Food and Drug Administration Performance and Accountability Act of 1996

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 and Biological Products Regulatory Reform

Title VI: Device Regulatory Reform

Title VII: Animal Drug Regulatory Reform

Title VIII: Food Regulatory Reform

Title IX: Establishment of Centers for Education and

Research on Drugs, Devices, and Biological Products

Title X: Program in Clinical Pharmacology

Food and Drug Administration Performance and Accountability Act of 1996 - Title I: Mission and Accountability - Food and Drug Administration Regulatory Reform Act of 1996 - 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 reviews under the Act and actions relating to advisory committees; (2) collaboration between the FDA, the National Institutes of Health, and other Federal science-based agencies; (3) an information system accessible by applicants, petitioners, and persons submitting notifications; and (4) a procedure regarding policy statements of general applicability.

(Sec. 107) Prohibits the Commissioner of Food and Drugs from delegating appointment and oversight authority related to scientific review groups. Regulates the groups.

(Sec. 108) Requires an intra-FDA appeal system including, on request, an evaluation by a scientific review group.

(Sec. 109) Limits future Commissioners of Food and Drugs to one term of five years, with removal allowed only for neglect of duty or malfeasance.

Title II: Expedited Access to Products for Seriously Ill Patients - Patient Rights Regulatory Reform Act of 1996 - Establishes or modifies requirements regarding: (1) expanded access to investigational drugs or devices for serious conditions; (2) humanitarian device exemptions; and (3) a time limit for approval of certain biological product, new drug, or premarket approval applications.

Title III: Revitalizing the Investigation of New Products - Investigational Products Regulatory Reform Act of 1996 - 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) clinical holds on ongoing clinical investigations; and (5) investigational device exemptions. Declares the sense of the Senate Labor and Human Resources Committee regarding mutual recognition agreements. Imposes requirements concerning meetings between the person proposing a preclinical or clinical investigation and the Secretary of Health and Human Services to review protocol design.

Title IV: Efficient, Accountable, and Fair Product Review - Product Review Regulatory Reform Act of 1996 - Establishes or modifies requirements regarding: (1) a mechanism to ensure the fair and consistent application of filing requirements; (2) automatic classification in the class specified by the sponsor if the Secretary fails to classify the device within a specified period; (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) the matters that may be considered in determining effectiveness; (9) performance standards for the prompt review of supplemental applications for approved articles and guidelines for the submission of supporting data; (10) market exclusivity for approved new drug applications involving pediatric studies; and (11) actions to be taken before introduction of devices into interstate commerce.

Title V: Drug and Biological Products Regulatory Reform - Drug and Biological Product Regulatory Reform Act of 1996 - 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. 505) Repeals provisions regarding the certification of drugs containing insulin or containing antibiotics. Allows export of insulin and antibiotics in certain circumstances.

(Sec. 506) Amends the Public Health Service Act to regulate biological products in interstate commerce.

(Sec. 507) Amends the FDCA to direct the Secretary to request that relevant parties collaborate to develop a long-range comprehensive action plan to achieve goals consistent with the FDA proposed rule "Prescription Drug Product Labeling: Medication Guide Requirements."

(Sec. 508) Regulates State and local requirements regarding nonprescription drugs.

(Sec. 509) Mandates proposed regulations regarding the approval of radiopharmaceuticals for diagnosis and monitoring.

Title VI: Device Regulatory Reform - Medical Device Reform Act of 1996 - Establishes or modifies requirements regarding: (1) premarket notification; (2) device classification; and (3) the circumstances in which device tracking or postmarket surveillance may be required.

(Sec. 606) Removes references to distributors from provisions relating to records and reports on devices.

(Sec. 607) Modifies premarket approval requirements.

(Sec. 608) Directs the Secretary to recognize appropriate device performance standards developed by any standard-setting organization accredited by the American National Standards Institute (ANSI), the International Standards Organization (ISO), or the International Electrotechnical Commission (IEC). Mandates establishment of a procedure governing FDA certification of other organizations.

(Sec. 609) Directs the Secretary to accredit persons to review and initially classify devices that are subject to a report prior to introduction into interstate commerce and to review and recommend approval or denial of premarket applications. Declares that this section continues in force for three years after the first person is accredited.

Title VII: Animal Drug Regulatory Reform - Animal Drug Regulatory Reform Act of 1996 - Sets forth what (for new animal drug provisions) 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. Exempts use in a minor species and the minor use of a drug from provisions prohibiting approval if there is a lack of substantial evidence that the drug will have its purported effect. Modifies residue requirements.

(Sec. 704) Sets forth circumstances in which an animal drug will be considered adulterated.

(Sec. 705) Regulates animal feed drugs that are limited by approved applications to use under the supervision of a licensed veterinarian (veterinary feed directive drugs).

(Sec. 706) Decreases the time limit for the Secretary to either approve a new animal drug application or give the applicant notice of an approvability hearing.

Title VIII: Food Regulatory Reform - Food Regulatory Reform Act of 1996 - 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).

(Sec. 803) Sets forth circumstances in which a label claim may be made characterizing the relationship of a nutrient to a disease or a health-related condition.

Title IX: Establishment of Centers for Education and Research on Drugs, Devices, and Biological Products - Mandates: (1) the establishment of a consortium of three or more centers for research on education on drugs, devices, and biological products; (2) grants to private entities for the establishment and operation of the centers; and (3) a related FDA oversight committee. Authorizes appropriations.

Title X: Program in Clinical Pharmacology - Authorizes appropriations to carry out provisions relating to a grant to evaluate whether a pilot training program can contribute to an increase in the number of trained biomedical, scientific personnel in clinical pharmacology.