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DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

FOOD AND DRUG ADMINISTRATION

General and special funds:

SALARIES AND EXPENSES

For necessary expenses not otherwise provided for, of the Food and Drug Administration, including reporting and illustrating the results of investigations; purchase of chemicals, apparatus, and scientific equipment; payment in advance for special tests and analyses and adverse reaction reporting by contract; payment of fees, travel, and per diem in connection with studies of new developments pertinent to food and drug enforcement operations; compensation of informers; payment for publication of technical and informational materials in professional and trade journals; and rental of special purpose space in the District of Columbia or elsewhere; [$35,805,000] $39,500,000. (Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301-392); the Tea Importation Act, as amended (21 U.S.C. 41-50); the Import Milk Act (21 U.S.C. 141-149); the Federal Caustic Poison Act (15 U.S.C. 401-411); the Filled Milk Act, as amended (21 U.S.C. 61-64); and the Federal Hazardous Substances Labeling Act (15 U.S.C. 401); Department of Health, Education, and Welfare Appropriation Act, 1964.)

Program and Financing (in thousands of dollars)

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Selected resources as of June 30 are as follows: Unpaid undelivered orders, 1962, $2,181 thousand (1963 adjustments. -$91 thousand); 1963, $1,741 thousand; 1964, $1,741 thousand; 1965, $1,741 thousand.

The laws enforced hereunder are designed to protect consumers against adulterated and misbranded foods, drugs, cosmetics, therapeutic devices, and household products containing hazardous substances.

The 1965 estimate provides for an increase of 12% in the number of man-years available to carry out the responsibilities for consumer protection vested in the Food

and Drug Administration. This continues the program of increasing and strengthening the agency's resources to cope with increased responsibilities due to industrial, economic, technological and population growth. The 1965 increase specifically provides for additional resources to implement the Drug Amendments of 1962. Other major increases are to provide additional resources and competences for medical and other scientific activities of the agency.

1. Field inspections, investigations, and laboratory analyses. Inspections of domestic plants, examinations of interstate and import shipments and special investigations are planned according to the relative incidence and seriousness of probable violations. About 100,000 establishments (manufacturing plants, warehouses, shippers) dealing in foods, drugs, devices, or cosmetics are subject to inspection. Retail establishments dealing in products received in interstate commerce are also subject to the prohibition against adulteration or misbranding. Samples are collected during inspections, and investigations and laboratory analyses are conducted to detect and identify adulteration.

2. Research and methodology.-Research is conducted to evaluate the components of foods, drugs, devices, cosmetics, and household products suspected of containing hazardous substances, and to appraise their efficacy, toxicity, and acute and long-range effects. Research is also performed to develop analytical methods for use in field analysis of inspectional samples and to develop food standards and pesticide, food additive, and color additive tolerances.

3. Compliance, consultation, and education.-Voluntary compliance with the law is promoted wherever possible, but legal action is taken when necessary. Legal proceedings include citations, seizures of illegal products, injunctions, and criminal prosecutions through the courts. Standards for foods, tolerances for poisonous substances in foods, and other regulations are promulgated. A program of consumer education is conducted. Liaison is maintained with, and assistance is given to, State and local food and drug agencies.

4. Medical evaluation.-Applications for new drugs to be marketed, or for modification of previously approved drugs, are evaluated and approved. The medical aspects of research and enforcement activities are coordinated. Labels for drugs and household products containing hazardous substances are evaluated for honesty of claims, sufficiency of information.

Workload is reflected in the following summary data:

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1 Selected resources as of June 30 are as follows: Unpaid undelivered orders, 1962, $1,470 thousand (1963
adjustment, $16 thousand); 1963, $1,279 thousand; 1964, $3,076 thousand; 1965, $6,101 thousand.

This appropriation consolidates all activities related to the planning, construction, and equipping of buildings and facilities for the Food and Drug Administration. Since 1957, the Food and Drug Administration has been engaged in a program to improve and enlarge its field facilities. Improvements have been provided for 11 of the 18 FDA district offices of which all but 1 have been done through the leasing of privately owned facilities. The remaining 7 districts will be provided through direct

Federal construction.

FDA has also had a program to provide additional space and facilities at headquarters. A new headquarters laboratory building (Federal office building No. 8) is now under construction and nearing completion. A special pharmacological animal laboratory is under construction

at Beltsville, Md. In 1964 planning will be completed for the first major laboratory to be located on the Beltsville site. A special dog whelping facility will also be constructed at Beltsville to provide necessary dog colonies for the pharmacological-animal laboratory.

Steps taken to provide interim laboratory space until permanent facilities become available include the renovation of building 197 at the Navy Yard in Washington and the retention of present laboratory space at Boston, New York, and Baltimore when operations at these locations are transferred to new facilities to be completed in 1964. Selected headquarters laboratory operations will be transferred to these locations as the space becomes available.

The program proposed for 1965 calls for:

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1. Preparation of a master-development plan for the site at Beltsville, Md., on which current and future headquarters facilities will be constructed.

2. Construction of a laboratory facility at Beltsville, Md., to augment the new laboratory building (Federal office building No. 8) now under construction. Planning for this building will be completed in 1964.

3. Site acquisitions and construction of district laboratory-office buildings at Chicago, Ill.; Denver, Colo.; and Philadelphia, Pa.

4. Planning and site acquisitions for district laboratoryoffice buildings at St. Louis, Mo., and San Francisco, Calif.

5. Equipping of facilities to be completed in 1964 at the following locations: New Orleans, La.; New York, N.Y.; and Seattle, Wash.

Object Classification (in thousands of dollars)

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