Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Library of Medicine (NLM) (No Longer Participating per NOT-LM-14-002)
Office of Dietary Supplements (ODS)
Office of Research on Women’s Health (ORWH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Dental and Craniofacial Research (NIDCR)

Funding Opportunity Title

Pre-application: Opportunities for Collaborative Research at the NIH Clinical Center (X02)

Activity Code

X02 Pre-application  

Announcement Type

New

Related Notices

NOT-HD-13-009

  • January 23, 2014 - See Notice NOT-DK-14-012. Notice of NIDDK Participation.
  • January 13, 2014 - See Notice NOT-HD-14-001. Notice of Change to Instructions regarding Letters of Intent and Letters of Support.
  • January 3, 2014 - See Notice NOT-LM-14-002. Notice to Discontinue Participation of NLM.
  • October 31, 2013 - See Notice NOT-HD-13-018. Rescheduled Pre-application Webinar.
  • October 17, 2013 - See Notice NOT-DE-13-007. Notice of NIDCR Participation.
  • September 26, 2013 - See Notice NOT-HD-13-016, Pre-application Webinar.
  • September 23, 2013 - See Notice NOT-HD-13-014. Notice of Additional Institute and Center Participation.
 

Funding Opportunity Announcement (FOA) Number

PAR-13-357

Companion Funding Opportunity

PAR-13-358, U01 Research Project – Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

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

Funding Opportunity Purpose

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

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

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

This FOA encourages X02 pre-applications for Opportunities for Collaborative Research at the NIH Clinical Center.  The X02 pre-application is the recommended (not required) first step in the application process for the companion FOA (PAR-13-358).  Potential applicants should read both FOAs.  Investigators whose X02 pre-applications are meritorious, can be supported by the resources of the NIH Clinical Center, and align with the research missions of the participating NIH ICs, will be notified of the opportunity to submit a U01 application under PAR-13-358.

No awards will be made under this FOA.

Key Dates
Posted Date

September 20, 2013

Open Date (Earliest Submission Date)

October 20, 2013  

Letter of Intent Due Date(s)

Not Applicable  

Application Due Date(s)

November 20, 2013, November 20, 2014, by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

November 20, 2013, November 20, 2014, by 5:00 PM local time of applicant organization.

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

Scientific Merit Review

December 2013 - January 2014 and December 2014 - January 2015  

Advisory Council Review

Not Applicable  

Earliest Start Date

Not Applicable 

Expiration Date

November 21, 2014  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose  

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

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

In order to be eligible for this program, the application must include at least one intramural scientist as Principal Investigator or collaborator, and at least some of the research must be conducted at the NIH Clinical Center.  Through this collaboration, external researchers may gain access to the NIH Clinical Center (CC) and leverage the diverse CC resources, expertise, and infrastructure available to test promising laboratory- and animal-based discoveries with potential for advancing 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 and includes:   

Specific Areas of Interest

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

NCI

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

NEI

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

NHGRI

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

NHLBI

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

NIAAA

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

NIAID

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

NIAMS

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

NIBIB

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

NICHD

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

NIDA

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

NLM

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

ORWH

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

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

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

Section II. Award Information
Funding Instrument

Other: A mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

No awards will be made under this announcement.

Award Budget

No awards will be made under this announcement.  Awards through the companion FOA (PAR-13-358) will be up to $500,000 direct costs per year, for a period of up to 3 years.

Award Project Period

Not Applicable 

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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

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

Required Registrations

Applicant Organizations

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

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

Section IV. Application and Submission Information


1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Page Limitations

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

Required and Optional Components

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

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.    

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

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:

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.

SF424(R&R) Senior/Key Person Profile

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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:

For all projects:

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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

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

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

No awards will be made under this announcement.  

6. Other Submission Requirements and Information

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

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

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

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

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

See more tips for avoiding common errors.

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

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

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated 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-13-358

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information


1. Award Notices

Not Applicable

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

Not Applicable

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

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

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

Scientific/Research Contact(s)

NIH Clinical Center

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

NICHD

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

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

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

NCI

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

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

NEI

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

NHLBI

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

NHGRI

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

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

NIAAA

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

NIAID

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

NIAMS

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

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

NIBIB

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

NIDA

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

NLM

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

ORWH

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

Peer Review Contact(s)

Not Applicable

Financial/Grants Management Contact(s)

Not Applicable

Section VIII. Other Information

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

Authority and Regulations

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


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NIH Funding Opportunities and Notices



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