[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.420]

[Page 742]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS--Table of Contents
 
 Subpart F_Inspection and Enforcement of Establishments Described in   
                                 1271.10
 
Sec. 1271.420  HCT/Ps offered for import.

    (a) Except as provided in paragraphs (c) and (d) of this section, 
when an HCT/P is offered for import, the importer of record must notify, 
either before or at the time of importation, the director of the 
district of the Food and Drug Administration (FDA) having jurisdiction 
over the port of entry through which the HCT/P is imported or offered 
for import, or such officer of the district as the director may 
designate to act in his or her behalf in administering and enforcing 
this part, and must provide sufficient information for FDA to make an 
admissibility decision.
    (b) Except as provided in paragraphs (c) and (d) of this section, an 
HCT/P offered for import must be held intact by the importer or 
consignee, under conditions necessary to prevent transmission of 
communicable disease, until an admissibility decision is made by FDA. 
The HCT/P may be transported under quarantine to the consignee, while 
the FDA district reviews the documentation accompanying the HCT/P. When 
FDA makes a decision regarding the admissibility of the HCT/P, FDA will 
notify the importer of record.
    (c) This section does not apply to reproductive HCT/Ps regulated 
solely under section 361 of the Public Health Service Act and the 
regulations in this part, and donated by a sexually intimate partner of 
the recipient for reproductive use.
    (d) This section does not apply to peripheral blood stem/progenitor 
cells regulated solely under section 361 of the Public Health Service 
Act and the regulations in this part, except that paragraphs (a) and (b) 
of this section apply when circumstances occur under which such imported 
peripheral blood stem/progenitor cells may present an unreasonable risk 
of communicable disease transmission which indicates the need to review 
the information referenced in paragraph (a) of this section.