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Similarly, these programs are assisting in the development of the hospital and medical facilities which are the setting for proper health services. And through the activities of the Welfare Administration, we are assisting in the financing of medical care for large numbers of people in need.

But resources, facilities, and personnel must be organized into programs if effective healtlh service is to be available in the right place and at the right time. Consequently, the Department, through grants, demonstrations, and the dissemination of information is intimately involved in program development. How does a rehabilitation program become part of a continuum of prevention, curative, and rehabilitative services in the community? What is the proper role of the outpatient clinic in the community? How are standards of health services met in the purchase of medical care for welfare recipients?

These are some of the program questions in which the Department participates with many other governmental and nongovernmental agencies and groups. The end point of all programs, both within and outside this Department, is the provision of health service of the highest level permissible within our present knowledge. This calls for the utmost cooperation between the Department and a vast array of public and private groups.

Since health service functions are located organizationally in almost all of the constituents of the Department, coordination is always necessary. It is also a normal and natural aspect of operations.

For example, informal exchanges among our professional and technical personnel are almost impossible to chart or to describe in concrete terms. Yet they are among our most effective methods of coordination. T'e are quite aware of the fact that this goes on within the Department day by day, hour by hour. We believe this exchange is a sign of strength.

There are reasons why this informal communication occurs. Chief among these is the knowledge a program director has of the professional and technical skills available to assist him in other parts of the Department. For example, Food and Drug Administration personnel tek information and consultation from the scientists and technicians of the Public Health Service on pertinent problems.

Also, the health service programs of the different agencies frequently converge in the same universities, the same hospitals, or the same communities. Every program director is a ware of the possibility of overap and duplication.

In many instances, however, informal coordination cannot be relied ipon completely, and formal mechanisms must be established. This an range from collaboration on specific projects to intradepartmenal committees on either a continuing or ad hoc basis. These mechnisms not only serve existing programs but also help in the developrent of new programs. Translating the report of the President's anel on Mental Retardation into the program for the mentally rerded, which is now before the Congress, required coordination and msultation among most of the agencies of the Department. This was fectively done through a departmental Committee on Mental tardation.

HEALTH RESEARCH Health research constitutes the third major grouping of health ivities within the Department. This function consists of two

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parts: research, which is conducted in the laboratories of the Department-intramural research; and research activities which are supported by grants and contracts extramural research. In terms of dollars, the latter activities are by far the largest.

The focal point of health research in the Department is in the National Institutes of Health. You have heard an extensive review of these activities earlier in these hearings, and there is little to add.

One observation, however, seems important to an understanding of the our role in health research. While all research has as its purpose the production of knowledge, there is a difference between the health research activities of the National Institutes of Health and of the other PHS bureaus and agencies of the Department. The objective of the blin National Institutes of Health is to develop knowledge for the prevention, treatment, and cure of diseases of man. Health research in other agencies serves as a means of producing knowledge to meet the specific objectives of those agencies. The objective of the community health service programs of the Bureau of State Services, for example

, is the application of knowledge to protect and promote the health of the public. The research activities of these programs are oriented around this mission.

It is appropriate, therefore, that such research is located primarily in communities throughout the Nation and is designed to find better che methods of applying health knowledge. Also, research activities of the Vocational Rehabilitation Administration can be visualized in a similar manner.

It is apparent, however, that coordination among the health rele search activities of the various agencies of the Department is essential

. Knowledge is knowledge-if it is produced in the laboratories of the Public Health Service and is useful to carrying out the mission of the Food and Drug Administration, then it should be available to FDA. The same can be said for the laboratory results of the Food and Drug Administration as they relate to the mission of the environmental health activities of the Public Health Service. In fact, the area of intramural scientific activities is precisely where coordination between the Food and Drug Administration and the Public Health Service is most important.

In the extramural research programs of the Department, coordination of another type is essential. Most of the extramural research is carried out by academic institutions, hospitals, research institutes industry, and community agencies. The same institution may be receiving grants for research work from various sources within the Department and for various purposes. Coordination is needed to prevent duplication and overlapping.

This is why, for example, the grants executive of the Vocational Rehabilitation Administration sits in on various study section and council meetings at the National Institutes of Health. This likewise is the purpose of the Science Information Exchange of the Smithsonian Institution which all our agencies use along with other Federal agencies

Coordination is also needed in grants management policy. The development of mechanisms within the Public Health Service for coordination of grants management policy are certainly steps in the right direction.

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From the foregoing, it is apparent that coordination of the Department's complex and far-reaching health activities is a continuing necessity. We view it as one of our most important responsibilities.

A considerable amount of coordination develops empirically and in response to the needs of our various programs. Much of it can be planned, however. We are constantly developing and refining such plans; and we put the plans into effect as rapidly as circumstances permit.

Some of the factors that will aid us in coordinating our programs now and in the future are

(1) Providing a climate that fosters coordination as a part of daily operations.

(2) Placing related functions in close proximity to each other.

(3) Improving the exchange of information, particularly science information.

(4) Getting the benefit of regular and systematic advice from outside scientists and leaders in public affairs.

(5) Improving administrative and management practices within the Department.

Mr. Chairman, it has been the purpose of this presentation to make clear that the pattern of development and manner of operation of the Department's health programs have been and are consistent and rational

. This is so even though the programs were authorized to meet specific needs at different periods of history, even though they have distinct missions, and even though some are under the jurisdiction of different committees of the Congress.

The essential features in this pattern are: (1) Federal involvement in a health problem occurs only upon demonstration of a national need.

(2) Federal participation consists essentially of grants-in-aid, accompanied by professional and technical guidance, to stimulate and assist local action; and of support, through grants and contracts, to individual institutions where the particular activity needed in the national health interest is located.

(3) Direct operations of the Federal Government serve specific objectives

, develop the competence needed to provide professional leaderhip in meeting our national health objectives, conduct research, and egulate and control interstate health problems.

During the course of these hearings, we have tried to do several ther things: describe in detail each of our health missions and prorams; outline the role of the Department in providing direction nd coordination for these programs; and suggest that no major overaul of these programs seems desirable at this time. We do recognize two handicapping situations as of now, however. ne is the lack of authority for the Public Health Service to make ganizational and administrative adjustments as shifts in emphases ay require. The other is the need for additional policy level pernnel in the Department for more effective policy determination d coordination. Finally, Mr. Chairman, we recognize the importance of the review the health activities of the Federal Government that is being

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Mr. Rogers of Florida. Do you foresee any difficulty in communicating with the sponsor with all of this information coming in? For in

you get a report of an adverse effect, would that be immediately communicated to the sponsors?

Mr. Jones. Immediately.

Mr. Rogers of Florida. So they can take whatever action is necessary?

Mr. Jones. They give priority to the obviously difficult situations. Adverse reports would be factored right into the communications system. Most of the sponsors would voluntarily take action immediately once they had the information. We are also working very hard on the communications aspect of adverse drug reactions.

Mr. ROGERS of Florida. The internal organization of Food and Drug and Public Health Service also comes within your jurisdiction?

Mr. Jones. Yes: I oversee this for the Secretary.
Mr. Rogers of Florida. The actual internal organization!

Mr. Jones. They are the responsibility of the respective constituent agency heads. The Commissioner has this responsibility, the Surgeon General has this, and the Secretary has the approval.

Mr. Rogers of Florida. For the Secretary you are the one who would handle the internal organization perhaps if they came up!

Mr. Jones. In collaboration with the administrative assistant secretary of the Department who has the general administrative function of the Secretary's office, but you are correct in your assumption.

Mr. Rogers of Florida. Are there any specific reorganization proposals pending with respect to either of those agencies, Food and Drug Administration and the Public Health Service!

Mr. Jones. Yes, sir. The Public Health Service has asked in the bill before your committee for specific authority which would be immediately used to provide a Bureau of Environmental Health, and a sister Bureau of Community Health Services. This would discontinue the Bureau of State Services because these two new Bureaus would be created out of it.

The Food and Drug Administration is studying along with us the recommendations of the Citizen's Advisory Committee which did make recommendations for major organizational shifts.

This report was a very constructive report. It was very direct. It pulled no punches. We consider it highly constructive.

The major recommendations of this report will be adopted by the Food and Drug Administration. A major portion of the report is devoted to organizational recommendations.

I think the Food and Drug Administration is getting geared and moving rapidly toward an organizational pattern that pretty well reflects the recommendations of this report.

Mr. Rogers of Florida. Could you let us have the specifics of what you are planning later on? And what about the discussion of aspects of the Mental Health Institute perhaps to be made into a bureau!

Mr. Jones. This is a matter that is much more complex than would appear on the surface. The Surgeon General has appointed a task force in the Public Health Service which is reviewing this particular issue at this particular time.

The ramifications of creating a Bureau of Mental Health are pretty widespread in the Service. I can give you some of the details.



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For example, if you create a Bureau of Mental Health, do you retain a National Institute of Mental Health independent of the Bureau of Mental Health. This is the pattern in the other categorical institutes where research is the focus in the institute and the community service programs are focused in the Bureau of State Services. This is just one illustration of one type of question that needs to be answered.

Mr. Rogers of Florida. When do you anticipate that report will be completed?

Mr. Jones. The task force has only recently been organized. I would hope that it will be fairly soon because it is an issue that will need to be resolved if Congress is successful in adopting the mental health and mental retardation legislation, which we strongly hope will become a program this year.

Mr. ROGERS of Florida. There has been some talk in the pharmaceutical industry, too, that they would be interested in the creation of an Advisory Council on Food and Drugs.

Has anything been done to consider this proposal ?
Mr. Jones. Yes, sir. There was a specific recommendation in the
Citizen's Advisory Committee report for the appointment of a Na-
tional Advisory Food and Drug Council.

This Council will be appointed. The Commissioner expects to do this and our anticipation is that the Council will be in operation in time to review the implementation of the Citizen's Advisory Committee report probably this fall.

Mr. ROGERS of Florida. The Advisory Council will be in effect ?
Mr. Jones. This would be our expectation.

Mr. ROGERS of Florida. What legislative authority does the Secretary use to provide this Council ?

Mr. Jones. His general authority under the Food and Drug Act which does provide for advice from nongovernmental consultants.

Mr. ROGERS of Florida. So that he can do with his present authority in the Department?

Mr. Jones. Yes, sir. That is correct. This Council we think, will be a very important adjunct to a continuing review of the Food and Drug programs by representatives of the public, of the regulated industries, of the consumers, and of the scientific community.

Mr. Rogers of Florida. What was the time limit when you expect this to be functioning?

Mr. JONES. We would expect it to be in operation probably by late fall, although we haven't set a timetable. It takes some time to select and establish the Council.

Furthermore, we wish time to put into effect as many of the recommendations of the Citizen's Advisory Committee prior to the creation of this Council so the first job would be to take a look at the implementation of the recommendations.

The Citizen's Advisory Committee is in and of itself a form of advisory council, although more specific in objective. We think a continuing council would be a very useful asset to the Commissioner and he feels this way about it.

Mr. ROGERS of Florida. When you firm this up could you let the committee have the details of it for the record ?

Mr. JONES. Surely.
(The information was not available for insertion in the record at

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this time.)

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