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Dr. GODDARD. As you know, you did request a report be submitted to the committee. Such a report has been provided the Department for its study prior to submission to the committee.

Do you want to comment on that?

Mr. CARDWELL. That is true. With Dr. Goddard having been in office just a short while, and with the possibility of some organizational changes still in sight, the Secretary would like to have some time to review and discuss this document with Dr. Goddard before presenting it to the committee, but he will present it to the committee prior to completion of your hearings and deliberations in time for a bill.

The amount of money provided in the budget is for an additional research facility, and the issue of where it might be located can still be discussed, and it will be discussed with the committee when we come forward with the paper.

The point in the budget is that the additional facility is needed. Dr. GODDARD. I have reviewed that, and it is.

Mr. FOGARTY. I don't think there is any question about that. The building you are in now is not half big enough.

Dr. GODDARD. We are also scattered around a number of facilities. I think we are in about five locations around town.

There is no question that to meet these added workloads we will have to have additional scientific laboratories to do the job.

Mr. FOGARTY. You were caught in a bind there in the leasepurchase problem. That held it up 3 or 4 years, did it not? Mr. CARDWELL. That is right, sir.

Mr. FOGARTY. It was really not your fault at the time, but so far as the planning of it is concerned and the square footage, that was your responsibility and not that of Congress.

Mr. CARDWELL. There were limitations on that site, though. The site is on a small city block and there were restrictions.

Mr. FOGARTY. Mr. Shriver?

SALARIES AND EXPENSES INCREASE

Mr. SHRIVER. In the "Salaries and expenses" on page 5 of the justifications, salaries for 1967 are estimated at $63,454,000. The 1965 comparable amount was $40,368,000, an increase of $23 million in 1965 compared with 1967, a 57-percent increase.

Dr. GODDARD. Yes.

Mr. SHRIVER. What is that increase for? Is it mostly new people? Dr. GODDARD. New personnel, the addition of persons to meet the responsibilities of the Drug Abuse Control Act, to speed up our review of scientific applications.

Mr. SHRIVER. What is the increase? How many additional people? Dr. GODDARD. A little over 1,100.

Mr. SHRIVER. Where do you expect to get that many trained people, or will you train them yourselves?

Dr. GODDARD. Some we will train. I can tell you as an example of availability of these kinds of personnel that we have 900 applications pending for some 270 positions in the drug abuse control program. Mr. SHRIVER. Where are they now working, in the States? Dr. GODDARD. Either in the States, in segments of industry. Mr. SHRIVER. Working for Government in the States? Dr. GODDARD. I am not aware. I have not reviewed that.

Mr. RANKIN. Many of them are.

Mr. SHRIVER. What will they do when you raid them?

Mr. CARDWELL. Many are still in college. Recruitment under this program would be done under a Civil Service Commission examination. It would be a national examination. We draw from a large reservoir there.

There would be students graduating from college coming into the pipeline for the first time, pipeline of employment. There would be persons from the pharmaceutical industry, and even in the case of auditors from the business world

Dr. GODDARD. As well as Federal agencies.

Mr. CARDWELL. That is right, as well as other Government agencies. The burden on any one element of our society perhaps should not be too great.

TYPES OF TRAINING PROGRAMS

Mr. SHRIVER. What kind of training program do you have?

Dr. GODDARD. This depends on which particular category we are recruiting for. There are two major activities underway-one in Rhode Island for food and drug inspectors and one in California at the University of California in Berkeley which is a special training program for the investigators working under the drug abuse control activity. Mr. SHRIVER. How long a program?

Dr. GODDARD. Twelve-week training program starting today.
Mr. SHRIVER. And the one in Rhode Island?

Dr. GODDARD. Three-week program for the Food and Drug inspectors.

INCREASE IN TRAVEL

Mr. SHRIVER. The budget also indicates a $1 million increase in travel in this same period of time I referred to. What accounts for that increase in travel?

Dr. GODDARD. Increased workload is the main relationship here. Mr. SPARER. A lot is related to the inspector's workload. An inspector travels 30 to 40 percent of the time.

Dr. GODDARD. With more people on the payroll there is more travel required.

RELATION OF OTHER COSTS TO STAFF EXPANSION

Mr. SHRIVER. And your rents and communications and utilities are up about three times what they were.

The same thing would be true of that, I suppose?

Mr. SPARER. Compared with 1965?

Mr. SHRIVER. Yes.

Mr. SPARER. Again this is for the most part related directly to staff expansion.

Mr. SHRIVER. If you were comparing from 1960, appropriation for salaries and expenses, it would be about five times.

Dr. GODDARD. That is right.

Mr. CARDWELL. One point should be made about the Food and Drug Administration. The very nature of its work and organization is that it relies on communications, communications in the form of inspectors traveling by car or by common carrier from one inspection point to another. The purchase of samples is involved, shipment

back to the point of examination, then back to a laboratory, the exchange of information, whether the sample was in violation of the law or not, communication going out to an inspector to seize a product, and so forth. It is a very heavy user of travel and other forms of communication by the very nature of its business.

Mr. SHRIVER. As I look this over, it is true in printing and reproduction, other services, the whole realm has increased from three to five times over 1960, and it will continue to increase?

Mr. CARDWELL. Yes, sir. The agency grew from 877 employees in 1954 to over 4,000 today. Its programs have grown tremendously. The number of new laws assigned to the Food and Drug Administration in the last 10 years would go up by 10 times perhaps.

PUBLIC KNOWLEDGE OF FOOD AND DRUG ADMINISTRATION

Mr. FLOOD. How are you accepted by the general public, by the man in the street? Are you respectable? Does he know about you? Are you an organization of integrity? How does the average citizen look upon you?

Dr. GODDARD. My knowledge of this tells me that the average citizen looks to us for his protection and if he can purchase a product then the Food and Drug Administration must have determined it was safe. He places great reliance on the agency and its activities. Mr. FOGARTY. I don't think that is an answer to Mr. Flood's question.

I know what the answer is. The average person doesn't know what the Food and Drug Administration does.

Mr. FLOOD. That is what I am concerned about.

Mr. FOGARTY. They have almost no citizens' committees in the country that inform the people that there is a Food and Drug Administration, such as the American Heart Association, the American Cancer Society, and so forth, in other areas.

The consumer groups are not organized, either.

Dr. GODDARD. I refer to a more general sense, that people have the feeling that the Government has determined that this product is good, but they don't necessarily know about the Administration.

Mr. FOGARTY. If you stop 10 people on the street, 9 would not even know this Administration exists. The main reason is that you do not have citizens groups talking about what you are doing. You cannot do it yourself, unless you get in the headlines because you closed down some pharmaceutical manufacturers, or something like that or the thalidomide incident.

Dr. GODDARD. This did a great deal in raising the confidence of the public, which is why I responded as I did, and also the controversy over the birth control pills, and the pesticide problem with foods. I am sure you are right, we can walk across the street, in Providence or my hometown of Atlanta, and find the same problem, people not knowing what the Food and Drug Administration does.

Mr. FOGARTY. Any other questions?

Thank you very much.

Dr. GODDARD. Thank you, sir.

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1966 enacted appropriation__ Unobligated balance lapsing.

Summary of changes

Transferred to operating expenses, PBS, GSA, for rent.

Total estimated obligations, 1966.

1967 estimated obligations..

Total change.

$53, 079, 000 -60, 000 -140, 000

52, 879, 000 63, 454, 000

+10, 575, 000

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1. Annualization of 406 new positions authorized in 1966 for
part of year under regular appropriation... –

2. Annualization of 269 new positions authorized in 1966 for
part of year under the drug abuse supplemental..
3. Full-year cost of rental space to be occupied in 1966.
4. Full-year cost of 1965 Pay Act...

Subtotal, mandatory increases.

$1, 130, 200

12, 006, 400 497, 000

452, 000

4, 085, 600

1 This increase is required to annualize the position plus support items such as informer fees, sample purchases and investigator pay differential which were budgeted for only of fiscal year 1966, but must be annualized for all of fiscal year 1967.

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Decreases: Nonrecurring expenses related to new programs in fiscal year 1966.
Transfer of mail and messenger service...

Total net change requested..

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Medical evaluation

EXPLANATION OF CHANGES

An increase of 42 positions and $597,000 is proposed to enable FDA to process, on a more timely basis, investigational new drug applications and new drug applications in both the human and veterinary areas. This workload also ineludes supplements and amendments to these applications, as well as the processing of progress reports on such applications. An increase of 31 positions and $312,000 are proposed for medical review including regulatory support, drug surveillance, and evaluation of medical advertising and devices. An increase of four positions and $41,000 are proposed to implement the Drug Abuse Control Amendments of 1965. Fifty-five positions and $1,078,000 are proposed to expand the medical information and communication programs with emphasis on the adverse reaction reporting program, the medical reference service, and implementation of the medical information subsystems which are part of the science information facility. Thirty-one positions and $507,500 are proposed to provide resources for a professional development program, staffing of medical advisory committees, administrative management and supports increased emphasis on review and revision of medical regulations, an expanded program of coordination with the drug industry, and a cooperative research program to support clinical investigations of drugs. Research

FDA's scientific research activity, composed of intramural research and cooperative extramural research programs, will be expanded primarily in the food and drug fields. Thirty-one positions and $404,600 would be used for research programs on normal constituent and natural contaminants of foods, research on pesticides and food additives, hazards in foods and for new research programs seeking novel approaches to scientific problems in this area. There will be an

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