and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK) |
|
Funding Opportunity Title |
Exploratory/Developmental Clinical Research Grants in Obesity (R21) |
Activity Code |
R21 Exploratory/Developmental Research Grant Award |
Announcement Type |
Reissue of PA-09-124 |
Related Notices
|
|
Funding Opportunity Announcement (FOA) Number |
PA-12-179 |
Companion Funding Opportunity |
None |
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.847, 93.393, 93.213, 93.837, 93.865 |
Funding Opportunity Purpose |
This FOA issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); the National Heart, Lung and Blood Institute (NHLBI); the National Cancer Institute (NCI); the National Center for Complementary and Alternative Medicine (NCCAM), Office of Dietary Supplements (ODS), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD of the National Institutes of Health (NIH), encourages research grant applications from institutions/organizations that propose to conduct exploratory/developmental clinical studies that will accelerate the development of effective interventions for prevention or treatment of overweight or obesity in adults and/or children. Exploratory epidemiological research with a goal of informing translational/clinical research will also be supported within this program. |
Posted Date |
May 2, 2012 |
Open Date (Earliest Submission Date) |
May 16, 2012 |
Letter of Intent Due Date |
Not Applicable |
Application Due Date(s) |
Standard dates apply, by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
(Changed to Standard AIDS dates apply, by 5:00 PM local time of applicant organization. per NOT-DK-13-012), Originally Not Applicable |
Scientific Merit Review |
Standard dates apply |
Advisory Council Review |
Standard dates apply |
Earliest Start Date(s) |
Standard dates apply |
Expiration Date |
New Date March 27, 2015 per issuance of PA-15-163. (Original Expiration Date: May 8, 2015) |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (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
Background
The goal of this initiative is to encourage exploratory/developmental clinical research that will accelerate the development of effective interventions for prevention or treatment of overweight or obesity in adults and/or children. The goal of this mechanism is to provide flexibility for initiating exploratory, short-term studies, thus allowing new ideas to be investigated in a more expeditious manner without stringent requirements for preliminary data. Such support is needed to encourage investigators to pursue new approaches, underdeveloped topics, or more creative avenues for research including new partnerships. Epidemiological research with a goal of informing translational/clinical research on prevention or treatment of obesity or overweight in adults and/or children is encouraged. The emphasis is thus on the development of exploratory clinical studies, pilot and feasibility studies, or small randomized clinical trials that will provide preliminary data for intervention and epidemiological studies that will inform translational/clinical research.
This initiative specifically encourages the submission of applications for pilot and feasibility or exploratory studies related to obesity. These studies should focus on research that is particularly innovative and/or potentially of high impact. Innovative research includes feasibility studies in which the technological, methodological, or theoretical approach to a problem lacks historical precedent or sufficient preliminary data but is highly promising. High impact research involves studies where successful outcomes would have a major effect on the area of obesity. Clinical pilot and feasibility studies could provide the data needed to design appropriately powered efficacy studies. Such trials may use pharmacological, dietary supplement, dietary, surgical, medical device, physical activity, or behavioral interventions aimed at prevention or treatment of obesity or overweight in adults and/or children. Applications to identify novel risk factors for the development of overweight and obesity and their complications are encouraged.
Clinical studies supported under this FOA are intended to fund the acquisition of preliminary data from pilot and feasibility or exploratory studies. As part of the process for evaluating scientific merit and determining relevance of the proposed research, peer reviewers and NIH Program staff will take into consideration future research directions that would be enabled by the preliminary data. Therefore, investigators should include a statement in the application that at least broadly indicates their vision of the anticipated next steps for research that would subsequently follow, under the assumption that a pilot or exploratory study supported by the R21 mechanism yields sufficient data to plan a more definitive project.
National Cancer Institute (NCI)
Because obesity has been observed to be associated with increased incidence and mortality of certain cancers, including breast and colon cancer, among others, the National Cancer Institute (NCI) will participate in this initiative. The NCI believes it is particularly important to foster research to identify effective interventions for prevention and treatment of obesity, including novel energy intake and expenditure modalities that alter body weight and/or composition in certain subpopulations of cancer patients and those at high risk for cancer. Thus, the types of research applications which NCI is interested in supporting include human intervention studies utilizing bioactive components (e.g., tea polyphenols, calcium) or variation in diet composition strategies that evaluate weight change in populations of interest to NCI. Such populations include individuals with a genetic propensity for cancer as well as those with cancer or those at risk for recurrence of cancer.
National Heart Lung and Blood Institute (NHLBI)
Overweight and obesity increase cardiovascular disease risks. Adverse pathophysiological effects include hypertension, dyslipidemia, left ventricular hypertrophy, atherosclerosis, thrombotic propensity, metabolic syndrome, sleep disorders, and non-alcoholic fatty liver disease as well as psychological effects such as stigmatization, discrimination, depression and emotional trauma. Obesity in childhood substantially increases the risk of being an obese adult, and adults who are obese during childhood have higher risks of developing hypertension, dyslipidemia, metabolic syndrome, diabetes, and coronary heart disease. In addition, obese mothers are at increased risk of delivering an infant with a congenital heart defect. The National Heart, Lung, and Blood Institute (NHLBI) encourages studies that will lead to research testing interventions that address combinations of individual, family and/or environmental factors for weight control such as social networks, peer influences, and built environment. Studies that use innovative approaches including social marketing approaches are needed to promote heart-healthy eating behaviors and increase physical activity. NHLBI is also interested in supporting observational studies that identify behavioral, psychosocial, and/or environmental factors that motivate or promote heart-healthy dietary and physical activity behaviors for obesity prevention or treatment. Studies that explore factors associated with weight loss maintenance or weight gain prevention are encouraged. Novel and exploratory clinical studies to establish phenotypic features as indicators of risk for obesity, response to treatment, or co-morbidities relevant to NHLBI in well characterized pediatric and/or adult subjects are encouraged. Exploratory clinical trials that employ genome-wide association studies to examine obesity and cardiovascular disease pathophysiology, biomarkers, and pharmacology are of interest to NHLBI. Studies that target populations that have high obesity prevalence rates (e.g., African Americans, Hispanics and American Indians), immigrants or individuals in rural areas are also of interest to the NHLBI and are encouraged.
National Center for Complementary and Alternative Medicine (NCCAM)
NCCAM participates in the NIH Obesity Research Task Force, and is exploring ways in which complementary and alternative medicine (CAM) practices might contribute to weight loss or adherence to weight maintenance regimens, or to prevention or treatment of obesity-related conditions. Applications to identify modifiable risk factors in CAM specific epidemiologic studies and interventional approaches, for addressing overweight problems or obesity conditions and their complications are encouraged. NCCAM is interested in studies that examine the safety and efficacy of novel CAM approaches to the obesity crisis such as clinical interventions and epidemiologic studies that address mind-body, meditation-based treatment for obesity disorders; studies that examine the impact of mind-body and/or integrative health approaches on activity, dietary patterns, energy intake and/or expenditure by utilizing innovative approaches such as novel devices and/or biotechnology strategies; epidemiologic studies that assess the impact of complementary and integrative health approaches on modifiable obesity risk factors of adults or children; and epidemiologic studies of comparative microbiota and energy balance, validation methods of functional food, dietary supplement bioactive compounds, biomarkers and obesity related conditions.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is interested in clinical studies that accelerate interventions for the prevention or treatment of obesity in children, adolescents, or families. NICHD encourages multilevel interventions that target individual, family and socio-environmental factors related to overweight and obesity. Observational studies to identify behavioral, psychosocial, and/or environmental factors that motivate or promote adherence to healthy dietary and physical activity behaviors for obesity prevention or treatment are also of interest. Applications that focus on reducing health disparities as well as those focused on minority populations are particularly encouraged.
Objectives and Scope
Studies on the prevention or treatment of overweight or obesity in children and/or adults, including dietary, physical activity, behavioral, psychosocial, pharmacologic, and surgical, and other biomedical approaches are of interest. The creative use of various devices, technologies, or communication strategies to help individuals monitor energy intake or energy expenditure in weight control programs would be appropriate. Innovative studies that test the synergy of creative partnerships among various groups such as industry, business, faith-based, academic, or community organizations to enhance obesity prevention or treatment outcomes are of interest. Studies of various approaches in combination to achieve weight maintenance or to maintain weight loss, such as physical activity or diet in combination with pharmacologic or surgical regimens would also be appropriate.
Basic laboratory research or studies of laboratory animals are not appropriate for this announcement. This funding opportunity also is not for development or implementation of outreach programs or educational curriculum development for the treatment or prevention of overweight or obesity. Research on stored bio-samples will not be accepted and studies that do not involve human subjects or are not patient-oriented research or epidemiological studies will not be supported through this funding opportunity and will be returned to the proposed Project Director/Principal Investigator (PD/PI) without undergoing peer review consideration. Applications for clinical studies that overlap with ongoing NIH sponsored studies may be denied funding.
Specific examples of research areas of interest include but are not limited to:
Studies of interventions for prevention and treatment of obesity in children and/or adults, including: modification of dietary practices or eating environments; strength training, aerobic conditioning, or other modifications of physical activity and sedentary behavior; modification of relevant associated behaviors and psychosocial influences that affect eating and physical activity patterns or environmental conditions that may have an impact upon energy balance.
Pilot and feasibility studies of novel interventions to promote healthier dietary or physical activity behaviors for obesity prevention or treatment in understudied populations, including racial and ethnic minority populations and medically underserved populations.
Novel and exploratory studies to either measure eating behavior in children and/or adults or to develop and validate instruments to measure eating behaviors.
Patient-oriented research to evaluate pharmacological, surgical, and other biomedical treatments of obesity.
Novel and exploratory clinical studies to establish specific body composition or other phenotypic features as indicators of risk for obesity, response to its treatment, or its co-morbidities relevant to NIDDK, NHLBI, or NCI in well characterized pediatric and/or adult patients.
Studies to identify and assess the impact of potentially modifiable determinants of childhood or adult overweight or obesity.
Observational studies to identify behavioral, psychosocial, and/or environmental factors that motivate or promote adherence to healthy dietary and physical activity behaviors for obesity prevention or treatment.
Studies to explore social marketing approaches for promoting healthy eating behaviors and increased physical activity aimed at weight control.
Diet and/or physical activity interventions designed to assess weight reduction in population subgroups at high risk for cancer or its recurrence.
Intervention studies that employ community-based participatory research strategies for obesity prevention.
Development and application of neuro-imaging technology to understand the many roles of the brain in human obesity, including homeostatic mechanisms, the interplay of brain systems that control eating behavior, brain control over peripheral metabolism, and the effect of bariatric surgery in the CNS.
Intervention studies that target minority populations are of particular interests including CAM epidemiologic and interventional approaches that target minority populations that have high obesity prevalence rates (e.g., African Americans, Hispanics, and American Indians), and understudied populations (e.g., rural areas).
Clinical pilot and feasibility studies to provide the data needed to design appropriately powered efficacy studies using mind-body, natural product and technological or behavioral CAM interventions for the prevention or treatment of overweight problems or obesity conditions in adults or children.
Studies that combine innovative herbal/dietary supplement, mind-body, and other CAM approaches with devices and other biotechnology strategies that validate or monitor energy intake or expenditure, and epidemiologic studies that assess the impact of CAM approaches on modifiable risk factors of adults or children.
Potential applicants are encouraged to contact program directors as they plan theirapplication. Program directors welcome the opportunity to talk with applicants before applications are submitted. Program staff contact information is listed in Section VII.
Applications for R21 awards should describe projects distinct from those supported through the traditional R01 mechanism. For example, long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under this mechanism should be exploratory and novel. These studies should break new ground or extend previous discoveries toward new directions or applications.
Funding Instrument |
Grant |
Application Types Allowed |
New |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications. |
Award Budget |
Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. F&A costs requested by consortium participants are not included in the direct cost limitation. |
Award Project Period |
The total project period for an application submitted in response to this funding opportunity may not exceed two years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
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 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 must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 4-6 weeks prior to the application due date.
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 PD(s)/PI(s), visit the Multiple
Program Director(s)/Principal Investigator(s) Policy and submission details in
the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R)
Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.
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.
The forms package associated with this FOA includes all applicable components, mandatory 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.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Foreign (non-US) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via 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.
Applicants are responsible for viewing their application 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 SF 424 (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 SF
424(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.
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 Central Contractor Registration (CCR). 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 required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
Reviewers will provide an overall impact/priority 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.
Significance
Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the project?
Are potential problems, alternative strategies, and benchmarks for success
presented? If the project is in the early stages of development, will the
strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
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/priority 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 Human
Subjects Protection and Inclusion Guidelines.
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 Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
Not Applicable.
Revisions
Not Applicable.
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/priority score.
Applications from Foreign Organizations
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.
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 for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned on the basis of established PHS referral guidelines 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:
After the peer review of the application is completed, the PD(s)/PI(s) will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
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 the DUNS,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
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.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov
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process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov
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registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov
Robert J. Kuczmarski, Dr.P.H.
Director, Obesity Prevention and Treatment Program
Division of Digestive Diseases and Nutrition
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 673
Bethesda, MD 20892-5450 (20817 for express mail)
Phone: 301-451-8354
Fax: 301-480-8300
Email: kuczmarskir@mail.nih.gov
Cindy Davis, PhD
Director of Grants and Extramural Activities
Office of Dietary Supplements
6100 Executive Boulevard, Room 3B01
Bethesda, MD 20892-7517
Telephone: (301)496-0168
FAX: (301)480-1845
Email: davisci@mail.nih.gov
Charlotte A. Pratt, Ph.D.
Program Director
Clinical Applications and Prevention Branch
Population and Prevention Sciences Program
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10118
Bethesda, MD 20892-7936
Telephone: (301)435-0382
FAX: (301)480-5158
Email: prattc@mail.nih.gov
Sharon A. Ross, Ph.D.
Division of Cancer Prevention
National Cancer Institute
6130 Executive Blvd. EPN Room 3175
Bethesda, MD 20892-7328
Telephone: (301)594-7547
FAX: (301)480-3925
Email: rosssha@mail.nih.gov
Linda C. Duffy, Ph.D.
Program Officer
Division of Extramural Research
National Center for Complementary and Alternative Medicine
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20892-5475
Telephone: (301)594-1285
Fax: (301) 480-1587
Email: duffyl@mail.nih.gov
Layla Esposito, PhD
Center for Research for Mothers and Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
6100 Executive Boulevard, Room 4B05F
Rockville, MD 20892
Telephone: (301) 435-6888
Fax: (301) 480-0230
Email: espositl@mail.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Sharon T. Bourque
Grants Management Specialist
National Institute of Diabetes, Digestive and Kidney Diseases
6707 Democracy Blvd., Room 719
Bethesda, MD 20892 MSC 5456
Telephone: (301)594-8846
FAX: (301)594-9523
Email: sb114m@nih.gov
Ms. Tawana McKeither
Grants Management Specialist
National Heart, Lung, and Blood Institute (NHLBI)
Division of Extramural Research Administration (DERA)
Office of Grants Management (OGM)
6701 Rockledge Drive, Room 7159
Bethesda, MD 20892-7924
Telephone 301-435-0166
FAX: 301-451-5642
Email: mckeitherta@nhlbi.nih.gov
Brett M. Hodgkins
Team Leader
National Cancer Institute (NCI)
National Institutes of Health (NIH)
6120 Executive Blvd., Suite 243
Rockville, MD 20852
Phone: 301-496-8657
Fax: 301-496-8601
Email: hodgkinsb@mail.nih.gov
Cornice Martin
Grants Management Office
National Center for Complementary and Alternative Medicine
National Institutes of Health
6707 Democracy Boulevard, Suite 401
Bethesda, MD 20817
Telephone: (301)594-6059
Fax: (301)480-1587
Email: cm586d@nih.gov
Bryan S. Clark, MBA
Chief Grants Management Officer
Grants Management Branch
Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD)
6100 Executive Boulevard, Room 8A01A, MSC 7510
Rockville, MD 20852 (for express/courier service; non-USPS service)
Phone: 301-435-6975
Fax: 301-451-5510
Email: clarkb@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 Parts 74 and 92.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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