View Information Collection Request (ICR) Package
Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0579-0013
ICR Reference No:
201410-0579-002
Status:
Historical Active
Previous ICR Reference No:
201307-0579-010
Agency/Subagency:
USDA/APHIS
Agency Tracking No:
Title:
Virus-Serum-Toxin Act and Regulations in 9 CFR Subchapter, Parts 101-124
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
03/10/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/30/2014
Terms of Clearance:
APHIS should continue to develop a system that allows the forms associated with this collection to be submitted electronically. APHIS should continue to determine whether it is feasible to waive the requirements for minor changes to labels or to perform additional inspections.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
03/31/2018
36 Months From Approved
03/31/2015
Responses
39,670
0
39,670
Time Burden (Hours)
78,382
0
78,382
Cost Burden (Dollars)
0
0
0
Abstract:
The purpose of this collection is to verify that compliance requirements for biological products used in the United States are met (i.e., the products are pure, safe, potent, and effective).
Authorizing Statute(s):
US Code:
21 USC 151-159
Name of Law: VIRUS-SERUM-TOXIN ACT
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
79 FR 150
08/05/2014
30-day Notice:
Federal Register Citation:
Citation Date:
79 FR 209
10/29/2014
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Virus-Serum-Toxin Act and Regulations - Business
APHIS 2001, APHIS 2008, APHIS 2008A, APHIS 2047S (Spanish), APHIS 2003, APHIS 2007, APHIS 2015, APHIS 2017, APHIS 2070, APHIS 2020, APHIS 2072, APHIS 2071, APHIS 2046, APHIS 2018, APHIS 2047, APHIS 2046S (spanish), APHIS 2005, APHIS FORM 2049, APHIS FORM 2048
APPLICATION FOR US VETERINARY BIOLOGICS ESTABLISHMENT LICENSE
,
APPLICATION FOR US VETERINARY BIOLOGICAL PRODUCT LICENSE
,
CONTACT AND QUALIFICATIONS OF VETERINARY BIOLOGICS PERSONNEL
,
TRANSMITTAL OF LABLES AND CIRCULARS OR OUTLINES
,
OFFICIAL EXPORT CERTIFICATE FOR ANIMAL BIOLOGICAL PRODUCTS
,
REQUEST FOR REFERENCE, REAGENT, OR REAGENT SEED MATERIAL
,
APPLICATION FOR UNITED STATES VETERINARY BIOLOGICAL PRODUCT PERMIT
,
AHIPMENT AND RECEIPT OF BIOLOGICS SAMPLES
,
VETERINARY BIOLOGICS PRODUCTION AND TEST REPORT
,
CONTINUATION FOR VETERINARY BIOLOGICS PRODUCTION AND TEST REPORT
,
CERTIFICATE OF LICENSING AND INSPECTION
,
CERTIFICADO DE LICENCIA E INSPECCION
,
CERTIFICATE OF LICENSING AND INSPECTION
,
CERTIFICADO DE LICENCIA E INSPECTION
,
Application for Authorization to Ship Master Seed or Cell Samples for Confirmatory Testing by APHIS
,
Application for Authorization to ship Experimental Veterinary Biological Products
,
Application for Authorization to Ship Biological Product Samples for Confirmation Testing by APHIS
,
Policy, Evaluation, and Licensing E-Submission Form
,
Inspection and Compliance E-Submission Form
Virus-Serum-Toxin Act and Regulations - Individual
Virus-Serum-Toxin Act and Regulations - State
ICR Summary of Burden
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
39,670
39,670
0
0
0
0
Annual Time Burden (Hours)
78,382
78,382
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$1,329,334
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Donna Malloy 301 734-3277
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
10/30/2014
An official website of the United States government
The .gov means it's official.
The site is secure.
