Free 3356 - Federal

See Instructions for OMB Statement. FORM APPROVED: OMB No. 0910-0543. Expiration Date: 8/31/10 DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

1. REGISTRATION NUMBER (Field Establishment Identifier)

2. REASON FOR SUBMISSION a. b. c. d. INITIAL REGISTRATION/LISTING ANNUAL REGISTRATION/LISTING CHANGE IN INFORMATION INACTIVE
11. HCT / Ps DESCRIBED IN 21 CFR 1271.10

VALIDATION ­ FOR FDA USE ONLY

ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)
(See reverse side for instructions)

FEI

PART I ­ ESTABLISHMENT INFORMATION
3. OTHER FDA REGISTRATIONS a. BLOOD FDA 2830 b. DEVICE FDA 2891 c. DRUG FDA 2656 NO. NO. NO.

PART II ­ HCT / P INFORMATION
10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT / Ps Establishment Functions Types of HCT / Ps
Recover Screen Test Package Process Store Label Distribute

13. HCT / Ps REGULATED AS DRUGS OR BIOLOGICAL DRUGS 12. HCT / Ps REGULATED AS MEDICAL DEVICES

14. PROPRIETARY NAMES

4. PHYSICAL LOCATION (Include legal name, number and street, city, state, country, and post office code.)

a. Bone b. Cartilage c. Cornea d. Dura Mater e. Embryo f. Fascia g. Heart Valve h. Ligament i. Oocyte
SIP Directed Anonymous SIP Directed Anonymous

a. PHONE: b. c.
SATELLITE RECOVERY ESTABLISHMENT (MANUFACTURING ESTABLISHMENT FEI NO. TESTING FOR MICRO-ORGANISMS ONLY )

5. ENTER CORRECTIONS TO ITEM 4

6. MAILING ADDRESS OF REPORTING OFFICIAL (Include institution name if applicable, number and street, city, state, country, and post office code.)

j. Pericardium k. Peripheral Blood Stem Cells l. Sclera m. Semen
SIP Directed Anonymous Autologous Family Related Allogeneic

a. PHONE: 7. ENTER CORRECTIONS TO ITEM 6 n. Skin o. Somatic Cell Therapy Products 8. U.S. AGENT a. E-MAIL ADDRESS: b. PHONE: 9. REPORTING OFFICIAL'S SIGNATURE p. Tendon q. Umbilical Cord Blood Stem Cells r. Vascular Graft s. t. u. d. DATE: v.

Autologous Family Related Allogeneic

Autologous Family Related Allogeneic

a. TYPED NAME: b. E-MAIL ADDRESS: c. TITLE:

FORM FDA 3356 (4/08)

PSC Graphics (301) 443-1090

EF

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INSTRUCTIONS FOR COMPLETING FORM 3356: ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/Ps)
Completion of Form FDA 3356 is required under 21 CFR Part 1271, 207.20 and 807.20 for all establishments engaged in the recovery, processing, storage, labeling, packaging, or distribution of any HCT/P, or the screening or testing of a cell or tissue donor. After we receive your form, we will update our records and send a validated form to the reporting official. PART I. ESTABLISHMENT INFORMATION NOTE: You are required to register and list your HCT/Ps by submitting this form if you recover, process, store, label, package, or distribute any HCT/P, or screen or test the HCT/P donor unless one of the following exceptions applies. You are not required to submit this form if: a. You use HCT/Ps solely for nonclinical scientific or educational purposes, b. You remove and then implant HCT/Ps solely for autologous use during the same surgical procedure, c. You are a carrier who accepts, receives, carries, or delivers HCT/Ps in the usual course of business as a carrier, d. You only receive or store HCT/Ps solely for implantation, transplantation, infusion, or transfer within your facility, e. You only recover reproductive cells or tissue and immediately transfer them into a sexually intimate partner of the cell or tissue donor, or f. You are an individual person who works under contract, agreement, or other arrangement with or for a registered establishment and only recover and send HCT/Ps to the registered establishment. Item 3. OTHER FDA REGISTRATIONS ­ Provide the registration number if your establishment is already registered with FDA as a Blood, Medical Device or Drug establishment. Your establishment will not be given a new registration number and you are not required to fill in items 4 to 8 of Part I. Item 9 must be filled out and signed on all forms. If you choose not to complete, Items 4 to 8 of Part I, you still must complete and sign Item 9. Then proceed to Part II and provide product information. Item 4. PHYSICAL LOCATION ­ Provide the legal name, street address including the postal code of the actual location and a. Telephone number. b. Indicate (with an X) if you are a satellite recovery establishment that supports recovery personnel in the field by providing temporary storage for recovered HCT/Ps for shipment to your parent manufacturing establishment, but do not perform any other activities or manufacturing steps. Provide the FEI NO. of your parent manufacturing establishment. c. Indicate (with an X) if you are an establishment that performs testing of HCT/Ps for micro-organisms if that is the only HCT/P processing function that you perform. Item 6. MAILING ADDRESS OF THE REPORTING OFFICIAL ­ Provide the reporting offcial's mailing address including the postal code if it is different from the actual location of the establishment. Items 8. U.S. AGENT ­ Non-U.S. establishments only; Provide your U.S. agent name, institution name if applicable, street address, e-mail address, and telephone number. United States agent means a person residing or maintaining a place of business in the United States whom a foreign establishment designates as its agent. Item 9. REPORTING OFFICIAL'S SIGNATURE ­ The reporting official as listed in Item 6 is the person appointed by the owner or operator to register the from and answer all the correspondence and inquiries relative thereto. The dated signature by the reporting official affirms that all information contained on the form is true and accurate, to the best of his or her knowledge. PART II. HCT/P INFORMATION (If item 2.c is checked, only indicate the information being changed.) Item 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT/Ps ­ Indicate (with an X) the activity (ies) performed by the registered establishment in conjunction with the type of HCT/P that the registered establishment manufactures. Test and screen refer to the donor, not the HCT/P. For reproductive HCT/Ps, indicate whether the HCT/Ps are from sexually intimate partners (SIP), directed, or anonymous. For hematopoietic stem/progenitor cells and somatic cells, indicate whether the HCT/ Ps are autologous, family related, or allogeneic. Family related means allogeneic use in a first degree or second degree relative. Item 11. LISTING FOR HCT/Ps DESCRIBED IN 21 CFR 1271.10 ­ To list HCT/Ps that are described in 21 CFR 1271.10 (a) indicate (with an X) each HCT/P that fulfills all of the following criteria: a. The HCT/P is minimally manipulated, b. The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent, c. The manufacture of the HCT/P does not involve the combination of the cell or tissue component with a drug or a device, except for a sterilizing, preserving, or storage agent, if the addition of the agent does not raise new clinical safety concerns with respect to the HCT/P, and either d. The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or the HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and (i) is for autologous use, (ii) is for allogeneic use in a first-degree or second-degree blood relative, or (iii) is for reproductive use. If your HCT/P type is not preprinted on the form, list it on lines s-v. Item 12. HCT/P LISTING FOR MEDICAL DEVICES ­ Indicate (with an X) each HCT/P that is regulated as a medical device under the Federal Food, Drug, and Cosmetic Act. Item 13. HCT/P LISTING FOR DRUGS OR BIOLOGICAL DRUGS ­ Indicate (with an X) each HCT/ P that is regulated as a drug or biological drug under the Federal Food, Drug, and Cosmetic Act and/ or section 351 of the Public Health Service Act. NOTE: For items 11, 12, and 13 indicate changes to HCT/P listing such as discontinuance (indicate with a D), or resumption (indicate with an R) of a HCT/P into commercial distribution in June and December or at the time the change occurs as directed under 21 CFR Part 1271.21. Dates of HCT/P discontinuance / resumption should be provided on an additional page. Item 14. PROPRIETARY NAMES ­ Indicate any applicable proprietary names used for the HCT/Ps listed, such as a trademark. NOTE: If necessary add an additional page to complete Items 11, 12, 13, or 14.

After completion, return the form to: Food and Drug Administration Center for Biologics Evaluation and Research (HFM-775) 1401 Rockville Pike, Rockville, MD 20852-1448 ATTENTION: Tissue Establishment Registration Coordinator FAX No. (301) 827-2844
FORM FDA 3356 (4/08)

Public reporting burden for this collection of information is estimated to average .75 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: An agency may not conduct or sponsor, and Department of Health and Human Services a person is not required to respond to, a Food and Drug Administration collection of information unless it displays a Office of Chief Information Officer (HFA-250) currently valid OMB control number. 5600 Fishers Lane Rockville, MD 20857

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