| Title: | FDA PN EDITS/CHNGS 110804 |
|---|---|
| Date: | 2004-11-03 |
| To: | abi |
| Links: | previous, next |
FDA HAS PUBLISHED A REVISED COMPLIANCE POLICY GUIDE (CPG) FOR PRIOR
NOTICE OF IMPORTED FOOD. THAT DOCUMENT IS AVAILABLE AT
WWW.CFSAN.FDA.GOV/~PN/CPGPN4.HTML. THE FOLLOWING PROVIDES INFORMATION ON
NEW PRIOR NOTICE (PN) EDITS/REJECTS AND OTHER SYSTEM CHANGES THAT WILL
BECOME EFFECTIVE NOVEMBER 8, 2004.
MANUFACTURER REGISTRATION INFORMATION:
CBP WILL CONTINUE TO REJECT PN SUBMISSIONS UNLESS A MANUFACTURER
REGISTRATION NUMBER IS PROVIDED FOR THE MANUFACTURER USING THE "PFR"
AFFIRMATION OF COMPLIANCE (AOFC) OR THE "FME" AOFC CODE AND REASON CODE
IS TRANSMITTED.
FDA WILL REJECT PN SUBMISSIONS WHICH CONTAIN A MANUFACTURER REGISTRATION
NUMBER THAT IS INVALID (NOT ON FILE OR MISMATCHED). FDA WILL ALSO REJECT
PN SUBMISSIONS RECEIVED WHICH CONTAIN A "FME" AOFC CODE IF THE REASON
CODE QUALIFIER TRANSMITTED IS INVALID. SIX NEW REASON CODES HAVE BEEN
ADDED TO INDICATE WHY A REGISTRATION NUMBER HAS NOT BEEN TRANSMITTED.
THE NEW CODES ARE I-M AND O. N (NO) HAS BEEN END-DATED AND USE OF THIS
CODE OR ANY OTHER CODE NOT LISTED BELOW WILL CAUSE AN FDA REJECT.
WITH THE ADDITION OF THESE NEW REASON CODES, ZERO-FILL OF THE AOFC "PFR"
QUALIFIER FIELD IS NO LONGER ALLOWED AND SUBMISSION WILL CAUSE AN FDA
REJECT.
FME QUALIFIER REASON CODES:
A. FACILITY IS OUT OF BUSINESS
B. FACILITY IS PRIVATE RESIDENCE
C. FACILITY IS A RESTAURANT
D. FACILITY IS RETAIL FOOD ESTABLISHMENT
E. FACILITY IS NONPROCESSING FISHING VESSEL
F. FACILITY IS NONBOTTLED DRINKING WATER COLLECTION AND DISTRIBUTION
ESTABLISHMENT
G. INDIVIDUAL GIFT LABEL NAME/ADDRESS IN LIEU OF REGISTRATION NUMBER
H. GROWER SATISFIES FARM EXEMPTION (21 CFR 1.226(B); 1.227(B)(3))
I. SAMPLES - QUALITY ASSURANCE, RESEARCH OR ANALYSIS PURPOSES ONLY
J. U.S. MANUFACTURING FACILITY THAT IS NOT REQUIRED TO REGISTER
K. UNABLE TO DETERMINE THE REGISTRATION NUMBER OF THE MANUFACTURER.
L. UNABLE TO DETERMINE IDENTITY OF MANUFACTURER - PROVIDING IDENTITY OF
MANUFACTURERS HEADQUARTERS
M. UNABLE TO DETERMINE IDENTITY OF MANUFACTURER OR HEADQUARTERS -
- PROVIDING INVOICING FIRMS IDENTITY
O. GIFT PACK FOR NON-BUSINESS PURPOSES PROVIDING SINGLE PRIOR NOTICE
AND IDENTITY OF PACKER
BILL OF LADING/AIRWAY BILL INFORMATION:
FDA WILL REJECT PRIOR NOTICE SUBMISSIONS FOR RAIL AND SEA MODES OF
TRANSPORTATION UNLESS THE BILL OF LADING NUMBER IS PROVIDED USING THE
"BOL" AOFC CODE AND QUALIFIER AND SUBMISSIONS FOR AIR MODE OF
TRANSPORTION UNLESS THE AIR WAYBILL IS SUBMITTED USING THE "AWB" AOFC
CODE AND QUALIFIER.
THE PNSI 1.5 RELEASE NOTES DESCRIBING SYSTEM MODIFICATIONS MADE TO
REFLECT CHANGES MADE IN THE CPG ARE AVAILABLE AT
WWW.CFSAN.FDA.GOV/~PN/PNSIREV.HTML AND ALSO REFERENCED AND LINKED AT
WWW.ACCESS.FDA.GOV/OAA/ AND WWW.CFSAN.FDA.GOV/~PN/PNOVIEW.HTML/
HOLDING FACILITY INFORMATION:
PNSI HAS BEEN MODIFIED TO ALLOW SUBMISSION OF HOLDING FACILITY
INFORMATION IN THE CASE WHERE FDA HAS REFUSED A FOOD ARTICLE. IF FDA OR
U.S. CUSTOMS AND BORDER PROTECTION (CBP) DIRECT AN ARTICLE TO A HOLDING
FACILITY, A PARTY WITH THE KNOWLEDGE OF THE HOLDING FACILITY LOCATION,
DATE AVAILABLE AT THE LOCATION, AND A CONTACT AT THE LOCATION ASSOCIATED
WITH THE PRIOR NOTICE MUST SUBMIT THE INFORMATION TO THE FDA. PNSI MUST
BE USED TO SUBMIT THE HOLDING FACILITY INFORMATION FOR PNS INITIALLY
SUBMITTED EITHER THROUGH THE AUTOMATED COMMERCIAL SYSTEM (ACS) OR
THROUGH PNSI.
PNSI NOW ALLOWS ANY PARTY TO SUBMIT THE HOLDING FACILITY INFORMATION,
REGARDLESS OF WHETHER OR NOT THEY TRANSMITTED THE ORIGINAL PRIOR NOTICE.
PN TRANSMITTERS CAN SEARCH FOR PNS SUBMITTED VIA THEIR ACCOUNT TO SUBMIT
HOLDING FACILITY INFORMATION. IF THE PN WAS SUBMITTED VIA ACS OR WAS
SUBMITTED VIA PNSI BY A PN TRANSMITTER USING A DIFFERENT ACCOUNT, THE
IDENTIFYING INFORMATION FOR THE ARTICLE CAN BE USED TO ALLOW ANOTHER
TRANSMITTER TO SUBMIT THE HOLDING FACILITY INFORMATION.
ONCE HOLDING FACILITY INFORMATION HAS BEEN SUBMITTED, THE TRANSMITTER
CAN VIEW THE STATUS OF THE HOLDING FACILITY INFORMATION SUBMISSION TO
DETERMINE IF IT WAS MATCHED TO A PRIOR NOTICE THAT WAS ORIGINALLY
SUBMITTED.
IF YOU ANY QUESTIONS ABOUT THE SYSTEM CHANGES OR THE CPG PLEASE CONTACT
FDA'S PRIOR NOTICE CENTER AT (866) 521-2297.