To improve health information services by providing funds to train professional personnel; to conduct research in biomedical informatics, bioinformatics and related computer and information sciences; to facilitate management of electronic health science information; to plan, develop and test feasibility

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of advanced information tools; to prepare certain kinds of biomedical publications; to advance biocomputing and bioinformatics through participation in the Biomedical Information Science and Technology Initiative (BISTI), and NIH Roadmap Initiatives relating to biomedical informatics, bioinformatics and biomedical computing; to stimulate and foster scientific and technological innovation through cooperative research development carried out between small business concerns and research institutions, through Small Business Research Innovation (SBIR) and Small Business Technology Transfer (STTR) grants.

In fiscal year 2007, 223 new and continuing awards were made for projects in biomedical informatics, bioinformatics, informatics training and health information management. It is anticipated that approximately 213 awards will be issued in fiscal year 2008 and approximately 213 awards will be issued in fiscal year 2009.

Uses and Use Restrictions

RESEARCH GRANT PROGRAMS: Research Grants are available for fundamental and applied research in biomedical informatics and bioinformatics.

Areas of research interest include: representation, organization and retrieval of biomedical and biological knowledge, data and images; enhancement of human intellectual capacities through virtual reality, dynamic modeling, artificial intelligence, and machine learning; medical decision-making; linguistic analyses for natural language processing and understanding; informatics topics relevant to public health and informatics for disaster management.

Research Project Grants (R01) are available for rigorous scientific research studies and experiments.

Small Project Grants (R03) provide short-term awards answer specific, targeted research questions, gather preliminary data, show proof of concept.

Exploratory/Developmental Grants (R21) support early, conceptual work and feasibility tests.

Other research grants include Informatics Conference Grants, and Innovations in Biomedical Computational Science and Technology (BISTI) Grants, and a number of NIH-wide grant programs on high priority topics such as health literacy.

Further information on research grants is available at http://www.nlm.nih.gov/ep/Grants.html#research.TRAINING PROGRAMS AND FELLOWSHIPS: To assure an adequate national pool of informatics researchers and health information specialists, training is offered through formal training programs and individual fellowships.

University Biomedical Informatics Research Training Programs promote the career training of talented persons who seek research careers in biomedical informatics, bioinformatics, and public health informatics.

A competition for these institution-based training grants is announced every five years.

University-based training support may be at the pre- or post-doctoral level.

Training sites recruit and choose their trainees, and are expected to have well established computer facilities, strong informatics research and education programs, experienced faculty and staff committed to research in the field of biomedical computing and/or bioinformatics, and available courses or experience in computer science, information science, and cognitive sciences.

Institutional training grants provide trainee stipends, tuition and fees, travel, and certain institutional support costs.

NLM also offers individual Informationist Fellowships for cross-training of information specialists to work in scientific and biomedical contexts.

Stipends are based on published predoctoral stipend levels that are updated each year.

Further information on training grants and fellowships grants is available at http://www.nlm.nih.gov/ep/Grants.html#training.

CAREER DEVELOPMENT PROGRAMS: NLM offers an early career development award to help informatics trainees make the transition to a successful independent research career.

NIH Pathway to Independence Career Development awards are for investigators who are making the transition to their first research positions.

These grants can last up to 5 years.

They include a mentored period, followed by an unmentored period, and provide both salary and a research fund.

Research supplement awards are also offered to promote diversity in health-related informatics research, and to promote re-entry into informatics careers.

Diversity and re-entry awards are issued as supplements to existing research grants funded by NLM.

NLM also participates in the NIH Loan Repayment Award (LRP) program.

The LRP awards are available to those who qualify and will commit to two years of clinical informatics research.

Further information on career development grants is available at http://www.nlm.nih.gov/ep/Grants.html#career.

RESOURCE GRANT PROGRAMS: Resource grants support the development and deployment of knowledge management tools, resources, and services that address identified, unmet needs for a broad audience.

Two types of resource grants are available: Knowledge Management & Applied Informatics grants and Planning Grants for Integrated Advanced Information Management Systems (IAIMS).

In addition, NLM offers Grants for Scholarly Works to support preparation of books in the history and philosophy of biomedicine, bioethics, and public policy areas of importance to health professionals and biomedical scientists.

The purpose, restrictions, funding periods and award limits vary for these grant programs.

Knowledge management and IAIMS Planning grants provide support for direct costs only.

Knowledge grants provide $150,000 per year for up to 3 years.

Awards for IAIMS planning are limited to $150,000 per year for 1 or 2 years.

Scholarly Works grants are limited to $50,000 annually for one, two or three years.

Further information on resource grants is available at http://www.nlm.nih.gov/ep/Grants.html#resource.

SMALL BUSINESS RESEARCH & DEVELOPMENT PROGRAMS: Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) grants are made to U. S. small businesses that seek to undertake informatics research and development leading to commercialization.

The STTR program requires a small business applicant organization to formally collaborate with a research institution in Phase I and Phase II.

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 the research initiated in Phase I and that are likely to result in commercial products or processes.

Only Phase I awardees are eligible to receive 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 on Phase II application.

Further information on SBIR/STTR grants is available at http://www.nlm.nih.gov/ep/Grants.html#small.

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Eligibility Requirements

Applicant Eligibility

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the project director/principal investigator (PD/PI)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.

See Beneficiary Eligibility below for further details.

Beneficiary Eligibility

Research Grants are available to public or private, domestic or foreign, for profit or not-for-profit institutions or organizations with research capabilities in biomedical informatics, bioinformatics, computer sciences, information sciences and related disciplines. Training Grants may be made to nonfederal public and nonprofit private institutions. Fellowships may be awarded to individuals at the pre-doctoral level. With the exception of NIH Pathway to Independence awards, trainees or fellows must be citizens or non-citizen nationals of the United States or have been lawfully admitted to the United States for permanent residence. Resource grants (IAIMS, Knowledge Management, Scholarly Works) are open to any U.S. public or private nonprofit health-related institution or organization. For Scholarly Works grants, an appropriate public or private nonprofit institution of higher education may apply in behalf of the principal investigator on the project, or an individual unaffiliated with an academic organization may apply directly. SBIR and STTR 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). 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.

Credentials/Documentation

Cost allowability will be determined in accordance with OMB Circular A-87 for State, Local, and Indian Tribal Governments, OMB Circular A-21 for Educational Institutions and for For-profit organizations, costs will be determined in accordance with 48 CFR Subpart 31.2 Federal Acquisition Regulation (FAR). Nonprofit institutions cost principles are outlined under OMB Circular A-122 and for Hospitals, 45 CFR Part 74, Appendix E. These cost principles are codified under 45 CFR 74.27 and 92.22. Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals, and Other Nonprofit Organizations are outlined in OMB Circular A-110. Documentation providing NIH grants policy and guidance can be found at http://grants.nih.gov/grants/policy/policy.htm. The Division of Extramural Programs, NLM provides program specific grant information at http://www.nlm.nih.gov/ep.

Aplication and Award Process

Preapplication Coordination

Not applicable.

This program is excluded from coverage under E.O.

12372.

Application Procedures

NIH is in the process of moving to electronic submission of applications for all of its grant programs. Only electronic applications are accepted for all types of Research Grants, SBIR and STTR grants, and Resource Grants. Electronic grant submission of the SF424 (R&R) form is via http://www.grants.gov. For instructions on submitting grants electronically, see http://era.nih.gov/ElectronicReceipt/. A timeline of transitions to electronic submission for each grant program is available at http://www.nlm.nih.gov/ep/Deadlines.html. For all other grant programs, a paper form is submitted to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. Form PHS-398 is used for NIH Pathway to Independence Grants and Biomedical Resource Grants. Forms and instructions for PHS-398 can be downloaded at http://grants1.nih.gov/grants/funding/phs398/phs398.html. For Informationist Fellowships, submit Form PHS-416-1, with forms and instructions downloadable at http://grants1.nih.gov/grants/funding/416/phs416.htm. These programs are subject to the provisions of 45 CFR, Part 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations. Updates on NLM application deadlines and links to available forms can also be found at http://www.nlm.nih.gov/ep/.

Award Procedures

Applications are evaluated for merit by a committee of scientific experts and for program relevance by the Board of Regents (BOR) of the National Library of Medicine (NLM). If favorably recommended, the application is considered for funding. An award notice is prepared when it is determined that a grant is to be paid. This notice is sent to the grantee with a letter from the program officer when special provisions are necessary. 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 priority score compete for available SBIR/STTR set-aside funds on the basis of scientific and technical merit and commercial potential of the proposed research, program relevance, and program balance among the areas of research.

Deadlines

Each program has 3 application deadlines per year, which vary by grant program and whether the application is new or revised. Special Requests for Applications (RFAs) or newly established Program Announcements (PAs) issued annually may have other limited deadline dates. For an up-to-date list of deadlines, see http://www.nlm.nih.gov/ep/Deadlines.html.

Authorization

Public Health Service Act, Title III, Part A, Section 301, Title IV, Part D, Subpart 2, Sections 472-476, as amended, Public Law 103-43; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564.

Range of Approval/Disapproval Time

From 9-10 months after the application deadline.

Appeals

NIH policy allows a principal investigator (PI) to appeal the outcome of a review if procedural errors or factual errors entered into the review of the application. A description of the NIH Peer Review Appeal procedures is available at http://grants.nih.gov/grants/guide/notice-files/not97-232.html. However, differences of scientific opinion that often occur between investigators and reviewers may not be contested through these procedures. In addition, communications from investigators consisting of additional information that was not available to the reviewers are not considered to be appeals.

Renewals

Competing renewal applications follow same review procedures and deadlines as new applications; dates for submission are at http://www.nlm.nih.gov/ep/Deadlines.html. NIH also permits the resubmission of an application that has been revised following merit review. Deadlines for resubmissions are listed with other deadlines.

Assistance Considerations

Formula and Matching Requirements

There are no statutory formula or matching requirements for NLM grants.

Length and Time Phasing of Assistance

The length of a grant award varies by the type of grant. R01 research grants generally last three or four years. Resource grants, Small Pilot and Exploratory/Developmental grants, Fellowships and NIH Pathway to Independence awards have defined maximum periods that are provided in the funding opportunity announcement.

Post Assistance Requirements

Reports

Annual grant progress reports and Financial Status Reports must be submitted as required.

At the end of a grant, the awardee must file a final progress report, final Financial Status Report and final statement of invention.

Audits

In accordance with the provisions of OMB Circular No. A-133, States, local governments, and nonprofit organizations that expend $500,000 or more in a year in Federal awards shall have a single or program-specific audit conducted for that year. In accordance with 45 CFR 74 Subpart C Section 74.26(d) for-profit organizations that expend more than $500,000 in DHHS awards in a year shall have an audit of the DHHS awards in accordance with the "Government Auditing Standards" (Yellow Book) or an audit that meets the requirements of OMB Circular A-133. Award recipients that do not meet the $500,000 threshold are exempt from Federal audit requirements for that year, except as noted in Circular A-133. In addition, grants and cooperative agreements are subject to review or audit by appropriate officials of the Federal (funding) agency, pass-through entity and the Government Accountability Office (GAO). Foreign organizations must use the for-profit audit requirements for DHHS supported awards. The NIH/DHHS Loan Repayment Program (LRP) is not subject to Federal auditing requirements. For OMB policy statements on grants, see http://www.whitehouse.gov/omb/grants/grants_docs.html. Government Auditing Standards is available on the GAO Web site at http://www.gao.gov/govaud/ybk01.htm.

Records

Financial and programmatic grant records must be retained for 3 years from the day on which the grantee submits the last (annual) Financial Status Report (FSR). Streamlined Noncompeting Application Process (SNAP) awardees beginning date for record retention purposes is the date of the FSR submission for the entire competitive segment of the grant.

Financial Information

Account Identification

75-0807-0-1-552.

Obigations

(Extramural Funding Awards) FY 07 $67,568,000; FY 08 est $63,389,000; and FY 09 est $63,389,000.

Range and Average of Financial Assistance

$7,000 to $1,561,223; $333,452 - FY 07 total average cost for Basic Research Grant (R01); $143,773 - FY 07 total average cost for Knowledge Management Grant (G08); $70,692 - FY 07 total average cost for Scholarly Works Grant (G13).

Regulations, Guidelines, and Literature

National Library of Medicine Grant Programs are awarded under the Public Health Service Act and the Medical Library Assistance Act. Grants and funding awards are made available under the authority of the Acts as codified under 45 CFR 74 (Uniform Administrative Requirements for Awards and Subawards to Institutions of Higher Education, Hospitals, Other Nonprofit Organizations, and Commercial Organizations; and Certain Grants and Agreements with States, Local Governments, and Indian Tribal Governments and 45 CFR 92 (Uniform Administrative Requirements for Grants and Cooperative Agreements to States and Local Governments); the NIH Grants Policy Statement is available to grantees as a single document governing the NIH/DHHS policy requirements and terms and conditions of NIH/DHHS grant awards. Additional regulations and guidelines are provided in the Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR - R43, R44) Grant and Cooperative Agreement Applications including the Omnibus Solicitation of the National Institutes of Health for Small Business Technology Transfer (STTR - R41, R42) Grant Applications.

Information Contacts

Regional or Local Office

Not applicable.

Headquarters Office

Extramural Programs, National Library of Medicine, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20894. Telephone: (301) 496-4621. Program Contacts: Telephone: (301) 594-4882. Grants Management Contact: Grants Management Officer: Telephone: (301) 496-4221. Grant Review Contact: Scientific Review Administrator. Telephone: (301) 496-4253. Use the same numbers for FTS. Website: http://www.nlm.nih.gov/ep.

Criteria for Selecting Proposals

The standard NIH review criteria, significance, approach, innovation, investigator, environment are used as the basis of merit review. For NLM resource grants, these include considerations as to relevance to program objectives; impact on the management and transmission of biomedical knowledge; institutional readiness and resources available to project; expertise of project director and key personnel; scientific or technical merit of project; sustainability of what is deployed, and appropriateness of budget. Comparative priorities on the above criteria are based on collective judgment of peer reviewers. The following criteria are 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 scientific, technical, or 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 are reviewed based upon the similar criteria, and on the degree to which the Phase I objectives were met and feasibility demonstrated General Services Administration Office of Governmentwide Policy Office of Acquisition Policy Regulatory and Federal Assistance Publication Division (MVA).