21cfr1271

§ 1271.20

21 CFR Ch. I (4–1–06 Edition)

package, or distribute, but only receives or stores HCT/P’s solely for implantation, transplantation, infusion,
or transfer within your facility.
(e) You are not required to comply
with the requirements of this part if
you are an establishment that only recovers reproductive cells or tissue and
immediately transfers them into a sexually intimate partner of the cell or
tissue donor.
(f) You are not required to register or
list your HCT/P’s independently, but
you must comply with all other applicable requirements in this part, if you
are an individual under contract,
agreement, or other arrangement with
a registered establishment and engaged
solely in recovering cells or tissues and
sending the recovered cells or tissues
to the registered establishment.
§ 1271.20 If my HCT/P’s do not meet
the criteria in § 1271.10, and I do
not qualify for any of the exceptions in § 1271.15, what regulations
apply?
If you are an establishment that
manufactures an HCT/P that does not
meet the criteria set out in § 1271.10(a),
and you do not qualify for any of the
exceptions in § 1271.15, your HCT/P will
be regulated as a drug, device, and/or
biological product under the act and/or
section 351 of the PHS Act, and applicable regulations in title 21, chapter I.
Applicable regulations include, but are
not limited to, §§ 207.20(f), 210.1(c), 210.2,
211.1(b), 807.20(d), and 820.1(a) of this
chapter, which require you to follow
the procedures in subparts B, C, and D
of this part.

Subpart B—Procedures for
Registration and Listing
§ 1271.21 When do I register, submit an
HCT/P list, and submit updates?
(a) You must register and submit a
list of every HCT/P that your establishment manufactures within 5 days after
beginning operations or within 30 days
of the effective date of this regulation,
whichever is later.
(b) You must update your establishment registration annually in December, except as required by § 1271.26. You
may accomplish your annual registration in conjunction with updating your

HCT/P list under paragraph (c) of this
section.
(c)(i) If no change described in
§ 1271.25(c) has occurred since you previously submitted an HCT/P list, you
are not required to update your listing.
(ii) If a change described in
§ 1271.25(c) has occurred, you must update your HCT/P listing with the new
information:
(a) At the time of the change, or
(b) Each June or December, whichever month occurs first after the
change.
[69 FR 68681, Nov. 24, 2004]

§ 1271.25 What information is required
for establishment registration and
HCT/P listing?
(a) Your establishment registration
Form FDA 3356 must include:
(1) The legal name(s) of the establishment;
(2) Each location, including the
street address of the establishment and
the postal service zip code;
(3) The name, address, and title of
the reporting official; and
(4) A dated signature by the reporting official affirming that all information contained in the establishment
registration and HCT/P listing form is
true and accurate, to the best of his or
her knowledge.
(b) Your HCT/P listing must include
all HCT/P’s (including the established
name and the proprietary name) that
you recover, process, store, label, package, distribute, or for which you perform donor screening or testing. You
must also state whether each HCT/P
meets the criteria set out in § 1271.10.
(c) Your HCT/P listing update must
include:
(1) A list of each HCT/P that you
have begun recovering, processing,
storing, labeling, packaging, distributing, or for which you have begun
donor screening or testing, that has
not been included in any list previously
submitted. You must provide all of the
information required by § 1271.25(b) for
each new HCT/P.
(2) A list of each HCT/P formerly listed in accordance with § 1271.21(a) for
which you have discontinued recovery,
processing, storage, labeling, packaging, distribution, or donor screening
or testing, including for each HCT/P so

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