Allergy, Immunology and Transplantation Research

Published on AidPage by IDILOGIC on Jun 24, 2005

Purpose of this program:

To assist public and private nonprofit institutions and individuals to establish, expand, and improve biomedical research and research training in allergic and immunologic diseases and related areas to assist public, private, and commercial institutions to conduct developmental research; to produce and test research materials; and to provide research services as required by the agency for research progress in allergic and immunologic diseases. NIAID's Allergy, Immunology and Transplantation Research concerns the immune system as it functions in the maintenance of health and as it malfunctions in the production of diseases. Because of this dual focus, the program encompasses both basic research and clinical research. Small Business Innovation Research (SBIR) program expands and improves private sector participation in biomedical research. The SBIR Program intends to increase and facilitate 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. The Small Business Technology Transfer (STTR) program stimulates and fosters 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. Research Career Development Awards support the development of scientists during the formative stages of their careers Individual National Research Service Awards (NRSAs) are made directly to approved applicants for research training in specified biomedical shortage areas. In addition, Institutional National Research Service Awards are made to enable institutions to select and make awards to individuals to receive training under the aegis of their institutional program.

Possible uses and use restrictions...

Beginning with fiscal year 1998, the direct costs awarded in the first year to a research project grant resulting from a competing renewal application will be limited to no more than a 20 percent increase over the direct costs awarded in the last non-competing year of that grant. Research grants provide funds for salaries, equipment, supplies, and travel. They also afford the collateral benefits of enriching the training experience of research workers. Grantees are expected to be judicious in using these funds. The application for a research grant sets forth specific terms and conditions and requires the signatures of the principal investigator and an official authorized to sign for the institution. Scientists and institutions are under an obligation to expend grant funds prudently for the purposes stated in the application and award document. For Research Career Development Awards (RCDAs) the scientists must demonstrate an outstanding research potential for independent research in the sciences related to transplantation, immunology, allergies, and immunological diseases. For National Research Service Awards (NRSAs), each individual who receives NRSA support is obligated upon termination of the award to comply with certain service and payback provisions. 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 which 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 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 the Phase II application.

Who is eligible to apply...

Universities, colleges, hospitals, laboratories, and other public or private nonprofit domestic institutions, including State and local units of government, and individuals are eligible to make application for grant support of research by a named principal investigator or a research career development candidate. For-profit organizations are also eligible, with the exception of NRSA. Individual NRSA 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 NRSA awardees must be citizens or have been admitted to the United States for permanent residence. To be eligible, predoctoral candidates 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). 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 being 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 possessions. 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 researches 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.

Eligible Applicant Categories:
Eligible Functional Categories:
Credentials/Documentation

: Research grant applicants must define the objectives, methodology, and facilities for the program, and must present the program director's competence and scientific interest. For SBIR 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. 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. Applicants for individual NRSAs must include their academic record, research experience, citizenship, institute sponsorship, and the proposed area and plan of training in their applications. The applicant for an institution must specify the objectives, methodology, and resources for the research training program, the qualifications experience of directing staff, the criteria to be used in selecting individuals for award, and a detailed budget justification for the amount of 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 Subpart 31.2 of the Federal Acquisition Regulations. For other grantees, costs will be determined by HHS Regulations 45 CFR, Part 74, Subpart Q.

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:

Use Form PHS-398 (Rev. May 1995) to apply for new, renewal, and supplemental research grants. Application forms and information concerning current areas of science being supported are available from the Division of Extramural Outreach and Information Resources, Office of Extramural Research, National Institutes of Health, 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. The standard application forms, as furnished by PHS and required by 45 CFR, Part 92, must be used for this program. This program is subject to the provisions of 45 CFR, Part 92 for State and local governments and OMB Circular No. A-110 for nonprofit organizations. Completed applications should be submitted to the Center for Scientific Review, National Institutes of Health, Bethesda, MD 20892. SBIR and STTR Grant Solicitations and SBIR Contract Solicitation may be obtained electronically through the NIH's "Small Business Funding Opportunities" homepage at www.nih.gov/grants/funding/sbir.htm on the World Wide Web. 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- 9385; 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 are reviewed for scientific merit by an appropriate initial review group and a national advisory council. If recommended for approval and a decision to make an award is made, a formal award notice will be sent to the applicant and applicant institution. 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.

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 Non-AIDS research applications: February 1, June 1 and October 1. For Renewal and Supplemental Non-AIDS research grant applications: March 1, July 1, and November 1. For all AIDS research grant applications: January 2, May 1, September 1. Research Career Development Award programs: February 1, June 1, October 1. Individual NRSAs: April 5, August 5, and December 5. Institutional NRSA: September 10. SBIR/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

From 8 to 9 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. Final decisions on unresolved appeals are made with the advice of the National Advisory Allergy and Infectious Diseases Council.

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

Renewals of research grant support are by competitive application and review. The competitive application may request support for a segmental period of up to 5 years.

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...

Project Grants

The funding, for fixed or known periods, of specific projects. Project grants can include fellowships, scholarships, research grants, training grants, traineeships, experimental and demonstration grants, evaluation grants, planning grants, technical assistance grants, survey grants, and construction grants.

How much financial aid...

Range and Average of Financial Assistance

(Grants) $2,000 to $4,769,797; $327,387. (NRSAs) $6,984 to $1,127,584; $185,655. SBIR Average Phase I awards are for approximately $195,660; Phase II awards may be made for amounts up to $591,860 (total for funding period). (STTR) average Phase I awards are for approximately $228,710; Phase II awards may be made for amounts up to $427,450 (total for the funding period).

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 03 $461,615,000; FY 04 est $585,818,000; and FY 05 est $614,864,000. (SBIR) FY 03 $5,512,000; FY 04 est $0; and FY 05 est $0. (STTR) FY 03 $1,341,000; FY 04 est $0; and FY 05 est $0.

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

75-0885-0-1-552.

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) Immunobiology and immunochemistry studies: (a) investigate the biology and chemistry of the immune system and its products; and (b) projects in lymphocyte biology supporting multi-disciplinary efforts in immunobiology, cell biology, genetics, biochemistry and immunochemistry with the goal of developing the capability to intervene and manipulate the immune system in health and disease. Particular focus is given to Acquired Immune Deficiency Syndrome. (2) Research in genetics and transplantation biology: (a) encompasses a broad approach to clarify how genes and gene products affect the immune response system, the goal being to understand the genetic and immunologic mechanisms involved in organ transplantation and in resistance or susceptibility to disease. (3) Studies in asthma and allergic diseases: (a) involve the etiology, pathogenesis, diagnosis, prevention, and treatment of both naturally occurring and acquired allergic diseases; and (b) asthma studies include both primary and predisposing factors. (4) Research in immunologic diseases: (a) investigates the underlying mechanisms of disease, as well as applications of basic knowledge to the etiology, prevention, and management of immunologic disorders; and (b) utilizes either of two disciplinary approaches - clinical immunology or immunopathology.

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...

In fiscal year 2003, a total of 1,411 grant awards were made to establish, expand, and promote research and research training in basic immunobiology and immunochemistry; hypersensitivity and inflammation; asthma and allergic diseases; the immune system and its disorders; immunopathology, transplantation biology immunogenetics and lymphocyte biology; and the support of research centers for the study of asthma and allergic diseases, immunodermatology, and immunological diseases. A total of 17 SBIR Phase I, 5 SBIR Phase II, 3 STTR Phase I, and 2 Phase II Awards were made in fiscal year 2003. An estimated 1,446 and 1,514 total awards will be made in fiscal years 2004 and 2005 respectively.

Criteria for selecting proposals...

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 facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) 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 requested 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.

Assistance considerations...

Length and Time Phasing of Assistance

Research grant project periods average 4 years; they may not be extended beyond 7 years. (Project periods are generally composed of 1-year budget periods.) 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 reports and financial status reports are required.

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 Nonprofit 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, Title IV, Section 301, as amended, Public Law 78-410; Small Business Research and Development Enhancement Act of 1992, Public Law 102-564, 42 U.S.C. 241.

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

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.

Contact information...

Web Sites
Regional Or Local Office

Not applicable.

Note: This section lists the agency contact person, address and telephone number of the Federal Regional or Local Office(s) to be contacted for detailed information regarding a program such as: (1) current availability of funds and the likelihood of receiving assistance within a given period; (2) pre-application and application forms required; (3) whether a pre-application conference is recommended; (4) assistance available in preparation of applications; (5) whether funding decisions are made at the headquarters, regional or local level; (6) application renewal procedures (including continuations and supplementals) or appeal procedures for rejected applications; and (7) recently published program guidelines and material. However, for most federal programs, this section will instruct the reader to consult the so-called Appendix IV of the Catalog due to the large volume of Regional and Local Office Contacts for most agencies. This information is provided in Additional Contact Information (see below).

Headquarters Office

: Program Contact: Dr. John J. McGowan, Director, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 496-7291. Grants Management Contact: Ms. Mary Kirker, Grants Management Officer, Grants Management Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Public Health Service, Department of Health and Human Services, Bethesda, MD 20892. Telephone: (301) 496-7075. Use the same numbers for FTS.

Note: This section lists names and addresses of the office at the headquarters level with direct operational responsibility for managing a program. A telephone number is provided in cases where a Regional or Local Office is not normally able to answer detailed inquiries concerning a program. Also listed are the name(s) and telephone number(s) of the information contact person(s) who can provide additional program information to applicants.

Additional Contact Information (Appendix IV)

Due to the large volume of regional and local office contacts for most agencies, full contact information is also provided separately here in a PDF format: