Program Coordinator Duties 

CONTROLLED//PROPIN//BASIC 

CVB-WI-0090.06 Page 1 of 4 

Issue Date: 23Aug23 

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

Source Document and Date of Issue or Edition: CVB-SOP-0038, Receiving Adverse Event Reports at 

the Center for Veterinary Biologics; CVB-SOP-0032, Processing Serial Records

The Program Coordinator, also known as PC, receives telephone calls from the public 

specifically to adverse event reports (AERs), firm questions, or general questions in 

regard to the CVB. The PC also is responsible for signing APHIS Form 2008s (Form 

2008s) for market release and reviewing other Form 2008s. The PC also moderates the 

daily Specialist Meetings. 

The PC is assigned on a weekly basis by the Product Manager but can be reassigned on a 

daily basis if needed. Changes to the assigned PC duty should be documented in the IC 

Calendar, but to enhance communication, the Specialist may inform the BCAs and the 

CVB Administration Unit. PC duty is covered Monday through Friday, 8 a.m. through 4 

p.m. 

I. Signing and Reviewing 2008s for Market Determination

1. See CVB-SOP-0032, Processing Serial Records, for information on Serial 

Release processes.

2. Signing and Reviewing Form 2008s

a. See CVB-SOP-0032, Ready for Signature Action in LSRTIS (Specialist and 

BCA duties), for LSRTIS workflow. 

b. Priority for the PC is signing Form 2008s for market determination. This is 

usually done prior to 10:30 a.m. for Electronic Notification for Serial Release 

(ENSR) emails to be sent to the manufacturers. The second ENSR goes out at 

3 p.m. daily as well. 

3. Reviewing Form 2008s at Specialist Review 

a. See CVB-WI-0082, Specialist Review Action within LSRTIS. b. Next priority is reviewing Form 2008s needing attention (i.e., those with “I” or 

“NT” conclusions in testing, or those with specific Firm Dispositions or 

comments). This occurs after the Form 2008s are entered and QA’d for entry 

requirements (usually after lunch). 

II. Phone Calls from Outside the CVB 

Phone calls should be documented and recorded in the PhoneLog module within 

LSRTIS. See the current version of CVB-WI-0141, Tracking Customer Service using 

LSRTIS Phone Log, for instructions on documenting these. 

1. Adverse Event Reports – should first determine if Epidemiologist are available, if 

so, they should field these calls. 

a. See CVB-SOP-0038, Receiving Adverse Event Reports at the Center for 

Veterinary Biologics, for further information. 

b. The employee can take the report directly from the caller and enter the 

information directly into the AER Website. 
Program Coordinator Duties 

CONTROLLED//PROPIN//BASIC 

CVB-WI-0090.06 Page 2 of 4 

Issue Date: 23Aug23 

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

c. The employee can direct the caller to the CVB Website. There is currently 

a shortened website URL for the AER landing page. See the Program 

Information Management and Security (PIMS) Program Analyst for this 

URL. 

2. FOIA 

Callers wanting specifics on previous AERs or other Confidential Business 

Information (CBI) may have to request this information through the Freedom of 

Information Act (FOIA) staff. Questions can be directed to the CVB PIMS 

Section Leader or the caller can be directed to the APHIS FOIA Website. Remind 

the caller that the licensing information and studies performed are property of the 

manufacturers (if applicable), and the manufacturers will have the opportunity to 

review this information for redaction of Confidential Business Information (CBI) 

prior to release. 

Remember that information already shared on the CVB Website or label 

information is public knowledge and does not have to be directed to FOIA staff. 

Current contact: 

APHIS FOIA Contact Information 

Tonya Woods, FOIA Director 

Legislative and Public Affairs 

Freedom of Information Act 

4700 River Road, Unit 50 

Riverdale, MD 20737 

Phone: 301-851-4102 

Fax: 301-734 -5941 

Email: foia.officer@aphis.usda.gov

3. Requests for Licensing of a New Biologic Product 

a. The employee can direct the caller to the CVB Website under Veterinary 

Biologics/Licensing a Biologic. The caller may want to familiarize 

themselves with this information prior to speaking with PEL staff. 

b. Take down the caller’s information and send this on to PEL by emailing the 

information to the CVB Inbox: cvb@usda.gov. 4. 116.5 Notifications from Licensed Manufacturers 

a. Be sure to get the following information from the manufacturer: 

i. Product(s), serial(s), or fraction(s) involved 

ii. Time frame of event 

iii. Preliminary suspect event 

iv. Location of event (especially important if manufacturer has 

multiple sites) 
Program Coordinator Duties 

CONTROLLED//PROPIN//BASIC 

CVB-WI-0090.06 Page 3 of 4 

Issue Date: 23Aug23 

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

v. Manufacturer’s actions (internal hold, voluntary stop sale, 

destruction of the serial(s), or any other action) 

b. The employee provides the information to the Specialist assigned to the 

firm, if applicable, and to the Section Leader, Compliance, for concurrence 

on manufacturer’s action.

c. If samples have been received and still within the 7 or 3 days at risk 

window for testing, provide the information to the Laboratory Vet/Micros, 

d. Also, determine if testing has been initiated by the Laboratory (do a serial 

stat). Discuss with the Laboratory if they should stop testing or not. 

5. Questions from Licensed Manufacturing 

a. Verbal releases: CVB does not routinely give out verbal releases due to the 

ENSR. Further information can be found in CVB-SOP-0032, Processing 

Serial Records. b. Other information regarding specific submission questions may be 

provided to firm personnel who have APHIS Form 2007s on file for such 

information. The employee should do their due diligence to assure the 

information can be provided. See a Section Leader or Manager for 

questions. 

c. Reagent Requests – send requests to the applicable laboratory. 

Inform the caller they may email the APHIS Form 2018 requests to 

the CVB@usda.gov mailbox; which will then be forwarded to the 

applicable laboratory. 

6. Information not under CVB Jurisdiction – examples:

a. Owners wanting to know what to do with animals possibly exposed to 

Rabies 

i. Inform the owner to contact their local or State Veterinarian 

ii. Consult with IC Management regarding specific responses 

b. Information regarding importation of non-biological products 

i. Inform the caller to contact National Import Export Services 

(NIES) – Previously NCIE 

ii. May direct the call to the ePermits Website via the CVB 

Import/Export Website

c. Information regarding NVSL testing 

Inform the caller to contact the applicable NVSL laboratory (DVL, 

DBL, PL). Current contact phone numbers can be found at the 

NVSL SharePoint site/Contact Info for NVSL Testing (NVSL 

Disease List)/external list. 
Program Coordinator Duties 

CONTROLLED//PROPIN//BASIC 

CVB-WI-0090.06 Page 4 of 4 

Issue Date: 23Aug23 

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

7. Media Inquiries

a.

III. Moderator of Specialist Meetings

1. The PC will moderate the Specialist Meetings, take notes if needed, and consult 

with Section Leaders if employee absences warrant cancelling the meeting.