Safeguarding American Agriculture

Federal Relay Service

APHIS is an agency of USDA’s Marketing and Regulatory Programs (Voice/TTY/ASCII/Spanish)

An Equal Opportunity Provider and Employer 1-800-877-8339

 January 14, 2013

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 13-02

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Richard E. Hill, Jr. /s/ Richard E. Hill, Jr.

Director

Center for Veterinary Biologics

SUBJECT: Quarterly Acknowledgement Summaries for Selected Submissions

I. PURPOSE

The Center for Veterinary Biologics (CVB) is currently implementing methods to 

increase efficiency. This Notice announces that the Policy, Evaluation, and Licensing 

(PEL) unit of the CVB will begin distributing quarterly acknowledgement summaries, in 

lieu of individual regulatory response letters, for routine or minor submissions to PEL 

that are not considered time sensitive and to which the CVB does not take exception.

II. BACKGROUND

The PEL unit writes numerous regulatory response letters simply to acknowledge receipt

of acceptable routine or minor submissions that do not require a time-sensitive reply. 

Each of these letters takes time to write and must undergo a quality assurance process 

before being mailed. Substantial efficiency is gained by combining acknowledgements in 

a summary format that can be generated as a report from the CVB’s submission tracking 

system.

III. POLICY

Instead of sending individual acknowledgement letters for each submission received by

PEL, licensees, permittees, and applicants will receive quarterly acknowledgement

summaries in tabular format for certain eligible submissions. An example summary is 

appended to this Notice. Every submission to the PEL will be acknowledged either by 

individual letter or quarterly summary.

Eligibility of individual submissions for inclusion in the quarterly summary will be made 

on a case-by-case basis, at the discretion of the PEL. Eligible submissions may include, 

but are not limited to:

United States 

Department of 

Agriculture

Animal and Plant 

Health Inspection 

Service

Veterinary Services

Center for Veterinary 

Biologics

1920 Dayton Avenue 

PO Box 844 

Ames, IA 50010 

(515) 337- 6100
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 13-02

Page 2

• Preliminary proof-of-concept studies filed solely for information (unless feedback

is specifically requested).

• Simple non-pivotal study summaries submitted as follow-up to authorizations

under 9CFR 103.3.

• Label inactivation requests.

• License termination requests (after licensee surrenders licenses to the CVB).

• Return of superseded licenses (e.g., after reissue). Notification of intent to 

discontinue product development (converting license applications to inactive

status).

• Removal of personnel from list of USDA liaisons and assistant liaisons.

• Inspection-Compliance (IC) submissions submitted to PEL staff by mistake (e.g., 

facility documents). IC staff will respond in real time, but PEL acknowledgement 

of transfer to IC will be on summary.

• Regulatory review priority lists.

• Adverse event monitoring summaries, when required on an established periodic 

basis for license maintenance, and provided the CVB has no particular comments 

to communicate.

• Routine updates to filed documents for unlicensed products exported under the 

Food and Drug Administration’s Export Reform and Enhancement Act of 1996.

• Lists of critical study dates.

Additional submission scenarios may be identified for inclusion in the summary. An 

updated list of eligible submissions will be maintained at 

http://www.aphis.usda.gov/animal_health/vet_biologics/vb_pelmanual_ToC.shtml.

If a submission involves a request for PEL action (e.g., label inactivations, forwarding 

items to Inspection-Compliance), action will continue to be initiated upon receipt, but 

confirmation of the completed action will be communicated to the submitter via the 

quarterly summary.

The summaries will be generated at the end of each calendar year quarter (March 31, 

June 30, September 30, December 31) and distributed to the primary USDA liaison for 

the establishment within two weeks afterward. Unless otherwise requested by the 

submitter, summaries in PDF format will be distributed by electronic mail. 

The quarterly summary is intended only for simple acknowledgement responses that are 

not time sensitive and will not impact the progress of product development plans. If, 

however, a submitter wishes to verify the disposition of a particular submission prior to 

the end of the quarter, an interim summary may be requested at any time. Address 

requests to your assigned licensing reviewer.

IV. IMPLEMENTATION/ APPLICABILITY

This new policy applies to any eligible PEL submissions reviewed on or after

January 1, 2013. The first summary will be distributed for the quarter ending March 31, 

2013.
Safeguarding American Agriculture

Federal Relay Service

APHIS is an agency of USDA’s Marketing and Regulatory Programs (Voice/TTY/ASCII/Spanish)

An Equal Opportunity Provider and Employer 1-800-877-8339

EXAMPLE

Center for Veterinary Biologics

Submission Acknowledgement Summary for Establishment ABC

Covering Period January 1 – March 31, 2012

Mail ID Product Brief Description

Submission 

Date

Submission 

Type

Submission 

Subtype CVB Action

103161 1000.00

Summary of preliminary efficacy 

study—equine influenza 01/18/2012 Report

Efficacy-proof 

of concept Filed for information

103117 NA

Firm ABC’s regulatory review 

priorities 01/13/2012 Correspondence Administrative Filed for information

104111

1999.AB, 

4999.0A

Discontinuing development of these 

products 02/27/2012 Correspondence Administrative

Converted product status to 

prelicense inactive and 

archived files.

105166 2999.99

No longer using labels 39482 and 

39874 03/02/2012 Correspondence Labeling

Labels moved to inactive 

status

Print date: 04/02/2012 Page 1 of 1