Pilot and Feasibility Clinical Research Grants Program (R21)

Pilot and Feasibility Clinical Research Grants Program (R21) is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and Office of Dietary Supplements (ODS), NIH. This opportunity supports mission-aligned projects and measurable outcomes.

Expired PA-12-139: Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition (R21) This notice has expired. Check the NIH Guide for active opportunities and notices. Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating National Institute of Diabetes and Digestive and Kidney National Cancer Institute ( NCI ) Office of Dietary Supplements ( ODS ) Funding Opportunity Title Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition (R21) R21 Exploratory/Developmental Research Grant Award July 31, 2015 - This PA has been reissued as PA-15-317 .

March 19, 2015 - See Notice NOT-DK-15-010 . Notice to Extend PA-12-139. June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.

3 regarding applications that are essentially the same. May 30, 2013 ( NOT-OD-13-074 ) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

July 3, 2013 - See Notice NOT-DK-13-013. Clarification of NIDDK Policy: Investigator-Initiated Multi-Center Clinical Studies. Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility .

Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This FOA issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Cancer Institute, and the Office of Dietary Supplements (ODS) of the National Institutes of Health encourages pilot and feasibility clinical and epidemiological research studies of new therapies or means of health promotion and prevention of digestive and liver diseases and nutritional disorders associated with digestive and liver diseases.

Open Date (Earliest Submission Date) Letter of Intent Due Date dates apply, by 5:00 PM local time of applicant organization. AIDS Application Due Date(s) New Date July 31, 2015 per issuance of PA-15-317 .

(Original Expiration Date: September 8, 2015 ) September 8, 2015 (previously May 8, 2015) Required Application Instructions It is critical that applicants follow the instructions in 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 Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information I. Funding Opportunity Description The goal of this pilot and feasibility mechanism is to provide flexibility for initiating preliminary, short-term clinical 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 experienced investigators as well as new investigators to pursue new approaches, underdeveloped topics, or more creative avenues of research. If successful, these awards should lead to significant scientific advances in digestive disease research and should facilitate translation into clinical practice to improve patient outcomes.

One focus of this funding opportunity is on diseases that ordinarily have little research support because they are uncommon or rare, or difficult to manage, or are not the focus of pharmacological therapy. There are several rare digestive diseases that may, nevertheless, have lasting and major consequences for the patients who have these conditions.

These conditions are particularly challenging when they occur in children and have life-long consequences. These diseases are often too rare to be adequately investigated by a single individual or at a single medical research institution.

For these reasons, applications for study of these conditions might be best performed by a consortium of investigators that come together with a common protocol to focus on natural history and clinical investigation rather than a specific therapeutic intervention.

Examples of these rare or uncommon digestive and liver diseases that are of particular focus in this funding opportunity include gastrointestinal motility disorders of children; eosinophilic gastroenteritis, intestinal pseudoobstruction, Wilsons disease; sclerosing cholangitis in children; hepatic congenital fibrosis; autoimmune hepatitis; primary biliary cirrhosis; and familial Many digestive diseases and nutritional disorders are diagnosed, monitored or treated using endoscopic or surgical techniques.

These techniques are often the consequence of years of study and development by a talented and innovative investigator or group of investigators. Once the final technique is developed and reported in the medical literature, however, there is often little independent analysis of its efficacy and risk-benefit ratio.

Thus, endoscopic management of gastrointestinal bleeding, gastroesophageal reflux disease, Barretts esophagus, retained biliary stones, pancreatitis and colonic ectasia may be widely practiced but have not been subjected to careful, large-scale, prospective randomized controlled trials. Among surgical procedures in digestive and nutritional disorders, there is also often little controlled evidence for efficacy and safety.

Thus, small bowel transplantation is an area in which surgical techniques have been introduced and widely used without controlled observations on the efficacy and relative safety of this approach. This funding opportunity is meant to provide a means for investigators to develop prospective randomized controlled trials of endoscopic and surgical therapies.

Additional areas of special focus of this funding opportunity are hepatitis B and C. These two diseases are major causes of morbidity and mortality from liver disease in the United States. Current estimates suggest that chronic hepatitis B affects 1 million and hepatitis C approximately 3 million Americans.

Hepatitis C accounts for at least 30% of liver transplants done in the United States, while hepatitis B and its complications account for 5-10% of transplants. Furthermore, chronic hepatitis B and C virus infections are a major risk factor for hepatocellular carcinoma worldwide.

While there are many industry-sponsored studies of new and innovative therapies of these diseases, many important approaches to the management, health promotion, prevention and treatment of acute and chronic hepatitis B and C are outside of the usual interest of industry-sponsors of clinical trials.

Thus, use of cytokines, innovative combination therapies, and bioactive food components in the treatment of hepatitis B and C might be the focus of a pilot and feasibility grant application.

In addition, approaches to management and therapy of hepatitis B and C in special populations might be the focus of a pilot and feasibility grant application; such populations might include children, patients with hemophilia, patients with renal failure, solid-organ transplant patients, patients with human immunodeficiency virus co-infection, injection drug users, patients with continuing problems with alcohol or substance abuse, and patients with significant psychiatric disease, such as schizophrenia and bipolar disorders.

Acute hepatitis C currently accounts for 20% of cases of acute viral hepatitis. Importantly, between 50 and 80% of persons with acute hepatitis C develop chronic infection and thus are at risk of the long-term consequences of this disease, such as cirrhosis, hepatic failure and liver cancer.

Several small, uncontrolled studies have suggested that treatment of hepatitis C during the acute phase is highly effective, leading to sustained clearance of virus in 80 to 98% of patients. What is unclear is the optimal timing, dosage and treatment regimen for acute hepatitis.

An application for support of a collaborative network of investigators interested in studying the natural history, immunopathogenesis, virology and treatment of acute hepatitis C is strongly encouraged. Some digestive diseases result in loss of bowel function and the need for individuals to utilize nutritional support such as parenteral nutrition and specialized enteral feeding.

Applications for innovative studies on ways to improve use of nutritional support to meet the nutritional needs of individuals with digestive diseases are encouraged. Diet has been implicated as a significant determinant of the risk of developing various cancers and of the progression of certain cancers.

The National Cancer Institute is particularly interested in the use of foods and of bioactive food components to evaluate outcomes in digestive and liver diseases that are either pre-neoplastic or associated with an increased risk of cancer.

Small randomized clinical trials that can measure the effect of the nutritional intervention on pre-neoplastic lesions, including but not limited to measuring the effect on cell proliferation, apoptosis, differentiation, and inflammatory response are of particular interest.

The National Cancer Institute is also interested in clinical trials designed to measure the effects of bioactive food components on cellular inflammation in those digestive and liver diseases associated with an increased risk of cancer, including but not limited to acute and chronic infection with hepatitis B and C viruses and inflammatory bowel disease.

This funding opportunity is intended to encourage pilot and feasibility clinical and epidemiological research studies to facilitate the translation of promising and relevant new developments into the clinical setting. The emphasis is thus, on the development of small, randomized clinical trials and epidemiological studies. Basic laboratory research or studies of laboratory animals are not appropriate for this announcement.

Consideration should be given to using the R01 mechanism for this type of study.

Specifically excluded from this program announcement are studies that focus Specific examples of research areas of interest include but Disorders of GI function, including irritable bowel syndrome, gastroparesis, non-ulcer dyspepsia, colonic inertia, pseudo-obstruction, ileus, and cyclic Disorders characterized by GI inflammation, including inflammatory bowel disease, celiac disease, collagenous colitis, microscopic colitis, eosinophilic gastroenteritis, or pre-neoplastic lesions.

Disorders characterized by nutritional deficiency, including intestinal failure and short gut syndrome. Preneoplastic conditions, such as Barretts esophagus. Gastrointestinal endoscopy research.

Acute and chronic pancreatitis. Hepatobiliary diseases, including acute and chronic hepatitis B and C, prevention and treatment of complications of liver transplantation, autoimmune hepatitis, fatty liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, Wilsons disease, hepatic congenital fibrosis, biliary atresia and neonatal cholestatic liver disease.

Altered nutrient requirements associated with digestive disease Interactions between nutrients, such as antioxidants and micronutrients on mediators of the inflammatory responses in digestive diseases, including cancer.

Role of probiotics and of bioactive food components in the setting of gastrointestinal diseases such as irritable bowel syndrome, inflammatory bowel disease, celiac disease and liver diseases such as acute and chronic hepatitis B and C infections. Improvements in nutritional support to meet the nutritional needs of individuals with digestive diseases.

Role of alterations of dietary fatty acids on clinical mediators of digestive diseases, for example, prostaglandins. Strategies using bioactive food components to examine pre-neoplastic lesions, or biomarkers associated with cancer change and tumor Studies of the role of endoscopic interventions for pancreatitis, (acute chronic and its complications), and in sphincter of Oddi dysfunction (biliary or pancreatic sphincter).

The clinical significance, natural history, and management of microlithiasis or "biliary sludge" in the pathogenesis of Clinical studies of the role of endoscopic and other advanced technologies in early diagnosis, staging or treatment of biliary or pancreatic Studies to enhance and evaluate training for laparoscopic common bile duct exploration (and other surgical techniques) and to improve training Development of endoscopic and laparoscopic simulators and other new technologies to facilitate training, maintenance and objective assessment of procedural performance.

Interventional studies leading to the prevention of digestive Descriptive and interventional studies directed toward health promotion and disease prevention in persons at risk for the identified Interventions designed to maximize the quality of life for persons with the identified diagnoses. 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.

Application Types Allowed Glossary and the SF 424 (R&R) Application Guide provide details on 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 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 The total project period for an application submitted in response to this funding opportunity may not exceed two years.

Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations 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 Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually 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.

Eligible Individuals (Program Director(s)/Principal Investigator(s)) 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/Principal Investigator 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 . Additional Information on Eligibility 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. 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 .

Form of Application Submission It is critical that applicants follow the instructions in (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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Required and Optional Components 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 All page limitations described in the SF424 Application Page Limits must be followed.

PHS 398 Research Plan Component All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instruction: Preliminary data are not required but may be included if 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 Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) Foreign (non-US) institutions must follow policies described Grants Policy Statement , and procedures for foreign institutions described throughout 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 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 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. 4. Intergovernmental Review (E.

O. 12372) This initiative is not subject to intergovernmental 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 .

R21 applications will use the modular as well as the non-modular budget formats and "Just-in-Time" information concepts, with direct costs requested in $25,000 modules, up to the total direct costs limitation of $275,000 over an R21 two-year period. No more than $200,000 in direct costs will be allowed in any single year. All foreign applicants must complete and submit budget requests using the Research & Related Budget 6.

Other Submission Requirements and 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 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. 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 Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115 . V. Application Review Information 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 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 bio-behavioral 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.

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?

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? 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? 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? 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 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/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 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 .

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the 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/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.

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

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

Review and Selection Process Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with NIH peer review policy and procedures , using the stated review criteria . Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications: May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact/priority Will receive a written critique.

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 submitted in response to this FOA. 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 Scientific and technical merit of the proposed project as determined by scientific peer review. Relevance of the proposed project to program priorities. 3.

Anticipated Announcement and Award Dates 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 Grants Policy Statement . Section VI.

Award Administration Information If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as 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. 2.

Administrative and National Policy 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: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities .

More information is Conditions and Information for NIH Grants . Cooperative Agreement Terms and Conditions of Award When multiple years are involved, awardees will be required to submit