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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:
0579-0213
ICR Reference No:
200805-0579-002
Status:
Historical Active
Previous ICR Reference No:
200509-0579-001
Agency/Subagency:
USDA/APHIS
Agency Tracking No:
Title:
Select Agent Registration
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
12/07/2008
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/04/2008
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2011
36 Months From Approved
12/31/2008
Responses
755
0
545
Time Burden (Hours)
1,286
0
938
Cost Burden (Dollars)
0
0
0
Abstract:
To create an effective, uniform, consistent, and efficient system that requires persons who possess, use, or transfer select agents and toxins to register those agents with either APHIS or CDC.
Authorizing Statute(s):
PL:
Pub.L. 107 - 188 Bioterrorism
Name of Law: Public Health Safety and Bioterrorism Preparedness and Response Act of 2002
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:
73 FR 126
06/30/2008
30-day Notice:
Federal Register Citation:
Citation Date:
73 FR 208
10/27/2008
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Select Agent Registration
PPQ 526, APHIS-CDC Form 2, APHIS-CDC Form 3, APHIS-CDC Form 4, APHIS-CDC Form 5, APHIS-CDC Form 1, VS 16-3, VS 16-7
Application for Permit to Import or Transport Controlled Material or Organisms or Vectors
,
Additional Information for Cell Cultures and Their Products
,
Application and Permit to Move Live Plant Pests or Noxious Weeds
,
Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins
,
Report of Transfer of Select Agents and Toxins
,
Report of Theft, Loss, or Release of Select Agents and Toxins
,
Report of the Identification of a Select Agent or Toxin in a Clinical or Diagnostic Laboratory
,
Request For Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational/Experimental Product
Select Agent Registration
VS 16-3, VS 16-7, PPQ 526, APHIS-CDC Form 2, APHIS-CDC Form 4, APHIS-CDC Form 3, APHIS-CDC Form 5, APHIS-CDC Form 1
Application for Laboratory Registration for Possession, Use, and Transfer of Select Agents and Toxins
,
Report of Transfer of Select Agents and Toxins
,
Report of Theft, Loss, or Release of Select Agents and Toxins
,
Report of the Identification of a Select Agent or Toxin in a Clinical or Diagnostic Laboratory
,
Request For Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational/Experimental Product
,
Application for Permit to Import or Transport Controlled Material or Organisms or Vectors
,
Application and Permit to Move Live Plant Pests or Noxious Weeds
,
Additional Information for Cell Cultures and Their Products
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
755
545
0
0
210
0
Annual Time Burden (Hours)
1,286
938
0
0
348
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:
There is an increase of +348 hours for this collection because of the increased number of respondents participating in the registration process.
Annual Cost to Federal Government:
$120,292
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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Mary VanDenk 3017340762
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:
11/04/2008
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