and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD) |
|
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 |
|
Funding Opportunity Announcement (FOA) Number |
PAR-13-357 |
Companion Funding Opportunity |
PAR-13-358, U01 Research Project Cooperative Agreements |
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; 93.879 |
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. |
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, New Date: December 10, 2014 per NOT-HD-14-014. 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, New Date: December 10, 2014 per NOT-HD-14-014 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 |
New Date: December 11, 2014 per NOT-HD-14-014. (Previously |
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.
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 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:
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.
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.
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
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.
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.
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.
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.
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:
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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 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.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
Type of Submission: Select "Pre-application".
Total Federal Funds Requested: Enter "0".
Total Federal and Non-Federal Funds: Enter "0".
Estimated Program Income: Enter "0".
Cover Letter: Applicants are encouraged to indicate the appropriate NIH Institute/Center in the cover letter.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
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.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: Specific Aims for the proposed research project should be included in the X02 pre-application.
Research Strategy: Within the Research Strategy, the applicant must describe how the application fulfills the requirements of this program. Specifically, the application must include at least one (NIH) intramural scientist as PD/PI or collaborator, and at least some of the research must be conducted at the NIH Clinical Center.
In describing the collaboration between the extramural applicant and the intramural investigator and the research they will conduct, applicants should demonstrate that each investigator will devote an appropriate amount of time/effort to the project and briefly describe the responsibilities of each investigator.
In describing the research to be conducted at the NIH Clinical Center, applicants should provide the following information, as applicable:
For projects involving patients/human subjects:
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.
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
No awards will be made under this announcement.
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.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
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.
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
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.
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.
Not Applicable
Not Applicable
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
Not Applicable
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA 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: [email protected]
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: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
NIH Clinical Center
Pat Piringer, RN, MSN
Special Assistant to the Director
NIH Clinical Center (CC)
Telephone: 301-496-4121
Email: [email protected]
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: [email protected]
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: [email protected]
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: [email protected]
NCI
Lee Helman, MD
National Cancer Institute (NCI)
Center for Cancer Research
Telephone: 301-496-4257
Email: [email protected]
Minkyung (Min) H. Song, PhD
Division of Cancer Treatment and Diagnosis
National Cancer Institute (NCI)
Telephone: 240-276-6139
E-mail: [email protected]
NEI
Donald F. Everett, MA
Director, Collaborative Clinical Research Program
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected].
NHLBI
Michelle Olive, PhD
Program Director
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0550
Email: [email protected]
NHGRI
Dan Kastner, MD, PhD
Division of Intramural Research
National Human Genome Research Institute (NHGRI)
Telephone: 301-402-2023
Email: [email protected]
Bettie J. Graham, PhD
Division of Extramural Research
National Human Genome Research Institute (NHGRI)
Telephone: 301-496-7531
Email: [email protected]
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: [email protected]
NIAID
Anna Ramsey-Ewing, Ph.D.
Director, Office of Extramural Research Policy and Operations
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2932
Email: [email protected]
Matthew J. Fenton, Ph.D.
Director, Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-7291
Email: [email protected]
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: [email protected]
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: [email protected]
NIBIB
Steven Krosnick, MD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Extramural Science Programs
Telephone: 301-594-3009
Email: [email protected]
NIDA
Raul Mandler, MD
National Institute on Drug Abuse
Center for Clinical Trials Network
Telephone: 301-435-0645
Email: [email protected]
NLM
Dr. Hua-Chuan Sim
NLM Extramural Programs
Telephone: 301-594-4882
Email: [email protected]
ORWH
Susan E. Maier, PhD
Associate Director for Special Projects
Office of Research on Women’s Health (ORWH)
Telephone: 301-435-1573
Email: [email protected]
Not Applicable
Not Applicable
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