View Information Collection Request (ICR) Package

OMB Control No: 0920-0576	ICR Reference No: 201306-0920-002
Status: Historical Active	Previous ICR Reference No: 201210-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No: 19723
Title: Possession, Use, and Transfer of Select Agents and Toxins (42 CFR 73)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/11/2013
	Date Received in OIRA: 06/10/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2015	11/30/2015	11/30/2015
Responses	6,370	0	6,370
Time Burden (Hours)	8,923	0	8,923
Cost Burden (Dollars)	0	0	0

Abstract: CDC is requesting continued OMB approval to collect information through the use of five separate forms. These forms are: 1) Application for Registration, 2) Request to Transfer Select Agent or Toxin, 3) Report of Theft, Loss, or Release of Select Agent and Toxin, 4) Report of Identification of Select Agent or Toxin, and 5) Request for Exemption. The Application for Registration (42 CFR 73.7(d)) will be used by entities to register with CDC. The Application for Registration requests facility information; a list of select agents or toxins in use, possession, or for transfer by the entity; characterization of the select agent or toxin; and laboratory information. The Request to Transfer Select Agent or Toxin form (42 CFR 73.16) will be used by entities requesting transfer of a select agent or toxin to their facility. The Report of Theft, Loss, or Release of Select Agent and Toxin form (42 CFR 73.19(a)(b)) must be completed by entities whenever there is theft, loss, or release of a select agent or toxin. The Report of Identification of Select Agent or Toxin form 42 CFR 73.5(a)(b) and 73.6(a)(b)) will be used by clinical and diagnostic laboratories to notify CDC that select agents or toxins identified as the result of diagnostic or proficiency testing have been disposed of in a proper manner. In addition, the form will be used by Federal law enforcement agencies to report the seizure and final disposition of select agents and toxins. The Request for Exemption form (42 CFR 73.5 (d)(e) and 73.6 (d)(e)) will be used by entities that are using an investigational product that are, bear, or contain select agents or toxins or in cases of public health emergency.

Authorizing Statute(s): PL: Pub.L. 107 - 188 Subtitle A Name of Law: Public Health Security 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:
0920-AA34	Final or interim final rulemaking	77 FR 61083	10/05/2012

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 78215	12/16/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 61083	10/05/2012
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	6,370	6,370
Annual Time Burden (Hours)	8,923	8,923
Annual Cost Burden (Dollars)	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: $280,117

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

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: Carol Walker 4046394773

View ICR - OIRA Conclusion