As part of a movement in 2015 toward single-tier effectiveness statements, 9CFR 112.5(b) was amended to require publication of efficacy and safety study summaries on the APHIS website productdata.aphis.usda.gov. This webpage provides details to licensees, permittees, and applicants on preparing and submitting information for those summaries.
A summary of a single study is known herein as an Individual Study Summary (ISS). It is prepared by the licensee and reviewed/edited/cleared by the Center for Veterinary Biologics (CVB) for standard content and appearance. All of the ISSs applicable to a single biological product are then compiled into a Product Compilation Summary (PCS), which is posted to productdata.aphis.usda.gov. The compilation is performed by the CVB.
Review this section to determine which of your firm's studies require an Individual Study Summary *Updated October 31, 2017
Use the ISS template provided by the CVB. Refer to the line-wise instructions provided in the following section for details. The ISS template is a Microsoft Word document to facilitate editing. Contact the CVB if you do not have access to Microsoft Word software.
Data Requirements *Updated February 6, 2018
Submission guidance and instructions *Updated February 6, 2018
Examples of a variety of Individual Study Summaries *Updated March 14, 2018
Implementation timeline *Updated November 19, 2019
Licensees and permittees may need to update the list of product codes associated with a cleared (approved) ISS. Click here for more instructions.
Get a printable version of this guidance *Updated August 1, 2018
Questions may be directed to CVB.Single.Tier@usda.gov.