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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Food and Drug Administration, HHS

§ 1271.45

listed, the identity by established
name and proprietary name, and the
date of discontinuance. We request but
do not require that you include the
reason for discontinuance with this information.
(3) A list of each HCT/P for which a
notice of discontinuance was submitted
under paragraph (c)(2) of this section
and for which you have resumed recovery, processing, storage, labeling, packaging, distribution, or donor screening
or testing, including the identity by established name and proprietary name,
the date of resumption, and any other
information required by § 1271.25(b) not
previously submitted.
(4) Any material change in any information previously submitted. Material
changes include any change in information submitted on Form FDA 3356, such
as whether the HCT/P meets the criteria set out in § 1271.10.
§ 1271.26 When must I amend my establishment registration?
If the ownership or location of your
establishment changes, you must submit an amendment to registration
within 5 days of the change.
§ 1271.27 Will FDA assign me a registration number?
(a) FDA will assign each location a
permanent registration number.
(b) FDA acceptance of an establishment registration and HCT/P listing
form does not constitute a determination that an establishment is in compliance with applicable rules and regulations or that the HCT/P is licensed or
approved by FDA.
§ 1271.37 Will establishment registrations and HCT/P listings be available for inspection, and how do I
request information on registrations and listings?
(a) A copy of the Form FDA 3356 filed
by each establishment will be available
for public inspection at the Office of
Communication, Training, and Manufacturers Assistance (HFM–48), Center
for Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448. In addition, there will
be available for inspection at each of
the Food and Drug Administration district offices the same information for

firms within the geographical area of
such district office. Upon request and
receipt of a self-addressed stamped envelope, verification of a registration
number or the location of a registered
establishment will be provided. The
following information submitted under
the HCT/P requirements is illustrative
of the type of information that will be
available for public disclosure when it
is compiled:
(1) A list of all HCT/P’s;
(2) A list of all HCT/P’s manufactured
by each establishment;
(3) A list of all HCT/P’s discontinued;
and
(4) All data or information that has
already become a matter of public
record.
(b) You should direct your requests
for information regarding HCT/P establishment registrations and HCT/P listings to the Office of Communication,
Training and Manufacturers Assistance
(HFM–48), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite
200N, Rockville, MD 20852–1448.

Subpart C—Donor Eligibility
SOURCE: 69 FR 29830, May 25, 2004, unless
otherwise noted.

§ 1271.45 What requirements does this
subpart contain?
(a) General. This subpart sets out requirements for determining donor eligibility, including donor screening and
testing. The requirements contained in
this subpart are a component of current good tissue practice (CGTP) requirements. Other CGTP requirements
are set out in subpart D of this part.
(b) Donor-eligibility determination required. A donor-eligibility determination, based on donor screening and
testing for relevant communicable disease agents and diseases, is required for
all donors of cells or tissue used in
HCT/Ps, except as provided under
§ 1271.90. In the case of an embryo or of
cells derived from an embryo, a donoreligibility determination is required
for both the oocyte donor and the
semen donor.
(c) Prohibition on use. An HCT/P must
not be implanted, transplanted, infused, or transferred until the donor

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