28 CFR §202.223

1. (a)The term human biospecimens means a quantity of tissue, blood, urine, or other human-derived material, including such material classified under any of the following 10-digit Harmonized System-based Schedule B numbers:
   1. (1)0501.00.0000 Human hair, unworked, whether or not washed or scoured; waste of human hair
   2. (2)3001.20.0000 Extracts of glands or other organs or of their secretions
   3. (3)3001.90.0115 Glands and other organs, dried, whether or not powdered
   4. (4)3002.12.0010 Human blood plasma
   5. (5)3002.12.0020 Normal human blood sera, whether or not freeze-dried
   6. (6)3002.12.0030 Human immune blood sera
   7. (7)3002.12.0090 Antisera and other blood fractions, Other
   8. (8)3002.51.0000 Cell therapy products
   9. (9)3002.59.0000 Cell cultures, whether or not modified, Other
   10. (10)3002.90.5210 Whole human blood
   11. (11)3002.90.5250 Blood, human/animal, other
   12. (12)9705.21.0000 Human specimens and parts thereof
2. (b)Notwithstanding paragraph (a) of this section, the term human biospecimens does not include human biospecimens, including human blood, cell, and plasma-derived therapeutics, intended by a recipient solely for use in diagnosing, treating, or preventing any disease or medical condition.