Extension of Dating – Process

ICWI0107.04 Page 1 of 3

Author: Renee M. Schnurr

Issue Date: 06Jul17

Source Document: Title 9, Code of Federal Regulations, part 114.14, and ICSOP0010, Processing Serial 

Records

Background:

Extension of expiration dating for a serial or subserial is allowed for in accordance with 

title 9, Code of Federal Regulations (9 CFR), part 114.14. This is part of the regulatory 

flexibility built into the 9 CFR regulations. 

Most steps follow the outline as listed in ICSOP0010, Processing Serial Records, with 

the following additions.

Biologics Compliance Assistant (BCA) Initial Review: 

1. The BCA reviews the information on the incoming APHIS Form 2008 (2008) request 

(hardcopy or NCAH Portal submission) for accuracy and completeness. The 

ICFRM0107, Extension of Dating Worksheet (9 CFR 114.14), is used to document the 

review.

2. The BCA may audit the submission back in accordance with the current version of 

ICWI0075, Audits and Reference Slips for IC Documents, for the following reasons:

a. The Proposed New Date is longer than allowed for under the Maximum 

Permitted Extension;

b. Results of all potency tests for the fractions listed in the outline of production 

are not included on the 2008 – see Section V.C. in the outline of production for 

the list of fractions;

c. If the location of the containers is not included in the submission; 

d. If the location of the containers is Off Premises and there is no letter attached 

explaining why; 

e. If the serial has not been previously released;

f. If the submission is otherwise incomplete.

3. If the submission is not audited back, it can be submitted to the Specialist for review.

a. ICFRM0107

b. If hardcopy 2008 submission for the EOD, include 2008

c. If originally released 2008 is hardcopy, make a copy

d. If originally released via NCAH Portal, print off Serial Stat – Export Profile

Specialist Review:

1. Review submission in accordance with the regulations listed in 9 CFR 114.14. All 

fractions must meet or exceed the potency release requirement(s) listed in the outline of 

production.

2. Review the information listed on ICFRM0107. 

3. NOTE – Extension of Dating IS NOT GRANTED for products containing a rabies 

fraction. 
Extension of Dating – Process

ICWI0107.04 Page 2 of 3

Author: Renee M. Schnurr

Issue Date: 06Jul17

Source Document: Title 9, Code of Federal Regulations, part 114.14, and ICSOP0010, Processing Serial 

Records

4. If testing is going to be requested, call the firm and request new samples be submitted 

prior to approval of the request.

5. If the outline of production does not indicate that stability has been confirmed for this 

product, use the following guidelines when making a decision:

a. Has the product been licensed for a sufficient period of time to allow for 

real-time stability data to be generated? 

Yes – Deny Request and ask the firm to submit a timeline in which data 

will be generated for submission to Policy, Evaluation, and Licensing 

(PEL) regarding confirmation of dating.

No – Ask if the firm has data to support the extension of dating requested. 

 

b. Has data been submitted to PEL and pending review? 

Yes – discuss the submission with the PEL Reviewer. If the firm has 

provided evidence of a satisfactory potency result, you may grant the 

extension.

c. Has PEL responded to a data submission requesting additional information 

regarding confirmation of dating? 

Yes – Determine if the request for data (what kind of data) outweighs the 

data submitted in support of the extension of dating. You may consider 

their extension. 

NOTE – This may be a situation that would warrant mid-dating potency 

testing and submission of results to you, or granting an extension other 

than full dating. You may add RELEASE REQUIREMENTS, see current 

version of ICWI0048, Section I. d. viii. 2.

6. Are the fractions, in general, stable? [Yes/No] This may require communicating with 

the antigen expert at the laboratory. 

7. Is the potency test an adequate indicator of stability? [Yes/No] For example, live 

virus titrations or live bacterial counts can provide information about antigen degradation. 

Animal test may not provide information about antigen degradation.

8. Review test results of the originally released 2008 and determine if there has been a 

significant drop in potency. This is most useful with live virus titrations and live bacterial 

counts, but may also be beneficial in situations in which serology or relative potency is 

used as the potency test.
Extension of Dating – Process

ICWI0107.04 Page 3 of 3

Author: Renee M. Schnurr

Issue Date: 06Jul17

Source Document: Title 9, Code of Federal Regulations, part 114.14, and ICSOP0010, Processing Serial 

Records

9. Compare the number of doses requested for extension to the original released 

inventory. This may provide some insight. 

NOTE:

 Just because they request an extension of dating does not mean we need to grant it 

or grant it for the length of dating they request. We may want to consider not 

granting another full dating period. 

 Only ONE extension of dating can be allowed per serial.

 We may also consider testing the product at CVB-Laboratory. 

10. Submit the 2008 (electronic and/or hardcopy) to the BCA for finalization.