OMB control number
Human Cells, Tissues, and Cellular and Tissue-Based Products
OMB 0910-0543 · 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 is listed under ICR 202301-0910-011.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0543 Supporting Statement 2023 7-11-23.docx | Supporting Statement A |
 Reporting and recordkeeping requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) |
Other-eHCTERS Screenshot |
| Third Party Disclosures for HCT/Ps |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202301-0910-011 | Extension without change of a currently approved collection | 2023-07-13 | Approved without change | |
| 202004-0910-007 | Extension without change of a currently approved collection | 2020-06-22 | Approved without change | |
| 201703-0910-007 | Extension without change of a currently approved collection | 2017-03-31 | Approved without change | |
| 201401-0910-008 | Extension without change of a currently approved collection | 2014-01-28 | Approved without change | |
| 201008-0910-004 | Extension without change of a currently approved collection | 2010-08-10 | Approved without change | |
| 200711-0910-002 | No material or nonsubstantive change to a currently approved collection | 2007-11-16 | Approved without change | |
| 200705-0910-001 | Extension without change of a currently approved collection | 2007-05-01 | Approved with change | |
| 200404-0910-004 | New collection (Request for a new OMB Control Number) | 2004-04-22 | Approved without change |
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