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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 National 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 this time.)

Mr. ROGERS of Florida. Also, there have been some suggestions I believe about the establishment of a scientific or research institute within Food and Drug. What is the statutes on this proposal?

Mr. JONES. This proposal calls for a Food and Drug Institute. If one reads the recommendations carefully, the Food and Drug Institute, as proposed, is essentially a vertical organization within the Food

a and Drug Administration of the activities that have to do with medicine and with science.

The general concept is quite sound. The Commissioner expects to follow the pattern fairly closely. We would concur strongly in this pattern.

Whether it will be called an institute or what the nomenclature will be of the exact pattern of organization is not clear at the moment, but generally it will follow the design as recommended and will effectively function with science having representation all the way up to the Commissioner.

Mr. ROGERS of Florida. When should this be affected ?

Mr. JONES. Just as soon as possible. It ought to be fairly quickly now.

Mr. ROGERS of Florida. Three months? Six months?
Mr. JONES. Oh, yes; undoubtedly so.

Mr. ROGERS of Florida. And would you let us have the details for the record ?

Mr. JONES. Yes, sir.
(The material follows:)




A reorganization of the Food and Drug Administration was announced today by Anthony J. Celebrezze, Secretary of Health, Education, and Welfare.

The reorganization adopts salient features from recommendations of the Second Citizens Advisory Committee on the Food and Drug Administration, which made its report in October 1962.

In making the announcement, Secretary Celebrezze said:

"An important feature of the reorganization is the upgrading of the scientific functions. I expect the reorganization to improve FDA operation all along the line, and thereby provide more effective protection of the consumers' interests.

“The reorganization will not entail the expenditure of additional funds. It adjusts existing functions and deploys the staff so that they will be able to operate more efficiently," the Secretary said.

George P. Larrick, Commissioner of Food and Drugs, made the following comment:

“The plan which has been approved by Secretary Celebrezze has been designed to modernize the structure of the Food and Drug Administration in the light of its new and growing responsibilities. It is a foundation for progressive strengthening of consumer protection in regard to foods, drugs, medical devices, cosmetics, and household chemical products over the next 10 years."

An important feature of the reorganization will be the appointment of a National Advisory Council to the Food and Drug Adminisrtation comprised of representative citizens under the chairmanship of the Commissioner of Food and Drugs. It will advise the Administration on national needs and the effectiveness of program policies.

A new Associate Commissioner, who will be a scientist, will give leadership from the Office of the Commissioner to the programs and functions having to do with medicine, science, and research.

Two new Bureaus with scientific activities are established-a Bureau of Scientific Research, supporting FDA's basic mission of consumer protection, and a Bureau of Scientific Standards and Evaluation, which will handle safety clearance functions in regard to pesticides, food additives and colors, and develop scientific data to be used in setting standards and tolerances. These Bureaus replace the present Bureau of Biological and Physical Sciences.

No change is contemplated in the present Bureau of Medicine, which has recently been reorganized to handle new responsibilties under the Kefauver-Harris Drug Amendments of 1962.

Enforcement activities will be consolidated in a single Bureau of Regulatory Compliance replacing in part the Bureau of Field Administration and the Bureau of Enforcement, which presently have divided enforcement responsibilities.

Educational functions of the Food and Drug Administration are emphasized in the creation of a new Bureau of Education and Voluntary Compliance. This will include the Division of Advisory Opinions, formerly in the Bureau of Enforcement, which answers industry inquiries on compliance problems. The Bureau will also include the Industry Education Branch, and the Consumer Education Branch and Consumer Inquiries Section from the present Division of Public Information, and the consumer consultant program now in the Office of the Commissioner. Press and public information services will be carried on by a new Office of Public Information.

All positions involved in the reorganization are in the career civil service. The following list released by Commissioner Larrick shows the organization units and top personnel of the Food and Drug Administration as they will be under the new plan: Commissioner of Food and Drugs, George P. Larrick, Deputy Commissioner, John L. Harvey. Associate Commissioner, to be appointed.

Special assistant to the Commissioner for National Advisory Council and
Special Projects, Dr. Kenneth L. Milstead.

Office of Public Information, W. F. Janssen, Director. .
Oflice of Federal-State Relations, James C. Pearson, Director.

Office of Emergency Preparedness, Dr. H. G. Underwood, Director.
Assistant Commissioner for Planning. Winton B. Rankin.
Assistant Commissioner for Science Resources, Dr. O. L. Kline.
Assistant Commissioner for Regulation, Malcolm R. Stephens.
Assistant Commissioner for Operations J. Kenneth Kirk.
Assistant Commissioner for Administration, Leo L. Miller.
Bureau of Medicine, Director to be appointed; Acting Director Ralph G.

Smith, M.D.
Bureau of Scientific Research, Director to be appointed; Deputy Director

Dr. Daniel Banes.
Bureau of Scientific Standards and Evaluation, R. S. Roe, Director.
Bureau of Regulatory Compliance, Allan E. Rayfield, Director.
Bureau of Education and Voluntary Compliance, Director to be appointed ;

Deputy Director Shelbey T. Grey. Mr. ROGERS of Florida. Of course, we have all read at some time some criticism of the administration of research project funds at NIH. Has your office played any role in evaluating the criticism and initiating new steps to correct any of this?

Mr. JONES. Yes. We have reviewed, with the responsible authorities in the Public Health Service and their bureau, the National Institutes of Health, their proposals for strengthening the administration of their grants program.

We have been able to make suggestions on their plans. We have been able to interpret these plans to some of the scientific community and we have followed this very closely. Personally, I am quite pleased with the method of management and the tightening of the management mechanism that has been evolved by the National Institutes of Health.

I might add that we are getting complaints from the scientific community as to some aspects of the tightened controls.

Mr. Rogers of Florida. Too much tightening?

Mr. Jones. Yes, this is a complaint. Personally, I think that the proposals that have been discussed pretty extensively throughout the country with the scientific community are justifiable and reasonable and I think properly administered. They will result in a net gain in the management of the NIH grants program without doing harm to the freedom of scientists or to their reasonable requirements for accountability.

The biggest problems, Mr. Rogers, center around whether or not there will be directed research.

In other words, inhibit the freedom of the scientist to determine what he should do.

Mr. ROGERS of Florida. In other words, you want certain research to follow certain lines?

Mr. Jones. The scientist wants to be free to follow leads from his original plan. All that is required where there is a major departure from the research for which the project was approved is that there be a report back to the NIH and a reapproval of the change of direction.

Mr. Rogers of Florida. You want the scientist to check with them?

Mr. Jones. Which is perfectly reasonable. The other thing has to do with the accountability of time of investigators. Research knows no barriers of time. Some of these scientists work all night or work on weekends and they were afraid that the restrictions of accountability pose undue hardship. I think here again the requirement that NIH is proposing that the time be accounted for after a quarter of a year has passed, reporting what part of the time was legitimately spent on research as supported by the project, are reasonable. I think they are beginning to understand that. Mr. ROGERS of Florida. I would agree with you 100 percent.

Rogers Mr. Jones. I think they have been more afraid of what might happen than what is likely to happen under these procedures.

I think there is understanding being achieved and I think that it is going to be a great help.

Mr. Rogers of Florida. About two more questions and then I will conclude. Of course, the bill before you vests the authority to reorganize the Public Health Service in the Surgeon Gene al?

Mr. Jones. With the approval of the Secretary, I believe.

Mr. Rogers of Florida. Yes. Is there any particular difficulty, do you feel, in vesting it in the Secretary or in the Surgeon General?

Mr. Jones. I think it is appropriate to vest it in the Surgeon General

Mr. Rogers of Florida. As approved by the Secretary!

Mr. Jones. As approved by the Secretary. This gives the Secretary all the authority he needs to be assured of

Nr. ROGERS of Florida. There is no objection by the Secretary to that?

Mr. Jones. No, sir.

Mr. ROGERS of Florida. Doesn't the President have authority to do this under the Reorganization Act?

Mr. JONES. Yes, he does.
Mr. Rogers of Florida. Is there any reason why he doesn't?

agree with

Mr. Jones. This was a matter of decision by the administration. It was decided that presenting a positive proposal to the Congress for full review under the jurisdiction of your Committee as you have given it would be preferable than to present a reorganization plan requiring action.

It calles for an active affirmative action instead of an active negative action on this particular matter. Mr. ROGERS of Florida. I must say I


100 percent there also. I think the Congress would feel that this is a proper effort to come before the committees and obtain the necessary legislation after going into it thoroughly.

Mr. Jones. The reorganization mechanism is a very effective one if there is a major overhaul and there is pretty good understanding of the whole background, as was true in the creation of the Department of Health, Education, and Welfare. But this time it represents something that your committee appropriately should have time to deliberate and not feel pressed by the 60-day limitation on action. This

was the thinking of the administration as I understand it.
Mr. ROGERS of Florida. Thank you.
Thank you, Mr. Chairman.
Mr. ROBERTS. Thank you, Mr. Rogers.

, Two quick questions. I realize you couldn't possibly conduct a dayto-day review of the operations of the two agencies, but do you have a plan of evaluating the effectiveness of the two agencies in administering the laws which they are supposed to carry out?

Mr. Jones. Mr. Chairman, this is a continuing responsibility. It is hard to respond directly except to say this is a responsibility of the Secretary which he expects to exercise and does in the normal contact with the operating agencies.

I think it is very important to say that neither I nor others in the Office of the Secretary, become involved in the direct operations of the agencies.

Except where there are problems or except where we see the need for some change. It is the function of the Office of Secretary primarily to see that the policies are properly implemented and designed.

Mr. ROBERTS. Maybe we can pin it down this way: Do you ask questions on your own, or does the Secretary refer specific questions to you, or do the agencies come to you for approval of policies?

Mr. Jones. All three; there is no restriction on how a problem comes into evidence.

We would like to think that we, ourselves, watch the operations closely enough to identify problems in time to get action on them.

This isn't feasible and possible always. I will give you one illustration. At the time we were considering and then proposed the new Institute of Child Health and Human Development, there immediately arose a question of duplication with some of the activity of the Children's Bureau in the Welfare Administration.

Mr. ROBERTS. I remember that.

Mr. Jones. So we moved in immediately and provided, by consultation between representatives of the respective agencies, a method of coordination which would avoid such duplication.

This is the kind of activity that we feel obligated to perform, and do as we are able to do so.

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