Expired RFA-OD-10-003: 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)

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

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:

August 16, 2010 - 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.
See Notice NOT-OD-10-033 and Notice NOT-OD-10-032.

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

Purpose. This NIH Funding Opportunity Announcement (FOA), supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5, invites applications for short-term mentored career development (K18) awards in the basic behavioral and social sciences research (b-BSSR) from three months to one year in duration. The program targets established, mid-career and senior investigators, to support their development of research capability in b-BSSR. Two categories of candidates are targeted: (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 basic-BSSR into their research programs. 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 social 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; it is not intended as a substitute for research project support. This FOA is sponsored by the National Institutes of Health (NIH) Basic Behavioral and Social Science Opportunity Network ( OppNet ). OppNet strongly encourages investigators to consult NIH-OBSSR’s definitions related to b-BSSR for OppNet-related FOAs.
Mechanism of Support. This FOA will utilize the K18 grant mechanism.
Funds Available and Anticipated Number of Awards. OppNet intends to commit up to $2 million to this FOA. We anticipate that 10-20 awards will be made for fiscal year 2010, pending the number and quality of applications and availability of funds.
Budget and Project Period. Because the nature and scope of the proposed research and training plan will vary from application to application, it is anticipated that the size and duration of each award will also vary. Funding may be requested for between 3 months and one year.
Research Strategy Length: The K18 application Research Strategy and items 2-5 of the Career Development Supplemental Form component of the application may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts. Items 2-5 of the Career Development Supplemental Form include; Candidate’s Background, Career Goals & Objectives, Career Development/Training Activities During Award Period, and Training in the Responsible Conduct of Research.
Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply. Foreign institutions/organizations are not eligible to apply.
Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/ 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.
Number of PDs/PIs. Only one PD/PI may be designated on the application
Number of Applications. Candidates may submit only one application in response to this FOA.
Resubmissions. Because this is a one-time-only solicitation, resubmissions are not permitted.
Renewals. Renewals are not permitted in response to this FOA.
Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates.
Application Materials. See Section IV for application materials. All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the most current forms and instructions.
General Information. For general information on SF424 (R&R) Application and Electronic Submission, see these Web sites:
- SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm
- General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

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:

Sensation and perception
Emotion and motivation
Vulnerability and resilience
Attention, learning and memory
Ingestive, sexual and aggressive behaviors
Language development
Social influences and social cognition
Family processes and social networks
Sociocultural and environmental processes, population dynamics

(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:

Gene by environment interactions and correlations, including epigenetic effects, over time and lifespan developmental phases
Behavior genetics
Behavioral, cognitive, affective, social and economic neurosciences
Psychoneuroimmunology and psychoneuroendocrinology
Psychopharmacology
Behavioral cardiology
Social networks and the spread of vectors of disease

(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:

Research on methods for analyzing complex dynamic systems
Development or application of technologies, such as information technology, wearable sensors, or monitoring systems for data collection, harmonization, and measurement
Statistical modeling techniques
Development of innovative research designs (e.g., multi-method, multi-informant designs)
Methods to reduce sampling, survey, and item non-response bias in research studies
Development of new technologies, tools, and methods for observing and analyzing behavior
Qualitative and ethnographic methods
Development of novel animal models of behavior or translation of existing models toward new problems
Development of new measurement procedures for behavioral, neuropsychological, and social phenomena

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.

Public/State Controlled Institutions of Higher Education
Private Institutions of Higher Education
Hispanic-serving Institutions
Historically Black Colleges and Universities (HBCUs)
Tribally Controlled Colleges and Universities (TCCUs)
Alaska Native and Native Hawaiian Serving Institutions
Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
State Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribally Designated Organizations
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public Housing Authorities/Indian Housing Authorities
U.S. Territory or Possession
Indian/Native American Tribal Governments (Other than Federally Recognized)
Regional Organizations
Other(s):

Eligible Agencies of the Federal Government
Faith-based or Community-based Organizations

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:

Grants.gov (http://www.grants.gov/applicants/get_registered.jsp) and
eRA Commons (http://era.nih.gov/ElectronicReceipt/preparing.htm)

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

Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
Direct questions regarding Grants.gov registration to:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email [email protected]

2) Organizational/Institutional Registration in the eRA Commons

To find out if an organization is already Commons-registered, see the "List of Grantee Organizations Registered in NIH eRA Commons.
Direct questions regarding the Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. 8:00 p.m. Eastern Time
Email [email protected]

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.

Each PD/PI must hold a PI account in the Commons. Applicants should not share a Commons account for both a Signing Official (SO) role and a PI role; however, if they have both a PI role and an Internet Assisted Review (IAR) role, both roles should exist under one Commons account.
When multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization must be affiliated with that organization. PDs/PIs located at another institution need not be affiliated with the applicant organization, but must be affiliated with their own organization to be able to access the Commons.
This registration/affiliation must be done by the AOR/SO or his/her designee who is already registered in the Commons.

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 301-710-0267; Email: [email protected].

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:

Descriptive title of proposed career development and research project.
Name, address, and telephone number of the PD(s)/PI(s).
Names of other key personnel.
Participating institutions.
Number and title of this funding opportunity.

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: [email protected]

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 electronically. 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. 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 :

All registrations must be complete prior to the submission deadline
The application must receive a Grants.gov tracking number and timestamp (or eRA help desk ticket confirming a system issue preventing submission) by 5:00 p.m. local time on the submission deadline date.
Any system identified errors/warnings must be corrected and the submission process completed within the error correction window.

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:

Initial application submission must be on-time.
The AOR/institutions is expected to enforce that application changes made within the error correction window are restricted to those necessary to address system-identified errors/warnings. NIH may reject any application that includes additional changes.
Proof of on-time submission (e.g., Grants.gov timestamp and tracking number) and description of all changes made within the window must be documented in the PHS 398 Cover Letter component of the application.

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.

If everything is acceptable, no further action is necessary. The application will automatically move forward to the Division of Receipt and Referral in the Center for Scientific Review for processing after two weekdays, excluding Federal holidays.
Prior to the submission deadline, the AOR/SO can Reject the assembled application and submit a changed/corrected application within the two-day viewing window. This option should be used if it is determined that some part of the application was lost or did not transfer correctly during the submission process; the AOR/SO will have the option to Reject the application and submit a Changed/Corrected application. In these cases, please contact the eRA Help Desk to ensure that the issues are addressed and corrected. Once rejected, applicants should follow the instructions for correcting errors in Section 2.12, including the requirement for cover letters on late applications. The Reject feature should also be used if you determine that warnings are applicable to your application and need to be addressed now. Remember, warnings do not stop further application processing. If an application submission results in warnings (but no errors), it will automatically move forward after two weekdays if no action is taken. Some warnings may need to be addressed later in the process.
If the two-day window falls after the submission deadline, the AOR/SO will have the option to Reject the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.
If the AOR/SO chooses to Reject the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted, but it will be subject to the NIH Late Policyguidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment.
Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two weekdays.

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 Commons https://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:

Specific Aims is limited to 1 page.
Items 2-5 (Candidate's Background, Career Goals and Objectives, Career Development/Training Activities During Award Period, and Training in the Responsible Conduct of Research) and Item 11 (Research Strategy) are limited to a combined total of 12 pages, including tables, graphs, figures, diagrams, and charts.
While each section of the Candidate Information and Research Strategy components needs to be uploaded separately as a PDF attachment, candidates are encouraged to construct the Candidate Information component and the Research Strategy component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable candidates to better monitor formatting requirements such as page limits. 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

The following information must be included in the application:

Candidate:

Describe the candidate s commitment to a health- and lifecourse-related research scientist career with a focus on expected contributions in the basic behavioral and social sciences.
Discuss the candidate s research efforts and accomplishments in health- and lifecourse-related research to this point as an independent investigator, including publications, prior research interests and experience and history of research support.
Discuss the candidate s objectives and long term career plans, and how these relate to the proposed activities in the career enhancement award, with a focus on how the proposed work will advance understanding of basic mechanisms of behavioral and social processes that will have broad relevance to the NIH mission.
Present evidence of the candidate’s potential to augment his/her research career through this career enhancement award.
Include a statement that the candidate will commit 25-50% effort to the short-term career enhancement program and related activities. Include a description of the candidate s professional responsibilities and show their relationship to the proposed activities of the career enhancement award.
Provide evidence of the candidate’s ability to interact and collaborate with other scientists.

Career Enhancement/Development Plan:

Provide details of the career enhancement plan, tailoring it to the candidate’s goals, prior experience and career level, as well as the intent of the K18 award.
Provide a systematic plan for progression of research experiences for the period of the award and beyond to exploit the career enhancement activities provided by the K18, emphasizing the potential to advance knowledge about the nature of behavior and social systems or to deepen our understanding of basic mechanisms of behavioral and social processes.
Justify the need for further career enhancement in relation to the candidate’s future research goals.
The candidate and the mentor are jointly responsible for the preparation of the career enhancement plan. A timeline for the phasing of the training and research phases of the K18 should be included.

Research Plan:

A small scale/pilot research project in the basic behavioral and social sciences that is consistent with the goals of this FOA and the objectives of the career enhancement should be described. The project must include research in the basic behavioral and social sciences, and may take the form of a small scale or pilot project which would expand the research scope of a currently funded project(s).
Organize the research plan as indicated in the Form 398, following instructions for Specific Aims, Research Strategy, (Significance, Innovation, Approach) , to the extent possible and appropriate. The candidate should consult with the mentor regarding the development of this section.

Training in the Responsible Conduct of Research:

Applications must include a plan to obtain instruction in the responsible conduct of research.
This section should document prior instruction in responsible conduct of research during the applicant’s current career stage (including the date of last occurrence) and propose plans to receive instruction in responsible conduct of research
Such plans must address five instructional components (format, subject matter, faculty participation, duration of instruction, and frequency of instruction), as outlined and explained in NOT-OD-10-019.
The plan may include career stage-appropriate, individualized instruction or independent scholarly activities that will enhance the applicant s understanding of ethical issues related to their specific research activities and the societal impact of that research.
The role of the sponsor/mentor in responsible conduct of research instruction must be described.
Applications lacking a plan for participation or instruction in responsible conduct of research will be considered incomplete and may be delayed in the review process.
The background, rationale and more detail about instruction in the responsible conduct of research can be found in NOT-OD-10-019.

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

Candidates must name a primary mentor who, together with the applicant, is responsible for the planning, direction, and execution of the program. Candidates may also nominate co-mentors, as appropriate to the goals of the program.
The mentor should be recognized as an accomplished investigator in his or her scientific domain, and have a track record of success in training independent investigators.
Where feasible, women, individuals from diverse racial and ethnic groups and individuals with disabilities should be involved as mentors to serve as role models.
The application must include a statement from the mentor providing: (1) information on his/her research qualifications and previous experience as a research mentor; (2) a mentoring plan describing the content and nature of the mentoring that will occur during the proposed award period; and (3) The ongoing research activities and research grant support of the mentor, along with how the research activities of the candidate will dovetail with these.
Similar information must be provided by any co-mentor, if more than one mentor is proposed. The respective areas of expertise and responsibility of the primary mentor and co-mentor(s) should be described.
Signed statements should be provided by each consultant/collaborator confirming his/her role in the project.

Environment and Institutional Commitment to the Candidate:

Describe the resources and facilities that will be made available to the candidate.
Describe how the research environment of the host laboratory/research program and institution is particularly suited for the advanced development of the candidate’s research career and the pursuit of the proposed research plan. A Resources format page is required for the host laboratory/research program.
The candidate s institution must provide a clear and unambiguous statement of assurance that during the active period of the K18 award the candidate will be released from all administrative, teaching and/or clinical duties that infringe on his/her commitment to the award, and that he/she will be able to devote a minimum of 25-50% total annual effort to the research career enhancement program in b-BSSR. The institutional statement should also indicate what, if any, duties or commitments the candidate will continue to maintain, and how any grant related responsibilities will be delegated.

Letters of Reference:

Letters of reference are not required. However, the mentor should submit a letter outlining his/her support of the application.

Budget for the Entire Proposed Period of Support:

Within the direct cost limitations for research development support, provide a detailed description, with justification, for all equipment, supplies, and personnel that will be used to help achieve the career development and research objectives of the award.

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:

Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit will be discussed and assigned an overall impact/priority score;
Receive a written critique; and
Receive a second level of review by appropriate national advisory council(s) or boards(s).

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.

Candidate
Career Enhancement/Development Plan
Research Plan Strategy
Mentor, Co-Mentor(s), Consultant(s) and Collaborator(s)
Environment and Institutional Commitment to the Candidate

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:

Does the candidate have an established record as an independent and productive researcher, including ongoing and previous research support and publication output?
Is the candidate a mid-career or senior investigator (Associate Professor or Professor or equivalent in non-academic setting)?
Is there evidence of the candidate’s commitment to a health- and lifecourse-related research scientist career with expected contributions in the basic behavioral and social sciences?
Is there a discussion of the candidate’s objectives and long term career plans related to basic behavioral and social sciences and the OppNet goals?
Is there evidence of the candidate’s potential to shift the focus of their research direction within the basic behavioral and social sciences, or to add a basic and behavioral sciences research component to their clinical research, augmenting his/her current research program through this award?

Career Enhancement/Development Plan:

Are the content, goals, scope and phasing of the career development plan appropriate, and is there a likelihood that the award will contribute substantially to the development of a new area of research expertise in basic behavioral and social science for this candidate in a direction consistent with OppNet goals?
Is the planned duration (3 months - 12 months) appropriate relative to the stated training and career development goals? Is there a planned progression of research and training experiences?
Is there documentation and commitment to devote 25-50% effort to the career enhancement award plan?
Is there likelihood that the proposed experience will prepare the candidate to forge a substantive shift in research direction within the basic behavioral and social sciences or to learn new research skills relevant to their ongoing research program that will substantially impact their ability to pursue future research in the basic behavioral and social sciences?

Research Plan

Is the research plan appropriate for developing or enhancing basic behavioral and social sciences research skills as described in the career development plan, and developing a collaborative, interdisciplinary research program in the new research trajectory?
Are the scientific and technical merits of the research question, design, and methodology appropriate?
Is the research project to be conducted in a different institutional setting, or within a different department in the same institutional setting, from the candidate’s primary appointment?
Is the proposed research project likely to advance knowledge of the nature of behavioral and social systems and deepen our understanding of mechanisms of behavioral and social processes?
Is the proposed research a novel extension of the research of the candidate? In cases where the candidate and the proposed host laboratory/research program have previous research collaborations, is there sufficient justification as to why this program will facilitate career development that could not be achieved solely through a research grant mechanism.

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

Are the mentor(s) research qualifications in the area of the proposed research appropriately strong, including evidence of an established, active research program in the relevant domain or discipline?
Is there evidence of the mentor(s) commitment to provide the proposed training?
Is a signed statement from each mentor included in the application addressing his/her research qualifications, experience as a mentor, a mentoring plan, an overview of the mentor’s ongoing research activities and grant support, and confirming their role?

Environment and Institutional Commitment

Is there a clear commitment of the candidate’s institution to ensure that 25-50% of the candidate’s effort will be dedicated to the research career enhancement plan during the active period of the award?
Does the mentor(s) institution have adequate and appropriate research facilities for the proposed research plan?
Is there evidence of institutional commitment to the candidate’s career development in the new research trajectory?
Are the research facilities and training opportunities available to the candidate at the location where the research is to be conducted (i.e., mentor s institution) of high quality and appropriate to the planned research?

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:

Data Sharing Plan: Not Applicable.
Sharing Model Organisms. [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html]
Genome Wide Association Studies (GWAS). [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html]

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:

Scientific and technical merit of the proposed project as determined by peer review.
Availability of funds.
Relevance of the proposed project to program priorities.

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:

The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.
The funds may be used for health-related research purposes.
The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment.

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:

A relinquishing statement is submitted by the original institution and a transfer application is submitted by the new institution at least three months prior to the transfer in order to allow the necessary time for administrative review by the NIH awarding Institute or Center.
The awardee must establish in the transfer application that the specific aims of the research program to be conducted at the new institution are within the scope of the original peer-reviewed research program, and that a new mentor has been identified who has the appropriate research expertise and support to provide adequate guidance to the awardee and research support for the awardee's research program.
All conditions of the award are met at the new institution.
The period of support requested is no more than the time remaining within the existing award.

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):

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: [email protected]

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.

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: [email protected]	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: [email protected]
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: [email protected]	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 : [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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 [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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 [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]
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: [email protected]	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: [email protected]	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: [email protected]
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: [email protected]	(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: [email protected]	(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: [email protected]	(n/a)