Administrative services are provided on an agency wide basis in the areas of mail and records, printing and distribution, facilities planning and management, supply management, data processing, management services, fiscal management, personnel, and training.

General services.-Expansion of agency programs-particularly those requiring additional facilities or equipment-has increased the workload of the Division of General Services. Full occupancy of Federal Office Building No. 8 has created larger workloads for the supporting services. For instance, FDA now has its own shipping and receiving area, central storeroom and warehousing capacity— all for the first time. This will result in more efficient supply operations and improved service to the scientific staff.

Even with the occupancy of Federal Office Building No. 8, FDA is faced with continued dispersal of headquarters units to other locations in the Washington area. Eight positions are requested to improve mail and messenger services between headquarters units and to provide better reproduction and distribution services to the agency. The increase of eight positions is being offset by a transfer of two FDA employees to the Office of the Secretary for transportation services as part of a management improvement program. They will be charged to the Office of the Secretary management fund.

FDA's building program at headquarters and in the field is expanding and is in urgent need of additional engineering support, including electrical, mechanical, and architectural skills. Five new positions are requested in this area. Four other positions are requested to meet the large increase in procurement (about 3,200 line items per month in fiscal year 1967) and contractual work (about $3 million total, primarily cooperative research studies), and 1 new clerical position is needed to support the professional staff in the office of the Director of General Services.

Management services.-Demands for services of the Division of Management Systems exist in virtually every bureau. The staff recently has completed studies for the Bureau of Medicine which have led to new control procedures in drug surveillance activities and provided the basis for incorporation of hazardous substances data into the science information system. An analysis of the procedures of the antibiotics and insulin certification programs is nearing completing. There is a constant challenge to find better ways of doing the work of the agency. Through organization and systems analyses, weaknesses are discovered and corrective measures undertaken. Changes in operations and/or paperwork procedures produce manpower savings, and improved service. To strengthen the management analysis and methods and procedures capabilities, three new positions are requested.

The use of data processing in FDA has been growing steadily over the past several years. A variety of scientific, regulatory, and administrative programs has been written, but more remain. The biggest task facing the data automation program is that of providing systems analysis, programming and operational support to the Science Information Facility. The 10 positions requested for data processing resources are justified in the special analysis section on science information.

Personnel. To obtain optimum use of staff resources, a number of personnel services must be performed in an efficient and timely manner. There is a constant need for recruitment and placement, classification, promotion of employee benefits, rights, and incentive programs, and training. FDA employees are classified in 114 different occupational series. These are predominantly in the professional and scientific categories and present a definite challenge in recruitment, professional training, and advancement. In addition to the above complexities, the workload created by the establishment of the Bureau of Drug Abuse Control has seriously taxed the personnel staff to provide the services essential to effective

agency operations. To meet the current demands for service and to keep pace with projected agency growth, five new positions are requested. Of these, three will work in the area of recruitment and placement, and two in classification.

Training. Maintaining the currency of the agency's scientific and technical staff in this era is a difficult problem. A number of approaches have been triedincluding tuition payments for academic courses related to an individual's work; special inhouse lectures, short courses, and seminars; and FDA attendance and participation in professional meetings, symposia, and similar gatherings. The Institute for Advanced Analytical Chemistry conducted at Georgetown University is an example of FDA's emphasis on upgrading its professional staff. Largely on the experience of the Georgetown program, FDA is planning to explore a new training concept wherein the agency itself will provide additional and technical training to its employees to keep them abreast of the latest developments in their fields. Initially we propose to offer training in such fields as advanced analytical methods, pharmacology, pharmaceutical chemistry, microbiology, and manufacturing technology. This program will capitalize upon existing knowledge and skills of FDA personnel, as will as outside expertise. The current inhouse training programs will be coordinated with this program.

Some of the benefits from such a program are improved uniformity and quality of instruction, consolidation of present attempts at such inhouse training programs, including relieving line supervisors of 80 percent of their training responsibilities, and more rapid development and utilization of scarce specialized skills. To provide an instruction cadre, five positions are requested. In addition, funds are requested to purchase scientific equipment, chemicals, glassware, textbooks, audiovisual and related instructional equipment, and to provide for student travel and per diem. The sum of $200,000 is needed for this purpose.

Technical services to agency operating programs will comprise about 23 percent of the total positions in the activity in fiscal year 1967. They include media preparation and equipment cleaning for the headquarters laboratories, and development and operation of a science information program, including a technical library.

Science information activities.-The special analysis on FDA's science information program discusses the background, current status, and projected development of the total system. Overall responsibility for the design, development, and implementation rests with the Science Information Facility (SIF) staff. This staff is charged with making the program operational. The program is an outgrowth of the original feasibility study performed by the Arthur D. Little Co., although modifications in design and implementation have been made to take into account changes in program emphasis, etc. Thus, the program is changing as it evolves into a total system. Twenty-nine new positions are requested and they are justified in the special science information analysis.

FDA Scientific Library.-When most of FDA's scientific staff was housed in the South Agriculture Building, they used the extensive reference resources provided by the Department of Agriculture library. Now that scientific personnel have moved into Federal Office Building No. 8, library services must be made available to them. To insure that additional library needs of FDA scientists are met, an additional seven positions are requested for fiscal year 1967. This increase will enable the library to furnish reference service and all of the other services normally provided in a scientific library: bibliographies, interlibrary loans, literature searches, abstracting, etc. An increase of $100,000 is requested to improve the basic collection, acquire journals, abstracts, and other reference materials, and to provide for maintenance and other operating costs.

Laboratory Services.-A major change in FDA's scientific operations is the installation of central laboratory services in Federal Office Building No. 8. The current staff is performing many of the routine services that previously occupied

the time of skilled empicyees such tasks as washing glasses, cages, and bottles, and preparing material for laboratory use. In fiscal year 1967, the laboratories wil be uperating an a higher capacity, and this will generate a greater workload fr the central hac services facility. Six new positions are requested: for work in media preparadice, for picking up and delivering stock, and for the washing A Total of $44,000 is requested for the purchase of an automatic pipette wwaing machine and an automatic refuse esan dumper. Both of these equipment Dems will to a better job for less money; the automatic refuse dumper, for example, vi diminate the need for one position.

This section is presented as a special analysis of the FDA science information system for the purpose of a mensubdated review of the program. The resources shown are nonadditive: actual resources are located in the several activities and cross-reference is made to that section where the program resources are located.

The need for an effective system to handle the large volume of scientific information generated by FDA and the regulated industry was recognized several years ago. The report of an internal FDA committee recommended the use of an outside consulting service to study the feasibility of a science information system for the agency. Such a study was performed by the Arthur D. Little Co. of Cambridge, Mass., whose final report concluded that such a system is feasible and could be implemented within a 5-year period.

Since the receipt of that report, FDA has been preparing to develop a system for handling scientific information that will be based in large part upon the fundamental design recommended in the A. D. Little study. In 1965, a followup contract was awarded to A. D. Little for the detailed design of the system. The final report will be rendered in February 1966.

To provide leadership and coordination in development and maintenance of the system, a science information facility was created in 1965 within the Office of the Assistant Commissioner for Science Resources. This office is headed by the science information coordinator who, along with his staff, is responsible for development of the system.

Under the general supervision of the science information coordinator, FDA is proceeding to develop an overall system by concentrating its efforts in two major areas. First, is the continued development of those subsystems or operations which have been started or are in being, and which are now effectively serving the immediate needs of program staff. These primarily are the programs that have been started in the Bureau of Medicine and cover the following: (1) pharmaceutical information and retrieval, and (2) adverse reactions. Coordination is maintained with the science information facility to assure development of these subsystems is generally compatible with the science information program.

Second, is the development of the essential elements and components on which the total system depends. Prime emphasis will be placed on establishment of the central retrieval index, the food, drug, and cosmetic subsystem with its some 22 files, and 3 "satellite" files-biomedical, product information, and label inserts-which will contain information common to several subsystems and also be independently accessible, i.e., not necessary to search through the computerized central retrieval index. Another major aspect of this effort will be to bring into the system those data sources that currently do not have a rapid searching, retrieval and/or processing capability.

With this two-pronged approach, there necessarily will be some periods of overlap when ongoing programs will be converted to new integrated procedures. However, it is anticipated that the agency's implementation of the main recommentations contained in the A. D. Little feasibility study will be achieved by the end of fiscal year 1969, and there will be an integrated FDA-wide program at that time. Close coordination is planned to insure that these operations will be compatible with those overall departmentwide programs which may be developed by the Office of the Secretary, HEW.

Science information facility.—The science information facility (SIF) has been organized into a research and development staff, a systems implementation staff, and an administrative support staff. Initial work is concerned on developing the detailed system design, including forms, establishing requirements for information, and conducting pilot runs and tests on developing systems. Primary emphasis is on the establishment of the food, drug, and cosmetic subsystem, and data systems for files such as pesticides, color additives, food additives, and animal toxicology, currently available within FDA. These will be designed, programed, and tested. Following testing, the implementation staff will work at setting up the actual systems and files, perform the abstracting, and answer questions from scientific, technical, and administrative personal throughout the agency. In order to move toward the implementation of significant portions of the food, drug, and cosmetic subsystem during fiscal year 1967, including having information in the three satellite files, additional research and development staff will be required. A coordinator of systems design will be needed to spearhead these efforts, and an additional six positions will be needed. In addition 16 positions will be required to do the implementation work. These positions will consist of three teams of four persons each to develop the three satellite files, in addition to supporting, clerical and supervisory staff.

In the support area, three positions are needed to coordinate the processing of backlog data into the system, the work being performed by the National Library of Medicine, and other related work.

In addition, three other positions are required for this office to design and implement a data retrieval system covering psychotoxic drugs. This specialty area was not included in the A. D. Little study.

Current personnel projections are somewhat higher than those mentioned in the initial feasibility study. The increases are the result of revised manpower projections by the A.D. Little staff due to the increased scope of the science information program.

Medical information.-In fiscal year 1965, the pharmaceutical retrieval program for a number of parameters; i. e., the NDA number, the trade name of the drug and the generic name, all ingredients and their quantitative formulation, chemical structure, on IND's and NDA's was fully implemented for all NDA's from 1938 to the present and for all IND's. In fiscal year 1966, the depth of this information will be expanded to encompass therapeutic use of drugs. The pharmacuetical information program will be expanded in fiscal year 1967 to encompass the clinical investigator monitoring system. This requires design, implementation, and conversion of a file which now contains information on approximately 150,000 drug investigators. There are 38 positions working in this area in fiscal year 1966. The above enumerated activities require the addition of three positions in fiscal year 1967.

Additional projects that will be started include a retrieval program for veterinary drugs now maintained manually, and the basic design of a therapeutic device information system. This will entail the development of codes and dictionaries for the device area and in fiscal year 1967, this program will be implemented.

At the end of fiscal year 1965, the development and design of an interim system for handling adverse reaction data was begun in the Bureau of Medicine. In fiscal year 1966 a total of 16 positions were reassigned from related science data activities the medical library, the editorial staff, and the statistical evaluation areas to the adverse reactions program. This action will speed implementation of the program by enabling the Bureau of Medicine to devote resources to the development of computer dictionaries, the coding of data, and search and dissemination of information from the system. These moves are considered necessary in order to handle the estimated increase in the current workload and to fulfill our commitment to the World Health Organization to run and maintain up-to-date adverse reactions reporting system. The system should be fully operational in fiscal year 1967. The program will include the hospital adverse reaction reports, and the reports from manufacturers on drug toxicity. The collection of basic data to be added to the adverse reaction computer system for statistical analysis

was begun in early fiscal year 1966 and should expand and grow in volume of information, as well as in the depth and scope of the information in fiscal year 1967. Sixteen additional positions (for a total of 32) will be necessary to operate this system in fiscal year 1967, including staff for systems implementation, evaluation and monitoring, and coding and indexing.

The study and design of the system for automating files of hazardous substances information has been started and implementation of this system will be carried forth in late fiscal year 1966. This will involve input to the computer system of current information contained in the files of BRC, BSSE, BSR, and BM. In fiscal year 1967, it will be necessary to continue implementation including the incorporation of current data as well as the large amount of accumulated data on human toxicity that exists in the manual files. For these purposes, three additional positions are requested.

Date automation services.-Crucial to the development of the overall science information program is an adequate data processing capability. Programing, computer operations, and system design support for the project will be provided by the data automation branch. This group is currently operating the data processing programs of the Bureau of Medicine including the pharmaceutical retrieval program. The principal data processing project now being initiated is the development of an automated system for handling adverse reactions, discussed in "Medical information" above. The data automation staff will become increasingly involved in late fiscal year 1966 and throughout fiscal year 1967 in the systems analysis, programing, testing, and operation of automated data handling for the overall system. Additional projects scheduled for fiscal year 1966 include automating the files on pesticides and animal pharmacology, development of data on laboratory methods and results of analyses, and systems analysis of a project to automate the files on hazardous substances. By fiscal year 1967, the staff will be deeply involved in the detailed design of the central retrieval index, and the food, drug, and cosmetic subsystem. It is anticipated that computer time requirements for the science information projects by some time in 1967 will require two full shifts. To provide necessary systems analysis programing and computer operation services for the project, an increase of 10 positions is requested.

The science bureaus.—The six positions requested for the Bureau of Scientific Standards and Evaluation will be used in file development in that Bureau. BSSE is the recipient of many petitions and other documents containing a multitude of scientific information. Five of the positions are needed in the development of drug information and one is needed for information on foods and hazardous substances. The 12 positions requested for 1967 in the Bureau of Scientific Research will work principally on abstracting current literature and the development of special satellite files dealing with research matters.

Nonstaff costs.-The net increase requested in nonstaff costs is $36,000. This is comprised of increases for computer rental, microform equipment, and abstracting services. These are offset by nonrecurring items largely budgeted in fiscal year 1966.

The table below shows the positions requested for science information by activity.