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Bill· SS. 2545 (108th)referred
United States · United States Congress · 17 June 2004
Advance Directives Improvement and Education Act of 2004 - Amends title XVIII (Medicare) of the Social Security Act, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, to provide for Medicare coverage of end-of-life planning consultations. Requires a service provider, Medicare Advantage organization, or prepaid or eligible organization to give effect to an advance directive executed outside the State in which it is presented, even one that does not appear to meet the formalities of execution, form, or language required by the State in which it is presented, to the same extent as such provider or organization would give effect to an advanced directive that meets such requirements. Permits a provider or organization to decline to honor such a directive if the provider or organization can reasonably demonstrate that it is not an authentic expression of the individual's wishes concerning his or her health care. Makes such advance directive requirements applicable under Medicaid, title XIX of the Social Security Act. Amends the Public Health Service Act to provide for grant programs to increase awareness of advance directive planning issues. Directs the Secretary to conduct a national public education campaign to: (1) raise public awareness of the importance of planning for care near the end of life; (2) improve the public's understanding of the various situations in which individuals may find themselves if they become unable to express their health care wishes; (3) explain the need for readily available legal documents that express an individual's wishes, through advance directives (including living wills, comfort care orders, and durable powers of attorney for health care); and (4) educate the public about the availability of hospice care and palliative care. Directs the Secretary to provide for the establishment of a national, toll-free, information clearinghouse as well as clearinghouses that the public may access to find out about State-specific information regarding advance directive and end-of-life decisions. Requires General Accounting Office studies and reports on end-of-life planning issues.
Bill· SS. 2535 (108th)referred
United States · United States Congress · 17 June 2004
Medicare Preventive Services Coverage Act of 2004 - Amends part B (Supplementary Medical Insurance Benefits for Aged and Disabled) of title XVIII (Medicare) of the Social Security Act to require the part B program to provide appropriate preventive benefits. Amends part E (Miscellaneous), as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, to provide for additional preventive services (including mental health services) under Medicare. Eliminates coinsurance in outpatient department (OPD) hospital settings and application of deductible with respect to additional preventive services.
Resolution· SCONRESS.Con.Res. 119 (108th)referred
United States · United States Congress · 17 June 2004
Recognizes as a compelling national priority the need to increase awareness about and prevent suicide. Reaffirms Congress's commitment to the priorities expressed in prior legislation (which recognized suicide as a national problem and declared suicide prevention to be a national priority). Encourages Americans, communities, and the nation to work to increase awareness about and prevent suicide.
Bill· HRH.R. 4610 (108th)referred
United States · United States Congress · 17 June 2004
Arthritis Prevention, Control, and Cure Act of 2004 - Amends the Public Health Service Act to require the Secretary of Health and Human Services: (1) to develop and implement a National Arthritis Action Plan; and (2) acting through the Director of the Centers for Disease Control and Prevention (CDC), to conduct, support, and promote the coordination of arthritis and other rheumatic diseases research. Requires the Secretary to award grants to: (1) support arthritis-specific research projects at the Centers for Prevention Research by the CDC; (2) support State comprehensive arthritis control and prevention programs and public health surveillance, prevention, and control activities; and (3) assist in the implementation of a national strategy for arthritis control and prevention. Requires the Secretary to coordinate a national education and outreach program on arthritis and other rheumatic diseases. Requires the Secretary to establish an Arthritis and Rheumatic Diseases Interagency Coordinating Committee to: (1) improve coordination of Federal research activities related to arthritis and rheumatic diseases; and (2) convene a summit to provide a detailed overview of such current Federal research. Requires the Director of the National Institutes of Health to expand and intensify juvenile arthritis research and related programs, including by awarding grants to establish new research programs. Allows the Secretary, acting through the Director of the CDC, to award grants to support the collection, analysis, and reporting of data on juvenile arthritis. Requires the Secretary, acting through the Director of the CDC, to support the development of a National Juvenile Arthritis Patient Registry to collect data for follow-up studies regarding the prevalence and incidence of juvenile arthritis, as well as capturing information on evidence-based health outcomes related to specific therapies and interventions. Requires the Secretary to promote and support pediatric rheumatology training, including by allowing the Secretary to establish a loan repayment program. Requires the Comptroller General of the United States to conduct a study on the economic impact of arthritis in the workplace.
Resolution· HCONRESH.Con.Res. 456 (108th)referred
United States · United States Congress · 17 June 2004
Recognizes as a compelling national priority the need to increase awareness about and prevent suicide. Reaffirms Congress's commitment to the priorities expressed in prior legislation (which recognized suicide as a national problem and declared suicide prevention to be a national priority). Encourages Americans, communities, and the nation to work to increase awareness about and prevent suicide.
Bill· SS. 2533 (108th)referred
United States · United States Congress · 16 June 2004
Ronald Reagan Alzheimer's Breakthrough Act of 2004 - Amends the Public Health Service Act to make Alzheimer's disease research a priority within the National Institute on Aging. Requires the Director of the Institute to: (1) undertake an Alzheimer's Disease Prevention Initiative to accelerate the discovery of new risk and protective factors, to rapidly identify therapies and preventive interventions, and to implement effective prevention and treatment strategies; (2) conduct and support cooperative clinical research regarding Alzheimer's; and (3) conduct research concerning early detection and diagnosis, the relationship between Alzheimer's and vascular disease, and interventions designed to help caregivers. Authorizes the Director to establish a National Alzheimer's Coordinating Center to facilitate collaboration among Alzheimer's Disease Centers and Alzheimer's Disease Research Centers. Requires the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), to educate the public and public health community regarding Alzheimer's disease. Authorizes the Secretary to award grants or cooperative agreements to develop coordinated respite care programs on a statewide basis. Defines "respite care" to mean planned or emergency care provided to a child or adult with a special need in order to provide temporary relief to the family caregiver of such child or adult. Directs the Secretary to award a grant or cooperative agreement to a public or private nonprofit entity to establish a National Resource Center on Lifespan Respite Care. Amends the Internal Revenue Code to allow: (1) a nonrefundable tax credit for each individual certified as having long-term care needs and for whom the taxpayer is acting as a caregiver; (2) a tax deduction for long-term care premiums paid under a qualified insurance contract; and (3) qualified long-term care insurance to be offered in a cafeteria plan and flexible spending arrangements.
Bill· SS. 2526 (108th)referred
United States · United States Congress · 16 June 2004
Children's Hospitals Educational Equity and Research Act of 2004 or CHEER Act - Amends the Public Health Service Act to require the Secretary of Health and Human Services to make payments through FY 2010 (currently, through FY 2005) to children's hospitals for costs associated with operating approved graduate medical resident training programs.
Bill· SS. 2524 (108th)open
United States · United States Congress · 16 June 2004
Directs the Secretary of Veterans Affairs (Secretary) to establish and operate at least one, but not more than three, centers for research, education, and clinical activities on blast injuries. Requires the Secretary to designate a center or centers upon the recommendation of the Under Secretary for Health subject to specified requirements and findings. Requires the official within the central office of the Veterans Health Administration (VHA) responsible for blast injury matters to establish a peer review panel to assess the scientific and clinical merits of proposals for the designation of centers. Authorizes clinical and scientific investigation activities at each center to compete on a priority basis for the award of funds from amounts appropriated to the Department of Veterans Affairs for medical and prosthetics research. Requires the Under Secretary for Health to ensure that useful information produced by the centers is disseminated throughout the VHA. Gives responsibility for supervising operation of the centers to the official within the central office of the VHA responsible for blast injury matters. Requires the Secretary to designate at least one center no later than January 1, 2005. Directs the Secretary to submit reports on center activities to the House and Senate Veterans' Affairs Committees.
Bill· SS. 2530 (108th)referred
United States · United States Congress · 16 June 2004
Unshackle Seniors Act of 2004 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to permit Medicare beneficiaries to purchase more than one prescription drug discount card. Authorizes an individual to elect to disenroll from a prescription drug program, and receive a mandatory refund of the entire annual enrollment fee, if: (1) the individual is involuntarily disenrolled from the program for a reason that is not the individual's fault; (2) the negotiated price of a covered discount card program increases; or (3) the card sponsor changes the applicable formulary.
Bill· SS. 2531 (108th)referred
United States · United States Congress · 16 June 2004
Keeping American Jobs at Home Act - Amends the Internal Revenue Code to: (1) prohibit tax credits or deductions for certain expenses relating to the outsourcing of goods and services from the United States; (2) provide for advance payments of the health insurance tax credit for trade adjustment assistance workers (TAA workers) for months prior to the issuance of a qualified health insurance costs credit eligibility certificate; (3) cover spouses of Medicare-eligible TAA workers under such tax credit; and (4) increase the amount of such tax credit from 65 to 75 percent of health insurance costs. Amends the Trade Act of 1974 to: (1) extend trade adjustment assistance to workers in the service sector and public agencies; (2) increase funding levels for job retraining programs; and (3) establish a wage insurance program for displaced workers which includes health insurance benefits. Creates a business judgment defense to shareholder lawsuits to protect corporate officers or directors who determine that it is in the best interest of their corporations to keep jobs or other business activities in the United States. Amends the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act, and the Internal Revenue Code to: (1) prevent a lapse of health care coverage for TAA workers; and (2) align coverage periods under such Acts with eligibility periods for TAA workers. Amends the Workforce Investment Act of 1998 to require a State or entity to use national emergency grant funds to provide TAA workers and their family members with health insurance coverage for periods prior to their first eligibility month.
Bill· HRH.R. 4598 (108th)open
United States · United States Congress · 16 June 2004
Accutane Safety and Risk Management Act - Requires the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to withdraw approval within 30 days for the sale of drugs that contain isotretinoin as an active ingredient, including Accutane. Allows the Secretary to approve subsequent supplemental applications for such drugs subject to certain restrictions, including safety reporting. Requires that distribution of such drugs be limited, including by: (1) allowing distribution only directly from manufacturers to pharmacists; (2) requiring pharmacists to register, receive education on side effects, dispense only those prescriptions from physicians at certified treatment centers, and file a statement of compliance; (3) developing educational materials for patients, including monthly questionnaires for patients to monitor the development of adverse side effects; (4) requiring patients to register, receive counseling on the drug, sign a statement providing informed consent for treatment, and undergo appropriate tests; and (5) limiting prescriptions to a 30-day supply with no refills. Specifies conditions for a clinic to be certified as a treatment center for a drug containing isotretinoin, including requiring each practitioner to meet certain conditions, such as requirements for registration, an agreement to prescribe in accordance with this Act, and reporting of adverse events. Requires the Secretary to monitor the distribution of such drugs to determine whether the drug is being distributed in accordance with this Act. Requires manufacturers and distributors of isotretinoin to report any information on adverse events associated with the drug to the Secretary. Requires the Secretary to conduct and support studies to explore the effects of isotretinoin on the central nervous system and behavior, including depression, suicide, and violent behavior.
Bill· HRH.R. 4595 (108th)referred
United States · United States Congress · 16 June 2004
Ronald Reagan Alzheimer's Breakthrough Act of 2004 - Amends the Public Health Service Act to make Alzheimer's disease research a priority within the National Institute on Aging. Requires the Director of the Institute to: (1) undertake an Alzheimer's Disease Prevention Initiative to accelerate the discovery of new risk and protective factors, to rapidly identify therapies and preventive interventions, and to implement effective prevention and treatment strategies; (2) conduct and support cooperative clinical research regarding Alzheimer's; and (3) conduct research concerning early detection and diagnosis, the relationship between Alzheimer's and vascular disease, and interventions designed to help caregivers. Authorizes the Director to establish a National Alzheimer's Coordinating Center to facilitate collaboration among Alzheimer's Disease Centers and Alzheimer's Disease Research Centers. Requires the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), to educate the public and public health community regarding Alzheimer's disease. Authorizes the Secretary to award grants or cooperative agreements to develop coordinated respite care programs on a statewide basis. Defines "respite care" to mean planned or emergency care provided to a child or adult with a special need in order to provide temporary relief to the family caregiver of such child or adult. Directs the Secretary to award a grant or cooperative agreement to a public or private nonprofit entity to establish a National Resource Center on Lifespan Respite Care. Amends the Internal Revenue Code to allow: (1) a nonrefundable tax credit for each individual certified as having long-term care needs and for whom the taxpayer is acting as a caregiver; (2) a tax deduction for long-term care premiums paid under a qualified insurance contract; and (3) qualified long-term care insurance to be offered in a cafeteria plan and flexible spending arrangements.
Bill· SS. 2519 (108th)referred
United States · United States Congress · 15 June 2004
Iraqi Women and Children's Liberation Act of 2004 - Expresses the sense of Congress that: (1) the United States should ensure that women and children in Iraq benefit from the liberation of Iraq; (2) women of all ethnic groups in Iraq should be included in the economic and political reconstruction of Iraq; and (3) the Government of Iraq should adhere to internationally accepted standards on human rights and rights of women and children. Authorizes the President to provide assistance for: (1) education and health care for Iraqi women and children living in Iraq or living as refugees in other countries; and (2) enhancement of political participation, economic empowerment, civil society, and personal security of women in Iraq. Expresses the sense of Congress that the President should ensure that such assistance is: (1) provided in a manner that protects and promotes the human rights of all people in Iraq, utilizing indigenous institutions and nongovernmental organizations, especially women's organizations; and (2) conditioned on the government of Iraq making continued progress toward internationally accepted standards of human rights and the rights of women.
Bill· HRH.R. 4578 (108th)referred
United States · United States Congress · 15 June 2004
Children's Hospitals Education Equity and Research (CHEER) Act of 2004 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to make payments through FY 2010 (currently, through FY 2005) to children's hospitals for costs associated with operating approved graduate medical resident training programs.
Bill· HRH.R. 4557 (108th)referred
United States · United States Congress · 14 June 2004
Youth Suicide Early Intervention and Prevention Expansion Act of 2004 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to award grants or cooperative agreements to eligible entities that: (1) develop and implement statewide youth suicide early intervention and prevention strategies in schools, educational institutions, juvenile justice systems, substance abuse programs, mental health programs, foster care systems, and other child and youth support organizations; (2) collect and analyze data on statewide youth suicide early intervention and prevention services to monitor the effectiveness of such services and for research, technical assistance, and policy development; and (3) assist States in achieving their targets for youth suicide reductions. Provides for preferential treatment in the award of grants for entities that engage in certain specified activities. Requires the Secretary to: (1) award technical assistance grants and cooperative agreements to State agencies to conduct assessments of the development of such intervention and prevention strategies; (2) conduct research and development on the efficacy of new and existing youth suicide early intervention techniques and technology; (3) promote the sharing of this research and development with relevant Federal and State agencies and statewide entities for the purpose of applying and integrating new techniques and technology into existing intervention systems; (4) collaborate with specified agencies, organizations, and individuals to carry out this Act; and (5) conduct an evaluation of the effectiveness of the activities conducted under this Act.
Law· HRH.R. 4555 (108th)enacted
United States · United States Congress · 14 June 2004
Mammography Quality Standards Reauthorization Act of 2004 - Amends the Public Health Service Act to authorize the Secretary of Health and Human Services to issue a temporary renewal certificate to a mammography facility seeking reaccreditation if the accreditation body has issued an accreditation extension because the facility: (1) has submitted the required materials but the accreditation body is unable to complete the reaccreditation process before the certificate expires; or (2) has acquired additional or replacement equipment or has had significant personnel changes or other unforeseen situations that have caused it to be unable to meet reaccreditation time frames but that have not compromised mammography quality. Authorizes the Secretary, upon the request of an accreditation body, to issue a limited provisional certificate to an entity to conduct examinations for educational purposes during an on-site visit by an accreditation body.
Bill· HRH.R. 4543 (108th)referred
United States · United States Congress · 9 June 2004
Post-Abortion Depression Research and Care Act - Requires the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health and the Director of the National Institute of Mental Health, to expand and intensify research and related activities of the Institute with respect to post-abortion depression and post-abortion psychosis. Requires the Director of the National Institute of Mental Health to: (1) conduct or support research to expand the understanding of the causes of, and to find a cure for, post-abortion conditions; and (2) conduct a national longitudinal study to determine the incidence and prevalence of cases of post-abortion conditions and the symptoms, severity, and duration of such cases, toward the goal of more fully identifying the characteristics of such cases and developing diagnostic techniques. Requires the Secretary to make grants to establish, operate, and coordinate effective and cost-efficient systems for the delivery of essential services to individuals with post-abortion depression or post-abortion psychosis.
Bill· HRH.R. 4531 (108th)referred
United States · United States Congress · 9 June 2004
Ronald Reagan Memorial Stem Cell Research Act of 2004 - Requires the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, to conduct and support research using human pluripotent stem cells. Requires that the research be conducted in compliance with the National Institutes of Health guidelines published on August 25, 2000, including provisions regarding informed consent and areas of research that are ineligible for funding, without regard to any Federal administrative policies regarding such research established after the publication of such guidelines, including restrictions on the sources of human pluripotent stem cells.
Resolution· HRESH.Res. 669 (108th)passed
United States · United States Congress · 9 June 2004
Commends national and community organizations and health care providers for supplying information concerning the importance of screening for prostate cancer and the treatment options. Declares that the Federal Government and the States should ensure that health care providers supply patients with appropriate information and tools necessary to receive readily understandable information about all medically efficacious treatments for prostate cancer.
Bill· SS. 2512 (108th)referred
United States · United States Congress · 8 June 2004
Drug Discount Card Simplification Act of 2004 - Amends title XVIII (Medicare) of the Social Security Act, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, to require the Secretary, on and after January 1, 2005, to limit to not more than three the number of prescription drug card sponsors in a State. Provides that on and after January 1, 2005: (1) the negotiated price of each covered discount card drug dispensed to an individual enrolled in an endorsed discount card program may not exceed the negotiated price of that drug under such program as of December 31, 2004; and (2) each prescription drug card sponsor shall ensure that the price paid by pharmacies participating in its network for each covered discount card drug dispensed to an individual enrolled in an endorsed discount card program offered by such sponsor does not exceed the price paid by those pharmacies for each such drug as of December 31, 2004. Requires sponsors that offer an endorsed discount card program to provide each discount card eligible individual enrolled in the program with access to negotiated prices for each covered discount card drug for which a negotiated price was available under such program as of December 31, 2004.
Resolution· SRESS.Res. 370 (108th)passed
United States · United States Congress · 7 June 2004
Designates September 7, 2004, as National Attention Deficit Disorder Awareness Day. Recognizes Attention Deficit/Hyperactivity Disorder (AD/HD) as a major public health concern. Encourages people to find out more about AD/HD and supporting mental health services and to seek treatment and support. Expresses the sense of the Senate that the Government has the responsibility to: (1) raise public awareness about AD/HD; and (2) consider ways to improve mental health services for children and adults with AD/HD.
Bill· SS. 2500 (108th)referred
United States · United States Congress · 3 June 2004
Assistance for Orphans and Other Vulnerable Children in Developing Countries Act of 2004 - Amends the Foreign Assistance Act of 1961 to authorize the President to provide assistance for basic care for orphans and other vulnerable children in developing countries, including assistance for: (1) community-based care; (2) school food programs; (3) education and employment training; (4) mental health care; and (5) protection of inheritance rights. Directs the President to develop a coordinating strategy for such assistance.
Bill· HRH.R. 4498 (108th)referred
United States · United States Congress · 3 June 2004
Small Employers Health Benefits Program Act of 2004 - Directs the Office of Personnel Management to administer a separate health insurance program for non-Federal employees who are either self-employed or employees of a small business with fewer than 100 employees. Allows the Office to contract with carriers to provide health insurance under this Act. Requires rates charged to reasonably and equitably reflect the costs of the benefits provided. Permits rates and premiums to vary based on age but not on health status factors. Permits the Office to reimburse a carrier for costs that exceed premiums received by a specified percentage. Requires a carrier to make payments to a contingency reserve fund established by the Office if the carrier's costs are lower than expected by a specified percentage. Allows the Office to use such funds to provide assistance to carriers that experience unanticipated financial hardships. Requires the Office to establish a reinsurance fund to provide payments to carriers that experience a catastrophic claim (a claim over $50,000) for benefits provided to an individual enrolled under this Act. Allows a participating employer to offer supplemental coverage options to employees for excepted benefits that are not subject to the Public Health Service Act requirements for health plans. Authorizes the Office to contract with entities to administer this health program regionally. Allows certain benefits to be offered to Medicare beneficiaries. Requires the Office to implement a public education campaign regarding this health insurance program. Allows a refundable tax credit for health insurance expenses of small employers who pay a specific percentage of employee expenses under such a health plan.
Bill· HRH.R. 4512 (108th)referred
United States · United States Congress · 3 June 2004
Medicare Prescription Drug Improvement Act - Amends title XVIII (Medicare) of the Social Security Act to repeal provisions prohibiting the Secretary of Health and Human Services from interfering with the negotiations between drug manufacturers and pharmacies and prescription drug plan sponsors. Grants the Secretary authority similar to that of the Secretary of Veterans Affairs, Secretary of Defense, and the heads of other Federal agencies and departments that purchase prescription drugs in bulk to negotiate contracts with manufacturers of covered Medicare part D (Voluntary Prescription Drug Benefit Program) drugs. Eliminates the initial coverage limit on the maximum costs that may be recognized for payment purposes (including the annual deductible) with respect to prescription drug benefits. Pharmaceutical Market Access Act of 2004 - Amends the Federal Food, Drug and Cosmetic Act to: (1) repeal certain sections of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 relating to importation of prescription drugs from Canada. and (2) restore previous law. Amends such restored law to direct the Secretary to promulgate regulations allowing qualifying individuals (in addition to pharmacists and wholesalers) to import covered products. Repeals the mandate that the Secretary require that a foreign seller specify the original source of the product and the amount of each lot of the product originally received. Amends provisions regarding the testing of imported covered products. Declares that specified tests shall not be required unless the importer is a wholesaler. Requires such tests to be conducted by the importer-wholesaler unless a product is a prescription drug subject to the provisions of this Act pertaining to counterfeit-resistant packaging. Classifies prescription drugs as misbranded if they do not incorporate specified counterfeit-resistant technologies in packaging. Directs the Secretary to require that the packaging of any subject drug incorporate specified overt optically variable counterfeit-resistant technologies.
Bill· HRH.R. 4511 (108th)referred
United States · United States Congress · 3 June 2004
Justice and Understanding By IMF Loan Elimination and Equity (JUBILEE) Act of 2004 - Amends the International Financial Institutions Act to require the Secretary of the Treasury to commence immediate efforts, within the Paris Club of Official Creditors, the International Monetary Fund (IMF), and other appropriate multilateral development institutions (MDI's), to accomplish: (1) cancellation of all debts owed to the IMF by specified eligible poor countries, and the financing of such debt cancellation from ongoing IMF operations, procedures, and accounts established as of the end of the most recent fiscal year, including the Poverty Reduction and Growth Facility (formerly known as the Enhanced Structural Adjustment Facility or ESAF); (2) limitation of any waiting period before receipt of debt cancellation to one month from the date of an eligible poor country's application for it; and (3) encouragement of the government of each eligible poor country to allocate at least 20 percent of its national budget, including the savings from such debt cancellation, for the provision of basic health care services, education services, and clean water services to individuals in the country. Sets forth requirements for: (1) a prohibition against the IMF's requiring any country receiving new concessional loans to privilege the IMF as a creditor over the United States; (2) establishment of a framework to ensure the transparency regarding each international financial institution's activities; and (3) availability on the Treasury Department's website of U.S. Executive Directors' remarks at meetings of international financial institutions' Boards of Directors. Requires the Secretary to commence immediate efforts, within the Paris Club, the IMF, and other appropriate MDI's, to ensure that the provision of debt cancellation to such countries is not conditioned on any agreement by such a country to implement or comply with specified policies that deepen poverty or degrade the environment. Bars funds appropriated in any Act (except those providing for debt relief to poor countries) from being obligated or made available to IMF unless specified conditions are met relating to debt cancellation for all eligible poor countries and termination of conditioning debt relief on certain structural adjustment.
Bill· SS. 2491 (108th)open
United States · United States Congress · 2 June 2004
Allied Health Reinvestment Act - Amends the Public Health Service Act to require the Secretary of Health and Human Services to develop public service announcements to promote the allied health professions. Requires the Secretary to award grants to promote such professions by: (1) supporting relevant State and local campaigns; (2) increasing education opportunities; (3) carrying out programs to facilitate the entry of students into relevant careers; (4) expanding enrollment into such programs; (5) providing education through new technologies and methods; (6) enhancing the workforce through retention programs; (7) developing retention strategies; (8) expanding area health education centers to develop models of excellence for such professionals; and (9) developing clinical education, internship, and resident programs that encourage mentoring and the development of specialties. Requires the Secretary, acting through the Administrator of the Health Resources and Services Administration, to enter into agreements to establish faculty loan funds to increase the number of qualified allied health faculty. Requires the Secretary to: (1) provide scholarships to individuals seeking allied health education who agree to provide service in rural and other medically underserved areas with personnel shortages; (2) develop a system for collecting and analyzing workforce data to determine education pipeline and practitioner shortages and to project future needs for such a workforce; and (3) include allied health schools among the schools eligible to receive grants to support Centers of Excellence in health professions education for underrepresented minority individuals. Requires the Comptroller General to conduct an evaluation of whether this Act has demonstrably increased the number of allied health education program applicants.
Bill· SS. 2493 (108th)referred
United States · United States Congress · 2 June 2004
Safe Importation of Medical Products and Other Rx Therapies Act of 2004 or Safe IMPORT Act of 2004 - Amends the Federal Food, Drug, and Cosmetic Act to allow individuals to import Food and Drug Administration (FDA)-approved prescription drugs from Canada for personal use. Permits the importation of prescription drugs from Canada by registered Internet pharmacies, pharmacies, or wholesalers in one year under specified conditions, including meeting proper labeling on all dispensed drugs to indicate that the drug has been imported. Allows the Secretary of Health and Human Services to designate additional countries from which to allow importation in three years. Requires the Secretary to give high priority to improving the information management systems of the FDA to improve the detection of intentionally adulterated prescription drugs. Sets forth Internet pharmacy licensing requirements and procedures. Makes providers of interactive computer and advertising services liable for violations under this Act if such providers accept advertising: (1) for a prescription drug from an unlicensed Internet pharmacy; or (2) stating that an individual does not need a prescription to obtain a prescription drug. Requires the Secretary to promulgate regulations requiring designated payment systems, including credit card companies, to prevent sales by unlicensed Internet pharmacies. Allows the FDA to detain or temporarily hold prescription drug shipments based on credible information that a drug presents a risk to the public health. Allows the Secretary to: (1) suspend or debar importation of a particular drug or dosage that poses such a risk or by a particular importer who violates Act requirements; (2) require owners of prescription drugs that have been refused admission into the United States to indicate that information on the drug containers; and (3) authorize other Federal and State officials to conduct inspections to enforce compliance with this Act Deems to be misbranded a prescription drug offered for importation that has previously been refused admission, unless the person reoffering the drug affirmatively establishes that it complies with applicable requirements. Sets forth anti-counterfeiting provisions.
Bill· SS. 2492 (108th)referred
United States · United States Congress · 2 June 2004
Improving Access to Nurse-Midwife Care Act of 2004 - Amends title XVIII (Medicare) of the Social Security Act to provide for the coverage of and payment for certified midwife services (currently only certified nurse-midwife services are covered) under Medicare part B (Supplementary Medical Insurance). Declares that nothing precludes certified nurse-midwives and certified midwives from teaching or supervising an intern or resident-in-training. Authorizes payment for such services to a person or entity (or the agent of such person or entity) the certified nurse-midwife (CNM) or certified midwife (CM) may designate under an agreement between the CNM or CM and such person or entity (by implication, including a free-standing birth center).
Bill· SS. 2487 (108th)referred
United States · United States Congress · 2 June 2004
Right Prescription for Seniors Act of 2004 - Amends title XVIII (Medicare) of the Social Security Act, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, to ensure that Medicare beneficiaries have access to a Medicare administered prescription drug plan option. Repeals provisions prohibiting the Secretary from interfering with the negotiations between drug manufacturers and pharmacies and prescription drug plan sponsors and from requiring a particular formulary or instituting a price structure for the reimbursement of covered part D drugs. Grants the Secretary the authority similar to that of other Federal entities that purchase prescription drugs in bulk to negotiate contracts with manufacturers of covered part D drugs, consistent with the requirements and in furtherance of the goals of providing quality care and containing costs. Requires the Secretary to use such authority to negotiate the prices of such drugs under prescription drug plans offered by PDP sponsors. Amends the Federal Food, Drug and Cosmetic Act to direct the Secretary to promulgate regulations allowing qualifying individuals to import covered products (in addition to pharmacists and wholesalers, whom current law authorizes to import such products). States that the Secretary shall not have to store records in cases in which qualifying individuals have imported a covered product. Amends provisions regarding the importation of covered products, repealing the mandate that the Secretary require that a foreign seller specify the original source of the product and the amount of each lot of the product originally received. Amends provisions regarding the testing of imported covered products. Declares that specified tests, including ones involving authenticity and degradation of products, shall not be required unless the importer is a wholesaler. Requires such tests to be conducted by the importer unless a product is a prescription drug subject to requirements for counterfeit-resistant packaging. (Currently either the importer or the manufacturer may conduct such tests). Eliminates the sunset date current law establishes for the provisions pertaining to the importation of covered products (thus making such provisions permanent). Limits prescription drug benefits for Members of Congress.
Bill· HRH.R. 4493 (108th)referred
United States · United States Congress · 2 June 2004
Newborn Screening Saves Lives Act of 2004 - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Associate Administrator of the Maternal and Child Health Bureau of the Health Resources and Services Administration, to awards grants to eligible entities to: (1) provide education and training in newborn screening and congenital, genetic, and metabolic disorders to health care professionals and State health department laboratory personnel; (2) develop educational programs about newborn screening for parents, families, and parents advocacy and support groups; and (3) establish, maintain, and operate a system to assess and coordinate treatment relating to congenital, genetic, and metabolic disorders.
Bill· HRH.R. 4491 (108th)referred
United States · United States Congress · 2 June 2004
Amends title XVIII (Medicare) of the Social Security Act, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, to repeal the reduction in Medicare payment for certain items of durable medical equipment.
Resolution· HRESH.Res. 659 (108th)referred
United States · United States Congress · 2 June 2004
Recognizes the need for consistent information, regulations, and guidelines regarding the safe disposal of used syringes outside medical facilities.
Law· SS. 2484 (108th)enacted
United States · United States Congress · 1 June 2004
Department of Veterans Affairs Health Care Personnel Enhancement Act of 2003 - Sets forth new pay provisions for physicians and dentists employed by the Veterans Health Administration. Requires total pay to be benchmarked to representative salaries for non-Department positions and to include three components: (1) base pay that is uniform nationwide; (2) market pay that varies based on geographic area, specialty, assignment, personal qualifications, and individual experience; and (3) performance pay linked to the achievement of specific corporate goals and individual performance objectives. Caps total compensation at the amount of annual compensation (excluding expenses) received by the President. Prohibits certain management and executive level physicians and dentists from receiving compensation from affiliated institutions. Authorizes the Secretary of Veterans Affairs to suspend or waive this limitation in certain circumstances. Sets forth transition provisions for the new pay system. Makes the Under Secretary for Health eligible for market pay (in addition to base pay). Requires the Secretary to: (1) prescribe regulations implementing the new pay system for physicians and dentists; and (2) report to the Committees on Veterans' Affairs of the Senate and House of Representatives on implementation 18 months after issuing regulations and annually thereafter for ten years. Authorizes alternate work schedules for registered nurses employed by Department of Veterans Affairs health care facilities and prescribes the pay applicable to such schedules. Requires the Secretary to pay special pay to nurse executives at each Department health care facility or at Central Office (in addition to other pay and allowances).
Bill· SS. 2473 (108th)referred
United States · United States Congress · 21 May 2004
Medicare Trust Fund Reimbursement Act of 2004 - Provides that if the Comptroller General of the United States determines that the Centers for Medicare and Medicaid Services have violated the restriction on using appropriated funds for publicity or propaganda purposes contained in the Consolidated Appropriations Resolution, 2003 or any other provision of law, the principal campaign committee of the President shall reimburse the Federal Government for the amount used in committing such violation as appropriate. Requires the amount reimbursed to be credited to the appropriate Medicare trust fund to the extent that it was initially appropriated to such trust fund.
Bill· SS. 2464 (108th)referred
United States · United States Congress · 20 May 2004
Internet Pharmacy Consumer Protection Act or the Ryan Haight Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to prohibit any person from dispensing a prescription drug pursuant to a sale if: (1) any part of the sales transaction for the drug is conducted through an Internet site; and (2) such site fails to meet specified requirements regarding inclusion of a page (and links thereto) providing the identities and licensing information of the seller, pharmacists, or medical consultants. Prohibits a person from selling or dispensing a prescription drug if: (1) the purchaser communicated with the person through the Internet; (2) the purchaser did not have a valid prescription when the communication began; (3) the person provided for the involvement of a practitioner; (4) the practitioner issued a prescription for the drug that was purchased; (5) the person knew that no qualifying medical relationship existed (defines "qualifying medical relationship" as requiring an in-person medical evaluation); and (6) the person received payment. Allows States to bring civil actions against a person for violations of this Act. Prevents Internet providers from being held liable for dispensing or selling prescriptions drugs on account of another person's activities. Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under the FFDCA. Requires the Secretary of Health and Human Services to award a grant or contract to the National Clearinghouse on Internet Prescribing to identify and report Internet sites that violate Federal or State laws concerning the dispensing of drugs.
Bill· SS. 2471 (108th)referred
United States · United States Congress · 20 May 2004
Safeguarding Americans From Exporting Identification Data (SAFE-ID) Act - Prohibits business enterprises from disclosing personally identifiable information regarding U.S. residents to any branch, affiliate, subcontractor, or unaffiliated third party located in a foreign country unless: (1) the business enterprise provides notice of privacy protections and complies with safeguards described in specified Federal laws; (2) the consumer is given the opportunity to object prior to such disclosure; and (3) the consumer is given an explanation of how to exercise the nondisclosure option. Prohibits: (1) health care businesses from terminating existing relationships with consumers to avoid objections to disclosure; and (2) business enterprises from discriminating against otherwise qualified consumers of financial products or health care services due to such objections. Makes business enterprises that knowingly and directly transfer personally identifiable information to foreign entities liable to persons suffering damages due to the misuse of that information. Authorizes injured parties to file civil actions for violations of the information transmission provisions of this Act. Requires the Secretary of Health and Human Services to revise existing regulations to require covered entities that outsource protected health information to a foreign country to include certain information relating to outsourcing in such entity's privacy protection notices. Amends the Gramm-Leach-Bliley Act to require the inclusion of similar information in privacy protection notices for consumers of financial services.
Bill· SS. 2461 (108th)referred
United States · United States Congress · 20 May 2004
Family Smoking Prevention and Tobacco Control Act - Amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration, including through disclosure, annual registration, inspection, recordkeeping, and user fee requirements. Sets forth criteria by which tobacco products are deemed adulterated or misbranded. Allows the Secretary to require prior approval of all label statements. Allows the Secretary to restrict the sale or distribution of tobacco products, including advertising and promotion, if the Secretary determines that such regulation would be appropriate for the protection of the public health. Prohibits such regulations from: (1) limiting product sales or distribution to authorization of a practitioner licensed to prescribe medical products; (2) prohibiting product sales in face-to-face transactions by a specific category of retail outlets; or (3) establishing a minimum age greater than 18 years of age for product purchases. Prohibits cigarettes from containing any artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, cinnamon, or coffee. Requires the Secretary to establish tobacco product standards to protect the public health, but reserves to Congress the power to ban any tobacco products or reduce the nicotine level to zero. Allows the Secretary to take specified actions, including public notification and recall, against unreasonably harmful products. Requires premarket approval of all new tobacco products. Sets forth standards for the sale of modified risk tobacco products. Sets forth provisions regarding: (1) judicial review; (2) coordination with the Federal Trade Commission (FTC); (3) congressional review of regulations; and (4) state and local authority. Requires the Secretary to establish a Tobacco Products Scientific Advisory Committee. Amends the Federal Cigarette Labeling and Advertising Act to change cigarette warning label and advertising requirements. Amends the Comprehensive Smokeless Tobacco Health Education Act of 1986 to change smokeless tobacco warning label and advertising requirements.
Bill· SS. 2466 (108th)open
United States · United States Congress · 20 May 2004
Unborn Child Pain Awareness Act of 2004 - Amends the Public Health Service Act to require an abortion provider, before beginning any abortion of a pain-capable unborn child (defined as an unborn child who has reached a probable stage of development of 20 weeks after fertilization), to: (1) make a specified statement to the pregnant woman that Congress has determined that there is substantial evidence that the process will cause the unborn child pain, and that the mother has the option of having pain-reducing drugs administered directly to the child; (2) provide to the woman an Unborn Child Pain Awareness Brochure (unless she waives receipt) and an Unborn Child Pain Awareness Decision Form; and (3) obtain on the form the woman's signature and her explicit request for or refusal of the administration of drugs to the child. Directs the Secretary of Health and Human Services to develop the brochure and form. Makes such provisions inapplicable to a provider in the case of a medical emergency. Requires the provider to certify that a medical emergency exists. Sets penalties for false statements. Establishes penalties for willfully failing to comply with this Act, including civil penalties, medical license suspension, or both. Authorizes: (1) specified officials to bring suit in Federal court; and (2) private rights of action by a parent or guardian of a woman who is an unemancipated minor. Requires each State and State medical licensing authority to promulgate procedures for the revocation or suspension of a provider's license upon a court finding that the provider has violated this Act. Subjects a State that fails to implement such procedures to loss of Medicaid funding.
Bill· HRH.R. 4433 (108th)referred
United States · United States Congress · 20 May 2004
Family Smoking Prevention and Tobacco Control Act - Amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration, including through disclosure, annual registration, inspection, recordkeeping, and user fee requirements. Sets forth criteria by which tobacco products are deemed adulterated or misbranded. Allows the Secretary to require prior approval of all label statements. Allows the Secretary to restrict the sale or distribution of tobacco products, including advertising and promotion, if the Secretary determines that such regulation would be appropriate for the protection of the public health. Prohibits such regulations from: (1) limiting product sales or distribution to authorization of a practitioner licensed to prescribe medical products; (2) prohibiting product sales in face-to-face transactions by a specific category of retail outlets; or (3) establishing a minimum age greater than 18 years of age for product purchases. Prohibits cigarettes from containing any artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, cinnamon, or coffee. Requires the Secretary to establish tobacco product standards to protect the public health, but reserves to Congress the power to ban any tobacco products or reduce the nicotine level to zero. Allows the Secretary to take specified actions, including public notification and recall, against unreasonably harmful products. Requires premarket approval of all new tobacco products. Sets forth standards for the sale of modified risk tobacco products. Sets forth provisions regarding: (1) judicial review; (2) coordination with the Federal Trade Commission (FTC); (3) congressional review of regulations; and (4) state and local authority. Requires the Secretary to establish a Tobacco Products Scientific Advisory Committee. Amends the Federal Cigarette Labeling and Advertising Act to change cigarette warning label and advertising requirements. Amends the Comprehensive Smokeless Tobacco Health Education Act of 1986 to change smokeless tobacco warning label and advertising requirements.
Bill· HRH.R. 4458 (108th)referred
United States · United States Congress · 20 May 2004
Medicare Trust Fund Reimbursement Act of 2004 - Provides that if the Comptroller General of the United States determines that the Centers for Medicare and Medicaid Services have violated the restriction on using appropriated funds for publicity or propaganda purposes contained in the Consolidated Appropriations Resolution, 2003 or any other provision of law, the principal campaign committee of the President shall reimburse the Federal Government for the amount used in committing such violation as appropriate. Requires the amount reimbursed to be credited to the appropriate Medicare trust fund to the extent that it was initially appropriated to such trust fund.
Bill· HRH.R. 4462 (108th)open
United States · United States Congress · 20 May 2004
Makes appropriations for homeland security programs within the Departments of Energy (DOE), Health and Human Services (HHS), and Homeland Security (DHS) for FY 2005, including to: (1) DOE for atomic energy defense and defense nuclear nonproliferation activities; (2) HHS for the Public Health and Social Services Emergency Fund, the Strategic National Stockpile, and for activities to ensure a year-round influenza vaccine production capacity and the development and implementation of rapidly expandable influenza vaccine production technologies; and (3) DHS for border and transportation security and customs and border protection, Federal air marshals, air and marine interdiction operations and procurement, the Transportation Security Administration (for civil aviation security and maritime and land transportation security), the Office for Domestic Preparedness (including for State and local government grants for terrorism prevention activities and for firefighter assistance grants), countering potential biological, disease, and chemical threats to civilian populations, and emergency management performance grants.
Bill· HRH.R. 4437 (108th)referred
United States · United States Congress · 20 May 2004
Medicare Prescription Drug Low-Income Assistance Act of 2004 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to provide for the automatic enrollment of beneficiaries under SSA title XIX (Medicaid) in the interim prescription drug discount program and the transitional assistance program, making them eligible for the $600 per year in low-income discount card assistance without requiring a separate enrollment process. Provides for automatic enrollment for MSP beneficiaries under the permanent Medicare part D prescription drug coverage program.
Bill· HRH.R. 4420 (108th)referred
United States · United States Congress · 20 May 2004
Unborn Child Pain Awareness Act of 2004 - Amends the Public Health Service Act to require an abortion provider, before beginning any abortion of a pain-capable unborn child (defined as an unborn child who has reached a probable stage of development of 20 weeks after fertilization), to: (1) make a specified statement to the pregnant woman that Congress has determined that there is substantial evidence that the process will cause the unborn child pain, and that the mother has the option of having pain-reducing drugs administered directly to the child; (2) provide to the woman an Unborn Child Pain Awareness Brochure (unless she waives receipt) and an Unborn Child Pain Awareness Decision Form; and (3) obtain on the form the woman's signature and her explicit request for or refusal of the administration of drugs to the child. Directs the Secretary of Health and Human Services to develop the brochure and form. Makes such provisions inapplicable to a provider in the case of a medical emergency. Requires the provider to certify that a medical emergency exists. Sets penalties for false statements. Establishes penalties for willfully failing to comply with this Act, including civil penalties, medical license suspension, or both. Authorizes: (1) specified officials to bring suit in Federal court; and (2) private rights of action by a parent or guardian of a woman who is an unemancipated minor. Requires each State and State medical licensing authority to promulgate procedures for the revocation or suspension of a provider's license upon a court finding that the provider has violated this Act. Subjects a State that fails to implement such procedures to loss of Medicaid funding.
Resolution· HCONRESH.Con.Res. 435 (108th)referred
United States · United States Congress · 20 May 2004
Declares that Congress: (1) supports the goals and ideals of National Celiac Awareness Month (May 2004); (2) should work with health care providers and celiac disease advocacy and education organizations to encourage screening and early detection of celiac disease; and (3) should increase Federal funding for celiac disease research.
Bill· SS. 2447 (108th)referred
United States · United States Congress · 19 May 2004
Children and Media Research Advancement Act or CAMRA Act - Amends the Public Health Service Act to require the Director of the National Institute of Child Health and Human Development to establish: (1) an independent panel of experts to review, synthesize, and report on research, theory, and applications in the social, behavioral, and biological sciences; and (2) research priorities regarding the roles and impact of the use of and exposure to electronic media on youth in certain core areas of child development. Requires the Secretary of Health and Human Services to conduct initial pilot projects to supplement and inform the panel's work. Requires the Director to develop and implement a program that funds additional research determined to be necessary by the panel concerning the role and impact of electronic media in the development of children and adolescents, with a particular focus on media content, format, length of exposure, age of the child, and nature of parental involvement.
Bill· SS. 2445 (108th)referred
United States · United States Congress · 19 May 2004
Direct to Consumer Prescription Drug Advertising Act of 2004 - Requires the Director of the National Institutes of Health to conduct research to compare the effectiveness and safety of prescription drugs covered under Federal Employees Health Benefits Program plans relative to other prescription drugs used to treat the same condition or disease. Requires the Secretary of Health and Human Services to promulgate amended regulations governing prescription drug advertisements, including to: (1) require such advertisements to present a fair balance between information on the effectiveness of, and side effects or contraindications of, the drug; (2) prohibit false or misleading advertising that would encourage a consumer to take the prescription drug for other than an approved use; and (3) require that all prescription drugs sold to consumers include an explanation of the benefits and risks of use in terms understandable to the general public. Amends the Federal Food, Drug, and Cosmetic Act to set forth civil penalties for the misbranding of a prescription drug in a direct-to-consumer advertisement if the Secretary provides the person written notice of the violation and the person fails to correct or cease the advertisement to eliminate the violation. Requires the Secretary to annually report specified details of all direct-to-consumer advertisements, including those that violate Federal law, and actions taken by the Secretary to respond to such violations. Requires the Secretary to expedite the review of direct-to-consumer drug advertisements. Prohibits the Secretary from adopting any policy that would delay reviews, except as a result of notice-and-comment rulemaking and as necessary to protect public health and safety.
Bill· SS. 2430 (108th)referred
United States · United States Congress · 18 May 2004
Medical Readiness and Tracking Act of 2004 - Directs the Comptroller General to carry out a health study of Armed Forces reservists called or ordered to active duty for more than 30 days in support of Operation Enduring Freedom and Operation Iraqi Freedom. Requires Selected Reserve members not on active duty to undergo physical fitness examinations every 30 months. Dispenses with physical fitness certification requirements. Requires reassignment or separation of reservists who are not medically qualified for performance of their duties. Requires the Secretary of Defense (Secretary) to establish a policy on deferral of medical treatment for reservists pending deployment. Directs the Secretary to: (1) conduct a health assessment program for Armed Forces recruits; (2) convene a working group to improve the medical tracking system for deployed members of the Armed Forces; and (3) prescribe a Department of Defense (DOD) policy on the collection and dissemination of in-theater individual personnel location data. Requires military installation commanders to conduct an anticipated health care needs assessment of members being redeployed. Requires audits of DOD blood sample records and the health assessment database. Directs the Secretary to facilitate declassification of certain data relevant to environmental hazards exposure. Requires the Chief Information Officer of the Department of the Army to ensure that the Army Knowledge Online website includes specified information. Directs the Secretary to take action to ensure full implementation of the Force Health Protection and Readiness Program. Requires the preparation of various health-related reports.
Bill· SS. 2431 (108th)referred
United States · United States Congress · 18 May 2004
Diabetes Self-Management Training Act of 2004 - Amends title XVIII (Medicare) of the Social Security Act to provide for recognition of certified diabetes educators as Medicare providers by a nationally recognized certifying body for diabetes educators for purposes of diabetes outpatient self-management training services.
Bill· SS. 2426 (108th)referred
United States · United States Congress · 17 May 2004
Critical Access to Clinical Lab Services Act of 2004 - Amends title XVIII (Medicare) of the Social Security Act to provide that clinical diagnostic laboratory services furnished by a critical access hospital shall be treated as being furnished as part of outpatient critical access services without regard to whether: (1) the individual for whom the services are furnished is physically present in the critical access hospital at the time the specimen is collected; (2) such individual is registered as an outpatient on the records of, and receives such services directly from, the critical access hospital; or (3) payment is available for such services under the fee schedule established for clinical diagnostic laboratory tests.
Bill· HRH.R. 4377 (108th)referred
United States · United States Congress · 17 May 2004
Science Over Politics Act - Requires the Commissioner of Food and Drugs to: (1) review the decision of the Food and Drug Administration (FDA) not to approve the application for the commercial distribution of the emergency contraceptive drug Plan B (levonorgestrel in 0.75 mg. tablet form) as an over-the-counter drug; (2) affirm that the decision was not politically influenced, was based on sound science, and conformed to FDA precedents and procedures; and (3) publish such affirmation in the Federal Register.