Genetics and Developmental Biology Research and Research Training
Published on AidPage by IDILOGIC on Jun 24, 2005
Purpose of this program:
To support studies aimed at gaining a better understanding of the fundamental mechanisms of inheritance and development. These studies are expected to eventually lead to the diagnosis, prevention, therapy, and cure of human genetic and developmental disorders. Small Business Innovation Research (SBIR) grants are made 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 the participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation. Small Business Technology Transfer (STTR) grants are made 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 the participation of socially and economically disadvantaged small business concerns and women-owned small business concerns in technological innovation.
Possible uses and use restrictions...
The research project grant is awarded to an eligible institution on behalf of a principal investigator to support a discrete project or group of related projects representing the investigator's area of interest and competence. Funds are used for reasonable costs of the research activity, as well as for salaries, equipment, supplies, travel, and other related expenses. National Research Service Awards are made directly to individuals for postdoctoral research training. In addition, grants are made to institutions to enable them to make National Research Service Awards to individuals selected by them for predoctoral or postdoctoral training. 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, NIH, Bethesda, MD 20892. SBIR Phase I grants (of approximately 6 months' duration) are to establish the scientific and 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 that is 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's 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 the results of research initiated in Phase I.
Who is eligible to apply...
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, and individuals. To be eligible for funding, a proposal must be approved for scientific merit and program relevance by a scientific review committee and 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 largely be performed in the U.S. or its possessions. 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) that "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. Nonfederal public and private nonprofit 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 noncitizen nationals of the United States, or must have been lawfully 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.D.S., D.O., D.V.M., Sc.D., D. Eng., or equivalent domestic or foreign degree.) Applications to the SBIR and STTR Programs must meet special requirements for small businesses, as defined by the Small Business Administration.
Credentials/Documentation
Each applicant for research projects must present a research plan and furnish evidence that scientific competence, facilities, equipment, and supplies are appropriate to carry out the plan. Use grant application Form PHS 398 (Rev. 5/01) provided by the Division of Extramural Outreach and Information Resources, National Institutes of Health, Bethesda, MD 20892. For SBIR and STTR grants, the 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. Grant forms PHS 6246-1 and PHS 6246-2 are used to apply for SBIR Phase I and Phase II, respectively. Grant forms PHS 6246-3 and PHS 6246-4 are used to apply for STTR Phase I and Phase II, respectively. 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. Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments. For-profit organizations' costs are determined in accordance with 48 CFR, Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined in accordance with HHS Regulation 45 CFR, Part 74, Subpart C.
Note:This is a brief description of the credentials or documentation required prior to, or along with, an application for assistance.
About this section:
This section indicates who can apply to the Federal government for assistance and the criteria the potential applicant must satisfy.
For example, individuals may be eligible for research grants, and the criteria to be satisfied may be that they have a professional or scientific degree,
3 years of research experience, and be a citizen of the United States. Universities, medical schools, hospitals, or State and local governments may also be eligible.
Where State governments are eligible, the type of State agency will be indicated (State welfare agency or State agency on aging) and the criteria that they
must satisfy.
Certain federal programs (e.g., the Pell Grant program which provides grants to students) involve intermediate levels of application processing, i.e., applications
are transmitted through colleges or universities that are neither the direct applicant nor the ultimate beneficiary. For these programs,
the criteria that the intermediaries must satisfy are also indicated, along with intermediaries who are not eligible.
How to apply...
Application Procedure:
Application forms (and information concerning the area of science being supported) may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, Bethesda, MD 20892, and must be submitted to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892 for assessment by a scientific review committee. The standard application forms, as furnished by PHS and required by 45 CFR, Part 92 for State and local governments, must be used for this program (these forms are available on-line at http://grants.nih.gov/grants/forms.htm). This program is subject to the provisions of 45 CFR, Part 92 for State and local governments, and OMB Circular No. A-110, "Grants and Agreements with Institutions of Higher Education, Hospitals, and other Nonprofit Organizations," as appropriate. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" Web site at http://grants.nih.gov/grants/funding/sbir.htm. A limited number of hard copies of these publications are produced. Subject to availability, they may be obtained by contacting the NIH support services contractor: Telephone: (301) 206-9696; fax: (301) 206-9722; E-mail: a2y@cu.nih.gov. The Solicitations include submission procedures, review considerations, and grant application or contract proposal forms. SBIR and STTR grant applications should be submitted to the Center for Scientific Review, 6701 Rockledge Drive, Room 1040 - MSC 7710, Bethesda, MD 20892-7710.
Note: Each program will indicate whether applications are to be submitted to the Federal headquarters, regional or local office, or to a State or local government office.
Award Procedure:
All accepted applications for project grants, SBIR/STTR grants, and institutional National Research Service Awards are reviewed for scientific merit by an appropriate initial review group and by a national advisory council. (NRSA applications for the support of individual fellows are not reviewed by the council.) All approved applications compete for available funds on the basis of scientific merit and program emphasis.
Note: Grant payments may be made by a letter of credit, advance by Treasury check, or reimbursement by Treasury check.
Awards may be made by the headquarters office directly to the applicant, an agency field office, a regional office,
or by an authorized county office. The assistance may pass through the initial applicant for further distribution by
intermediate level applicants to groups or individuals in the private sector.
Deadlines and process...
Deadlines
New Research Projects: February 1, June 1, and October 1. Renewals: March 1, July 1, and November 1. NRSA (institutional): January 10 (predoctoral and postdoctoral) and May 10 (predoctoral). NRSA (individual): April 5, August 5, and December 5. SBIR and STTR: April 1, August 1, and December 1.
Note:
When available, this section indicates the deadlines for applications to the funding agency which will
be stated in terms of the date(s) or between what dates the application should be received.
When not available, applicants should contact the funding agency for deadline information.
Range of Approval/Disapproval Time
Project Grants: About 9 months. NRSA: (institutional) 9-12 months, (individual) 6 months. SBIR/STTR: About 7-1/2 months.
Preapplication Coordination
Not applicable. This program is excluded from coverage under E.O. 12372.
Note:
This section indicates whether any prior coordination or approval is required with governmental or nongovernmental units
prior to the submission of a formal application to the federal funding agency.
Appeals
A principal investigator (P.I.) may question the substantive or procedural aspects of the review of his/her application by communicating with the staff of the Institute. A description of the NIH Peer Review Appeal procedures is available on the NIH Web site at http://grants.nih.gov/grants/guide/notice-files/not97-232.html.
Note:
In some cases, there are no provisions for appeal. Where applicable, this section discusses appeal procedures or allowable rework time for resubmission
of applications to be processed by the funding agency. Appeal procedures vary with individual programs and are either listed in this section or
applicants are referred to appeal procedures documented in the relevant Code of Federal Regulations (CFR).
Renewals
Renewal grants are generally made prior to the expiration of any current award.
Note:
In some instances, renewal procedures may be the same as for the application procedure, e.g., for projects of a non-continuing nature renewals will be treated as new, competing applications; for projects of an ongoing nature, renewals may be given annually.
Who can benefit...
Any nonprofit or for-profit organization, company, or institution engaged in biomedical research.
Beneficiaries
About this section:
This section lists the ultimate beneficiaries of a program, the criteria they must satisfy and who specifically is not eligible. The applicant and beneficiary will generally be the same for programs that provide assistance directly from a Federal agency. However, financial assistance that passes through State or local governments will have different applicants and beneficiaries since the assistance is transmitted to private sector beneficiaries who are not obligated to request or apply for the assistance.
What types of assistance...
How much financial aid...
Range and Average of Financial Assistance
$20,000 to $3,000,000; $296,734. SBIR Phase I awards are for approximately $100,000; Phase II awards may be made for amounts up to $750,000. STTR Phase I awards are for approximately $100,000; Phase II awards may be made for amounts up to $500,000.
Note:
This section lists the representative range (smallest to largest) of the amount of financial assistance available. These figures are based upon funds awarded in the past fiscal year and the current fiscal year to date. Also indicated is an approximate average amount of awards which were made in the past and current fiscal years.
Obligations
(Grants) FY 01 $416,052,000; FY 02 est $466,623,000; and FY 03 est $491,387,000.
Note:
The dollar amounts listed in this section represent obligations for the past fiscal year (PY), estimates for the current fiscal year (CY), and estimates for the budget fiscal year (BY) as reported by the Federal agencies. Obligations for non-financial assistance programs indicate the administrative expenses involved in the operation of a program.
Account Identification
75-0897-0-1-552.
Note:
Note: This 11-digit budget account identification code represents the account which funds a particular program.
This code should be consistent with the code given for the program area as specified in Appendix III of the Budget of the United States Government.
Examples of funded projects...
(1) Function of the Subunits of Eukaryotic Chromosomes; (2) Molecular Basis for Genetic Control of Development; (3) Behavior of P Factors: Movable Elements in Drosophila; and (4) Cellular Regulatory Mechanisms.
About this section
This section indicates the different types of projects which have been funded in the past. Only projects funded under Project Grants or Direct Payments for Specified Use should be listed here. The examples give potential applicants an idea of the types of projects that may be accepted for funding. The agency should list at least five examples of the most recently funded projects.
Program accomplishments...
Development, gene regulation and structure, DNA replication, and control mechanisms for genetic expression for a range of organisms from viruses and bacteria to humans are being studied. The "Human Genetic Cell Repository" provides stocks of well-characterized human tissue culture cells and DNA samples representing human genetic diseases and are available to researchers in the field. A total of 1,525 research grants and National Research Service Awards were funded in fiscal year 2001. A total of 1,656 research grants and National Research Service Awards are estimated to be funded in fiscal year 2002. A total of 1,635 research grants and National Research Service Awards are estimated to be funded in fiscal year 2003.
Criteria for selecting proposals...
Research Grants: The major elements in evaluating proposals include assessments of the significance, approach, innovation, investigator, and scientific environment.
Assistance considerations...
Length and Time Phasing of Assistance
All awards are made for at least 1 year, with additional support (up to 4 more years) depending on the recommendation of the scientific review group, the national advisory council, successful annual performance, and the availability of funds. SBIR: Normally, Phase I awards are for 6 months; normally, Phase II awards are for 2 years. STTR: Normally, Phase I awards are for 1 year; normally, Phase II awards are for 2 years.
Formula and Matching Requirements
This program has no statutory formula or matching requirements.
Note:
A formula may be based on population, per capita income, and other statistical factors. Applicants are informed whether there are any matching requirements to be met when participating in the cost of a project. In general, the matching share represents that portion of the project costs not borne by the Federal government. Attachment F of OMB Circular No. A-102 (Office of Management and Budget) sets forth the criteria and procedures for the evaluation of matching share requirements which may be cash or in-kind contributions made by State and local governments or other agencies, institutions, private organizations, or individuals to satisfy matching requirements of Federal grants or loans.
Cash contributions represent the grantees' cash outlay, including the outlay of money contributed to the grantee by other public agencies, institutions, private organizations, or individuals. When authorized by Federal regulation, Federal funds received from other grants may be considered as the grantees' cash contribution.
In-kind contributions represent the value of noncash contributions provided by the grantee, other public agencies and institutions, private organizations or individuals. In-kind contributions may consist of charges for real property and equipment, and value of goods and services directly benefiting and specifically identifiable to the grant program. When authorized by Federal legislation, property purchased with Federal funds may be considered as grantees' in-kind contribution.
Maintenance of effort (MOE) is a requirement contained in certain legislation, regulations, or administrative policies stating that a grantee must maintain a specified level of financial effort in a specific area in order to receive Federal grant funds, and that the Federal grant funds may be used only to supplement, not supplant, the level of grantee funds.
Post assistance requirements...
Reports
Annual progress and selected financial status reports for continuing projects and final reports on all projects upon conclusion are required. Recipients of National Research Service Awards are required to file termination reports to ascertain compliance with the service and payback provisions.
Note:
This section indicates whether program reports, expenditure reports, cash reports or performance monitoring are required by the Federal funding agency, and specifies at what time intervals (monthly, annually, etc.) this must be accomplished.
Audits
In accordance with the provisions of OMB Circular No. A-133 (Revised, June 24, 1997), "Audits of States, Local Governments, and Non-Profit Organizations," nonfederal entities that expend financial assistance of $300,000 or more in Federal awards will have a single or a program-specific audit conducted for that year. Nonfederal entities that expend less than $300,000 a year in Federal awards are exempt from Federal audit requirements for that year, except as noted in Circular No. A-133. In addition, grants and cooperative agreements are subject to inspection and audits by DHHS and other Federal government officials.
Note:
This section discusses audits required by the Federal agency.
The procedures and requirements for State and local governments and nonprofit entities are set forth in OMB Circular No. A-133.
These requirements pertain to awards made within the respective State's fiscal year - not the Federal fiscal year,
as some State and local governments may use the calendar year or other variation of time span designated as the fiscal year period,
rather than that commonly known as the Federal fiscal year (from October 1st through September 30th).
Records
Expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the last financial status report for the report period.
Note:
This section indicates the record retention requirements and the type of records the Federal agency may require.
Not included are the normally imposed requirements of the General Accounting Office.
For programs falling under the purview of OMB Circular No. A-102, record retention is set forth in Attachment C.
For other programs, record retention is governed by the funding agency's requirements.
Regulations...
Authorization
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.
Note:
This section lists the legal authority upon which a program is based (acts, amendments to acts, Public Law numbers, titles, sections, Statute Codes, citations to the U.S. Code, Executive Orders, Presidential Reorganization Plans, and Memoranda from an agency head).
Regulations, Guidelines, And Literature
42 CFR 52; 42 CFR 66; 45 CFR 74; 45 CFR 92; NIH Extramural Programs brochure; and miscellaneous program literature 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 USC 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.
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