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

---
identifier: "/us/fr/08-55500"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Human Cells, Tissues, and Cellular and Tissue-Based Products"
title_number: 0
title_name: "Federal Register"
section_number: "08-55500"
section_name: "Human Cells, Tissues, and Cellular and Tissue-Based Products"
positive_law: false
currency: "2008-01-18"
last_updated: "2008-01-18"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "08-55500"
document_type: "rule"
publication_date: "2008-01-18"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 1271"
fr_citation: "73 FR 3387"
fr_volume: 73
---

#  How and where do I register and submit an HCT/P list?

**CFR Correction**

In Title 21 of the Code of Federal Regulations, Parts 800 to 1299, revised as of April 1, 2007, in part 1271, on page 718, § 1271.22 is reinstated to read as follows:

§ 1271.22

(a) You must use Form FDA 3356 for:

(1) Establishment registration,

(2) HCT/P listings, and

(3) Updates of registration and HCT/P listing.

(b) You may obtain Form FDA 3356:

(1) By writing to the Center for Biologics Evaluation and Research (HFM-775), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, Attention: Tissue Establishment Registration Coordinator;

(2) By contacting any Food and Drug Administration district office;

(3) By calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800; or

(4) By connecting to *http://www.fda.gov/opacom/morechoices/fdaforms/cber.html* on the Internet.

(c)(1) You may submit Form FDA 3356 to the Center for Biologics Evaluation and Research (HFM-775), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, Attention: Tissue Establishment Registration Coordinator; or

(2) You may submit Form FDA 3356 electronically through a secure web server at *http://www.fda.gov/cber/tissue/tisreg.htm* .