IA 57-20, 7/14/06, IMPORT ALERT #57-20, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF IMPORTED DURA MATER REGULATED UNDER SECTION 361 OF THE PUBLIC
HEALTH SERVICE ACT (PHS ACT)"
TO: IMPORT PROGRAM MANAGERS
TYPE OF ALERT: Detention Without Physical Examination
NOTE: This import alert represents the Agency's current
instructions to FDA field personnel regarding the
manufacturer(s) and/or product(s) at issue. It does
not create or confer any rights for or on any person,
and does not operate to bind FDA or the public.
PRODUCT: Dura Mater
PRODUCT CODE: 57T[][]01
84L[][]EM
PROBLEM: Possible risk of Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD) transmission, and
transshipment from countries of geographic risk of Bovine
Spongiform Encephalopathy (BSE).
PAC: 41R800
PAF: REG
COUNTRIES: ALL
MANUFACTURER/
SHIPPER: All
CHARGE: "This Human Cell, Tissue, and Cellular and Tissue-Based
Product is in violation of section 361 of the Public Health
Service Act."
OASIS Charge
Codes: "[PSQI 361] OASIS Charge Code = 361 HCT/P."
RECOMMENDING
OFFICE: CBER, Office of Compliance and Biologics Quality, Division
of Case Management, HFM-610
REASON FOR
ALERT: Human cells, tissues, and cellular and tissue-based
products (HCT/Ps), particularly HCT/Ps such as dura mater
that are closely associated with the central nervous
system, may transmit some human transmissible spongiform
encephalopathies (TSEs)such as CJD and vCJD. Currently,
FDA does not recommend testing for human TSEs such as CJD
and vCJD and there are no FDA-approved donor screening
tests. However, manufacturers must screen donors of dura
mater by reviewing the donor's relevant medical records for
risk factors for and clinical evidence of TSE, including
vCJD and CJD (( 1271.75(a)). Such factors include
residence in a country where there is a geographic risk of
BSE and, related, vCJD. In addition, manufacturers must
perform an adequate assessment for donors of dura mater to
detect evidence of TSE ( 1271.85(e)).
GUIDANCE: Districts may detain without physical examination all
imported Dura Mater due to the possible risk of CJD and
vCJD transmission.
1. Districts may request documents to determine if
entries of dura mater are:
a. Imported from a country of geographical risk of
BSE (See the updated list below for your
reference);
b. Imported following transshipment from a country
of geographical risk of BSE.
2. Dura mater that is directly imported from a country
of geographical risk of BSE or imported following
transshipment from a country of geographical risk of
BSE may be refused entry.
3. Districts encountering Dura Mater that is not
directly imported from a country of geographical risk
of BSE, or imported following transshipment from a
country of geographical risk of BSE should contact
OCBQ/DCM, Import/Export Staff at (301) 827-6201 to
determine admissibility.
Countries List Based on Geographic Risk of BSE:
Albania(AL), Andorra (AD), Austria(AT), Belgium(BE),
Bosnia-Herzegovina (BA), Bulgaria(BG), Croatia(HR),
Czech Republic(CZ), Denmark(DK), Finland(FI),
France(FR), Germany(DE), Greece (GR), Hungary(HU),
Ireland(IE),Israel(IL), Italy(IT), Japan (JP),
Liechtenstein (LI), Luxembourg(LU), Macedonia(MK),
Monaco (MC), Netherlands(NL), Norway(NO), Oman (OM),
Poland(PL), Portugal(PT), Romania(RO), San
Marino(SM), Slovak Republic(SK), Slovenia(SI),
Spain(ES), Sweden(SE), Switzerland(CH), United
Kingdom(GB), and Yugoslavia(YU).
PRIORITIZATION
GUIDANCE: N/A
FOI: No purging required
KEY WORDS: Dura Mater
PREPARED BY: Kimberly A. Cressotti, CBER, OCBQ
Anthony W. Lee, DIOP, 301-594-3874
DATE LOADED
INTO FIARS: July 14, 2006
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