CBP-FDA         Focus on Coronavirus related Importing/Exporting Material/Product.        USA Importer must Read carefully,   CN Exporter need to follow FDA/CBP's Requests. 
                          http://mask.bz/cbpfda                CSMS #42635055             CSMS #42590577         CSMS #42586002    


FDA Document Submission During COVID-19 Pandemic  5-8-2020   CSMS #42635055


CSMS #42635055 - FDA Document Submission During COVID-19 Pandemic  5-8-2020

The Food and Drug Administration (FDA) continues critical work to protect public health during the COVID-19 pandemic.
This work includes review of FDA regulated products offered for importation.
If a request for documents is received from FDA, filers and/or importers are strongly encouraged to submit product labeling along with regularly submitted
entry documents (commercial invoice, packing list, way bill, etc.). Submission of labeling will help expedite the admissibility process during this pandemic.

Labeling along with entry documents should be submitted electronically via the FDA Import Trade Auxiliary Communication System (ITACS).
 ITACS functionality can be accessed at https://itacs.fda.gov. This includes checking statuses, providing requested documentation and location of goods electronically,
 and checking the estimated laboratory analysis completion dates for lines which have been sampled.

Additional information on ITACS, including questions and answers, can be found on FDA’s ITACS for Industry webpage: https://www.fda.gov/industry/import-systems/itacs .
For further questions regarding ITACS, please contact itacssupport@fda.hhs.gov.

CSM # 42635055 - FDA文档提交COVID-19大流行期间
美国食品和药物管理局(FDA)继续关键工作COVID-19大流行期间保护公众健康。这项工作包括提供进口食品及药物管理局监管产品的审查。如果收到 FDA要求文件,申请人和/或进口商强烈建议定期提交产品标签连同提交入口文件(商业发票,装箱单,比尔,等等)。提交标签将有助于加快可容许的过程在这 个大流行。

电 子标签和输入文件应提交通过FDA进口贸易辅助通信系统(ITACS)。ITACS功能可以访问https://itacs.fda.gov。这包括检查状态,提供请求的电子文档和货物的位置,检查实验室 分析估计完成日期已取样。

ITACS附加信息,包括问题和答案,可以发现在FDA的ITACS行业网页:https://www.fda.gov/industry/import-systems/itacs。关 于ITACS进一步的问题,请联系itacssupport@fda.hhs.gov.

  Hand Sanitizers for FDA   5-5-2020    CSMS #42590577


Cargo Systems Messaging Service


CSMS #42590577 - Filing Entries of Hand Sanitizers for FDA     5-5-2020


The U.S. Food and Drug Administration (FDA) is providing this update to clarify expectations regarding filing entries of hand sanitizers.

FDA has recently become aware that some entries of hand sanitizers have been disclaimed to FDA, and the full message set was not filed for FDA review. Additionally, we are aware that some entries of hand sanitizers have been transmitted as cosmetics instead of drugs.

Hand sanitizers are drugs regulated by the FDA and are generally considered as over-the-counter (OTC) drug products. Hand sanitizers (and other drugs) imported into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act and the pertinent regulations found in Title 21 of the Code of Federal Regulations (21 CFR).  As such, entries of hand sanitizers are required to be filed with the FDA upon importation with the appropriate PG Message set data for OTC drug products. Importers/entry filers should not disclaim entries of hand sanitizers.

Regarding the COVID-19 public health emergency, the FDA’s Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) and Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) do not affect the requirement to file entries of hand sanitizers with the FDA, or the product specific requirements verified by FDA at the time of entry.

As described in the temporary policies, foreign manufacturers whose drugs, including over-the-counter drugs, are imported into the United States are required to register with FDA and submit a listing of drugs in commercial distribution, before the drugs are imported (as required by section 510 of the FD&C Act and 21 CFR Part 207). 

For more information on the drug importation process, please see: https://www.fda.gov/industry/regulated-products/human-drugs.

Tips to Help Entry Submission:

The FDA product code is determined according to the hand sanitizer’s active ingredient.  For example:

Active Ingredient in OTC Hand Sanitizer

FDA Product Code

Ethyl Alcohol

62HAL05

Isopropyl Alcohol

62FAL23

Benzalkonium Chloride

62HAL99

ACE requirements for the electronic transmission of drug products to FDA can be found in the FDA Supplemental Guide beginning on page 79.  OTC drug products are transmitted using PG-01 Government Agency Program Code “DRU” and PG-01 Government Agency Processing Code “OTC”.

FDA is issuing this message as part of its continued outreach efforts to assist the import community; please make this information available to importers of record, consignees, manufacturers, shippers and other stakeholders.

Any questions or concerns regarding this message should be addressed to FDAImportsInquiry@fda.hhs.gov.



货物系统通讯服务   

csm  # 42590577 -文件条目FDA的洗手液     5-5-2020 


美国食品和药物管理局 (FDA)提供此更新澄清预期有关文件条目的洗手液。

FDA最近意识到,一些条目 的洗手液已经否认FDA,完整的消息集合并没有申请FDA审查。此外,我们都知道,一些条目的洗手液传播作为化妆品而不是药物。

洗 手液是由美国食品及药物管理局监管,一般的药物  作为非处方药(OTC)药物产品.洗手液(和其他药物) 进口而美国必须符合所有适用的要求根据联邦食 品,
药品和化妆品法案,和相关的法规标题21的联邦法规(21 CFR)的代码。,条目的洗手液需要向FDA对进口与适当的PG消息设置为非处方药 产品数据。
进口商/入境申请人不应该否认条目的洗手液。

关 于COVID-19突发公共卫生事件,FDA 临时准备的政策 某些含酒精的洗手液产品在突发公共卫生事件(COVID-19)  和 临时政策纳入酒 精的洗手液产品制造酒精在突发公共卫生事件(COVID-19)  不影响文件条目的要求与FDA的洗手液,或产品具体要求验证了FDA的条目。

中描述的临时政策,外国制造 商的药物,包括非处方药,是需要进口到美国FDA注册并提交商业分布、上市的药物在药物进口(根据510条款的使用行为和21  CFR 207部分)。

药 品进口过程的更多信息,请参见: https://www.fda.gov/industry/regulated-products/human-drugs.

 
提示,以帮助条目提交:

FDA 产品代码决定根据洗手液的活性成分。例如:


活 性成分在场外洗手液


FDA 产品代码


酒 精


62HAL05


异 丙醇


62FAL23


苯 扎氯铵


62HAL99

ACE 要求的电子传输药物产品,FDA可以发现的 FDA补充指南  从79页开始。非处方药产品传播使用PG-01政府机构程序代码“营养”和PG-01政府机构处理代码“场外交易”。

FDA 发布这个消息的继续协助导入社区外联工作;请把这些信息提供给进口商的记录,收货人,制造商,船运公司和其他利益相关者。

任 何问题或问题关于这个消息应该解决 FDAImportsInquiry@fda.hhs.gov.

CSMS #42586002 - Food and Drug Administration (FDA) Entry Processing Delays at this Time    05-04-2020

CSMS #42586002 - Food and Drug Administration (FDA) Entry Processing Delays at this Time    05-04-2020

The Food and Drug Administration (FDA) Interoperability Web Service (IWS), the interface between U.S. Customs and Border Protection (CBP) and FDA, is currently experiencing entry processing delays. Technicians are investigating the issue.

During this time:

  • FDA will not process any Inbound entries or Outbound messages.
  • FDA Prior Notice System Interface (PNSI) will be operational under Contingency Scenario 1. Please Do Not resubmit entries during this window as it will add to the backlog to be processed

If Prior Notice has been submitted via ACE and confirmation has been received:

  • No further action is required.

If Prior Notice has been submitted via ACE and confirmation has not been received:

  • Please do not resubmit entries as this will cause additional delays.
  • Filers have the option to:
    • Wait until the issue is resolved, unless this will cause the prior notice submission to be untimely. Filers who choose this option should understand that they remain responsible under section 801(m) of the Federal Food, Drug, and Cosmetic Act and under the prior notice final rule for filing timely prior notice.
    • Provide CBP officers with evidence to show prior notice was submitted via ACE (e.g. signed copy of the ABI/ACE transmission)

If Prior Notice has not been submitted:

Filers have the option to:  
    • Wait until the issue is resolved, unless this will cause the prior notice submission to be untimely.
    • Filers who choose this option should understand that they remain responsible under section 801(m) of the Federal Food, Drug, and Cosmetic Act and under the prior notice final rule for filing timely prior notice.
    • Submit Prior Notice via the Prior Notice System Interface (PNSI) The prior notice confirmation number must accompany the article(s).
    • Presenting the PNSI confirmation page(s) to CBP officers is recommended.

For additional details, see Prior Notice Contingency Scenario 1

For questions regarding Prior Notice, or with perishable shipments, please contact the FDA's Division of Food Defense Targeting (DFDT).
The DFDT can be reached 24/7/365 at (866) 521-2297 or prior.notice@fda.hhs.gov

For ACE inquiries, contact FDA ACE Support, 877-345-1101, ACE_Support@fda.hhs.gov.
ACE Support Hours: Monday - Friday, 6AM-8PM ET, Saturdays, 8AM-4PM ET. ACE Support is Closed on Sundays.    

 

csm  # 42586002 -食品和药物管理局(FDA)条目处理延迟    05-04-2020

美国食品和药物管理局(FDA) Web服务的互操作性(手册),美国海关和边境保护局之间的接口(CBP)和食品及药物管 理局,目前正在经历条目的处 理延迟
技术人员正在调查这个问题。

在此期间:

  • FDA将不处理任何入站或出站消息条目。
  • 食品及药物管理局事先通知系统接口(PNSI)将运行在应急情况下1。请不要提交条目在这个窗口,因为它会增加处理积压

如果事先通知被提交通过ACE和确认已经收到:

  • 不需要进一步的行动。

如果事先通知被提交通过ACE和确认还没有收到:

  • 请不要提交条目,因为这将导致额外的延迟。
  • 申请人可以选择:
    • 等待,直到问题得到解决,除非这将导致事先通知提交是不合时宜的。申请人选择这个选项应该明白,他们仍然负责根据第 801节(m)
    • 的联邦食品,药品和化妆品法案,并事先通知下最终规则申请及时另行通知。
    • 海关与边境保护局官员提供证据显示事先通知提交通过ACE(例如ABI的签署副本/ ACE传输)
如果事先通知尚未提交:

  • 申请人可以选择:
    • 等待,直到问题得到解决,除非这将导致事先通知提交是不合时宜的。申请人选择这个选项应该明白,他们仍然负责根据第 801节(m)
    • 的联邦食品,药品和化妆品法案,并事先通知下最终规则申请及时另行通知。
    • 提交事先通知通过事先通知系统接口(PNSI)本文事先通知确认号码必须伴随(年代)。呈现PNSI确认页面(s),海关与边 境保护局官员建议。

有关更多细节,请参见事先通知应急场景1

For questions regarding Prior Notice, or with perishable shipments, please contact the FDA's Division of Food Defense Targeting (DFDT). The DFDT can be reached 24/7/365 at (866) 521-2297
or prior.notice@fda.hhs.gov

ACE调查,接触食品及药物管理局ACE的支持,877-345-1101,ACE_Support@fda.hhs.gov。ACE 支持时间:周一——周五,6 am-8pm ET,星期六,8 am-4pm等。星期天ACE支持关闭。