[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: 21CFR1271.85]

[Page 730]
 
                        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 C_Donor Eligibility
 
Sec. 1271.85  What donor testing is required for different types
of cells and tissues?

    (a) All donors. To adequately and appropriately reduce the risk of 
transmission of relevant communicable diseases, and except as provided 
under Sec. 1271.90, you must test a specimen from the donor of cells or 
tissue, whether viable or nonviable, for evidence of infection due to 
relevant communicable disease agents, including:
    (1) Human immunodeficiency virus, type 1;
    (2) Human immunodeficiency virus, type 2;
    (3) Hepatitis B virus;
    (4) Hepatitis C virus; and
    (5) Treponema pallidum.
    (b) Donors of viable, leukocyte-rich cells or tissue. In addition to 
the relevant communicable disease agents for which testing is required 
under paragraph (a) of this section, and except as provided under Sec. 
1271.90,
    (1) You must test a specimen from the donor of viable, leukocyte-
rich cells or tissue to adequately and appropriately reduce the risk of 
transmission of relevant cell-associated communicable diseases, 
including:
    (i) Human T-lymphotropic virus, type I; and
    (ii) Human T-lymphotropic virus, type II.
    (2) You must test a specimen from the donor of viable, leukocyte-
rich cells or tissue for evidence of infection due to cytomegalovirus 
(CMV), to adequately and appropriately reduce the risk of transmission. 
You must establish and maintain a standard operating procedure governing 
the release of an HCT/P from a donor whose specimen tests reactive for 
CMV.
    (c) Donors of reproductive cells or tissue. In addition to the 
communicable disease agents for which testing is required under 
paragraphs (a) and (b) of this section, as applicable, and except as 
provided under Sec. 1271.90, you must test a specimen from the donor of 
reproductive cells or tissue to adequately and appropriately reduce the 
risk of transmission of relevant communicable disease agents of the 
genitourinary tract. Such testing must include testing for the 
communicable disease agents listed in paragraphs (c)(1) and (c)(2) of 
this section. However, if the reproductive cells or tissues are 
recovered by a method that ensures freedom from contamination of the 
cells or tissue by infectious disease organisms that may be present in 
the genitourinary tract, then testing for the communicable disease 
agents listed in paragraphs (c)(1) and (c)(2) of this section is not 
required. Communicable disease agents of the genitourinary tract for 
which you must test include:
    (1) Chlamydia trachomatis; and
    (2) Neisseria gonorrhea.
    (d) Retesting anonymous semen donors. Except as provided under Sec. 
1271.90 and except for directed reproductive donors as defined in Sec. 
1271.3(l), at least 6 months after the date of donation of semen from 
anonymous donors, you must collect a new specimen from the donor and 
test it for evidence of infection due to the communicable disease agents 
for which testing is required under paragraphs (a), (b), and (c) of this 
section.
    (e) Dura mater. For donors of dura mater, you must perform an 
adequate assessment designed to detect evidence of transmissible 
spongiform encephalopathy.