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Guidance to Industry Preparing Supporting Summaries for Single Tier Effectiveness Statements

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 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 The compilation is performed by the CVB.

Scope of Products Affected by Single-Tier

  • Vaccines, bacterins, toxoids, and immunomodulators are included under the scope of the new rule.
  • Products exempted include: antibody products, diagnostic test kits, autogenous or prescription products, and allergenic extracts.

Scope of Studies Requiring Single-Tier Summaries

Review this section to determine which of your firm's studies require an Individual Study Summary *Updated October 31, 2017

Individual Study Summary (ISS) Procedure

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.

ISS template

ISS template line-wise instructions

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

Product Compilation Summaries (PCSs)

Review this section for more information on Product Compilation Summaries

Updating Product Codes Associated With Approved ISSs

Licensees and permittees may need to update the list of product codes associated with a cleared (approved) ISS. Click here for more instructions.

Revisions to Outlines of Production for Single Tier Label Claims

Review this document for more information on Outline of Production Revisions for Single Tier Label Claim and see an example

Want a Printable Version?

Get a printable version of this guidance *Updated August 1, 2018


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