scribe what is involved in this licensing, it might give some clarification.

Mr. ROBERTS. You may do so.

Dr. MURRAY. As soon as measles virus was isolated some 8 or 9 years ago by Dr. Enders, it was immediately evident to those active in this field that a vaccine was a definite probability, once the necessary scientific processes had been worked out.

This proved to be a long-drawn-out business and it was only this year that the vaccine was eventually licensed.

In order to meet this eventuality the Public Health Service started very early in order to meet the problems involved, to develop scientific research programs so that information would be available at about the time the product might be available for licensing.

In addition, it conferred with experts in this country and from abroad and in the process of this it developed a series of recommendations which industry could use for the testing and production of such a vaccine. This was looking forward to the development of a set of regulations which would cover the essential aspects of safety, purity, and potency. This also included the clinical efficacy of the vaccine in the field, so that these would be in effect at the time that manufacturers were ready to apply for a license.

This was a very laborious task, as you might imagine, but it was accomplished, and in the spring of this year measles vaccine was licensed on the basis that the manufacturer had met the requirements which had been set forth in these regulations which had been previously published.

Mr. ROBERTS. That is very interesting, Doctor. When will we make this measles vaccine available and, if so, will we do it under the provisions of the mass vaccine program?

Dr. MURRAY. That is completely outside of my field of responsibility and I am unable to answer that. Our Division is concerned with the problems entirely related to the safety, purity, and potency of the product and not in its supply in the field.

Mr. ROBERTS. Do you know when the vaccine will be available in volume?

Dr. MURRAY. It is available in rather substantial amounts at the present time.

Mr. ROBERTS. So far, have you had any reaction from the use of it? Have you had any response, or is it successful, in your opinion?

Dr. MURRAY. The reports from the field have been rather gratifying. It is expected from the clinical evidence that was available even before licensing that there will be a certain number of children who would have mild reactions, such as a fever for a couple of days, and some might even have rash, but this would be a mild illness and would in no way incapacitate them.

Upward now of 2 million doses have been used.

Mr. ROBERTS. Upward of 2 million doses?

Dr. MURRAY. Yes, sir.

Mr. ROBERTS. How many injections would they have to have?

Dr. MURRAY. One.

Mr. ROBERTS. Would they be given with other vaccines?

Dr. MURRAY. Not mixed, but separately. It is possible to give them simultaneously.

Mr. ROBERTS. How serious is measles as a problem in this country? Dr. MURRAY. I cannot give you any exact figures but it is considered to be a rather serious problem in the sense that it does cause a considerable amount of encephalitis and a number of children who have had measles do suffer from mental dullness as a result of that.

Mr. ROBERTS. Thank you, Doctor. The committee would certainly like to compliment you and all the members of your staff and the people at the NIH and everyone who has a part in bringing this wonderful blessing to our people and the people of the world.

Mr. Brotzman?

Mr. BROTZMAN. When you say "biological products," what does that mean?

Dr. MURRAY. Largely this concerns materials which are in the nature of vaccines, serums as commonly understood, and human blood for transfusion and products made from human blood such as albumin and gammaglobulin. Some of the vaccines I could mention are smallpox vaccine, typhoid vaccine, cholera vaccine. Serums would be tetanus antitoxin, diptheria antitoxins and products which are analogous to these.

Mr. BROTZMAN. I think you stated that you make a determination as to "safety, purity, and potency." Is that correct?

Dr. MURRAY. That is correct.

Mr. BROTZMAN. You have looked at this particular bill we are considering here this morning?

Dr. MURRAY. Yes.

Mr. BROTZMAN. What I am interested in knowing is what kind of record is made in your agency that would be available for review by the Court.

Can you explain to me what sort of hearings are prepared? I am talking about just fundamental things such as, does a reporter take testimony or are documents filed to make a record.

Dr. MURRAY. What usually happens is that a manufacturer interested in a particular product will submit documents which constitute an application for a license for this particular product.

The documentation will vary according to the kind of product. Obviously in a thing like measles or polio vaccine, the documentation will be very extensive.

Mr. BROTZMAN. Pardon me at this juncture. To whom does he submit this documentation at the initiation of his application?

Dr. MURRAY. To the Surgeon General but it is handled within the Division of Biological Standards.

Mr. ELLENBOGEN. You asked before what kind of hearing record was made. The fact is that there has never been an application for a hearing under section 351 of the Public Health Service Act so that there is no actual case of a hearing.

Never in the history of this program has there ever been a request for an opportunity for a hearing although the regulations do afford that opportunity, so the documentation that Dr. Murray referred to was not at the hearing stage although if it went to the hearing stage these documents would presumably be submitted for inclusion in the record.

Mr. BROTZMAN. Now I think we are making some progress as far as I am concerned.

If the hearing is requested under the applicable regulations, then a record would be made at that particular juncture? Is that right? Mr. ELLENBOGEN. That is correct.

Dr. MURRAY. As I understand Mr. Brotzman's question, it was, how did we develop the record for a new product so that in the event that a hearing might come up at a later date this documentation might be available?

Mr. BROTZMAN. This is correct.

Dr. MURRAY. I mentioned, first of all, the documentation in connection with the initial application by the manufacturer. Subsequent to that there would be correspondence, clarification, there would be conferences held with the manufacturer's scientific personnel in order to clarify points that were not clear, there might be requests for additional information, and in addition to that there would be a record of laboratory and other tests which are carried out by our own division and other scientific bodies, references to the scientific literature, and

so on.

Usually this would all culminate in the issuance of a license, because if the license is not going to be issued it becomes evident at an early stage that the information required is not going to be available.

Mr. BROTZMAN. In the event the license application was refused and let us say the aggrieved party desired to pursue his or her remedy under section 351, at the hearing is the right of cross-examination and all of the other rights of a fair hearing afforded to the particular individual at that juncture?

Dr. MURRAY. I would have to defer to Mr. Ellenbogen.

Mr. ELLENBOGEN. The regulations do not spell out the procedures for the hearing but the right of cross-examination is inherent in the concept of a fair hearing, so that my answer would be "Yes," but it is not spelled out in so many words in the regulations.

It just says "an opportunity for hearing.

Mr. BROTZMAN. That is section 351.

Mr. ELLENBOGEN. Yes, of the Public Health Service Act.

May I say that section 351 does not refer to a hearing. Section 351 says, "All such licenses shall be issued, suspended, and revoked as prescribed by regulations," and the regulations, in turn, provide for an opportunity for hearing.

Mr. BROTZMAN. The reason I am asking these questions is I was trying to find out what kind of record there would be at the time the Court might be called upon to review them.

Mr. ELLENBOGEN. If we had a hearing there would be a presiding officer or board; the regulations provide for a board, in certain cases, of officers. While this is not spelled out in the regulations, there would be documentary evidence, there could be oral testimony on both sides and cross-examination, and all of this would be taken down and included in a full record, just as it is in hearings under the Food and Drug Act.

Mr. BROTZMAN. Is testimony taken under oath?

Mr. ELLENBOGEN. I don't recall offhand whether under the Food and Drug Act testimony is taken under oath. Presumably an oath would be administered when there is oral testimony.

Mr. BROTZMAN. The answer really is you do not know?

Mr. ELLENBOGEN. I would have to inquire how we proceed in that respect under the Food and Drug Act. The Administrative Proce

dure Act, in enumerating the powers of presiding officers, says that the hearing officer, subject to the agency's rules "and within its powers," may administer oaths. I can supply the information for the record as to how we proceed under the Administrative Procedure Act on that point, under the Food and Drug Act.

(The following letter was later received from Mr. Ellenbogen :)

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,

July 12, 1963. Hon. KENNETH A. ROBERTS, Chairman, Subcommittee on Public Health and Safety, Committee on Interstate and Foreign Commerce, House of Representatives, Washington, D.C. DEAR MR. CHAIRMAN: At the hearing on H.R. 3408 held before your subcomcommittee on July 9, I was asked by Congressman Brotzman whether, if the bill were enacted, witnesses appearing at hearings under the bill would be put under oath. I responded that we would follow the same practice as is employed at hearings under the new-drug section (sec. 505) of the Federal Food, Drug, and Cosmetic Act, and I undertook to supply the information as to that practice for the record (pp. 21 and 22 of typed transcript).

I have now examined the applicable regulations under that act and find that section 130.17 of the regulations provides that the hearing examiner "will have the power to administer oaths and affirmations * and section 130.21 provides: "Each witness shall, before proceeding to testify, be sworn or make affirmation."

I should appreciate it if you would be good enough to have this information inserted at the appropriate place in the record of the hearing.

Sincerely yours,

THEODORE ELLENBOGEN,

Deputy Chief, Legislation Division, Office of the General Counsel. Mr. BROTZMAN. I think it makes a difference, and I believe the sponsor would agree, what kind of record there was available for the court to review.

Mr. ELLENBOGEN. The provision in this bill is a fairly standard provision subject to certain corrections.

Mr. BROTZMAN. Did I understand there were certain amendments your agency is recommending that might improve the bill?

Mr. ELLENBOGEN. Yes, indeed. When I said before that we had no objection to the bill, I should have said," if certain perfecting amendments are made." I can summarize those if you wish.

Mr. BROTZMAN. Maybe the chairman intends to proceed to find out what they are but I would be interested, of course, in knowing what they are at the appropriate time.

Mr. LIBONATI. They are purely amendments within the procedures of the HEW itself to arrive at the situation where they have in fulfillment carried out their questions of appeal, giving the right of appeal to the applicant.

Mr. ROBERTS. I have just one brief question. I am sure, Dr. Murray, you and your associates are familiar with the various efforts that have been made to license Krebiozen.

Would this bill or its provisions cover that particular product?

Dr. MURRAY. I think it is fair to say the Department made a determination some years ago that Krebiozen was a biological product subject to the Public Health Service Act and therefore would be covered.

However, it was in an investigative state and a license application for the product has not been filed so we have taken no action on it. Mr. ROBERTS. No application for a license has actually been made?

33-262-643

Dr. MURRAY. That is correct. The proponents have stated that they believe it is subject to the Food and Drug Act and I understand they did submit a new-drug application.

Mr. ROBERTS. No application has been made so far as you know to the Division of Biological Standards for the issuance of a license? Dr. MURRAY. That is right. No license application has been filed. Mr. ROGERS of Florida. There are no substantive amendments; is that right?

Mr. ELLENBOGEN. We consider them all procedural. The only amendment that may have substantive implications is one which your committee included in the Harris-Kefauver amendments last year authorizing a summary suspension pending hearing where there is an imminent hazard to the public health.

I might say that that is also provided for in the regulations at present.

Mr. ROGERS of Florida. In your mind, who has the burden of proof on an appeal of this nature?

Mr. ELLENBOGEN. The appellant has the burden of showing that either the findings of fact of the Secretary are not supported by substantial evidence when considered on the record as a whole, or that there was some error of law.

Mr. ROGERS of Florida. Must the Secretary make a positive showing that the questions of fact are sustained by substantial evidence?

Mr. ELLENBOGEN. I think the burden is on the other side. Whoever appeals to an appellate court always has the burden of showing that the order from which he appeals is wrong, whether on the facts or on the law.

Mr. ROGERS of Florida. What, in your definition, is substantial evidence?

Mr. ELLENBOGEN. The bill refers to substantial evidence on the record as a whole. This phrase, or a similar one, is used in the Administrative Procedure Act and has been interpreted by the Supreme Court in the Universal Camera case. That case arose under the National Labor Relations Act but that decision, I think, is pertinent in answering your question, and there Justice Frankfurter explained that the term "substantial evidence on the record as a whole" does not permit the court to search the record for some isolated piece of evidence that might, in itself, be substantial and say that that supports the decision below. It must look at the record as a whole, and only if on that basis the evidence in support of the findings is substantial will the findings be sustained.

Mr. ROGERS of Florida. It is your understanding, then, that this law would allow the Court to determine facts, as such.

Mr. ELLENBOGEN. Not to substitute its own judgment for that of the factfinder below. This is a standard provision, requiring the court to determine whether on the record-looking at the whole record, both pro and con-it can be said that the evidence that supports the findings is substantial.

That much the Court would do on the facts, and I would say that under the National Labor Relations Act the Court has sometimes gone pretty far in upsetting decisions as not being supported by substantial evidence on the whole record.