Electronic dup trip
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Electronic Dup/Trip. GADA April 20, 2010. Background. Sponsors may submit electronic duplicate (dup) and triplicate (trip) copies of the submission at this time. Submission of electronic copies is NOT a requirement at this time. Participation is voluntary. Types of Submissions.

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Electronic Dup/Trip

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Electronic dup trip

Electronic Dup/Trip

GADA

April 20, 2010


Background

Background

  • Sponsors may submit electronic duplicate (dup) and triplicate (trip) copies of the submission at this time.

  • Submission of electronic copies is NOT a requirement at this time. Participation is voluntary.


Types of submissions

Types of Submissions

  • All submission types are eligible for submission of electronic dup/trip.

  • ANADA originals (A0000)

    • For ANADA A0000 submissions, we would prefer that you continue to submit 2 paper copies. The trip can be submitted in an electronic format


Considerations

Considerations

  • The paper copy should be a print out of the electronic version of the submission.

  • Certify that the paper copy is a direct print from the electronic copy or describe how the paper copy was created and what quality assurance procedures were used to assure that the paper and electronic copies are identical.

    • If the source documents are only available in paper and the documents were scanned to make the submission electronic, the paper copy should still be a direct print of the electronic copy and not the original/photocopy.

    • Not necessary to create a paper copy of SAS datasets or SAS programs

  • If you submit electronic dup/trip, you should still submit 3 copies of the cover letter in order to facilitate consulting reviews. It is not necessary to submit additional copies of the 356V.


Additional considerations for labeling

Additional Considerations for Labeling

  • If product labeling is included in the submission, a minimum of 3 paper copies of all labeling components should still be submitted

  • Each component of the labeling (e.g. immediate container label, outside container label, Type A Medicated Article label, Type B Feed label, etc) should be converted from its original document (Microsoft Word, Power Point, etc) to its own PDF file.


Format of electronic submission

Format of Electronic Submission

  • Submissions should be saved on a CD/DVD in PDF format

  • The PDF files should, at a minimum, include a bookmark hierarchy (list of bookmarks to show relationship between topics) to link the table of contents to specific sections in the submission

  • Files should have all security settings removed, including but not limited to read-only and password protection

  • If the PDF documents were created from scanned paper copies, Optical Character Recognition (OCR) should be run to allow for searchable text within the document

  • Each PDF file should be no more than 50 MB in size


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