the total number of months of program support for which an individual is eligible.

D. Percent Effort Policies: Under certain circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75 percent (equivalent to 9 person months). Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50 percent effort (equivalent to 6 person months). The nature of the circumstances requiring a change in the appointment status or percent effort might include personal or family situations such as parental leave, child care, elder care, medical conditions, or a disability. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to at least 75 percent effort as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

E. Changes in Research or Career Development Program: Consultation with the applicable NIH funding Institute or Center Program staff is strongly encouraged when a change in the approved career development program and/or research plan is being considered.

Individual awards are made for career development in a specific research program. A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH Institute or Center. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by staff of the awarding IC to ensure that the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

In rare cases where a mentor must be replaced, the institution must submit a letter from the proposed mentor and awardee documenting the need for substitution, the new mentor's qualifications for supervising the program, and the level of support for the PD/PIs continued career development. The letter must also document that the specific aims of the research program will remain within the scope of the original peer reviewed research program. Staff within the NIH funding component will review the request and will notify the institution of the results of the evaluation.

F. Change of Institution or Termination: Consultation with the applicable NIH funding Institute or Center program and/or grants management staff is strongly encouraged when either termination or a change of institution is being considered.

A change of grantee institution normally will be permitted only when all of the benefits attributable to the original grant can be transferred, including equipment purchased in whole or in part with grant funds. In reviewing a request to transfer a grant, NIH will consider whether there is a continued need for the grant-supported project or activity and the impact of any proposed changes in the scope of the project. A change may be made without peer review, provided the PD/PI plans no significant change in research and career development objectives and the facilities and resources at the new organization will allow for successful performance of the project. If these conditions or other programmatic or administrative requirements are not met, the NIH awarding office may require peer review or may disapprove the request and, if appropriate, terminate the award.

If the K awardee is moving to another eligible institution, career award support may be continued provided:

When a grantee institution plans to terminate an award, the Grants Management Specialist listed on the Notice of Award (NoA) must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. The Director of the NIH awarding component may terminate an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, NIH shall notify the grantee institution in writing of this determination, the reasons, the effective date, and the right to appeal the decision.

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.

In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds.  As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards.  The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

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. Until such time as HHS has migrated to the SF 425 FFR, award recipients will utilize the SF 269 FSR.

Section VII. Agency Contacts


This funding announcement is subject to restrictions on oral conversations during the period of time commencing with the submission of a formal application [1] by an individual or entity and ending with the award of the competitive funds. Federal officials may not participate in oral communications initiated by any person or entity concerning a pending application for a Recovery Act competitive grant or other competitive form of Federal financial assistance, whether or not the initiating party is a federally registered lobbyist. This restriction applies unless:

(i) the communication is purely logistical;

(ii) the communication is made at a widely attended gathering;

(iii) the communication is to or from a Federal agency official and another Federal Government employee;

(iv) the communication is to or from a Federal agency official and an elected chief executive of a state, local or tribal government, or to or from a Federal agency official and the Presiding Officer or Majority Leader in each chamber of a state legislature; or

(v) the communication is initiated by the Federal agency official.

For additional information see http://www.whitehouse.gov/omb/assets/memoranda_fy2009/m09-24.pdf

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research and Financial/Grants Management Contact(s):

Scientific/Research Contact
Financial/Grants Management Contact
John E. Fogarty International Center (FIC)
Myat Htoo Razak, M.B.B.S., Ph.D.
Division of International Training & Research
Building 31, Room B2C39 
31 Center Drive
Bethesda, MD 20892-2220
Telephone: 301-496-1652
Fax: 301-402-0779
Email: MyatHtoo.Razak@nih.gov
John E. Fogarty International Center (FIC)
Bruce R. Butrum
Division of International Training & Research
Building 31, Room B2C29
31 Center Drive
Bethesda, MD 20892- 2220 
Telephone: 301-496-1670 
Fax: 301-594-1211
Email: butrumb@nih.gov
National Cancer Institute (NCI)
Paige A. McDonald, Ph.D., M.P.H.
Chief, Basic and Biobehavioral Research Branch
Division of Cancer Control and Population Sciences
6130 Executive Boulevard, MSC 7363
Executive Plaza North, Room 4066
Bethesda, MD 20892-7363
Rockville, MD 20852 for Fed Ex
Telephone: 301-435-5037
Fax: 301-435-7547
Email: Paige.McDonald@nih.gov
National Cancer Institute (NCI)
Crystal Wolfrey
Chief, Cancer Control and Population Sciences Branch
Office of Grants Administration
6120 Executive Blvd., Suite 243
Bethesda, MD 20892 (regular mail)
Rockville, MD 20852 (express mail)
Phone: 301-496-8634
Email : wolfreyc@mail.nih.gov
National Center for Complementary
and Alternative Medicine (NCCAM)
John R. Glowa, Ph.D.
Division of Extramural Research
6707 Democracy Blvd, Ste 401
Bethesda, MD  20892
For Federal Express: Rockville, MD 20817
Telephone: 301-496-0527
Fax: 301-480-1552
Email: glowaj@mail.nih.gov
National Center for Complementary
and Alternative Medicine (NCCAM)
George Tucker
Grants Management
Division of Extramural Activities
6707 Democracy Blvd, Ste 401
Bethesda, MD  20892
For Federal Express: Rockville, MD 20817
Telephone: 301-594-9102
Fax: 301-480-1552
Email: tuckerg@nccam.nih.gov
National Center on Minority Health and Health Disparities (NCMHD)
Paula Goodwin, Ph.D.
Division of Extramural Activities and Scientific Programs            
Democracy Plaza 2, Suite 800
6707 Democracy Blvd
Bethesda, MD 20892-5465
Telephone: 301-402-1366
Fax: 301-480-4049
Email: goodwinpy@mail.nih.gov
National Center on Minority Health and Health Disparities (NCMHD)
Priscilla Grant, J.D., C.R.A.
Division of Extramural Activities and Scientific Programs
Democracy Plaza 2 Suite 800
6707 Democracy Blvd
Bethesda, MD 20892-5465
Telephone: 301-594-8412
Fax: 301-480-4049
Email: grantp@mail.nih.gov
National Eye Institute (NEI)
Neeraj Agarwal, Ph.D.
Division of Extramural Research, Research Training Officer
BG 5635FL RM 1300 MSC 9300
5635 Fishers LN
Rockville, MD 20892-9300
Telephone: (301) 451-2020
Fax:  301-402-0528
Email: agarwalnee@nei.nih.gov
National Eye Institute (NEI)
William W. Darby
Division of Extramural Research, Grants Management Branch, Chief
BG 5635FL RM 1300 MSC 9300
5635 Fishers LN
Bethesda, MD 20892-9300
Telephone: (301) 451-2020
Fax: 301-496-9997
Email: darbyw@nei.nih.gov
National Heart, Lung, and Blood Institute (NHLBI)
Catherine M. Stoney, Ph.D.
Division of Cardiovascular Sciences
6701 Rockledge Drive, Suite 10018
Bethesda, MD 20892-7936
Telephone: (301) 435-6670
Fax: (301) 480-5158
Email: stoneyc@mail.nih.gov
National Heart, Lung, and Blood Institute (NHLBI)
Robert L. Tarwater
Lead Grants Management Specialist
Office of Grants Management
Division of Extramural Research Activities
6701 Rockledge Drive, Room 7150
Bethesda, Maryland 20892-7926
Telephone: 301-402-6090
Fax: 301-451-5462
Email: tarwater@nih.gov
National Human Genome Research Institute (NHGRI)
Joseph Campbell
5635 Fishers Lane Suite 4076, MSC 9305
Bethesda, Maryland 20892-9305
Rockville, Maryland 20852 (courier/overnight service)
Telephone: 301-443-6811
Fax: 301-480-2770
JOSEPHCAMPBELLARRA@mail.nih.gov
National Human Genome Research Institute (NHGRI)
Cheryl Chick
Chief Grants Management Officer
Grants Administration Branch, DER
5635 Fishers Lane, Ste. 3058
Bethesda, MD  20892-9307
Courier services should use:
Rockville, Maryland 20852
Telephone: 301-435-7858
Fax: 301-451-5434
Email: ChickC@mail.nih.gov
National Institute on Aging (NIA)
Lis Nielsen, Ph.D.
Division of Behavioral and Social Research
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax:301-402-0051
Email: nielsenli@nia.nih.gov
National Institute on Aging (NIA)
Jeff Ball
Grants & Contracts Management Branch
7201 Wisconsin Avenue, Room 2N212
Bethesda, MD 20892-9205 overnight mail use 20814
Telephone: (301) 402-7732
Fax: (301) 402-3672
E-mail: ballj@nia.nih.gov
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Ellen D. Witt, Ph.D.
Division of Neuroscience and Behavior
5635 Fishers Lane, Room 2055, MSC 9304
Bethesda, MD 20892-9304
Telephone:  301-443-6545
Fax: 301-443-1650
Email:  ewitt@mail.nih.gov
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Judy S. Fox
Chief, Grants Management Branch
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD  20892-9304
Telephone: 301-443-4704
Fax: 301-443-3891
Email: jfox@mail.nih.gov
National Institute of Allergy and Infectious Diseases (NIAID)
Sheryl Zwerski, M.S.N., C.R.N.P.
Division of Acquired Immunodeficiency Syndrome
6700B Rockledge Dr,   RM 5116
Bethesda, MD 20892-7628
Telephone: 301-402-4032
Fax: 301-496-8530
Email:  szwerski@nih.gov
National Institute of Allergy and Infectious Diseases (NIAID)
Jane Paull
Chief, Branch A, Grants Management Program
6700B Rockledge Drive, Room 2119, MSC7614
Bethesda, MD  20892-7614
(Express Mail:  Bethesda, MD  20817)
Telephone:  301-594-1544
Fax:  301-493-0597
E-Mail:  paullj@mail.nih.gov
National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS)
James Witter M.D., Ph.D.
6701 Democracy Boulevard
One Democracy Plaza, Suite 878
Bethesda, MD 20892-4872
Telephone: 301-594-1963
Fax: 301-480-4543
Email: witterj@mail.nih.gov
National Institute of Arthritis and
Musculoskeletal and Skin Diseases (NIAMS)
Yen Thach
6701 Democracy Boulevard
One Democracy Plaza, Suite 846
Regular Mail: Bethesda, MD 20892-4872
Express mail: Bethesda, MD 20817
Telephone: 301-594-3505
Fax: 301-480-5450
Email: thachy@mail.nih.gov
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Zeynep Erim, Ph.D.
Division of Interdisciplinary Training
6707 Democracy Boulevard, Room 200
Bethesda, MD 20892-5477
Telephone: 301-451-4797
Fax: 301-480-1614  
Email erimz@mail.nih.gov
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Florence T. Turska
Office of Grants Management
6707 Democracy Boulevard, Room 900
Bethesda, MD  20892-5469
Telephone: 301-496-9314 
Fax: 301-451-5735 
Email: ft7p@nih.gov

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Rosalind B. King, Ph.D.
Demographic and Behavioral Sciences Branch
6100 Executive Blvd., Room 8B07
Bethesda, MD 20892-7510
Telephone: (301) 435-6986
Fax: (301) 496-0962
Email: rozking@mail.nih.gov

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Bryan S. Clark, M.B.A.
Chief Grants Management Officer
6100 Executive Boulevard, Room 8A01A
Bethesda, MD 20892-7510
Rockville, MD 20852-7510 (for express mail or courier service)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov
National Institute on Deafness and Other Communication Disorders (NIDCD)
Daniel A. Sklare, Ph.D.
Research Training Officer
Program Director, Assessment and Management of Hearing and Balance Disorders
Division of Scientific Programs
Executive Plaza So, Rm 400C
6120 Executive Blvd, MSC-7180
Bethesda, MD 20892-7180 (for regular mail)
Rockville, MD 20852 (courier/express mail)
Telephone: 301-496-1804
Fax: 301-402-6251
Email: sklared@nidcd.nih.gov 
National Institute on Deafness and Other Communication Disorders (NIDCD)
Christopher Myers
Chief, Grants Management Branch
Division of Extramural Activities
Executive Plaza South, Room 400B
6120 Executive Blvd., MSC 7180
Bethesda, MD  20892-7180  
(20852 for express mail)
Telephone:  301-435-0713
Fax:  301-451-5365
Email: myersc@mail.nih.gov
National Institute of Dental and Craniofacial Research (NIDCR)
David Clark, Dr.P.H.
Behavioral and Social Sciences Research Branch
6701 Democracy Blvd, Room 650
Bethesda, MD 20892-4878
Telephone: (301) 594-4814
Fax: (301) 480-8319
Email: David.Clark2@nih.gov
National Institute of Dental and Craniofacial Research (NIDCR)
Diana Rutberg
6701 Democracy Blvd, Room 656
Bethesda, MD 20892-4814
Telephone: (301) 594-4798
Fax: (301) 480-3562
Email: rutbergd@nidcr.nih.gov
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Christine M. Hunter, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Disease
6707 Democracy Boulevard, Room 605
Bethesda, MD 20892-5460
Telephone: 301-594-4728
Fax: 301-480-0475
Email: hunterchristine@niddk.nih.gov
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Elizabeth Gutierrez
Grants Management Specialist
Grants Management Branch
6707 Democracy Boulevard, Room 605
Bethesda, MD 20892-5460
Telephone: 301-594-4728
Fax: 301-480-0475
Email: gutierrezel@niddk.nih.gov
National Institute on Drug Abuse (NIDA)
Allison Chausmer Hoffman, Ph.D.
Basic Neuroscience and Behavioral Research Division
6001 Executive Blvd, Room 4251, MSC 9555
Bethesda, MD 20892-9555
Telephone: 301-402-5088
Fax: 301-594-6043
Email: HoffmanAL@nida.nih.gov
National Institute on Drug Abuse (NIDA)
Carol Alderson
NIDA Grants Management Branch
6001 Executive Boulevard, 5th Floor, MSC 9560
Bethesda, MD 20892-9560
Telephone: 301-933-6196 
Fax: 301-594-6869
Email: ca10h@nih.gov
National Institute of Environmental Health Sciences (NIEHS)
Annette Kirshner, Ph.D.
Division of Extramural Research and Training
530 Davis Drive, Keystone Room 3020
Research Triangle Park, NC 27713
Telephone: 919-541-0488
Fax: 919-541-0462
Email: kirshner@niehs.nih.gov
National Institute of Environmental Health Sciences (NIEHS)
Dorothy Duke
Division of Extramural Research and Training
Street Address: 530 Davis Drive
Research Triangle Park, NC 27713
Telephone: 919-541-2749
Fax: 919-541-0462
Email: duke3@niehs.nih.gov
National Institute of General Medical Sciences (NIGMS)
Juliana M. Blome, Ph.D.
Office of the Director
Room 2AN.32F
45 Center Drive MSC 6200
Bethesda, MD 20892-6200
Telephone: (301) 594-2762
Fax: (301) 480-1852
Email: blomeju@mail.nih.gov
National Institute of General Medical Sciences (NIGMS)
Grace Olascoaga
Grants Administration Branch
Room 2AN 32C
45 Center Drive MSC6200
Bethesda, MD 20892-6200
Telephone: (301) 594-5520
Fax: (301) 480-2554
Email: olascoag@mail.nih.gov
National Institute of Mental Health (NIMH)
Andrew Rossi, Ph.D.
Division of Neuroscience and Basic Behavioral Science
Neuroscience Center, Room 7172
6001 Executive Blvd
Bethesda, MD 20892-9637
Telephone: 301-443-1576
Fax: 301-402-4740
Email: rossia@mail.nih.gov
National Institute of Mental Health (NIMH)
Rebecca Claycamp
Division of Extramural Activities
Neuroscience Center, Rm 6122
6001 Executive Blvd
Bethesda, MD 20892-9605
Telephone: 301-443-2811
Fax: 301-480-1956
Email: rclaycam@mail.nih.gov
National Institute of Neurological Disorders and Stroke (NINDS)
James Gnadt, Ph.D.
Program Director, Systems & Cognitive Neuroscience
2230 Neuroscience Center
6001 Executive Blvd
Rockville, MD 20892-9521
Telephone: 301-496-9964
Fax: 301-402-2060
Email: gnadtjw@mail.nih.gov
National Institute of Neurological Disorders and Stroke (NINDS)
Tijuanna Decoster
Grants Management Branch
3258 Neuroscience Center
6001 Executive Blvd
Rockville, MD 20892- 9537
Telephone: 301-496-9231
Fax: 301-402-0219
Email: decostert@mail.nih.gov
National Institute of Nursing Research (NINR)
Linda S. Weglicki, Ph.D., R.N.
Division of Extramural Activities
6701 Democracy Blvd, Room 710
Bethesda, MD 20892-4870
Telephone: 301-594-6908
Email: weglickils@mail.nih.gov
National Institute of Nursing Research (NINR)
Ron Wertz
6701 Democracy Blvd, Rm. 710
One Democracy Plaza
Bethesda, MD 20892-4870
(Courier use 20817)
Telephone: 301-594-2807
Fax: 301-402-4502
National Library of Medicine (NLM)
Dr. Valerie Florance
NLM Extramural Programs
6705 Rockledge Drive, Room 301
Bethesda, MD 20892
Telephone: 301-496-4621
Fax: 301-402-2952
Email: florancev@mail.nih.gov
National Library of Medicine (NLM)
Ebony Simmons
NLM Extramural Programs
6705 Rockledge Drive, Room 301
Bethesda, MD 20892
Telephone: 301-496-4221
Fax: 301-402-0421
Email: florancev@mail.nih.gov
Office of Behavioral and Social Sciences Research (OBSSR)
William N. Elwood, Ph.D.
Office of the Director
Suite B1-C19 (MSC 2027)
31 Center Drive, Room B1-C19
MSC 2027
Bethesda, MD  20892-2027
Telephone: 301-402-0116
Fax: 301-402-1150
Email: william.elwood@nih.hhs.gov
(n/a)
Office of Disease Prevention (ODP)
Barry Portnoy, Ph.D.
Office of the Director
6100 Executive Blvd, Room 2B03
Bethesda, MD 20892
Telephone: 301-402-4337
Fax: 301-480-7660
Email: portnoyb@od.nih.gov
(n/a)
Office of Research on Women's Health (ORWH)
Dennis F. Mangan, Ph.D.
6707 Democracy Blvd., Suite 400
Bethesda, MD  20892-5484
Telephone:  301-496-9006
Email: Dennis.Mangan@nih.gov
(n/a)

2. Peer Review Contact(s):

Estina Thompson PhD, MPH
Center for Scientific Review
6701 Rockledge Dr, Room 3178
Bethesda, MD 20892-7776
Telephone: (301) 496-5749
Email: thompsone@csr.nih.gov

Section VIII. Other Information


Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf

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 (45 CFR 46) 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 institutional review board (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/.

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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.

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.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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-09-116.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 Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). 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 (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 Sections 301 and 405 of the PHS Act, as amended (42 USC 241 and 284) and are subject to 42 CFR Part 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 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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.



[1] Formal application includes the preliminary application and letter of intent phases of the program.



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