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Bill· HRH.R. 3569 (96th)referred
United States · United States Congress · 10 April 1979
Amends the Federal Food, Drug, and Cosmetic Act, the Federal Meat Inspection Act and the Poultry Products Inspection Act to allow the use, in meat, poultry, or other food products, of a food additive for dietary management of health disorders or disease, even though such additive is found to induce cancer in animals, if the Secretary of Health, Education, and Welfare or, where appropriate, the Secretary of Agriculture determines the benefits to human health of such use outweigh the risks. Directs the Secretary to take into account in making such a determination: (1) all scientific data and information on the additive; (2) the scientific validity and analysis of the tests of such additive; and (3) current knowledge about the reliability of predicting cancer in humans from use of an additive found to induce cancer in animals.
Bill· HRH.R. 3582 (96th)referred
United States · United States Congress · 10 April 1979
Authorizes the Secretary of Health, Education, and Welfare to take necessary action to promulgate certain regulations regarding saccharin proposed in the notice of proposed rulemaking published in Part III of the Federal Register for April 15, 1977, but stays the effective date of such regulations until three years following their date of promulgation, unless a safe and effective substitute is developed within such period, or on the basis of new evidence the Secretary finds that saccharin presents an unreasonable and substantial risk of illness.
Bill· HRH.R. 3574 (96th)referred
United States · United States Congress · 10 April 1979
Prohibits the Secretary of Health, Education, and Welfare from promulgating a proposed rule applicable to vitamin and mineral products for over-the-counter human use published on March 16, 1979, or from taking any other action which would have the same effect as such proposed rule.
Bill· HRH.R. 3555 (96th)referred
United States · United States Congress · 10 April 1979
Amends title XIX (Medicaid) of the Social Security Act to qualify an individual who, although employable, is unable to care for his or her personal needs without assistance as a disabled person eligible for the services of a home health aide.
Bill· HRH.R. 3566 (96th)referred
United States · United States Congress · 10 April 1979
Amends the Saccharin Study and Labeling Act to extend from 18 to 36 months the period during which the Secretary of Health, Education, and Welfare may not take specified actions to restrict the continued use of saccharin or of any food, drug, or cosmetic containing saccharin.
Bill· SS. 925 (96th)referred
United States · United States Congress · 9 April 1979
Minority Concerns Act of 1979 - Amends title II of the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963 (Community Mental Health Centers) to direct the Secretary of Health, Education, and Welfare to establish the Office of Minority Concerns at the level of the Office of the Administrator within the Alcohol, Drug Abuse, and Mental Health Administration with authority for the National Institutes on Drug Abuse, Alcohol Abuse, and Alcoholism, and Mental Health. Authorizes such Office to provide financial assistance to professional associations, universities, nonprofit entities, and State or local agencies to improve the delivery of alcohol, drug abuse, and mental health services to minority populations, including research, demonstration, and training programs aimed at eliminating institutional racism.
Bill· HRH.R. 3544 (96th)referred
United States · United States Congress · 9 April 1979
Prohibits the Secretary of Agriculture from taking any action under the Wholesome Meat Act or any other law to prohibit the sale, distribution, or use of nitrites as a food preservative solely on the basis of any carcinogenic effect in humans that nitrites may be represented to have, unless validated evidence is made available to the Secretary which proves beyond a reasonable doubt that nitrites as a food preservative have a significant carcinogenic effect on humans. States that such prohibition shall not apply if the Secretary determines, and publishes in the Federal Register, that a food preservative is commercially available: (1) which may be used in the place of nitrites; (2) which is effective in the protection of public health from botulism and other forms of food poisoning; and (3) the use of which is economically feasible for meat processors and the consumer. Requires the Secretary to conduct or support, by grant or contract research and development activities for a food preservative alternative to nitrites.
Bill· HRH.R. 3522 (96th)referred
United States · United States Congress · 9 April 1979
Amends title XIX (Medicaid) of the Social Security Act to prohibit Medicaid payments for specified periods with respect to nursing home care furnished to an individual if, within the 24 month period preceding such individual's application for such care or in any subsequent month with respect to which such application is effective, such individual: (1) disposed of assets which if retained would have caused such individual to be ineligible for such care; and (2) received compensation for such assets in an amount such that the difference between the fair market value of such assets and the compensation therefor exceeded $3,000.
Bill· SS. 913 (96th)referred
United States · United States Congress · 5 April 1979
Amends part B (Professional Standards Review) of title XI of the Social Security Act to mandate participation of nurses, dentists, psychologists and other health care practitioners in the professionals standards review process. Establishes an advisory committee to the National Professional Standards Review Council.
Bill· SS. 886 (96th)referred
United States · United States Congress · 5 April 1979
Nitrite Moratorium and Food Safety Act - Prohibits the Secretary of Health, Education, and Welfare and the Secretary of Agriculture from prohibiting commerce, prior to May 1, 1980, in any food, meat product, or poultry product by reason of the carcinogenic or other toxic effect of the nitrite added to that food, if: (1) addition of such nitrite was permitted under applicable Federal law on May 1, 1979; and (2) the quantity of such nitrite is within the tolerances in effect on May 1, 1979, or within such tolerances as may thereafter be established, for the purpose of preventing botulism. Prohibits either Secretary from prohibiting commerce on or after April 30, 1980, in any food to which nitrite has been added if the addition of such nitrite: (1) is shown to be safe; or (2) if not shown to be safe, is shown to be necessary to protect against botulism. Extends the period of such moratorium until such time as an alternative anti-toxin becomes available. Requires each Secretary to make an annual review of all regulations issued under this Act in order to determine progress toward making available effective and feasible alternative means for preventing botulism.
Bill· HRH.R. 3501 (96th)referred
United States · United States Congress · 5 April 1979
Amends title XVIII (Medicare) of the Social Security Act to permit payment for eye care, eyeglasses, hearing aids and related examinations, dental care and dentures under the supplementary medical insurance program. Increases the Government contribution to the Federal Supplementary Insurance Trust Fund by twice the amount of premiums that are presently paid into the Fund each month, while decreasing the portion of the Fund comprised of premiums from one-half to one-third. Excludes from the coverage of the supplementary medical insurance program expenses relating to referrals of individuals by a doctor of optometry for the diagnosis or detection of eye diseases.
Bill· HRH.R. 3494 (96th)referred
United States · United States Congress · 5 April 1979
National Vitiligo Control Act of 1979 - Amends title XI of the Public Health Service Act (Genetic Diseases, Hemophilia Programs, and Sudden Infant Death Syndrome) to direct the Secretary of Health, Education, and Welfare to establish a program for the diagnosis, treatment, and control of vitiligo, including information services and health education with respect to such disease. Requires the Secretary to report to Congress on the administration of the program.
Bill· HRH.R. 3490 (96th)referred
United States · United States Congress · 5 April 1979
Amends the Federal Food, Drug, and Cosmetic Act to provide that new drugs for human or animal use will be regulated under such Act solely to assure their safety, and not their effectiveness.
Bill· HRH.R. 3482 (96th)referred
United States · United States Congress · 5 April 1979
Amends the Federal Food, Drug, and Cosmetic Act to allow the use of a food additive for dietary management of health disorders or disease, even though such additive is found to induce cancer in animals, if the Secretary of Health, Education, and Welfare determines the benefits to human health of such use outweigh the risks. Directs the Secretary to take into account in making such a determination: (1) all scientific data and information on the additive; (2) the scientific validity and analysis of the tests of such additive; and (3) current knowledge about the reliability of predicting cancer in humans from use of an additive found to induce cancer in animals.
Bill· SS. 865 (96th)referred
United States · United States Congress · 4 April 1979
Privacy of Medical Information Act - Title I: Requirements Applicable to Medical Care Facilities - Requires medical care facilities to permit individuals to inspect and have copies of their medical records. Provides for the correction of medical records at the individual's request. Directs medical care facilities to notify individuals of disclosures that may be made without the individual's authorization and the procedures to learn of such disclosures. Limits the disclosure of medical information to properly identified persons. Permits the disclosure of medical records without the individual's authorization in specified circumstances, including employee use, health research, statutory requirements, audits and evaluations, law enforcement functions, judicial and administrative provisions, and benefit determinations. Authorizes U.S. district courts to grant delays, in specified circumstances, before making written statements available to the individual concerning such disclosure. Requires medical care facilities receiving Federal funds to comply with the disclosure provisions. Exempts medical information compiled by a medical care facility in anticipation of a civil action from the provisions concerning individual access and corrections. Requires penal authorities to comply only with the provisions concerning permissible disclosures of medical information. Title II: Requirements Applicable to Government Authorities - Sets forth limits on disclosures of medical information to governmental authorities. Establishes procedures for obtaining medical information pursuant to administrative and judicial search warrants, subpoenas, and written requests. Stipulates that the individual be notified of such disclosures unless an appropriate court orders a delay. Permits an individual to challenge a summons or subpoena of such individual's records by a governmental authority. Title III: General Provisions - Provides criminal and civil penalties for violations of the disclosure provisions. Exempts compliance surveys from the disclosure provisions in the Social Security Act. Requires Federal authorities requesting medical information concerning an individual to maintain records on its requests for such information. Exempts medical records maintained by medical care facilities from the disclosure provisions generally applicable to government agencies.
Bill· HRH.R. 3444 (96th)referred
United States · United States Congress · 4 April 1979
Privacy of Medical Information Act - Title I: Requirements Applicable to Medical Care Facilities - Requires medical care facilities to permit individuals to inspect and have copies of their medical records. Provides for the correction of medical records at the individual's request. Directs medical care facilities to notify individuals of disclosures that may be made without the individual's authorization and the procedures to learn of such disclosures. Limits the disclosure of medical information to properly identified persons beyond the extent necessary. Permits the disclosure of medical records without the individual's authorization in specified circumstances, including employee use, health research, statutory requirements, audits and evaluations, law enforcement functions, judicial and administrative provisions, and benefit determinations. Authorizes U.S. district courts to grant delays, in specified circumstances, before making written statements available to the individual concerning such disclosure. Requires medical care facilities receiving Federal funds to comply with the disclosure provisions. Exempts medical information compiled by a medical care facility in anticipation of a civil action from the provisions concerning individual access and corrections. Requires penal authorities to comply only with the provisions concerning permissible disclosures of medical information. Title II: Requirements Applicable to Government Authorities - Sets forth limits on disclosures of medical information to governmental authorities. Establishes procedures for obtaining medical information pursuant to administrative and judicial search warrants, subpoenas, and written requests. Stipulates that the individual be notified of such disclosures unless an appropriate court orders a delay. Permits an individual to challenge a summons or subpoena of such individual's medical records by a governmental authority. Title III: General Provisions - Provides criminal and civil penalties for violations of the disclosure provisions. Exempts compliance surveys from the disclosure provisions in the Social Security Act. Requires Federal authorities requesting medical information concerning an individual to maintain records on its requests for such information. Exempts medical records maintained by medical care facilities from the disclosure provisions generally applicable to government agencies.
Bill· HRH.R. 3436 (96th)referred
United States · United States Congress · 4 April 1979
Amends the Health Programs Extension Act of 1973 to prohibit any entity which receives financial assistance under the Public Health Service Act, the Community Mental Health Centers Act, or the Developmental Disabilities Services and Facilities Construction Act from discriminating against any applicant for training or study because of such applicant's reluctance or unwillingness to counsel, assist, or in any way participate in the performance of abortions or sterilizations contrary to his or her religious belief or moral convictions.
Bill· HRH.R. 3424 (96th)referred
United States · United States Congress · 4 April 1979
Sets a cost-related cap on the fee which a blood bank may charge or collect with respect to its collection and distribution of blood. Prohibits a blood bank from: (1) conditioning the provision of blood to an entity on the donation or provision of blood by an individual; and (2) basing a reduction or elimination of a fee for the collection or distribution of blood on the donation or provision of blood by an individual. Sets forth enforcement procedures, including: (1) the right of an entity charged a fee in violation of this Act to treble damages in a State court (plus attorney's fees); (2) the availability of injunctive relief in a district court to blood donors; and (3) civil penalties for violations of this Act.
Bill· HRH.R. 3425 (96th)referred
United States · United States Congress · 4 April 1979
Amends title XVIII (Medicare) of the Social Security Act to prohibit a provider of services, when furnishing blood to medicare recipients, from: (1) charging more than the processing fee paid by the provider for the blood; and (2) charging for the cost of the administration of the blood by the provider. Eliminates the deductible for the first three pints of whole blood furnished during any spell of illness.
Bill· HRH.R. 3422 (96th)referred
United States · United States Congress · 4 April 1979
Prohibits any Federal employee or agency from inspecting medical or dental records of patients not receiving medical or dental assistance from the Federal Government. Specifies the way in which a patient may authorize disclosure of such information. Prescribes penalties and injunctive relief for violations of this Act.
Bill· HRH.R. 3400 (96th)referred
United States · United States Congress · 3 April 1979
Brown Lung Disease Act of 1979 - Directs the Secretary of Labor to compile and publish a list of State workers' compensation laws found to provide adequate coverage for byssinosis ("brown lung disease", arising out of employment in a textile plant), utilizing specified criteria. Subjects such a determination to judicial review in an appropriate circuit court. Requires any claim for death or total disability due to byssinosis to be filed under the State workers' compensation law, but entitles a worker or surviving family members to claim benefits under this Act during any period when such persons are not covered by a State law providing adequate coverage. Specifies the amounts of benefits to which retired and other workers suffering from byssinosis are entitled to be paid by the Secretary. Provides that such benefit payments shall be reduced by the amount of payments received from certain other sources, such as workers' compensation, unemployment compensation, disability insurance, or a percentage of Social Security benefits. Directs the Secretary, in conjunction with the National Institute for Occupational Safety and Health, to establish standards for determining whether a worker is, or deceased worker was, totally disabled from byssinosis. Makes every employer liable for the securing of benefits equal to or greater than those provided by this Act. Sets forth the means by which such an employer shall secure the payment of such benefits during any period in which the State workers' compensation law is not found to provide adequate coverage. Stipulates that this Act does not relieve any employer of the duty to comply with any State workers' compensation law and that any such law which provides greater benefits shall not be construed to conflict with this Act. Provides that during any period in which a State workers' compensation law is not included on the list published by the Secretary, certain provisions of the Longshoremen's and Harbor Workers' Compensation Act shall be applicable. Authorizes the Secretary to enter into contracts with and make grants to public and private agencies and organizations and individuals for the construction, purchase, and operation of fixed site and mobile clinical facilities for the analysis, examination, and treatment of respiratory and pulmonary impairments in active and inactive textile plant workers. Requires the Secretary to initiate research within the National Institute for Occupational Safety and Health, and authorizes the Secretary to make research grants to public and private agencies and organizations and individuals for the purpose of devising a simple and effective test to measure, detect, and treat respiratory and pulmonary impairments in active and inactive textile plant workers.
Bill· HRH.R. 3410 (96th)referred
United States · United States Congress · 3 April 1979
Extends the authorization of appropriations to fiscal year: (1) 1985 to assist States in constructing facilities for providing veterans with domiciliary care, nursing home care, and for the alteration and expansion of existing structures for providing such care in State homes; and (2) 1984 for medical information pilot programs. Prohibits the Administrator of Veterans' Affairs from entering into any agreement for providing any assistance to health manpower training programs, to Veterans Administration - affiliated medical schools, or to establish new State medical schools, after December 31, 1979. Authorizes appropriations for such medical schools and training programs for each succeeding fiscal year (presently authorized for each of the six succeeding fiscal years). Eliminates a requirement for grants to affiliated medical schools and to health manpower training institutions that a proposed project will substantially increase the number of students at such medical school or training institution.
Bill· HRH.R. 3368 (96th)referred
United States · United States Congress · 2 April 1979
Nitrite Substitute Research Act - Directs the Secretary of Agriculture to conduct or arrange for the conduct of: (1) further research on the effects of nitrites on animals other than the Sprague-Dawley species of rat; and (2) research on possible nitrite substitutes, and preservative methods and processes, or combinations thereof, that may be used in the preservation of meat, poultry, or fish. Requires the Secretary to report to Congress, one year after enactment, about the actions he has taken to develop an acceptable nitrite substitute. Directs the Secretary to petition the Secretary of Health, Education, and Welfare for the issuance of a regulation prescribing conditions for the safe use of any such nitrite substitute. Authorizes the Secretary to reallocate funds appropriated for the Department of Agriculture for other agricultural research programs to conduct the research required by this Act. Requires the Secretary, within 30 days after enactment, to report to Congress on the funds he plans to commit to nitrite substitute research, on the sources of such funds, and any recommendations about the funding necessary to fully effect such research. Prohibits the Secretary of Agriculture and the Secretary of Health, Education, and Welfare from taking any action under the Wholesome Meat Act, the Federal Food, Drug, and Cosmetic Act, or any other law to prohibit the sale, distribution, or use of nitrites as a food preservative solely on the basis of any carcinogenic effect in humans that nitrites may be represented to have, unless validated evidence is made available to the Secretaries which proves beyond a reasonable doubt that nitrites as a food preservative have a significant carcinogenic effect on humans.
Bill· HRH.R. 3377 (96th)referred
United States · United States Congress · 2 April 1979
Botulism Prevention Act of 1979 - Prohibits the Secretary of Agriculture, for a three-year period, from issuing any order or regulation: (1) restricting the use of nitrites or nitrates as preservatives in meat products to a lesser level than permitted on January 1, 1979; (2) restricting the use of nitrites or nitrates on the basis of test results which show quantities of these or related substances not sufficient ordinarily to render such meat products injurious to health; or (3) requiring labeling on meat products concerning nitrites or nitrates in addition to the requirements in effect on January 1, 1979.
Bill· HRH.R. 3364 (96th)referred
United States · United States Congress · 2 April 1979
Nitrite Moratorium and Food Safety Act - Prohibits the Secretary of Health, Education, and Welfare and the Secretary of Agriculture from prohibiting commerce, prior to May 1, 1980, in any food by reason of the carcinogenic or other toxic effect of the nitrite added to that food, if: (1) addition of such nitrite was permitted under applicable Federal Act on May 1, 1979; and (2) the quantity of such nitrite is within the tolerances in effect on May 1, 1979, or within such tolerances as may thereafter be established, for the purpose of preventing botulism. Prohibits either Secretary from prohibiting commerce on or after May 1, 1980, in any food to which nitrite has been added if the addition of such nitrite: (1) is shown to be safe; or (2) if not shown to be safe, is shown to be necessary to protect against botulism. Extends the period of such moratorium until such time as an alternative anti-toxin becomes available. Requires each Secretary to make an annual review of all regulations issued under this Act in order to determine progress toward making available effective and feasible alternative means for preventing botulism.
Bill· HRH.R. 3391 (96th)referred
United States · United States Congress · 2 April 1979
Nurse Training Amendments of 1979 - Amends title VIII of the Public Health Service Act (Nurse Training) to redefine the purposes of the special projects for which the Secretary of Health, Education, and Welfare is authorized to make grants to nursing schools and entities. Extends the authorization of appropriations through fiscal year 1980 for such special projects and nurse practitioner programs. Eliminates the current requirement that nurse practitioners reside in health manpower shortage areas to participate in traineeship programs. Repeals the provision relating to loan agreements with nursing schools that prohibits a student who has attended such school before October 1, 1978, from receiving a loan from a fund established under the National Defense Education Act of 1958. Amends title VII of such Act ( Health Research and Teaching Facilities and Training of Professional Health Personnel) to eliminate the current requirement that a certain percentage of the funds appropriated for National Health Service Corps scholarships be obligated for specified types of scholarships. Makes full-time students in graduate nursing degree programs eligible for health education assistance loans. Applies the current limitations on individual federally insured loans to such students.
Bill· HRH.R. 3382 (96th)referred
United States · United States Congress · 2 April 1979
Nitrite Moratorium and Research Act - Prohibits the Secretary of Health, Education, and Welfare and the Secretary of Agriculture from prohibiting commerce, prior to April 1, 1982, in any food by reason of the carcinogenic or other toxic effect of the nitrite added to that food, if: (1) addition of such nitrite was permitted under applicable Federal Act on April 1, 1979; and (2) the quantity of such nitrite is within the tolerances in effect on April, 1, 1979, or within such tolerances as may thereafter be established, for the purpose of preventing botulism. Prohibits either Secretary from prohibiting commerce on or after April 1, 1982, in any food to which nitrite has been added unless the addition of such nitrite: (1) is shown not to be safe; or (2) if not shown to be safe, is shown not to be necessary to protect against botulism. Extends the period of such moratorium until such time as an alternative anti-toxin becomes available. Requires each Secretary to make an annual review of all regulations issued under this Act in order to determine progress toward making available effective and feasible alternative means for preventing botulism.
Bill· HRH.R. 3378 (96th)referred
United States · United States Congress · 2 April 1979
Amends the Federal Food, Drug, and Cosmetic Act to repeal the blanket prohibition against regulations deeming safe any cancer-inducing food additives or color additives in food, drugs, or cosmetics. Abolishes the advisory committee of experts established to review regulations disapproving color additives as cancer-inducing.
Bill· HRH.R. 3328 (96th)referred
United States · United States Congress · 29 March 1979
Amends title XVIII (Medicare) of the Social Security Act to authorize payment for specified services performed by chiropractors, including x-rays and for physical examinations, and for related routine laboratory tests.
Bill· SS. 818 (96th)referred
United States · United States Congress · 28 March 1979
Prohibits the Secretary of Agriculture and the Secretary of Health, Education, and Welfare from taking any action under the Wholesome Meat Act, the Federal Food, Drug, and Cosmetic Act, or any other law to prohibit the sale, distribution, or use of nitrites as a food preservative solely on the basis of any carcinogenic effect in humans that nitrites may be represented to have, unless validated evidence is made available to the Secretaries which proves clearly and convincingly that nitrites as a food preservative have a significant carcinogenic effect on humans. States that such prohibition shall not apply if the Secretaries determine that a food preservative is commercially available: (1) which has essentially the same effect on meat products as nitrites; (2) which is effective in the protection of public health from botulism and other forms of food poisoning; and (3) will not impose an unreasonable economic burden on consumers or meat processors. Requires the Secretaries to conduct or support (by grant or contract) research and development activities for a food preservative alternative to nitrites.
Bill· HRH.R. 3313 (96th)referred
United States · United States Congress · 28 March 1979
Amends the Federal Trade Commission Act and the Clayton Act to exempt incorporated or unincorporated, nonprofit professional associations of health care practitioners, who are licensed and regulated by the States, from the Federal Trade Commission Act and the antitrust laws.
Bill· HRH.R. 3304 (96th)referred
United States · United States Congress · 28 March 1979
Amends title XIX (Medicaid) of the Social Security Act to authorize a State plan under such title to provide that, in determining the income and resources of a married couple one spouse of which is in a skilled nursing facility or intermediate care facility, there may be disregarded from income and resources such amounts as a State determines by law.
Bill· HRH.R. 3282 (96th)referred
United States · United States Congress · 28 March 1979
Asbestos School Hazard Detection and Control Act of 1979 - States the purposes of this Act to be to: (1) establish a Federal task force to ascertain the extent of the danger from asbestos materials in schools to children or employees; (2) require States to establish programs for asbestos inspection in schools; (3) provide scientific and technical assistance to States and local school boards; (4) provide loans for the mitigation of serious asbestos hazards in schools; (5) assure that no disciplinary action be taken against employees for calling attention to such hazards; and (6) require certain persons involved in mining, refining, or importing asbestos used in construction material to reimburse the Federal Government for a share of the costs of the asbestos program conducted under this Act. Establishes the Asbestos Hazards School Safety Task Force. States that such Task Force's duties shall include: (1) compiling and disseminating medical, scientific, and technical materials to State and local entities; (2) reviewing and approving State applications for grants and loans; and (3) assisting in formulating standards and safety procedures. Requires State educational agencies which seek administrative funds to submit to the Secretary a plan which: (1) describes the manner such State shall disseminate information on the health hazards of asbestos fibers; (2) describes the content of such information; and (3) describes the procedures to be used by the State in maintaining records on asbestos. Authorizes the Secretary to make grants to local educational agencies for the Federal share of the costs of carrying out an asbestos detection program meeting the standards of this Act. Prohibits the making of such grants unless an application has been submitted to and approved by the Secretary after consultation with the task force. Authorizes the Secretary to allocate up to 20 percent of such asbestos detection funds for use in education and technical assistance programs. Requires recipients of such asbestos detection funds to file a report with the Secretary describing detection and testing activities undertaken, the results, and the plan for correcting any discovered asbestos hazards. Establishes an Asbestos Hazards Control Loan Program in the Department of Health, Education, and Welfare. Stipulates that loans from such program shall be: (1) available only to correct imminent asbestos hazards in schools to school children or school employees; (2) limited to projects covering more than 2,500 square feet; (3) for a period not exceeding 20 years; and (4) interest free. Requires applications for such loans to describe: (1) the nature of the asbestos problem; (2) the results of preliminary testing; and (3) the methods to be used to correct such problem. Requires the Secretary to report annually to the appropriate House and Senate committees regarding such loan program. Directs the Secretary to promulgate and distribute to the States safety standards and procedures for testing the level of asbestos in schools, for determining the likelihood of the leakage of asbestos into the school environment, and for determining which contractors are qualified to carry out testing and evaluation procedures. Stipulates that no employer receiving funds under this Act shall discharge or discriminate against any worker who focuses public attention on an asbestos problem in his or her school district. Stipulates that nothing in this Act shall restrict any other legal rights in connection with the purchase or installation of asbestos materials in schools, or with any claim of disability or death from exposure to asbestos in a school setting.
Bill· SS. 785 (96th)referred
United States · United States Congress · 27 March 1979
Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health, Education, and Welfare to designate an official name for any prescription drug within the purview of such Act. Deems such a prescription drug misbranded if its labeling or advertising bears any name other than such official name. Authorizes the Secretary to exempt such a prescription drug from this labeling and advertising requirement for up to one year in order to avoid confusion and permit the orderly transition of labeling and advertising names.
Bill· SS. 781 (96th)referred
United States · United States Congress · 27 March 1979
Amends the Federal, Food, Drug and Cosmetic Act to permit the Secretary of Health, Education, and Welfare to provide for batch-by-batch certification of a drug within the purview of such Act intended for human use. Establishes the criteria for such certification. Permits the Secretary to issue a release, in lieu of certification, for any batch manufactured prior to the effective date of such certification if the Secretary judges such batch safe. Authorizes the Secretary to exempt certain drugs or categories of drugs from this Act. Permits any interested party to file a petition proposing the issuance, amendment, or repeal of any regulation issued under this Act. Requires the Secretary to: (1) publish notice of such proposal; (2) afford all interested parties an opportunity to present their views; (3) make public his action on such proposals; (4) hold public hearings if objections are made to such action; and (5) make public his action on such objections. Requires every person engaged in the manufacture, compounding, or processing, of any drug within the purview of such Act to maintain records and make such reports relating to clinical experiences as the Secretary determines necessary to assure compliance with such Act.
Bill· SS. 777 (96th)referred
United States · United States Congress · 27 March 1979
Amends the Federal Food, Drug, and Cosmetic Act to require the labeling of certain drugs, whose safety, effectiveness, or potency become diminished after storage, with the date beyond which the drug should not be used.
Bill· SS. 773 (96th)referred
United States · United States Congress · 27 March 1979
Title I: Federal Drug Compendium - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health, Education, and Welfare to prepare and publish a drug compendium and distribute it to all practitioners licensed to prescribe and administer drugs. States that the compendium shall list all drugs by established name and requires such listing to include adequate and reliable prescribing information for each drug. Directs the Secretary to list the proprietary names of all listed drugs and the names of suppliers from whom such drugs may be obtained. Allows the Secretary to issue a price information supplement to the compendium. Permits the Secretary to exclude any drug of questionable safety from the compendium. Establishes procedures to insure due process of law for any person adversely affected by a decision of the Secretary to include or exclude a drug from the compendium. Allows the Secretary to establish an Advisory Committee on matters pertaining to the compendium. Authorizes the Secretary to require persons engaged in manufacturing, preparing, distributing, or importing drugs to furnish any available information relating to such to the Secretary. Empowers the Secretary to require the maintenance of records of clinical experience and other such data relevant to such drugs. Permits the Secretary to waive certain package insert requirements established by regulation. Deems a drug misbranded if it has labeling or advertising inconsistent with the compendium description, except a drug shall not be deemed misbranded solely by reason of such inconsistency if it is in full conformity with labeling regulations. Title II: Drug Certification - Permits the Secretary to require batch-by-batch certification of any drug intended for human use if he determines protection of the public health requires such certification. Requires the certification of any batch of drugs meeting the requirements established by the Secretary. Grants to the Secretary the power to exempt any drug from such certification requirements if in his judgment such certification is no longer necessary to protect the public. Directs the Secretary to promulgate regulations exempting from such certification requirements drugs: (1) processed or packed at a place other than where manufactured, provided such drugs are subsequently certified; (2) used to manufacture other drugs; and (3) used for investigational purposes only. Requires every person manufacturing, compounding, or processing any drug to keep such records and make such reports as the Secretary may require. Permits the Secretary to ban any drug he has found, after holding a hearing, presents an unreasonable risk of illness, injury, or deception and the public cannot be adequately protected by regulation. Title III: Drug Labeling - Requires any drug whose effectiveness or potency diminishes over time to bear a label specifying the date beyond which such drug should not be used. Requires any prescription drug intended for human use and determined to be potentially dangerous when taken as directed to carry a clear warning of such fact on its label. Imposes specific labeling requirements on any drug containing only one active ingredient. Requires the Secretary to designate an official name for any new drug and permits the Secretary to designate an official name for any other drug. Title IV: Administration and Enforcement - Redefines the term "new drug" to delete the exception granted to drugs subject to the Food and Drug Act of 1906. Subjects all new drugs intended for human or animal use to the full requirements of the Federal Food, Drug, and Cosmetic Act. States that misleading advertising or promotional material shall be considered in determining whether an article is misbranded. Deems advertising, labeling, or promotional material misleading if the representations made or suggested by such material bear upon: (1) the safety or effectiveness of a drug and such representations cannot be supported by scientific investigation; or (2) any aspect of a drug and such representations cannot be supported by appropriate data. Exempts specified members of the communication media from the penalties imposed for the dissemination of any false or misleading advertisement or promotional material unless such member refuses a request of the Secretary to furnish the name and address of the party causing such member to disseminate such false advertising on promotional material. Exempts an advertising agency from the penalties imposed for having caused the dissemination of any false advertisement or promotional material unless such agency has refused a request of the Secretary for the name and address of such party causing such agency to disseminate such false advertisement or promotional material. Excludes from the operation of any restraining order or injunction directed against such false advertising or promotional material any issue of a regularly published publication whenever it appears: (1) the regular delivery of such issue would be delayed; and (2) such delay is due to the method of publication and is not a device to avoid such injunction or restraining order. Declares a food or cosmetic misbranded if the advertising or promotional material for such food or cosmetic is misleading. Permits the Secretary to withdraw approval for a new drug if the advertising or promotional material for such drug: (1) suggests such drug will have an effect that is unsupported by evidence; and (2) is false or misleading and was not corrected after notice. Grants to the Secretary certain powers contained in the Federal Trade Commission Act. Includes within the coverage of the inspection and subpena powers of the Secretary: (1) consulting laboratories; and (2) the financial, sales, pricing, and personnel data of any party subject to this Act to the extent that such data relates to representations made in advertising or promotional material. Specifies the term "inspection" shall include the taking of photographs and the copying of documentary materials. Authorizes the Secretary to require by subpena the attendance of witnesses and the production of evidence. Grants use immunity to any person compelled to attend a hearing or produce documentary evidence.
Bill· SS. 787 (96th)referred
United States · United States Congress · 27 March 1979
Public Health Price Protection Act of 1979 - Amends the Public Health Service Act to direct the Secretary of Health, Education, and Welfare to certify to the Federal Trade Commission that the average price to the consumer of a patented drug is more than 500 percent of the direct cost thereof to the producer when such a situation exists. Requires the Federal Trade Commission, upon verification of such certification, to determine whether the existence of a patent has been a substantial contributing factor to the high price of such drug, and if the patent has so contributed, to order the mandatory licensing of such patent with a reasonable royalty rate.
Bill· SS. 783 (96th)referred
United States · United States Congress · 27 March 1979
Drug Quality Control and Formulary Act of 1979 - Establishes a Formulary Committee within the Department of Health, Education, and Welfare for the purpose of compiling and publishing a Formulary of the United States, listing those drugs determined to be necessary for good medical practice. Limits drug purchases or payments therefor by any department or agency of the Government to those drugs listed in the Formulary.
Bill· SS. 784 (96th)referred
United States · United States Congress · 27 March 1979
Federal Drug Compendium Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health, Education, and Welfare to establish a Federal Drug Compendium. Requires the listing of drugs in the Compendium by established name and proprietary name, and permits the issuance of a price information supplement. Authorizes the Secretary to establish an advisory committee to assist him. Imposes reporting, record keeping, and disclosure requirements on manufacturers, processors, and distributors of drugs.
Bill· SS. 780 (96th)referred
United States · United States Congress · 27 March 1979
Drug Amendments Act of 1979 - Eliminates certain exceptions from the definition of the term "new drug" as used in the Federal Food, Drug, and Cosmetic Act. Provides that any drug which is a new drug as defined by such Act is subject to all requirements of such Act without regard to: (1) the dates upon which such drug was ever commercially used or sold in the United States; (2) whether or not a new drug application was in effect on or before October 9, 1962; (3) whether or not such drug was a new drug on or before October 9, 1962 as then defined by the Federal Food, Drug and Cosmetic Act; and (4) whether or not such drug is intended solely for use under the conditions prescribed, recommended, or suggested in labeling with respect to such drug prior to October 9, 1962. Provides that labeling, advertising, or promotional material for an article is deemed to be misleading if the representation made or suggested by statement, word, design, device, or any combination thereof relate to, concern, or otherwise bear upon; (1) the safety or effectiveness of use of a drug or device, unless such representations are based upon adequate and well controlled investigations; and (2) any attributes, characteristics, or qualities of the article, or any matter relating thereto, unless such representations are based on data, upon which experts qualified in the evaluation of such data, could fairly and responsibly conclude that the representations made for the article in its labeling, advertising, or promotional material are fully supported. States that no publisher, radio broadcast licensee, or agency medium for the dissemination of advertising or promotional material, except the manufacturer, packer, distributor, or seller of the article to which the the false advertisement related, shall be liable under this Act for the dissemination of any false advertisement or promotional material unless he has refused, after the request of the Secretary of Health, Education and Welfare, to furnish the name and post office address of the manufacturer, packer, distributor, seller, or advertising agency residing in the United States who caused him to disseminate such advertisement or promotional material. Removes the inspection restrictions, for purposes of enforcement of the Federal Food, Drug, and Cosmetic Act, of research data with respect to drugs. Provides that the Secretary may require by subpoena the attendance and testimony of witnesses and the production of documentary evidence bearing on whether any food, drug, device or cosmetic is in violation of the Federal Food Drug and Cosmetic Act.
Bill· SS. 779 (96th)referred
United States · United States Congress · 27 March 1979
Amends the Federal Food, Drug, and Cosmetic Act to require a statement of: (1) biological criteria relating to therapeutic effectiveness and safety; and (2) performance data relating to such biological criteria, as part of the application for approval of a new drug under such Act. Requires that such information also be on the labeling of a new drug approved for marketing.
Bill· SS. 775 (96th)referred
United States · United States Congress · 27 March 1979
Amends the Federal Food, Drug, and Cosmetic Act to require any drug which the Secretary of Health, Education and Welfare determines to be potentially dangerous to carry a warning on the label. Requires the label to carry additional information if the Secretary determines such information would be in the public interest. Establishes labeling criteria for drugs with: (1) one active ingredient; and (2) those with more than one active ingredient prescribed by either trade or established name. Requires the Secretary to designate an official name of any new drug approved under the Federal Food, and Cosmetic Act, and continues the authority of the Secretary to designate an official name for any other drug or combination of drugs.
Bill· SS. 776 (96th)referred
United States · United States Congress · 27 March 1979
Amends the Federal Food, Drug, and Cosmetic Act to impose certain restrictions on oral representations about drugs made to practitioners or pharmacists by persons involved in the manufacture, preparation, processing, or distribution of such drugs. Prohibits advertising of any drug or device unless the Secretary of Health, Education, and Welfare has first approved such advertising. Specifies the criteria for such approval. Requires any publication intended for health professionals to identify the source of financial support for the author and the research of such publication.
Bill· SS. 772 (96th)referred
United States · United States Congress · 27 March 1979
Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health, Education, and Welfare to impose conditions and limitations on the distribution or prescription of any drug to assure that it is used safely and effectively and that adequate information regarding the effects of such use is furnished to the practitioner licensed to administer such drug. Permits immediate suspension of the marketing of any such drug upon a finding of noncompliance with any such condition or limitation. Requires the labeling of certain new drugs and antibiotics to indicate that their approval is for limited marketing only and that use may involve hazards that have not yet been discovered.
Bill· SS. 786 (96th)referred
United States · United States Congress · 27 March 1979
Amends the Federal Food, Drug, and Cosmetic Act to require that labels of prescription drugs manufactured in final dosage form show the name and place of business of the manufacturer and, if different, the name and place of business of the packer or distributor.
Bill· SS. 782 (96th)referred
United States · United States Congress · 27 March 1979
Sample Drug Regulation Act of 1979 - Amends the Federal Food, Drug, and Cosmetic Act to require the labeling and control of sample prescription drugs. Deems misbranded any such sample drug not so labeled. Limits the distribution of such drugs, and requires manufacturers, processors, distributors, and dispensers to maintain accurate records accessible to investigation by the Secretary of Health, Education, and Welfare.
Bill· SS. 778 (96th)referred
United States · United States Congress · 27 March 1979
Amends the Federal Food, Drug, and Cosmetic Act to prohibit the export of any drug from United States unless it complies with all applicable provisions of such Act. Authorizes the Secretary of Health, Education, and Welfare to permit the export of a drug if the Secretary finds that such export: (1) is for health purposes; and (2) has the approval of the receiving country, even though it does not comply with such Act.
Bill· SS. 774 (96th)referred
United States · United States Congress · 27 March 1979
National Drug Testing and Evaluation Act of 1979 - Establishes a National Drug Testing and Evaluation Center which shall be operated and maintained as a part of the Food and Drug Administration subject to the supervision and control of the Secretary of Health, Education, and Welfare. Provides that the Secretary of Health, Education, and Welfare shall be responsible for conducting all tests for investigations on new drugs submitted to him for approval in order to determine whether such new drugs should be approved for commercial distribution, and shall be responsible for conducting tests or investigations on drugs which have been approved to determine whether or not approval of such drugs should be withdrawn. Authorizes the Secretary to contract out such studies to qualified individuals, organizations, or institutions and makes it his responsibility to insure that the testing or investigation of any drug is conducted by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. Directs that the sponsor of any drug submitted to the Secretary for testing and investigation, upon request, be provided with a report every 60 days on the results of the testing or investigation. Establishes a three-member drugs testing review panel to review, upon request of the sponsor, any facet of the investigation to which the sponsor objects. Provides that the sponsor of any new drugs submitted to the Secretary for testing or investigation shall be liable for the expenses incurred, including a appropriate share of the cost of staffing, maintaining and equipping the Center. Establishes a National Drug Testing Evaluation Center Fund which shall be available to the Secretary for the purpose of establishing the National Drug Testing Evaluation Center, for the purpose of furnishing initial working capital, and for other specified purposes. States that nothing in this Act prohibits the sponsor of any drug from conducting tests or investigations on such drug in accordance with other provisions of the Food and Drug Act.
Bill· HRH.R. 3276 (96th)referred
United States · United States Congress · 27 March 1979
Catastrophic Health Insurance Act - Title I: Catastrophic Illness Insurance - Establishes a Catastrophic Health Insurance program under the Social Security Act. Sets forth the eligibility criteria for individuals. Entitles every individual who: (1) is a resident of the United States; and (2) is a citizen of, or a lawfully admitted alien in, the United States to catastrophic health insurance benefits provided by this Act in cases where the individual is not covered by an employer plan. Delimits the scope of benefits, including therein hospital and related insurance benefits (hospital, post-hospital and home health services) and medical and other health services. Provides for a general deductible from: (1) the reasonable costs of inpatient hospital services past 60 days; and (2) inpatient hospital benefits of the higher of the following: (A) $2,000 or (B) $2,000 adjusted by the Consumer Price Index to reflect changes in fees for physician services (in $100 increments). Permits payments for specified mental health care services. Requires the Secretary of Health, Education, and Welfare to promulgate regulations prescribing standards designed to assure that services consisting of the furnishing of blood or blood products, or the application of procedures or courses of treatment which are experimental or extraordinarily complex, will be provided only when such services are appropriate to the health care needs of the patient. Creates, in the United States Treasury, a Federal Catastrophic Health Insurance Trust Fund to provide a reserve for payment of benefits authorized by this Act. States that individuals covered under approved employer or self-employed plans shall be entitled to those benefits rather than the benefits provided by the catastrophic health insurance plan. Defines the term "employer plan" as meaning an insurance policy, contract, or other arrangement entered into between an employer and a carrier, in consideration of premiums or other periodic payments, undertaken to pay for the costs of health services received by the employer's employees. Requires that the coverage provided under such plans must include a package of benefits which is the same as that provided by the Federal catastrophic health insurance benefits plan established under this Act. Sets forth additional requirements governing employer health plans. Establishes an Actuarial Committee to prepare and recommend annually to the Secretary a Table of Values of Catastrophic Health Insurance Coverage, which shall establish the actuarial value of one year's catastrophic health insurance coverage for employers, carriers, and others involved in the programs. Creates a tax on self-employment income and an excise tax on employers. Allows a tax credit up to the entire amount of such taxes under the Internal Revenue Code for the actuarial value of catastrophic health insurance coverage for the self-employed and for the employees covered under approved employer plans. Title II: Private Basic Health Insurance Certification Program - Establishes a program, under the Social Security Act, under which any insurer may submit any health insurance policy to the Secretary for examination and certification. Sets forth the standards under which the Secretary shall deny certification of any such insurance policy. Requires the Secretary to offer basic Federal health insurance to individuals residing in States in which no private health insurance program has been certified. Title III: Other Amendments - Authorizes payments for immunizations which the Secretary determines are appropriate under title XVIII (Medicare) of the Social Security Act, but only if provided on a scheduled allowance basis, as determined under regulations promulgated by the Secretary. Increases the amount of reimbursement under Medicare for outpatient mental health care. Reduces the monthly premium for optional coverage under the Medicare hospital insurance programs. Extends coverage of the renal disease program authorized under such Act to specified individuals not previously covered. Expresses the policy of Congress to encourage and expand philanthropic support for health care.