0579-0013 Nonsubstantive Change

Justification for Nonsubstantive Changes
OMB Control No. 0579-0013
May 17, 2019
1. APHIS Form 2018, Request for Reference, Reagent, or Reagent Seed Material, has been
edited to update URL’s to webpages and the email address for submitting CVB reagent requests.
a. The updated URL’s are in Items 5 and 10 of the instruction page.
b. The updated email address is located at the top of the form to the left of the title, and on
the instruction page in the second column.
2. APHIS Form 2080, Adverse Event Report, has been edited to include the removal of
obsolete fields, corrections of minor misspellings, deletion of a subsection, and the addition of a
Privacy Act statement and a continuation page to the form.
a. In Item 1, the “Licensed Partner” checkbox was removed. Also, “NOS Other” was
changed to “Other”.
b. In Item 4, “Contract” was changed to “Contact”.
c. In Item 10, the “Field Safety Study” and “Inquiry” checkboxes were removed.
d. In Item 11, the “Inquiry” checkbox was removed.
e. Within the four columns under the PRODUCT INFORMATION section, the “Unknown
to Company” checkboxes were removed.
f. Within Item 1 of the SUSPECTED ADVERSE EVENT DATE(S) section, the “APX”
checkbox was removed.
g. Within Items 1, 2, and 3 of the ANIMAL INFORMATION section, the “Estate”
checkboxes were removed.
h. Within Item 1 of the REPORTER INFORMATION section, the “Licensed Partner”
checkbox was removed. “NOS Other” was changed to “Other”. The entire Other Report
subsection was removed.
i. A Privacy Act statement was added to the bottom of second page of the form.
j. A blank continuation sheet was added as page 3 to allow respondents to continue their case
narrative within the same document.
The impact on the information collection burden assessment is negligible.