Human Cells, Tissues, and Cellular and Tissue-Based Products

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 2023-07-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
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

All Historical Document Collections

202301-0910-011 Approved without change	Extension without change of a currently approved collection	2023-07-13
202004-0910-007 Approved without change	Extension without change of a currently approved collection	2020-06-22
201703-0910-007 Approved without change	Extension without change of a currently approved collection	2017-03-31
201401-0910-008 Approved without change	Extension without change of a currently approved collection	2014-01-28
201008-0910-004 Approved without change	Extension without change of a currently approved collection	2010-08-10
200711-0910-002 Approved without change	No material or nonsubstantive change to a currently approved collection	2007-11-16
200705-0910-001 Approved with change	Extension without change of a currently approved collection	2007-05-01
200404-0910-004 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