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funds to the States for the health programs that the States think are important ones for them to be emphasizing within the State. Mr. RogFRs. 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. RogFRs. It is the total grant and they apportion? Dr. STEwART. That is correct. Mr. RogFRs. 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 $6214 million and É. Congress appropriates this fund it is an increase over last year’s d. 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. RogFRs. 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

C#. is available. en you could say, “How about a contingency appropriation?” Mr. KELLY. Mr. Brown, I think that we all know }. 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 o 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 jo. 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 }." has the responsibility is the one that has to organize and und 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?

Mr. KELLY. I think that we could have gained from the availabilit of the 4 months in launching the exploitation of this finding. turned out to be a long-range investigation that has resulted from this finding including the development of new facilities which had never been àojī: Mr. Brown. But with this kind of early commitment by Congress, in other words, this willingness to take testimony in advance of the actual presentation of the request for funds and so forth, isn't it true that you can also go ahead and begin to presume your plans and frequently do perhaps up to the point where you take the legal steps to put them into effect; in other words, sign a contract or in effect commit yourselves? This is what I am trying to find out. How important is it that the cash be on hand, ...'. important is it that we presume that the Congress is going to act fast enough? § KELLY. I think your point is well taken and necessarily, in order to carry out any amount of work, you have to do some planning, The very presentation of a budget constitutes this planning, that you have identified the problem, how you will approach the problem and what the next steps are; but by and large, this is the planning which was done prior to being able to present the estimate and prior to being able to present testimony with respect to it so that this loss of time is really occurring to a marked degree after this initial preliminary planning has been done. Don't misunderstand. You know, and I know, that we do divert staff resources to try and get as far along as we can in moving down the road. I thing that we have had examples in the past that indicate the extent to which a greater degree of flexibility would have been useful. I think that you can foresee this problem occurring in the future that makes this an important piece of flexibility for the Secretary, We are not asking, however, in any sense as I see it for a blank . One, we are asking for the legislative committees to authorize the use of a o fund. We are asking for the appropriations committees to then implement that provision and tell us each year that we are authorized to use it and the extent that we can use it. We are suggesing that we give to the Congress a report 10 days in advance of its use of our intention to use it and an annual report on our use of the fund. Mr. JARMAN. The Chair hates to interrupt, because this is an imortant and, perhaps, maybe a controversial part of the bill before us, §. I o point out that we do hope to finish with this part of the hearing by 12 o'clock this Fo: since we have a full agenda of witnesses for tomorrow. If that deadline can be kept in mind with several other members of the committee yet to ask questions, the Chair would appreciate it. Perhaps this matter can be developed more completely from the Secretary and Mr. Kelly, and others, in the materials which you submit to the committee.

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Mr. KELLY...We would be glad to submit data on the time lag involved in receiving supplemental appropriations. (The information follows:)

Chronological history of Department of Health, Education, and Welfare supplemental appropriations, fiscal years 1962–67

[In thousands of dollars)

Appropriation Act Amount Date requested Date enacted enacted Supplemental Appropriation Act, $1,125, 222 -------------------------------------- Sept. 30, 1961 1962. Department of Health, Educa- 253,579 July 13, 1961 (H. Doc. 210); Aug. 8, tion, and Welfare items. 1961 (H. Doc. 217); Aug. 14, 1961 (H. Doc. , 224); Sept. 18, 1961 (S. Doc. 51). 2d Supplemental Appropriation Act, 378,551 -------------------------------------- July 25, 1962 1962. Department of Health, Educa- 16,526 Feb. 7, 1962 (H. Doc. 333); Apr. 3, tion, and Welfare items. 1962 (S. Doc. 83). Supplemental Appropriation Act, 1,467,230 ---- May 17, 1963 1963. Department of Health, Educa- 216,753 Aug. 13, 1962 (H. Doc. 514); Sept. 28, tion, and Welfare items. 1962 (S. Doc. 149); H. Doc. 514 resubmitted on Feb. 7, 1963 (H. Doc. 61); Feb. 11, 1963 (H. Doc. 63). Supplemental appropriations, De- 289,688 Feb. 10, 1964 partment of Health, Education, and Welfare, 1964. Department of Health, Educa- 289,258 tion, and Welfare items. Deficiency Appropriation Act, 1964--- 1,336,687 June 9, 1964 Department of Health, Educa- 160, 3 tion, and Welfare items. Supplemental Appropriation Act, 1, 117, 196 Oct. 7, 1964 1965. Department of Health, Educa- 69, 750 tion, and Welfare items. 2d Supplemental Appropriation Act, 2,227,564 Apr. 30, 1965 1965. Department of Health, Educa- 446,374 Mar. 2, 1965 (H. Doc. 98); Mar. 15, tion, and Welfare items. 1965 (H. Doc. 110); Mar. 15, 1965 (H. Doc. 111); Mar. 16, 1965 (H. Doc. 119). Departments of Labor, and Health, 1,223, 182 -------------------------------------- Sept. 23, 1965 Education, and Welfare Supplemental Appropriation Act, 1966. Department of Health, Educa- 1,066,655 Apr. 19, 1965 (H. Doc. 147); Apr. 22, tion, and Welfare items. 1965 (H. Doc. 149); June 24, 1965 (H. Doc. 220). Supplemental Appropriation Act, 4,741, 645 – Oct. 31, 1965 1966. Department of Health, Educa- 577,821 || Aug. 26, 1965 (H. Doc. 278); Sept. tion, and Welfare items. 29, 1965 (H. Doc. 295); Oct. 5, 1965 (H. Doc. 298); Oct. 8, 1965 (S. Doc. 62); Oct. 15, 1965 (S. Doc. 63); Oct. 18, 1965 (S. Doc. 65). Second Supplemental Appropriation 2,788, 143 13, 1966 Act, 1966. Department of Health, Educa- 908,070 Feb. 14, 1966 (H. Doc. 380); Feb. 21, tion, and Welfare items. 1966 (H. Doc. 383); Mar. 8, 1966 (H. Doc. 405). Supplemental Appropriation Act, 5,025, 265 |-------------- --| Oct. 27, 1966 1967. Department of Health, Educa- 2, 177, 179 || Jan. 24, 1966 (H. Doc. 335); Oct. 5,

tion, and Welfare items.

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Mr. JARMAN. Mr. Rogers?
Mr. RogBRs. I have no questions.
Mr. JARMAN. Mr. Nelsen?
Mr. NELSEN. Thank you, Mr. Chairman.

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