1. Annualization of 406 new positions authorized in 1966 for part of year under regular 2. Annualization of 269 new positions authorized in 1966 for part of year under the drug 3. Full-year cost of rental space to be occupied in 1966. 4. Full-year cost of 1965 Pay Act. Subtotal, mandatory increases.. $53,079, 000 -60,000 -140,000 52,879,000 63, 454, 000 +10, 575,000 1, 130, 200 12,006, 400 497,000 452, 000 4,085, 600 1 This increase is required to annualize the position plus support items such as informer fees, sample purchases, and investigator pay differential which were budgeted for only of fiscal year 1966, but must be annualized for all of fiscal year 1967. An increase of 42 positions and $597,000 is proposed to enable FDA to process, on a more timely basis, investigational new drug applications and new drug applications in both the human and veterinary areas. This workload also includes supplements and amendments to these applications, as well as the processing of progress reports on such applications. An increase of 31 positions and $312,000 are proposed for medical review including regulatory support, drug surveillance, and evaluation of medical advertising and devices. An increase of four positions and $41,000 are proposed to implement the Drug Abuse Control Amendments of 1965. Fifty-five positions and $1,078,000 are proposed to expand the medical information and communication programs with emphasis on the adverse reaction reporting program, the medical reference service, and implementation of the medical information subsystems which are part of the science information facility. Thirty-one positions and $507,500 are proposed to provide resources for a professional development program, staffing of medical advisory committees, administrative management and support, increased emphasis on review and revision of medical regulations, an expanded program of coordination with the drug industry, and a cooperative research program to support clinical investigations of drugs. Research FDA's scientific research activity, composed of intramural research and cooperative extramural research programs, will be expanded primarily in the food and drug fields. Thirty-one positions and $404,600 would be used for research programs on normal constituent and natural contaminants of foods, research on pesticides and food additives, hazards in foods, and for new research programs seeking novel approaches to scientific problems in this area. There will be an expansion of 22 positions and $305,000 for research on drug mechanisms, psychotoxic drugs, exploration of new approaches to drug problems and on drug integrity and misrepresentation. Research on composition and safety of cosmetics will be expanded by eight positions and $160,000. Research support activities require an increase of 17 positions and $226,000, including $75,000 for "research breakthrough funds." Scientific evaluation An increase of nine positions and $146,900 is proposed for FDA's programs concerned with the promulgation of food regulations and food investigations. Eleven positions and $225,000 are proposed for the program of pesticide regulation setting and pesticide investigations for verification of safety of products. An increase of 21 positions and $220,000 is to keep pace with a greater influx of human and veterinary drug submissions from industry and permit the more timely processing of these applications. The resources also permit supporting drug investigations. An increase of two positions and $20,000 will permit expansion of reviews and investigations of hazardous substances. Bureau administrative and statistical support will require an increase of nine positions and $65,000. Education and voluntary compliance Nine positions and $581,900 are proposed to expand the consumer information program. Program emphasis will be placed on greater use of mass media: particularly, television and programs designed for segments of the population with special consumer problems. To expand the voluntary compliance program with regulated industries, including emphasis on industry workshops and training films, 10 positions and $161,000 are requested. Five positions and $23,000 are requested to meet industry requests for advisory opinions. In addition, 11 positions and $85,000 are requested for improved and expanded visual and editorial services, program direction and evaluation, and administrative support functions. Regulatory compliance An increase of 170 positions and $1,008,000 is proposed for regulatory compliance activities, relating to drugs. This will permit an increase in the number of inspections and samples analyzed, and will also permit more timely followups and improved surveillance of drug industry control procedures, and increased efforts in education and voluntary compliance by the field. To take advantages of increased productivity in the general foods category, a transfer of 28 positions is proposed from this area to the potentially hazardous foods category. The increase will permit expansion of inspection coverage of the food industry where potentially hazardous problems are present. In the imports area, 30 positions and $173,000 are requested to provide more wharf examinations and in-depth coverage of drug imports. In addition, $384,700 is proposed for such items as telecommunications network, attendance at scientific meetings, increased court costs, equipment, increased training requirements, etc. Drug abuse control An increase of 104 positions and $2,752,200 is needed to annualize the drug abuse control program authorized in fiscal year 1966 and to expand the field investigation program by expanding audit and undercover activities. Executive direction and technical support An increase of 29 positions and $218,000 is proposed for the science information program, which in fiscal year 1967 will be in full-scale development. Six positions and $87,500 is proposed for central laboratory services to meet the anticipated increased workload resulting from increased laboratory capacity at headquarters. Five positions and $219,000 are for the establishment of a new FDA training program. Thirteen positions and $87,200 are requested to provide improved and expanded organization and methods and data processing services. Ten of these positions will be indirect support of the science information program. Twenty-eight positions and $249,000 are requested for other administrative areas to expand necessary services such as facilities planning. supply management, records, personnel, and fiscal administration. An increase of seven positions and $243,500 is needed for program planning and evaluation, increased use of outside consultants for committees, improved issuance of regulations, and better utilization of scientific resources. |