Title: Facility Documents: Biologics Compliance Assistant (BCA) Preliminary Review
Release Date: 22 Aug 2022 Author: ALBYERSDORFER Document Number: CVB-WI-0109.02
CONTROLLED//PROPIN//BASIC

3. Click the ML hyperlink, select Documents Tab, and open the IC Clean Copy

ScI1c3c3c 3 |

Create

‘Comments.

Doe 1D a File Name
= id ae Date vn Copy
477863-3 _Plot Plan Legend ‘Ames - 1st electronic submission.pt 06/04/2018
477863-4 IC Clean Copy 999 Ames PPL version 1 cleancopy.pdt 081042018
417863-5 Outgoing Enclosures 999 Ames PPL 1-REV.pdt 06/04/2018

177863-6 Outgoing General Corr. 180530-1.pdt 06/04/2018

Showing 1 to 4 of 4 entries

4. Go to the Active ML, Document Tab and open the submission. Now both should be
opened as PDFs.

ile Edit View Window Help

Home __ Tools 999 Ames_PPL_ver... x Ames_revised versi...

DRBHBQ @O1r2 kK MOO we - RABE
o

taal

5. Document Comparison

a. On the Adobe Acrobat menu bar choose “Tools”

File Edit vi indow Help
Home Tools Revised PL submitt. PL Legend from Sha. *
 & Q D® [1 )72 re @2ooO TM- BREET S&S #2

Establish Name Document Title
Est. XXXX Version XX

Site Address

Building 1

Function: Prenaration of viral veterinary biological nroducts.

CVB-WI-0109.02 Page 4 of 11

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Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents: Biologics Compliance Assistant (BCA) Preliminary Review
Release Date: 22 Aug 2022 Author: ALBYERSDORFER Document Number: CVB-WI-0109.02
CONTROLLED//PROPIN//BASIC

G. If submission is incomplete, return unprocessed.

1. For electronic submissions:

a. Use CVB-TEM-0042 to create a response to firm as to why the submission is being
returned unprocessed. The resubmission date is customarily 1 month from the current
date.

The BCA moves forward to Finalization and self-assigns

Sign the response electronically

Select Return Unprocessed as a TAG in the ML on Info tab

Fill out “Follow-Up” information on Jnfo tab and enter “Follow-up Due Date” and
“Follow Up By”

Update the Submission Response on the Jnfo tab of the ML: select date for “Date of
Letter/2015” and “Date Mailed.” Select Portal under “Shipment Type.”

g. Attach to the ML and identify as “Outgoing General Correspondence”

h. Move forward in the ML to the Section Leader — Final Authorization

eae

bac)

2. For Hard Copies:

a. Sign and date the FDS

b. Place \ in Block 9C “Documents Returned” of FDS

c. Scan the FDS and attach to the ML. Identify document type as “Outgoing General
Correspondence”

d. Use CVB-TEM-0042, Facility Document Correspondence, to create a response to the
firm as to why the submission is being returned unprocessed. Customarily, give the
firm 1 month to respond.

e. Attach to the ML and identify as “Outgoing Enclosure”

f. Select Suppress Response from Portal and Return Unprocessed as a TAG in Info tab
in the ML

g. Ifreturning via USPS (Certified Mail Receipt)

1. Grab “Green Card” and White CERTIFIED MAIL RECEIPT (CMR) USPS label
from Hive
2. Usea First-Class USDA-APHIS manilla or white envelope (depending on size of
documents being returned)
3. Print three return address labels from the DYMO printer (select using Liaison
Return Labels from the Address Book drop down in DYMO program)
a. Place one label in Box 1 of Green Card
b. Place one label in box under “OFFICIAL USE” on white CMR
c. Place one label on the front of the First-Class envelope
Remove perforated portion of USPS CMR to keep
Place CMR Sticker in upper right-hand corner of the First-Class envelope
Place tracking number sticker in Box 2 of Green Card
Write ML #, Est. #, BCA’s Initials, Date, and VBI # (if applicable) somewhere on
the Green Card and white CMR. This way, when the Green Card is returned, the EDE
knows which BCA to return to.
8. Check the “Certified Mail/Certified Mail Restricted Delivery” as well as
“Signature Confirmation/Signature Confirmation Restricted Delivery” options in Box
3 of Green Card.

NAAR

CVB-WI-0109.02 Page 9 of 11

Printed by: TABLANCO on 23 Aug 2022, 09:40:14 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents: Biologics Compliance Assistant (BCA) Preliminary Review
Release Date: 22 Aug 2022 Author: ALBYERSDORFER Document Number: CVB-WI-0109.02
CONTROLLED//PROPIN//BASIC

d. Check the box “Compare text only” and click OK.

As a double check, you can click on “Settings” to make sure that text is the only box
check the show in report area.

Select Files to Compare

Old File Ni

Building ...ature.pdf Building ...evi

e. Click Compare

Select Files to Compare

Old Fite New File

CVB-WI-0109.02 Page 6 of 11

Printed by: TABLANCO on 23 Aug 2022, 09:40:14 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents: Biologics Compliance Assistant (BCA) Preliminary Review

Release Date: 22 Aug 2022 Author: ALBYERSDORFER

CONTROLLED//PROPIN//BASIC

b. Choose “Compare Files”

Create & Edit

Forms & Signatures

Document Number: CVB-WI-0109.02

c. Make sure the “Old File” is the IC Clean Copy document. The IC Clean Copy should
have the CVB stamp and date on it. If it isn’t, select the arrows in the middle to

switch files around.

Select¢Files to Compare
Old File New File
—s
—
Revised P..om ML.pdf
’ Change File .

CVB-WI-0109.02
Printed by: TABLANCO on 23 Aug 2022, 09:40:14 am.

Page 5 of 11

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents: Biologics Compliance Assistant (BCA) Preliminary Review
Author: ALBYERSDORFER
CONTROLLED//PROPIN//BASIC

Release Date: 22 Aug 2022

To name the document, use the following tables as guidance:

Document Number: CVB-WI-0109.02

Document Code Building
Number
Plot Plan PP NO
Plot Plan Legend PPL NO
Plot Plan Legend Addendum PPLA NO
Plot Plan Addendum PPA NO
Blueprint BP Name of
Blueprint Legend BPL Name of
Blueprint Legend Addendum BPLA In Name of
= _ single building Document
Blueprint Legend Addendum BPLA Comments
- multiple buildings
Blueprint Addendum BPA Name of
Addendum Type Abbreviation
Fraction List Fraction
Decontamination Procedures Decon
Biocontainment & Biosafety Practices BB
Exemptions to 9 CFR 109 109
Movement of Materials Between Licensed Premises Movement
Storage of Master Seed off Licensed Premises MSS
Alternative Location for Storage of Records RS
Other Precaution Against Contamination
Most BPA and PPA are related to mitigating cross- cc
contamination
Other Other
Add the “Compare Report” to the ML identified as “Compared Document”
CVB-WI-0109.02 Page 8 of 11

Printed by: TABLANCO on 23 Aug 2022, 09:40:14 am.

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents: Biologics Compliance Assistant (BCA) Preliminary Review

Release Date: 22 Aug 2022 Author: ALBYERSDORFER Document Number: CVB-WI-0109.02

Service

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

CONTROLLED//PROPIN//BASIC

Facility Documents: Biologics Compliance Assistant (BCA)
Preliminary Review

Document Number: CVB-WI-0109 Revision: 02
Previous Number: ICWI0081.04

Vault: CVB-Released

Section/Area: CVB-WI-IC

Effective Date: 22 Aug 2022

Notes:

Printed by: TABLANCO on 23 Aug 2022, 09:40:14 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


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Title: Facility Documents: Biologics Compliance Assistant (BCA) Preliminary Review

Release Date: 22 Aug 2022 Author: ALBYERSDORFER Document Number: CVB-WI-0109.02

CONTROLLED//PROPIN//BASIC

9. Remove the stickers on the back of the Green Card and place on the back of the
First-Class envelope.

h. If returning via UPS

1. Sign on to UPS Campus Ship website (account will need to be created by NCAH
Shipping Department)

2. Enter the Establishment’s Mailing address and address to the firm’s Liaison

3. Select “UPS Next Day Air” and check “Receive Confirmation of Delivery” box
4. Ensure all information is correct and print the shipping label

5. Use the UPS folder found in BCA Hive

Fill out “Follow-Up” information on Jnfo tab and enter “Follow-up Due Date” and
“Follow Up By”

Update the Submission Response on the Info tab of the ML: select date for “Date of
Letter/2015” and “Date Mailed,” select US Certified Mail or UPS under “Shipment
Type,” and enter Shipment Tracking Number.

Move forward in ML to Section Leader — Final Authorization

Send the Hard Copy FDS form, CVB-TEM-0042, and Facility Document submission
back to the firm, see CVB-SOP-0033, Outgoing Correspondence.

This will close the ML — any resubmission should reference the original ML.

CVB-WI-0109.02 Page 10 of 11

Printed by: TABLANCO on 23 Aug 2022, 09:40:14 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents: Biologics Compliance Assistant (BCA) Preliminary Review
Release Date: 22 Aug 2022 Author: ALBYERSDORFER Document Number: CVB-WI-0109.02
CONTROLLED//PROPIN//BASIC

f. This will generate the “Compare Report.”

ome Tools = 5 a
Beea k 800 a) 22
Corepara Files fa B cere B Newre V nes crange | 9 rae
Summary
Compare Results
» 3 - 2 0
: 0
B vom 1
Bow
[cote comes ene
g. Go to File and “Save As” to F:\Facility Doc Compare folder using nomenclature below.
Designation — this includes Building number or Addendum designation.
EXAMPLES:
A) If the document is for Building 2, the designation would be “Bld2.”
123_Ames_Roland_BPL_Bld2_Compare_ML12345
B) If the document is Addendum A, Fraction List for Building 2, the designation would
be “Bld2_A.”
123_Ames_Roland_BPLA_Bld2_A_Fraction_Compare_ML12345
C) Ifthe document is an Addendum A, Fraction List that covers multiple buildings, the
designation would not include the Building number in the name but would in the
comment field.
123_Ames_Roland_BPLA_A_Fraction_Compare_ML12345
CVB-WI-0109.02 Page 7 of 11

Printed by: TABLANCO on 23 Aug 2022, 09:40:14 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents: Biologics Compliance Assistant (BCA) Preliminary Review

Release Date: 22 Aug 2022 Author: ALBYERSDORFER Document Number: CVB-WI-0109.02

3.

4.

CONTROLLED//PROPIN//BASIC

Only one site location, as listed on a Plot Plan, is permitted per ML submission. There may
be multiple buildings and documents associated with a single site.

If more than one site is submitted per ML, return the submission without further review
(See Section G).

If discrepancies are found during preliminary review

Create a review attachment identifying specific document(s) and brief description(s) of
discrepancy

Attach to ML, ie., PR identify as “internally routed”

Submit to Specialist as Review (Specialist)

Provide Hard Copies of submission if received through USPS.

E. Ifno discrepancies are found, there is no need for a discrepancy attachment.

1.

2.

3.

Do document compare, if applicable. (See Section F)

Add comment “No discrepancies found” in Comment section prior to sending to
Specialist

Submit to Specialist as Review (Specialist)

F. Electronic Document Compare for Legend and Addendum Submissions via the NCAH
Portal

The BCA will use the comparison aspect of Adobe Acrobat to generate a document compare
report which the Specialist will use to evaluate the revisions of the submitted Facility Documents
as compared. NOTE — This is only for Legends and Addendums - not applicable to drawings,
such as Blueprints or Plot Plans.

**If this is the first electronic submission, this function should not be used.

1. Go to the CVB File Room in SharePoint Site and select Facility Documents
2. Locate the currently filed document (Legend/Addendum) needed to compare to active
CVB-WI-0109.02 Page 3 of 11

Printed by: TABLANCO on 23 Aug 2022, 09:40:14 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents: Biologics Compliance Assistant (BCA) Preliminary Review
Release Date: 22 Aug 2022 Author: ALBYERSDORFER Document Number: CVB-WI-0109.02
CONTROLLED//PROPIN//BASIC

B. The BCA will verify the documents submitted are identified correctly under the Documents
tab or the Hard Copies received.

1. Electronic Submission Review:
a. Open the ML and go to Documents Tab.
b. Open File and ensure it matches the Type: for example, if the document you open is a
PDF document and it is a Blueprint, make sure the Type is labeled “Blueprint.”

2. Hard Copy Review:

a. Ensure proper data entry into LSRTIS — see CVB-WI-0159, Mail Receipt, Process, and
Distribution for CVB-IC Hard Copy Submission.

b. Review submission against the incoming Hard Copy Center for Veterinary Biologics
Inspection and Compliance FDS. Export Document Examiner (EDE) fills out the Hard
Copy FDS sheet, scans it in, and attaches it to the ML. Place a V in the CVB USE ONLY
column, verifying the document has been received. If the document is not part of the
submission, do not ¥ the box. If there are any documents included that are not listed on
the FDS, document in Box 5 — Miscellaneous Documents Type.

CVB USE
[A] Type of Document [6] Comments yeu

Plot Plan

Plot Plan Legend

Blueprint Building 1

‘Addendum - Fraction List Building 1, pages 1-3

c. A Summary of Changes is required for all Hard Copies with the exceptions noted above.

Blueprint Legend | Building 1, pages 1-20
Summary of Changes (required) |

d. For all Legends and Addenda submitted, page numbers should be provided next to each
entry under Column B.

If during initial review, the submission is found to be incomplete, the submission (whether
electronic or Hard Copy) may be returned unprocessed by the BCA. See Section G.

C. Perform preliminary review — for both electronic and Hard Copy submissions

1. The BCA reviews the documents using the Facility Document Review Aid, which is an
encapsulated guidance document created from title 9, Code of Federal Regulations (9 CFR),
part 108, and Veterinary Services Memorandum No. 800.78. See attachment.

2. Establishment name and site address
a. The site shown should match the submission information.

CVB-WI-0109.02 Page 2 of 11

Printed by: TABLANCO on 23 Aug 2022, 09:40:14 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents: Biologics Compliance Assistant (BCA) Preliminary Review
Release Date: 22 Aug 2022 Author: ALBYERSDORFER Document Number: CVB-WI-0109.02
CONTROLLED//PROPIN//BASIC

Facility Documents: Biologics Compliance Assistant (BCA) Preliminary Review

Source Document: CVB-SOP-0039, Processing Facility Documents

Facility Documents can be submitted as Hard Copy or received electronically through the NCAH
Portal.

Electronic Submission Hard Copy Submission
Mail Log (ML) Creation Automatic through Portal CVB-WI-0159
Version Identification Required Recommended — can use
supersedes date
Facility Document Submission| No Yes
(FDS) form Used
Summary of Changes Required only for drawings Required for all documents
and first electronic
submissions of Legends and
Addenda
Signature of Liaison/Alternate | No Required on Plot Plans and
Blueprints
Two copies No Yes

A Summary of Changes is not required for the corresponding document(s) if:
a. It’s anew site or building (Check SharePoint for previously filed electronic documents
and the establishment’s License to determine which sites have been approved for use).
b. The Legend or Addendum have already been approved electronically and are on file with
the Center for Veterinary Biologics (CVB).

Submissions are reviewed on a first in/first out basis. The CVB goal is to conduct preliminary
review within 10 working days of entry into LSRTIS. Once the firm starts submitting
electronically for a site, they cannot return to submitting with Hard Copies.

A. The BCA self-assigns a Facility Document. This moves the ML to the BCA’s Active Queue
under the activity Review (BCA).

os nr 2017 Ps
— OO  ————
CVB-WI-0109.02 Page | of 11

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Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100