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you may use an abbreviated donor screening procedure on repeat donations. The abbreviated procedure must determine and document any changes in the donor's medical history since the previous donation that would make the donor ineligible, including relevant social behavior. [66 FR 5466, Jan. 19, 2001, as amended at 71 FR 14798, Mar. 24, 2006)
)) Donors of viable, leukocyte-rich cells tissue. In addition to the relevant nmunicable disease agents and dises for which screening is required ler paragraph (a) of this section, and ept as provided under $1271.90, you st screen the donor of viable, leuyte-rich cells or tissue by reviewing donor's relevant medical records risk factors for and clinical eviice of relevant cell-associated comnicable disease agents and diseases, luding Human T-lymphotropic us. 2) Donors of reproductive cells or tis· In addition to the relevant commuable disease agents and diseases for ich screening is required under paraiphs (a) and (b) of this section, as apcable, and except as provided under 171.90, you must screen the donor of productive cells or tissue by review3 the donor's relevant medical Pords for risk factors for and clinical idence of infection due to relevant mmunicable diseases of the genitoinary tract. Such screening must inide screening for the communicable lease agents listed in paragraphs (1) and (c)(2) of this section. Hower, if the reproductive cells or tissues
recovered by a method that ensures edom from contamination of the Ils or tissue by infectious disease ornisms that may be present in the nitourinary tract, then screening for e communicable disease agents listed
paragraphs (c)(1) and (c)(2) of this iction is not required. Communicable sease agents of the genitourinary act for which you must screen inade: (1) Chlamydia trachomatis; and (2) Neisseria gonorrhea. (d) Ineligible donors. You must deterine ineligible a donor who is identid as having either of the following: (1) A risk factor for or clinical evince of any of the relevant commucable disease agents or diseases for ich screening is required under paraaphs (a)(1), (b), or (c) of this section;
$ 1271.80 What are the general require
ments for donor testing? (a) Testing for relevant communicable diseases is required. To adequately and appropriately reduce the risk of transmission of relevant communicable diseases, and except as provided under $1271.90, if you are the establishment that performs donor testing, you must test a donor specimen for evidence of infection due to communicable disease agents in accordance with paragraph (c) of this section. You must test for those communicable disease agents specified in § 1271.85. In the case of a donor 1 month of age or younger, you must test a specimen from the birth mother instead of a specimen from the donor.
(b) Timing of specimen collection. You must collect the donor specimen for testing at the time of recovery of cells or tissue from the donor; or up to 7 days before or after recovery, except:
(1) For donors of peripheral blood stem/progenitor cells, bone marrow (if not excepted under $1271.3(d)(4)), or 00cytes, you may collect the donor specimen for testing up to 30 days before recovery; or
(2) In the case of a repeat semen donor from whom a specimen has already been collected and tested, and for whom retesting is required under $1271.85(d), you are not required to collect a donor specimen at the time of each donation.
(c) Tests. You must test using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases; however, until such time as appropriate FDA-licensed, approved, or cleared donor screening tests for Chlamydia trachomatis and for
(2) Any communicable disease risk sociated with xenotransplantation (e) Abbreviated procedure for repeat doITs. If you have performed a complete inor screening procedure on a living inor within the previous 6 months,
Neisseria gonorrhea are available, you death or specimen collection, whichmust use FDA-licensed, approved, or ever occurred earlier, or cleared tests labeled for the detection (2) More than 2,000 mL of crystalloids of those organisms in an asymp within 1 hour before death or specimen tomatic, low-prevalence population. collection, whichever occurred earlier, You must use a test specifically la- (B) Regardless of the presence or abbeled for cadaveric specimens instead sence of blood loss, the donor is 12 of a more generally labeled test when years of age or younger and has reapplicable and when available. Re ceived a transfusion or infusion of any quired testing under this section must amount of any of the following, alone be performed by a laboratory that either is certified to perform such test (1) Blood (e.g., whole blood, red blood ing on human specimens under the
cells) or colloids within 48 hours before Clinical Laboratory Improvement death or specimen collection, whichAmendments of 1988 (42 U.S.C. 263a)
dments of 1988 142 Usc 2622 ever occurred earlier, or and 42 CFR part 493, or has met equiva
(2) Crystalloids within 1 hour before lent requirements as determined by the
death or specimen collection, whichCenters for Medicare and Medicaid ever occurred earlier. Services.
(69 FR 29830, May 25, 2004, as amended at To (d) Ineligible donors. You must deter FR 29952, May 25, 2005] mine the following donors to be ineligible:
$ 1271.85 What donor testing is re
quired for different types of cells (1) A donor whose specimen tests re
and tissues? active on a screening test for a communicable disease agent in accordance
(a) All donors. To adequately and apwith $ 1271.85, except for a donor whose
propriately reduce the risk of transspecimen tests reactive on a non
mission of relevant communicable distreponemal screening test for syphilis
eases, and except as provided under and negative on a specific treponemal
$ 1271.90, you must test a specimen from confirmatory test;
the donor of cells or tissue, whether (2)(i) A donor in whom plasma dilu
viable or nonviable, for evidence of intion sufficient to affect the results of
fection due to relevant communicable
disease agents, including: communicable disease testing is suspected, unless:
(1) Human immunodeficiency virus,
type 1; (A) You test a specimen taken from the donor before transfusion or infu
(2) Human immunodeficiency virus, sion and up to 7 days before recovery of
(3) Hepatitis B virus; cells or tissue; or
(4) Hepatitis C virus; and (B) You use an appropriate algorithm
(5) Treponema pallidum. designed to evaluate volumes adminis
(b) Donors of viable, leukocyte-rich cells tered in the 48 hours before specimen
or tissue. In addition to the relevant collection, and the algorithm shows
communicable disease agents for which that plasma dilution sufficient to af
testing is required under paragraph (a! fect the results of communicable dis
of this section, and except as provided ease testing has not occurred.
under $1271.90, (ii) Clinical situations in which you
(1) You must test a specimen from must suspect plasma dilution sufficient
the donor of viable, leukocyte-rich to affect the results of communicable
cells or tissue to adequately and approdisease testing include but are not lim
priately reduce the risk of transited to the following:
mission of relevant cell-associated (A) Blood loss is known or suspected communicable diseases, including: in a donor over 12 years of age, and the (i) Human T-lymphotropic virus, type donor has received a transfusion or in- I; and fusion of any of the following, alone or (ii) Human T-lymphotropic virus, in combination:
type II. (1) More than 2,000 milliliters (mL) of (2) You must test a specimen from blood (e.g., whole blood, red blood the donor of viable, leukocyte-rich cells) or colloids within 48 hours before cells or tissue for evidence of infection
lue to cytomegalovirus (CMV), to ade a donor-eligibility determination under quately and appropriately reduce the $1271.50 or to perform donor screening 'isk of transmission. You must estab or testing under $8 1271.75, 1271.80 and ish and maintain a standard operating 1271.85 for: procedure governing the release of an (1) Cells and tissues for autologous ICT/P from a donor whose specimen use; or ests reactive for CMV.
(2) Reproductive cells or tissue do(c) Donors of reproductive cells or tis- nated by a sexually intimate partner of ue. In addition to the communicable the recipient for reproductive use; or lisease agents for which testing is re
(3) Cryopreserved cells or tissue for quired under paragraphs (a) and (b) of reproductive use, other than embryos, his section, as applicable, and except originally exempt under paragraphs LS provided under $1271.90, you must
(a)(1) or (a)(2) of this section at the est a specimen from the donor of re
time of donation, that are subseproductive cells or tissue to adequately quently intended for directed donation, ind appropriately reduce the risk of
provided that ransmission of relevant communicable
(i) Additional donations are unavaillisease agents of the genitourinary
able, for example, due to the infertility ract. Such testing must include test
or health of a donor of the ing for the communicable disease
cryopreserved reproductive cells or tisigents listed in paragraphs (c)(1) and
sue; and (c)(2) of this section. However, if the re
(ii) Appropriate measures are taken productive cells or tissues are recov
to screen and test the donor(s) before ered by a method that ensures freedom
transfer to the recipient. from contamination of the cells or tis
(4) Acryopreserved embryo, origisue by infectious disease organisms that may be present in the genito
nally exempt under paragraph (a)(2) of
this section at the time of irinary tract, then testing for the communicable disease agents listed in
cryopreservation, that is subsequently
intended for directed or anonymous doparagraphs (c)(1) and (c)(2) of this sec
nation. When possible, appropriate tion is not required. Communicable
measures should be taken to screen and lisease agents of the genitourinary
test the semen and oocyte donors betract for which you must test include:
fore transfer of the embryo to the re(1) Chlamydia trachomatis; and
cipient. (2) Neisseria gonorrhea.
(b) Required labeling. As applicable, (d) Retesting anonymous semen donors.
you must prominently label an HCT/P Except as provided under $ 1271.90 and except for directed reproductive donors
described in paragraph (a) of this sec
tion as follows: as defined in $1271.3(1), at least 6
(1) “FOR AUTOLOGOUS USE months after the date of donation of semen from anonymous donors, you
ONLY,” if it is stored for autologous
use. must collect a new specimen from the donor and test it for evidence of infec
(2) "NOT EVALUATED FOR INFECtion due to the communicable disease
TIOUS SUBSTANCES," unless you igents for which testing is required
have performed all otherwise applicainder paragraphs (a), (b), and (c) of this
ble screening and testing under section.
$81271.75, 1271.80, and 1271.85. This para(e) Dura mater. For donors of dura
graph does not apply to reproductive mater, you must perform an adequate
cells or tissue labeled in accordance issessment designed to detect evidence
with paragraph (b)(6) of this section. of transmissible spongiform
(3) Unless the HCT/P is for encephalopathy.
autologous use only, “WARNING: Ad
vise recipient of communicable disease 1271.90 Are there exceptions from risks,”
the requirement of determining (i) When the donor-eligibility deterdonor eligibility, and what labeling mination under $1271.50(a) is not perrequirements apply?
formed or is not completed; or (a) Donor-eligibility determination not (ii) If the results of any screening or required. You are not required to make testing performed indicate:
(A) The presence of relevant commu- fungi, parasites, and transmissible nicable disease agents and/or
spongiform encephalopathy agents, (B) Risk factors for or clinical evi CGTP requirements govern the methdence of relevant communicable dis ods used in, and the facilities and conease agents or diseases.
trols used for, the manufacture of HCT (4) With the Biohazard legend shown Ps, including but not limited to all in $1271.3(h), if the results of any steps in recovery, donor screening, screening or testing performed indi donor testing, processing, storage, lacate:
beling, packaging, and distribution. (i) The presence of relevant commu The CGTP provisions specifically govnicable disease agents and/or
erning determinations of donor eligi(ii) Risk factors for or clinical evi
bility, including donor screening and dence of relevant communicable dis
testing, are set out separately in subease agents or diseases.
part C of this part. (5) “WARNING: Reactive test results
(b) Core CGTP requirements. The folfor (name of disease agent or disease),”
lowing are core CGTP requirements: in the case of reactive test results.
(1) Requirements relating to facili(6) “Advise recipient that screening
ties in § 1271.190(a) and (b); and testing of the donor(s) were not
(2) Requirements relating to environperformed at the time of
mental control in § 1271.195(a); cryopreservation of the reproductive
(3) Requirements relating to equipcells or tissue, but have been performed
ment in § 1271.200(a); subsequently,” for paragraphs (a)(3) or
(4) Requirements relating to supplies (a)(4) of this section.
and reagents in $ 1271.210(a) and (b); [69 FR 29830, May 25, 2004, as amended at 70 (5) Requirements relating to recovery FR 29952, May 25, 2005]
in § 1271.215;
(6) Requirements relating to procSubpart D-Current Good Tissue essing and process controls in § 1271.220: Practice
(7) Requirements relating to labeling
controls in § 1271.250(a) and (b); SOURCE: 69 FR 68681, Nov. 24, 2004, unless
(8) Requirements relating to storage otherwise noted.
in $ 1271.260 (a) through (d);
(9) Requirements relating to receipt, $ 1271.145 Prevention of the introduc predistribution shipment, and distribu
tion, transmission, or spread of tion of an HCT/P in $ 1271.265(a) through communicable diseases.
(d); and You must recover, process, store,
(10) Requirements relating to donor label, package, and distribute HCT/Ps, eligibility determinations, donor and screen and test cell and tissue do screening, and donor testing in nors, in a way that prevents the intro SS 1271.50, 1271.75, 1271.80, and 1271.85. duction, transmission, or spread of (c) Compliance with applicable require communicable diseases.
ments—(1) Manufacturing arrangements
(i) If you are an establishment that en$ 1271.150 Current good tissue practice gages in only some operations subject requirements.
to the regulations in this subpart and (a) General. This subpart D and sub subpart C of this part, and not others, part of this part set forth current then you need only comply with those good tissue practice (CGTP) require requirements applicable to the operments. You must follow CGTP require- ations that you perform. ments to prevent the introduction, (ii) If you engage another establishtransmission, or spread of commu- ment (e.g., a laboratory to perform nicable diseases by HCT/Ps (e.g., by en communicable disease testing, or an irsuring that the HCT/Ps do not contain radiation facility to perform terminal communicable disease agents, that sterilization), under a contract, agreethey are not contaminated, and that ment, or other arrangement, to perthey do not become contaminated dur- form any step in manufacture for you, ing manufacturing). Communicable that establishment is responsible for diseases include, but are not limited to, complying with requirements applicathose transmitted by viruses, bacteria, ble to that manufacturing step.
ii) Before entering into a contract, of this chapter supplement, and do not eement, or other arrangement with supersede, each other unless the reguther establishment to perform any lations explicitly provide otherwise. In pin manufacture for you, you must the event that a regulation in part 1271 ure that the establishment complies of this chapter is in conflict with a reh applicable CGTP requirements. If, quirement in parts 210, 211, or 820 of ing the course of this contract, this chapter, the regulations more speeement, or other arrangement, you cifically applicable to the product in ome aware of information sug question will supersede the more genting that the establishment may no eral. ger be in compliance with such re (e) Where appropriate. When a requirerements, you must take reasonable ment is qualified by “where approps to ensure the establishment com priate,” it is deemed to be “approes with those requirements. If you priate" unless you can document jusermine that the establishment is tification otherwise. A requirement is ; in compliance with those require "appropriate" if nonimplementation of nts, you must terminate your con the requirement could reasonably be ict, agreement, or other arrange expected to result in the HCT/P not nt with the establishment.
meeting its specified requirements re2) If you are the establishment that lated to prevention of introduction, termines that an HCT/P meets all re transmission, or spread of commuise criteria and makes the HCT/P nicable diseases, or in your inability to ailable for distribution, whether or carry out any necessary corrective act you are the actual distributor, you tion. e responsible for reviewing manufacring and tracking records to deter
$ 1271.155 Exemptions and alterine that the HCT/P has been manu
natives. ctured and tracked in compliance (a) General. You may request an exth the requirements of this subpart emption from or alternative to any red subpart of this part and any quirement in subpart C or D of this her applicable requirements.
part. (3) With the exception of 88 1271.150(c) (b) Request for exemption or alternative. id 1271.155 of this subpart, the regula Submit your request under this section ons in this subpart are not being im to the Director of the appropriate Cenemented for reproductive HCT/Ps de ter (the Director), e.g., the Center for ribed in $1271.10 and regulated solely Biologics Evaluation and Research or ader section 361 of the Public Health the Center for Devices and Radioervice Act and the regulations in this logical Health. The request must be acart, or for the establishments that companied by supporting documentaanufacture them.
tion, including all relevant valid sci(d) Compliance with parts 210, 211, and entific data, and must contain either: O of this chapter. With respect to HCT/ (1) Information justifying the re3 that are drugs (subject to review quested exemption from the requireider an application submitted under ment, or ction 505 of the Federal Food, Drug, (2) A description of a proposed alterid Cosmetic Act or under a biological native method of meeting the require'oduct license application under sec ment. on 351 of the Public Health Service (c) Criteria for granting an exemption ct) or that are devices (subject to pre or alternative. The Director may grant arket review or notification under an exemption or alternative if he or le device provisions of the act or she finds that such action is consistent nder a biological product license ap with the goals of protecting the public ication under section 351 of the Pub health and/or preventing the introducc Health Service Act), the procedures tion, transmission, or spread of comIntained in this subpart and in sub- municable diseases and that: art C of this part and the current good (1) The information submitted justilanufacturing practice regulations in fies an exemption; or arts 210 and 211 of this chapter and the (2) The proposed alternative satisfies uality system regulations in part 820 the purpose of the requirement.