Unless added incentives like these are provided, FDA cannot hope to attract the topflight talent it needs in this area.

The problems that exist in the unit that reviews veterinary drug submissions are similar to those outlined above for human drug review. The current staff is unable to keep up with the workload; in fiscal year 1965, they fell at least 10 percent behind. An increase in fiscal year 1967 will enable them to keep abreast of petitions and drug submissions and to devote time to professional development and laboratory investigations, which are necessary to improve the caliber of the scientific staff.

Investigations

The level of effort for drug research in BSSE is disproportionately low, compared to the ratio between the investigational and regulatory activities in the areas of food and pesticides, where the investigational staff comprise over 50 percent of the total, compared to less than 25 percent of the total staff in the drug area.

The increasing emphasis on reproduction data submitted with drug applications calls for expanded studies by BSSE to confirm the reliability of industry tests or to develop tests that might be preferable. The possibility that a dangerous drug like thalidomide can appear to be harmless after being subjected to approved tests clearly demonstrates the need for reevaluation of the testing procedures now in use. FDA is also concerned about nonprescription drugs, and plans to examine some of them to determine whether they contain ingredients capable of producing harmful reactions that may have gone urnoticed or unexplained in the past. For instance, it was recently found that kidney damage was associated with the overuse of phenacetin, a chemical used in certain nonprescription drugs; a warning was required on the label of drugs containing this component. Other over-the-counter drugs may require similar action. Six additional positions are requested for these projects in fiscal year 1967.

Pathological data is contained in every type of submission reviewed by BSSE. The quality of this data is extremely variable, owing to the short supply of competent pathologists and the subjective character of their reports, which do not contain the mathematically objective information that toxicological reports do. A pathology register will serve as a mechanism for the exchange of information and will prove to be an invaluable source for scientists working with animal pathology data. At first a great deal of the material will be developed and supplied by FDA; eventually, outside participation in the project is expected to increase as the facilities grow and become familiar to scientists outside of the agency. To implement this project in fiscal year 1967, four positions are needed to collect photographs, microscopic slides, tissue specimens, and other samples, and to organize them into a series of illustrative cases.

Growing concern over the potential dangers inherent in the indiscriminate use of new products will place an added burden on the agency in the coming year to gather more information on these items, particularly where untested chemicals are being used. One position is needed to identify and classify biological and physical hazards of household formulations into an organized source of background data.

Research in this area has been neglected, yet ignorance of the possible harmful effects on the skin, eyes, and internal organs of such things as cleaning agents, special containers, toilet articles, and countless other familiar items could lead to many casualties in the home. Special attention in fiscal year 1967 will be devoted to products that could cause serious injury or death. One position is requested to work on new hazardous substances projects concerning the flammable and explosive properties of pressurized containers, and the harmful effects of various products that may be inhaled or ingested orally.

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An expansion in personnel and programs in BSSE will call for three additional support positions. One position is needed to aid in the planning and budgeting process: specifically, (1) to enhance BSSE's efficiency by channeling Bureau efforts into a coordinated and more meaningful pattern, and (2) to maintain essential liaison with the FDA planning and budget offices. Another position is needed to handle the increasing statistical workload originating in petitions and proposals for regulations, tolerances, and new approvals, for Bureau administrative tasks, and for the evaluation of investigation results. An additional clerical position is requested to support the increased professional staff.

Six positions are requested to implement BSSE's portion of the Science Information program. The requirements in this area are outlined in the special analysis on science information.

During the first full year of its existence- fiscal year 1965-the Bureau of Education and Voluntary Compliance consolidated a number of activities which were previously scattered throughout the agency. In fiscal year 1966, under the direction of a new Bureau Director, an evaluation and revision of current activities is being carried out to enhance program effectiveness. Significant projects for 1966 include the completion of five movies (one for industry, one for physicians, and three for consumers) and increased use of workshops and seminars. A drug seminar, sponsored by FDA and industry, was held in the early part of fiscal year 1966 and three additional workshops or seminars are planned this year. A major educational program is being initiated in fiscal year 1966 to inform industry and the public of the dangers of drug abuse.

During fiscal year 1967, the programs and projects underway in fiscal year 1966 will be continued with appropriate refinements. Principal new projects will be directed at specific categories of consumers and industries with particular needs and problems. The drug abuse program will be expanded significantly in fiscal year 1967. To more effectively reach the public, there will be greater reliance on television and radio. The program emphasis will continue to shift from activities that respond to outside influences-inquiries, and requests for advice-to a more positive program of education initiated by FDA based upon regulatory experiences, industry contacts, feedback from consumer consultants and surveys. In our consumer programs close liaison is maintained with the President's Committee on Consumer Interests.

In fiscal year 1966, $75,000 is available for surveys. This will fund several surveys conducted in concert with private survey organizations, two costing about $25,000 each, and several smaller surveys. A survey initiated in fiscal year 1965 and carrying over into fiscal year 1966 will identify areas for more intensive investigation, such as consumer attitudes toward the use of pesticides, food additives, and potentially dangerous drugs. A survey of consumer attitudes toward medical quackery is planned for later in fiscal year 1966. It will be a joint project with several other agencies. This will provide insights into consumer information needs and a foundation upon which to develop more specific surveys and hard-hitting education programs. An increase of $125,000 in contract funds is proposed for 1967 to provide for about six major surveys. Examples of the proposed surveys are:

1. A survey of consumer habits to determine label reading practices. This survey would assess the effectiveness of current labeling regulations and information programs.

2. A survey to determine consumer understanding of food standards. This information will permit FDA to determine what additional educational programs, if any, are needed in this area.

3. A survey to determine consumer awareness and understanding of warning statements used on hazardous household products. This data will improve FDA's information programs in this area and serve as a basis for increased regulatory attention if indicated.

Consumer consultant program (headquarters)

This group plans, organizes and directs a program providing channels of communication on consumer needs, views and attitudes toward FDA program. It also plans ways in which the consumer consultants can serve as a channel of communication between FDA and consumers. The consumer consultants located in the district offices are budgeted in regulatory compliance activity. While the field specialists develop some of their own material, most of it is prepared at headquarters. Frequently the field inspectors provide the consultants with helpful suggestions for educational programs.

A considerable amount of staff time is spent providing the field staff with information of interest to consumers, such as the proposed food standards for peanut butter and fruit juices. In fiscal year 1966 emphasis is being placed on preparing materials on the drug abuse program, including information packets for portable exhibits and motion picture prints.

In fiscal year 1967 two positions are proposed to develop and maintain contacts with national consumer organizations, Government agencies, and mass media representatives and design drug abuse information programs for the field staff.

Consumer information

In fiscal year 1966 programs aimed at low-income, low-literacy and Spanishspeaking groups are being expanded. The emphasis continues to shift toward radio and television as the prime means of reaching the public. Of special importance in fiscal year 1967 will be the consumer information program on drug abuse started in fiscal year 1966. Initial efforts are directed toward informing the public about provisions of the new law.

Plans for fiscal year 1967 are balanced between programs for consumers with special interest and needs and programs aimed at the general public. The techniques of communication will vary, depending on the circumstances and requirements.

1. Consumer inquiries.-Based on increase consumer awareness and our expanding consumer information activities, consumer inquiries are projected to increase in fiscal year 1967. It is anticipated that the majority of these can be answered by form letters, but about one-third of them will require individual replies. To meet this anticipated increase in inquiries one new position is requested for fiscal year 1967.

2. Radio-motion pictures-TV.-Recent studies report a daily radio audience of 80 million in the United States, a daily TV audience of 139 million, with 70 percent of all men, 78 percent of all women, and 81 percent of all teenagers viewing TV at some time during each day. A 1964 survey showed usage of FDA radio and television spot announcements in every State of the Union (except Alaska). FDA currently distributes its radio TV packets quarterly. Plans for fiscal year 1967 call for production of these kits to be stepped up to one a month, with each TV packet accompanied by visual support. The visuals used would be 1-minute, sound-animated film clips, 1-minute sound filmographs, and 1-minute spots featuring an FDA executive or prominent personality. It is proposed that several TV programs be produced in fiscal year 1967. These would combine filmed laboratory sequences with live material originating in the local district and would portray the scientific basis for consumer protection programs. In addition, in order to meet demand, tapes or disks will be supplied with our radio packets instead of mimeographed scripts. For these purposes, an increase of $45,000 is requested.

One major education TV show will be produced to service the growing number of education channels serving both formal school situations and the wider adult public. A timely subject for the show is the "Safe Use of Drugs." A movie to serve this purpose is proposed at a cost of $30,000.

The library of consumer information materials should be increased by at least two 30-minute movies for 1967. These could be used on TV and for school and consumer groups covering such subjects as: food safety, wise "buymanship," quackery, etc. In addition, two special movies on drug abuse are planned for 1967, one for school-age audiences and the other for adults. They will stress the need for proper administration of psychotoxic drugs and be written in such a way as to present experimenting with drugs as being unrewarding. In order to produce these movies with a suitable number of prints, an increase of $82,000 is requested. FDA filmstrips have been well received in the schools where they serve as instruction or discussion aids. FDA plans to develop 15 filmstrips for school and general use in fiscal year 1967. An increase of $29,000 is requested for this purpose. An increase of three professional positions is requested for fiscal year 1967 to assist on the projects outlined above.

3. Exhibits. In addition to the mass media and publications programs discussed elsewhere, one of the most effective ways of teaching the general public is through exhibits. Consumer consultants need additional portable exhibits, story panels, and drug abuse exhibits. In addition, other exhibit techniques will be tried. A consumermobile is proposed on a pilot basis in fiscal year 1967. The consumermobile would be similar to bookmobiles which have long since proven their value. The consumermobile, a tractor-drawn van, would be placed on display at shopping centers, fairs, and schools. It would be manned by consumer consultants from the district offices. An increase of $40,000 is requested for the exhibits and the consumermobile.

4. Senior citizen education.-FDA currently is engaged in several projects aimed at the Nation's 18 million senior citizens, a group particularly subject to quack health promotions. By fiscal year 1967 a vigorous educational program will be underway. A quarterly newsletter is planned that will contain information on false promotions and worthless cures, etc., for distribution through senior citizen's clubs, retirement homes, etc. Also, some of FDA's current publications will be adopted for distribution to the elderly. Use of special spot announcements on radio and television will be increased.

5. Drug abuse education. Increased enforcement powers under the drug abuse amendments means that FDA will become, by necessity, involved in one of the major social problems facing the country.

The problems arising from the information program on drug abuse are expected to be considerably more difficult than those encountered in the traditional food and drug programs. To reach the groups that should be informed, it will be necessary to develop new approaches and vehicles to get the message across. By fiscal year 1967 it is expected that groups requiring specialized program development will be identified and programs developed to reach them. These programs will provide a specifically tailored content, language, format, media,

and audience approach. Development work, to be performed by outside specialists, will begin in fiscal year 1966. They will recommend program concepts for implementation by the agency. An increase of $130,000 is requested for the program in fiscal year 1967. To direct and coordinate the overall consumer program on drug abuse, three new positions are requested in fiscal year 1967.

6. Special population groups. To reach the low-income groups, particularly those with literacy and language problems, $26,000 is requested for simplified writing and translation services, and publication of consumer information.

The industry information program assists the regulated industries toward improved compliance through self-regulation. The increase in FDA's responsibilities for premarketing clearance of new drugs, food and color additives make it essential that adequate communications exist between FDA and regulated industries. As a result of recently reported labeling mixups, contamination of one drug with another, and other errors, FDA is cosponsoring an FDA-industry course on drug controls in fiscal year 1966. To assist industry in carrying out its responsibilities under the Drug Abuse Amendments a special program is being mounted, which will employ pamphlets, posters, and the novel technique of a traveling briefing team which will conduct workshops for manufacturers, trade associations, wholesalers, and similar groups.

In fiscal year 1967 cooperative work with trade associations in planning industry information programs has revealed a great demand for visual aids such as short motion pictures on the essentials of drug control, food plant sanitation, and good manufacturing practices in medicated fees. Five short motivational films are planned for showing to plant personnel, local trade associations, local unions with apprenticeship programs, and vocational agriculture and food technology students. Four headquarters and six district workshops are planned. These will be supplemented by three seminars, mainly covering subjects of concern in the drug area. Exhibits are a necessary adjunct of FDA industry workshops and seminars. A properly designed and manned exhibit provides an effective contact with representatives of industry groups and distribution point for "compliance" literature and other publications. To supplement the workshop and exhibit program, fiscal year 1967 plans call for: (1) the preparation of Guidance Manual for publishers, advertising agencies, and drug firms; (2) the preparation of special articles for drug and advertising trade journals; and (3) the preparation and distribution of trade press releases on FDA requirements and programs on prescription drug advertising and drug abuse.

Studies conducted in consultation with the U.S. Office of Education indicate that instructors of vocational agriculture would benefit by having instructional materials on FDA programs related to agriculture; i.e., pesticides and feed additives. Filmstrips and information material will be produced to reach a potential 828,000 students. From experience with a pilot series, it is estimated that in 1967 industrial training kits on six FDA subjects will be needed. A total of 600 kits, 100 on each subject will reach a significant percentage of a given industry when distributed through trade associations.

Three professional and two clerical positions and $63,000 in nonstaff funds are requested for 1967 to support the above enumerated activities. To expand the traveling briefing team program begun in fiscal year 1966, four specialists and a clerk are requested for fiscal year 1967. This will permit more in-depth presentations and greater coverage of the industries, trade associations, and similar groups.

Advisory opinions

This

The principal responsibility of the advisory opinions program is to promote voluntary compliance by providing industry with a free advisory service. service through consultation, telephone contacts, meetings, and correspondence