It is critical that applicants follow the Research (R) 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 (http://www.cc.nih.gov/translational-research- resources/resources.html) 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;
• 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 (http://clinicalstudies.info.nih.gov/) 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

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 first be determined, then provided if applicable 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.

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 investigator is responsible for coordination with the Clinical Center (ClinicalCtrPartner@mail.nih.gov (mailto:ClinicalCtrPartner@mail.nih.gov)) to assure that all NIH Clinical Center related costs are clearly identified and documented in a timely manner. 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. Resubmission or renewal applications will need to submit an updated Budget Template. 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 (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 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.

Letters of Support
Applications must include Letters of Support from the NIH Clinical Center and on of the participating NIH Institutes/Centers

For those applicants who submit an X02 pre-application, as described in the companion FOA (PAR-15-286 (https://grants.nih.gov/grants/guide/pa-files/PAR-15-286.html)), 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 the required letters of support to:

Jennifer Simmons, MPH, Management Analyst
NIH Clinical Center (CC)
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov

or

David J. Eckstein, PhD
Program Director, Strategic Partnerships and Policy Development
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov

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:

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 (http://www.cc.nih.gov/ccc/btb/) 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 (http://www.cancer.gov).

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 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; and
• Evaluating patients

The National Human Genome Research Institute research areas of interest include the genetics, genomics and molecular biology of normal and abnormal human development.

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. More information about research conducted by NHLBI intramural investigators can be found at https://www.nhlbi.nih.gov/research/intramural/researchers.

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.

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.

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.

For this Funding Opportunity Announcement, NIBIB will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility or other small clinical trials that inform early-stage technology development. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials or trials in which the primary outcome is efficacy, effectiveness or a post-market concern. Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this FOA for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial applications that NIBIB supports

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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.

The mission of the National Institute on Drug Abuse (NIDA) 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. NIDA is interested in collaborative translational projects addressing programmatic priorities established by its strategic plan https://www.drugabuse.gov/about-nida/2016-2020-nida-strategic-plan. For this FOA NIDA will prioritize applications proposing neuroscience and medication development projects. Areas of specific interest include research in human genetics, imaging, the comorbidity of HIV and substance use, treatment of opioid overdose and addiction and implementation of specific measures pertinent to negative affect, incentive salience, and executive function for deep phenotyping. Research to further understand the mechanisms and utility of neuromodulation approaches for the treatment of pain and addiction are also of interest.

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.

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/ (http://www.nidcr.nih.gov/Research/NIDCRLaboratories/OverviewDIR/)

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.

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 (http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml) 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. NIMH's 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 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 (http://irp.nih.gov/our-research/principal- investigators)

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 (https://nccih.nih.gov/research/intramural)

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 (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 are 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 (http://clinicalcenter.nih.gov/translational-research-resources/index.html).

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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 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.

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).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) 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.

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

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.

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

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

Other Attachments

The following attachments must be included, as applicable.

1. 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 interactions and responsibilities of key personnel: and
• Description of how research teams will communicate (e.g., videocast, web meeting, etc.).

2. 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. A .pdf of the Budget Template is also acceptable.

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

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

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.

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 may also include travel costs for any patients not already at the NIH Clinical Center.

Intramural Investigator Costs

Each NIH Institute and Center maintains individual policies with respect to the scope of resources available for intramural collaboration. The requests by NIH intramural scientists will be limited to the incremental costs required for participation. 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. The NIH Clinical Center costs and intramural investigator's costs will not be included in the award paid to the grantee. Support for intramural participation will be provided by a budget allocation within the NIH.

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:

Consortium/Contractual Arrangements: The Clinical Center collaboration should be described here. The cost spreadsheets should be appended in the "Other Attachments" as described above.

Letters of Support: Applications submitted to this FOA must include a current (i.e. within 3 months of application due date) letter from the NIH Clinical Center and a current 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.

Resubmission or renewal applications will need to obtain new letters of support. 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.

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 include a Data Sharing Plan. The Data Sharing Plan will be considered during peer review and by program staff as award decisions are being made as appropriate and consistent with achieving the goals of the program. It is expected that the results of NICHD-funded research will be shared with the wider scientific community in a timely manner.

Awardees are strongly encouraged to deposit large-scale, human genetic data in the database for Genotype and Phenotype "dbGaP" (https://www.ncbi.nlm.nih.gov/gap). For other data and biospecimens from human genetic or non-genetic studies, awardees are encouraged to use the NICHD Data and Specimen Hub "DASH" (https://dash.nichd.nih.gov/) or other equivalent broad-sharing data and/or biospecimen repositories."

The following resource describing Common Data Elements may be helpful during the planning phases of a project when considering ways to optimize data collection in order to facilitate broad data sharing: https://www.nlm.nih.gov/cde/.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

If the project includes a clinical protocol, the following additional documents must be included in the Appendix material:

• - The informed consent form(s) and, if applicable, assent form(s);
• - Copies of data collection forms, questionnaires or other relevant materials;
• - The Investigator's Brochure or equivalent for the study products(s);

If a protocol is part of the grant, the complete Clinical Protocol must be included. Investigators are referred to the NIH-FDA Clinical Trials Protocol Template with guidance and sample text to help write protocols. https://grants.nih.gov/policy/clinical-trials/protocol-template.htm

Note: 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 justify this adequately could adversely affect the score.

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.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Section 2 - Study Population Characteristics

2.7 Study Timeline

If the research involves a clinical trial, a Milestone Plan must be included. The milestone plan must include a timeline for the following general milestones, as applicable:

• Completion of regulatory approvals;
• Enrollment of the first subject;
• Enrollment of 25%, 50%, 75% and 100% of the projected recruitment time period for all study subjects, including women, minorities and children (as appropriate);
• Completion of data collection time period;
• Completion of primary endpoint and secondary endpoint data analyses time period; Completion of final study report; and
• Detailed protocol-specific performance milestones and timeline; these milestones may be negotiated at the time of the award, if appropriate.

Section 3 - Protection and Monitoring Plans

3.3 Data and Safety Monitoring Plan

The DSM plan should be commensurate with the risk level of the proposed clinical research and must be included for all clinical trials (see https://grants.nih.gov/grants/guide/notice-files/not98-084.html (https://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).

4.2.c Interventions

If appropriate to the study, a description and justification for the selection of the dose, frequency and administration of the intervention(s).

4.4 Statistical Design and Power

. The statistical analysis 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.

4.6 FDA Regulated Intervention

4.6.a If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status

If the research involves an FDA regulated intervention, a statement addressing the need (if applicable) for IND/IDE approval from the FDA must be provided, including the date of submission and disposition of the IND/IDE application; if FDA staff have determined that IND/IDE approval is not required, a copy of the FDA letter/email stating no IND/IDE is required and the date of the decision.

Section 5 - Other Clinical Trial-related Attachments

5.1 Other Clinical Trial-related Attachments

A description of the data management and quality control plan, including methods for monitoring the quality and consistency of the intervention(s) and data collection; policies and methods for ensuring blinding of study results; and data confidentiality and subject privacy

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

Delayed Onset Study

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

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

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.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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 and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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.

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.

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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

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 the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

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.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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).

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

In addition, for applications involving clinical trials: Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is the trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

In addition, for applications involving clinical trials: With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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?

In addition, for applications involving clinical trials: Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

In addition:

• Is the Collaboration 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 or resources in the NIH Clinical Center will be utilized?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials: Does the application adequately address the following, if applicable:

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Clinical Trial Protocol

Does the application adequately address any potential biases or challenges in the protocol and how they will be addressed? Does the protocol clearly describe primary and secondary endpoints? Are outcome measures appropriate and clearly described? Does the application adequately address compliance with regulatory requirements? Does the protocol describe an effective Laboratory Plan and Site Quality Management Plan, if appropriate? Are the consent and data collection forms, sites, pharmacies, labs, brochures, and MOPs appropriate?

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?

In addition, for applications involving clinical trials: If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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.

Study Timeline

Specific to applications proposing clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Milestones

Does the application present adequate milestones with regard to completion of regulatory approvals, when applicable; timely enrollment of subjects; completion of data collection time period; completion of primary endpoint and secondary endpoint data analyses time period; completion of final study report?

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 criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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.

For Renewals, the committee will consider the progress made in the last funding period.

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 Data Sharing Plan (GDS).

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 for scientific and technical merit by (an) appropriate 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:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Compliance with resource sharing policies
• Likelihood of effective collaboration between the PD(s)/PI(s) of the applicant institution and the NIH intramural investigator(s)
• Utilization of unique opportunities in the Clinical Center

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

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.

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.

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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials by law (Title VIII, Section 801 of Public Law 110- 85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov (https://register.clinicaltrials.gov)). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nig.gov/ClinicalTrials_fdaaa/ (//grants.nih.gov/ClinicalTrials_fdaaa/).

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm (//grants.nih.gov/grants/policy/hs/data_safety.htm) and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

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, as appropriate and consistent with achieving the goals of the program.

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 awardee, an NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. 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 the manner in 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.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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.

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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)

Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 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

Jennifer Simmons, MPH, Management Analyst
Clinical Center (CC)
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov

David J. Eckstein, PhD
Program Director, Strategic Partnerships and Policy Development
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov

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

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

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

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

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

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

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

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

Petra Jacobs, MD
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6501
Email: pjacobs@mail.nih.gov

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

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

Dena Fischer, DDS
National Institute of Dental and Craniofacial Research (NIDCR) Telephone: 301-594-4876
Email: fischerdj@mail.nih.gov

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

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

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

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

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).

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

Deanna Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 240-669-2989
Email: Deanna.Ingersoll@nih.gov

Beckie Chamberlin
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0183
Email: chamberr@nhlbi.nih.gov

William Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: darbyw@nei.nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

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

Angela M. Eldridge
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4793
Email: Angela.Eldridge@nih.gov

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: myersc@nidcd.nih.gov

Diana Rutberg
National Institute of Dental and Craniofacial Research NIDCR)
Telephone: 301-594-4798
Email: rutbergd@mail.nih.gov

Dee Doherty
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8838
Email: dohertyd@niddk.nih.gov

Tamera Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tkees@mail.nih.gov

Tijuanna Decoster
National Institute of Neurological Diseases and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@mail.nih.gov

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: carows@mail.nih.gov

Pam Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-253-8729
Email:pfleming@nida.nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

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.