federal_register: 06-4370
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 06-4370 | Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Companion Document to Direct Final Rule | Proposed Rule | The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are proposing to amend their regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue- based products (HCT/Ps) (FDA regulation). We (HRSA and FDA) are taking this action to provide that blood vessels recovered with organs and intended for use in organ transplantation will be governed by the regulations pertaining to organs. The regulation of other recovered blood vessels would remain unchanged. We believe that this change will eliminate the unnecessary burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. We are taking this action because the proposed changes are noncontroversial, and we do not anticipate any significant adverse comments. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule. | 2006-05-12 | 2006 | 5 | https://www.federalregister.gov/documents/2006/05/12/06-4370/blood-vessels-recovered-with-organs-and-intended-for-use-in-organ-transplantation-companion-document | https://www.govinfo.gov/content/pkg/FR-2006-05-12/pdf/06-4370.pdf | Health and Human Services Department; Food and Drug Administration; Health Resources and Services Administration | 221,199,222 | The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are proposing to amend their regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ... |