Food and Drug Administration_Research

Published on AidPage by IDILOGIC on Jun 24, 2005

Purpose of this program:

To assist profit-making organizations, public and other nonprofit institutions, to establish, expand, and improve research, demonstration, education and information dissemination activities; acquired immunodeficiency syndrome (AIDS), biologics, blood and blood products, therapeutics, vaccines and allergenic projects; drug hazards, human and veterinary drugs, clinical trials on drugs and devices for orphan products development; nutrition, sanitation and microbiological hazards; medical devices and diagnostic products, radiation emitting devices and materials; food safety and food additives. Small Business Innovation Research (SBIR) Programs: to stimulate technological innovation; to encourage the role of small business to meet Federal research and development needs; to increase private sector commercialization of innovations derived from Federal research and development; and to foster and encourage participation by minority and disadvantaged persons in technological innovation.

Possible uses and use restrictions...

Research grants are awarded to an eligible institution in the name of a principal investigator for a discrete project representing the investigator's interest and competence. Funds are to be used for salaries and wages, equipment, supplies, travel, and other costs directly required to carry out the research. Small Business Innovation Research (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. SBIR Phase II grants for this program are for the competitive 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 apply for Phase II support. All approved applications compete for available SBIR set-aside funds on the basis of technical merit and program relevance. Conference grants provide partial support for domestic or scientific conferences.

Who is eligible to apply...

Research grants, including application for Orphan Product Developments, can be made to any public or private nonprofit university, college, hospital, laboratory or other institution, including State and local units of government. Commercial, nonprofit, and faith-based organizations are also eligible. Small Business Innovation Research (SBIR) grants can only be awarded to domestic small businesses (entities that are independently owned and operated for a 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 the award and during the conduct of the proposed project. In both Phase I and Phase II, the research must be performed in the United States and its possessions.

Eligible Applicant Categories:
Eligible Functional Categories:
Credentials/Documentation

Research, including Orphan Product Development and conference grant applicants must present a plan and furnish evidence that scientific competence, facilities, and equipment are appropriate to carry out the plan. For Small Business Innovation Research, each applicant must present a research plan and furnish evidence that scientific competence, experimental methods, facilities, equipment, and supplies are appropriate to carry out the plan. Furthermore, in Phase I, there should be an idea or concept with commercial potential, and in Phase II there should be evidence that commercialization of the research results is plausible. Costs will be determined in accordance with OMB Circular No. A-87 for State and local governments, for-profit organizations' with Subpart 31.2 of the Federal Acquisition Regulations (FAR), OMB Circular No. A-21 for universities, and OMB Circular No. A-122 for nonprofit organizations.

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:

Consultation of Program Staff is available by contacting the Headquarters Office listed below. The standard application forms, as furnished by FDA and required by 45 CFR 74 and 92 must be used for this program. The applicant must complete PHS Form 398 for new competing continuations or supplemental research grants. State and local governments may use form PHS 5161-1 (rev 7-00). All unsolicited applications, with the exception of those directed to the Center for Veterinary Medicine, are submitted to the Center for Scientific Review, National Institutes of Health, Suite 1040, 6701 Rockledge Drive MSC 7710, Bethesda, MD 20892. Unsolicited applications directed to the Center for Veterinary Medicine will be subject to Field Reader review or ad hoc panel reviews directed by the Center. Applications in response to Federal Register Announcements (solicited) shall be sent to the address listed below for Information Contacts, Headquarters Office. All application kits may be obtained from the FDA office listed below or from the CSR/NIH at the above address. All applicants for solicited grant programs are cautioned to follow the specific mailing instructions published in the RFA.

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:

Research: All accepted research grant applications, including Orphan Product Development and Small Business and Innovative Research, receive a dual scientific review for technical merit, a recommendation for approval by an appropriate initial review group and a secondary review by a national advisory council. All approved applications compete for available funds on the basis of scientific merit and program emphasis. All applications accepted under the Radiation Control for Health Safety Act of 1968, Public Law 90-602 and Small Scientific Conference grants, are evaluated under objective review procedures and receive a single initial review.

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

Contact Headquarters Office listed below for solicited research application deadlines. Orphan Products Development Grant Applications and other Research grant applications due dates are published in the Federal Register and may vary from year to year. SBIR: April 15, August 15 and December 15. Conference grant applications: October 15, January 15, April 15, and July 15. Unsolicited and SBIR applications are received and processed by the Center for Scientific Review/ National Institutes of Health.

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 6 to 9 months for research grant applications. SBIR applications: Approximately 6 months. Conference applications: Approximately 3 months.

Preapplication Coordination

Not applicable. This program is excluded from coverage under Executive Order 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

None.

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 are available. Procedures are the same as for new applications.

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...

Colleges, universities, profit-making organizations, nonprofit institutions, hospitals, faith-based and State and local governments.

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

$889 to $3,000,000; $232,030.

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 $28,539,762; FY 04 est $15,223,000; and FY 05 est $14,370,000.

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

75-0600-0-1-554.

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) Radiation Effects and Exposure Criteria; (2) Analytical Methodology for Animal Drug Tissue in Milk; (3) Post Marketing Surveillance of Adverse Drug Reactions; (4) International Program on Chemical Safety; (5) ADI-PEG for Metastatic Melanoma; (6) Continuation of the National Center for Food Safety and Technology; (7) Interferon Gamma Treatment of Osteoporosis; and (8) SBIR: Phase I - Detection of Campylobacteria in Foods, Phase II Point of Care Lead Instrument and Sensor.

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...

Research and Conference Grants: In fiscal year 2003, 174 new competitive applications were received and 43 new awards were funded. 54 continuation awards were also funded in fiscal year 2003. In fiscal year 2004, it is anticipated that approximately 97 new competitive applications will be received, approximately 43 new awards will be funded, and approximately 35 continuation awards will be made. In fiscal year 2005, it is anticipated that approximately 98 new competitive applications will be received, approximately 23 new awards will be funded, and approximately 65 continuation awards will be made. SBIR: In fiscal year 2003, 24 new competitive phase one applications and 3 phase two applications were received and 4 new phase one and 1 phase two awards were funded. In fiscal year 2004, it is anticipated that approximately 25 phase one and 2 phase two new competitive applications will be received, approximately 1 phase one and 2 phase two new awards will be funded. In fiscal year 2005, it is anticipated that approximately 25 phase one and 2 phase two new competitive applications will be received, approximately 3 phase one and 1 phase two new awards will be funded.

Criteria for selecting proposals...

The major elements in evaluating proposals include the assessment 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 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. For Small Business Innovation Research applications, the major elements in evaluating Phase I grant applications include the assessment of: (1) The technical merit of the proposed research; (2) the soundness of the proposed design and methods; (3) the qualifications of the proposed principal investigator, supporting staff, and consultants; (4) the potential of the proposed research for technological innovation and commercial application; (5) the appropriateness of the budget requested; and (6) the adequacy and suitability of the facilities and research environment. In review of Phase II applications, criteria include those listed above, in addition to the following: (1) the degree in which Phase I objectives were met and the feasibility demonstrated; and (2) the adequacy of the Phase I objectives and methodology for addressing the proposed research.

Assistance considerations...

Length and Time Phasing of Assistance

Normally, awards are made for 1-year with additional support (up to 5 years) depending on the recommendation of the dual review groups, successful annual performance and availability of funds. Small Business Innovation Research Phase I awards are generally for 6 months; Phase II awards are generally for 2 years. Conference grant awards are for one year.

Formula and Matching Requirements

This program has no statutory formula or matching requirements. Cost participation is not required.

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 program progress reports and financial status reports are required for continuation at the end of each budget period. Final program progress and financial status reports and an invention statement on all projects must be submitted upon completion.

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

Progress reports, expenditures and other financial records must be retained for 3 years from the day on which the grantee submits the final 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 III, Section 301(c), Public Law 78-410, as amended; Radiation Control for Health Safety Act of 1968, Public Law 90-602, 42 U.S.C. 241 and 263; 42 U.S.C. 300u, Title XVII; Small Business Innovation Research Program Reauthorization Act of 1992, as amended, Public Law 102-564 and 106-554.

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 Part 52 - Grants for Research Project; 45 CFR Part 46 - Protection of Human Subjects; 45 CFR Part 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; 45 CFR Part 92 - Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments; the PHS Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000, (Rev.) April 1, 1994; and the Public Health Omnibus Solicitation for Small Business Innovation Research.

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 and Grants Management Contact: Peggy L. Jones, Chief Grants Management Officer, Division of Contracts and Grants Management, Office of Acquisition and Grant Services, Food and Drug Administration, Department of Health and Human Services, HFA-531, Room 2129, 5630 Fishers Lane, Rockville, MD 20857. Telephone: 301-827-7160; SBIR: 301-827-7182; Fax 301-827-7101; Internet address: pjones1@oc.fda.gov.

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: