21cfr1271

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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