Title: Mail Log Work Flow for Correspondence for Inspection and Compliance - Biologics Specialist Review
Release Date: 20 May 2021 Document Number: CVB-WI-0139.02
CONTROLLED//PROPIN//BASIC

b. Save this document on a designated drive, and re-upload that signed document into
the Mail Log. ENSURE THIS IS THE SAME DOCUMENT TYPE.

6. Section Leader Final Authorization

a. The Section Leader will review the document for policy if it is the first time
reviewing the letter and ensure the letter is signed by the Specialist and meets the
criteria for a portal document as under ICSOP0045, Inspection and Compliance
Correspondence (LSRTIS, Mail Log Procedures). Upon acceptance, move the mail
log to Records Management (RM).

b. The document is moved to Records Management. Records Management will perform
a Quality Review Audit, and upon completion (Filing), the Record will be complete.

7. CVB Responses to Portal

Responses and completed records without CVB responses will be sent back to the firms
through the NCAH Portal after the mail log is complete (through Records Management
review).

11 a.m. and 3 p.m. Central time, daily
a. All final versions (highest document number) of any Outgoing Attachment,
regardless if the document initiated in the NCAH Portal or with CVB
b. Tag of “No Outgoing Correspondence”
c. Awaiting Update from Submitter (from CVB child workflow of Request Info from
Submitter)

3:30 p.m. Central time, daily - NCAH Portal Daily CVB Submission email, Submissions to
CVB-IC with the following status:

a. Update from Submitter Received

b. Awaiting Update from Submitter

c. Completed items

CVB-WI-0139.02 Page 4 of 5

a. 24 May 2021, 05:40:25 pm.
Controlled by: emer for Veterinary Biologics, 515-337-6100


Title: Mail Log Work Flow for Correspondence for Inspection and Compliance - Biologics Specialist Review
Release Date: 20 May 2021 — Document Number: CVB-WI-0139.02
CONTROLLED//PROPIN//BASIC

v. If Response by the Firm is required:
Tag the Mail log with- “Return Action Required by the Firm”. This will
notify the firm through their daily email notification and NCAH Portal.

e. If wanted or needed, move forward for Specialist Review for another Specialist to
review the document.
i. After review, open document by clicking on document link under “Document”
tab, modify as needed, and Save As on your computer drive
ii Then repeat steps under 4.d.
CRITICAL! When uploading a modified document, make sure it is tagged as the
same type of correspondence as the original version.

f. Move forward to Section Leader Review (IC) if required.
e Facility documents letters - ERE Facility Manager) has Section
Leader functionality for Facility Documents
e All outgoing correspondence during specialist training period until otherwise
determined by supervisor
e Controversial letters, uncommon submissions or infrequent situations should

be routed to the SL responsible for the policy
e NOTE E icaion Manager) has Section Leader
functionality for Compliance Correspondence in HE absence — See

CVB-SOP-0024, Delegation of Authority for Center for Veterinary Biologics
- Inspection and Compliance

e See CVB-WI-0105, Mail Log Work Flow for Correspondence for Inspection
and Compliance: Section Leader Review, for specifics regarding this review

g. Move Forward to Finalization (IC) if no Section Leader review is required or if letter
has been reviewed and approved by Section Leader previously.

5. Ifa response was drafted, the BCA will finalize the document and push to you as the
Specialist for Signature under Sign Correspondence (IC) activity.

a. The Specialist should open the pdf document and Digitally Sign the document with
the approved USDA Logo Signature block.

CVB-WI-0139.02 Page 3 of 5

aa. 24 May 2021, 05:40:25 pm.
Controlled by: nter for Veterinary Biologics, 515-337-6100


Title: Mail Log Work Flow for Correspon ic ind Compliance - Biologics Specialist Review
Release Date: 20 May 2021 Document Number: CVB-WI-0139.02
CONTROLLED//PROPIN//BASIC

Hard Copy Incoming Submissions
1. Biologics Compliance Assistant (BCA) places purple folder on your desk with
correspondence from the firm. Review items in folder and determine if a written response
is required.
2. Ifno written response is required

a. a. Refer to Section 2 a-d under Portal - Electronic Submissions.

3. Ifwritten response is required

a.a. Refer to Sections 4 a-f under Portal — Electronic Submissions

b. Move Forward to Finalization (IC) if no Section Leader review is required or if letter
has been reviewed and approved by Section Leader previously.

4. Ifa response was written, the BCA will finalize the document.

a. The BCA will provide the finalized document in a purple folder for the Specialist to
sign.

b. After signing the document, the Specialist needs to get Section Leader initials on the
yellow copy of the correspondence.

c. The Specialist returns the purple folder to the BCA whose name is on the folder, and

the BCA mails letter after SL Final Authorization. The Mail Log then gets sent to
Records Management final a final QA Check.

CVB-WI-0139.02 Page 5 of 5

mn 24 May 2021, 05:40:25 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Mail Log Work Flow for Correspondence for Inspection and Compliance - Biologics Specialist Review
Release Date: 20 May 2021 Document Number: CVB-WI-0139.02

USDA
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Animal and Plant

Heal tnapection Mail Log Work Flow for Correspondence for Inspection and

Veterinary Services Compliance - Biologics Specialist Review

Center for Veterinary
Biologics

fo)
CONTROLLED//PROPIN//BASIC

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(515) 337-6100

Document Number: CVB-WI-0139 Revision: 02
Previous Number: ICWI0236.07

Vault: CVB-Released

Section/Area: CVB-WI-IC

Effective Date: 20 May 2021

Notes:

HR 24 May 2021, 05:40:25 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Mail Log Work Flow for Correspondence for Inspection and Compliance - Biologics Specialist Review
Release Date: 20 May 2021 Document Number: CVB-WI-0139.02
CONTROLLED//PROPIN//BASIC

Mail Log Work Flow for Correspondence for Inspection and Compliance —
Biologics Specialist Review

Source Document: CVB-SOP-0049, /nspection and Compliance Correspondence (LSRTIS, Mail Log Procedures)

This is a main activity queue in which the Biologics Specialist does a review of compliance
issues or firm requests. They may also determine if a response is needed or not.

Once the Specialist moves the Mail Log out of their Review queue, a new queue will appear
“Reviewed — Not Completed”. It is an informational pending queue that does not need action but
allows the Specialist to see MLs that have not yet been finalized, regardless of whose activity it
may be with.

aamin~ — ( Seacc Search

v-Up (3) | Reviewed - Not Mailed (1)| | Reviewed - Not Completed (11) | Mail Correspondence!2015 P:

PORTAL -— Electronic Submissions

1. BCA will electronically assign the mail log to appropriate Specialist in the LSRTIS, Mail
Log. Specialist may receive an email that an item has been assigned.

2. Ifno written response is required

a. My Queues, Active Tab and click on Mail Log (ML) number link.
- Can also use mail item # search function to find document

b. Click the “Edit Mail Item” tab at the bottom of the screen.

c. Go to the middle of the page under “Submission Classification” and click on the
drop-down box beside “Tags”. Select “No Outgoing Correspondence” in drop down
and then click the add button to the side of the drop-down box. Then click the
“Update” box at the bottom of the screen.

d. Move Forward to Finalization (IC), click on BCA who provided the correspondence
to you.

3. Ifmore information is needed from the firms, request the information by initiating a child
workflow through the “Request Info from Submitter” activity.

a. If bench records, additional information, or corrected information is needed, specify
the request within the Routing Comments.

b. Once this request has been received by the firm, they may append additional
attachments to the Mail Log item. This may be additional information or replacing an
incorrect document.

i, The CVB user(s) who are assigned to the Mail Log item will receive an email
notification with the subject “Submitter has appended documents to Mail Item
XXXXXX”,

CVB-WI-0139.02 Page | of 5

mn 24 May 2021, 05:40:25 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Mail Log Work Flow for Correspondence for Inspection and Compliance - Biologics Specialist Review
Release Date: 20 May 2021 Eee Document Number: CVB-WI-0139.02
CONTROLLED//PROPIN//BASIC

ii. Upon receiving this email, the CVB User must complete the child workflow,
which will be found in the Pending Other Input tab in Mail Log.

To Close Child Loops:
You must click on the activity you want to close. Then the option to close child loop

4. Ifwritten response is required

a. Write response and save to your computer drive.
i. Specialist are responsible for reviewing the product codes and serial numbers
to ensure they are valid
ii. Specialist are responsible for adding the correct em: on the template letters
b. Go to My Queries, Active Tab and click on ML number link.
- Can also use mail item # search function to find document
c. Click on Documents tab.
d. Click on “Create New Document Record” button.
i. Select File Type as Uploaded File (This is the default and is usually already
selected.)
ii. Click on “Choose File” button to find document, click on document, and then
click open to attach document
iii. Click on the drop down box beside “Type”. Select one of the following types of
correspondence:
Outgoing General Correspondence
Outgoing Compliance Correspondence
Outgoing Inspection Report
Outgoing Enclosure
WRP Correspondence
iv. Click on “Save and Return to Item Record Button”
IMPORTANT: TWO SITUATIONS IN WHICH MORE THAN ONE
DOCUMENT MUST BE ATTACHED TO A MAIL LOG ITEM prior to Section
Leader Review:
1. Inspections
a. Attach the report as Outgoing Inspection Report
b. Attach the cover letter as Outgoing General Correspondence
c. Attach the list of records audited and processes observed as Inspection
Notes
2. Regulatory Actions
a. Attach regulatory letter as Outgoing Compliance Correspondence
b. Attach WRP item (Weekly Report to the President) as WRP
Correspondence.

CVB-WI-0139.02 Page 2 of 5

 ccasratsicgemrcacil 24 May 2021, 05:40:25 pm.
Controlled by: renter for Veterinary Biologics, 515-337-6100