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U.S. Department of Health and Human Services

Drugs

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Biomarker Cover Letter Template

  • Date:
  • Subject: (in bold print) DDT QUALIFICATION SUBMISSION
  • DDT Type: (in bold print), BIOMARKER
  • DDT Tracking Record Number (if previously assigned): (in bold print) DDT BIOMARKER XXXXXX
  • Submission Type: (in bold print)
        • PRE-SUBMISSION REQUEST   or
        • LETTER OF INTENT    or
        • INITIAL BRIEFING PACKAGE SUBMISSION   or 
        • SUPPORTING DOCUMENT FOR CONSULTATION AND ADVICE STAGE    or  
        • QUALIFICATION PACKAGE
  • DDT Name(s): (in bold print): Identify the specific DDT (by name) that is being submitted
  • Context of Use: Describe the intended use of the DDT (1 to 2 sentences)
  • Complete submitter contact information including name(s), affiliation, mailing address, email address, phone and fax numbers