Food and Drug Administration Performance and Accountability Act of 1996

Summary

TABLE OF CONTENTS: Title I: Mission and Accountability Title II: Expedited Access to Products for Seriously Ill Patients Title III: Revitalizing the Investigation of New Products Title IV: Efficient, Accountable, and Fair Product Review Title V: Drug, Biological Products, Devices Export Reform Title VI: Drug and Biological Products Regulatory Reform Title VII: Device Regulatory Reform Title VIII: Animal Drug Regulatory Reform Title IX: Food Regulatory Reform Food and Drug Administration Performance and Accountability Act of 1995 - Title I: Mission and Accountability - Food and Drug Administration Regulatory Reform Act of 1995 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to set forth a Food and Drug Administration (FDA) mission statement. (Sec. 103) Mandates: (1) performance standards for FDA product reviews; (2) an applicant-accessible information system; and (3) a procedure regarding policy statements of general applicability. (Sec. 106) Authorizes the Commissioner of Food and Drugs to delegate authority related to scientific review groups to a center director. (Sec. 107) Requires an intra-FDA appeal system. Empowers any person to request an evaluation by a scientific review group. Title II: Expedited Access to Products for Seriously Ill Patients - Patient Rights Regulatory Reform Act of 1995 - Establishes or modifies requirements regarding: (1) distribution of an investigational drug or device for a serious condition; (2) humanitarian device exemptions; and (3) a time limit for approval of certain biological product or new drug applications. Title III: Revitalizing the Investigation of New Products - Investigational Products Regulatory Reform Act of 1995 - Regulates: (1) automatic commencement of new drug clinical investigations; (2) criteria for the safety information that must be initially submitted; (3) regarding a mechanism to ensure the fair application of clinical investigation safety standards; (4) investigational device exemptions; and (5) concerning meetings between the sponsor proposing a preclinical or clinical investigation and the Secretary. Title IV: Efficient, Accountable, and Fair Product Review - Product Review Regulatory Reform Act of 1995 - Establishes or modifies requirements regarding: (1) a mechanism to ensure fair and consistent filing requirements; (2) automatic classification in the class specified by the sponsor; (3) criteria for the information to be included in the application; (4) contracts with outside organizations and individuals to review applications; (5) collaborative review; (6) accreditation of organizations to conduct good manufacturing practice inspections; (7) environmental consideration of FDA action; (8) dissemination of certain information on treatment use of investigational new drugs, a use of a new drug for which approval is in effect, and a use of a device produced by a registered manufacturer; (9) approval of a new use drug, biological product, or device application; and (10) the matters that may be considered in determining effectiveness. Title V: Drug, Biological Products, Devices Export Reform - Drug, Biological Products, Devices Export Reform Act of 1995 - Revises requirements regarding the importing and exporting of a drug, biological product, or device. (Sec. 503) Amends the Public Health Service Act to modify partially processed biological product export requirements. Title VI: Drug and Biological Products Regulatory Reform - Drug and Biological Product Regulatory Reform Act of 1995 - Amends the FDCA with regard to: (1) what constitutes substantial evidence; (2) using a small facility to demonstrate the safety and effectiveness of a new drug or biological product; and (3) requirements regarding changes in the manufacture of a new drug, biological product, or new animal drug. (Sec. 605) Repeals provisions regarding the certification of drugs containing insulin or containing antibiotics. Allows export of insulin and antibiotics in certain circumstances. (Sec. 606) Amends the Public Health Service Act to regulate biological products in interstate commerce. (Sec. 607) Mandates proposed regulations governing products of human tissue and cell therapy. Title VII: Device Regulatory Reform - Medical Device Reform Act of 1995 - Amends the FDCA to establish or modify requirements regarding: (1) premarket notification requirements; (2) device classification standards; and (3) the circumstances in which device tracking or postmarket surveillance may be required. (Sec. 706) Removes references to distributors from provisions relating to records and reports on devices. Removes provisions regarding reports of removals and corrections. (Sec. 707) Modifies premarket approval requirements. (Sec. 708) Establishes procedures regarding the recognition of an existing performance standard for a device. Title VIII: Animal Drug Regulatory Reform - Animal Drug Regulatory Reform Act of 1995 - Sets forth what constitutes substantial evidence. Regulates what must be considered in evaluating an animal drug containing more than one active ingredient or to be used in combination with other drugs. Modifies approval and residue requirements. (Sec. 804) Sets forth the circumstances in which an animal drug will be considered adulterated. Title IX: Food Regulatory Reform - Food Regulatory Reform Act of 1995 - Establishes an alternate approval procedure for an indirect food additive (a food additive intended to contact food but not intended for consumption as a food ingredient).

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6 official files

• Reported to Senate (text)

  Reported to Senate · EN · 20 June 1996

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• Reported to Senate (PDF)

  Reported to Senate · EN · 20 June 1996

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• Reported to Senate with amendment(s)

  summary · EN · 20 June 1996

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• Introduced in Senate (text)

  Introduced in Senate · EN · 13 December 1995

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 13 December 1995

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• Introduced in Senate

  summary · EN · 13 December 1995

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