CSMS# 18-000681 - New FDA Programming: VQIP and Rule Maintenance
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11/15/2018 12:10 PM EST
Trade Policy Updates
CBP will deploy new FDA programming into the certification environment tonight, November 15, 2018.
The specific programming changes are:
1. For Program Code “FOO”: Adding the new and optional Affirmation of Compliance code “VQI” and its associated 5-digit (numeric) qualifier. This is an optional affirmation of compliance for food products. For more information refer to the FDA Supplemental Guide.
The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program, which offers expedited review and entry of human and animal food into the United States. Importers interested in participating in VQIP will be required to meet eligibility requirements, which include ensuring the facilities of their foreign supplier are certified under the FDA’s Accredited Third-Party Certification Program.
For more information visit: https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm490823.htm.
Importers can apply to VQIP via the online application at the FDA Industry Systems website: https://www.access.fda.gov/
The VQIP Importers Help Desk will be available to answer questions and/or assist with the VQIP application process at FSMAVQIP@fda.hhs.gov or 1-301-796-8745.)
2. Rule Maintenance to bring programming up to date with FDA Supplemental Guide 2.5.1:
- For BIO, processing code “BRD” is no longer a valid processing code (PG01).
- For BIO, if processing code is “BLD” and intended use code is 180.009, then “IND” must be provided as an Affirmation of Compliance (PG23)
- For BIO, if processing code is “ALG”, then the intended use code must be one of the following: 180.009, 080.000, 180.016, 155.000, 100.000, 150.007, 140.000, 110.000, 170.000, 970.000, 180.000, 940.000, 920.000, or UNK.
- For BIO, if processing code is “VAC”, then the intended use code must be one of the following: 180.009, 080.000, 180.016, 155.000, 100.000, 150.007, 140.000, 110.000, 170.000, 970.000, 180.000, 940.00, 920.000 or UNK.
- For BIO, if processing code is “HCT”, then the intended use code must be one of the following: 082.000, 170.000, 180.000, 940.000, 920.000, or UNK.
- For BIO, if processing code is “BLD”, then the intended use code must be one of the following: 080.000, 970.000, 180.016, 150.007, 155.000, 100.000, 140.000, 180.000, 180.009, 110.000, 170.000, 940.000, 920.000, or UNK.
- For BIO, if processing code is “BLO”, then the intended use code must be one of the following: 080.000, 970.000, 180.016, 150.007, 155.000, 100.000, 140.000, 180.000, 110.000, 170.000, 940.000, 920.000, or UNK.
- For BIO, if processing code is “BDP”, “XEN”, or “CGT”, then the intended use code must be one of the following: 080.000, 970.000, 180.016, 150.007, 155.000, 100.000, 140.000, 180.009, 180.000, 110.000, 170.000, 940.000, 920.000 or UNK.
- For BIO, if processing code is “BBA” or “PVE”, then the intended use code must be one of the following: 080.000, 970.000, 150.007, 100.000, 140.000, 180.009, 180.000, 110.000, 170.000, 940.000, 920.000 or UNK.
- For FOO, if processing code is “NSF”, “PRO”, “FEE”, ADD”, or “DSU”, then the following are allowed Affirmation of Compliance codes (PG23): AIN, CAN, CFR, CIN, ERR, FAP, FCC, FCE, FME, FSX, GFR, IBP, IFE, IFR, JIF, LFR, ORN, PFR, PKC, RNE, RNO, SFR, SID, SIF, SRN, TFR, UFR, VES, VFT, VOL, and VQI.
- For FOO, if Affirmation of Compliance codes (PG23) “SIF” and “JIF” are transmitted, then a 1-10N qualifier must also be transmitted.
- For FOO, if one of the following conditions is true on the PG02:
(1) Positions 10-11 are equal to ‘7’, ‘9’ '69', '70', '71', or '72' OR
(2) Positions 10-11 are:
BETWEEN '02' and '05'
OR BETWEEN '12’ and ‘18’
OR BETWEEN '20’ and '42’
OR BETWEEN '45’ and '47’ OR
(3) Positions 10 -12 are equal to '52D' OR
(4) Positions 10-12 are equal to '50C' '50D', '50E', '50F', '50G', or '50L' OR
(5) Positions 10-11 are equal to '54' AND position 13 is equal to one of the following: 'A','B','C','L','M', or 'Y', THEN a product is subject to Prior Notice requirements, unless Entry Type = 06 OR Entry Type = 21 with a PG30 with inspection status code = "F" .
This programming will be deployed to the production environment on January 12, 2019.
Software vendors and filers who are testing in the certification environment can contact FDA ACE Support for assistance at ACE_Support@fda.hhs.gov or 1-877-345-1101.
CBP will deploy new FDA programming into the certification environment tonight, November 15, 2018.
The specific programming changes are:
1. For Program Code “FOO”: Adding the new and optional Affirmation of Compliance code “VQI” and its associated 5-digit (numeric) qualifier. This is an optional affirmation of compliance for food products. For more information refer to the FDA Supplemental Guide.
The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program, which offers expedited review and entry of human and animal food into the United States. Importers interested in participating in VQIP will be required to meet eligibility requirements, which include ensuring the facilities of their foreign supplier are certified under the FDA’s Accredited Third-Party Certification Program.
For more information visit: https://www.fda.gov/Food/GuidanceRegulation/ImportsExports/Importing/ucm490823.htm.
Importers can apply to VQIP via the online application at the FDA Industry Systems website: https://www.access.fda.gov/
The VQIP Importers Help Desk will be available to answer questions and/or assist with the VQIP application process at FSMAVQIP@fda.hhs.gov or 1-301-796-8745.)
2. Rule Maintenance to bring programming up to date with FDA Supplemental Guide 2.5.1:
- For BIO, processing code “BRD” is no longer a valid processing code (PG01).
- For BIO, if processing code is “BLD” and intended use code is 180.009, then “IND” must be provided as an Affirmation of Compliance (PG23)
- For BIO, if processing code is “ALG”, then the intended use code must be one of the following: 180.009, 080.000, 180.016, 155.000, 100.000, 150.007, 140.000, 110.000, 170.000, 970.000, 180.000, 940.000, 920.000, or UNK.
- For BIO, if processing code is “VAC”, then the intended use code must be one of the following: 180.009, 080.000, 180.016, 155.000, 100.000, 150.007, 140.000, 110.000, 170.000, 970.000, 180.000, 940.00, 920.000 or UNK.
- For BIO, if processing code is “HCT”, then the intended use code must be one of the following: 082.000, 170.000, 180.000, 940.000, 920.000, or UNK.
- For BIO, if processing code is “BLD”, then the intended use code must be one of the following: 080.000, 970.000, 180.016, 150.007, 155.000, 100.000, 140.000, 180.000, 180.009, 110.000, 170.000, 940.000, 920.000, or UNK.
- For BIO, if processing code is “BLO”, then the intended use code must be one of the following: 080.000, 970.000, 180.016, 150.007, 155.000, 100.000, 140.000, 180.000, 110.000, 170.000, 940.000, 920.000, or UNK.
- For BIO, if processing code is “BDP”, “XEN”, or “CGT”, then the intended use code must be one of the following: 080.000, 970.000, 180.016, 150.007, 155.000, 100.000, 140.000, 180.009, 180.000, 110.000, 170.000, 940.000, 920.000 or UNK.
- For BIO, if processing code is “BBA” or “PVE”, then the intended use code must be one of the following: 080.000, 970.000, 150.007, 100.000, 140.000, 180.009, 180.000, 110.000, 170.000, 940.000, 920.000 or UNK.
- For FOO, if processing code is “NSF”, “PRO”, “FEE”, ADD”, or “DSU”, then the following are allowed Affirmation of Compliance codes (PG23): AIN, CAN, CFR, CIN, ERR, FAP, FCC, FCE, FME, FSX, GFR, IBP, IFE, IFR, JIF, LFR, ORN, PFR, PKC, RNE, RNO, SFR, SID, SIF, SRN, TFR, UFR, VES, VFT, VOL, and VQI.
- For FOO, if Affirmation of Compliance codes (PG23) “SIF” and “JIF” are transmitted, then a 1-10N qualifier must also be transmitted.
- For FOO, if one of the following conditions is true on the PG02:
(1) Positions 10-11 are equal to ‘7’, ‘9’ '69', '70', '71', or '72' OR
(2) Positions 10-11 are:
BETWEEN '02' and '05'
OR BETWEEN '12’ and ‘18’
OR BETWEEN '20’ and '42’
OR BETWEEN '45’ and '47’ OR
(3) Positions 10 -12 are equal to '52D' OR
(4) Positions 10-12 are equal to '50C' '50D', '50E', '50F', '50G', or '50L' OR
(5) Positions 10-11 are equal to '54' AND position 13 is equal to one of the following: 'A','B','C','L','M', or 'Y', THEN a product is subject to Prior Notice requirements, unless Entry Type = 06 OR Entry Type = 21 with a PG30 with inspection status code = "F" .
This programming will be deployed to the production environment on January 12, 2019.
Software vendors and filers who are testing in the certification environment can contact FDA ACE Support for assistance at ACE_Support@fda.hhs.gov or 1-877-345-1101.
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