sender preparing item


What is the sender's safety report unique identifier?

    The Sender’s Safety Report Unique Identifier is comparable to the Manufacturer Report Number (also referred to as the Manufacturer Control Number (MCN)). This is the company’s unique case report number, which is used for the life of the case. C. Authorization/Application Number Format (B.4.k.4.1)

What do I need to know before transmitting or transporting COMSEC materials?

    Before transmitting or transporting COMSEC materials, you will need the approval of the COMSEC Custodian and should refer to CNSSI No. 4001 and DODM 5200.01 for guidance. Question 4 of 5: Look at the type of information the package on your chair contains. Which sources would you consult for guidance on transmitting and transporting it?

How do I contact CDER?

    For questions regarding this technical specifications document, contact (CDER) Suranjan De at 240- 402-0498, or (CBER) Office of Communication, Outreach and Development at 301-827-1800 or 800-835-4709. U.S. Department of Health and Human Services

How do I prepare my ICSR for electronic submission?

    Each initial ICSR or follow-up ICSR may consist of several parts, including structured information and nonstructured information, such as ICSR attachments. In order for FDA to process, review, and archive the ICSRs, prepare your ICSR for electronic submission as follows: A. Provide a unique filename for the submission; see section II of this
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