Document
Reporting and recordkeeping requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
ICR 202609-0910-001 · OMB 0910-0543 · Object 172512700.
Document Viewer [docx]
Document Metadata
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
|---|---|
| File Title | Reporting and recordkeeping requirements for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) |
| Author | Bullock, Monica-Tia |
| Last Modified By | Writer |
| File Modified | 2023-07-11 |
| File Created | 2026-09-19 |
| Conversion State | complete |
Extracted Text
CBER On-Line- Login Screen CBER On-Line Main Menu Screen Note: After eHCTERS application is selected, the OMB control number and expiration date are displayed on all subsequent pages (see next page for an example). Electronic Human Cells and Tissue Establishment Registration System (eHCTERS) Activity Selection Screen (screenshot of the entire page) The text highlighted in yellow will be replaced with: OMB Control Number 0910-0543; Expiration Date 07/31/2023 See OMB Burden Statement The hyperlink will lead to this text: OMB Burden Statement Public reporting burden for this collection of information is estimated as follows: The time required to complete registration and listing for existing establishments is estimated to average 30 minutes per response, for new establishments it is estimated to average 45 minutes per response, and updates to a list are estimated to average 30 minutes per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden, to [email protected]. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. User Establishments Screen Active Users Screen Submissions Pending Screen Initial Establishment Registration Information Screen Edit Establishment Registration Information Screen Establishment Registration Address Information Screen Possible Establishment Matches Found Screen Establishment Reporting Official Information Screen Establishment U.S. Agent Information Screen Establishment Importer Information Screen HCT/P Listing Information Screen Function Information Screen Donor Information Screen Additional Information to Complete HCT/P Information Listing Screen Reporting Official Signature Screen Submitted Establishment Registration Information Screen Registration Summary Report Provided to the Establishments (Example-Page 1) Registration Summary Report Provided to the Establishments (Example-Page 2)