Single Tier Label Claim (STLC) Industry Guidance

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 Licensed Veterinary Biological Product Information. This web page 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 Licensed Veterinary Biological Product Information. The compilation is performed by the CVB.

Scope of Products Affected by Single-Tier

• Vaccines (including prescription platform products), bacterins, toxoids, and immunomodulators are included under the scope of the new rule.
• Products exempted include: antibody products, diagnostic test kits, autogenous, 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

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 on how to prepare the ISS. Submit the ISS to CVB as a Microsoft Word document to facilitate editing by CVB. Contact the CVB at CVB.Single.Tier@usda.gov if you do not have access to Microsoft Word software.

ISS template (24.29 KB)

ISS template line-wise instructions (203.41 KB)

Data Requirements

Submission guidance and instructions

Examples of a variety of Individual Study Summaries (685.66 KB) *Updated April 8, 2020

Implementation timeline (96.42 KB) *Updated November 19, 2019

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. See 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 (109 KB)

Do you want a printable version of all the STLC guidance?

Click here for the printable version of the "Guidance to Industry Preparing Supporting Summaries for Single Tier (Single Label Claim) Effectiveness Statements" document (436.3 KB)

Questions?

Questions may be directed to CVB.Single.Tier@usda.gov.