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FDA Assistance Policies
A. Assistance Application Procedures
B. Further Information
FDA Procurement Policies
A. Solicitation of Bids and Proposals
B. Publicizing Procurement Actions
C. Small Business Opportunties
D. Minority Business Enterprise
E. Commodities and Services Purchased by Major FDA Procurement
Offices
1. FOREWORD
The philosophy of the Food and Drug Administration's extramural program is to stimulate competition among potential recipients and to award contracts and grants on a competitive basis to the fullest degree consistent with quality, efficiency, and economy. It is our further philosophy that opportunities for minority organizations and small businesses be greatly increased. We shall seek out, motivate, and provide guidance to minority and small business organizations so that their opportunities to participate in FDA'S extramural program be consistent with their rights as citizens to share in the economic and social progress of this Nation.
In furtherance of this philosophy, this booklet has been prepared to provide helpful information to assist individuals and firms - - small business or otherwise - - as well as institutions, both for profit and non-profit in doing business with the Food and Drug Administration. This booklet addresses itself primarily to individuals and concerns that previously have done little or no business with the Federal Government.
This booklet contains a brief description of the mission and programs of FDA and is intended to acquaint potential contractors and/or grant recipients with the opportunities for grants and contracts in the fields of research, development, testing, evaluation, demonstration, training and technical services. In this connection, it provides a listing of FDA grants and procurement offices indicating the types of funding administered by each, and their governing policies.
2. MISSION OF FDA
The mission of the FDA is to protect the public health of the Nation as it may be impaired by foods, food additives, drugs, cosmetics, diagnostic and therapeutic devices, natural poisons, pesticides, and various other types of consumer products. FDA's regulatory functions are geared to ensure that: foods are safe, pure and wholesome; drugs are safe and effective; all the above are honestly and informatively labeled and packaged; counterfeiting of drugs is stopped; and that hazards incident to the use of various types of medical and cosmetic products are reduced.
These major programs areas are technically administered by the following organizations within FDA:
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
CENTER FOR DRUG EVALUATION AND RESEARCH
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
CENTER FOR VETERINARY MEDICINE
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH
OFFICE OF THE COMMISSIONER
3. FDA ASSISTANCE POLICIES
The FDA grants program is governed by Title 45, Code of Federal Regulations, Part 74 and Part 92. Those regulations are implemented through DHHS.
Grants are available to colleges and universities, State and local governments, and non-profit and for-profit organizations.
A. Assistance Application Procedures:
The FDA's assistance program is described in the "Catalog of Federal Domestic Assistance." When funds become available for specific targeted programs, such availability is announced in the Federal Register as a Request for Applications (RFA).
Grant application kits (PHS 398) are available at the business office of most universities and colleges. Caution must be exercised to insure that the application is mailed to the proper address and not DRG, as instructed. However, they may also be obtained by contacting the FDA Grants Office at (301) 827-7150
Applicants who wish to apply for support of a project which is generally compatible with FDA's overall mission and program areas should submit their application to the Division of Research Grants (DRG) at the National Institutes of Health (NIH) and a courtesy copy should be mailed to the Grants Management Officer, FDA at the address listed below. The application and the transmittal letter should indicate that the application is being submitted for Primary Consideration by the FDA. Upon receipt, all applications are reviewed for programmatic/scientific relevance and referred to individual funding Agencies accordingly. Submission deadlines are March 1, July 1, and November 1.
When responding to a specific Request for Applications, the Federal Register Announcement will describe application procedures and specify submission dates.
Questions regarding the administration of FDA's grant program may be directed to
Ms. Maura Stephanos, Grants Management Specialist, or Ms. Olia M. Hopkins, Director, Division of Contracts and Procurement Management. Both Ms. Stephanos and Ms. Hopkins may be reached at (301) 827-7150 or EMAIL to mstepha1 @ oc.fda.gov.
The following paragraphs contain a brief description of FDA's major program areas. Individuals seeking information about specific projects should contact the coordinator(s) within FDA for the appropriate program area. Those individuals, their phone numbers and addresses are listed below:
Maura Stephanos
Grants Management Specialist, OFACS, FDA
5630 Fishers Lane, (HFA-521), Room 2110
Rockville, MD 20857
Telephone: (301) 827-7183
Center for Food Safety and Applied Nutrition
Ms. Juanita Pointer (HFF-9)
Room 6002, Federal Building 8
200 C Street, S.W.
Washington, DC 20202
Telephone: (202) 205-4098
Center for Drug Evaluation and Research
Lowell Lima (301) 827-0506
Ralph Lillie (ADP)(301) 827-6240
7500 Standish Place
Rockville, MD 20855
Center for Biologics and Evaluation Research
James Sigg (301) 827-1414
Stanley Powlowski(ADP) (301) 827-2728
1401 Rockville Pike
Rockville, MD 20852
Center for Veterinary Medicine
Dr. David Batson (HFV-502)
MOD II
8401 Murkirk Road
Laurel, MD 20708
Telephone: (301) 827-8021
JoAnne Kla (HFV-12)
(Small Business)
7500 Standish Place
Rockville, MD 20855
Telephone: (301) 827-6507
Center for Devices and Radiological Health
Sandra Cordes (301) 594-3006 x158
Kathleen Johnson(ADP/Information Systems) (301) 594-4550 x155
2098 Gaither Road
Rockville, MD 20850
National Center for Toxicological Research
Mr. Stephen G. Goodrich
NCTR Drive, Highway 365N
County Road 3
Jefferson, AR 72079
Telephone: (870) 543-7248
Office of the Commissioner
Ms. Carrie Smith-Hanley
5600 Fishers Lane, Room 1482
Rockville, MD 20857
Telephone: (301) 827-3389
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
The Center for Food Safety and Applied Nutrition is responsible for providing consumer protection by assuring that the food industry meets its responsibility of supplying the Nation with safe, pure, and honestly labeled food products, and safe, honestly labeled cosmetic products. This is a monumental task primarily because of the sheer amount of food produced, distributed and consumed in this country, but also because food is subject to natural and man-made contamination by toxins, insects, pathogenic bacteria and molds, industrial chemicals, and toxic metals. Also, food additives and color additives are added in increasing amounts to food products. Some ingredients formerly used as additives have been found to be unsafe in view of new toxicological knowledge. Ingredients or pathogenic microorganisms have caused some severe adverse reactions. Cosmetics containing unsafe ingredients or pathogenic microorganisms have caused some adverse reactions.
One of the Center's major activities can be classified as science and research.
Scientific studies and knowledge are fundamental to the formulation of the Center's regulatory policy and the operation of effective surveillance and compliance programs.
The acquisition of sound information regarding the safety of various substances requires a broad range and mixture of skills and the necessary facilities. Because it is clearly beyond the capability of the Center to possess all these skills and facilities, appropriate research assistance from other sources is necessary. The Center accomplishes its scientific activities jointly with other government agencies, with the use of outside consultants, and through contract mechanisms. Together these assure that the best expertise is available to support Center management and Agency management in regulatory decision-making.
The nature of the Center's mission requires it to maintain a substantial research, testing, and analytical capability. The Center has laboratories located in the District of Columbia, and in Beltsville, Maryland. In all of these laboratories (chemistry, toxicology, microbiology, nutrition, and pathology), the Center has diverse types of sophisticated instrumentation. The laboratories and equipment are used for detecting very low levels of potentially hazardous substances in foods or cosmetics, conducting short-term toxicity studies, developing analytical methods for routine use in enforcement activities, and determining the characteristics of substances that may present health hazards in foods or cosmetics.
The Center's laboratory in Beltsville, Maryland, serves as the research center for special toxicological investigations involving larger animals. Mini-pigs and beagle dogs are used to serve as man's surrogate in the toxicity testing of food additives, food contaminants (and various drugs and other chemical substances).
CENTER FOR DRUG EVALUATION AND RESEARCH
A. Pharmaceutical Evaluation of the Safety and Efficacy of Drugs
(1.) In vitro dissolution and in vitro methodology development including quantitative analytical techniques and bioavailability/bioequivalence measurement.
(2.) Biopharmaceutical dosage form studies, including new drug delivery systems and new dosage forms, e.g., prodrugs, osmotic pumps, depots, implants, etc.
B. Parmacokinetic Methods Development
(1.) Quantitative analytical techniques.
(2.) Effects of physiological variables, health state and food-drug interactions on bioavailability and pharmacokinetic assessment of ADME (absorption, distribution, metabolism, and excretion) processes of drugs to support labeling or dosage regimen modifications, or both.
(3.) Pharmacokinetic assessment in specialized patient population, e.g., pediatrics, geriatrics, diseased state, etc. and equivalence assessment of generic drugs.
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
A. Vaccines
(1.) Viral
(2.) Bacterial
(3.) Rickettsial
B. Blood and Blood Products
(1.) Plasma
(2.) Serums
(3.) Serum fractions for diagnostic and therapeutic use
C. Toxids, Toxins, Antitoxins
D. Antivenins
E. Skin Test Antigens and Allergenics Products
F. In Vitro Diagnostics
G. Formulation of Improved Control Procedures relating to the purity, potency, safety and efficacy of experimental and licensed biologics used in the control and prevention of human disease.
CENTER FOR VETERINARY MEDICINE
Animal Pharmacology and Toxicology
(1.) Development of better animal models for use in the evaluation of safety and efficacy of specific drugs and in vitro diagnostic products.
(2.) Improved methodologies for clinical evaluation.
(3.) Adverse drug reaction methodology analysis and evaluation.
(4.) Drug and poison epidemiology and postmarketing surveillance.
(5.) Analysis of patterns of use of drugs in clinical medicine.
(6.) Research on the communication of prescribing information and ethical pharmaceutical promotion.
(7.) Research on natural toxins and chemical contaminants in animal feeds.
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Area of Medical Devices
The FDA considers applications concerning the quality, safety, and effectiveness of medical devices and diagnostic products, including research to assist in the establishment of performance standards for medical devices and product class standards for diagnostic products; collection and evaluation of information to support the updating of standards and labeling on the use of marketed medical devices and diagnostic products and adverse reactions to these products; and development research for advancing medical device or diagnostic product related science and technology not receiving attention elsewhere. Investigations leading to improved clinical and analytical methodology, animal models, and analysis patterns required for development of the above objectives are also considered.
Area of Radiological Health
The FDA is interested in investigations of electromagnetic radiations (including ionizing, microwave, radio frequency, ultraviolet, visible light and infrared), magnetic fields, infrasound, sound, and ultrasound as they ultimately affect man (P.L. 90-602 Sec. 355). Of prime interest are experimental and epidemiologic investigations leading to a better understanding of the health risks associated with exposure to these radiations and to the development of applicable biologic criteria for standards setting, instrumentation and methods for the measurement, control, and reduction of population exposure to the above radiations. The guiding principle underlying a proposal should be that the investigation promotes the safe and efficacious use of radiation with the elimination or reduction of unnecessary and unproductive exposure of human beings. Research may be basic, exploratory, or applied.
NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH
The Center's research is directed toward the areas of biomarkers, modulators of toxicity, characterization of exposure and extrapolation of laboratory and animal data to humans. The programs provide basic understandings necessary for the Assessment of Human Health Ricks associated with exposure to environmental chemicals.
A. Biomarkers. This program concentrates on the development and evaluation of biochemical procedures in animal models and human tissues to provide quantitative indicators of exposures to a toxic chemical or to assess species variation in susceptibility to chemicals or to classes of chemicals.
B. Modulators of Toxicity. This program is directed toward molecular or cellular responses and whole-animal disease or maintenance of the normal biochemical processes within cells caused by toxic chemicals. Research to current knowledge of combined effects on toxic chemical exposure and cellular changes or response.
C. Extrapolation/Exposure Assessment. This program pursues the testing of major existing risk assumptions which have not been adequately tested so more accurate procedures can be developed and utilized. One example of this is the center's program to evaluate dosing rate in which we assess the impact of single, intermittent and continuous dosing on endpoints such as cancer, aging, birth defects and genetic alteration.
OFFICES OF THE COMMISSIONER
The Commissioner and the Deputy Commissioners are responsible for the efficient and effective implementation of the Food and Drug Administration's mission.
FDA procurement activities are governed by the Federal Acquisition Regulations (FAR), which is published in Title 48, Chapter 1 of the Code of Federal Regulations (CFR), and the Federal Property Management Regulations (FPMR) which is published in Title 41, Chapter 101, of the CFR. These regulations are implemented and supplemented, as necessary, by the HHS Acquisitions Regulations, which is published as 48 CFR, Chapter 3.
Procurement regulations require that all purchases and contracts, whether by formal advertising or by negotiation, shall be made on a competitive basis to the maximum practicable extent.
A. Solicitation of Bids and Proposals:
FDA procurement offices maintain bidder's mailing lists to ensure access to adequate sources for supplies and services.
When requirements arise for the acquisition of services, supplies, or equipment, FDA procurement offices send invitations for bids (IFBs) or requests for proposals (RFPs) to prospective sources appearing on the bidder's list. Concerns and institutions desirous of receiving IFBs or RFPs for bidding purposes should submit a completed Standard Form 129, Bidder's Mailing List Applications to:
Department of Health and Human Services
Food and Drug Administration
Office of Facilities, Acquisitions and Central Services
5630 Fishers Lane, (HFA-505) Room 2038
Rockville, MD 20857
The forms may be obtained from any HHS Regional Office as well as other procurement offices of the Federal Government.
B. Publicizing Procurement Actions:
With few exceptions, proposed procurements of $25,000 or more are publicized in the "Commerce Business Daily, Synopsis of U.S. Government Proposed Procurement, Sales and Contract Awards," informally known as "Department of Commerce Synopsis." The primary purpose of this publication is to provide organizations with information concerning current Government contracting or subcontracting opportunities. As a result of these announcements, concerns and institutions may request copies of solicitation documents.
The Department of Commerce Synopsis is published daily and appears on the internet @ http://cbdnet.access.gpo.gov, except Saturdays, Sundays, and holidays, and is available on an annual subscription basis from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9371, telephone (202) 512-1800.
C. Small Business Opportunities:
In consonance with Congressional directives, special effort is made to assure maximum participation by small businesses in the procurement of materials and services by the Administration. In the furtherance of this principle, the Agency has a Small and Disadvantaged Business Utilization Specialist available to assist and counsel small business firms for the purpose of promoting small business participation. The mailing address is:
Small and Disadvantaged Business Utilization Specialist
Food and Drug Administration
Office of Facilities, Acquisitions and Central Services, HFA-505
5630 Fishers Lane, Room 2038
Rockville, MD 20857
In the event a small business firm cannot undertake the performance of a prime contract but could perform a part or component thereof, it may obtain information on subcontracting opportunities directly from FDA prime contractors. In requesting this information, the small business firm should furnish pertinent data concerning its facilities, capabilities, experience, personnel, and financial status.
Procurements which offer substantial subcontracting opportunities are publicized in the "Commerce Business Daily, Synopsis of U.S. Government Proposed Procurement, Sales and Contracts Awards," listing names and addressed of firms to which solicitations will be mailed so that firms interested in subcontract work may contact the sources listed early enough in the procurement process to assure timely opportunity to participate in subcontracting.
D. Minority Business Enterprise:
The Food and Drug Administration fully supports the Government's minority business enterprise program, and has established an aggressive program within the Office of Facilities, Acquisitions and Central Services to foster the 8(a) program. Additional information about the 8(a) program may be obtained from the Office of Facilities, Acquisitions and Central Services, FDA (HFA-505) Mail Stop 2038, 5630 Fishers Lane, Rockville, Maryland 20857, telephone (301) 827-7020.
E. Commodities and Services Purchased by the FDA Procurement Offices
Department of Health and Human Services
Food and Drug Administration
Office of Facilities, Acquisitions and Central Services
5630 Fishers Lane, (HFA-500) Room 2038
Rockville, MD 20857
The Division of Contracts and Procurement Management and the Division of Construction, Facilities and Service Contracts within the Office of Facilities, Acquisitions and Central Services (OFACS) contracts for the following types of products and services:
Products and Services:
Office furniture, equipment, and supplies
Animal feed
Bedding and cages
Laboratory glassware
Chemicals and supplies
Pharmaceuticals, drugs, and intravenous solutions
Electronic components and supplies
Plastic and metal rods, sheets, and tubing
X-ray equipment
Scientific equipment
Laboratory furniture, equipment, and supplies
Animals for research (including horses, calves, cats, dogs, guinea pigs, chicks,
hens, etc.)
Computer hardware and software
Research studies
Investigations, surveys
Tests and analyses of a scientific or medical nature
Examinations, surveys, inspections, and reviews
Management evaluations
Conference support
Training
New construction and construction renovation
Construction management projects
Architect/engineering support
Computer support services
Operation and maintenance of facilities
Facilities support (e.g. custodial, trash, guard services)
