This script search US Code. View Rule
Menu Item - Home
Menu Item - Agenda Main page
Menu Item - Historical Agenda
Menu Item - Historical Agenda
Menu Item - Agenda Search
Menu Item - Agenda XML Reports
Menu Item - EO Dashboard
Menu Item - Reg Review
Menu Item - EO Agency lists
Menu Item - EO Search
Menu Item - EO Historical Reports
Menu Item - Review Counts
Menu Item - OIRA Letters
Menu Item - EOM 12866 Search
Menu Item - EO XML Reports
Menu Item - ICR Dashboard page
Menu Item - ICR Main page
Menu Item - ICR Search
Menu Item - ICR XML Reports
Menu Item - FAQ
Menu Item - Additional Resources
Menu Item - Contact Us
Search: Agenda Reg Review ICR

View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AF65 Publication ID: Spring 2007 
Title: Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation 
Abstract: FDA and Health Resources and Services Administration (HRSA) issued a direct final rule and companion proposed rule to amend the regulations to consider as part of an organ (and regulated by HRSA) those blood vessels recovered with vascularized human organs that are intended for use in organ transplantation and labeled as such; and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products (regulated by FDA). We took 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. We believe this change will eliminate unnecessary burden resulting from an organ procurement organizationís efforts to comply with both FDA and HRSA requirements with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). We received significant adverse comments in response to the direct final rule. Therefore, the direct final rule was withdrawn. FDA and HRSA finalized the proposed rule after considering all comments. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1271    42 CFR 121   
Legal Authority: 42 USC 216    42 USC 243    42 USC 263a    42 USC 264    42 USC 271    42 USC 273 to 274d    42 USC 1302    42 USC 1306   
Legal Deadline:  None
Action Date FR Cite
NPRM - Companion to Direct Final Rule  05/12/2006  71 FR 27649   
Direct Final Rule  05/12/2006  71 FR 27606   
Comment Period End  07/26/2006    
Direct Final Rule-Withdrawal  09/14/2006  71 FR 54198   
Final Action  03/12/2007  72 FR 10922   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Related Agencies: Joint: HHS/HRSA; 
Agency Contact:
Denise Sanchez
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike,
Rockville, MD 20852-1448
Phone:301 827-6210
Fax:301 827-9434

About Us   Vertical Spacer Spacer Related Resources   Vertical Spacer Spacer Disclosure   Vertical Spacer Spacer Accessibility   Vertical Spacer Spacer Privacy Policy   Vertical Spacer Spacer Contact Us