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HHS/FDA RIN: 0910-AG53 Publication ID: Spring 2011 
Title: Amendment to the CGTPs To Create Urgent Medical Need Exception for Distribution of Certain HCT/Ps That May Not Meet Release Criteria 
Abstract: The Food and Drug Administration (FDA) is proposing to amend the current good tissue practice (CGTP) regulations to provide an exception in situations of documented urgent medical need for distribution of certain minimally manipulated human cells, tissues, and tissue-based products (HCT/Ps) for homologous use, which may not meet release criteria because of the potential or actual presence of bacteria or fungi. As part of this rulemaking, FDA also is proposing amendments to the CGTP regulations in connection with labeling and physician notification as to these HCT/Ps. This action is intended to enhance access to medically necessary products in cases of documented urgent medical need where there is no comparable HCT/P available and the treating physician has determined that the recipient is likely to suffer death or serious morbidity without the HCT/P. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1271   
Legal Authority: 42 USC 243    42 USC 264    42 USC 262    42 USC 271   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  To Be Determined    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Lori Jo Churchyard
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 71, Room 7301,
Silver Spring, MD 20993
Phone:240 402-7911
Email: lori.olsenchurchyard@fda.hhs.gov