requirements for in-depth audits. Support manpower for this operation is 1 supervisor for each 10 inspectors and 1 clerk for each 4 professionals. Actual experience may demonstrate the need for closer supervision and coordination of this operation.

To advance the program of audit investigation to assure that all establishments are inspected by fiscal year 1969, a total of 142 positions is proposed for fiscal year 1967 consisting of 106 general investigators, 10 supervisors, and 26 clerks. This is an increase of 46 positions over fiscal year 1966.

Criminal investigations.-As with the field audit program FDA's goal in the area of criminal undercover investigations is to achieve a four-phase buildup to be largely completed by fiscal year 1969. This will approximately double the level of effort in investigation achieved in fiscal year 1965 before enactment of the new law. This goal has been based upon the assumption that an effective field audit program will substantially reduce the "easy" diversion of psychotoxic drugs from legitimate channels and thus bring illegal distribution of psychotoxic drugs within workable bounds.

If experience shows that the audit investigation curtails the "easy" diversion to our expectation, it is possible that illegal manufacturing and distribution would increase to meet the demand. If so, the level of effort and resources for this program will be reconsidered. The fiscal year 1966 supplemental (including the transfer of BRC positions to this area) provides a total of 119 positions for direct criminal investigative activities. In the second phase of the program, FDA proposes 21 additional positions in fiscal year 1967, consisting of 12 criminal investigators, 5 supervisors, and 4 clerks to bring the ratio of inspectors to support positions to the same level of the audit function.

A total increase of $237,000 in nonstaff funds will be required to support the undercover program. This includes $15,000 for criminal investigator pay differential, $19,000 for special equipment purchase, $5,000 for special equipment rental, and $198,000 for annualization of the cost of several fiscal year 1966 items on a full-year basis.

The theoretical breakdown in BDAC field operations into categories of audit and criminal investigations is used to quantify the two major definable methods of approach to the problem of drug abuse on all of its levels from the manufacturer to the abuser. Each investigator will be trained in both operations. He may follow an investigation from the initial lead uncovered during an audit or series of audits or by complaint through to the arrest of the illegal distributors. In this way, an investigation followed through and coordinated by its initiator will not lose the perspective gained in gathering the basic facts since the routine plant audit becomes an investigation as soon as the first clue of diversion is found. This knowledge of the basic data is invaluable.

Training. A well-informed and trained field staff is imperative if the new law is to be enforced in an enlightened and effective manner. This staff not only must have a high degree of technical training in investigational procedures and self-defense, but they must also bring to their work a knowledge of the overall problem of drug abuse with which they will be dealing, and an understanding of the complex legal decisions in search, seizure, and arrest. To prepare the investigational and audit staff for their work, an intensive training program will be undertaken, during which new employees will be given a basic orientation to FDA programs and the new law, training in audit and investigative procedures, legal and courtroom procedures, self-defense and disarmament, and an academic course on the sociological and psychological aspects of drug abuse.

This comprehensive training program, initiated in fiscal year 1966, will be conducted under contract with one of the country's major universities. The training will be accomplished over an 8-week period. In fiscal year 1966, 150 persons will be trained and during fiscal year 1967, approximately 85 persons will require this training at a total cost of $179,000. Of this amount, $111,000 would be required for tuition, supplies, audiovisual materials, and the remaining $68,000 would be required to pay for travel to and from the training site and to provide per diem compensation for the trainees.

Field organization. The fiscal year 1966 supplemental makes provisions for the resources for the initial establishment of five drug abuse control field offices, with average supervisory and clerical staffing of six positions per office (an area

1 Items annualized are: Informer fees, $63,000; investigator pay differential, $61,000; extraordinary travel, $17,000; special equipment rentals, $10,000; special room rental, $15,000; sample purchases, $120,000; props, $12,000. Items decreased are special equipment purchases, $70,000; and truck rentals, $30,000. The net annualization is $198,000.

director, an audit program chief, a criminal investigation program chief, and three clerks). Since the drug abuse problem is nationwide and since effective coordination and economical operation of the drug abuse field program is essential to effective operation, FDA proposes resources to permit the establishment of four new area offices to bring the number of field units to nine in fiscal year 1967. Two new types of positions are requested for the offices established in fiscal year 1966: A chief investigator, who will act as the area director's deputy and who will assist the director in such critical areas as Federal-State liaison and liaison with local enforcement agencies and professional groups: and a hearings examiner for each area to handle the anticipated legal workload. This position is essential to assure that the legal proceedings which result from the uncovering of violations are properly, effectively and expeditiously handled. To accomplish this expansion of field offices and the addition of these new positions to existing resources, 34 positions are proposed, consisting of 22 professional and 12 clerical support personnel.

Nonstaff funds required will amount to $278,000, including $147,000 for annualization of fiscal year 1966 costs and $131,000 for new field space rental.

The fiscal year 1966 supplemental provided headquarters resources to assure strong and effective leadership during the critical first phase of drug abuse control program development. FDA plans to continue with basically this same staffing component in fiscal year 1967, with the exception of two new positions proposed for headquarters to provide additional staff in the case assistance area to help coordinate the increased legal workloads projected for fiscal year 1967.

An amount of $35,000 in nonstaff funds is requested to reimburse the Civil Service Commission for special field background investigations of new professional personnel proposed in fiscal year 1967. This background investigation is essential because of the special nature of drug abuse control work. Agents will carry guns, make arrests, and present cases to U.S. attorneys, thus their character must be beyond reproach. They must be emotionally stable and able to operate under stress. Approximately $27,000 will be required for space rental, including annualization of full-year requirements for fiscal year 1966 positions.

Coordination and direction of the various programs of FDA are accomplished in this activity. This activity also contains functions and services that can best be performed on a centralized basis. These include agency administrative services. In addition, technical support to the scientific staff is placed here. This includes the central laboratory services operation and a major portion of the science information program.

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The functions within this subactivity include the establishment of policy; the formulation and promulgation of agencywide plans, budgets, regulations, and directives; the allocation of resources; the day-to-day direction of the agency; the dissemination of information to the press and to the public; and, the evaluation of performance and accomplishments. In addition, programs are conducted to promote cooperative Federal-State relations; and to obtain advice from outside consultants.

Policy and direction.-The Office of the Assistant Commissioner for Regulations is charged with responsibility for screening all documents on new drugs, and processing and reviewing for approval by the Commissioner all documents proposed for the Federal Register. With the increased emphasis being placed upon preclearance and prevention in enforcement activities, the workload has been expanding over the past several years. By 1967, the workload resulting from new drug and antibiotic regulations will exceed the capacity of the existing staff to handle it on a timely basis, and backlogs will start to accrue. One additional position is requested.

The Office of the Assistant Commissioner for Science Resources reviews FDA's research programs and provides a focal point for the coordination of all scientific activities, including the science information program, which is separately justified in a special analysis on page 75. Two important functions of this Office are the coordination and monitoring of cooperative research studies and the upgrading of FDA's scientific manpower. Over $1 million will be awarded in fiscal year 1966 for cooperative research studies, and approximately $2.5 million in fiscal year 1967. To insure that FDA keeps its scientists current in their scientific disciplines, programs are planned that will provide an exchange of scientists between selected universities and FDA, and the rotation of scientists within the agency to broaden their experience. Three positions are requested to coordinate and monitor these programs.

Planning and budgeting.-Key to successful development and implementation of consumer protection programs are the planning and budgeting processes. In its first year, fiscal year 1965, the planning staff developed a comprehensive 5-year plan for FDA, which contains the agency's goals and program objectives through fiscal year 1970. The current budget request reflects the agency plan for fiscal year 1967 and anticipates future year requirements. The complexities and continued growth of agency operations has resulted in increased workloads in the planning and budgeting areas.

In addition, during the past year it has been necessary to detail personnel on a temporary basis from other units to assist the staff working on FDA's legislative matters. FDA's legislative program will require extensive work by the legislative staff to provide timely assistance in the consideration of draft and pending legisla tion. Three additional positions are requested for these activities.

Special programs

Three programs are conducted by FDA on a centralized basis, relating to the specialized mission and needs of the agency: emergency preparedness, FederalState relations, and outside consultation. The Special Adviser to the Commissioner handles the arrangements, including financing, of all outside consultation to the agency. These include standing committees such as the National Advisory Food and Drug Council, ad hoc committees to provide specific advice on specific problems, scientific seminars and symposia to discuss important scientific subjects and exchange information and views, and individual consultants retained to advise or to work on special projects. In fiscal year 1966. $200,000 is available for this program. In fiscal year 1967, 5 additional standing committees, 22 additional panels of experts, and an additional seminar are planned. To fund these, an increase of $50,000 is requested.

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.

The

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