OMB control number
Human Cells, Tissues, and Cellular and Tissue-Based Products
OMB 0910-0543 ยท HHS/FDA.
OMB 0910-0543
The information collection supports agency regulations regarding eligibility determination for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Respondents to the collection are manufacturers of these products subject to public health protection provisions under the Federal Food, Drug, and Cosmetic Act.
The latest form for Human Cells, Tissues, and Cellular and Tissue-Based Products expires 2026-08-31 and can be found here.
Latest Forms, Documents, and Supporting Material
0543 Supporting Statement 2023 7-11-23.docx
Reporting and recordkeeping requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) All Historical Document Collections
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Approved without change |
Extension without change of a currently approved collection | 2023-07-13 | |
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Approved without change |
Extension without change of a currently approved collection | 2020-06-22 | |
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Approved without change |
Extension without change of a currently approved collection | 2017-03-31 | |
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Approved without change |
Extension without change of a currently approved collection | 2014-01-28 | |
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Approved without change |
Extension without change of a currently approved collection | 2010-08-10 | |
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Approved without change |
No material or nonsubstantive change to a currently approved collection | 2007-11-16 | |
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Approved with change |
Extension without change of a currently approved collection | 2007-05-01 | |
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Approved without change |
New collection (Request for a new OMB Control Number) | 2004-04-22 |
OMB Details
Reporting and recordkeeping requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
Federal Enterprise Architecture: Health - Consumer Health and Safety