Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Library of Medicine (NLM)
Office of Dietary Supplements (ODS)
Office of Research on Women’s Health (ORWH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title

Opportunities for Collaborative Research at the NIH Clinical Center (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of PAR-13-029

Related Notices

  • August 18, 2014 - See Notice NOT-LM-14-004. Updated to include NLM's participation in this PAR.
  • May 9, 2014 - Notice of Change in Eligibility for PAR-13-358. See Notice NOT-HD-14-015.
  • January 17, 2014 - See Notice NOT-DK-14-011. Notice of NIDDK Participation.
  • January 13, 2014 - See Notice NOT-HD-14-001. Notice of Change to Instructions regarding Letters of Intent and Letters of Support.
  • January 3, 2014 - See Notice NOT-LM-14-001. Notice to Discontinue Participation of NLM.
  • October 31, 2013 - See Notice NOT-HD-13-018. Rescheduled Pre-application Webinar.
  • October 17, 2013 - See Notice NOT-DE-13-006. Notice of NIDCR Participation.
  • September 26, 2013 - See Notice NOT-HD-13-016, Pre-application Webinar.
  • September 23, 2013 - See Notice NOT-HD-13-015. Notice of Additional Institute and Center Participation.
  • July 25, 2013 - See Notice NOT-HD-13-009. Changes made to application process for next year's competition.

Funding Opportunity Announcement (FOA) Number

PAR-13-358

Companion Funding Opportunity

PAR-13-357, X02 Pre-application

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.865; 93.233; 93.839; 93.838; 93.837; 93.286; 93.856; 93.855; 93.273; 93.173; 93.399; 93.396; 93.395; 93.394; 93.393; 93.172; 93.279; 93.879; 93.173; 93.242; 93.853; 93.121; 93.847  

Funding Opportunity Purpose

The goal of this program is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health.  It encourages high quality science demonstrating the potential to result in understanding an important disease process or lead to new therapeutic interventions, diagnostics, or prevention strategies within the research interests and priorities of the participating NIH Institutes/Centers (ICs).

Specifically, the program seeks to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science by promoting partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs outside the NIH), and by providing support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting research projects in collaboration with NIH intramural investigators.

In order to be eligible for this program, the application must include at least one intramural scientist as Program Director/Principal Investigator or collaborator, and at least some of the research must be conducted at the NIH Clinical Center.  Through this collaboration, external researchers may gain access to the NIH Clinical Center and leverage the diverse Clinical Center resources, expertise, and infrastructure available to test promising laboratory- and animal-based discoveries with potential for advancing disease diagnosis, treatment and prevention.  The special environment of the Clinical Center can support studies that may not be readily supported elsewhere.

The companion FOA (PAR-13-357) encourages X02 pre-applications for Opportunities for Collaborative Research at the NIH Clinical Center.  The X02 pre-application is the recommended (not required) first step in the application process for this FOA.  Potential applicants should read both FOAs.  Investigators whose X02 pre-applications are meritorious, can be supported by the resources of the NIH Clinical Center, and align with the research missions of the participating NIH ICs, will be notified of the opportunity to submit a U01 application to this FOA.

Key Dates
Posted Date

September  20, 2013

Open Date (Earliest Submission Date)

February 20, 2014  

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

March 20, 2014, March 20, 2015, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

March 20, 2014, March 20, 2015, by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Scientific Merit Review

June/July 2014, June/July 2015  

Advisory Council Review

October 2014, October 2015   

Earliest Start Date

November/December 2014, November/December 2015 

Expiration Date

March 21, 2015 

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.


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Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose/Research Objectives

The goal of this funding opportunity announcement (FOA) is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. This opportunity is specifically to promote partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs and clinics outside of the NIH).  It will provide support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting research projects in collaboration with NIH intramural investigators.  

While translating basic research into clinical practice is increasingly difficult, time consuming, and expensive, translational research is crucially important in converting basic scientific discoveries into new diagnostics and therapies for patients.  As such, this FOA intends to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science. All teams will have at least one intramural and one extramural investigator.

This grant program will provide access for external researchers to the NIH Clinical Center and will leverage the diverse Clinical Center resources, expertise, and infrastructure available to test promising laboratory- and animal-based discoveries with potential implications for disease diagnosis, treatment and prevention. The NIH Clinical Center is a hospital exclusively dedicated to clinical research, thus research is the culture and research studies are routine. Its mission includes the support of clinical studies that are considered intellectually challenging and risky but with the potential of high reward with new breakthroughs in medicine. The special environment of the Clinical Center supports studies that may not be readily supported elsewhere. Examples include a host of special resources, such as:

For entry to the program, projects must have a collaborating Investigator in the NIH Intramural Program.  As a collaborative partner, the intramural investigator will be actively involved in the planning and execution of the research project.

Applications for this program will be submitted by the extramural institution with the participation of the intramural investigator(s) integrated into the application as described in the Collaboration Plan, and with the budget requirements for the NIH Clinical Center and intramural investigators included in the Budget form of the application.  Funded projects will include an award to the applicant organization which will exclude funds to support the participation of the Clinical Center.  Support for intramural participation will be provided by a budget allocation within the NIH.  Annual progress reports will be prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of which Clinical Center unique resources were utilized and any new intramural-extramural partnerships that developed.

Specific Areas of Interest

Awards for high quality science demonstrating the potential to result in understanding an important disease process or lead to a new therapeutic intervention will be available in topics relevant to the research interests and priorities of the participating NIH Institutes/Centers (ICs), to include:

NCI

The National Cancer Institute (NCI) invites applications in research areas relevant to the Institute’s mission, which is to provide global leadership for research, training, health information dissemination, and other programs with respect to the cause, prevention, diagnosis, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.  The NCI encourages bench-to-bedside research to: increase understanding of the molecular and physiological basis of health and disease; stimulate clinical discoveries about the mechanisms underlying disease to develop improved prevention, diagnosis, and treatment; enable the translation of basic discoveries into clinical practice for the benefit of personal and public health; foster training and mentoring of emerging scientists and physicians; and communicate research advances to the public.  The NCI Vision and Priorities are found at http://www.cancer.gov.

NEI

The National Eye Institute’s mission is to “conduct and support research, training, health information dissemination, and other programs with respect to blinding eye diseases, visual function, preservation of sight, and the special health problems and requirements of the blind.”  Specific areas of interest include:

NHGRI

The National Human Genome Research Institute research areas of interest include: biochemical genetics, vesicular trafficking defects, pigment defects, storage diseases, holoprosencephaly, and autoinflammatory diseases.  More detail may be found in the NHGRI website, at: www.genome.gov

NHLBI

The National Heart, Lung, and Blood Institute (NHLBI) invites applications in research areas relevant to the Institute’s mission, which is to provide global leadership for a research, training, and education program to prevent and treat heart, lung, blood, and sleep disorders and diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI encourages basic research to increase understanding of the molecular and physiological basis of health and disease; stimulates clinical discoveries about the mechanisms underlying disease to develop improved prevention, diagnosis, and treatment; enables the translation of basic discoveries into clinical practice for the benefit of personal and public health; fosters training and mentoring of emerging scientists and physicians; and communicates research advances to the public. Specific research interests of the Institute are identified in the NHLBI Strategic Plan (http://www.nhlbi.nih.gov/about/strategicplan/index.htm).

NIAAA

The National Institute on Alcohol Abuse and Alcoholism invites translational, collaborative research projects aimed at reducing alcohol related problems in a wide range of scientific areas including genetics; neuroscience; epidemiology; health risks and benefits from alcohol consumption on prevention and treatment.  Of particular interest are studies which increase the understanding of normal and abnormal biological functions and behavior relating to alcohol use as well as improving the diagnosis, prevention and pharmacological treatment of alcohol use disorders across the lifespan.

NIAID

The mission of the National Institute of Allergy and Infectious Diseases (NIAID) is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. To accomplish its mission, NIAID conducts and supports a comprehensive portfolio of research on the biology, pathogenesis, and host response to microbes; the mechanisms of normal immune function and immune dysfunction resulting in autoimmunity, immunodeficiency, allergy, and transplant rejection; and translational research to develop vaccines, therapeutics, and diagnostics to prevent and treat the many infectious, immune-mediated, and allergic diseases that afflict people throughout the world.  Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID http://www3.niaid.nih.gov/about/whoWeAre/planningPriorities/.)

NIAMS

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases.  Areas of particular interest to the NIAMS intramural clinical program which would enhance the use of Clinical Center resources include studies on the genetics, genomics, prevention, and treatment of immune deficiencies associated with inflammation, systemic lupus erythematosus, inflammatory muscle disease, genetic autoinflammatory diseases, osteoporosis, ankylosing spondylitis and spondyloarthropathies, and the development and use of stem cells in therapy.

NIBIB

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) seeks to improve human health through the development and acceleration of applications of biomedical technologies. The Institute is committed to integrating engineering and physical sciences with the life sciences to advance basic research and medical care. The NIBIB Intramural Research Program plays a key role in fulfilling the Institute’s mission, particularly to advance knowledge in imaging and bioengineering research using a combination of basic, translational, and clinical science and to develop effective training programs in related fields.  Advanced imaging resources at the NIH Clinical Center available for investigators include high field MR imaging, MRI/PET, advanced cardiovascular CT/ MRI/ PET capability, and interventional oncology capabilities.  Multiple cyclotrons are on-site, and advanced radiotracer synthesis is available for application in oncology, neurological, cardiovascular, and infectious disease research.  Image processing services are available for 3D analysis and processing, as well as transfer/ storage of large scale image data.  More information about research conducted by NIBIB intramural investigators can be found at http://www.nibib.nih.gov/Research/Intramural.

NICHD

The Eunice Kennedy Shriver National Institute of Child Health and Human Development invites research project grant applications in research areas relevant to the institute’s scientific objectives. The general mission of NICHD is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives. In pursuit of these goals, NICHD supports a broad spectrum of research on normal and abnormal human development, including contraception, fertilization, pregnancy, childbirth, prenatal and postnatal development, childhood development through adolescence, and research on intellectual and developmental disabilities.

NIDA

The National Institute on Drug Abuse is interested in collaborative translational projects addressing programmatic priorities of the Institute. NIDA's mission is to lead the Nation in bringing the power of science to bear on drug abuse and addiction. To achieve this mission, NIDA encourages researchers to build strategic alliances, including those with the NIH Clinical Center that will increase the pace at which translational research findings can become clinical applications that improve community and population health. The research areas of focus for this FOA include neuroscience, human genetics, imaging, medication development, the comorbidity of HIV and substance use, and the intersection of pain, analgesia and addiction.

NLM

For this initiative, the National Library of Medicine is interested in projects relating to enhancement or use of electronic health records.

ORWH

Office of Research on Women’s Health (ORWH) is responsible for fostering and facilitating research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) through the Trans-NIH ME/CFS Working Group (WG).  One of the goals of the WG is to increase focus on collaborative ME/CFS research by identifying NIH resources that may be useful to advance the translational research within this field. ORWH encourages applications from investigators to address research questions focused on the etiology, diagnosis, underlying mechanism, or treatment of ME/CFS.

For more complete listing of resources in these areas at the NIH Clinical Center and for assistance in identifying intramural scientists for possible collaboration, please refer to the web-based listing of resources.         

IMPORTANT: Applicants are strongly encouraged to consult with the Scientific/Research Contacts for the area of science for which they are planning to develop an application. Early contact provides an opportunity for IC staff to discuss the program scope and goals, and to provide information and guidance. Other aspects of an application that are unique to this program including collaboration with Intramural Investigators may also be discussed.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets need to reflect the actual needs of the proposed project.  The maximum amount available per application is $500,000 direct costs (exclusive of any contract/consortium F&A) per year for a period of up to 3 years; this amount includes Clinical Center costs and intramural investigator's costs attributed to the proposed research project.

The NIH Clinical Center costs and intramural investigator's costs will not be included in the award paid to the grantee. 

Award Project Period

The scope of the proposed project should determine the project period.  The maximum project period is three years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This program requires the full collaboration of the (extramural) PD/PI of the applicant institution and the intramural investigator.  Accordingly, the Multiple PD/PI model is strongly encouraged but not required.  For those applicants opting not to use the Multiple PD/PI model, the intramural investigator can hold any role other than the PD/PI role.  

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Other Attachments: The following attachments should be included, as applicable.

Collaboration Plan

Applications must include a proposed Collaboration Plan, describing how the proposed collaboration will be maintained throughout the duration of the award.  The following areas should be addressed:

The filename "Collaboration Plan-PI-NAME.pdf" should be used and will be reflected in the final image bookmarking for easy access by reviewers. 

Clinical Protocol Synopsis

The clinical protocol synopsis should be included as an attachment.  The filename "ClinicalProtocolSynopsis-PI-NAME.pdf" should be used. If the research includes a clinical protocol, applications that lack the Clinical Protocol Synopsis will not be peer reviewed. The clinical protocol synopsis must include the following information:

Statistical Analysis Plan

A statistical analysis plan should also be provided in the application as an attachment."  The filename "StatisticalAnalysisPlan-PI-NAME.pdf" should be used.  This plan is critical to knowing whether applicants have selected the correct cohort size based on proper power calculations and/or are using the most appropriate methods to analyze the resulting data and make correct conclusions at the end of the study.  The ability to make conclusions of primary outcomes other than safety will be particularly important in small studies.

Data and Safety Monitoring (DSM) Plan

If the research includes a clinical protocol, a Data and Safety Monitoring (DSM) Plan should be included as an attachment.  The filename "DSMplan-PI-NAME.pdf" should be used.  The DSM plan should be commensurate with the risk level of the proposed clinical research must be included for all clinical trials (see http://grants.nih.gov/grants/guide/notice-files/not98-084.html). All applications or study protocols must include a general description of the monitoring plan, policies, procedures, responsible entities, and approaches to identifying, managing and reporting reportable events (adverse events and unanticipated problems), to the applicable regulatory agencies (e.g., Institutional Review Board (IRB)), the Office of Biotechnology Activities (as appropriate), the Office of Human Research Protections, the Food and Drug Administration, and the Data and Safety Monitoring Board (if one is used).

The DSM Plan must address the following areas:

Milestone Plan and Complete Clinical Protocol for Projects Involving Clinical Trials

If the research includes a clinical protocol, a Milestone Plan and Complete Clinical Protocol must be included as a single attachment.  The filename "MilestonePlan&ClinicalProtocol-PI-NAME.pdf" should be used.  Applications that lack the Milestone Plan and/or the Complete Clinical Protocol will not be reviewed.

Applicants are required to provide detailed project performance and timeline objectives in a section entitled “Milestone Plan”. This section must include:

If a protocol is part of the grant, the complete Clinical Protocol must be included immediately after the Milestone Plan. Investigators are referred to the Trans-NIAID Clinical Research Toolkit for examples of clinical protocol guidance and templates. Investigators are urged to be succinct.

Additional Guidance about the Clinical Protocol

There may be situations where the complete Clinical Protocol is not available at the time of submission -- for example, if the protocol cannot be developed until after results have been obtained from basic research that is being proposed.  In such a situation, the attachment should provide a justification to explain why the Clinical Protocol is not available and the Milestones should address when the Clinical Protocol will be finalized.  Failure to address this could adversely affect the score.

Extramural Collaborations Budget Template

Applications must include the completed Extramural Collaborations Budget Template, identifying all Clinical Center related costs.  Guidance on developing this attachment may be found under "NIH Clinical Center Costs" in the R&R Budget instructions, below.  Applicants should also attach any additional Clinical Center cost justifications and documentation.  The filename "BudgetTemplate.xls" should be used.  A .pdf of the Budget Template is also acceptable.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

Because of the anticipated complexity of the budget information and the need to clearly delineate costs for the extramural awardee, the intramural investigator, and the NIH Clinical Center, applicants will need to submit a detailed R&R budget.  Submission of a Modular Budget is NOT allowed for this FOA. 

The budget request for this FOA must distinguish between extramural costs, the NIH intramural investigator costs, and NIH Clinical Center costs.  Extramural costs are associated with the extramural investigator and the applicant organization. NIH intramural investigator costs are those required by the intramural investigator for carrying out the proposed work and which are specifically identified with the project. NIH Clinical Center costs are additional costs to the Clinical Center that directly result from the proposed research project.  The total of all three types of cost shall not exceed $500,000 (direct costs) per year.

Extramural Grantee Costs

Extramural costs may include such items as salary support for the extramural PD/PI and staff at the applicant organization, supplies, laboratory animals, data analysis, and other allowable costs for work performed at the (extramural) applicant organization, as well as travel costs for the extramural investigator(s).  Extramural costs would also include travel costs for any patients not already at the NIH Clinical Center.

Intramural Investigator Costs

Intramural investigator costs may include salary for contract staff to be specifically hired under a temporary appointment for the project, consultant costs, supplies, and other items typically listed under Other Expenses.  Budget requests from the NIH intramural program may not include any salary and related fringe benefits for career, career conditional or other federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative costs).  Although the budget request may not include salary support for such individuals, it should indicate person months for any key personnel.  Resources required need to be determined before the research protocol can be approved by the respective NIH Institute/Center.  Once the intramural investigator costs are known, the extramural applicant will enter this amount as a "subaward" budget in the application, and attach appropriate justification and documentation, including any spreadsheets as appropriate.

NIH Clinical Center Costs

Clinical Center costs include inpatient services, outpatient and day hospital services, pharmaceuticals, specialized research services, and other additional costs incurred by the Clinical Center as a result of the proposed research project.  Resources required need to be determined before the research protocol can be approved by the Clinical Center.  The collaborating intramural PD/PI is responsible for coordination with the Clinical Center (ClinicalCtrPartner@mail.nih.gov) to assure that all NIH Clinical Center related costs are clearly identified and documented.  The extramural applicant should work with the intramural investigator to complete the Extramural Collaborations Budget Template, to identify the NIH Clinical Center related costs.  Once the Clinical Center costs are known, the (extramural) applicant will enter this amount as a "subaward" budget in the budget section of the application, using "NIH Clinical Center Costs" as the descriptor.  The extramural applicant must attach the Budget Template and any additional justification and documentation to the application.  Applicants should allow sufficient time to identify and calculate these costs.  More detailed information about Clinical Center costs may be found at: http://www.cc.nih.gov/translational-research-resources/funding.html.

F&A (Indirect) Costs: Applicant organizations are reminded that Facilities and Administrative (F&A) or “indirect costs” are allowable for only the allowable extramural costs of the project.  F&A will not be paid for any NIH Clinical Center services or intramural investigator costs.

Budget Justification: Detailed information about intramural investigator costs and NIH Clinical Center costs should be included in the narrative "Budget Justification" section.

Additional Guidance on Budget Preparation

The budget requests for this FOA are more complex and will require more coordination than those of other grant programs.  Therefore, extramural investigators are encouraged to begin discussions about logistics and budget issues with their intramural collaborators and with NIH staff in the early phases of application preparation.  Calculation of the Clinical Center costs will require detailed coordination between the intramural investigator and the Clinical Center Office of the Chief Financial Officer, and sufficient time should be allowed for this process.  Specific questions about budget preparation may be addressed to the Agency Contacts listed in Section VII or to ClinicalCtrPartner@mail.nih.gov

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Consortium Contractual Arrangements: The Clinical Center cost spreadsheets may be appended in the Research Plan Attachments.

Letters of Support: Applications submitted in response to this FOA must include a letter from the Director of the NIH Clinical Center and a letter from the respective NIH Institute/Center to confirm that the Clinical Center facilities will be able to accommodate the proposed research and that the intramural scientist from the respective NIH Institute/Center will be able to collaborate on the project.  Both letters must be included in the "Letters of Support" attachment for the PHS 398 Research Plan.  APPLICATIONS SUBMITTED WITHOUT BOTH LETTERS WILL BE CONSIDERED INCOMPLETE AND WILL NOT BE REVIEWED.

In addition, letter(s) from the collaborating intramural investigator(s) along with any other collaborators/consultants should also be included in the "Letters of Support" section.

For those applicants who submit an X02 pre-application, as described in the companion FOA (PAR-13-357), their X02 pre-application will also be considered as a request for the required letters of support.    

Applicants who do not submit an X02 pre-application may send requests for Collaboration Letters to:

Pat Piringer, RN, MSN
Special Assistant to the Director
NIH Clinical Center
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide, with the following modification(s):

If the research plan includes a clinical protocol, the following additional documents should be included in the Appendix material:

If any of these documents are not available at the time of submission, the applicant should attach a justification and the Milestone Plan should address when these materials will be available.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

If an award is made, the grantee will receive only the extramural costs and associated F&A.  The NIH Clinical Center and the intramural investigator’s costs associated with the research project will not be paid to the grantee, but instead will be supported directly by the awarding NIH Institute/Center.  The Clinical Center and intramural investigator costs will not appear in the Notice of Award.  

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are strongly encouraged to submit well before the submission deadline (days, not hours) and to remember that on high volume submission due dates, it may take a few hours for the application to process through both Grants.gov and eRA Commons. Applicants should be sure to take this processing time into consideration and leave enough time to make any corrected submissions that might be needed to ensure submission of an error-free application by the deadline.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, please note the additional questions listed under "Approach" below.

Overall Impact

Reviewers will provide an overall impact 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 review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

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

In addition:

Is the Collaborative Plan well defined with identifiable responsibilities for the NIH intramural investigator and the extramural applicant?

Is a plan for management of the collaboration clearly presented, with well-defined  descriptions of what each participant proposes to provide to the collaborative partnership?

Is there a clear and well described advantage to bringing the intramural and extramural investigators together in a collaborative partnership?

Is it clear which unique research opportunities in the NIH Clinical Center will be utilized?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?   

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by  the Center for Scientific Review or an appropriate IC Scientific Review Group(s), in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

Additional information that may be required as part of “just-in-time” procedures includes:

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

If an award is made, the grantee will receive only the extramural costs and associated F&A.  The NIH Clinical Center and the intramural investigator's costs associated with the research project will not be part of the extramural NoA or paid to the grantee, but instead will be supported directly by the awarding NIH Institute/Center. 

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.      

The PD(s)/PI(s) will have the primary responsibility for:

The PD(s)/PI(s) will have the primary responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.

Awardees are responsible for identifying specific milestones toward disease intervention that will be achieved during the project period.

Awardees agree to participate in the overall coordination of research efforts. This participation includes collaboration and consultation with NIH investigators, and the sharing of information, data, and research materials.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIH intramural scientist is expected to have primary responsibility for a substantial portion of the proposed research, and provide advice and technical assistance as needed.  The NIH intramural scientist will also participate in the analysis, interpretation, and reporting of findings in the scientific literature, to the community at large and to the public policy community within the Federal government through various media, as appropriate.  The NIH intramural scientist is subject to the same publication/authorship policies as the official NIH publication policy.

The NIH Program Officer will have substantial involvement in the study and will be responsible for the normal scientific and programmatic stewardship of the award.  The Program Officer will have decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property issues. The responsibility for final decision making may reside with Senior Institute management, separate organizational components and/or oversight committees.

The NIH reserves the right to phase out or curtail the study (or an individual award) in the event of (a) failure to develop or implement a mutually agreeable protocol, (b) substantial shortfall in subject recruitment, consortium participation and collaboration with other awardees, (c) substantive changes in the agreed-upon methodologies and tools with which NIH cannot concur, (d) human subject ethical issues that may dictate a premature termination, or (e) results that substantially diminish the scientific value of study continuation.

Areas of Joint Responsibility include:

Since the purpose of this FOA is to establish and/or further develop collaborative arrangements between extramural and intramural investigators, many responsibilities are shared between awardees and NIH staff and will require close coordination.  Responsibilities will be divided between awardees and NIH staff, as described above.

Annual progress reports will prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of what Clinical Center unique resources were utilized and the new intramural-extramural partnerships that developed.  This will be evaluated by the program official/IC program director.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

T&C Inclusions and Modifications

The Terms and Conditions of Award will include references to the currently approved versions of the Collaboration Plan and the Multiple PD(s)/PI(s) Leadership Plan, if applicable, and the Sharing Plans for Resources and Data.  Before the initial award is made, NIH and the awardees may negotiate changes or additions to the versions of these plans in the application.  Future changes or additions to these plans may be developed by the NIH and the PD(s)/PI(s).  Changes will be documented by an exchange of correspondence and the updated plans will become part of the Terms and Conditions of a revised Notice of Award.

Program Evaluation

In addition to ongoing monitoring by program staff, the NIH plans to conduct a prospective and comprehensive evaluation of the Opportunities for Collaborative Research at the NIH Clinical Center (U01) program, including (but not necessarily limited to) the processes supporting the collaboration and the various types of projects and their outcomes relative to meeting the strategic goals of this announcement.  Accordingly, potential areas of interest to this evaluation may include understanding how and which research review, funding, or administrative processes and procedures influenced the outcomes of the collaborations; and identifying the scope and impact of the research projects that were implemented – their publications; the range and types of resources utilized, including patient; and the formation of new research partnerships.  To support this effort, the NIH will request that grantees participate in various aspects of the evaluation.  In addition, awardees are hereby notified that they may be contacted during or after the completion of this award for information helpful in assessing the program’s overall impact.

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

Annual progress reports will be prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of what CC unique resources were utilized and any new intramural-extramural partnerships that developed.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

NIH Clinical Center

Pat Piringer, RN, MSN
Special Assistant to the Director
NIH Clinical Center (CC)
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov

NICHD

Constantine A. Stratakis, MD, D(Med)Sc
Director, Division of Intramural Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-594-5984
Email: stratakc@mail.nih.gov

Catherine Y. Spong, MD
Director, Division of Extramural Research
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6894
Email: spongc@mail.nih.gov

Eugene G. Hayunga, PhD
Director, Office of Extramural Policy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6856
Email: ehayunga@mail.nih.gov

NCI

Lee Helman, MD
National Cancer Institute (NCI)
Center for Cancer Research
Telephone: 301-496-4257
Email: helmanl@mail.nih.gov

Minkyung (Min) H. Song, PhD,
Division of Cancer Treatment and Diagnosis
National Cancer Institute (NCI)
Telephone: 240-276-6139
E-mail: songm@mail.nih.gov

NEI

Donald F. Everett, MA
Director, Collaborative Clinical Research Program
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: dfe@nei.nih.gov.

NHLBI

Michelle Olive, PhD
Program Director
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0550
Email: olivem@mail.nih.gov

NHGRI

Dan Kastner, MD, PhD
Division of Intramural Research
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-2023
Email: kastnerd@mail.nih.gov

Bettie J. Graham, PhD
Division of Extramural Research
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email: bettie_graham@nih.gov

NIAAA

Raye Z. Litten, PhD
Associate Director
Division of Treatment and Recovery Research
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0636
BlackBerry: 240-393-7018
Email: rlitten@mail.nih.gov

NIAID
H. Clifford Lane, MD
Deputy Director for Clinical Research
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-7196
Email: clane@niaid.nih.gov

NIAMS

Susana Serrate-Sztein, MD
Director, Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: szteins@mail.nih.gov

Richard Siegel, MD, PhD
Chief, Immunoregulation Section  
Clinical Director, NIAMS
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301 496-3761
Fax 301-451-5394 
Email: rsiegel@nih.gov

NIBIB

Steven Krosnick, MD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Extramural Science Programs
Telephone: 301-594-3009
Email: krosnics@mail.nih.gov

NIDA

Raul Mandler, MD
National Institute on Drug Abuse
Center for Clinical Trials Network
Telephone: 301-435-0645
Email: mandlerr@mail.nih.gov

NLM

Dr. Hua-Chuan Sim
NLM Extramural Programs
Telephone: 301-594-4882
Email: simh@mail.nih.gov

ORWH

Susan E. Maier, PhD
Associate Director for Special Projects
Office of Research on Women’s Health (ORWH)
Telephone: 301-435-1573
Email: Susan.Maier@nih.gov   

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

NICHD

Bryan S. Clark, MBA
Chief Grants Management Officer
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

NHLBI

Ms. Suzanne White
National Heart, Lung, and Blood Institute
Division of Extramural Research Activities (DERA)
Office of Grants Management
Telephone: 301-435-0166
Email: whitesa@mail.nih.gov

NHGRI

Cheryl Chick
Grants Administration Branch
National Human Genome Research Institute
Telephone: 301-435-7858
Email: cc149o@nih.gov

NEI

Mr. William Darby
Grants Management Officer
National Eye Institute
Telephone: 301-451-2020
Email: darbyw@nei.nih.gov.

NIAID

Ms. Tina M. Carlisle
Lead, Grants Management Specialist
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-402-6579Email: tc48k@nih.gov

NIAMS

Mark Langer
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-451-8216
Email: langerM@mail.nih.gov

NIBIB

Angela M. Eldridge
Grants Management Specialist
National Institute of Biomedical Imaging and Bioengineering
Telephone: 301-451-4793
Email: Angela.Eldridge@nih.gov

NLM

Mr. Dwight Mowery
NLM Extramural Programs
Telephone: 301-496-4221
Email: moweryd@mail.nih.gov   

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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