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![Official portrait of Rep. Longley, James B., Jr. [R-ME-1]](https://www.congress.gov/img/member/l000431_200.jpg)
United States · Official source
No stored named vote for this person. House roll-calls come from Congress.gov; Senate member lists come from senate.gov LIS XML.
United States · United States Congress · 30 September 1996
Expresses the sense of the House of Representatives that the format of the 1996 Presidential debates should be modified so that Ross Perot can have an equal opportunity to participate.
United States · United States Congress · 28 September 1996
TABLE OF CONTENTS: Title I: Statement of Congressional Purpose Title II: Binding Budget Law Title III: Enforcement of Budget Discipline Subtitle A: Supermajority Required to Break Budget Law Subtitle B: Line Item Reduction Subtitle C: "Blank Check" Appropriations Prohibited Subtitle D: "Pay-as-You-Go" Requirement for New Spending Subtitle E: "Lock-Box" for Savings From Spending Reductions Title IV: Sustaining Mechanism Title V: Protection of Social Security Title VI: Technical Amendments to Federal Law to Carry Out This Act Title VII: Definitions and Rules of Interpretation Budget Process Reform Act - Title I: Statement of Congressional Purpose - Expresses the sense of the Congress that the Federal budget process should focus the attention of policymakers and the public on the aggregate impact of Federal spending on the economy, and on the tradeoffs that must be made among priorities in order to control overall levels of spending. Declares that the budget process should contain safeguards against delay and inaction, so that temporary shut-downs of the Government may be avoided. Title II: Binding Budget Law - Requires the Congress to enact a binding budget law, in the form of a joint resolution, by April 15 of the calendar year before that in which the fiscal period commences. (Sec. 202) Makes it out of order in the House of Representatives or the Senate to consider any spending bill affecting spending in a major functional category unless and until a joint resolution on the budget is enacted. Amends the Congressional Budget Act of 1974 (CBA) to require a two-thirds majority vote in the House and the Senate to consider any spending bill prior to the enactment of the budget law. Repeals authority for consideration of spending bills prior to adoption of the budget resolution. (Sec. 203) Prohibits baseline budgeting. Requires objective year- to-year comparisons under budget law, with the starting point for both Presidential and congressional budgets the levels of budget outlays for the current fiscal year. (Sec. 204) Amends the CBA to establish a rainy day fund for natural disasters. Requires budget law to include a major functional category for natural disasters, under specified conditions. (Sec. 205) Amends Federal law relating to the contents of the President's annual budget submission to the Congress to require the President to submit: (1) a budget of the U.S. Government for the following fiscal period on a single page, which sets forth specific budget ceilings in each major functional category, by the first Monday in February of each year before that in which a fiscal period commences; and (2) a detailed budget for that fiscal period, on or before the 15th day after a joint resolution on the budget for the following budget period is enacted. Title III: Enforcement of Budget Discipline - Subtitle A: Supermajority Required to Break Budget Law - Amends CBA to require the Congressional Budget Office (CBO) to provide to the Congress an estimate of the costs in each major functional category of each spending bill before being voted on by the Senate or the House. (Sec. 301) Requires a two-thirds affirmative vote in the House and the Senate to consider over-budget spending bills. (Sec. 302) Requires a two-thirds affirmative vote in the House and the Senate to waive any provision of this Act. Subtitle B: Limited Enhanced Rescission Authority - Amends the Impoundment Control Act of 1974 to authorize the President to exercise line-item reduction authority if the Congress exceeds the budget ceilings in the binding budget law or an automatic continuing resolution for a fiscal period. Declares that such authority shall permit the reduction of over-budget spending in a major functional category to the level established in the binding budget law or automatic continuing resolution. Sets forth procedures for congressional introductions of line-item bills after the President transmits a special message to rescind an item of budget authority. Prohibits amendments to such bills. Subtitle C: "Blank Check" Appropriations Prohibited - Declares the intent of the Congress to end open-ended, "blank check" appropriations which typically authorize spending "such sums as may be necessary." (Sec. 306) Amends CBA to require fixed-dollar appropriations for every account except Social Security and interest on the debt. Prohibits open-ended appropriations. (Sec. 307) Requires Executive agencies to adjust expenditures, including program eligibility requirements and benefit levels, to ensure that appropriations for entitlement programs are not exceeded. (Sec. 308) Restricts budget authority and entitlement authority to one fiscal period. Subtitle D: "Pay As You Go" Requirement for New Spending - Amends CBA to prohibit the Congress from considering any legislation which exceeds the budget ceiling unless it offsets such increased spending with an equal amount of reductions. Requires a two-thirds affirmative vote in the House or in the Senate to waive such prohibition. Sets forth special rules in the case of legislation that exceeds a budget ceiling for the natural disaster functional category. Repeals a CBA provision for an exemption in the House from pay-as- you-go rules. Subtitle E: "Lock-Box" for Savings From Spending Reductions - Amends CBA to: (1) establish "lock-box" procedures to ensure budget savings from House and Senate amendments to appropriations bills result in actual spending cuts; (2) require Congressional Budget Office (CBO) reports on such procedures; and (3) mandate reduction of spending allocations to House and Senate committees and subcommittees to meet "lock-box" levels. Title IV: Sustaining Mechanism - Makes appropriations to provide for an automatic continuing resolution if for any account an appropriation for a fiscal period does not become law before the beginning of such period. (Sec. 402) Provides for contingency regulations for automatic continuing resolutions. Grants each State the option of receiving an aggregate amount for the fiscal period for social safety net programs equal to the allocation to the State for such programs in the preceding fiscal period. (Sec. 403) Restricts consideration of legislation providing budget or spending authority to only that reported by the Committees on Appropriations. Makes such restriction inapplicable in the case of Social Security benefits. Title V: Protection of Social Security - Provides that nothing in this Act shall be construed to require or permit reductions in otherwise payable Social Security benefits. (Sec. 502) Provides that no reduction in benefits under title II of the Social Security Act (Old Age, Survivors and Disability Insurance) shall be made as a consequence of this Act. Title VI: Technical Amendments to Federal Law to Carry Out This Act - Makes various technical and conforming amendments, including changing references to a concurrent resolution on the budget to references to a joint resolution on the budget. Title VII: Definitions and Rules of Interpretation - Sets forth definitions for specified terms. Changes the definition of budget authority to exclude offsetting receipts.
United States · United States Congress · 12 September 1996
Veterans Medicare Subvention Demonstration Project Act - Directs the Secretaries of Veterans Affairs (VA) and Health and Human Services (HHS) to jointly establish a demonstration project to provide the Department of Veterans Affairs with reimbursement, under provisions of title XVIII (Medicare) of the Social Security Act, for health care services provided to certain Medicare-eligible veterans. Requires the Secretaries to conduct the project: (1) in not more than three Veterans Integrated Service Networks; and (2) during the three-year period beginning on January 1, 1997. Requires the Secretaries to include a provision for expanding the project to incorporate health care services provided to Medicare-eligible veterans under fee-for-service arrangements if the Secretaries determine that such expansion is feasible and advisable. Directs the HHS Secretary to make monthly payments to the Department from the Federal Hospital Insurance Trust Fund and the Federal Supplementary Medical Insurance Trust Fund (HHS trust funds) representing appropriate reimbursement amounts. Provides for the determination of such amounts. Directs the Secretaries to: (1) establish a minimum and maximum enrollment level for veteran participants in the project; and (2) determine baseline costs of such care and coverage. Directs the VA Secretary to: (1) establish and operate a managed health-care plan through which Medicare-eligible veterans who participate in the project receive health care; and (2) waive any enrollment fee for such participants. Directs the Secretaries to report to the Congress concerning specified project participation, findings, and results. Directs the Comptroller General, for each year of the project, to report to the Secretaries and the Congress on the extent to which the costs of the Secretaries have increased as a result of the project. Requires the Secretaries to modify the project following such reviews to correct any discrepancies between project cost targets and actual spending.
United States · United States Congress · 11 September 1996
Commission on the Future for America's Veterans Act - Establishes the Commission on the Future for America's Veterans (the Commission), the Panel on Veterans' Employment Opportunities (Opportunities Panel), and the Panel on Veterans' Health Benefits (Health Panel). Requires the Commission chairman to oversee the progress of each panel, review weekly progress reports, and allocate Commission resources to the panels. Requires the Opportunities Panel to: (1) review the efficacy and appropriateness of veterans' transition assistance and adjustment programs in providing assistance to members of the armed forces in making the transition and adjustment to civilian life; (2) evaluate proposals for improving such programs; and (3) make appropriate recommendations to the Congress. Requires the Health Panel: (1) to conduct a comprehensive study of health care services available to veterans from the Department of Veterans Affairs; (2) to submit a legislative proposal to the Congress (demonstration project bill) which authorizes the Secretary of Veterans Affairs to implement temporary demonstration projects to improve Department health care services; and (3) together with the Commission chairman, to report thereon to the Congress. Provides for the expedited congressional consideration of the demonstration project bill. Provides Commission funding.
United States · United States Congress · 2 August 1996
Congressional Pension Forfeiture Act of 1996 - Amends Federal law to provide that any service as a Member of Congress of an individual convicted of a felony committed while a Member during the 105th Congress or later shall not be taken into account as creditable service for purposes of annuity or retirement provisions. Entitles such individual (or his or her beneficiary or estate, if applicable) to be paid so much of such individual's lump-sum credit as is attributable to such service. Prohibits: (1) the individual, while serving as a Member after the date of the conviction, from being eligible to participate in the Civil Service Retirement System or the Federal Employee's Retirement System; and (2) interest from being computed on such lump-sum payment for the period after the conviction or commission of the violation, or after September 26, 1961, whichever is later.
United States · United States Congress · 2 August 1996
Revises Federal criminal code provisions to set mandatory prison terms for possessing, brandishing, or discharging a firearm or destructive device during a Federal crime of violence or a drug trafficking crime. Establishes penalties for second or subsequent convictions. Bars the court from imposing probationary sentences or concurrent terms of imprisonment on persons convicted of such violations.
United States · United States Congress · 2 August 1996
Authorizes the President to award the Congressional Medal of Honor posthumously to Theodore Roosevelt for his actions in the attack of San Juan Heights, Cuba, during the Spanish-American War on July 1, 1898.
United States · United States Congress · 2 August 1996
GI Bill of Health - Directs the Secretary of Veterans Affairs (Secretary, when not otherwise specified) to establish a process for the enrollment into Veterans Health Plans (VHPs) of: (1) entitled and eligible veterans (as defined under this Act) and their dependents; and (2) individuals who are eligible for benefits under the Civilian Health and Medical Program of the Uniformed Services. Requires the Secretary to provide for a continuous VHP open enrollment period of 18 months following the enactment of this Act, an annual enrollment period of at least 30 days, and special enrollment periods for veterans with changed circumstances. Authorizes the Secretary to terminate VHP coverage for the nonpayment of premiums. Includes as an "entitled" veteran any veteran: (1) with a service-connected disability; (2) whose discharge or release from active duty was for a disability incurred or aggravated in the line of duty; (3) who is in receipt of veterans' disability compensation due to a disability received by treatment or vocational rehabilitation; (4) who is a former prisoner of war; (5) of the Mexican border period or World War I; (6) who is unable to defray the expenses of necessary care; (7) who served on active duty in the Republic of Vietnam during the Vietnam era and who the Secretary finds may have been exposed to a toxic substance during such service; (8) who the Secretary finds was exposed to ionizing radiation during certain nuclear testing during World War II; (9) who served on active duty in the Southwest Asia theater of operations during the Persian Gulf War and who the Secretary finds has an illness or disability which may be associated with exposure to a toxic substance or environmental hazard during such service; (10) who, while on active duty, was exposed to mustard gas during certain testing during World War II; (11) who suffers from a catastrophic illness or injury, payment for which would render such veteran destitute; or (12) who is proven to be uninsurable in the private health insurance market. Includes as an "eligible" veteran those veterans who do not otherwise qualify under this paragraph. Requires entitled veterans to receive any medically necessary and appropriate care and services: (1) associated with a service-connected disability; and (2) for an established disability or illness determined to be proximately due to or the result of such disability or illness. Provides special benefits for entitled veterans having a disability rating of 50 percent or more. Provides for enrollment under a basic, comprehensive, or supplemental health benefits package for entitled veterans and their dependents, with benefits under each package depending upon degrees of disability and related factors. Outlines services provided under each of the benefits packages. Prohibits the Secretary from imposing any premium charges upon an entitled veteran for any medically necessary and appropriate care or services when such veteran has a service-connected disability rated at 50 percent or more. Outlines premium payment requirements for: (1) entitled veterans with disabilities rated at less than 50 percent; (2) other veterans (and their dependents) enrolled in a VHP; (3) veterans eligible for federally-administered health care programs; (4) eligible veterans and veterans' dependents with Medicare Supplemental health insurance coverage; and (5) fee-for-service benefits. Establishes in the Treasury the Department of Veterans Affairs Health Plan Fund consisting of specified deposits, including premiums paid for VHP coverage. Requires Fund proceeds to be used for the delivery of veterans' health care services. Directs the Secretary of the Treasury to deposit quarterly into the Fund the amount certified to such Secretary as an amount representing (and determined according to a specified formula) the full Federal cost of veterans' health care delivery services for such quarter. Directs such Secretary to allocate at least 75 percent of amounts deposited into the Fund to the VHP or Department facility that provided the care or services for which payment was made. Requires the remaining 25 percent to be used to operate and maintain the veterans health system and to ensure that Department resources and health care services are allocated in a reasonable, efficient, and equitable manner throughout the United States. Requires the Secretary to: (1) administer the veterans health system through the use of a medical practice model known as "managed care"; (2) organize veterans' hospitals and medical facilities and services into VHPs; (3) establish standards for the operation of VHPs; (4) ensure that payment schedules are uniform throughout the veterans health system (with exceptions permitted under the Secretary's discretion); (5) establish procedures and guidance for VHPs with respect to agreements with non-Department entities for the furnishing of necessary and appropriate medical care to veterans and their dependents; and (6) maintain full responsibility for treatment outcomes and quality of contracted care. Authorizes the Secretary to enter into such contracts and agreements. Authorizes the Secretary and VHP directors to contract with outside employers to provide health care services to their employees who are otherwise eligible for care through a VHP. Authorizes the Secretary to enter into agreements for the provision of administrative services to VHPs. Directs the Secretary to establish criteria and application procedures for veterans and dependents covered by this Act. Provides appropriate responsibilities of VHPs and their directors with respect to the enrollment of eligible individuals and their care and treatment. States that a VHP shall be considered a qualified health care provider or carrier under any State health care reform plan, law, or regulation. Supersedes and preempts conflicting State or local laws, but allows the Secretary to require VHPs to follow any State or local law or regulation that: (1) is in the best interests of individuals enrolled in the VHP; or (2) will assist the VHP in achieving or maintaining a competitive position with the State or locality. Directs the Secretary to report annually to the Congress on costs incurred, premiums received, and payments made under this Act.
United States · United States Congress · 2 August 1996
Restores Federal armed forces provisions relating to the status of missing persons as in effect before amendments made by the National Defense Authorization Act for Fiscal Year 1997.
United States · United States Congress · 1 August 1996
Authorizes the Secretary of Veterans Affairs to quarantee veterans loans for adjustable rate mortgages in a manner similar to the manner in which the Secretary of Housing and Urban Development insures adjustable rate mortgages under provisions of the National Housing Act.
United States · United States Congress · 18 July 1996
Urges the national broadcast television networks to renew their commitment to voluntarily reserving the first hour of prime-time broadcasting for programming suitable for American family members of all ages.
United States · United States Congress · 16 July 1996
Requires the Administrator of the Environmental Protection Agency to provide a grant, in a specified amount, to the State of Maine to be used for refunds to persons (including governmental entities) for testing, repair, and other costs incurred pursuant to automobile inspection and maintenance requirements adopted by the State for Clean Air Act purposes. Authorizes appropriations.
United States · United States Congress · 11 July 1996
TABLE OF CONTENTS: Title I: Congressional Compensation Title II: Lobbying Title III: Congressional Travel R.I.G.H.T. Congress Act - Title I: Congressional Compensation - Applies existing Federal law regarding special accrual rates for Members of Congress and congressional employees under the Civil Service and Federal Employees' Retirement Systems only with respect to congressional service performed before the beginning of the 105th Congress. Eliminates the automatic cost of living adjustment for that portion of an annuity of a Member that is based solely on service as a Member. Amends the Legislative Reorganization Act of 1946 to: (1) eliminate automatic pay adjustments for Members until otherwise provided under the Federal Salary Act of 1967; and (2) require a recorded vote on any pay adjustment for Members. Title II: Lobbying - Modifies the Ethics in Government Act of 1978 to: (1) increase from one to two years after leaving office the period of time during which a Member or employee is prohibited from engaging in certain lobbying activities; (2) include employees of a congressional committee on which a Member serves among those persons whom former Member employees may not lobby for such period; and (3) decrease the salary level of congressional employees below which lobbying restrictions do not apply. Amends rule XXXII of the Rules of the House of Representatives to deny admission to the House floor to former Members who are registered lobbyists. Prohibits such a former member from entering any Capitol dining facility or any gymnasium facility that is reserved for Members. Amends the Lobbying Disclosure Act of 1995 to require registered lobbyists to wear identification badges when in the U.S. Capitol or in a House or Senate office building while engaged in lobbying activities. Title III: Congressional Travel - Prohibits the Secretary of Defense from providing transportation on a military aircraft for a Member unless: (1) the transportation is provided on a space-available basis as part of scheduled operations unrelated to the provision of transportation to the Member; (2) the destination, or an airfield located within a reasonable distance thereof, is inaccessible by regularly scheduled commercial aircraft flights; or (3) the transportation is the least expensive method for the Member to reach the destination by aircraft. Requires prior approval from the House Committee on Standards of Official Conduct for Members and staff travelling on military aircraft to a hearing. Prohibits a retiring Member, or such Member's personal staff, from engaging in foreign travel unless such Committee determines such travel is essential to the Member's official responsibilities. Requires that any travel award that accrues by reason of official travel of a House Member, officer, or employee be used only for official travel, or by the spouse or children of that Member for travel between Washington, D.C. and that Member's district.
United States · United States Congress · 19 June 1996
War Crimes Act of 1996 - Amends the Federal criminal code to provide that anyone, whether inside or outside the United States, who commits a grave breach of the Geneva conventions, where the person who commits such breach or the victim of such breach is a member of the U.S. armed forces or a U.S. national, shall be fined or imprisoned for life or any term of years, or both, or, if death results to the victim, be subject to the death penalty.
United States · United States Congress · 12 June 1996
Women's Preventive Health Care Act of 1996 - Requires every policy or contract for health insurance coverage and every group health plan to include coverage for screening pap smears and low-dose screening mammographies. Regulates cost sharing and frequency of coverage and provides for enforcement. Declares that this Act does not preempt State law to the extent State law provides greater protection to women.
United States · United States Congress · 29 May 1996
Applies State laws concerning vehicle weight limitations to specified segments of the Interstate System in New Hampshire and Maine.
United States · United States Congress · 16 May 1996
National Marine Sanctuaries Preservation Act - Amends the National Marine Sanctuaries Act to authorize appropriations to carry out the Act. Mandates a long-range, comprehensive plan for the management, stabilization, preservation, and recovery of artifacts and materials of the U.S. ship Monitor. Modifies national marine sanctuary advisory committee meeting notice requirements. Authorizes adoption of a symbol for the national marine sanctuary program (NMSP) or any individual sanctuary and the related designation of official sponsors, the collection of symbol use fees, and the selling of products to promote the NMSP. Makes it unlawful for a sponsor to try to influence any national marine sanctuary decision. Establishes the National Marine Sanctuaries Program Account and authorizes the use of Account funds, without further appropriations, for the NMSP or specific sanctuaries.
United States · United States Congress · 7 May 1996
Breast-Cancer Research Stamp Act - Requires the U.S. Postal Service to establish a special rate of postage for first-class mail that is one cent higher than the regular rate as an alternative that patrons may use voluntarily to contribute to funding for breast-cancer research. Authorizes the Service to design and sell special stamps. Requires the Service to pay amounts attributable (additional revenues minus costs) to the one-cent differential to the National Institutes of Health as mutually agreed.
United States · United States Congress · 2 May 1996
Amends the Solid Waste Disposal Act to require the Administrator of the Environmental Protection Agency (EPA) to distribute to States at least 85 percent of the funds appropriated to EPA from the Leaking Underground Storage Tank Trust Fund each fiscal year for the reasonable costs under cooperative agreements of: (1) State actions under the EPA program for petroleum release responses; (2) corrective action and compensation programs under State financial responsibility requirements; (3) enforcement of an approved State or local underground storage tank (UST) program or similar provisions; and (4) State and local corrective actions pursuant to regulations regarding corrective action in response to UST releases. Prohibits use of such funds to provide financial assistance to an owner or operator in meeting regulatory requirements for upgrading of existing UST systems. Sets forth requirements for allocation of funds to States. Makes inapplicable to owner or operator recipients of Trust Fund amounts under programs described in (2), above, provisions for recovery of petroleum release corrective or enforcement action costs.
United States · United States Congress · 1 May 1996
Declares that it is the sense of the Congress that the Board of Trustees of the Federal Hospital Insurance Trust Fund should submit to the Congress without further delay its annual report due on April 1, 1996.
United States · United States Congress · 24 April 1996
United States Armed Forces Protection Act of 1996 - States certain congressional findings and policy concerning the placement of U.S. armed forces under United Nations (UN) operational or tactical control. Prohibits Department of Defense funds from being obligated or expended for activities of any element of the armed forces that is placed under UN operational or tactical control, unless: (1) the President, at least 15 days before UN control is to become effective (or not later than 48 hours afterwards in an emergency), certifies to the Congress that such action is in the national security interests; or (2) such placement is specifically authorized by law or is part of a North Atlantic Treaty Organization operation. Specifies information to be submitted with the President's certification, including: (1) information on the national security interests to be advanced; (2) the mission, size, and composition of the U.S. forces involved; (3) the command and control relationship of the U.S. forces with the UN command structure and with the U.S. unified command for the region; (4) the exit strategy for, and withdrawal authority of, U.S. forces; and (5) the anticipated monthly incremental cost of U.S. participation. Provides that this Act shall not apply to activities of the armed forces carried out as part of specified ongoing activities of the UN Protection Force in Macedonia or Croatia. Requires that members of the armed forces be informed of their unit's mission and their chain of command in any operation to which their unit is assigned.
United States · United States Congress · 22 April 1996
Entitles a named individual to widow's insurance benefits under the Social Security Act.
United States · United States Congress · 29 March 1996
Medical Device Reform Act of 1996 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to set forth the Food and Drug Administration (FDA) mission. (Sec. 3) Allows device approval applicants to declare a review impasse and mandates use of a dispute resolution process. (Sec. 4) Revises requirements regarding: (1) investigational devise exemptions; (2) premarket approval requirements (mandating a device review priority); (3) humanitarian device exceptions; (4) safety and effectiveness performance standards (allowing consensus standards recognition); (5) effectiveness determinations (as used in classifying devices); (6) premarket notification; (7) classification panels; and (8) premarket approval application review (allowing review by accredited persons). (Sec. 12) Mandates procedures for accrediting parties that review premarket approval applications and conduct good manufacturing practice inspections. (Sec. 13) Mandates reclassification of certain devices. (Sec. 14) Modifies requirements regarding: (1) device tracking; (2) postmarket surveillance; and (3) good manufacturing practice regulations (including foreign harmonization) and inspections (including adding references to accredited entities and post-inspection procedural requirements). (Sec. 18) Regulates the effect of the dissemination of medical texts, peer-reviewed scientific publications, displays at trade shows, and other material. (Sec. 19) Removes distributors from record keeping and reporting requirements. Declares that the failure of a device to perform as labeled or in an acceptable manner does not constitute a malfunction when caused by improper servicing. Repeals user reporting requirements. (Sec. 20) Prohibits subjecting a person to penalties if the person acted in good faith and had no reason to believe the acts violated the law. (Sec. 21) Allows using monetary penalties for violation correction. Entitles violators to reasonable discovery. (Sec. 22) Mandates an information system to track the status of each submission requesting FDA action. (Sec. 23) Prohibits actions by the Secretary of Health and Human Services under the FDCA from requiring the preparation of an environmental impact statement or assessment. (Sec. 24) Prohibits the Secretary from relying on any statements not promulgated in accordance with rulemaking requirements to require any action under the FDCA. (Sec. 25) Mandates training programs for FDA employees regarding FDCA regulations and policies. Allows the FDA to conduct or contract for scientific research only if directly related to FDCA implementation. (Sec. 26) Regulates communications to non-FDA persons regarding certain matters before completion of related investigations.
United States · United States Congress · 29 March 1996
Drug and Biological Products Reform Act of 1996 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to set forth the mission of the Food and Drug Administration (FDA) and mandate an annual report to specified congressional committees. (Sec. 3) Modifies new drug requirements regarding: (1) clinical investigation commencement; (2) application contents and review; (3) effectiveness determinations; (4) the use of scientific advisory panels; and (5) marketing approval application review by accredited persons. (Sec. 8) Provides for the accreditation of persons to: (1) review applications for new drugs or for certification of insulin-containing drugs; and (2) conduct good manufacturing practice (GMP) inspections. (Sec. 9) Allows applicants to declare an impasse in a review or a submission for an investigational use exemption and mandates use of a dispute resolution process. (Sec. 10) Adds references to accredited persons to provisions relating to GMP inspections. Imposes post-inspection requirements. Deems certain chemistry, manufacturing, and controls to comply with current GMP and prohibits actions to delay or prevent the manufacture or marketing of a drug for failure to conform to GMP, subject to exception. (Sec. 12) Allows a new drug manufactured in a small facility to be used to show safety and effectiveness. (Sec. 13) Regulates changes in the manufacture of a new drug, biological product, new animal drug, blood, or blood component. (Sec. 14) Repeals provisions relating to the certification of drugs containing insulin or antibiotics. (Sec. 15) Requires that applications or petitions requesting conversion from prescription to nonprescription status and all matters relating to nonprescription drugs be reviewed by a single office in the Center for Drug Evaluation and Research. Allows a single scientific advisory panel to provide recommendations. (Sec. 16) Mandates an applicant-accessible information system to track applications and submissions to the FDA. (Sec. 17) Prohibits actions by the Secretary of Health and Human Services from requiring an environmental impact statement or environmental assessment. (Sec. 18) Regulates drugs compounded by a licensed pharmacist on the order of a licensed physician. (Sec. 19) Directs the Secretary to meet with foreign countries to discuss harmonization of regulatory requirements. (Sec. 20) Controls the effect of the dissemination of medical texts, peer-reviewed scientific publications, and other material. (Sec. 21) Prohibits the Secretary from relying on statements not promulgated in accordance with rulemaking requirements to require any action under the FDCA. (Sec. 22) Mandates training for FDA employees on regulations and policies under the FDCA. (Sec. 23) Regulates: (1) the delegation of authority under the FDCA; (2) judicial review of decisions regarding investigational new drugs and new drugs; and (3) communication to non-FDA persons regarding certain matters before completion of an investigation. (Sec. 26) Defines "biological product" and "human tissue." Declares that blood, a blood component, an organ, milk, or human tissue is not a drug. Prohibits subjecting computer software developed or modified by, or used in, a human tissue establishment to any premarket clearance requirement. Requires such software to be validated to demonstrate that it achieves its intended purpose before use and subjects it to the GMP requirements of the FDCA. Requires licenses to introduce biological products, blood, and blood components into interstate commerce. Regulates licensing. Allows regulation of human tissue only if the Secretary demonstrates that voluntary regulation is inadequate to protect the public health. Provides for such regulation.
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