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prepaid medical plan. Through coded diagnostic and drug utilization information on these patients, FDA will be able to make determinations and projections of the incidence of reaction and of disease in a given population, and determine the relative safety and, in some cases, the efficacy-of two or more drugs marketed for the same purpose. The cost of this contract is based on an estimated receipt of 270,000 reports each year, at a cost of $1.50 per report, cataloging drug data for a million and a half outpatient visits and 200,000 inpatient days.

In fiscal year 1966, preliminary steps will be taken to establish a program for the international exchange of adverse reaction reports through the World Health Organization (WHO). This program, which will involve 8 to 10 countries, will be implemented in fiscal year 1967 when a reporting center within the Bureau is staffed. It will provide a more thorough procedure for the early detection of harmful effects of drugs that are used fairly extensively in one part of the world before reaching this country.

To meet all of these responsibilities in the adverse reactions area, the Bureau requests an additional 19 positions for fiscal year 1967, including 11 to staff the WHO reporting center.

Medical reference service

During fiscal year 1965, the Bureau's medical reference unit was unable to meet half of the requests for services it received. No significant improvements were made in this area during fiscal year 1966 because the high priority science information retrieval area required available resources. An additional nine positions are requested for fiscal year 1967. In addition to staff, an increase of $50,000 is proposed for the purchase of microfilm editions of certain reference works, microfilm reader printers, medical references, and journal subscriptions.

Medical evaluation of hazardous substances

Information on the hazards of household chemicals and of cosmetics, pesticides, food additives, and accidental drug ingestion is collected, evaluated, and stored within the Bureau for ultimate dissemination to interested activities in the agency. FDA receives about 60,000 injury reports each year, as well as 4,000 certificates of death caused by chemicals, etc. The New York University Medical Center submits over a thousand reports annually on the effects of various household products on the skin. To keep abreast of this data and, equally as important, to develop new sources of information, five additional positions are needed.

Science information

In fiscal year 1967, an increase of 22 positions is requested for the science information program. These are justified in a special analysis on this program on

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An expanded program for liaison with the medical and scientific community will require additional positions in fiscal year 1967. The Bureau plans to employ the services of more ad hoc committees and more extramural research performers. In addition, the professional development program will be greatly expanded, and positions will be necessary to fill the gap created by the time lost throughout the Bureau.

Advisory committees

The advisory committees on investigational drugs and the medical advisory board now meet on a regular schedule and are providing important aid in clarifying basic issues for the Bureau. In general, communications with the scientific and medical community are improving, particularly through the AMA Council on Drugs and through liaison with scientists in PHS and other Government agencies. Eleven medical advisory committees will be appointed in fiscal year 1966, 18 in fiscal year 1967. The use of committees and panels entails a great deal of work in preparing for meetings and distributing committee decisions and recommendations. In addition to two clerical positions available for this work

in fiscal year 1966, Bureau professional staff devote portions of their time to the medical details involved. To use their time more effectively, a professional "secretariat" staff is needed in this area: two additional positions are requested. Cooperative research

For FDA to determine the safety and efficacy of drugs, access to independent clinical studies conducted in hospital facilities is required. During fiscal year 1965, these studles included investigations of two appetite depressants, various medicated room sprays, and an alleged cancer cure. During fiscal year 1966, $340,000 will be available for clinical studies of other drugs and devices, such as oral contraceptives, anti-infective agents, and psychotherapeutic agents. This program will be continued at the same level in fiscal year 1967. The $320,000 program for a "quick-response" clinical-pharmacological laboratory initiated in fiscal year 1966 in the metropolitan Washington area will also continue at the same level. This laboratory will provide for clinical investigators and facilities to be immediately available on a regular basis for urgent questions that may develop during the processing of IND's, NDA's, litigation on seizures, or upon the report of adverse drug reactions.

Recognizing the problems connected with the effect of drugs on the newborn and on genetic functions, the Commission on Drug Safety conceived the idea of a series of workshops on teratology. Two of these workshops have been held to date, both supported by industry grants. These workshops have played an important role in disseminating information on teratology, particularly to workers in the field. FDA proposes to continue this program in fiscal year 1967 by sponsoring two workshops at a total of about $60,000.

Two additional positions are requested to aid in implementing all of these cooperative programs in fiscal year 1967.

Professional development

To maintain and improve the quality of medical and scientific review, the professional staff in FDA must keep in touch with those outside of the Agency who are involved in the same work, and it must maintain a continuous program of postgraduate education. To achieve this end in fiscal year 1967, FDA proposes the part-time assignment of medical and scientific personnel to research and teaching centers at a rate amounting to about 10 percent of professional staff time. To offset the manpower loss in regulatory programs that would result from these aassignments, 22 additional positions are proposed for fiscal year 1967.

Medical regulations

Experience has demonstrated the need for continuing review and revision of the drug regulations promulgated by FDA. Delayed action in making needed changes in the regulations may adversely affect the public interest, place unnecessary burdens on the staff, and result in hardships to the regulated industries. An Assistant for Medical Regulations has been designated to keep abreast of the need for new and revised regulations. During fiscal year 1966 his activities will be limited to the identification of problem areas and to handling the most urgent regulation changes. An increase of three positions is requested for fiscal year 1967, which will enable this unit to revise and simplify 15 to 20 percent of the new drug regulations and to provide assistance in other important areas, such as the development of regulations for good manufacturing procedures.

Drug coordination

There has long been a need for a focal point in the Bureau with whom industry representatives could communicate on the status of their submissions to FDA. To meet this need, the position of Assistant for Drug Coordination was created at the time of the 1965 reorganization. This function has been welcomed by the drug industry, and over 60 visits were made in the first several months of operation. Approximately 450 pieces of correspondence were received during the same period. Visits and inquiries are becoming more frequent, and by fiscal year 1967 it is anticipated that the workload in this area will more than triple. To meet the demands expected in this area, two additional positions are requested.

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With the reorganization and resulting centralization of four separate mail, file, and control functions, responsibility for receipt, jacketing, maintenance, and ecntrol of all documents was centralized in one branch in the Director's office. No new positions are requested for the Office of the Medical Director in fiscal year 1967. An increase of $65,000 for space rental to accommodate the 163 new positions requested for the Bureau in fiscal year 1967 has been prorated among the various activities.

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New veterinary drugs must now be evaluated and approved by FDA or virtually the same basis as human drugs. In addition to evaluating veterinary IND's and NDA's, conducting research, and maintaining surveillance over drugs subject to approval, the Bureau must also grant its imprimatur before animals that have been administered test drugs may be slaughtered for human consumption. A new Bureau of Veterinary Medicine was formed in October 1965 in recognition of the growing importance of veterinary products and medicated feeds, and their effect on animals consumed as food.

During fiscal year 1965, approximately 1,500 records and reports were submitted to FDA in accordance with provisions of the new drug regulations that require these reports for drugs that had been previously approved. The Bureau was able to process about a thousand of these reports by diverting personnel from their customary duties primarily from regulatory support work. In fiscal year 1966, the staff increase authorized should permit FDA to eliminate backlogs in this area and keep pace with the day-to-day workload.

In fiscal year 1967, an increase in the number of submissions is anticipated. With each publication of a food additive regulation involving a veterinary NDA, for example, past experience indicates that FDA can expect several thousand submissions from feed mills in the months following. Another important responsibility in this area is the evaluation of veterinary IND's. In fiscal year 1965, about 3 man-years were devoted to the processing of some 600 items. The primary function of this staff is to approve the slaughter of animals that have been administered investigational drugs. In fiscal year 1967, over a thousand IND's are anticipated. To keep pace with this influx of IND's and NDA's, an additional eight positions are requested.

FDA also proposes to strengthen its veterinary research capabilities in fiscal year 1967 with the addition of two positions. More tests of human products on animals are needed, as well as studies to determine tissue residues of marketed drugs and to assist in the design of investigations to determine the safety of new animal growth-promoting agents and other veterinary drugs. An increase of $10,000 is proposed to purchase experimental animals for these tests.

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The Bureau of Scientific Research (BSR) was established as an integral organization within FDA in January 1964. This budget is the first program plan specifically designed to meet the research needs of the Bureau as disclosed by operational experience. The disciplines represented in this program cover the entire spectrum of the sciences, from bacteriology and botany to zoology. Of the total of approximately 600 positions in this program in fiscal year 1967, over 350 (about three-fifths of the total) will be filled by professional personnel with 1 or more college degrees in the various fields of science.

One of the fetures of this presentation worthy of special note is the expansion of the extramural research program from $330,000 in fiscal year 1966 to $580,000 in 1967: an increase of $250,000, or about 70 percent.

The requirements of a vital and progressive research program must inevitably exceed the availability of personnel and facilities to meet these requirements. An extramural program makes it possible to secure the professional support required for the program but unavailable within FDA's own ranks. Often, the use of outside talent-particularly for specific research problems-is more effective and more economical than hiring and training personnel and purchasing equipment for the same tasks. Furthermore, the various advisory committees that have examined FDA operations in the past have consistently recommended that the agency strengthen the ties between its professional personnel and leading non-Government investigators.

A second noteworthy feature of the proposed fiscal year 1967 budget is the inclusion of "research breakthrough funds" under research support. These are envisioned as unrestricted funds that may be used to support promising research for which the requirements were not anticipated in the preparation of the annual budget some 18 months before the actual initiation of the research program. The need for funds of this type was clearly defined in a report to President Kennedy by a high-level committee assigned to discover improved mechanisms for supporting and encouraging Government research. This device has been employed with success by the Defense Department in some of its research laboratories for several years. The total funding requirements for this purpose cannot be predicted accurately, since there is no past FDA experience as a basis for comparison. A reasonable level, based upon past experience in the Defense Department, appears to be about 1 percent of the total in-house research budget for the Bureau: a total of $75,000. This amount is included in the amount available for extramural research in the Bureau support program and will be administered by the Bureau Director.

Another feature of this budget presentation is the identification of new approaches to the solution of research problems. It is a fundamental obligation of a research program to explore the unknown and to probe continually beyond the present limits of applied science in the certain knowledge that the routine scientific tools of the future will emerge from present-day hypotheses and speculative experimentation. Many of the techniques currently employed in areas of research outside of FDA can undoubtedly be used with good results in Agency investigations. Many new instruments, such as the mass spectrometer, have been used successfully in the field of organic chemistry and can be used with equal success to separate, identify, and examine chemicals found in food, drugs, cosmetics, and hazardous substances. About a fifth of the new positions requested by BSR in fiscal year 1967 are intended for inclusion in this area of new research approaches.

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Research in this area has been directed largely toward the nutritional aspects of food components and toward the chemical characteristics of animal fats, vegetable oils, and the manufactured fat-like materials used in food and in feeds. Studies will continue on the relationship between diet and body functions like tissue changes and growth, and on the nutritional role of various diet components, such as vitamins and minerals. Other studies will deal with the effects of obesityinducing drugs and the possible connection between diet and diseases of the arteries.

New or expanded projects in fiscal year 1967 call for an increase of seven positions. In order to evaluate manufacturers' claims for various dietary supplements, FDA needs more information on the relation of hormone balance, antibiotics, and environmental influences to the availability of mineral nutrients, and the effects of changes in temperature and humidity on nutritional requirements. Another project will be aimed at methods for determining vitamins and other nutrients in foods and dietary preparations. In addition, preliminary findings have convinced FDA that it must investigate in more depth the effects on fats and oils of prolonged heating and of storage at various temperatures. An increase of $45,000 is requested for extramural cooperative studies: bringing the total to $70,000 in this area. Recent clinical evidence has created certain doubts about the wholesale, unqualified use of vitamin preparations. Extramural studies are proposed to determine if a surplus of one or more specific vitamins in the diet may have a harmful effect-particularly on children. Two other studies are proposed: one on the effects of diet on the chemical composition of the unborn child and one on the role of certain trace elements like zinc and selenium in nutrition.

Natural Contaminants of Food

Research in this area has centered around four major sources of contamination: microbial organisms, radioactive material, filth, and mycotoxins that are derived from molds. This last problem is relatively new for FDA scientists. Mycotoxins are known to be extremely harmful to certain animal species, but their effect on man is not yet fully understood. Molds which may grow on bread, grapes, peanuts, corn, peaches, and cocoa beans produce a group of closely related chemical substances know as aflatoxins. The discovery that molds can produce several different types of this toxin, as well as others not yet clearly characterized, has suggested the need for more research in this entire areaparticularly on methods for separating the various known aflatoxins, on determining the different molds and fungi that can produce toxins, on analysis of conditions affecting mold growth, and on investigations of the effects of these toxins on animals, humans, and tissue cells.

Another problem that demands immediate FDA attention is the relation of foodborne viruses to human illness. Anticipating future requirements to evaluate the efficacy of antiviral drug preparations, FDA plans a study in this area. Also, work should be expanded on the effects of various methods of food preservation (such as freeze-drying, the use of antibiotics, and ionizing radiation) on decomposition. Five positions are requested to expand ongoing projects and initiate new work in these areas.

Four studies totaling $78,000 are proposed in this area, an increase of $23,000 over fiscal year 1966. One of these is a pharmacological study of the effects of controlled amounts of aflatoxin as part of the cooperative research program already underway at the medical college outlined in the pesticides section of this budget, on page 30. These experiments are aimed at the detection of subtle microscopic changes in human tissue and organs that occur long before a person is seriously harmed; the safety of the procedures used in these tests is fully guaranteed by adequate advance animal experimentation. The other studies relate to microbiological contamination of food: Two are on botulism and represent extensions

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