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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:
201110-0579-016
Status:
Historical Active
Previous ICR Reference No:
200909-0579-006
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:
02/07/2012
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/13/2011
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2015
36 Months From Approved
02/29/2012
Responses
1,164
0
755
Time Burden (Hours)
2,290
0
1,286
Cost Burden (Dollars)
0
0
0
Abstract:
The purpose of this collection is to ensure that persons who possess, use, or transfer select agents and toxins to register those agents with either APHIS or CDC and meet all security and safety requirements
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:
76 FR 100
05/24/2011
30-day Notice:
Federal Register Citation:
Citation Date:
76 FR 239
12/13/2011
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
APHIS-CDC Form 4B, APHIS/CDC 4C, PPQ 526, APHIS-CDC Form 2, APHIS-CDC Form 3, APHIS-CDC Form 4A, 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 Registration for Possession, Use, and Transfer of Select Agents and Toxins
,
Request to Transfer of Select Agents and Toxins
,
Report of Theft, Loss, or Release of Select Agents and Toxins
,
Reporting the Identification of a Select Agent or Toxin in a Clinical/Diagnostic Specimen
,
Request For Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational Product
,
Reporting the Identification of a Select Agent or Toxin: Proficiency Testing Report
,
Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report
Select Agent Registration
APHIS-CDC Form 1, APHIS-CDC Form 4B, APHIS/CDC Form 4C, VS 16-3, VS 16-7, PPQ 526, APHIS-CDC Form 2, APHIS-CDC Form 4A, APHIS-CDC Form 3, APHIS-CDC Form 5
Application for Registration for Possession, Use, and Transfer of Select Agents and Toxins
,
Request to Transfer Select Agents and Toxins
,
Report of Theft, Loss, or Release of Select Agents and Toxins
,
Reporting the Identification of a Select Agent or Toxin in a Clinical/Diagnostic Specimen
,
Request For Exemption of Select Agents and Toxins for Public Health or Agricultural Emergency or Investigational 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
,
Reporting the Identification of a Select Agent or Toxin: Proficiency Testing Report
,
Reporting the Identification of a Select Agent or Toxin: Federal Law Enforcement Seizure Report
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
1,164
755
0
0
409
0
Annual Time Burden (Hours)
2,290
1,286
0
0
1,004
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:
The respondents registering agents and toxins for this program has increased from 655 to 1,163; an increase of 508 respondents participating in the registration process. This has resulted in an adjusted increase of + 409 annual responses and 1,004 hours for this collection.
Annual Cost to Federal Government:
$32,573
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:
Charles Divan 301 734-5960
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:
12/13/2011
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