Title: Reviewer Staff Meetings
Release Date: 11 Jan 2021 Author: Document Number: CVB-SOP-0058.03
CONTROLLED//PROPIN//BASIC

CVB-SOP-0058.03
Page 3 of 3

Consistency Questions are submitted to the Consistency Question Coordinator. The item may be
submitted as a detailed description of the issue or an actual consistency question (i.e., scenario
with several possible answers). The Consistency Question Coordinator will edit as necessary for
grammar and clarity, then confirm the question phrasing with the originator. The question is then
emailed to all Reviewers for a response prior to the meeting, as well as to the Program Support
Assistant to the PEL Director for inclusion on the next staff meeting agenda. The Consistency
Question Coordinator compiles the Reviewers’ responses, and presents a summary at the next
staff meeting.

4, Documentation of Staff Meeting Discussion

Staff meeting notes re psc

Printed by: CRHERR on 11 Jan 2021, 04:14:10 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Reviewer Staff Meetings
Release Date: 11 Jan 2021 Author: Document Number: CVB-SOP-0058.03
CONTROLLED//PROPIN//BASIC

Health Inspection Reviewer Staff Meetings
Service

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

Document Number: CVB-SOP-0058 Revision: 03
Previous Number: PEL Reviewer Manual Ch. 1.4

Vault: CVB-Released

Section/Area: CVB-SOP-PEL-REV

Effective Date: 11 Jan 2021

Notes:

Printed by: CRHERR on 11 Jan 2021, 04:14:10 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Reviewer Staff Meetings
Release Date: 11 Jan 2021 Author: Document Number: CVB-SOP-0058.03
CONTROLLED//PROPIN/IBASIC

CVB-SOP-0058.03
Page 1 of 3
Reviewer Staff Meeting

Mention of trademark or proprietary product does not constitute a guarantee or warranty of the product by USDA
and does not imply its approval to the exclusion of other products that may be suitable.

Table of Contents
1. Purpose and Scope
2. Types of Issues Discussed at Staff Meetings
3. Procedure for Adding a Topic to the Agenda

4, Documentation of Staff Meeting Discussion

Printed by: CRHERR on 11 Jan 2021, 04:14:10 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Reviewer Staff Meetings
Release Date: 11 Jan 2021 Author: Document Number: CVB-SOP-0058.03
CONTROLLED//PROPIN//BASIC

CVB-SOP-0058.03
Page 2 of 3

1. Purpose and Scope

Center for Veterinary Biologics-Policy, Evaluation, and Licensing (CVB-PEL) Reviewer Staff
meetings provide an opportunity for staff to discuss current issues regarding licensure of new and
existing products, as well as provide a forum for communicating information of common
interest. Regular attendees of PEL staff meetings include the PEL Reviewers, Statisticians,
Section Leaders, CVB-PEL Director, and recorder (Program Support Assistant to the PEL
Director). A standing invitation has also been issued to the Legal Instrument Examiners,
Program Assistants, and the CVB Assistant Director. Other attendees may also be invited to
these meetings, based on the agenda.

2. Types of Issues Discussed at Staff Meetings

Issues discussed at staff meetings include consistency questions, regulatory issues, and
informational items. Regulatory issues are items that require generation of new policy, or
confirmation of existing policy. Informational items are presented to inform other reviewers of
current events, and may include such things as Coordinated Review Team reports, training
summaries, or reviews of scientific educational materials. Consistency Questions are posed
regularly as a means to determine how reviewers currently handle a particular issue. They may
arise from review of historical files, the Reviewers’ Manual, published Notices and Memos,
and/or when communication with other Reviewers indicates that no policy exists regarding an
issue or that an issue is being approached in several different ways.

3. Procedure for Adding a Topic to the Agenda

Regulatory items that require an immediate decision to facilitate review should be discussed with
the appropriate Section Leader prior to the staff meeting (e.g., issues related to bacterins should
be discussed with the Bacteriology Section Leader). The Section Leader will either resolve the
issue through such discussion (i.e., provide guidance regarding the appropriate action to take) or
approve the issue to be brought to the staff meeting for discussion.

If the item is approved for discussion at the staff meeting, the originator should email a summary
of the issue to the Program Support Assistant to the PEL Director no later than close of business
the Monday prior to the meeting. The Program Support Assistant will add the item to the agenda,
and will email an agenda to all attendees prior to the meeting.

Informational items should be emailed to the Program Support Assistant to the PEL Director for
inclusion on the agenda. Informational items also may be discussed at the staff meeting without
prior notice.

Printed by: CRHERR on 11 Jan 2021, 04:14:10 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100