A bill to amend the Public Health Service Act to provide reasonable assurances that human tissue intended for transplantation is safe and effective, and for other purposes.
Human Tissue Transplantation Act of 1992 - Amends the Public Health Service Act to provide for the regulation of tissue banks and human tissue for transplantation.
Prohibits human tissue intended for transplantation from being procured, processed, or distributed unless: (1) it is processed and distributed by one or more tissue banks licensed by the Secretary of Health and Human Services; and (2) it is subject to voluntary professional standards (established under this Act). Exempts from such requirements transplants in the same patient and non-frozen transplants within 72 hours of procurement.
Requires the Secretary to enter into a contract with a nonprofit entity that is not engaged in any significant activity unrelated to human tissue banking to establish and operate a National Council on Tissue Transplantation. Sets forth reporting requirements and routine duties of the Council. Requires the Council to develop and disseminate voluntary professional standards for: (1) the procurement of human tissue from donors to provide reasonable assurances that such tissue does not transmit disease; (2) the processing and distribution of human tissue banks; (3) a type or types of human tissue (including the basis for such standard); and (4) human heart valves.
Requires the Secretary to promulgate regulations for the annual registration of every tissue bank and every entity (other than a tissue bank) that procures human tissue within a State.
Requires the Secretary to promulgate regulations for the licensing of tissue banks that process or distribute human tissue that is intended for transplantation. Specifies the process for obtaining such a license.
Sets forth the standards for accrediting a tissue bank for purposes of licensure.
Grants authority to the Secretary to make inspections of tissue banks subject to licensure requirements at reasonable times and in a reasonable manner.
Requires the Secretary to publish voluntary professional standards for a type or types of human tissue and provide opportunity for public comment.
Sets forth enforcement provisions for violations of this Act. Provides for judicial review in accordance with the Federal Food, Drug, and Cosmetic Act.
Provides that State laws may continue in effect to the extent that they are not inconsistent with this Act.
Authorizes the Secretary, after consultation with the Council, to prescribe regulations requiring that providers of services under Medicare or Medicaid establish and maintain records of transplantation of tissue in a manner that facilitates the identification of transplant patients, donors, and the distributor of such tissue.
Prohibits the Secretary from enforcing existing regulations that treat human heart valves as medical devices subject to premarket approval. Rescinds the determination by the Secretary that human heart valves must undergo premarket approval.
Provides for the expedited determination of whether a public standard applicable to human heart valves should be established.
Introduced in Senate
Read twice and referred to the Committee on Labor and Human Resources.
Committee on Labor and Human Resources. Hearings held. Hearings printed: S.Hrg. 102-1161.
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