Human Genome Research
NHGRI supports the development of resources and technology that will accelerate genome research and its application to human health. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research. NHGRI also supports the training of investigators and the dissemination of genome information to the public and to health professionals. Small Business Innovation Research (SBIR) program: To expand and improve the SBIR program; to increase private sector commercialization of innovations derived from Federal research and development; to increase small business participation in Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. Small Business Technology Transfer (STTR) program: To stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions; to foster technology transfer between small business concerns and research institutions; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.
General information about this opportunity
Last Known Status
Agency: Department of Health and Human Services
Office: National Institutes of Health
Type(s) of Assistance Offered
Fiscal Year 2014: The 1000 Genomes Project. The international 1000 Genomes Project discovered almost all common human genetic variants and many rare variants, to support studies relating genetic variation to health and disease. The project sequenced the genomes of 2,504 people from 26 populations around the world and released the data publicly. The sequence data allowed the project to identify variants including single DNA base differences among people, insertions or deletions in their genomes, and larger structural variants. Many of these variants contribute to an increased risk for particular diseases, or to differences in drug response. Researchers use these data to help find the genes and variants affecting risk of diseases and drug responses, and to study the demographics of human populations. Fiscal Year 2015: Genotype-Tissue Expression (GTEx) Project. The aim of the Genotype-Tissue Expression (GTEx) Project is to increase our understanding of how changes in our genes contribute to common human diseases, in order to improve health care for future generations. Launched as a two-year pilot project supported by the National Institutes of Health (NIH), GTEx will create a resource that researchers can use to study how inherited changes in genes lead to common diseases and will establish a database and a tissue bank that can be used by many researchers around the world for future studies. GTEx researchers are studying genes in different tissues obtained from many different people. In addition, the GTEx project includes an Ethical, Legal, and Social Implications (ELSI) study to explore the effectiveness of the GTEx donor consent process. This study will help ensure that the consent process and other aspects of the project effectively address the concerns and expectations of participants in the study. GTEx is a pioneering project that uses state-of-the-art protocols for obtaining and storing a large range of organs and tissues and for testing them in the lab. Until now, no project has analyzed genetic variation and expression in as many tissues in such a large population as planned for GTEx. After a successful pilot study, GTEx is being scaled up to a final resource of ~900 donors total by 2015. Fiscal Year 2016: Encyclopedia of DNA Elements (ENCODE). After completing the full sequence of the human genome, scientists faced the challenge of understanding what that sequence means and how it contributes to health and disease. One approach NHGRI has taken to address this question is to support the Encyclopedia of DNA Elements (ENCODE) Project, which aims to identify the parts of the human genome sequence that are functional, that is, sequences that are thought to play a critical role in biological processes as measured by having some biochemical activity. Research laboratories participating in the ENCODE Project use a variety of methods to catalog the functional elements of the human genome. The resulting list of functional elements, which includes genes and regions that control the expression of genes, is presented as a resource that is freely available on the internet. This resource gives scientists a new set of tools to use while investigating biological phenomena and human disease.
Public Health Service Act, Sections 301, 461 and 487, as amended; Public Laws 78-410 and 99-158, 42 U.S.C. 241, as amended; 42 U.S.C. 285k; 42 U.S.C. 288; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.
Who is eligible to apply/benefit from this assistance?
Research Projects: Awards can be made to any public or private, for-profit or nonprofit university, college, hospital, laboratory, or other institution, including State and local units of government, qualifying small businesses (through the Small Business Innovation Research/STTR Programs, and to individuals. To be eligible for funding, an application must be approved for scientific merit and program relevance by a scientific review committee and by a national advisory council. SBIR grants can be awarded only to domestic small businesses (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed, and have no more than 500 employees). Primary employment (more than one- half time) of the principal investigator must be with the small business at the time of award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the U.S. or its territories. To be eligible for funding, an SBIR grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. STTR grants can be awarded only to domestic small business concerns (entities that are independently owned and operated for profit, are not dominant in the field in which research is proposed and have no more than 500 employees) which "partner" with a research institution in cooperative research and development. At least 40 percent of the project is to be performed by the small business concern and at least 30 percent by the research institution. In both Phase I and Phase II, the research must be performed in the U.S. and its possessions. To be eligible for funding, a grant application must be approved for scientific merit and program relevance by a scientific review group and a national advisory council. Non-federal public and private domestic organizations may apply for an Institutional National Research Service Award. Individual National Research Service awardees must be nominated and sponsored by a public or nonprofit private institution having staff and facilities appropriate to the proposed research training program. All awardees must be citizens or have been admitted to the United States for permanent residence. Predoctoral awardees must have completed the baccalaureate degree, and postdoctoral awardees must have a professional or scientific degree (M.D., Ph.D., D.O., D.V.M., Sc.D., E.Eng., or equivalent domestic or foreign degree). Applicants to the Small Business Innovation Research/STTR Programs must meet special requirements for small businesses, as defined by the Small Business Administration.
Any nonprofit or for-profit organization, company, or institution engaged in biomedical research can apply for research support.
Each applicant for a research project must present a research plan and furnish evidence that scientific competence, facilities, equipment, and supplies are appropriate to carry out the plan. Applications must submit an electronic grant application form SF424 which can be accessed from the funding opportunity announcement. For applicants for National Research Service Awards, the academic record, research experience, citizenship, institutional sponsorship, and the proposed area and plan of training must be included in the application. The applicant institution must show the objectives, methodology, and resources for the research training program, the qualifications and experience of directing staff, the criteria to be used in selecting individuals for the award, and a detailed budget and justification for the grant funds requested. For-profit organizations, costs are determined in accordance with 48 CFR. For other grantees, costs will be determined in accordance with HHS Regulation 45 CFR 75. For SB IR and STTR grants, applicant organization (small business concern) must present in a research plan an idea that has potential for commercialization and furnish evidence that scientific competence, experimental methods, facilities, equipment, and funds requested are appropriate to carry out the plan. SF424 applications are used for SBIR and STTR programs. In order to be eligible for a NRSA award, the individual must be a US citizen or permanent resident of the US. 2 CFR 200, Subpart E - Cost Principles applies to this program.
What is the process for applying and being award this assistance?
Preapplication coordination is not applicable. Environmental impact information is not required for this program. This program is excluded from coverage under E.O. 12372.
This program is excluded from coverage under 2 CFR 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards. Application forms and information concerning the area of science being supported may be obtained via a funding opportunity announcement.T he standard application forms, as furnished in the Funding Opportunity Announcements at www.grants.gov, must be used for this program. This program is subject to the provisions of 45 CFR 75. The SBIR and STTR Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH "Small business Funding Opportunities" homepage at www.nih.gov/grants/funding/sbir.htm on the World Wide Web. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. Completed SBIR and STTR grant applications are submitted electronically to grants.gov.
All accepted applications for project grants and institutional National Research Service Awards must respond to a funding opportunity announcement, must be reviewed for scientific merit by an appropriate initial review group and by the National Advisory Council for Human Genome Research (NACHGR). (Individual NRSA applications are not reviewed by council.) All approved applications compete for available funds on the basis of scientific merit and program emphasis, the exception being if the application is in response to a Request for Applicatons, in which case a specific amount of funds is set aside, but awards are based primarily on the quality of the applications. Awards are issued throughout the year. All accepted SBIR/STTR applications are evaluated for scientific and technical merit by an appropriate scientific peer review panel and by a national advisory council or board. All applications receiving a impact score ranging from the best (10) to worst (90) compete for the available funds on the basis of scientific and technical merit (which includes the potential of the proposed research for commercial application), program relevance, and program balance among the areas of research. However, in reality, applications with impact scores of 40 or greater are rarely considered for funding.
Oct 05, 2015: This is the first of three deadlines that occur annually for new research projects. The other two dates are June 5, 2010 and October 5, 2010. New Research Projects (R01) and Renewals: February 5, June 5, and October 5. Program Project, Center and Institutional Training Grants: January 25, May 25, and September 25. Other Research Grants (R03, R21, R33, R21/R33, R34, R36): February 16, June 16, and October 16. Individual NRSA: April 5, August 5, and December 10. Institutional NRSA: January 25, May 25, and September 25. SBIR/STTR Applications: April 8, August 8, and December 8.
Approval/Disapproval Decision Time
From submission to award of funds: Individual, project and institutional grants about 9 months; SBIR/STTR about 6 months.
A description of the NIH Peer Review Appeal procedures is available on the NIH home page www.nih.gov/grants/guide/1997/97.11.21/n2.html.
Renewal grants are competitively awarded.
How are proposals selected?
The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed project; and (5) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific and technical merit of the proposed approach for achieving the Phase II objectives; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the technological innovation, originality, or societal importance of the proposed research; (5) the potential of the proposed research for commercial application; (6) the reasonableness of the budget request for the work proposed; (7) the adequacy and suitability of the facilities and research environment; and (8) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment.
How may assistance be used?
The research project grant is awarded to an eligible institution in the name of a principal investigator for a discrete project or group of related projects representing the investigator's interest and competence. Funds may be used for salaries and wages, equipment, supplies, travel and other costs required to carry out the research project. National Research Service Awards are made directly to individuals for research training in disciplines supporting the research areas. In addition, grants may be made to institutions to enable them to select individuals for National Research Service Awards. Each individual who receives a National Research Service Award is responsible for certain service and payback provisions. Responsibilities of grantees and restrictions on use of funds are set forth in the Public Health Service policy statement on grants for research projects, which is available on request from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health (NIH), 6701 Rockledge Drive, Room 6207, MSC 7910, Bethesda, MD 20892-7910. Telephone: (301) 435-0714. Fax (301) 480- 0525. E-mail: asknih.od.nih.gov. Small Business Innovation Research (SBIR) Program: SBIR Phase I grants (of approximately 6 months' duration) are to establish the technical merit and feasibility of a proposed research effort that may lead to a commercial product or process. Phase II grants are for the continuation of research initiated in Phase I and which are likely to result in commercial products or processes. Only Phase I awardees are eligible to apply for Phase II support. STTR Phase I grants (normally of 1-year duration) are to determine the scientific, technical, and commercial merit and feasibility of the proposed cooperative effort that has potential for commercial application. Phase II funding is based on results of research initiated in Phase I and scientific and technical merit and commercial potential of Phase II application.
What are the requirements after being awarded this opportunity?
Annual progress and financial status reports for continuing projects and final reports on all projects upon conclusion are required. For more complex grants, more frequent reports may be required. Cash reports are not applicable. Annual progress and financial status reports for continuing projects and final reports on all projects upon conclusion are required. For annual progress reports, information about past progress, publications and proposed research for the next year are reported. Depending on the complexity of the grant, a budget may also be required. The expenditure reports consists of whether there is 25% or more unspent funds on the grant. If so, the principal investigator is asked to explain why there is a large unobligated balance. Program Directors review the reports and contact the PI for a verbal discussion that expands upon what was written. If problems are noted, the program director will note this in the report and talk with the PI about how what can be done to ensure progress. For more complex grants, the Program Director may request the PI for more frequent accounting of progress. The Grants Management Specialist/Officer reviews applications for the appropriateness of the budget requested.
In accordance with the provisions of 2 CFR 200, Subpart F - Audit Requirements, non-Federal entities that expend financial assistance of $750,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Non-Federal entities that expend less than $750,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in 2 CFR 200.503. In addition, grants and cooperative agreements are periodically subject to inspection and audits by DHHS and other Federal officials.
Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last expenditure report for the report period.
Other Assistance Considerations
Formula and Matching Requirements
This program has no statutory formula.
This program has no matching requirements.
This program does not have MOE requirements.
Length and Time Phasing of Assistance
Research and program projects are awarded for 3-5 years. Institutional training grants are awarded for 5 years. Individual fellowships and career development awards are from 2-5 years. For SBIR and STTR applications, normally Phase I awards are for 6 months and Phase II awards are or 2 years. Method of awarding/releasing assistance: quarterly.
Who do I contact about this opportunity?
Regional or Local Office
Bettie J. Graham 5635 Fishers Lane, Suite 4076, Bethesda, Maryland 20892 Email: email@example.com
Phone: (301) 496-7531
(Project Grants) FY 14 $368,507,785; FY 15 est $365,995,000; and FY 16 est $379,749,000 - NRSAs: FY 13 actual $7,785,039; FY14 est $6,459,000: FY15 est $6,144,000.
SBIR/STTR Grants: FY 13 actual $10,99,6736; FY 14 est $11,272,825; FY 15 est 12,324,000.
Range and Average of Financial Assistance
Range is between $70,000 and $4,900,000, Average is $594,689.
Regulations, Guidelines and Literature
42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; NIH Extramural Programs brochure and other miscellaneous program literature are available from Headquarters Office. Grants will be available under the authority of and administered in accordance with the PHS Grants Policy Statement and Federal regulations at 42 CFR 52 and 42 U.S.C. 241; Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications. Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR) Grant applications.
Examples of Funded Projects
Fiscal Year 2014: Centers of Excellence in Genomic Science (CEGS)Since the publication of the Human Genome Project (HGP) and the advancement of DNA sequencing technologies, scientists have access to a vast amount of genomic data. The next step is analyzing that data for biomedical information. The Centers of Excellence in Genomic Science (CEGS) program supports interdisciplinary teams to develop critical advances in genomic research that address important biomedical research issues. The approaches and concepts used to address these issues will improve the ability of the broader biomedical community to produce, analyze and use genomic data. Overall, the CEGS are meant to precipitate novel projects that have the potential to change the way in which genomics is performed and utilized in biomedicine. Fiscal Year 2015: Genomics of Gene Regulation (GGR). The goal of the Genomics of Gene Regulation (GGR) project is to develop better methods to construct predictive, accurate gene regulatory networks using genomic data. (Gene regulatory networks are computer models that predict the activity of genes by building a mathematical relationship between genes, the regulatory elements that control those genes, and the signals to which the regulatory elements respond.)
GGR projects are designed to advance genomic science towards the long-term goal of NHGRI research in this area, which is to be able to predict, just by reading DNA sequence, when and at what level a gene is expressed, in a given cell type. Understanding gene regulatory networks could facilitate interpreting the role of genetic variation in human disease, particularly for regions of the genome that don’t contain instructions for making proteins. This is a highly significant problem, as the vast majority of disease-associated variants found using GWAS lie outside of protein-coding sequences. The ability to make accurate predictions from gene regulatory networks could support genomic medicine and precision medicine, by providing us with one more tool to understand the consequences of genetic variation. Fiscal Year 2016: Centers for Common Disease Genomics. The National Human Genome Research Institute (NHGRI) seeks to fund a collaborative large-scale genome sequencing effort to comprehensively identify rare risk and protective variants contributing to multiple common disease phenotypes. This initiative will explore a range of diseases with the ultimate goal of undertaking variant discovery for enough different examples of disease architectures and study designs to better understand the general principles of genomic architecture underlying common, complex inherited diseases; understand how best to design rare variant studies for common disease; and develop resources, informatics tools, and innovative approaches and technologies for multiple disease research communities and the wider biomedical research community. NHGRI plans to make 2-5 awards in FY16.