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.

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

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 must have at least one intramural and one extramural investigator.

This 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. This may include collaborations that propose targeted increases in new patients enrolled in protocols at the Clinical Center. Examples of the special resources of the Clinical Center include:

• Large cohorts of patients, including studies of >500 rare diseases;
• A good manufacturing practices (GMP) pharmacy facility for new biological or clinical products;
• Specialized clinical phenotyping facilities (including a metabolic and other units);
• The manufacturing and use of newly designed PET ligands for imaging studies;
• The availability of blood products for special research studies;
• Collaborative opportunities on clinical protocols on unique pharmaceutical agents and/or other modes of therapy, or extraordinarily rare diseases with investigators who are known experts;
• A robust training curriculum in clinical research;
• The ability to support long-term clinical studies at minimal cost to patients and their families.
• On-campus amenities (e.g., Family Lodge and Children s Inn) to assist patients and families in supportive, home-like environments as they leave their own homes to participate in clinical research; and
• A number of other resources.

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 through the U01 FOA in topics relevant to the research interests and priorities of the participating NIH Institutes/Centers, 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:

• Eye movement recording facility including stimuli presentation, video and eye coil recording equipment, and software to analyze the recordings is available for collaborative research in eye movement research;
• Collaborative genetic research through eyeGENE;
• Collaborative research using cohorts of children and adults with inherited eye diseases and ocular malformations including but not limited to: uveal coloboma, Stargardt disease/ABCA4 retinopathy, for spinocerebellar ataxia, type 7 (SCA7), albinism, and modeling disease pathogenesis using induced pluripotent (iPS) cells derived from patients;
• Collaboration in ongoing studies with a focus on retinal vascular diseases and uveitis.
• Examples can be found at: http://clinicalstudies.info.nih.gov/cgi/protinstitute.cgi?NEI.0.html
• Collaborative research using cohorts of children with ocular inflammatory disease, including juvenile ideopathic arthritis (JIA) as well as monogenic disorders
• Collaboration in evaluating African Americans with ocular inflammatory disease with a particular emphasis on Sarcoidosis. In addition, studying the role of the immune system in African American patients with age-related macular degeneration (AMD);
• Collaboration with those interested in investigating autoimmune retinopathy, the underlying pathophysiology and treatment;
• Evaluating patients with ocular toxoplasmosis.

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; and 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/behavioral treatment of alcohol use disorders across the lifespan. Studies investigating the underlying neurobiological, psychological, and social mechanisms of behavior change are also encouraged.

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 vasculitis; systemic lupus erythematosus; inflammatory muscle disease; autoinflammatory diseases; ankylosing spondylitis and spondyloarthropathies; and inflammatory disease associated with primary immunodeficiencies.

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.

NIDCD

NIDCD seeks to conduct and support biomedical and behavioral research and research training in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. The faculty and research interests of the NIDCD intramural research program can be found at http://www.nidcd.nih.gov/research/faculty/pages/alpha.aspx. The intramural program uses a variety of tools of molecular and cellular biology, genetics, development, physiology, neuroimaging and systems biology to understand normal and disordered processes. The research areas of focus for intramural/extramural collaborations under this FOA include hearing, balance, taste, voice, speech and language.

NIDCR

The National Institute of Dental and Craniofacial Research (NIDCR) seeks to conduct and support collaborative translational projects addressing programmatic priorities of the Institute while enhancing a partnership with the NIH Clinical Center and available resources unique to the NIH. The mission of the NIDCR is to improve oral, dental and craniofacial health while promoting the timely translation to clinical application. Areas of particular interest to the NIDCR intramural clinical program include collaborations in oral cancer and craniofacial congenital disorders to diagnose, prevent or treat these conditions. More information about the NIDCR intramural investigators and research interests in these areas can be found at http://www.nidcr.nih.gov/Research/NIDCRLaboratories/OverviewDIR/.

NIDDK
The mission of the clinical component of the NIDDK Intramural Research Program is to conduct research, primarily related to the following disorders: Diabetes, obesity, metabolic and endocrine diseases; digestive and liver diseases; nutritional disorders; kidney diseases; and hematologic diseases. Details about the NIDDK clinical investigators and specific clinical projects being conducted in the NIH Clinical Center are available on the NIDDK website, www.niddk.nih.gov.

NIMH

The mission of the National Institute of Mental Health (NIMH) is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for recovery, prevention, and cure. To support its mission, NIMH has formulated a Strategic Plan with the following four overarching objectives:

• Define the mechanisms of complex behaviors. http://www.nimh.nih.gov/about/strategic-planning-reports/strategic-objective-1.shtml
• Chart mental illness trajectories to determine when, where, and how to intervene. http://www.nimh.nih.gov/about/strategic-planning-reports/strategic-objective-2.shtml
• Strive for prevention and cures. http://www.nimh.nih.gov/about/strategic-planning-reports/strategic-objective-3.shtml
• Strengthen the public health impact of NIMH-supported research. http://www.nimh.nih.gov/about/strategic-planning-reports/strategic-objective-4.shtml

These four Strategic Objectives form a broad roadmap for the Institute’s research priorities over the next 5 years, beginning with the fundamental science of the brain and behavior, and ending with public health impact. Our overall funding strategy is to support a broad spectrum of investigator-initiated research in fundamental science, with increasing use of Institute-solicited initiatives for applied research where public health impact is a short-term measure of success. Full implementation of these Strategies, will, we hope, transform the diagnosis, treatment, and prevention of these devastating illnesses

NINDS

NINDS intramural investigators conduct research at the NIH Clinical Center in the following areas: Neurogenetics, Movement Disorders, Neurosurgery, Neuroimmunology, and Neurovirology. More details about specific investigators can be found at: http://irp.nih.gov/our-research/principal-investigators

NCCIH

The NCCIH encourages applications for collaboration with one or more of its intramural investigators focused on better understanding of central pain pathways and the mechanisms by which complementary health approaches modulate pain. NCCIH’s intramural research program focuses on mechanistic understanding of acute and chronic pain, the development and maintenance of chronic pain, and the modulation of pain by non-pharmacological interventions. Much of the research is targeted at understanding how cognitive, emotional and environmental factors influence pain states. Studies to test the efficacy of specific interventions are not appropriate for this mechanism of support. More details about the program and its investigators can be found at: https://nccih.nih.gov/research/intramural

ORWH

The Office of Research on Women’s Health (ORWH) has a research directive encompassing both the influence of sex and gender on health and disease and the total health of women. ORWH works in partnership with other institutes, centers and offices at the NIH as well as with the extramural research community to support research that is in alignment with the 2010 NIH Strategic Plan for Women s Health and Sex Differences Research, Moving into the Future with New Dimensions and Strategies, http://orwh.od.nih.gov/research/strategicplan/index.asp. This strategic plan includes five research goals to advance women’s health and a number of specific objectives under each of the first three goals to which the reader is referred for examples of general areas in which sex/gender differences and women’s health research is encouraged. ORWH is interested in assisting to support research in many of the areas that are encouraged by the participating institutes and centers in this announcement in their specific areas of interest..

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.

For a more complete listing of resources in these research 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.

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.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or 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
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• 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

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government (including the Intramural Research Program of the NIH)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

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

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 6 pages.

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.

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

Type of Submission: Select "Pre-application".

Total Federal Funds Requested: Enter "0".

Total Federal and Non-Federal Funds: Enter "0".

Estimated Program Income: Enter "0".

Cover Letter: Applicants are encouraged to indicate the appropriate NIH Institute/Center in the cover letter.

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

All instructions in the SF424 (R&R) Application Guide must be followed. 1

Are Human Subjects Involved: Answer "No".

Are Vertebrate Animals Used: Answer "No".

Other Attachments:

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:
- Organizational structure
- Management plan detailing how existing resources, including unique resources available through the NIH Clinical Center, will be utilized.
- Planned interaction and responsibilities of key personnel
- Description of how research teams will communicate (e.g., videocast, web meeting, etc.)

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

Attachments Related to Clinical Trials
Attachments such as the Clinical Protocol, Statistical Analysis Plan, Data and Safety and Monitoring Plan, Informed Consent Forms, etc., are NOT required for the X02 pre-application. These materials will, however, be required for the companion U01 FOA.

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

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

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

Specific Aims: Specific Aims for the proposed research project should be included in the X02 pre-application.

Research Strategy: Within the Research Strategy, the applicant must describe how the application fulfills the requirements of this program. Specifically, the application must include at least one (NIH) intramural scientist as PD/PI or collaborator, and at least some of the research must be conducted at the NIH Clinical Center.

In describing the collaboration between the extramural applicant and the intramural investigator and the research they will conduct, applicants should demonstrate that each investigator will devote an appropriate amount of time/effort to the project and briefly describe the responsibilities of each investigator.

In describing the research to be conducted at the NIH Clinical Center, applicants should provide the following information, as applicable:

For projects involving patients/human subjects:

- describe the research population (e.g., pediatric, geriatric, behavioral health, etc.);

- indicate whether inpatient, outpatient or both;

- indicate whether the project will utilize an existing NIH clinical protocol, or if a new protocol will be written;

- estimate the number of patients/human subjects and approximate lengths of stay/clinic visits;

- identify any special procedures/tests and estimate the number of patients/human subjects undergoing the procedures/tests.

For all projects:

- describe the Clinical Center and/or intramural resources (technology, specimens, etc.) that will be used. For a list of Clinical Center resources, please see: http://clinicalcenter.nih.gov/translational-research-resources/resources.html

- describe the intramural resources (technology, specimens, etc.) that will be used. Although a detailed budget justification is not required for the X02 pre-application, it is important to indicate whether the intramural NIH program can accommodate the project with existing resources or whether significant additional staff or resources will be needed.

Letters of Support: Letters of support are NOT required for the X02 pre-application.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix: Not applicable. Appendix material is NOT required for the X02 pre-application.

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

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

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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.

This initiative is not subject to intergovernmental review.

No awards will be made under this FOA.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 for updated review language for applications for due dates on or after January 25, 2016.

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, the following review criteria will be used:

• Is there a collaborative team of at least one NIH intramural investigator and one (non-NIH) extramural investigator?
• Does the NIH intramural investigator plan to devote an appropriate amount of time/effort to the research project?
• Is the Collaboration Plan well defined with identifiable responsibilities for the NIH intramural investigator and the (non-NIH) 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?
• Does the research plan clearly describe the work that will be performed at the NIH Clinical Center?
• Is it clear which unique research opportunities in the NIH Clinical Center will be utilized?
• Can the NIH Clinical Center facilities accommodate the proposed research?
• Can the Intramural laboratory or program accommodate the proposed research?
• Does the research project address an important problem that is of programmatic relevance to one of the participating Institutes/Centers?
• If the research project includes a clinical trial are regulatory requirements in place?
• Will this project utilize an existing NIH clinical protocol, or will a new protocol be written?
• Can the proposed objectives be accomplished within the 4-year project period?

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.

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.

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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.

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.

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.

Not Applicable

Not Applicable

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.

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

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).

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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

Applications will be evaluated by NIH staff, using the review criteria described in Section V.1., above.

Applications will be administratively assigned to NICHD for processing, but will be reviewed by appropriate staff of the participating NIH Institutes/Centers and the NIH Clinical Center.

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 Institutes, will be notified of the opportunity to submit a U01 application under PAR-15-287

Not Applicable

Not Applicable

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

Not Applicable

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: https://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

NIH CLINICAL CENTER
Julie Orlando, MA
NIH Clinical Center (CC)
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov

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

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

Eugene G. Hayunga, PhD
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)
Telephone: 301-496-4257
Email: helmanl@mail.nih.gov

Minkyung (Min) H. Song, PhD,
National Cancer Institute (NCI)
Telephone: 240-276-6139
Email: songm@mail.nih.gov

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

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

NIAAA
Raye Z. Litten, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0636
Email: rlitten@mail.nih.gov

David Goldman, MD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0059
Email: davidgoldman@mail.nih.gov

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

Richard Siegel, MD, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301 496-3761
Email: rsiegel@nih.gov

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

NIDA
Raul Mandler, MD
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-0645
Email: mandlerr@mail.nih.gov

NIDCD
Andrew Griffith, MD, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-2829
Email: griffita@nidcd.nih.gov

Judith A Cooper, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-496-5061
Email: cooperj@nidcd.nih.gov

NIDCR
Robert C. Angerer, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-496-1483
Email: rang@mail.nih.gov

Jane C. Atkinson, DDS
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-435-7908
Email: Jane.Atkinson@nih.gov

NIDDK
James E. Balow, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-496-4181
Email: jimb@niddk.nih.gov

Karl F. Malik, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8843
Email: malikk@niddk.nih.gov

NIMH
Maryland Pao, MD
National Institute of Mental Health (NIMH)
Telephone: 301-435-5770
Email: paom@mail.nih.gov

NINDS
Debra J. Babcock, PhD, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: dbabcock@mail.nih.gov

NCCIH
M. Catherine Bushnell, PhD
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-2222
Email: Mary.bushnell@nih.gov

ORWH
Terri L. Cornelison, MD, PhD
Office of Research on Women's Health (ORWH)
Telephone: 301-402-1770
Email: t_cornelison@nih.gov

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

Not Applicable

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.

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 Part 75.