What is the request of the Department on the vaccination program?
Are you coming in with a new program or are you letting it
Dr. STEWART. Are you talking about German measles?

Mr. ROGERS. A vaccination program is what I am talking about. Dr. STEWART. The Vaccination Assistance Act expires in 1968 and we think that this can be included in the Public Law 749 extension act that we are talking about.

Mr. ROGERS. Wait. Let me get this clear. Are you asking for renewal of the vaccination program or not?

Dr. STEWART. No; we are not.

Mr. ROGERS. You are not?

Dr. STEWART. That is correct.

Mr. ROGERS. There is a German measles problem and maybe a breakthrough.

Mr. CARTER. That is a distinct disease?

Mr. ROGERS. So was the vaccination program for distinct diseases as I understand it.

Dr. STEWART. At the present time with the German measles vaccine, of course, it is still in the research stage. We don't know whether there will be a breakthrough to an available vaccine.

Mr. ROGERS. You don't think we need a continuation of our vaccination program?

Dr. STEWART. We think this can be built into the normal program that we have in parts of Public Law 89-749.

Mr. ROGERS. Then there is some flexibility there?

Dr. STEWART. There is flexibility to the point at which you suddenly need to move on something. If a breakthrough on a vaccine should occur right away, assuming that Public Law 89-749 had been implemented, the States have already got programs going under these funds. Their flexibility is on a year-by-year basis, too.

Mr. ROGERS. Don't you have the flexibility to work in any vaccine that comes in?

As I recall, we gave the Secretary the authority to say which vaccine would be used or included in case of breakthrough. We specifically made provisions in that law for him to have that authority so that you could completely set aside one program for a minute if there was a great emergency come through until you could get some additional funds.

Dr. STEWART. That is correct, Mr. Rogers, but it could be that you have a year in which the States have used the money under the present Vaccination Assistance Act for their regular measles campaign, for example.

Mr. ROGERS. That is what I am saying. Yet you are not asking to continue it?

Dr. STEWART. I think that we are not talking about flexibility within one item of the Public Health Service budget. We are talking about flexibility because we have so many items and one can't tell what contingencies are going to arise. It may be vaccine. It may be a disaster

on an Indian reservation. It may be a disaster on our rivers. It be something else.

may

Mr. ROGERS. We have a lot of flexibility there, particularly with our comprehensive health policy that we just passed to give lump sums to the States.

Dr. STEWART. That money is for the States to conduct their health programs as they set priorities on a regular basis. It does not take care of contingencies. They would have the same difficulty of meeting contingencies that we have.

Mr. ROGERS. But you also have project grants that you are continuing for these contingencies?

Dr. STEWART. No; the project grants are not for contingencies. The project grants are for special problems that are not national in scope, or for initiating new programs or this type of thing.

They will be used in a regular movement of the health programs within the State.

Mr. ROGERS. Let's get back to the central point, then. What are you going to do about your vaccination program?

Dr. STEWART. Well, the vaccination program has now become part of the regular program of the States.

Mr. ROGERS. It is still being funded through that program, isn't it? Dr. STEWART. In part.

Mr. ROGERS. How are you going to fund it?

Dr. STEWART. That money was to fund communities or States on a project basis if they felt they needed the assistance and it can be either for the purchase of vaccine or they can get the vaccine from us. It also pays for the public information campaigns that go with such programs.

Our program has shown that you can develop vaccination programs but the vaccination effort is being built more and more into the regular programs of health departments and other agencies in communities and States.

Mr. ROGERS. Where is the money coming from?

Dr. STEWART. Well, it is coming from private sources. It is coming from State and local governments.

Mr. ROGERS. In other words, you are saying that it is not necessary to have Federal funds for the vaccination programs now?

Dr. Stewart. I think it is only necessary in the future to the extent that the State would choose to use some of the Federal funds under the formula grants in Public Law 89-749 for vaccination programs. There is a vaccination program going all the time and the States use these funds for special purposes under the Vaccination Assistance Act but with Public Law 89-749 they can build this into their normal program.

Mr. ROGERS. You mean for comprehensive health planning?

Dr. STEWART. It is not in the health planning. It is in the section of the Formula grants in Public Law 89-749 which were formerly categorized into heart disease, cancer, and so on, but are now a pool of

funds to the States for the health programs that the States think are important ones for them to be emphasizing within the State.

Mr. ROGERS. That is the theory of the comprehensive health planning as I understand it, isn't it?

Dr. STEWART. It is a major portion of the Comprehensive Health Planning and Public Services Act, yes.

Mr. ROGERS. It is the total grant and they apportion?

Dr. STEWART. That is correct.

Mr. ROGERS. You are saying that vaccination program would be under that administration?

Dr. STEWART. The vaccination program would apply within the program of grants in Public Law 89-749 as the State uses this money for its health programs.

Mr. ROGERS. What I want to know is if you are taking away any money by not continuing the vaccination program?

Dr. STEWART. I don't think I would use that phrase "taking away.” The authorization for 1968 in Public Law 89-749 is $621⁄2 million and if the Congress appropriates this fund it is an increase over last year's fund.

Mr. ROGERS. But you are not asking for a continuation as such of the vaccination program?

Dr. STEWART. No. The whole idea of the formula and project grants of Public Law 89-749 was to consolidate the various categories of grants we had in order to give the States and communities more flexibility in meeting the problems they had.

Many communities have been able to put on vaccination campaigns without Federal assistance. Others did not need it.

It varied, depending upon the resources they had available and the community interest they had.

Mr. ROGERS. Then you are saying that if you have a breakthrough in measles they can program it in this overall program they have if they want to put the priority on it.

Dr. STEWART. This is correct; yes.

Mr. BROWN. Would the gentleman yield?

Mr. ROGERS. I yield.

Mr. BROWN. I would like to ask how much timelag there is between proof of a breakthrough and the implementing of it would you estimate under normal circumstances?

Dr. STEWART. The breakthrough for use by the general population would mean that the vaccine had been licensed.

Mr. BROWN. And is that prior to that established medically?

Dr. STEWART. Prior to that is a process of experimenting with the vaccine. Then there is the trial and error testing of the vaccine, meaning the trial that is given in a population group to make sure that it works. And by the way, this is a contingency that comes up every once in a while.

We may have a vaccine that has been tested on small groups and we suddenly need larger field trials. This is the next developmental stage. We can rarely anticipate the field trial stage. It comes very quickly because of the nature of the experiments.

Mr. BROWN. But you have that flexibility in the fund that you can divert from other areas; in research, for example.

Dr. STEWART. No; we do not have the ability to divert funds for these field trials and also for the implementation of a vaccine program after it has been licensed.

Mr. BROWN. You suggested beforehand-I am not talking about after it has been licensed.

Dr. STEWART. We have the funds with which to do the basic research on developing the vaccine and the testing of the feasibility.

Mr. BROWN. You can switch the vaccine to some other areas in the basic research; can you not? You have that discretion?

Dr. STEWART. No. We have difficulty meeting contingencies of need for large-scale field trials of a vaccine prior to licensing.

This situation emerged in the regular measles vaccine program and it could have been so in the polio vaccine development although that was financed mainly by the polio foundation. This is one type of contingency that can come up-the field trials of a vaccine.

Mr. BROWN. How would you resolve that?

Dr. STEWART. The field trials on the regular measles were conducted in Africa using money abroad rather than money of our own. Mr. BROWN. This is prior now?

Dr. STEWART. Public Law 480.

Mr. BROWN. Prior to its being proven, proven in terms of licensing? Dr. STEWART. Prior to being licensed. There were massive field trials in Africa.

Mr. BROWN. You don't know whether this vaccine is yet good enough to be licensed?

Dr. STEWART. This vaccine is now licensed. At that time we did not know that it would be licensed. We were as sure as one could be before the field trials. The field trials in this instance depended in a sense—the contingency that had come up, depended upon the availability of Public Law 480 funds in Africa.

Mr. BROWN. That is one contingency that you handled but I would like to return to my point of where you have established through field trials and are ready for licensing.

How much leadtime is there here? I am trying to determine whether or not there is, in fact, time for Congress to act and it seems to me that Congress has gotten itself involved with the doctoring of the economy by the 7-percent investment credit suspension.

We are doing that on a month-to-month basis apparently. We are acting on that kind of economic rate. Can't we move on a month-tomonth basis, to appropriate funds for any breakthrough that comes in medicine?

Mr. Rogers made the point that it takes a certain amount of time to establish the validity of the vaccine, the treatment, the licensing, and Congress is available.

Then you could could say, "How about a contingency appropriation?"

Mr. KELLY. Mr. Brown, I think that we all know that Congress has demonstrated a capability of acting almost instantly if the requirement

arose for it to do so. We have seen something go through the Congress in a period of 24 hours when that is required, but I think if you were to take the tradition as Mr. Cohen was suggesting on the handling of supplemental appropriations, you would find that the period from the time that there was a determination of need until funds were available to carry out that need by a supplemental appropriation would range anywhere from 7 months to 2 months. It is also unlikely that you can find anything except a very extraordinary incident in which that time lag was less than 2 months in duration.

We had an example of a development involving viruses as the potential causation of cancer, in which there was a desire to exploit the research findings. In this particular instance the Congress became aware of the problem concurrently with our becoming aware of it, and prior to the actual submission of a supplemental appropriation request the Appropriations Committee took testimony on it and put it into our regular appropriation bill which was then under consideration by the Congress.

This was probably the most rapid method by which you could handle that particular transaction. It took about 4 months from the time that this illustration came up until we actually had the funds available.

Now, the particular problem that you were talking about on the development of the German measles vaccine, this work is being done in part by the Division of Biologic Standards of the National Institutes of Health.

This is a relatively small appropriation. The exact amount of it I don't recall, but it is an appropriation of less than $10 million that relates to all of the problems associated with licensing biologic products. Scientists in the Division are the ones that have done much of the work on the development of this vaccine.

The Division does not have any resources except this small appropriation; and, if you want to move this project into expensive field trials, at some particular point you have to find some way of doing it, because within that appropriation, although you think of the National Institutes of Health as being an organization funded in excess of a billion dollars, when you take this into individual pieces, and the planned use of those pieces, and the commitments that have already been made against them, these amounts are not large.

In this particular instance, the problem is associated with a very small appropriation which is within the National Institutes of Health. But there is no availability for transfer of funds between the various accounts of the National Institutes of Health, so that whichever account has the responsibility is the one that has to organize and fund it.

Mr. BROWN. If Mr. Rogers will be patient with me for one moment, further, let's go back to the example of the virus causal effect in cancer. Let me ask you if in this 4-month lag which you described you had actually any delay in putting the program into effect as a result of that 4-month lag time?