OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Viruses, Serums, Toxins, and Analogous Products; Records and Reports

ICR 201805-0579-005 · OMB 0579-0209 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Form APHIS 2080 Business Form Modified Available
Form APHIS 2080 State Form Modified Available
Form APHIS 2080 Individuals Form Modified Repair queued
0579-0209 Final Rule SS.pdf Supporting Statement A Uploaded 2018-05-17 Available
0579-0209 Final Rule APHIS 79.pdf Supplementary Document Uploaded 2018-05-16 Repair queued
0579-0209 Final Rule APHIS 71.pdf Supplementary Document Uploaded 2018-05-16 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
2387 Business Form Modified
218105 State Form Modified
218104 Individuals Form Modified
ICR Details
0579-0209 201805-0579-005
Historical Active 201504-0579-002
USDA/APHIS
Viruses, Serums, Toxins, and Analogous Products; Records and Reports
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 08/24/2018
Retrieve Notice of Action (NOA) 05/17/2018
  Inventory as of this Action Requested Previously Approved
08/31/2021 36 Months From Approved
15,999 0 0
31,998 0 0
0 0 0
APHIS amended the Virus-Serum-Toxin Act regulations to require veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of biological products that they produce or distribute.
US Code: 21 USC 151-159 Name of Law: Virus-Serum-Toxin (VST) Act
  
None
0579-AE11 Final or interim final rulemaking 83 FR 22832 05/17/2018
  80 FR 53475 09/04/2015
Yes
3
IC Title Form No. Form Name
Individuals APHIS 2080, APHIS 2081 Adverse Event Report ,   Adverse Event Report Follow-up Information
State APHIS 2080, APHIS 2081 Adverse Event Report ,   Adverse Event Report Follow-up Information
Business APHIS 2080, APHIS 2081 Adverse Event Report ,   Adverse Event Report Follow-up Information
  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 15,999 0 0 14,999 0 1,000
Annual Time Burden (Hours) 31,998 0 0 30,998 0 1,000
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
The total burden increased because the hours per response estimate increased from .33 hours to 2.00 hours. The estimates for number of respondents (9,999) and responses (15,999) are unchanged.
$465,685
No
    No
    No
No
No
No
Uncollected
Donna Malloy 301 734-3277
  No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
05/17/2018