S00503-003 National Alcoholism Program Information System (NAPIS). Program: Alcoholism Management and Information Authority: Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 (P.L. 91-616, § 301, 312). Availability: System output is provided to all projects, to each State in which a project is located, to DHEW Regional Offices, to NIAAA, and others as appropriate. Geographic Relevance: National Purpose: This system provides information on effectiveness and efficiency of National Institute on Alcohol Abuse and Alcoholism (NIAAA) funded alcoholism treatment programs. Data are used for program accountability, program management, program information, and research. Input: Providers of the information are all NIAAA-funded alcoholism treatment projects They include Alcoholism Treatment Centers (ATCS), poverty program, occupational program, Native American program, public inebriate program, cross-population program, and problem drinking driver program. Content: Data collected include client demographics, client condition, treatments or services provided, and client outcome. Information on program resource use and revenues also is collected. Output: Computer processed routine output reports are provided monthly. These are trend reports which show program activity, staff activity, client outcome, costs of services, client referral sources, revenues, and expenditures. Exception reports, special computer runs, and evaluations are routinely developed from the data. Agency Contact: Alcohol, Drug Abuse, and Mental Health Administration. (301) 443-2858. S00503-004 Research Grants Data System. OMB Funding Title/Code: Alcohol, Drug Abuse, and Mental Health/75-1361-0-1-550. Program: General Mental Health Research Congressional Recipient: House Committee on Interstate and Foreign Commerce; House Committee on Appropriations: LaborHealth, Education and Welfare Subcommittee; Senate Committee on Human Resources; Senate Committee on Appropriations: Labor, Health, Education and Welfare Subcommittee. Authority: Public Health Service Act (P.L. 78-410, § 472). Developmental Disabilities Services and Facilities Construction Act (P.L. 88-164, § 231(d)). Availability: Computerized access is limited to the Program Analysis and Evaluation Section, NIMH. Output is generally of interest and use internally, but it is publicly available with certain restrictions related to the Freedom of Information Act and the Privacy Act. Since the information is kept in coded not narrative form, it is often more useful for the general public to make content inquiries of the Scientific Project Analysis and Retrieval System (SPARS: ADAMHA) Geographic Relevance: National; State; City Purpose: The Research Grants Data System is a management information system for use in research grant analysis, planning, and administration by the components of the National Institute of Mental Health (NIMH) research grant program. All NIMH research grant applications are covered. Application content inquiries are also handled. These come from various NIMH or Agency staff as well as the general public. Input: Objective grant data (title, investigator, dates, etc.) are obtained by tape from Division of Research Grants, NIH. Content coding of applications is done by NIMH professional staff, primarily in the Program Analysis and Evaluation Section. Data from final reports submitted by grantees are also entered. Con tent: The information on file consists of all administrative facts about a research grant application, such as title, investigator, dates sponsoring institution, location down to city, review action, and funding. The information is updated every 2-4 weeks via NIH tapes. The system also includes content coding of the proposed research and later coded information about the research from the final report. The content coding is updated whenever an applicant recompetes for support. Output: Frequent reports on management information which are content searches are produced. Yearly output includes NSF report, case report, NIH survey, a data sourcebook, and the ADAMHA grant book. The system puts out about 100-150 11" x 15" lists per year. Output is possible in a large variety of media such as cards, tapes, etc. Agency Contact: Alcohol, Drug Abuse, and Mental Health Administration. (301) 443-3104. S00503-005 Saint Elizabeth's Hospital Clinical System. OMB Funding Title/Code: Salaries and Expenses / 75-1101-0-1-554. Program: Saint Elizabeth's Hospital Congressional Recipient: House Committee on Interstate and Fo- Authority: Public Health Service Act (P.L. 78-410). Purpose: This system is to provide clinicians with patient treatment information. Input: Input data include psychological data, medical data, and test results. Clinicians and support personnel supply the information. Content: Information on patients pertains to demography, psychological state, medication, and clinical history. Output: Output data include patient history, medical test results, and drug profiles. The end use is patient treatment administration. Agency Contact: Alcohol, Drug Abuse, and Mental Health Administration. (202) 574-7339. S00503-006 Saint Elizabeth's Hospital Information System. OMB Funding Title/Code: Salaries and Expenses / 75-1101-0-1-554. Congressional Recipient: House Committee on Interstate and Fo- Purpose: This system is designed to provide program managers with data about their operation on a periodic basis to monitor and evaluate performance. Input: As a series of unrelated subsystems, input varies from patient movement data, supply and inventory data, and fiscal data. Data sources include a variety of hospital programs. Content: The system includes data about patients on the rolls at Saint Elizabeth's Hospital and descriptive data about fiscal and physical support programs. The data pertain to items of inventory, equipment numbers, and kinds of patients. Output: Output includes patient statistics, inventory reports, equipment lists, and financial reports. Agency Contact: Alcohol, Drug Abuse, and Mental Health Administration. (202) 574-7339. S00503-007 ADAMHA Contract Information System. OMB Funding Title/Code: Alcohol, Drug Abuse, and Mental Health/75-1361-0-1-550. Program: All Programs Congressional Recipient: House Committee on Appropriations: Labor-Health, Education and Welfare Subcommittee; House Committee on Interstate and Foreign Commerce; Senate Committee on Appropriations: Labor, Health, Education and Welfare Subcommittee; Senate Committee on Human Resources. Authority: Public Health Service Act (P.L. 78-410). Developmental Disabilities Services Construction Act (P.L. 88-164). Narcotic Addict Rehabilitation Act of 1966 (P.L. 89-793). Comprehensive Alcohol Abuse and Alcoholism Prevention and Treatment Act (P.L. 91-616). Drug Abuse Office and Treatment Act of 1972. P.L. 92255. Purpose: The purpose of this system is to provide accurate and timely information on all Alcohol, Drug Abuse and Mental Health Administration (ADAMHA) contracts. Input: Information is gathered from all ADAMHA contracts. Content: This system contains all financial information and other pertinent data on ADAMHA contracts, delivery date, length of contract, and type of contract. Output: This system provides reports to management on Alcohol, Drug Abuse, and Mental Health Administration contracts. Related reports are available for ADAMHA users. Agency Contact: Alcohol, Drug Abuse, and Mental Health Administration. (301) 443-4147. $00503-008 Community Mental Health Center Management Information System (CMHC/MIS). Date: 1968 OMB Funding Title/Code: Alcohol, Drug Abuse, and Mental Health/75-1361-0-1-550. Program: Mental Health CFDA NO.: 13.240; 13.295 Congressional Recipient: House Committee on Interstate and Foreign Commerce; Senate Committee on Labor and Human Resources. House Committee on Appropriations: Labor-Health, Education and Welfare Subcommittee; Senate Committee on Appropriations: Labor, Health, Education and Welfare Subcommittee. Authority: Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963 (P.L. 88-164; 77 Stat. 290; 42 U.S.C. 2681). Community Mental Health Centers Amendments of 1970 (P.L. 91-211). Special Health Revenue Sharing Act of 1975 (P.L. 94-63). Community Mental Health Centers Extension Act of 1978 (P.L. 95-622, title I). Health Planning and Health Services Research and Statistics Extension Act of 1977. P.L. 95-83, title I. Availability: Agency contact; GPO Geographic Relevance: National; State; City; Congressional District Purpose: This management information system provides a variety of information on the community mental health centers funded by the National Institutes of Mental Health since 1965. Input: Data for this system are obtained primarily from grant applications, grant awards, and reports pursuant to monitoring visits. Content: This system compiles information on the composition of the community mental health centers (lead agency and affiliates), sponsorship, services provided, types and amounts of grants awarded, poverty and operational status, and a brief narrative description of the service area and the program thrust. The results of monitoring visits and other topics are also summarized. Data are provided for 1968 and subsequent years. Output: The system generates the following hardcopy reports on request and annually: complete listings of community mental health centers; the number of centers operational and funded by State and by region, including poverty status; overview of grant monitoring; listings of services offered by centers and affiliates; population data on the service areas and cities in which the centers are located; and all grants awarded to each center, together with the award amounts, dates, and other identifying information. Agency Contact: Alcohol, Drug Abuse, and Mental Health Administration. (301) 443-4673. S00503-009 Scientific Project Analysis and Retrieval System. OMB Funding Title/Code: Alcohol, Drug Abuse, and Mental Program: All Programs Congressional Recipient: House Committee on Interstate and Foreign Commerce; Senate Committee on Labor and Human Resources. House Committee on Appropriations: Labor-Health, Education and Welfare Subcommittee; Senate Committee on Appropriations: Labor, Health, Education and Welfare Subcommittee. Authority: Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963 (P.L. 88-164). Availability: Agency contact Geographic Relevance: International; National; State; City Purpose: The Scientific Project Analysis and Retrieval System (SPARS) is the central information system for the analysis of the content of the Alcohol, Drug Abuse, and Mental Health Administration's programs and for answering inquiries concerning them. Input: Analysts process awarded program information in a manner producing 22 formatted fields and text for each document which provides the input for this system. Content: The indicative abstracts in the system present the overall goal and content of each grant, contract, or intramural project. The computer system contains about 17,000 documents which can be searched and interfaced with other systems to provide information on awards for any subject area requested. All centrally administered projects active in 1972 or awarded since then are in the system, as well as over 2,500 projects terminated before 1972. The system is updated four to six time per year. Microfiche records provide detailed information about particular programs. These records contain copies of the grant applications, reviews of applications prepared prior to funding; and contract agreements. Output: As inquiries are received, searches are formulated to retrieve specific documents in hardcopy in the relevant subject matter areas, sorted by any combination of formatted fields. Agency Contact: Alcohol, Drug Abuse, and Mental Health Administration. (301) 443-3376. CENTER FOR DISEASE CONTROL S00504-001 Registry of Toxic Effects of Chemical Substances. OMB Funding Title/Code: Preventive Health Service / 75-0943-01-553. Program: Occupational Health: Direct Operations Congressional Recipient: House Committee on Education and Labor; House Committee on Interstate and Foreign Commerce; House Committee on Appropriations: Labor-Health, Education and Welfare Subcommittee; Senate Committee on Human Resources; Senate Committee on Appropriations: Labor, Health, Education and Welfare Subcommittee. Authority: Occupational Safety and Health Act of 1970 (P.L. 91596). Availability: The book is available to the public through GPO. Purpose: The purpose of the system is to accomplish the National Institute of Occupational Safety and Health (NIOSH) mandate in the Occupational Safety and Health Act of 1970 to publish "at least annually, a list of all known toxic substances by generic family or other useful grouping, and the concentrations at which such toxicity is known to occur." Since the list now includes 22,000 chemicals and 81,000 synonyms, a data processing capability is needed for updating, correcting, and searching the file. The audience is anyone who works with or makes decisions about the use of chemicals. Input: The primary sources of data are published reports and unpublished data. The published reports are the world literature of toxicity. The unpublished data come from industry sources, Government reports, and academic institutions. Content: The system contains unevaluated toxicity information on the chemicals whose effects are acute lethal animal toxicity; carcinogenic, teratogenic and mutagenic effects in experimental animals; and any human toxic effects correlated to a published dose of the chemical. In addition to the toxicity data, as made available, there has been added the molecular weight and formula, Wiswesser line notation, Chemical Abstracts registry number, synonyms, and pertinent occupational health standards. The descriptions, unevaluated toxicity data with original document references, and standards present a hazard profile of the chemical and its effects. The file is updated monthly with information from new references. The references are as old as 80 years. Output: A book containing all data is published annually. Subfiles of the data are also published to identify substances which may warrant additional research or standards. Computer tapes are available on request, and batch searches can be done. The file is machine-searchable by the chemical structure, empirical formula, and certain classifications such as carcinogens, mutagens, teratogens, drugs, and agricultural chemicals. Agency Contact: Center for Disease Control. (202) 245-6541. S00504-002 Automated Scientific Information Storage and Retrieval. OMB Funding Title/Code: Preventive Health Service / 75-0943-01-553. Program: Occupational Health: Direct Operations Congressional Recipient: House Committee on Education and Labor; House Committee on Interstate and Foreign Commerce; House Committee on Appropriations: Labor-Health, Education and Welfare Subcommittee; Senate Committee on Human Resources; Senate Committee on Appropriations: Labor, Health, Education and Welfare Subcommittee. Authority: Occupational Safety and Health Act of 1970 (P.L. 91596). Availability: The output is available to the public. Other Government agencies can access the computer system by arranging for reimbursable computer accounts with NIOSH. Purpose: The purpose of the system is to create a universe of indexed techincal information. The system will provide information from published documents and also information from unpublished internal nonconfidental files. The audience will be National Institute of Occupational Safety and Health (NIOSH) employees and the occupational health and safety community. Input: The primary sources of data are journals, conference proceedings, technical reports, and other publications. Other sources are nonconfidental internal NIOSH correspondence and reports. Content: The data are composed of occupational safety and health related data. The articles are abstracted by a contractor and also key-worded. The system created is a document storage and retrieval system based on keywords in an abstract. The data are stored on a disk pack and accessed through Time Sharing Option. The data are updated periodically. Output: The output is a hardcopy printout on computer paper. It is generated as needed. The system is queried through TSO or batch. Agency Contact: Center for Disease Control. (202) 245-6541. S00504-003 Occupational Health Field Research Studies. OMB Funding Title/Code: Preventive Health Service / 75-0943-01-553. Program: Occupational Health: Direct Operations Congressional Recipient: House Committee on Education and Labor; House Committee on Interstate and Foreign Commerce; House Committee on Appropriations: Labor-Health, Education and Welfare Subcommittee; Senate Committee on Human Resources; Senate Committee on Appropriations: Labor, Health, Education and Welfare Subcommittee. Authority: Occupational Safety and Health Act of 1970 (P.L. 91596). Availability: The reports are not available to the public unless a system notice is published in the Federal Register to allow disclosure of the data. Reports are available that do not contain personal identifiers. Purpose: The Occupational Health Field Research Studies System processes and analyzes environmental, medical, and demographic data on industrial employees. The statistical summaries generated by the system are used by National Institute of Occupational Safety and Health (NIOSH), Department of Labor, and other Agencies. Input: The data for the system are provided by NIOSH health hazard evaluations and clinical investigations conducted by NIOSH. Information is also supplied from technical assistance provided to industry by NIOSH. Content: The data in the system are environmental, medical, and demographic data collected from employees. The employees sign a consent form to allow NIOSH to collect the data. The data are used to determine any health problems in industry. Output: Statistical hardcopy reports are produced as needed. Most of the computer work is done by a NIOSH contractor who accesses the system by batch. Industry and unions receive reports, but they do not receive personal identifiers. Therefore, only NIOSH knows the results of the investigations. The employees who participate in the study are notified of their test results by mail. Agency Contact: Center for Disease Control. (202) 245-6541. S00504-004 National Occupational Hazard Survey Data Projection System. OMB Funding Title/Code: Preventive Health Services / 75-09430-1-550. Program: Occupational Safety and Health Congressional Recipient: House Committee on Appropriations: Labor-Health, Education and Welfare Subcommittee; House Committee on Education and Labor; House Committee on Interstate and Foreign Commerce; Senate Committee on Appropriations: Labor, Health, Education and Welfare Subcommittee; Senate Committee on Human Resources. Authority: Occupational Safety and Health Act of 1970 (P.L. 91596). Purpose: The purpose of this system is to respond to queries on national exposure levels for selected hazardous occupations and in-. dustries. Input: Input data are collected from National Institute of Occupational Safety and Health-generated survey data. Content: This system contains information on urban industries covered by the Occupational Safety and Health Act. Information collected includes exposure of employees to chemical, physical, and biological hazards. Output: Output from the system includes statistical selected exposure levels and National Institute of Occupational Safety and Health surveyor reports. Agency Contact: Center for Disease Control. (513) 684-2723. S00504-005 Coal Miner Medical Information Processing System. OMB Funding Title/Code: Preventive Health Services / 75-09430-1-550. Program: Occupational Safety and Health Congressional Recipient: House Committee on Appropriations: Labor-Health, Education and Welfare Subcommittee; House Committee on Education and Labor; House Committee on Interstate and Foreign Commerce; Senate Committee on Appropriations: Labor, Health, Education and Welfare Subcommittee; Senate Committee on Human Resources. Authority: Coal Mine Health and Safety Act of 1969, as amended. Geographic Relevance: National; State Purpose: The purpose of this system is to maintain results of Xrays and detect the development of pneumoconiosis. Input: The information is gathered from medical examinations and occupational history and individual questioning. Content: The system covers all underground coal miners in the United States and contains x-rays, medical examinations, and the results of interviews. Output: Outputs from this system include letter reports and statistical reports regarding the results of X-rays and medical examinations of coal miners. Agency Contact: Center for Disease Control. (FTS) 923-7301. S00504-006 National TB Statistics System (ST01). OMB Funding Title/Code: Preventive Health Services / 75-09430-1-550. Program: Disease Control Congressional Recipient: House Committee on Interstate and Foreign Commerce; House Committee on Education and Labor; House Committee on Appropriations: Labor-Health, Education and Welfare Subcommittee; Senate Committee on Appropriations: Labor, Health, Education and Welfare Subcommittee; Senate Committee on Labor and Human Resources. Authority: Public Health Service Act (P.L. 78-410). Purpose: The purpose of this system is to monitor the status of the tuberculosis problem in the United States. Input: Information is generated from case-details. Content: The system contains information gathered from State and local tuberculosis control programs. Information collected from these sources include statistical summaries, geographical area reports, case registers, contacts, laboratory results, drugs, case treatment, and therapy population estimates. Output: The products of this system include statistical profiles, special studies, projections and evaluations of programs, and annual statistical summaries by State and city. Agency Contact: Center for Disease Control. (404) 633-3127. FOOD AND DRUG ADMINISTRATION $00505-001 ASTRO-4 Drug Information System. OMB Funding Title/Code: Salaries and Expenses / 75-0600-0-1-553. Program: Drugs and Devices Congressional Recipient: House Committee on Interstate and Foreign Commerce; House Committee on Appropriations: Agriculture and Related Agencies Subcommittee; Senate Committee on Human Resources; Senate Committee on Appropriations: Agriculture and Related Agencies Subcommittee. Authority: Tea Importation Act (P.L. 29-358). Import Milk Act of 1927 (P.L. 69-625). Federal Food, Drug and Cosmetic Act (P.L. 75-717). Public Health Service Act (P.L. 78-410). Fair Packaging and Labeling Act. P.L. 89-755. Availability: Outputs are used within the Bureau of Drugs and are provided to other internal Agency organizations (the executive Director for Regional Operations, General Counsel, and the Office of Planning and Evaluation). Some information is available under FOI, but the system contains proprietary information and is not generally available for public use. Geographic Relevance: City; State Purpose: The ASTRO-4 Drug Information System was designed and developed to provide information relating to Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Antibiotic Form 5s and Form 6s. Data in the various files of the system support the new drug evaluation process, the preparation of special purpose reports on individual or classes of drugs, compliance programs, and major publications, such as the Approved Prescription Drug Products With Therapeutic Equivalence Evaluations. Input: Selected data from IND/NDA bound jackets and correspondence are extracted onto coding sheets for data entry on a minicomputer system with on-line editing capability. Chemists identify ingredients in an application, and the name, structure, and molecular formula are placed into a manual and automated chemical nomenclature file. Data are reviewed by pharmacists and technical information specialists to assure conformity with Bureau of Drugs standards. Content: Information that supports ASTRO-4 processing and report generation comes from data that have been collected since 1938. The ASTRO-4 data base comprises approximately 85,500 records (44,740 INDs and 40,760 NDAs, ANDAs, Form 5s and Form 6s) for a total of 100 million bytes of data. The principal data of the ASTRO-4 files are related to drug formulation, activity, use, and legal status. These data include the following: document/product number, application holder, drug composition, use and supporting information (e.g., legal status and supporting documents). Levels of geocoding are FDA districts and city/state for application holder. Internal (FDA) and external (FOI) requests for ad hoc reports from the ASTRO-4 file number approximately 50 per month. Output: The system output is in the form of standard hardcopy and computer output microfiche (COM). Master listings are produced at least monthly containing all file data elements used for internal system maintenance. Ad hoc reports are produced upon request for internal users, principally reviewing officers, approximately 40 times per month. Standard reports are produced for internal purposes and FOI requests. Special purpose reports are supported by ASTRO-4 and particularly the major publication Approved Prescription Drug Products With Therapeutic Equivalence Evaluations. All of these reports are produced in the batch mode. Agency Contact: Food and Drug Administration. (301) 443-4610. S00505-002 Drug Product Problem Reporting System. OMB Funding Title/Code: Salaries and Expenses / 75-0600-0-1-553. Program: Drugs and Devices Congressional Recipient: House Committee on Interstate and Foreign Commerce; House Committee on Appropriations: Agriculture and Related Agencies Subcommittee; Senate Committee on Banking, Housing and Urban Affairs; Senate Committee on Appropriations: Agriculture and Related Agencies Subcommittee. Authority: Tea Importation Act (P.L. 29-358). Import Milk Act of 1927 (P.L. 69-625). Federal Food, Drug, and Cosmetic Act (P.L. 75-717). Public Health Service Act (P.L. 78-410). Fair Packaging and Labeling Act. P.L. 89-755. Availability: Data are available to the public through Freedom of Information (FOI) requests. Most FOI requests received ask for all defect reports on a specified drug by a particular manufacturer. Since public information requests tend to be unique and nonstandard they are handled by the agency, rather than report distribution by the Government Printing Office or the National Technical Information Service. Purpose: The Drug Product Problem Reporting System is a voluntary, spontaneous reporting system, dependent upon hospital and community pharmacists and nurses voluntarily reporting drug defects to the Food and Drug Administration (FDA) via the U.S. Pharmacopeia (USP). The FDA shares the information with the USP and the American Society of Hospital Pharmacists. The system is used to help determine if the reported defect is peculiar to the product itself, might occur in other products made by that company, or is an industry-wide phenomenon. FDA also pursues compliance action as deemed appropriate. Input: Initial input to the system is the three problem reports (Hosptial Pharmacists's Drug Problem Report, Community Pharmacist's Drug Problem Report, and the Nurse's Drug Problem Report) which are submitted directly to the USP by hospital pharmacists (55%), community pharmacists (31%) and nurses (14%). The USP acknowledges the reports, prepares them for keytaping by transposing data from the relatively free-form defect report to the fixed form problem coding sheet, and keytapes the data for data entry. Internal data relative to report follow-up are entered on a coding form by personnel in the compliance area, keypunched, and entered into the system. Content: The system maintains a single comprehensive file of voluntarily submitted reports from hospital and community pharmacists and nurses on defective drug products. The data base is cumulative from 1972. It is updated weekly. The principal data elements are National Drug Code (NDC) code, drug name, manufacturer, address (uses USPS State and zip codes), defect, and report text. Output: A cumulative basic report log is used for internal review and reference is produced with each update. A quarterly alphabetic report of drugs reported is produced for internal maintenance functions (review, reference, elimination of duplicate reports). Reports by FDA district are produced semiannually and sent to respective districts for use in inspections. Internal reports and reports mailed to the districts are computer-generated hardcopy. The system is programed in the MARK IV File Management System to allow for batch mode retrieval. Agency Contact: Food and Drug Administration. (301) 443-4610. S00505-003 Drug Experience Information System. OMB Funding Title/Code: Salaries and Expenses / 75-0600-0-1-553. Program: Drugs and Devices Congressional Recipient: House Committee on Interstate and Foreign Commerce; House Committee on Appropriations: Agriculture and Related Agencies Subcommittee; Senate Committee on Human Resources; Senate Committee on Appropriations: Agriculture and Related Agencies Subcommittee. Authority: Tea Importation Act (P.L. 29-358). Import Milk Act of 1929 (P.L. 69-625). Federal Food, Drug and Cosmetic Act (P.L. 75-717). Public Health Service Act (P.L. 78-410). Fair Packaging and Labeling Act. P.L. 89-755. Availability: Quarterly reports are restricted to internal use only. FOI reports for public distribution are accompanied by a disclaimer of accuracy because the data are subject to interpretation. Purpose: The Drug Experience Information System maintains data files of drug experience case reports related to both marketed and investigational drugs. The reports are submitted either as a requirement of law by drug manufacturers or as voluntary information by health professionals, hospitals, and the public. Computer reports are generated to assist the agency in evaluating trends in drug experience and in preparing reports for dissemination within and without the agency regarding the significance of the epidemiological aspects of the drug experience information. The DEIS data base currently contains two files (AROLD from 1966-1968 and ARNEW from 1969 to the present) which contain 10,000 and 90,000 cases, respectively, for a total of 58.5 million bits of drug experience data. The ARNEW file grows by approximately 1,000 case reports per month. Input: Adverse drug reaction cases are reported voluntarily by hospitals, physicians, and the public. FDA regulation requires the reporting of cases by manufacturers of drugs. Data are extracted from letters or forms and keypunched. Content: The system is operated in batch mode and programed in the MARK IV File Management System, with updates scheduled weekly. Original collection of data began in 1966. The file content consists of patient demographic data, patient adverse reactions experienced (maximum of four) with associated severity, outcome, factors, categories, and dates; names of drugs taken (maximum of five) with associated manufacturer, identifying numbers, administration data, therapeutic indication, interaction evaluation; causal relationship to the adverse reactions, category and previous history of usage indicators. Output: The principal output is hardcopy reports produced quarterly for internal use. All queries are made in batch mode against the entire file or subsets based on drugs, adverse reactions or both; but no queries are made on individual adverse drug experience reports. Many ad-hoc FOI reports are also produced. A microfilm copy is made of all the original drug experience reports for internal use. Agency Contact: Food and Drug Administration. (301) 443-4610. S00505-004 Drug Registration and Listing System. OMB Funding Title/Code: Salaries and Expenses / 75-0600-0-1-553. Program: Drugs and Devices Congressional Recipient: House Committee on Interstate and Foreign Commerce; House Committee on Appropriations: Agriculture and Related Agencies Subcommittee; Senate Committee on Human Resources; Senate Committee on Appropriations: Agriculture and Related Agencies Subcommittee. Authority: Tea Importation Act (P.L. 29-358). Import Milk Act of 1927 (P.L. 69-625). Federal Food, Drug and Cosmetic Act (P.L. 75-717). Public Health Service Act (P.L. 78-410). Fair Packaging and Labeling Act. P.L. 89-755. Availability: The NDC directory, containing selected drug establishment and product information, is published from the system and given to the Government Printing Office for printing and distribution. The data contained in the National Drug Code Directory is placed on magnetic tape and sent to the National Technical Information Service for sale to the public. Purpose: The drug registration and listing system maintains files of drug establishments registered with the Food and Drug Administration and product data submitted by drug Establishments as required by the Drug Listing Act of 1972. An inventory of marketed drugs and establishments, the system provides information to organizational units within the Agency to assist in regulatory activities. The system contains human drugs, biologicals, in vitro diagnostic products, and veterinary drugs. Input: Input data are collected from drug establishments on offical FDA forms, Registration of Drug Establishments (FD 2656), Drug Product Listing (FD 2657) and Registered Establishment of Private Label Distributors. Content: The system operates in batch mode and is programed in the MARK IV File Management System. Registration data are updated annually and product data semiannually or as needed by drug establishments. Data maintained include establishment name, FDA registration number, address (uses USPS state and zip codes), types of business engaged in, types of products marketed, and years registered with FDA. Product data include name, class, legal status, ingredients, and dosage. When the data base of the current system is complete, it will contain data pertaining to all registered drug establishments and drugs in commercial distribution in the United States. Output: Standard reports include the National Drug Code Directory, lists of approved drugs for State governments, and computer-prepared registration forms. Internal reports are used for editing data, in support of compliance programs, and to answer FOI requests and inquiries from other units within the Bureau of Drugs and the Department. Agency Contact: Food and Drug Administration. (301) 443-4610. S00505-005 Compliance Activities Planning and Evaluation System (CAPES). Congressional Recipient: House Committee on Interstate and Foreign Commerce; House Committee on Appropriations: Agriculture and Related Agencies Subcommittee; Senate Committee on Human Resources; Senate Committee on Appropriations: Agriculture and Related Agencies Subcommittee. Authority: Tea Importation Act (P.L. 29-358). Import Milk Act of 1927 (P.L. 69-625). Federal Food, Drug and Cosmetic Act (P.L. 75-717). Public Health Service Act (P.L. 78-410). Fair Packaging and Labeling Act. P.L. 89-755. Availability: Output is publicly available. The source for the output is the bureau's Division of Compliance. Purpose: The major intent of the Automated Compliance Activities Planning and Evaluation System (CAPES) is to assist the Bureau in control, analysis, and decision-making with respect to data submitted under requirements of the Radiation Control for Health and Safety Act, The system provides the Bureau with the ability to keep track of pertinent compliance data, to combine data from several sources, to perform complex calculations and estimations, and to compare results with requirements of applicable performance stand |