Title: Processing Administrative Inspection Reviews

Release Date: 04 Nov 2019 Author: APJWATSON Document Number: CVB-SOP-0028.03

4.4

4.5

4.6

CONTROLLED//PROPIN//BASIC

CVB-SOP-0028.03
Page 4 of 5

Firm Responsibilities when responding to AIR

4.4.1 All reports and directions will be uploaded and submitted via to the
NCAH Portal the firm’s primary liaison. A submittal sheet (CVB-TEM-0047)
will be attached to indicate the reports that should be included in the submission.
Hard copies will be sent for those firms that are not enabled for the NCAH Portal.

4.4.2. Each report should be reviewed for accuracy by the licensee/permittee in
accordance with the instructions provided. The manufacturers should utilize the
drawing mark-ups and/or annotations through Adobe comments, or any other
suitable means, to indicate the changes needed.

4.4.3 The submittal sheet and reports, with comments, can be returned back to
the CVB via the NCAH Portal. Hard copies may also be mailed to the CVB, if
desired by the manufacturer.

4.4.4 See CVB Notice 15-08, Changes to the Administrative Inspection Review
Program, for more information.

Review of Incoming Documents for AIR.

See CVB-WI-0144 for specific processes.

4.5.1 Receipt of Documents

Documents will be submitted electronically. If submitted hard-copy, each item
will be scanned in and the mail log will become the official record of received
items.

4.5.2 Review of Documents and Updating Information in LSRTIS

Many of the attachments will have corrections that need to be validated and
entered into LSRTIS in a timely fashion. Different positions within the Center are
responsible for this review and data entry. See CVB-WI-0144.

4.5.3 If at any time there are questions or issues that need to be brought back to
the firm, the Product Specialist, IC, will be the point of contact for CVB
personnel.

Requests for Additional or Clarifying Information

4.6.1 Ifthere are questions regarding the information submitted, the CVB
responsible person has three options.

Printed by: CRRYAN on 04 Nov 2019, 04:26:08 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Processing Administrative Inspection Reviews

Release Date: 04 Nov 2019 Author: APJWATSON Document Number: CVB-SOP-0028.03

CONTROLLED//PROPIN//BASIC

CVB-SOP-0028.03
Page 3 of 5

3.3 Biologics Specialists (Specialists), or those acting in their capacity, shall provide
assistance, when necessary for review of incoming submissions.

3.4 Product Specialist, or those acting in this capacity, shall provide assistance when
necessary, and follow up on any information that may be necessary. They are also
responsible for updates to serial release information.

3.5 Legal Instrument Examiner (LIE), Program Assistant (PA) or Records
Management personnel, or those acting in their capacity, shall perform updates to the
appropriate database entries, when necessary. They may contact the Product Specialist, or
designates, for any questions or issues with the documents.

3.6 Lead Biologics Compliance Assistant (Lead BCA), or those acting in their
capacity, shall verify documents prior to submission to the licensee/permittee and
validate the review process has been completed prior to closing the request.

Procedures
41 Overview

The CVB-IC sends AIR requests to the licensed firms on an annual basis. This request
usually consists of verification of reports containing the firms’ data pertaining to licensed
or unlicensed products. The majority of these reports are produced from the LSRTIS
databases.

4.2 Assignment of Administration Inspection Reviews

The BCA, or those acting, will draft AIR documents based upon a set schedule of firms
for each month. They will also initiate Mail Log items by following procedures in CVB-
WI-0144, Processing Incoming Administrative Inspection Review (AIR) Documents by
CVB. The Mail Log number is the identifier used to track progress with the AIR.

4.3 Preparation and Distribution of AIR Documents

The process will be completely electronic and up to 12 reports may be generated to be
submitted to biologics manufacturers.

Follow CVB-WI-0145, Preparation of Administrative Inspection Review. Some
documents are not submitted to the firms for specified years. The current work instruction
will determine the listing of reports to be sent.

Printed by: CRRYAN on 04 Nov 2019, 04:26:08 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Processing Administrative Inspection Reviews
Release Date: 04 Nov 2019 Author: APJWATSON Document Number: CVB-SOP-0028.03
CONTROLLED//PROPIN//BASIC

CVB-SOP-0028.03
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4.6.1.1 Return the item in question to the licensee/permittee requesting

more information or a clarification of information. This can be done in an
email, which is added to the Mail Log item.

4.6.1.2 Contact the liaison via phone or email to clarify information. If a
phone call, attach the phone log to the Mail Log.

4.6.1.3 Return the mail log to the manufacturer with “Request Info from
Submitter” child loop to respond to question.

4.6.2 This information should be informationally linked to the original Mail Log
item for tracking purposes, if a new Mail Log item is created.

NOTE:

1. There will not be an acknowledgement of receipt to the firm if there are no issues in
regard to the submission. There may be correspondence with the liaison if there is any

follow-up needed, usually within 90 days of receipt.

2. The AIR documents are kept in the CVB Mail Log; therefore, documents will not be
routinely printed and/or filed by Records Management. In cases of additional

correspondence, files will be kept within the Records Management, Administrative
Inspection Review files.

5. Summary of Revisions

Revision .03
e Updated information regarding job titles not reflected in the latest revision.
e Section 5: Summary of Revisions added.

Revision .02
e Updated document numbers referenced throughout the document.

¢ Document alphanumeric number has changed from CVBSOP0027.01 to CVB-SOP-
0028.02

e Information updated regarding job positions/duties. Updated procedures that only form of
communication should be by letter or portal; email should not be utilized any longer.

Printed by: CRRYAN on 04 Nov 2019, 04:26:08 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Processing Administrative Inspection Reviews
Release Date: 04 Nov 2019 Author: APJWATSON Document Number: CVB-SOP-0028.03
CONTROLLED//PROPIN//BASIC

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Veterinary Services
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Hott iceeen Processing Administrative Inspection Reviews

Service

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

Document Number: CVB-SOP-0028 Revision: 03

Previous Number: CVBSOP0027.01

Author: APJWATSON
Section/Area: CVB-SOP
Release Date: 04 Nov 2019
Notes:

Printed by: CRRYAN on 04 Nov 2019, 04:26:08 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Processing Administrative Inspection Reviews
Release Date: 04 Nov 2019 Author: APJWATSON Document Number: CVB-SOP-0028.03
CONTROLLED//PROPIN//BASIC

CVB-SOP-0028.03
Page | of 5

Processing Administrative Inspection Reviews

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. Definitions

3. Responsibilities

4. Procedures

4.1 Overview

4.2 Assignment of Administration Inspection Reviews

4.3 Preparation and Distribution of AIR

4.4 Firm Responsibilities when Responding to AIR

4.5. Review of Incoming AIR

4.6 Request for Additional/Clarifying Information Licensee

5. Summary of Revisions

Printed by: CRRYAN on 04 Nov 2019, 04:26:08 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Processing Administrative Inspection Reviews
Release Date: 04 Nov 2019 Author: APJWATSON Document Number: CVB-SOP-0028.03
CONTROLLED//PROPIN//BASIC

CVB-SOP-0028.03
Page 2 of 5

1. Purpose and Scope

The purpose of this document is to give guidance to employees on the procedures for processing
Administrative Inspection Reviews (AIR).

The AIR is an annual review of records on file with the Center for Veterinary Biologics (CVB)
for active licensees and permittees to ensure the information is accurate and complete. This
annual review provides open communication between the regulatory authority and the regulated
entity and facilitates the review of all other submissions. This authority is granted under title 9,
Code of Federal Regulations (9 CFR), part 116.5(a).

Administrative Inspection Review documents will be electronically sent from the CVB,
Inspection and Compliance (IC). Validated information regarding the AIR documents will be
electronically submitted by the licensee/permittee for review.

2. Definitions

2.1. Administrative Inspection Review (AIR): A review of information on file with
the CVB by the active licensee/permittee to validate accuracy and completeness of the
data regarding all aspects of the regulatory process. The components of this review are
specific to each licensee and permittee; this may include reports from CVB’s databases,
certified documents, and a generated list of requested information about the licensee and
permittee. These documents are reviewed for sufficiency and authenticated by the
licensee’s official liaison.

2.2 Licensing, Special Requests, Testing and Information System (LSRTIS)
Database: A secure internet system that maintains an integrated, real-time, automated

information management system for CVB. Refer to the Program Documentation file
‘cat oa

for complete instruction of use.

2.3. LSRTIS — Mail Log: A module within the LSRTIS database in which documents
are routed and tracked.

3. Responsibilities

3.1 Export Document Examiner, IC, or those acting in their capacity, shall receive
incoming mail.

3.2. Biologics Compliance Assistants (BCAs), or those acting in their capacity, shall
finalize any outgoing correspondence. The BCAs are also responsible for LSRTIS
updates for personnel information.

Printed by: CRRYAN on 04 Nov 2019, 04:26:08 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100