§202.223. Human biospecimens.
28 C.F.R. § 202.223
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:
0501.00.0000 Human hair, unworked, whether or not washed or scoured; waste of human hair
3001.20.0000 Extracts of glands or other organs or of their secretions
3001.90.0115 Glands and other organs, dried, whether or not powdered
3002.12.0010 Human blood plasma
3002.12.0020 Normal human blood sera, whether or not freeze-dried
3002.12.0030 Human immune blood sera
3002.12.0090 Antisera and other blood fractions, Other
3002.51.0000 Cell therapy products
3002.59.0000 Cell cultures, whether or not modified, Other
3002.90.5210 Whole human blood
3002.90.5250 Blood, human/animal, other
9705.21.0000 Human specimens and parts thereof
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.
Notes, amendments, and revision history
Authority
Authority: 50 U.S.C. 1701 et seq.; 50 U.S.C. 1601 et seq.; E.O. 14117, 89 FR 15421.
Source
Source: 90 FR 1706, Jan. 8, 2025, unless otherwise noted.