OMB.report

Federal forms, ICRs, and supporting documents

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 2027-03-31 and is listed under ICR 202609-0910-001.

View the official OMB control history on Reginfo.gov.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
0543 HCT Products SSA 2026 for Emergency Review of Reinstatement.docxSupporting Statement A
0543 HCT Products SSA 2026 for Emergency Review of Reinstatement.docxSupporting Statement A
0910-0543 Emergency Review Request 9-16-26 (signed).pdfSupplementary Document
0910-0543 Emergency Review Request 9-16-26 (signed).pdfSupplementary Document
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All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202609-0910-001 Reinstatement without change of a previously approved collection 2026-09-18
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