activities will require the use of approximately 40,000 square feet of assignable space. If, by the time Module 1 is complete, the Agency has not been successful in locating suitable laboratory space for the Bureau of Medical Devices, an additional 22,150 square feet of laboratory space would be assigned to that Bureau as interim housing for their laboratory functions. This would permit further consolidation of FDA programs into one downtown location, since the Bureau of Medical Devices laboratory staff is now occupying space in the South Agriculture Building. Assuming that no other FDA space needs develop in the interim, the remaining 30,000 square feet of space that would have been vacated by the relocation of animal holding and associated laboratory functions to Module 1 would be turned back to GSA for reassignment to other agencies. Moreover, the relocation of animal studies to Module 1 will relieve overcrowding in the present animal support areas and permit more effective use of the building for other types of testing. Mr. WHITTEN. The January budget requested funds for construction of Module 2, but this item was deleted in the revised budget. Is Module 1 capable of fully functioning as a stand-alone facility? Doesn't this further disperse your Washington area laboratories and aggravate the management problems which you have testified about in the past?

Dr. NOVITCH. Each of the modules contained in the Agency's site development plan for the Beltsville property will be able to function as a stand-alone facility if that proves to be necessary. There are already some Bureau of Foods labs using experimental animals located on the land where Module 1 is to be built, so the construction of Module 1 will not further disperse our laboratory activities. Rather, it will concentrate more of our lab work with experimental animals at a single site.

The scheme of modular construction for the site was established in priority order, and the completion of Module 1 will solve our most urgent facility problems, even though it will not provide the centralization of laboratories we have sought. Of overriding consideration, however, is the fact that the new facilities will provide for safer, more efficient conduct of animal studies, with a higher degree of reliability.

Mr. WHITTEN. You discuss the reallocation of resources which is necessary to "reflect the ever-changing priorities of the FDA." Please provide a ten-year table showing the various Commissioners, Acting Commissioners, and Departmental Secretaries. To what extent does this history create, in and of itself, the "ever-changing" nature of FDA's priorities?

Dr. NOVITCH. While it's obviously true that changes in administration and leadership often result in reorderings of priorities or changes in organizational goals, the changing priorities referred to in the budget are not those driven or directed by any one individual. What is meant is the continuing need to change or alter priorities to provide optimal protection for the public health. And these considerations are those regarding changing patterns of product use by consumers, as well as the changing nature and numbers of products themselves. Also, our ever-expanding base of knowledge in science and technological advances in related equipment and instrumentation present new sets of considerations and ever-widen

ing parameters for action that condition present and future priorities. Natural disasters and accidents such as the eruption of Mt. St. Helens and the Three-Mile Island event also dictate unplanned reorderings of program priorities and resources dedicated to them. In summary, our budget is meant to convey the general dynamics of FDA programs, with their attendant problems and relative lack of reliable predictability.

I will submit a list of the Commissioners and Acting Commissioners of FDA, and the Secretaries of the Department of HHS during the past ten years.

[The information follows:]

Mr. WHITTEN. You state in the highlights of the explanatory notes that the agency is continuing two major efforts designed to limit the cost of necessary regulation. You then tell us about one of these efforts. What is the other one?

Dr. NOVITCH. The other effort that we have undertaken, and intend to expand, is in the area of small business. A one year pilot program has been extended for a second year, with FDA employees at four regional service desks helping small business to understand FDA rules, obtain information, and fill out applications and, on invitation, visiting small companies to discuss their concerns.

The regional service desk personnel are located in existing FDA offices in East Orange, New Jersey; Atlanta, Georgia; Chicago, Illinois; and Santa Ana, California. The desks in New Jersey and California deal only with medical devices, while the ones in Georgia and Illinois help businesses involved with drugs, foods, cosmetics, biologics, and radiation-emitting products.

The program is considered successful and well received, and will probably be expanded to the remaining regions when resources permit.

REDUCED PAY COST SUPPLEMENTAL

Mr. WHITTEN. It appears that FDA bore a disproportionate reduction in the requested pay cost supplemental for 1981. How was this reduction calculated, and how will you be able to bear a reduction of this magnitude?

Dr. NOVITCH. The directed savings in 1981, amounting to some $10.5 million, was determined to be FDA's fair share in the Administration's goal for reductions this year, but was not directed in its entirety at payroll savings. In fact, a majority of the savings were from other cost items, such as equipment and contracts. The sav

supplemental only as a convenience. The only alternative would have been a rescission request, which was not necessary in this

case.

PUBLIC LAW 480 FUNDS

Mr. WHITTEN. Under the revised budget you will be spending $100,000 in both 1981 and 1982 under the Public Law 480 program. Please describe how FDA's portion of Public Law 480 funds is determined, and describe the activities you will conduct under Public Law 480 in 1981 and 1982.

Dr. NOVITCH. FDA's portion of Public Law 480 funds is determined in the following manner. Once a year the operating components of FDA are asked to submit their requests for foreign travel, and to assign a priority rating to each. These requests are reviewed by the Director of the Special Foreign Currency Program and the Division of Financial Management. Those trips deemed of sufficient importance to be included in a realistic budget request are then submitted to the Department of Health and Human Services for approval.

Project officers of Public Law 480 funded projects are expected to make annual site visits to discuss with the Principal Investigator and staff, the progress of the research or other project-related activities and/or problems that might have arisen. Prior to approval and signing of a new Public Law 480 agreement, it is important to visit the person who would be responsible for doing the work in order to make certain that the facilities are adequate and the staff knowledgeable. Public Law 480 funds are also used to fund travel of FDA personnel to conduct various technical courses in Egypt requested by the Minister of Health, and to attend any symposia or conventions pertinent to FDA's mission.

ACCOUNTS OTHER THAN SALARIES AND EXPENSES

Mr. WHITTEN. In the revised budget for 1982, you are showing that the entire reduction is being taken out of Salaries and Expenses, with no reduction in the Parklawn Computer Center, the Fund for Certification, or advances and reimbursements. Why did you decide that these "overhead" functions should not participate in the reduction?

Dr. NOVITCH. These are not really "overhead" functions. FDA's operating budget, Salaries and Expenses, includes funds that are used to pay for ADP support provided by the Parklawn Computer Center, and some of those services will be curtailed. However, the Revolving Fund for Certification Services, and Advances and Reimbursements do not represent funds appropriated to FDA.

The Revolving Fund for Certification provides certification services to industry of the purity, potency, and safety of antibiotics, insulin, and colors as required by law. The costs are borne by fees from the manufacturers.

The positions shown in the budget for Advances and Reimbursements provide for staffing for the various sorts of services we provide to other governmental agencies. The cost of these services are reimbursed to us by the other agencies. If those agencies re

quire a lower level of support due to their own funding reductions, our expenditures for such services could decline proportionately.

EPA SUPPORT OF NCTR

Mr. WHITTEN. In the revised budget you do not anticipate any reduction in the amount of Environmental Protection Agency's support for the National Center for Toxicological Research in either 1981 or 1982. What assurances have you received from EPA that they intend to maintain the $5 million level of support, in light of their own budget reductions?

Mr. MEYER. We have received the $5.0 million from EPA for 1981, and we have been assured by various EPA staff members that a like amount will be transferred in 1982.

STATUTORY AUTHORITIES

Mr. WHITTEN. Under the revised budget the entire reduction is being borne in your activities conducted under the authority of the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. Why are there no reductions in your activities under the Fair Packaging and Labeling Act, the Import Milk Act, and the Import Tea Act?

Dr. NOVITCH. The Fair Packaging and Labeling Act, and the Import Milk and Tea Acts were not subjected to further reduction because they are already funded at minimal levels. To further reduce them would be to make them ineffective, or not meet pertinent legal mandates.

OBJECT CLASS TABLE

Mr. WHITTEN. You have given us a revised object class table, reflecting your recent reductions. Please submit this table for the record, adding two additional columns which will display the percent of decrease in both 1981 and 1982.