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1
2INSTRUCTIONS 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
Item 9. REPORTING OFFICIAL’S SIGNATURE – The reporting official as listed in Item 6 is the
establishments engaged in the recovery, processing, storage, labeling, packaging, or distribution of
person appointed by the owner or operator to register the form and answer all the correspondence
any HCT/P, or the screening or testing of a cell or tissue donor. After we receive your form, we will
and inquiries relative thereto. The dated signature by the reporting official affirms that all information
update our records and send a validated form to the reporting official.
contained on the form is true and accurate, to the best of his or her knowledge.
PART I. ESTABLISHMENT INFORMATION
PART II. HCT/P INFORMATION (If item 2.c is checked, only indicate the information being changed.)
NOTE: You are required to register and list your HCT/Ps by submitting this form if you recover, pro-
Item 10. ESTABLISHMENT FUNCTIONS AND TYPES OF HCT/Ps – Indicate (with an X) the activity
cess, store, label, package, or distribute any HCT/P, or screen or test the HCT/P donor unless one of
(ies) performed by the registered establishment in conjunction with the type of HCT/P that the
the following exceptions applies. You are not required to submit this form if:
registered establishment manufactures. Test and screen refer to the donor, not the HCT/P. For
a. You use HCT/Ps solely for nonclinical scientific or educational purposes,
reproductive HCT/Ps, indicate whether the HCT/Ps are from sexually intimate partners (SIP), directed,
b. You remove and then implant HCT/Ps solely for autologous use during the same surgical
or anonymous. For hematopoietic stem/progenitor cells and somatic cells, indicate whether the HCT/
procedure,
Ps are autologous, family related, or allogeneic. Family related means allogeneic use in a first-degree
or second-degree relative.
c. You are a carrier who accepts, receives, carries, or delivers HCT/Ps in the usual course of
business as a carrier,
Item 11. LISTING FOR HCT/Ps DESCRIBED IN 21 CFR 1271.10 – To list HCT/Ps that are described
d. You only receive or store HCT/Ps solely for implantation, transplantation, infusion, or transfer
in 21 CFR 1271.10 (a) indicate (with an X) each HCT/P that fulfills all of the following criteria:
within your facility,
a. The HCT/P is minimally manipulated,
e. You only recover reproductive cells or tissue and immediately transfer them into a sexually inti-
mate partner of the cell or tissue donor, or
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,
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
c. The manufacture of the HCT/P does not involve the combination of the cell or tissue component
establishment.
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
Item 3. OTHER FDA REGISTRATIONS – Provide the registration number if your establishment is
d. The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of
already registered with FDA as a Blood, Medical Device or Drug establishment. Your establishment
living cells for its primary function; or the HCT/P has a systemic effect or is dependent upon the
will not be given a new registration number, and you are not required to fill in items 4 to 8 of Part I. Item
metabolic activity of living cells for its primary function, and (i) is for autologous use, (ii) is for
9 must be filled out and signed on all forms. If you choose not to complete Items 4 to 8 of Part I, you
allogeneic use in a first-degree or second-degree blood relative, or (iii) is for reproductive use.
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
If your HCT/P type is not preprinted on the form, list it on lines s-v.
the actual location and
Item 12. HCT/P LISTING FOR MEDICAL DEVICES – Indicate (with an X) each HCT/P that is
a. Telephone number.
regulated as a medical device under the Federal Food, Drug, and Cosmetic Act.
b. Indicate (with an X) if you are a satellite recovery establishment that supports recovery personnel
Item 13. HCT/P LISTING FOR DRUGS OR BIOLOGICAL DRUGS – Indicate (with an X) each HCT/
in the field by providing temporary storage for recovered HCT/Ps for shipment to your parent
P that is regulated as a drug or biological drug under the Federal Food, Drug, and Cosmetic Act and/
manufacturing establishment, but do not perform any other activities or manufacturing steps. Pro-
or section 351 of the Public Health Service Act.
vide 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-organ-
NOTE: For items 11, 12, and 13 indicate changes to HCT/P listing such as discontinuance (indicate
isms if that is the only HCT/P processing function that you perform.
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
Item 6. MAILING ADDRESS OF THE REPORTING OFFICIAL – Provide the reporting offcial’s
discontinuance/resumption should be provided on an additional page.
mailing address including the postal code if it is different from the actual location of the establishment.
Item 14. PROPRIETARY NAMES – Indicate any applicable proprietary names used for the HCT/Ps
Items 8. U.S. AGENT – Non-U.S. establishments only: Provide your U.S. agent name, institution
listed, such as a trademark.
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
NOTE: If necessary, add an additional page to complete Items 11, 12, 13, or 14.
establishment designates as its agent.
The information below applies only to requirements of the Paperwork Reduction Act of 1995.
After completion, return the form to:
The burden time for this collection of information is estimated to average .75
Department of Health and Human Services
Food and Drug Administration
hour per response, including the time to review instructions, search existing data
Food and Drug Administration
Center for Biologics Evaluation and Research
sources, gather and maintain the data needed and complete and review the
Office of Chief Information Officer
Document Control Center
collection of information. Send comments regarding this burden estimate or any
Paperwork Reduction Act (PRA) Staff
10903 New Hampshire Avenue, Building 71, Room G112
other aspect of this information collection, including suggestions for reducing this
PRAStaff@fda.hhs.gov
Silver Spring, MD 20993-0002
burden to the address to the right:
ATTENTION: Tissue Establishment Registration Coordinator
"An agency may not conduct or sponsor, and a person is not required to respond
DO NOT SEND YOUR COMPLETED FORM
TO THIS PRA STAFF EMAIL ADDRESS.
to, a collection of information unless it displays a currently valid OMB number."
FAX No. (301) 595-1303
FORM FDA 3356 (5/14)
Page 2 of 2
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