We would then investigate the effects of these toxins on animals. and tissue cells. Work will also be expanded on the effects of various methods of food preservation such as freeze drying, the use of antibiotics, and effects of ionizing radiation. Additional emphasis on food additive research will attempt to find more subtle "early warning" signs of toxicity that will reveal harmful effects more quickly than current methods. A portion of our research program will explore novel approaches to the development of multiple detection procedures for analysis of mycotoxins and food additives. Nutrition in germ free animals and the role that intestinal organisms play in making nutrients available to their host will be studied. PESTICIDES An increase of six positions and $93,000 is requested for additional work on pesticides. This involves the study of the chemical and biological behavior of pesticides after they are assimilated into an animal's body. FDA will also study additional animal species in order to ascertain if any have biological characteristics that more nearly resemble those of man. DRUGS An increase of 17 positions and $194,000 is requested for additional research on drugs. This will include the development of new techniques for the identification and determination of drug substances to increase the sensitivity of analysis so that single tablets and capsules can be analyzed. Recent experience has shown that the potency of individual tablets may have a significant variation within a lot of drugs like digitoxin or thyroxin which could present a serious hazard to users. As in our food research programs, methods will be shown to disclose early signs of toxic reactions to drugs including increased attention to the examination of tissues and cells in hormone and enzyme systems for these warning signs. DRUG ABUSE CONTROL In implementing FDA's new drug abuse control responsibilities, FDA is recruiting a specialist in psychopharmacology who will develop the outlines of our research program in this area. This kind of research differs in many ways from pharmacological studies now conducted in FDA in that it involves the study of more subtle reactions to drugs. Five additional positions and $111,000 are requested in fiscal year 1967 to help implement these new ideas and approaches. Senator HILL. This is something which is very new. Dr. GODDARD. Yes, sir. I want to add that we are well aware of the work that is going on at NIH, some of Dr. Jonathon Coles' work there. They assist us in many ways and we have good channels of communication open to take care of their research activities and the research which they report. Senator HILL. That is very good. Dr. GODDARD. Dr. Shannon has been most helpful to us. SCIENCE EVALUATION An increase of 52 positions and $676,000 is requested for the science evaluation programs. These resources will aid the Bureau in assuring a more timely review of industry proposals and provide the necessary supporting research. This Bureau plays a major scientific role in evaluating proposals from industry for food additives and pesticides, and it performs the pharmacological review of data contained in every IND and NDA submitted to FDA. Our objectives in providing a more timely review of industry proposals mentioned in the earlier discussion of medical evaluation are applicable to this area. Indeed, a buildup in capability of our medical staff to review IND's in a timely fashion would have no real effect if the analysis of the pharmacological data was not also completed in a timely fashion. Nineteen positions are requested for the more timely evaluation of petitions including IND's and NDA's. Fourteen additional positions are requested to perform research and development that will lead to the development of speedier and more accurate analysis of this data. This includes additional studies to improve requirements for data contained in these proposals covering such critical areas as reproduction, genetics, and teratology (birth defects). Two additional positions are requested for research on the possible harmful effects on the skin, eyes, and internal organs of such things as cleaning agents, toilet articles, and other relatively familiar household items that could lead to injury. Nine positions are requested to aid in the development of an FDAwide science information program and to provide administrative support to these programs. EDUCATION AND VOLUNTARY COMPLIANCE An increase of 35 new positions and $850,000 is requested for these programs. This is one of the newly emphasized program areas of the agency. It provides information to consumer groups, with special language groups. Nine new positions are requested for consumer information and education programs. Program emphasis will be placed on greater use of mass media, particularly television, and programs designed for special segments of the population, including special information programs oriented toward the drug abuse problem. Another aspect of the program seeks to promote industry self-regulation by providing information on how they can meet FDA regulatory requirements. Senator HILL. As you know, there are a lot of advertisements about drugs now on TV. Dr. GODDARD. That involves the Federal Trade Commission as much as it involves the Food and Drug Administration. Senator HILL. I think the only thing that excells drug advertisements on TV would be cigarettes. Dr. GODDARD. Fifteen additional positions are requested for these programs. This will permit increased emphasis on industry workshops and training films and provide more rapid response to industry requests for information. Eleven positions are requested for improved visual and editorial services and administrative support. REGULATORY COMPLIANCE This bureau provides essential field support to almost every activity of FDA. It provides support to the medical evaluation processes by inspecting drug manufacturers to review manufacturing practices prior to the approval of new drug applications. It provides support to the science bureaus by conducting special field studies on pesticides, aflatoxins, and the food standards programs. The field staff attempts to promote voluntary compliance during the course of establishment inspections and by talking to professional, industry, and consumer groups. They also provide advice and assistance to State and local governments on food and drug matters. The increase requested, 200 positions and $1.5 million, will improve the current level of consumer protection in areas which pose a potential hazard to health. All drugs and food products with a high potential for hazard to consumers' health and similar aspects of our import program will receive increased attention. One hundred and seventy positions will be used for domestic drug programs. This will permit 18,000 drug inspections and 35,000 drug sample examinations compared to 16,000 inspections and 31,000 sample examinations scheduled for fiscal year 1966. Thirty positions are requested for FDA's import programs. This will make possible 100 percent coverage of imported commercial drug shipments and will also permit additional attention to those food products which have a high potential for health hazard. DRUG ABUSE CONTROL One hundred and four positions and a $2.7 million increase are requested to implement the Drug Abuse Control Amendments of 1965. The fiscal year 1966 supplemental appropriation approved by the Congress in August 1965 provides the initial resources to establish the nucleus of a new Bureau of Drug Abuse Control. This supplemental was based upon an assumed phased buildup of this program which will come to full strength in fiscal year 1969. During 1967, FDA would use the increased resources to widen the scope of its field audit and criminal investigative capabilities by adding new area offices to its field structure. One hundred and two of these positions will be in the field. These will provide staff to audit the approximately 4,000 establishments that are required to register. Since the legislation requires manufacturers to maintain records for 3 years from February 1966, it is imperative that FDA complete an initial audit of all of these establishments by fiscal year 1969, and at the same time provide for adequate manpower to check and audit in depth where necessary. Additional criminal investigative staff will be required to followup on the leads that will come out of the audit programs. A key element of this program is the development of specialized training programs. If the new law is to be enforced in an enlightened and effective manner, a well-informed and well-trained field staff is imperative. A comprehensive training program initiated in fiscal year 1966 will train 150 persons. Funds are requested to train 85 additional people in fiscal year 1967. Only two positions are requested at headquarters to support this field staff increase. EXECUTIVE DIRECTION AND TECHNICAL SUPPORT An increase of 88 positions and $1.1 million is requested for executive direction and technical support. Of this amount, only seven positions and $133,000 are requested for policy, planning and budgeting, add special programs conducted directly out of the Commissioner's Office. Twenty-nine positions and $437,000 are requested for agency administrative services. These are directly related to the increased workload placed on such activities as shipping and warehousing, mail and messenger, facilities management, management services, personnel, and training. In particular, FDA is planning to explore a new training concept where the agency itself will provide additional technical training to its employees to keep them abreast of developments in their fields. This will include training in advanced analytical methods, pharmacology, pharmaceutical chemistry, and manufacturing technology. An increase of 52 positions and $532,000 is requested for technical support, including 46 positions for our science information activities and 6 positions for laboratory services. SUMMARY Of the 720 new positions requested, 302 positions are field positions and 418 will be located at headquarters. Viewed in another way, 500 of the increase is for work directly in the vital drug area and the remainder is for work in foods, pesticides, and general support. BUILDINGS AND FACILITIES For construction, alteration, and equipment of facilities, including acquisition of sites, and planning, architectural, and engineering services, [$5,720,000] $4,080,000, to remain available until expended. Amounts available for obligation Appropriation.... Unobligated balance brought forward.. Comparative transfer from "Pharmacological Animal Laboratory building, Unobligated balance carried forward.. Total.. Additional headquarters laboratory facilities.. Pharmacological-Animal Laboratory building. Total.. 25 Other services.. 31 Equipment.. 32 Lands and structures. Total. 60-302-66-9 |