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AGRICULTURE, RURAL DEVELOPMENT AND
RELATED AGENCIES APPROPRIATIONS
FOR 1982

HEARINGS

BEFORE A

SUBCOMMITTEE OF THE

COMMITTEE ON APPROPRIATIONS
HOUSE OF REPRESENTATIVES

NINETY-SEVENTH CONGRESS
FIRST SESSION

SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT AND
RELATED AGENCIES

JAMIE L. WHITTEN, Mississippi, Chairman
BOB TRAXLER, Michigan VIRGINIA SMITH, Nebraska

BILL ALEXANDER, Arkansas J. KENNETH ROBINSON, Virginia

MATTHEW F. McHUGH, New York JOHN T. MYERS, Indiana

WILLIAM H. NATCHER, Kentucky JERRY LEWIS, California

JACK HIGHTOWER, Texas
DANIEL K AKAKA, Hawaii
WES WATKINS, Oklahoma

Robert B. Foster, Staff Assistant

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COMMITTEE ON APPROPRIATIONS

JAMIE L. WHITTEN,

EDWARD P. BO LAND, Massachusetts

WILLIAM H. NATCHER, Kentucky

NEAL SMITH, Iowa

JOSEPH P. ADDABBO, New York

CLARENCE D. LONG, Maryland

SIDNEY R. YATES, Illinois

DAVID R. OBEY, Wisconsin

EDWARD R. ROYBAL, California

LOUIS STOKES, Ohio

TOM BEVILL, Alabama

BILL CHAPPELL, Florida

BILL ALEXANDER, Arkansas

JOHN P. MURTHA, Pennsylvania

BOB TRAXLER, Michigan

JOSEPH D. EARLY, Massachusetts

CHARLES WILSON, Texas

LINDY (MRS. HALE) BOGGS, Louisiana

ADAM BENJAMIN, Jr., Indiana

NORMAN D. DICKS, Washington

MATTHEW F. McHUGH, New York

BO GINN, Georgia

WILLIAM LEHMAN, Florida

JACK HIGHTOWER, Texas

MARTIN OLAV SABO, Minnesota

JULIAN C. DLXON, California

VIC FAZIO, California

W. G. (BILL) HEFNER, North Carolina

LES AuCOIN, Oregon

DANIEL K. AKAKA, Hawaii

WES WATKINS, Oklahoma

WILLIAM H. GRAY, III, Pennsylvania

BERNARD J. DWYER, New Jersey

Mississippi, Chairman

SILVIO O. CONTE, Massachusetts
JOSEPH M. McDADE, Pennsylvania
JACK EDWARDS, Alabama
JOHN T. MYERS, Indiana
J. KENNETH ROBINSON, Virginia
CLARENCE E. MILLER, Ohio
LAWRENCE COUGHLIN, Pennsylvania
C. W. BILL YOUNG, Florida
JACK F. KEMP, New York
RALPH S. REGULA, Ohio
CLAIR W. BURGENER, California
GEORGE M. O'BRIEN, Illinois
VIRGINIA SMITH, Nebraska
ELDON RUDD, Arizona
CARL D. PURSELL, Michigan
MICKEY EDWARDS, Oklahoma
BOB LIVINGSTON, Louisiana
BILL GREEN, New York
TOM LOEFFLER, Texas
JERRY LEWIS, California
CARROLL A. CAMPBELL, Jr.,

South Carolina
JOHN EDWARD PORTER, Illinois

Keith F. Mainland, Clerk and Staff Director (n>

AGRICULTURE, RURAL DEVELOPMENT AND RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 1982

Wednesday, March 18, 1981.
FOOD AND DRUG ADMINISTRATION
WITNESSES

CHARLES MILLER, ACTING ASSISTANT SECRETARY FOR HEALTH, PHS/
HHS

MARK NOVITCH, M.D.. ACTING COMMISSIONER OF FOOD AND DRUGS JEFFREY B. SPRINGER, ACTING CHIEF COUNSEL, FOOD AND DRUG ADMINISTRATION

GERALD F. MEYER, ASSOCIATE COMMISSIONER FOR MANAGEMENT AND OPERATIONS, FDA

FRANK P. CLAUNTS, DIRECTOR, DIVISION OF FINANCIAL MANAGEMENT, FDA

ELLEN F. WORMSER, DIRECTOR, DIVISION OF HEALTH BUDGET ANALYSIS. OS/HHS

GERALD B. GUEST, D.V.M., ACTING DIRECTOR, BUREAU OF VETERINARY MEDICINE, FDA

CALL TO ORDER

Mr. Whttten. We have before us today Dr. Mark Novitch and his associates in the Food and Drug Administration, accompanied by Mr. Miller, the Acting Assistant Secretary for Health.

We are glad to have all of you here, and to see that the former Deputy Commissioner still attends our hearings. We do not get into the habit of it, but now and then we are fortunate enough to give someone downtown a nickname—Mr. Zero Gardner. He changed the definition of zero. I never did understand it. I don't know how a zero can be changed.

We are glad to have you with us. Dr. Novitch, we would be glad to have you present your associates who are new to the subcommittee, and we will put your biographical sketches in the record at this point.

[The information follows:]

Department Of Health And Human ServicesBiographical Sketch Name: Charles Miller H.

Position: Acting Assistant Secretary for Health.

Birthplace and date: Philadelphia, Pennsylvania, November 22, 1923.

Education: BA, Princeton University 1947, Major, History; MA, University of Pennsylvania 1948, Major, Political Science.

Honors: Graduated Cum Laude from Princeton, 1947; elected to National Social Science Honor Society (Pi Gamma Mu) 1948; Superior Service Award, DHEW, 1964; Quality Salary Increase, November 1968; Distinguished Service Award, April 1972;

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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.

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

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 Economics of Drug Innovation, American University, 1970.

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.

Ovennedication: 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 Present— Acting 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
AdministrationBiographical 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

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