Mr. JONES. I think, Mr. Chairman, that the Administration will propose some legislation in this field. I shall be glad to check this and advise your committee on it if you like.

Mr. ROBERTS. I would like to say to the other members of the subcommittee the Chair has consumed too much time.

Mr. Rhodes, do you have any questions?

Mr. RHODES. Thank you, Mr. Chairman.

Mr. Jones, would you give us a little more information on the type of work that is being done at the National Institutes of Health?

Mr. JONES. Mr. Rhodes, in reference to their total research activity, or in reference to some specific field?

Mr. RHODES. I understand that you study just several of the most serious of crippling and killing diseases. Is that correct?

Mr. JONES. Yes. The Institutes of Health are organized primarily along disease category lines. They are designed to provide a framework of research effort to find the answers to disease problems that constitute our major health concerns as of now.

There are seven of these Institutes that are categorical in nature. The Congress last year, supported by your committee, passed legislation and for two new Institutes, one for Child Health and Human Development, which is a horizontal institute in nature as contrasted with the vertical categorical one, and an Institute of General Medical Sciences, which has the broad mission of support of basic sciences which undergird research in the categorical areas.

The work of the National Institutes of Health has had a tremendous impact on our scientific knowledge in the some 18 years of their existence. I think the results of their impact has been presented to you by Dr. Shannon, the Director of the Institutes, and the Surgeon General.

In my own personal experience, I think I can not only point to the work being done by the National Institutes of Health at Bethesda, but beyond that to the tremendous impact of the grants programs in strengthening biological sciences all over the country, Mr. Rhodes. In my judgment, every medical school in this country would be in serious trouble to keep up with advancing knowledge in the biological sciences, were it not for the grant programs of the National Institutes of Health.

Considerably more of its resources go toward supporting research effort in institutions about the country-the university with strong programs of biology and chemistry, the schools of public health, medicine, dentistry, the major hospitals that have research capacity, and some of the private research institutions.

This program, I think, cannot be minimized in terms of the impact on health not only in this country, but around the world. It has been as responsible for pushing forward by many years our ability to manage some of these more severe health problems which require the most sophisticated kind of research.

I think the National Institutes of Health are doing a remarkably effective and efficient job, especially under circumstances that have become rather difficult for them in the last several years.

Mr. RHODES. Mr. Jones, on page 7 you mention a budget of $25.7 million for the St. Elizabeths Hospital, of which $6.3 million is appropriated by the Federal Government. Where does the other money come from?

Mr. JONES. The District of Columbia, Mr. Rhodes.

Mr. RHODES. Are all the employees there on the District of Columbia payroll?

Mr. JONES. No. They are on the St. Elizabeths payroll, but the District of Columbia reimburses for the patients of the District that are served at St. Elizabeths on a formula basis that has been developed by the Budget Bureau and approved by the Congress.

Mr. RHODES. What part of that money is raised by collecting from the patients or families of the patients?

Mr. JONES. Some portion of it, Mr. Rhodes. I don't know to what extent this constitutes a major part of the income. I can get that for you if you would like to have it.

Mr. RHODES. Yes; I would

Mr. JONES. I can give you a breakdown of the sources of income and the expenditures.

(The material to be furnished follows:)

Source of funds, St. Elizabeths Hospital, 1963

None of these funds were received by the hospital from patients as payment by them for hospital services. Collections from patients and families of patients at St. Elizabeths Hospital are made by the District of Columbia and in 1963 such collections amounted to $1,852,624.

Mr. RHODES. Mr. Jones, in matching-fund grants to the States, is this money all earmarked for specific programs, or is it simply allocated to the States for Public Health Service? Is it earmarked, for instance, for programs like aid to dependent children, or aid to the

blind?

Mr. JONES. Under some of the public assistance programs a State can develop its own plan in terms of the qualifications of eligibility, the basis of need other than strictly a welfare recipient.

They can determine the extent of the service provided in their State plan. They submit the plan and once it is approved the grant program under the welfare activities then becomes a matter of reimbursment by the Federal Government for a share of these expenses at whatever level these expenses turn out to be.

In the grant-in-aid programs under the Public Health Service, as contrasted with welfare administration, for the most part, these are

specifically directed toward disease problems or categories of national concern, as have been specifically authorized by Congress. Grants are made to States for control programs in various disease categories and for other special purposes in relation to the recognition of a national need by the Congress.

Mr. RHODES. Thank you.

That is all.

Mr. ROBERTS. Mr. Nelsen?

Mr. NELSEN. Do the Under Secretary and the Assistant Secretaries have any responsibility in the Public Health Service and the Food and Drug under the Food and Drug Act?

Mr. JONES. No. The Under Secretary and the Assistant Secretaries derive their particular responsibilities, Mr. Nelsen, from the authority of the Secretary.

He assigns their duties rather than to have their duties provided directly by Statutory authority.

Mr. NELSEN. Then actually the only authority the Assistant Secretaries and the Under Secretary have is the same as your own, and that is the authority that is delegated to you by the Secretary. Is that right?

Mr. JONES. Except that the Reorganization Act that created the position I hold spelled out specifically the kind of responsibility the incumbent in the position I hold was to have, which is not true of the other jobs.

The Under Secretary is the No. 2 man in line of authority and serves as Acting Secretary when the Secretary is not there.

Mr. NELSEN. He is not named in the Reorganization Act; is he? Mr. JONES. He is named. Yes, by position, but the duties were not prescribed except in general terms of the kind I suggest. I can provide that whole section-it is very brief-of the Reorganization Act for you that has this spelled out if you would like. (The material mentioned follows:)

REORGANIZATION PLAN No. 1 of 1953

SEC. 2. Under Secretary and Assistant Secretaries.-There shall be in the Department an Under Secretary of Health, Education, and Welfare and two Assistant Secretaries of Health, Education, and Welfare, each of whom shall be appointed by the President by and with the advice and consent of the Senate, shall perform such functions as the Secretary may prescribe, and shall receive compensation at the rate now or hereafter provided by law for under secretaries and assistant secretaries, respectively, of executive departments. The Under Secretary (or, during the absence or disability of the Under Secretary or in the event of a vacancy in the office of Under Secretary, an Assistant Secretary determined according to such order as the Secretary shall prescribe) shall act as Secretary during the absence or disability of the Secretary or in the event of a vacancy in the office of Secretary.

Mr. NELSEN. In other words, the Secretary has a pretty wide variety of responsibilities and a pretty big job?

Mr. JONES. That is right, and too few people, Mr. Nelsen, to adequately carry out the functions of the Secretary in relation to the constituent agencies of the Department.

It is for this reason he has asked for additional assistants at the assistant secretary level.

Mr. NELSEN. Wouldn't there be some merit to a little more statutory authority to people in lesser positions and responsibility with it?

It seems to me that as we go down the list it all goes back to the Secretary himself.

It seems to me it is a pretty big operation.

Mr. JONES. I think, Mr. Nelsen, it should be this way. The Secretary is the person held responsible as head of the Department. He should have the freedom to organize the activity of his office and to divide the responsibilities among the people made available to him by congressional authority. These responsibilities shift from time to time and he should have the freedom to make the necessary shifts of assignment according to the abilities of the people in these particular jobs, according to the loads that may develop such as some of the problems I have suggested here that have required particular attention from time to time.

Mr. NELSEN. In your office, Mr. Jones, what assistants do you have in the discharge of your responsibilities? How many do you have working for you?

Mr. JONES. I am entitled under the particular staffing pattern of the approved budget to two staff assistants and to three secretarial positions.

I now have as staff assistant Dr. William H. Stewart, who is a board-certified pediatrician, a medical doctor, who has had wide experience in the Public Health Service.

He was assigned to this detached duty from the Public Health Service at my specific request, so the Public Health Service is reimbursed for him.

Mr. NELSEN. Are they under civil service?

Mr. JONES. No, sir. He is in the Commissioned Corps of the Public Health Service on detached assignment and responsible exclusively to me in his work, but he retains his professional relation with the corps.

I am now negotiating for the addition of a second staff assistant who I hope also will be a medical doctor, likewise, qualified particularly to deal with these difficult professional problems of chemicals, drugs, and the like, to give us this kind of additional professional assistance.

Mr. NELSEN. Is there any information available as to the number of positions in the Department that are under civil service and the number that are, shall we say, appointive?

I am just a little curious. Do you know in the Rural Electrification Administration most of our people were under civil service, including my two assistants?

Mr. JONES. I am sorry. I don't understand.

Mr. NELSEN. That wasn't my previous point, but my curiosity has been aroused and I am just curious. If you do have that information I would like to have it for the record.

Mr. JONES. Yes, sir. I can provide it.

(The information follows:)

Paid HEW employees by type of appointment as of Apr. 30, 1963

Mr. NELSEN. Another question I would like to ask is in the formulation of the budget as far as the Department is concerned. Do you have any responsibility in that area?

Mr. JONES. Yes, sir; I do. The Secretary has appointed a budget committee that is chaired by the Under Secretary and consists of the two Assistant Secretaries, the Administrative Assistant Secretary, the General Counsel, and myself.

These are the policy people in the Office of the Secretary and I do participate in the budget hearings in the Department.

Mr. NELSEN. I have another question, Mr. Chairman. In the legislation of a year ago on the so-called Food and Drug Act, we had several things to try to correct and one of the things that seemed to be to some degree controversial was the provision for advertising as compared to labeling.

As I recall, the generic name and the trade name were to be mentioned in labeling, and it was our assumption that we had written a pretty good record not to go overboard and requiring an unnecessary amonut of language in advertising.

Yet, it seems that there was some conflict in the record between the House and Senate as to what finally happened and I don't know if the record is so written that the Food and Drug hands are tied, but it was my understanding through all of this negotiation that there should be reasonable requirements in advertising. Yet, in the labeling, of course, more careful attention should be given.

In this area, do you have some responsibility of interpretation as to this language and things of that kind?

Mr. JONES. On policy issues, Mr. Nelsen, we do become involved as a representative of the Secretary to whom these matters, if they cannot be resolved, otherwise are referred, and we make recommendations to him in the resolution of policy issues of this kind.

Sometimes he doesn't take them. Sometimes he does. However, the responsibility ultimately is his. However, we are involved in policy decisions that affect health and medical affairs activities of the Department all the way through.

Mr. NELSEN. This leads to a question here. What happens when an outside interest like the drug manufacturers, for example, complain that a Food and Drug Administration decision or proposed decision in a particular situation is not based on a correct history and correct statutory interpretation or was contrary to commonsense?

How do you proceed in a situation like this? For example, the one I cite; if we have a conflict, how would you proceed to correct a situation?

Mr. JONES. Perhaps the best way to answer that question, Mr. Nelsen, is to discuss the development of the new drug regulations, the investigational drug regulations primarily.

There was a great deal of concern when the Food and Drug Administration issued its preliminary regulations having to do with investigation of drugs. These required a tightening of procedure and a reporting to the Department which sponsors of new drugs had not been required to provide before.

The scientific community, the academic community, and scientists in industry involved in the development of drugs were deeply concerned that such regulations might inhibit the development of new drugs.