Secretary's Special Citations, January 1973, August 1975, and December 1976; President's Distinguished Executive Award (Senior Executive Service) $20,000, 1980.

Military Service: 1943-1946, U.S. Army, 2nd Lieutenant.

Experience:

1/81-Pres. Acting Assistant Secretary for Health

4/78-1/81 Deputy Assistant Secretary for Health Operations

3/77-4/78 Deputy Assistant Secretary for Financial Management

4/74-3/77 Deputy Assistant Secretary, Comptroller

1970-1074 Deputy Assistant Secretary, Budget

1969-1970 Director, Division of Budget, Office of the Secretary, DHEW

1968-1969 Director, Office of Financial Management, Health Services and Mental Health Administration, DHEW

1967-1968 Director of Finance, Public Health Service, DHEW

1965-1967 Chief, Financial Management Branch, National Institutes of Health, DHEW

1960-1965 Chief, Management Policy Branch, National Institutes of Health, DHEW

1958-1960 Assistant to Assistant Secretary for Administration, DHEW 1950-1958 Management Analyst, Social Security Administration, DHEW.

CURRICULUM VITAE-MARK NOVITCH, M.D.

Personal Data: Born: April 23, 1932, New London, Connecticut; Married: October 9, 1971, to Katherine Louise Henderson.

Education and Professional Activities:

1946-50 Bulkeley School, New London, Connecticut

1950-54: Yale University, New Haven, Connecticut; A.B., June 7, 1954.

1954-58: New York Medical College, Flower and Fifth Avenue Hospitals, New York, N.Y.; M.D., May 27, 1958.

1958-60: Intern (58-59), and Assistant Resident in Medicine (59-60), Fifth and Sixth Medical Services, Boston City Hospital, Boston, Massachusetts.

1960-67: Research Fellow (60-62), Assistant in Medicine (62–64), and Instructor in Medicine (64-67), Harvard Medical School, Boston.

Assistant in Medicine (60-82) and Junior Associate in Medicine (62-67), Peter Bent Brigham Hospital, Boston.

ty.

1961-67: Assistant Physician to the University Health Services, Harvard Universi

1963-67: Private practice of Medicine, Cambridge, Massachusetts.

1963-67: Attending Physician, U.S. Veterans Administration Hospital, West Roxbury, Massachusetts.

1967-70: Assistant to the Deputy Assistant Secretary for Health and Scientific Affairs, and Assistant Staff Director, Task Force on Prescription Drugs, Department of Health, Education, and Welfare.

1970-71: Federal Executive Fellow, Brookings Institution, Washington, D.C.

1971-78: Deputy Associate Commissioner for Medical Affairs, Food and Drug Administration, HEW.

1978-present: Associate Commissioner for Health Affairs, Food and Drug Administration.

1979-81: Acting Deputy Commissioner of Food and Drugs. 1981-present: Acting Commissioner of Food and Drugs.

Memberships: American Public Health Association, Massachusetts Medical Society, United States Pharmacopeial Convention (Delegate-at-large 1980-85).

Civic activities:

1968-70: Volunteer physician, Medical Clinic, Walter Reed Army Medical Center, Washington, D.C.

1976-78: Chairman, Economic Development Committee, Advisory Neighborhood Commission, 3F, District of Columbia.

Medical licensure: Massachusetts, California, District of Columbia.

Awards and grants: U.S. Public Health Service Fellowship, 1960-62, Secretary's Special Citation, U.S. Department of Health, Education, and Welfare, 1968 and 1975; Commissioner's Special Citation, Food and Drug Administration, 1977; Award of Merit, Food and Drug Administration, 1979; and Presidential Meritorious Executive Award, 1980.

Publications:

Pharmacy and the Task Force on Prescription Drugs. Journal of the American Pharmaceutical Association, Vol. NS9, No. 1, p. 27, 1969 (excerpts).

Images of the Drug Scene: The Executive Branch View in Cooper J: The Econom

Experiences of the HEW Task Force on Prescription Drugs. Proceedings of the Symposium on Physicological Equivalence of Drug Dosage Forms, Canadian Food and Drug Directorate, 1970.

Overmedication: International Perspectives. Hospital Formulary Management, Vol. 8, No. 8, August 1973.

OTC Review: An Update, FDA Consumer, Vol. 8, No. 4, May 1974, pp. 12-18. Looking Beyond Drug Payment, Wertheimer, A. I., and Schubert, M. L. eds., Perspectives in Pharmacy, University of Minnesota, 1976.

The FDA Outlook. Medical Dimensions, Vol. 7, No. 5, May 1978, p. 27.

What the FDA Can Do to Help Hospitals Improve Antibiotic Usage, in Kunin, CM, Ed.: Practical Aspects of Antibiotic Review, Atlanta: American Health Consultants, 1979; pp. 81-87.

Food and Drug Administration Report. Association of Food and Drug Officials Quarterly Bulletin, Vol. 44, No. 4, October 1980, pp. 192–96.

Health Services and Pharmaceuticals: A United States Perspective. Proceedings of the Second International Congress of Pharmacy Education, American Association of Colleges of Pharmacy. (In Press)

Flight into the Eighties. Journal of the National Pharmaceutical Association, Vol. 26, No. 2 Fall 1980, p. 12.

The FDA and Cosmetics: Looking to the 1980s. CTFA Cosmetic Journal, Vol. 12, No. 4, Oct-Dec 1980, pp. 7-9.

Harter, J. G., and Novitch, M.:

Use of ACTH with Every-Other-Day Steroids. Journal of Allergy, Vol. 36, p. 209, 1965 (abstract).

Evaluation of Steroid Analogs in Terms of Suitability for Use in Alternate Day Steroid Therapy. Journal of Allergy, Vol. 37, p. 108, 1966.

DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG
ADMINISTRATION-BIOGRAPHICAL SKETCH

Name: Jeffrey B. Springer.

Position: Acting Chief Counsel, Food and Drug Administration.

Birthplace and date: Farragut, Idaho, June 28, 1943.

Education: Georgetown University Law Center, Washington, D.C.; J.D., 1968; and
George Washington University, Washington, D.C.; B.A. (History) 1965.
Bar membership: District of Columbia (1968); Maryland (1968).

Honors and awards: Food and Drug Administration-Commendable Service Award (1975, 1978); and George Washington University Scholarship.

Experience: Department of Health and Human Services, Office of the Secretary, Office of the General Counsel, Food and Drug Division: January, 1981 to PresentActing Chief Counsel; August 1978 to January 1981-Deputy Chief Counsel; May 1975 to August 1978-Deputy Chief Counsel for Regulations and Hearings; June 1973 to May 1975–Special Assistant to the Chief Counsel; October 1968 to June 1973-Trial Attorney.

DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD and Drug

ADMINISTRATION-BIOGRAPHICAL SKETCH

Name: Gerald F. Meyer.

Position: Associate Commissioner for Management and Operations, Food and Drug Administration.

Birthplace and date: Maquoketa, Iowa, September 16, 1936.

Education: June, 1958, B.S., cum laude, Commerce, University of Notre Dame, South Bend, Indiana.

Honors and awards: Senior Executive Service Performance Award-1980; Food and Drug Administration-Award of Merit, May 31, 1973; DHEW Superior Performance Award-May 28, 1968.

Experience: April 1979 to Present, Associate Commissioner for Management and Operations, Food and Drug Administration; 1978 to 1979, President, Microbiological Associates, a Division of the Wittaker Corporation, Bethesda, Maryland; 1973 to 1978-Associate Commissioner for Management and operations, FDA; 1972 to 1973-Director, Office of Legislative Services, Food and Drug Administration; 1971 to 1972-Chief, Health Branch, Division of Budget, Office of the Secretary, Department of Health, Education and Welfare; 1969 to 1971-Clerk to the Minority, Appropriations Committee, U.S. House of Representatives; 1964 to 1969-Administrative Officer, Etiology Research Program directed at the Cause and Prevention of Cancer, National Cancer Institute; 1962 to 1964—Administrative Officer, National

Institutes of Health, Research Program in West Africa undertaken to assist the Government of Ghana develop its first medical school; 1960 to 1961-Budget Analyst, National Cancer Institute; 1958 to 1960-Management Intern, National Institutes of Health, (Interrupted for six months military duty); 1958—U.S. Army National Guard-six months active duty; Summers of 1954, 1955, 1956, Refugee Relief Program, Department of State.

DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD and Drug

ADMINISTRATION-BIOGRAPHICAL SKETCH

Name: Frank P. Claunts.

Position: Director, Division of Financial Management, Office of the Associate Commissioner for Management and Operations.

Birthplace and date: Bartlesville, Oklahoma, September 5, 1942.

Education: Bachelor of Arts, Texas Tech, June, 1964; and Master of Business Administration, American University, May, 1975.

Honors and awards: Food and Drug Administration Commendable Service Award, 1980; Quality Increases in 1975, 1973, and 1971; "Distinction" on MBA Comprehensive Exams in 1975; Special College Leadership Award at Texas Tech in 1964. Experience: July 1980 to Present, Director, Division of Financial Management, Food and Drug Administration; September 1977-June 1980, Director, Division of Management Services, Food and Drug Administration; July-September, 1977, Special Assistant to the Associate Commissioner for Management and Operations, Food and Drug Administration; August 1976-June 1977, Legislative Analyst, Office of Management and Budget; July 1972-August 1976, Management Analyst, Food and Drug Administration; June 1971-May 1972, State Director of the Peace Corps in Bihar, India; July 1969-June 1971, India Desk Officer, Peace Corps, Washington, D.C.; September 1966-July 1969, Peace Corps Field Officer in north-eastern India; June 1964-June 1966, Peace Corps Volunteer, Tripura, India.

GERALD B. GUEST, D.V.M.

Position: Acting Director, Bureau of Veterinary Medicine, Food & Drug Administration.

Date and place of birth: July 20, 1936. Hart County, Georgia.

Education: D.V.M.-University of Georgia-1960; Two years-University of Georgia, School of Agriculture-No degree.

Employment:

1. Private practice, Veterinary Medicine, Carrollton, Georgia, 1960.

2. Field Veterinarian, USDA, Wytheville, Virginia, September 1963-February 1966.

3. Visiting Scientist, National Animal Disease Laboratory, Ames, Iowa, Diagnostic Virology, February 1966-April 1966.

4. Epidemiologist, USDA assigned to the Department of Virology, Institute for Medical Reseach, Camden, New Jersey, April 1966-February 1968

5. Epidemiologist, USDA assigned to the University of Pennsylvania School of Veterinary Medicine, Viral Oncology Section, Research Instructor in Microbiology in Medicine, February 1968 to May 1970.

6. Veterinary Medical Officer, Food and Drug Administration Division of Veterinary Medical Review, Surveillance Branch, Rockville, Maryland, May 1970-August 1970.

7. Advisor on Animal Foods Safety, Div. of Veterinary Medical Review, Bureau of Veterinary Medicine, Food & Drug Administration, U.S. Dept. of Health, Education & Welfare, Rockville, Md. August 1970 to July 1972.

8. Special Assistant to the Director, Bureau of Veterinary Medicine, Food and Drug Administration, Rockville, Md., July 1972 to January 1977.

9. Acting Director, Division of Swine and Minor Species, Bureau of Veterinary Medicine, Food and Drug Administration, Rockville, Maryland, January 1977 to September 1977.

10. Acting Associate Director for Scientific Evaluation, Bureau of Veterinary Medicine, Food and Drug Administration, Rockville, Md., September 1977-February 1979.

11. Director, Division of Drugs for Non-Food Animals, Bureau of Veterinary Medicine, Food and Drug Administration, Rockville, Md., February 1979-July 1979. 12. Associate Director for Human Food Safety, Bureau of Veterinary Medicine,

13. Acting Director, Bureau of Veterinary Medicine, Food and Drug Administration, Rockville, Md., August 1980-Present.

Publications:

1. Evidence in support of Virus Etiology for Bovine Leukemia, Dutcher, R. M., Larkin, E. P., Tumilowicz, J. J., Nazerian, K., Eusebio, C. P., Stock, N. D., Guest, G. B., and Marshak, R. R. Cancer 20: 851-856, 1967.

2. Two Types of Virus-Like Particles Found in a Transplantable Rat Mammary Carcinoma. Engle, G. C., Shirahama, S., Guest, G. B., Larkin, E. P., and Dutcher, R. M., presented American Society of Microbiologist Meeting, May 1969.

3. Electron Microscopic Studies on Tissue Cultured Cells and Density Gradient Fractions of a Transplantable Rat Mammary Carcinoma. Shirahama, S., Engle, G. D., Guest, G. B., Larkin, E. P., Dutcher, R. M., Oncology, 24: 98-107, 1970.

4. Further Characterization of Bovine Leukemic Cell Culture, Lin, P. S., Guest G. B., Stock, N. D., Dutcher, R. M., and Hare, W. C. D. IVth International Symposium on Comparative Leukemia Research, 1969.

5. Comparative Studies on Monolayer and Suspension Cell Cultures from a Transplantable Rat Mammary Carcinoma Containing C-Type Virus Particles. Guest G. B., Lin, P. S., Stock, N. D., Dutcher, R. M., and Engle, G. C. Oncology, 25: 104-118, 1971. 6. Electron Microscopic Studies on C-Type Particles in Phytohemagglutinin Treated Buffy Coat Cultures of Bovine Origin. Stock, N. D., and Guest G. B., Meeting of the American Cancer Society, Chicago, April 1971.

7. Electron Microscopic and Immunological Studies on Short and Long Term Cultures of Peripheral Blood Leukocytes from Leukemic Cattle. Ferrer, J. F., Avila, L., Stock, N. D., Lin, P. S., and Guest G. B., the V International Symposium on Comparative Leukemia Research, 1971.

8. Dishing Up and Dog Food. McHenry, S. L., and Guest G. B., FDA Consumer 2527, Feb., 1973.

9. Use of Drugs in Feeds. Guest G. B., Food, Drug, & Cosmetic Law Journal, 29, No. 1, January, 1974.

10. Status of FDA's Program on the Use of Antibiotics in Animal Feeds. Guest G. B., Journal of Animal Science, Vol. 42, No. 4, 1976.

11. Antibiotics in Animal Feeds: Current Status. Guest G. B., Food, Drug, & Cosmetic Law Journal, 32, No. 1, January, 1977.

Honors and awards: Academic scholarship, 1954 & 1955; Nominated Blue Key Honor Society, 1959, University of Georgia; Society of Phi Zeta, University of Pennsylvania; Commissioner's Special Commendable Service Award (1977); Commissioner's Special Citation (1978); Outstanding Performance Rating (1978); Nominated for Meritorious Senior Executive Award, 1980.

Membership in other organizations: Alpha Psi, University of Georgia, President, 1959; American Veterinary Medical Association, U.S. Animal Health Association, National Association of Federal Veterinarians, American Association of Food Hygiene Veterinarians.

Mr. WHITTEN. We are glad to have you here at this time. We have read of numerous changes that have gone on and various statements that have been made. When a new administration comes in, this usually happens. Therefore, we have considerable interest in your presentation today. You may proceed in such a way as you may wish.

INTRODUCTION OF WITNESSES

Dr. NOVITCH. Thank you, Mr. Chairman.

First, I would like to introduce my colleagues at the table. On the far right is Ellen Wormser, Director, Division of Health Budget Analysis; on her left is Charles Miller, Acting Assistant Secretary for Health. On my right is Jeffrey Springer, the Acting General Counsel of FDA. On my left is Gerald Meyer. He is not Acting; he is the permanent Associate Commissioner of Management and Operations at FDA, and on his left is Frank Claunts, Director of our Division of Financial Management.

STATEMENT OF DR. NOVITCH

Mr. Chairman, I do have a statement that is of some length and I would like to submit it for the record.

Mr. WHITTEN. We would be glad to have you do so.

[CLERK'S NOTE.-The full text of Dr. Novitch's statement appears on pages 376 through 394. Mr. Miller's statement appears on pages 395 through 397. The explanatory notes appear on pages 398 through 675.]

Mr. WHITTEN. In view of the interest this committee has in the activities of your agency, we would be pleased to have you cover the high points rather thoroughly.

Dr. NOVITCH. That is what I would like to do.

OVERVIEW OF FDA

It has been some time since the Committee has been presented with a broad overview of FDA. With the help of some charts, Mr. Chairman, I would like to briefly go through FDA's mission and organization. I think it might be of particular help to the new members of the Committee. The first chart depicts the broad array of products for which FDA is responsible. People naturally associate the Food and Drug Administration with foods and drugs, but there are other products that come as a surprise to most folks.

Starting with foods, we have the responsibility for making sure that foods are produced and stored under sanitary conditions; that they are free of unacceptable biological contamination; that they are free of chemical contaminants and pesticides; and that they are properly labeled.

We also evaluate food additives to make sure they are safe for