Title: Processing Serial Records
Release Date: 20 May 2021 Document Number: CVB-SOP-0032.02
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4.2 Receipt and Review of Incoming Form 2008s — See CVB-WI-0159, Mail
Receipt, Process, and Distribution

Form 2008s are received via the NCAH Portal, a courier service, or the United States
Postal Service. Hand-delivered Form 2008s are no longer accepted. Incoming Form
2008s must include the original signature of the Authorized Firm representative in Block
13 and an exact copy. Submission via the NCAH Portal is considered an authentic
submission and does not require any additional electronic signatures.

4.3 Log APHIS 2008 — See CVB-WI-0163, Log APHIS Form 2008

All incoming Form 2008s that are received hard copy are entered into LSRTIS for
processing. Form 2008s that are received via the NCAH Portal are received at the time
the firm personnel submits them to the CVB, no data entry is required by CVB personnel.

4.4 BCA Initial Review — See CVB-WI-0164, BCA Initial Review

The functions of the BCA initial review serve as a quality assurance check for data entry
and the technical review of the Form 2008 for accuracy and completeness of submissions.

If internal data entry errors are noted, they are corrected during this review. If the Form
2008 does not contain adequate or complete information, it should be audited back to the
firm. See Section 5, Audit Form 2008s.

If there are questions concerning scientific information or non-standard test results, the
BCA submits the Form 2008, electronically and hard copy (if applicable), to the
Specialist for review.

45 2008 Review — See CVB-WI-0166, Mock Checks in LSRTS Phase II

The BCA compares the Form 2008 to the test system (serial spec sheet) from LSRTIS. A
mandatory check may be requested by either a Specialist or Reviewer.

Criteria for a Mandatory 2008 Review include: program diseases, items with a long term
review hold (items needing review longer than 3-6 months should be considered under
Mandatory 2008 Review instead of Review Hold); also, products newly licensed should
be entered for a period of one year post licensure.

4.6 Specialist Reviews — See CVB-WI-0082, Specialist Review Action within
LSRTIS

Specialists are required to review the information on many Form 2008s. Form 2008s with
test results other than “S” (Satisfactory) are forwarded to the Specialist to determine the
acceptability of the test outcome. In cases where the test information on the Form 2008
does not match the test system in LSRTIS, the Specialist will research the issue and
provide an action.

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Title: Processing Serial Records
Release Date: 20 May 2021 De Document Number: CVB-SOP-0032.02
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10. Retention of Documents

10.1 Form 2008s for the current year and the past two years are kept in the current
files.

Hl Form 2008s released during the current calendar year are filed in Folder A. Folders B
and C contain Form 2008s from previous years. Form 2008s are retained for a total of
seven years.

10.2 The Action Sheets are retained in the Form 2008 Pending Files for at least 6

months. After this time, the Action Sheets are archived at the CVB record retention area
located at 1920 Dayton Avenue, Ames, Iowa.

10.3. The “List of Release Actions” is considered to be a checklist and not an activity
report. These lists are maintained for six months.

10.4 Electronic records are kept for a total of 7 years, at which time LSRTIS system
automatically archives all associated records, unless they are a part of a CVB
investigation.

11. Summary of Revisions

Version CVB-SOP-0032.02

e Document numbers updated throughout the document and hyperlinks added.

e Document alphanumeric number has been changed from ICSOP0010 to CVB-SOP-
0032.

Version ICSOP0010.03
e Incorporated changes related to the NCAH Portal.

e Included information related to work instructions not previously mentioned in the
SOP.

Version ICSOP0010.02
e The Contact information has been updated.

e This document has been rewritten to more accurately reflect the current practices in
place.

e The information has been updated to reflect the LSRTIS rewrite in 2014.

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instruction. BCAs or Product Specialist will monitor this list to ensure action is
taken soon after the problem has been fixed.

4.9 Specialist Ready for Signature — See CVB-WI-0088, Ready for Signature
Action in LSRTIS (Specialist and BCA Duties)

The PC or Specialist is responsible for the final review of Form 2008s authorizing
marketing disposition, prior to signing the electronic record and in Block 17 of the hard
copy Form 2008 if applicable, as the Authorized APHIS representative.

The BCA may review and sign Form 2008s which acknowledge firm actions.
4.10 QA Process — See CVB-WI-0162, QA Process for Serial Release

The Lead BCA or their designee does a final quality check of the hard copy signed Form
2008s prior to redistributing to the BCAs for mailing and filing. This is to ensure the
Form 2008s are complete and meet the purpose intended.

4.11 Mailing and Filing Processed Form 2008s — Including Electronic Notification
of Serial Release — See CVB-WI-0118, CVB-IC Mail/Filing

The hard copy Form 2008s are returned to the firms one day per week (usually
Wednesdays) to serve as written notification of the marketing status of each serial.
However, the firms that have signed up for Email Notification of Serial Release (ENSR)
are notified electronically by the LSRTIS notification process at 11 a.m. and 3 p.m.,
Central time, daily.

For Form 2008s received through the NCAH Portal, notification is submitted at 11 a.m.
and 3 p.m., Central time, as well.

4.12 Phone and Verbal Releases
Phone releases may be authorized by CVB-IC management. This communication is
captured in the LSRTIS IC Phone Log. This customer service is not utilized except in
rare cases as the ENSR and NCAH Portal has replaced this service.
5. Audit Form 2008s — See CVB-WI-0104, Audits and Reference Slips for IC Documents
If a discrepancy is observed at some point during the processing of the Form 2008, an APHIS

Form 2044 (Form 2044) is generated documenting the issue. The Form 2044 and the Form 2008
are sent back to the firm for correction on a daily basis.

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Title: Processing Serial Records
Release Date: 20 May 2021 Document Number: CVB-SOP-0032.02
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Firm requests submitted on Form 2008s should be sent to the Specialist for review. See
Section 7 for these types of requests.

In cases when the Specialist has deemed necessary, a Release Requirement may be
applied when the information submitted or discovered by CVB-IC warrants additional
information during the marketing of a specific serial or product.

A release requirement is an obligation place on the establishment in conjunction with the
marketing of a specific serial or product. Release requirements are at the discretion of the
Biologics Specialist, Product Specialist, and/or Section Leader. See CVB-WI-0082,
Specialist Review Action within LSRTIS.

A Special Test Request may be considered by the Specialist as well. See CVB-SOP-
0047, LSRTIS Special Test Request Procedures for Inspection and Compliance, for
guidance.

4.7 Lab Actions

4.7.1 Form 2008s that have completed the BCA Initial Review, mock check
procedures, and if needed, Specialist Review, move to Lab Actions area. There
are six sections under laboratory actions: waiting samples, waiting samples > 90
days, waiting testing, on test, pending licensure, and subserials. The system
automatically determines the acceptability of a serial to move on to the next area,
if the criterion is met.

4.7.2. Conditional Release - See CVB-WI-0151, Conditional Serial Release

Product samples still within the selection period or under test by the CVB may be
conditionally released in documented emergency situations and on condition of
immediate recall. (Use the current version of CVB-FRM-0087, Serials Ready for
Conditional Action.) A request for conditional release must be made in writing.

4.8 BCA Ready for Approval — See CVB-WI-0165, BCA Ready for Approval

After the Form 2008 has been reviewed, the “at risk” date has passed and all testing by
CVB has been completed, the Form 2008 can be prepared for signature and released to
the marketplace.

4.8.1 Guidance on APHIS Disposition and criteria for choosing specific
dispositions may be found in CVB-WI-0129, APHIS Dispositions and Associated
Information on Form 2008s.

4.8.2 Serials listed under “Rejected” in LSRTIS have been placed there because
of either an error in the system or a human error. Once the error has been
remedied, the BCA can process this serial in accordance with the work

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Title: Processing Serial Records
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8.1 Daily Emails to the Firms

Serial Release notifications are sent at 11 a.m. and 3 p.m., Central time, through the serial
release inbox. Included in these notifications are the APHIS Disposition, CVB
Laboratory Test Reports, Audit reports, and Reference Slips. These are sent to one email
per firm and the email may be updated per instructions in CVB-WI-0142, Process for
Email Address for Electronic Notification of Serial Release.

8.2 Documents/Information Released to the NCAH Portal

The Liaison/Alternate Liaison, Quality Review role, and Serial Release role at the firm,
who has level Verified Identity (Formerly Level 2 eAuthentication) through the USDA,
may search on 2008 information. Updates to the NCAH Portal are sent at 11 a.m. and 3
p.m., Central time, also. Updates include a status change with the applicable CVB
Response (APHIS Disposition, Audits, Reference Slips and Test Reports).

8.3 Status Changes for the Firm (within the NCAH Portal):

e Submitted — items have been received by the CVB. The item will not be
updated until it is either complete, or the sample has been put on test.

e Serial is on Test — items have been received by the CVB and gone through
the initial review. The firm may see the projected off-test date and the testing
that is being performed. Updated off-test dates will be provided to the firm
through the NCAH Portal as well.

e¢ Completed — items have been signed by the CVB. If an APHIS Disposition
shows, this will be the disposition assigned to the Form 2008. However, if a
completed item does not have an APHIS Disposition showing, this Form 2008
was audited. The User must open the “Info” link to see the details of the
release or audit.

All “open” submissions will remain in the NCAH Portal until they are
completed. Completed submissions are available to the firm for 60 days after
their last action. Firms are expected to download the CVB response to their
own system

9. Delays in the Serial Release Processing

If for any reason the normal serial release process is interrupted (e.g., weather-related mail
delays, issues with the computer system), releases may be granted verbally via telephone the next
working day.

e Speak only to individuals authorized by the firm to receive serial release information.
Read only the information on the Serial Status sheet.

e Mail the Form 2008s during the regular mailing process and add to customer service
database.

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Tit rocessing Serial Records

Release Date: 20 May 2021

USDA
a7

Animal and Plant 3 3
Health Inspection Processing Serial Records

Service

Document Number: CVB-SOP-0032.02
CONTROLLED//PROPIN//BASIC

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(515) 337-6100

Document Number: CVB-SOP-0032 Revision: 02
Previous Number: ICSOP0010.03

Vault: CVB-Released

Section/Area: CVB-SOP-IC

Effective Date: 20 May 2021

Notes:

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Title: Processing Serial Records
Release Date: 20 May 2021 Document Number: CVB-SOP-0032.02
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CVB-SOP-0032.02
Page 10 of 10

e Information has been removed that relates to the HP3000/Reflections computer
system.

e The information detailed specific job duties and time frames have been removed and
incorporated into work instructions

e Information regarding electronic notification has been added.

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Title; Processing Serial Records
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6. Hold Management — See CVB-WI-0158, Hold Management Process for APHIS Form
2008s

There are two types of Hold Releases: Legal and Review. Both types of holds in the serial
release process may be placed at the establishment level, product code level, or for a specific
serial. A review hold can also have an agent level hold.

The hold may be requested by a Specialist for several reasons. Review holds do not need

management approval. Legal holds must be submitted to a Section Leader, who has the
responsibility to approve or deny the request.

Serial specific items, short term review, or those with specific release criteria (i.e., bench record
review) should be considered for Review Holds. Legal Holds may have the criteria for anything
that will delay or prohibit market release.

7. Processes for Firm Requests and Non-Typical Releases

Circumstances in which a possible change in the release process noted above may not be
followed include the following situations:

7.1. Inventory Transfers: See CVB-WI-0147, Processing Inventory Transfers

7.2 Reprocessing and Retesting, and Rebottling Requests: See CVB-WI-0106,
Reprocessing/Rebottling = Process

7.3 Extensions of Dating: See CVB-WI-0117, Extension of Dating — Process

7.4 Short Dating: A regulatory flexibility used if a serial meets the following criteria
within CVB-WI-0130, Shortened Dating -Process.

7.5 Firm Mergers. See CVB-WI-0077, Processing of APHIS Form 2008s for
Prelicensing Serials related to Firm Mergers. Inventory Transfers may also be related to
mergers, see Section 7.1.

7.6 Challenged Test Results by the Firm. See CVB-WI-0091, Processing APHIS

Form 2008s if Unsatisfactory Testing by the CVB and the Possible Challenge of the Test
Results by the Manufacturer

8. System Functions/Releases to NCAH Portal

See the System Administrators for LSRTIS for functionality in which the normal process
needs to be halted or updated, specifically for ENSR or NCAH Portal releases.

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Title; Processing Serial Records

Release Date: 20 May 2021 Document Number: CVB-SOP-0032.02

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Responsibilities
3.1 Document Export Examiner and Biologic Compliance Assistant (BCA)

Processes incoming mail, reviews records, enters data, prepares serials for APHIS
disposition, and mails a copy to firm.

3.2 Lead BCA

Monitors the entry and release process, provides training, and performs quality assurance
duties throughout the process.

3.3 Biologics Specialist

Reviews selected test results from firm for compliance and determines acceptability,
fields scientific questions and provides input, reviews and signs Form 2008s as the
Authorized APHIS representative.

3.4 Section Leaders

Provide guidance to overarching issues for the process, approve hold management
requests, and make final decisions on issues of non-conformity.

3.5. Product Manager

Provides guidance regarding issues for the process and acts as liaison with PEL regarding
prelicensing issues and test results.

Procedures
41 Overview

Firms submit Veterinary Biologics Production and Test Summaries for serials prepared,
either on a Form 2008 or through the NCAH Portal. This includes serials to be considered
eligible for release, serials destroyed by the firm, filed for information, to correct data
related to a specific serial, or requesting permission for a specific action related to a
serial, such as a request to reprocess a serial or extend the dating of a serial.

There are two exceptions in which a summary format may be used in lieu of Form 2008:
e First Serial Autogenous Products — See VS Memorandum No. 800.69
e Allergenic Extracts — See VS Memorandum No. 800.53

jon 24 May 2021, 09:00:50 am.
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Title: Processing Serial Records
Release Date: 20 May 2021 fC Document Number: CVB-SOP-0032.02
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1. Purpose

Licensees and permittees of biological products shall submit to the Animal and Plant Health
Inspection Service (APHIS) test summaries using the NCAH Portal or an APHIS Form 2008
(Form 2008) of testing performed on each serial or subserial of product, according to the title 9,
Code of Federal Regulations (9 CFR), part 116.7. The Center for Veterinary Biologics-
Inspection and Compliance (CVB-IC) evaluates the firm’s summaries and additional testing by
CVB-Policy, Evaluation, and Licensing (PEL) and if found satisfactory, the serial or subserial
may released by IC for sale and distribution. CVB-IC has the delegation of authority to release
serials based on all factors supplied. Guidelines for preparing and submitting Form 2008 are
described in Veterinary Services (VS) Memorandum No. 800.53.

This document details the steps in the review process of the Form 2008, determining the

appropriate disposition, and the process to release the serial in the Licensing, Serial Release, and
Testing Information System (LSRTIS).

2. Definitions
2.1 APHIS Form 2008
Form 2008, Veterinary Biologics Production and Test Report, or an equivalent approved
by APHIS (see CVB-WI-0065, Approving Alternate Form 2008), reports the entire
testing summary for one serial or subserial submitted to CVB for serials eligible for
marketing. APHIS Form 2008A is used as a continuation page for summaries requiring

more than one page.

In this document the Form 2008 may also refer to the test summaries supplied by the
manufacturers through the NCAH Portal.

2.2 Program Coordinator (PC)

A Biologics Specialist (Specialist) assigned to perform certain unit-wide duties, including
signing Form 2008s ready for final disposition and release. Refer to CVB-WI-0098,
Program Coordinator Duties for specifics.

2.3 Licensing, Serial Release and Testing Information System (LSRTIS)

This database system is the information management system used by the CVB for serial
information and processing.

2.4 NCAH Portal

An external-facing application which enables web-based electronic submissions and
responses between biologics firms and the CVB.

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Title: Processing Serial Records

Release Date: 20 May 2021 Document Number: CVB-SOP-0032.02

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Processing Serial Records

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

Pepe

10.
11.

Purpose

Definitions

Responsibilities

Procedures

41 Overview

4.2 Receipt and Review of Incoming Form 2008s

43 Log APHIS 2008

44 BCA Initial Review

45 2008 Review

4.6 Specialist Reviews

4.7 Lab Actions

4.8 BCA Ready for Approval

4.9 Specialist Ready for Signature

4.10 QA Process

4.11 Mailing and Filing Processed Form 2008s — Including Electronic
Notification of Serial Release (ENSR)

4.12 Phone and Verbal Releases

Audit Form 2008s

Hold Management

Processes for Firm Requests and Non-Typical Releases

71 Inventory Transfers Requests

7.2 Reprocess and Retesting and Rebottling Requests

7.3 Extension of Dating Requests

7.4 Short Dating

7.5 Firm Mergers

7.6 Challenged Test Results

System Functions/Releases to the NCAH Portal

8.1 Daily Emails to the Firms

8.2 Documents/Information Released to the NCAH Portal

8.3. Status Changes for the Firms in the NCAH Portal

Delays in the Serial Release Processing

Retention of Documents

Summary of Revisions

jon 24 May 2021, 09:00:50 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100