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; [$39,200,000] $50,352,000. (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 Appropriation Act, 1965.) Program and Financing (in thousands of dollars) 1965 1966 estimate estimate 4,567 8,040 2. Research.. 3,193 3. Scientific evaluation... 2,036 2,450 4. Education and voluntary compliance......... 1,117 1,315 5. Regulatory compliance. 20,016 22,888 6. Executive direction and technical sup port.. 3,192 3,726 40,431 1 Selected resources as of June 30 are as follows: Unpaid undelivered orders, 1963, $1.741 thousand (1964 adjustments, $432 thousand); 1964, $2,022 thousand; 1965, $2,022 thousand; 1966, 2022 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. 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. 150 2. Research.-Broad and long-range research is con50,443 ducted concerning foods, drugs, and cosmetics and related products. The research includes 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. -60 -63 -91 35,621 35,805 40,368 50,352 39,200 50,352 New obligational authority New obligational authority: 40 Appropriation.. lic Buildings Service" General Services Administration (77 Stat. 436 and 78 Stat. 655)... 3. Scientific evaluation.-Scientific evaluations are made of pesticide, food additive, color additive, and food standards petitions, and the labeling of hazardous substances. Regulations are developed and promulgated for pesticide tolerances and exemptions, food additives, color additives, food standards, antibiotic, and insulin. Antibiotics, insulin, and certain colors are certified. Toxi50,352 cological evaluations are performed concerning investigational drugs and new drug applications. Methods and bases for evaluation of petitions and tolerances are developed and studied. SALARIES AND EXPENSES-Continued sumers of the objectives of the laws and to help prepare Informational and guidance materials are prepared and distributed to assist industry in voluntary compliance and to promote understanding of FDA regulations and policies. Working relationships are established and maintained with industry, trade, and professional organizations. Studies, surveys, and evaluations are made of consumer attitudes, interests, prejudices, purchasing, and other trends. Printed and graphic materials are prepared and published on subjects of consumer interests for dissemination to the general public and news media. Consumer consultants are used to provide consultation services, furnish information and materials, and make speeches and presentations to consumer and other groups. FOOD AND DRUG ADMINISTRATION-Continued Workload is reflected in the following summary data: 1964 actual 1965 estimate 1966 estimate Number of other inspections made (pesti cides, hazardous substances, etc.).. Wharf examinations..... tic and import..... Laboratory analyses and other examina- tories.. Object Classification (in thousands of dollars) Identification code 09-05-0900-0-1-651 Personnel compensation: 11.1 Permanent positions.. 11.3 Positions other than permanent. 11.4 Special personal service payments.. 11.5 Other personnel compensation.... 5. Regulatory compliance.-Nationwide inspectional, investigational, and analytical programs are conducted to enforce the Food, Drug, and Cosmetic Act, Hazardous Substances Labeling Act, and related statutes. Central direction and coordination of the inspectional and analytical programs and operations performed in the 18 district offices insures consistency in the enforcement of the laws. Inspectional, investigational, and other field actions are reviewed to evaluate the degree of compliance or noncompliance with the provisions of the law; from these reviews determinations are made for securing compliance through legal or voluntary action. Initiates and directs the preparation of legal cases for enforcement of the law and those designed to test and interpret the law. 6. Executive direction and technical support.-This activity includes the establishment of goals and policy; the formulation and promulgation of agencywide plans, regulations, and directives; the allocation of resources; the day-to-day direction of the agency; and the evaluation of performance and accomplishments. Programs are conducted to promote cooperative Federal-State relations; to disseminate information to the press and general public, to prepare for operations under emergency conditions, and to obtain the services of outside consultants. Technical support is provided on an agencywide basis in the areas of financial management, facilities planning, laboratory cleaning and needed preparation services, technical reference services, procurement and property, records, data processing, management services, personnel, and training. 25.1 25.2 Services of other agencies.. 26.0 Supplies and materials.. 42.0 99.0 Lands and structures.... 1 Selected resources as of June 30 are as follows: Unpaid undelivered orders, 1963, $1.279 thousand (1964 This appropriation consolidates all activities related to the planning, construction, and equipping of buildings and facilities for the Food and Drug Administration. Since 1958, the Food and Drug Administration in collaboration with the General Services Administration has been engaged in a program to improve and enlarge its field facilities, and funds have been appropriated for all phases of modernization for 13 of the 18 FDA district offices. In addition to improvements in its field facilities, FDA has also made progress in upgrading its space and facilities at headquarters. A new headquarters laboratory building (Federal office building No. 8) will be ready for occupancy by scientific personnel by the end of 1965. A Special Pharmacological Animal Laboratory was occupied during 1964, and in 1965 a special dog whelping facility will be completed to provide necessary dog colonies for the pharmacological animal laboratory. In addition, FDA's 1965 appropriation includes funds for the construction of a laboratory facility at the Beltsville site. The program proposed for 1966 calls for: (1) Acquisition of portable laboratory equipment for Federal office building No. 8 and the modification of office space to accommodate additional scientific personnel in 1966. (2) Planning for an additional headquarters laboratory facility at the Beltsville site to house approximately 450 personnel. (3) Construction of district office facilities at St. Louis and San Francisco, and the equipping of district office facilities authorized for construction at Chicago, Denver, and Philadelphia. Object Classification (in thousands of dollars) Identification code FOOD AND DRUG ADMINISTRATION 1964 actual 1965 1966 estimate estimate 25.2 Services of other agencies. 31.0 Equipment............. 32.0 Land and structures.. Total obligations, Food and Drug Ad- ALLOCATION TO GENERAL SERVICES ADMINISTRATION 25.2 Services of other agencies. 32.0 Land and structures... 72 Obligated balance, start of year... 74 Obligated balance, end of year.. 89 year. -142 53 -53 Obligated balance, start of year.. 367 380 74.98 Obligated balance, end of year. -367 -380 -38 53 90 Expenditures. 379 -77 Cash transactions: 93 Gross expenditures. 94 Applicable receipts.. The Food and Drug Administration certifies batches of antibiotics, insulin, and color additives for use in food, drugs, or cosmetics; it also establishes tolerances for residues of pesticide chemicals in or on raw agricultural products and for color additives in foods, drugs, and cosmetics. These services are financed wholly by fees paid by the industries affected. In 1964, this account was converted from an indefinite special fund to a self-sustaining revolving fund. The workload in pesticide tolerances decreased sharply in 1964 as a result of the establishment of a new requirement for certification that caused most manufacturers to withhold their petitions until certain time-consuming reproduction studies were completed and their results could be included with the petitions. This means that 392 activity in this area will return to normal in 1965; i.e., to a level comparable to that maintained in 1963. Workload data are as follows: Adjustment for conversion of accrued annual leave to a funded basis.. 1965 1966 estimate estimate 24,000 24,000 Total operating costs, funded.......... Capital outlay funded: Purchase of Batches of color additives tested.. 5,812 378 6,302 350 350 6,800 6,800 equipment.. Changes in selected resources 1 55 Adjustment in selected resources (unpaid undelivered orders). Revenue, Expense, and Retained Earnings (in thousands of dollars) -109 1965 1966 estimate estimate |