Example+of+CBER+UNII+Letter

UNII Assignment Letter - Example
Our STN: BL 123456

Sponsor Address ...

The Food and Drug Administration Amendments Act of 2007 (Publ L. No 110-85) (FDAAA) requires that establishment registration and drug listing be accomplished electronically. Therefore, to facilitate your compliance with FDAAA, FDA has assigned Unique Identifier (UNII) codes to your product Influenza Virus Vaccine (TRADENAME).

The UNIIs for Influenza Virus Vaccine/(TRADENAME) are:

__Normalized Name__: INFLUENZA A VIRUS ANTIGEN (Active Moiety) __UNII__: R9HH0NDE2E __Identifying Description:__    **INFLUENZA A VIRUS         
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__Normalized Name__: INFLUENZA A VIRUS H1N1 HEMAGGLUTININ ANTIGEN, E __UNII__: YWZ0U7C41B __Identifying Description:__   <CLASS_OF_INFECTIOUS_AGENT>**VIRUS**<CLASS_OF_INFECTIOUS_AGENT/> **INFLUENZA A VIRUS** <STRAIN_DESCRIPTION>**A/ANYWHERE/00/2000 (H1N1)**</STRAIN_DESCRIPTION> </PARENT_ORGANISM>  <IDENTIFICATION>**HEMAGGLUTININ**</IDENTIFICATION> <CHARACTERIZATION>**SPLIT VIRION** </CHARACTERIZATION/> <MODIFICATION-STATE/>**INACTIVATED** <INACTIVATION_METHOD>**PHYSICAL METHOD** <AGENT>**PHYSICAL METHOD 1**</AGENT> </INACTIVATION_METHOD> <INACTIVATION_METHOD>**CHEMICAL METHOD** <AGENT>**CHEMICAL AGENT 1**</AGENT> <AGENT>**CHEMICAL AGENT 2**</AGENT> </INACTIVATION_METHOD> </MODIFICATION-STATE/> </ANTIGEN> <HOST_SOURCE-EXPRESSION_SYSTEM>**EMBRYONATED EGGS**</HOST_SOURCE-EXPRESSION_SYSTEM> </VACCINE> </COMPLEX_SUBSTANCE>

...more UNII descriptions...

Please be aware that your UNIIs and substance name have been published on our website at http://www.fda.gov/oc/datacouncil/SRS.htm. These UNIIs have also been associated with the accompanying information found herein. This information will be considered public within 30 days of the date of this letter. However, it is not our intent to publish nonpublic, proprietary information. Therefore, please contact us within 15 days if this accompanying information set forth above are nonpublic, proprietary information (if you need to contact us, please refer to STN BL 123456.

UNIIs are a part of the joint United States Pharmacopeia (USP)/FDA Substance Registration System (SRS), which has been designed to support health information technology initiatives by providing unique identifiers for substances in drugs, biologics, foods, and devices based on molecular structure and/or descriptive information. For more information regarding UNIIs, please go to http://www.fda.gov/oc/datacouncil/SRS.htm.

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