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; not to exceed $20,000 for miscellaneous and emergency expenses of enforcement activities, to be authorized or approved by the Secretary and to be accounted for solely on his certificate; purchase of not to exceed nine passenger motor vehicles for police-type use which may exceed by $300 each the general purchase price limitation for the current fiscal year; 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; [$50,352,000.] $63,454,000. [For an additional amount for "Salaries and expenses", including not to exceed $20,000 for miscellaneous and emergency expenses of enforcement activities, to be authorized or approved by the Secretary and to be accounted for solely on his certificate; and purchase of not to exceed thirty-five passenger motor vehicles for police-type use which may exceed by $300 each the general purchase price limitation for the current fiscal year; $2,727,000.] (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); Departments of Labor, Health, Education, and Welfare Appropriations Act, 1965.) Program and Financing (in thousands of dollars) 1966 1967 estimate estimate 4.360 7,879 10,418 4,952 52,929 63,454 1. Medical evaluation. 2. Research.. 3. Scientific evaluation............. 2,490 3,220 1,837 5. Regulatory compliance.. 23,142 24,545 2,688 26,101 6. Drug abuse control.. 2,200 -50 1 Selected resources as of June 30 are as follows: Unpaid undelivered orders, 1964, $2,022 thousand (1965 adjustments. -$215 thousand); 1965, $1,576 thousand; 1966, $1,576 thousand; 1967, $1,576 thousand. The laws enforced by the Food and Drug Administration are designed to protect the public against adulterated and misbranded foods, drugs, and cosmetics, therapeutic devices, household products containing hazardous substances, and the harmful social effects resulting from abuse of drugs that affect the central nervous system. 1. Medical evaluation.-Medical policy is developed and promulgated with respect to efficacy and safety of drugs and devices for man and animals. Advice is furnished the Commissioner concerning the health effects of toxic substances found in foods, drugs, cosmetics, and household substances. New drug applications for human and veterinary drugs and claims for investigational drugs are evaluated; an adverse drug reaction reporting program and clinical studies of drugs and devices are conducted; and medical aspects of FDA's inspectional and investigational programs and court cases are developed. 2. Research.-Broad and long-range research is conducted concerning foods, drugs, presticides, and cosmetics and related hazardous substances. The research programs 52,929 63,454 include fundamental research concerning the effects and interrelationships of substances occurring in the products that FDA regulates and experimentation to find new and better methods of detecting and identifying harmful and insanitary substances to add to the cumulative knowledge concerning man and the products he consumes. 200-100-66-27 FOOD AND DRUG ADMINISTRATION-Continued General and special funds-Continued SALARIES AND EXPENSES-Continued concerning investigational drugs and new drug applications for human and veterinary drugs. Methods and bases for evaluation of petitions and tolerances are developed and studied. 4. Education and voluntary compliance. Encompasses the planning, conduct, and evaluation of programs to obtain voluntary compliance with laws on the part of the regulated industry and to inform consumers of the objectives of the laws and to help prepare them to achieve a greater degree of self-protection. Advisory opinions relating to laws and regulations are furnished to industry and a large volume of consumer inquiries are answered. Informational and guidance materials are prepared and distributed to industry. Working relationships with trade, professional, and industry organizations are maintained to promote better understanding of FDA regulations and policies and to assist industry in voluntary compliance. 5. Regulatory compliance.-Nationwide inspectional, investigational, and analytical programs are conducted through 18 district offices and a number of resident inspector posts, to enforce the Food, Drug, and Cosmetic Act, Hazardous Substances Labeling Act, and related statutes. Research is performed to improve methodology and analyses of samples. Activities are performed during the conduct of inspections to promote voluntary compliance. Inspectional and other field actions are reviewed to evaluate the degree of compliance or noncompliance with the law; from these reviews, determinations are made for securing compliance through legal or voluntary action and, where necessary, legal cases are prepared and initiated for enforcement of the law. 6. Drug abuse control.-Programs are developed to curtail the illegal traffic in stimulant, depressant, and counterfeit drugs. These programs involve regular inspection of manufacturers' and distributors' establishments and records, as well as special investigations and law enforcement work to apprehend violators. 7. Executive direction and technical support. This activity contains the resources for overall agency management and certain administrative and technical services provided on a centralized basis. Executive functions include the establishment of policy, the formulation and promulgation of agencywide plans, budgets, regulations, and directives, allocation of resources, day-to-day direction of the Agency, dissemination of public information and evaluation of performance and accomplishments. The coordination and operation of the FDA-wide science information program and the science library is included under this activity. In addition, programs are conducted to promote cooperative Federal-State relations and to prepare for operations under emergency conditions. Administrative services such as personnel, management analysis, |