Change Request for FDA 3613

United States Food and Drug Administration
Export Certificates for FDA Regulated Products
under U.S.C. Sections 801(e) and 802
OMB Control No. 0910-0498
JUSTIFICATION MEMORANDUM FOR 83-C CHANGE REQUEST

The Food and Drug Administration is submitting this nonmaterial/non-substantive
change request (83-C) in order to add an electronic option for submitting requests for
export certificates. This effort satisfies, with regard to animal food, animal drugs, and
veterinary devices, the terms of clearance from the NOA dated May 29, 2009, for OMB
#0910-0498, expiration date 04/30/2021, which states: “FDA shall make this collection
electronically submittable as soon as possible to be in compliance with the Government
Paperwork Elimination Act.” This will allow respondents the option of submitting
requests for export certificates via the CVM Export Certification Application and
Tracking System (CVMeCATS) module of the FDA Unified Registration and Listing
System (FURLS). Respondents are required to register and list in FURLS (see OMB
#0910-0625), and therefore already have all the software and training necessary to use the
system. Minor changes were made in converting the existing paper forms to electronic.
The electronic system will not request the following information currently requested on
the existing paper forms:


Paper Form FDA 3613, sections 5A., 5B., and 5C: information about recall,
injunction, and seizure. The electronic system will obtain this information from
the FEI number.



Paper Form FDA 3613, section 8 and Paper Form FDA 3613a section 6: yes or no
question about listing the destination country on the certificate. This question is
unnecessary since CVM requires all certificates issued have the importing country
written on them.



Paper Form FDA 3613 and 3613a, section 1C: Shipping Account Number. These
certificates will be delivered electronically.



Paper Form FDA 3613 and 3613a, section 2: no longer requires both the Firm
name and FEI number. Respondents may enter one or the other.



Paper Form FDA 3613a: information about Section 802 of the Act. This
information does not apply to animal products.



Paper Form FDA 3613a: information about Product Class. This information does
not apply to animal products.



Paper Form FDA 3613b, section 2B.1 – 2B.3: information regarding unapproved
biological drugs. This information is not relevant to CVM and thus no longer
necessary.



Paper Form FDA 3613b: information about the facilities involved in
manufacturing of the exported product. The license number and the Firm FDA
Registration number is no longer needed; only the FEI number is needed.



Paper Form FDA 3613b: information about shipping account. We will no longer
ask for the mail carrier name or account number. We will only ask for the
shipping label.

The electronic system will ask respondents to identify their product with the use of a
code, as is currently done on the similar electronic Form FDA 3613 forms for CDER and
CDRH products. An animal drug product will be identified by its National Drug Code
(NDC). Form FDA 3613a will ask respondents to upload labels of each product listed on
the application to conform with the Center’s other two forms (3613 and 3613b) and as is
standard operating procedure for CDER and CDRH. Form FDA 3613b will ask to
include the telephone and fax number of the billing contact if different from the
requestor. This is in case an email address is entered incorrectly. In order to conform
with CDER and the World Health Organization we will include a Remarks section for
Form FDA 3613b.
Though we expect the majority of respondents to make use of the electronic submission
option, respondents can still submit the information using the paper forms (Forms FDA
3613, 3613a, and 3613b). We do not expect a change in the hour or cost burden
estimates.
We would like to obtain OMB approval of the electronically submitted version of Forms
FDA 3613, 3613a, and 3613b, so that IT development work may continue in accordance
with the contracting timeline.
Submitted: March 2020