DOCSLIB.ORG

FDA Supplemental Guide Release 2.5.1 2018 0319

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
FDA Supplemental Guide Release 2.5.1 2018 0319 FDA Supplemental Guidance CBP and Trade Automated Interface Requirements FDA Supplemental Guidance for the Automated Commercial Environment/International Trade Data System (ACE/ITDS) Version 2.5.1 April 10, 2018 FDA Supplemental Guidance - Release 2.5.1 FDA Supplemental Guidance Contents Change Log ................................................................................................................................................................6 General Introduction ................................................................................................................................................ 20 FDA Overview ..................................................................................................................................................... 20 Points of Contact ................................................................................................................................................. 21 Legends ................................................................................................................................................................... 22 Field Requirements ............................................................................................................................................. 22 Field Data Types ................................................................................................................................................. 22 Required (Mandatory and/or Conditional)Data Elements for all FDA Commodities ............................................... 23 FDA Commodities, Commodity Sub-Types & Corresponding Industry Codes ....................................................... 24 Biologics Commodity Data Elements and Values ................................................................................................... 25 Biologics Example ............................................................................................................................................... 27 Record Identifier PG01 (PGA Identifier) .............................................................................................................. 28 Record Identifier PG02 (Product Identifier) ......................................................................................................... 31 Record Identifier PG04 (Product Constituent Element) ...................................................................................... 32 Record Identifier PG06 (Product Origin) ............................................................................................................. 33 Record Identifier PG07 (Product Trade Names) ................................................................................................. 34 Record Identifier PG10 (Product Characteristics) ............................................................................................... 35 Record Identifier PG19 (Entity Data) ................................................................................................................... 36 Record Identifier PG20 (Entity Address) ............................................................................................................. 38 Record Identifier PG21 (Point of Contact) ........................................................................................................... 39 Record Identifier PG23 (Affirmation of Compliance) ........................................................................................... 40 Record Identifier PG24 (Remarks) ...................................................................................................................... 45 Record Identifier PG25 (Product Condition)........................................................................................................ 46 Record Identifier PG26 (Product Packaging) ...................................................................................................... 47 Record Identifier PG27 (Shipping Container Information) .................................................................................. 51 Record Identifier PG30 (Anticipated Arrival Information) .................................................................................... 52 Record Identifier PG55 (Additional Entity Roles) ................................................................................................ 54 Record Identifier PG60 (Additional Information) ................................................................................................. 55 Record Identifier PG00 (Data Substitution) ......................................................................................................... 56 Cosmetics Commodity Data Elements and Values ................................................................................................. 57 Cosmetics Example ............................................................................................................................................. 58 Record Identifier PG01 (PGA Identifier) .............................................................................................................. 59 Record Identifier PG02 (Product Identifier) ......................................................................................................... 60 Record Identifier PG06 (Product Origin) ............................................................................................................. 61 Record Identifier PG07 (Product Trade Names) ................................................................................................. 62 Record Identifier PG10 (Product Characteristics) ............................................................................................... 63 Record Identifier PG19 (Entity Data) ................................................................................................................... 64 Record Identifier PG20 (Entity Address) ............................................................................................................. 66 Record Identifier PG21 (Point of Contact) ........................................................................................................... 67 Record Identifier PG23 (Affirmation of Compliance) ........................................................................................... 68 Record Identifier PG24 (Remarks) ...................................................................................................................... 69 Record Identifier PG25 (Product Condition)........................................................................................................ 70 Record Identifier PG26 (Product Packaging) ...................................................................................................... 71 Record Identifier PG27 (Shipping Container Information) .................................................................................. 73 Record Identifier PG30 (Anticipated Arrival Information) .................................................................................... 74 Record Identifier PG55 (Additional Entity Roles) ................................................................................................ 76 Record Identifier PG60 (Additional Information) ................................................................................................. 77 Record Identifier PG00 (Data Substitution) ......................................................................................................... 78 Drug Commodity Data Elements and Values .......................................................................................................... 79 Drug Example ...................................................................................................................................................... 81 Record Identifier PG01 (PGA Identifier) .............................................................................................................. 82 Record Identifier PG02 (Product Identifier) ......................................................................................................... 85 Record Identifier PG04 (Product Constituent Element) ...................................................................................... 87 FDA Supplemental Guidance - Release 2.5.1 FDA Supplemental Guidance Record Identifier PG06 (Product Origin) ............................................................................................................. 90 Record Identifier PG07 (Product Trade Names) ................................................................................................. 91 Record Identifier PG10 (Product Characteristics) ............................................................................................... 92 Record Identifier PG19 (Entity Data) ................................................................................................................... 93 Record Identifier PG20 (Entity Address) ............................................................................................................. 95 Record Identifier PG21 (Point of Contact) ........................................................................................................... 96 Record Identifier PG23 (Affirmation of Compliance) ........................................................................................... 97 Record Identifier PG24 (Remarks) ...................................................................................................................
Load more

Recommended publications
  • Country-Of-Origin Labeling for Foods
    Country-of-Origin Labeling for Foods Remy Jurenas Specialist in Agricultural Policy July 15, 2010 Congressional Research Service 7-5700 www.crs.gov RS22955 CRS Report for Congress Prepared for Members and Committees of Congress Country-of-Origin Labeling for Foods Summary Many retail food stores are now required to inform consumers about the country of origin of fresh fruits and vegetables, seafood, peanuts, pecans, macadamia nuts, ginseng, and ground and muscle cuts of beef, pork, lamb, chicken, and goat. The rules are required by the 2002 farm bill (P.L. 107- 171) as amended by the 2008 farm bill (P.L. 110-246). Other U.S. laws have required such labeling, but only for imported food products already pre-packaged for consumers. Both the authorization and implementation of country-of-origin labeling (COOL) by the U.S. Department of Agriculture’s Agricultural Marketing Service have not been without controversy. Much attention has focused on the labeling rules that now apply to meat and meat product imports. A number of leading agricultural and food industry groups continue to oppose COOL as costly and unnecessary. They and some major food and livestock exporters to the United States (e.g., Canada and Mexico) also view the new requirement as trade-distorting. Others, including some cattle and consumer groups, maintain that Americans want and deserve to know the origin of their foods, and that many U.S. trading partners have their own, equally restrictive import labeling requirements. Obama Administration officials announced in February 2009 that they would allow the final rule on COOL, published just before the end of the Bush Administration on January 15, 2009, to take effect as planned on March 16, 2009.
    [Show full text]
  • 879 Part 134—Country of Origin Marking
    U.S. Customs and Border Protection, DHS; Treasury Pt. 134 removal or obliteration of the name, Subpart A—General Provisions mark, or trademark by reason of which 134.1 Definitions. the articles were seized. 134.2 Additional duties. (b) Copyright violations. Articles for- 134.3 Delivery withheld until marked and feited for violation of the copyright redelivery ordered. laws shall be destroyed. 134.4 Penalties for removal, defacement, or (c) Articles bearing a counterfeit trade- alteration of marking. mark. Merchandise forfeited for viola- Subpart B—Articles Subject to Marking tion of the trademark laws shall be de- stroyed, unless it is determined that 134.11 Country of origin marking required. the merchandise is not unsafe or a haz- 134.12 Foreign articles reshipped from a U.S. possession. ard to health and the Commissioner of 134.13 Imported articles repacked or manip- Customs or his designee has the writ- ulated. ten consent of the U.S. trademark 134.14 Articles usually combined. owner, in which case the Commissioner of Customs or his designee may dispose Subpart C—Marking of Containers or of the merchandise, after obliteration Holders of the trademark, where feasible, by: 134.21 Special marking. (1) Delivery to any Federal, State, or 134.22 General rules for marking of con- local government agency that, in the tainers or holders. opinion of the Commissioner or his des- 134.23 Containers or holders designed for or capable of reuse. ignee, has established a need for the 134.24 Containers or holders not designed merchandise; or for or capable of reuse.
    [Show full text]
  • International Committee of the Red Cross
    INTERNATIONAL COMMITTEE OF THE RED CROSS 19, avenue de la Paix CH-1202 Geneva Switzerland Tel: +41 22 730 20 93 (direct) Geneva, September 4, 2017 Please acknowledge receipt of this tender request by e-mail on [email protected] REQUEST FOR TENDER FOR COLLAPSIBLE JERRY CANS 10 & 20 LITERS - FRAME AGREEMENT N° RFT/ICRC/GVA17/000102 Closing date for samples delivery: September 29, 2017 at 12:00 (Geneva time) Closing date commercial offer along with laboratory results: November 10, 2017 at 12:00 (Geneva time) Validity of the offer until: March 31, 2018 The International Committee of the Red Cross (ICRC) is an independent, neutral organization ensuring humanitarian protection and assistance for victims of war and other situations of violence. It has a permanent mandate under international law to take impartial action for prisoners, the wounded and sick, and civilians affected by conflict. With its headquarters in Geneva, Switzerland, the ICRC is based in around 80 countries and has a total of more than 13,000 staff. The organisation is at the origin of both the International Red Cross / Red Crescent Movement and of International Humanitarian Law, notably the Geneva Conventions Within the above mandate and its consequences around the world, the ICRC invites suppliers to tender for the below mentioned items. ICRC's yearly estimated need for collapsible jerry cans (Sum of both 10 & 20 liters) is approximately 350'000. This quantity is an estimate and does not in any way represent a commitment from the ICRC. The quantities to be purchased will depend on actual requirements from ICRC operations in the field.
    [Show full text]
  • Chemical Safety Report
    CHEMICAL SAFETY REPORT Functional chrome plating with decorative character for sanitary applications (Use 1) This document shall not be construed as expressly or implicitly granting a license or any rights to use related to any content or information contained therein. In no event shall applicant be liable in this respect for any damage arising out or in connection with access, use of any content or information contained therein despite the lack of approval to do so. Substance Name: chromium trioxide EC Number: 215-607-8 CAS Number: 1333-82-0 Applicants Identity: Aloys F. Dornbracht GmbH & Co. KG Copy right protected - Property of Aloys F. Dornbracht GmbH & Co. KG - No copying / use allowed EC number: Chromium trioxide – Functional chrome plating with decorative character for CAS number: 215-607-8 sanitary applications 1333-82-0 9. EXPOSURE ASSESSMENT (and related risk characterisation) 9.0. Introduction This exposure assessment aims to provide reliable estimates of current work place exposure level at the applicant’s facility in Iserlohn Germany. Occupational work place exposure to hexavalent chromium [Cr(VI)] is regulated in most European countries. National Occupational Exposure Limits (OELs) across Europe respect a range of 8 hour Time Weighted Average (TWA) values between 1 µg/m3 and 50 µg/m3. The US Occupational Safety and Health Administration (OSHA) OEL is at 5 µg/m3. In 2014, France introduced a new OEL of 1 µg/m3. This is one of the most stringent OEL currently in place anywhere in the World and compliance requires substantial research and investment. In Germany, the evaluation standard is 1 µg/m3.
    [Show full text]
  • Changealife Uganda: Migyera Community Water Project
    2015 ChangeALife Uganda: Migyera Community Water Project Duke Student Consultants: Elizabeth Kendall, MEM ‘15 Francis Oggeri, MEM ’15 Alayne Potter, MEM ’15 Advisers: Dr. Erika Weinthal, Duke University Dr. Avner Vengosh, Duke University Jean Selmer, ChangeALife Uganda Executive Summary In many parts of the developing world, poor water quality and water scarcity affect human health and their economic and social well-being. Although much progress has been made towards increasing access to improved water supplies on a global level, there is a significant disparity between those living in urban and rural settings (UNICEF and WHO 2014). Following this trend, in the country of Uganda 85% of the total population of 34 million lives in rural areas. Of those rural Ugandan households, 70% have access to an improved water supply (UNICEF and WHO 2014). Partnering with ChangeALife Uganda (CALU), a local Ugandan non-profit organization, this project evaluates the water supply in the rural village of Migyera while taking into account the multitude of compounding factors, such as seasonal fluctuations in rainfall and diversity of water sources. CALU’s interest in water stems from its mission to provide education and health care, improving the livelihoods of children who are the most susceptible to water borne illnesses. The project seeks to evaluate current, local perceptions of quality, access, distribution, and use of water resources in Migyera Town Council, Uganda in order to provide recommendations to the client. Primary research comprised of three key data collection areas 1) household surveys, 2) water quality testing, and 3) geospatial analysis, was used to examine overarching questions on water management and sanitation and health of the community.
    [Show full text]
  • Brick 10002093: Camping Cooking/Drinking/Eating Equipment – Replacement Parts/Accessories
    Brick 10002093: Camping Cooking/Drinking/Eating Equipment – Replacement Parts/Accessories Definition Includes any products that can be described/observed as an accessory or replacement part for camping cooking equipment, drinking equipment or eating equipment. Includes products such as Camping Water Canister Stands, Camping Stove Fittings and Camping Water Filter Cartridges. Excludes all other products currently classified within the Camping Cooking/Drinking/Eating Equipment class, such as Camping Cookware and Camping Tableware. Also excludes products such as Fuel Bottles, Canisters and Pumps classified in Fuels/Fuels Additives. Type of Camping Cooking/Drinking/Eating Replacement Part/Accessory (20001628) Attribute Definition Indicates, with reference to the product branding, labelling or packaging, the descriptive term that is used by the product manufacturer to identify the type of replacement part or accessory for a camping cooking product, camping drinking product or camping eating product. Attribute Values CAMPING STOVE CAMPING WATER CAMPING WATER CAMPING WATER FILTER RING/PLATE FITTING CANISTER FILLER TUBE CANISTER STRAP CARTRIDGE (30010640) (30010579) (30009529) (30009531) CAMPING WATER FILTER CAMPING STOVE TOASTER CAMPING WATER CAMPING WATER CLEANING KIT (30009534) FITTING (30010580) CANISTER STAND CANISTER TAP (30009532) UNCLASSIFIED (30002515) (30009530) UNIDENTIFIED (30002518) Page 1 of 38 Brick 10002094: Camping Cooking/Drinking/Eating Equipment Other Definition Includes any products that can be described/observed as equipment or an accessory specifically designed for the preparation, cooking and/or serving of food, as well as the inclusion of products that cater for the provision and maintenance of drinking supplies, where the user of the schema is not able to classify the products in existing bricks within the schema.
    [Show full text]
  • 1L to 5L Packaging Container1 Specification - PET and HDPE Containers
    Technical Specifications for the manufacture of: 1L to 5L packaging container1 specification - PET and HDPE containers Specification reference: WINGS code (see below) This version is superseding the packaging section in all Scope : Vegetable oil Vegetable specifications Version: 2, adopted June 2020 Replacing: version 1, 04/10/2018 Date of OSCOQ issue: 24/06/2020 VOLUME CONTAINER PER CARTON WINGS CODE 1L 12 CC2 1L 15 CC5 1L 20 CC6 1.5 L 12 CC3 2L 3 CQ0 2L 6 CC7 2L 12 CC4 3L 6 CN7 4L 2 CP0 4L 4 CP6 5L 4 CC1 5L 2 CL9 Note: the list of volume and containers per carton is not exhaustive 1 Container in this specification (expect §6: REQUIRED SHIPPING PALLETIZATION) is used as the technical generic term for all type of packaging containing the oil. ______________________________________________________________________________________ 1. SPECIFICATION PURPOSE 1L to 5L packaging container specification - PET and HDPE containers is the packaging technical specification describing the physical and performance parameters that the packaging must fulfill to be used for vegetable oil products sold to WFP. 2. GENERAL REQUIREMENTS The packaging covered by the provisions of this specification must be packed in appropriate packaging, which safeguard the hygienic, nutritional, technological, and organoleptic qualities of the product. The containers, including packaging material, shall be made of substances that are safe and suitable for their intended use. They should not impart any toxic substance or undesirable odor or flavor to the product. The packaging is expected to provide physical support to be stacked up to minimum 10 cartons height for PET bottles and 8 cartons height for HDPE jerrycans in their filled state while stored in a warehouse.
    [Show full text]
  • Catalogue.Pdf
    Welcome to Silverlock Packaging Established in 1976, Silverlock Packaging supply retail and industrial packaging products and material handling solutions to a diverse range of industries across Australia. We pride ourselves on our market reputation of superior service and attention to detail. We are a Quality Assured Company compliant with the ISO900.2003 Standard. Silverlock Packaging - A National Solution With external sales staff situated throughout Victoria, South Australia and Western Australia together with our Central Telesales operation we can readily service your requirements anywhere in Australia. Silverlock Packaging - Providing A Solution A constantly evolving product range in line with international market trends and changes in technology, as well as our depth of range and variation allows the delivery of a customer specific solution at a cost effective price. Product Index Page Flexible Packaging 5 Glass Jars and Bottles 6 - General Purpose - Food and Beverage - Pharmaceutical and Cosmetic Vials and Securitainers 14 Plastic Jars and Bottles 15 - General Purpose - Food and Beverage - Pharmaceutical and Cosmetic Jerrycans and Cubes 23 Cube and Barrel Accessories 24 Barrels 24 Dispensing Closures 26 Pails 28 Industrial Buckets 29 Industrial Round Tubs 30 Materials Handling 31 - Trays and Crates - Stack’N’Nest Crates - Tubs - Pallet Bins - Mobile Storage and Bins - Pallets - Miscellaneous Small Storage Bins and Trays 40 Utility Boxes 41 Intermediate Bulk Containers 42 Tanks 43 Marina Floats 44 Bulk Bins 45 Coolbins and Coolbin Accessories 46 Safety Equipment 48 How to Place an Order Orders can be placed by Fax, Telephone or Email. You can also place your order in person by visiting our showroom (open Monday to Friday from 8.30 am to 4.00 pm, except public holidays).
    [Show full text]
  • HP Color Laserjet Pro MFP M479 Series Lighten Your Workload, Focus on Your Business Winning in Business Means Working Smarter
    Data sheet HP Color LaserJet Pro MFP M479 series Lighten your workload, focus on your business Winning in business means working smarter. The HP Color LaserJet Pro MFP M479 is designed to let you focus your time where it’s most effective-growing your business and staying ahead of the competition. HP Color LaserJet Pro M479dw HP Color LaserJet Pro M479fnw Dynamic security enabled printer. Only Built to keep you – and your business – moving forward Scan files directly to Microsoft® SharePoint®, email, USB, and network folders.1 intended to be used with cartridges using an Help save time by automating all the steps in a complicated workflow and apply saved HP original chip. Cartridges using a non-HP settings.2 chip may not work, and those that work today Print wirelessly with or without the network, stay connected with dual band Wi-Fi and 3,4,5 may not work in the future. Learn more at: Wi-Fi direct. Print effortlessly from any device, virtually anywhere, to any HP printer – securely http://www.hp.com/go/learnaboutsupplies through the cloud.6 Highlights HP's best-in-class security – detect and stop attacks7 A suite of embedded security features help protect your MFP from being an entry point 2 sided printing for attacks.7 Dual-band Wi-Fi & wireless Help ensure security of confidential information with optional PIN/Pull printing to retrieve Embedded Security features print jobs.8 HP Roam enabled Optional HP JetAdvantage Security Manager lets you set configuration. Scan to Sharepoint, email, USB and network folders Thwart potential attacks and take immediate action with instant notification of security issues.9 Simply designed to uncomplicate your day Set up this MFP fast, and easily manage device settings to help increase overall printing efficiency.
    [Show full text]
  • Economic Analysis of Country of Origin Labeling (COOL)
    REPORT TO CONGRESS Economic Analysis of Country of Origin Labeling (COOL) April 2015 U.S. Department of Agriculture Office of the Chief Economist Washington, D.C. Economic Analysis of Country of Origin Labeling (COOL) Contents Summary ......................................................................................................................................... 1 Modeling Approaches ..................................................................................................................... 3 Equilibrium Displacement Model Approach .............................................................................. 3 Other Approaches ........................................................................................................................ 4 Assumed Regulatory Costs ......................................................................................................... 5 Results ............................................................................................................................................. 8 Estimated Impacts on Consumers ............................................................................................... 8 Estimated Impacts on Producers, Processors, and Retailers ....................................................... 9 Estimated Impacts of the 2009 Rule ........................................................................................ 9 Estimated Impacts of the 2013 Rule ...................................................................................... 12 Conclusions
    [Show full text]
  • Marking of Country of Origin on U.S. Imports
    Marking of Country of Origin on U.S. Imports Informed Compliance Publication Publication No. 1150-0620 Every article of foreign origin entering the United States must be legibly marked with the English name of the country of origin unless an exception from marking is provided for in the law. SPECIAL NOTE: This webpage is strictly about marking of country of origin on U.S. imports and is for general information purposes only. Reliance solely on this general information may not be considered reasonable care. Recognizing that many complicated factors may be involved in origin issues (raw materials are from one country while the product is assembled in another), an importer may wish to obtain a binding ruling from U.S. Customs and Border Protection. For more information please see determining the correct Country of Origin to use under the Customs Regulations, 19 CFR Part 177. Please be aware that in addition to this information, certain products are subject to additional labeling requirements. For example, clothing must have labels indicating fabric content and washing instructions. Other products with special labeling requirements include tobacco (the Surgeon General’s Warning Statement), food and pharmaceuticals, and automobiles. General Information What is the purpose of marking? To inform the ultimate purchaser in the United States of the country in which the imported article was made. Who is the ultimate purchaser? The ultimate purchaser is generally the last person in the United States who will receive the article in the form in which it was imported. If the article will be used in manufacture, the manufacturer or processor in the United States is the ultimate purchaser if the processing of the imported article results in a substantial transformation of the imported article, becomes a good of the United States under the NAFTA Marking Rules (19 CFR Part 102), or becomes a good of the United States under the textile rules of origin (19 CFR 102.21), as applicable.
    [Show full text]
  • Proquest Dissertations
    INFORMATION TO USERS This manuscript has been reproduced from the microfilm master UMI films the text directly from the original or copy submitted. Thus, some thesis and dissertation copies are in typewriter face, while others may be from any type of computer printer. The quality of this reproduction is dependent upon the quality of the copy submitted. Broken or indistinct print, colored or poor quality illustrations and photographs, print t>leedthrough, substandard margins, and improper alignment can adversely affect reproduction. In the unlikely event that the author did not send UMI a complete manuscript and there are missing pages, these will be noted. Also, if unauthorized copyright material had to be removed, a note will indicate the deletion Oversize materials (e.g., maps, drawings, charts) are reproduced by sectioning the original, beginning at the upper left-hand comer and continuing from left to right in equal sections with small overlaps. Photographs included in the original manuscript have been reproduced xerographically in this copy. Higher quality 6’ x 9” black arxf white photographic prints are available for any pfiotographs or illustrations appearing in this copy for an additional charge. Contact UMI directly to order. Bell & Howell Information and Learning 300 North Zeeb Road, Ann Arbor, Ml 48106-1346 USA 800-521-0600 UMI TRADE IN THE EASTERN MEDITERRANEAN, 100-700 AD: THE CERAMIC EVIDENCE DISSERTATION Presented in Partial Fulfillment of the Requirements for The Degree Doctor of Philosophy in the Graduate School of The Ohio State University By Robert Scott Moore, M.A., B.A. The Ohio State University 2000 Dissertation Committee: Approved by Professor Timothy E.
    [Show full text]