2011-26008. Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at [phone] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to [phone]. Written comments should be received within 30 days of this notice.

Proposed Project

Possession, Use, and Transfer of Select Agents and Toxins (OMB) Control No. (0920-0576) Exp. 12/31/2011—Revision—Office of Public Health Preparedness and Response (OPHPR), Division of Select Agents and Toxins (DSAT), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Subtitle A of Public Law 107-188 (42 U.S.C. 262a), requires the United States Department of Health and Human Services (HHS) to regulate the possession, use, and transfer of biological agents or toxins (i.e., select agents and toxins) that could pose a severe threat to public health and safety. The Agricultural Bioterrorism Protection Act of 2002, Subtitle B of Public Law 107-188 (7 U.S.C. 8401), requires the United States Department of Agriculture (USDA) to regulate the possession, use, and transfer of biological agents or toxins (i.e., select agents and toxins) that could pose a severe threat to animal or plant health, or animal or plant products. In accordance with these Acts, HHS and USDA promulgated regulations requiring entities to register with the CDC or the Animal and Plant Health Inspection Service (APHIS) if they possess, use, or transfer a select agent or toxin (42 CFR part 73, 7 CFR part 331, and 9 CFR part 121).

CDC is requesting continued OMB approval to collect this information through the use of five forms: (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. Revision will be made to (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. There will be no revisions made to the Application for Registration and Request for Exemption The total estimated annualized burden for all data collection is 8,878 hours. Information will be collected via fax, e-mail and mail from respondents of the 320 entities registered with the Select Agent Program. Annualized burden hours were calculated by multiplying the average number of hours used to complete the: (1) Application for Registration; (2) Request to Transfer Select Agent or Toxin; (3) Report of Theft, Loss, or Release of Select Agent or Toxin; (4) Report of Identification of Select Agent or Toxin; and (5) Request for Exemption. The estimated annualized burden for the 2008 Possession, Use, and Transfer of Select Agents and Toxins submission was 9,656.5 hours. The 2011 estimated annualized burden hours are 8,878. Burden has been reduced by 778.5 hours due to the removal of similar questions on the Request to Transfer Select Agent or Toxin (Form 2), Report of Theft, Loss, or Release of Select Agent or Toxin (Form 3) and the Report of Identification of Select Agent or Toxin (Form 4). Therefore respondents are not required to answer as many questions as requested in the previous data collection tool.

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. CDC in conjunction with APHIS has revised the Request to Transfer Select Agent or Toxin form by requiring the recipient to submit the initial request, be notified by the sender of the expected shipment date, and verify if the shipment did not occur. Estimated average time to complete this form is 1 hour, 30 minutes. Based on data regarding the transfer requests received since the last submission, CDC estimates 1 transfer requests submitted per registered entity on an annual basis.

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. Estimated average time to complete this form is 1 hour. Based on data regarding the reports received since the last submission, CDC estimates that 1 report per respondent will be received on an annual basis.

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. CDC in conjunction with APHIS has revised the Report of Identification of Select Agent or Toxin form to ensure duplicate reports are not submitted by requesting the entity making the final identification report the select agents or toxins identified as the result of diagnostic or verification testing. Estimated average time to complete this form is 1 hour. Based on data regarding the reports received since the last submission, CDC estimates that 9 reports per respondent will be received on an annual basis.

There is no cost to the respondents other than their time. The total estimated annualized burden hours are 8,878, which is a reduction of 778.5 hours from the previously approved ICR.

Estimated Annualized Burden Hours

CFR	Form name	Number of respondents	Number responses per respondent	Average burden per response
73.3(d)	Application for Registration	5	1	4.5
73.7(h)(1)	Amendment to Registration Application	320	8	1
73.16	Request to Transfer Select Agents or Toxins	320	1	1.5
73.19(a)(b)	Notification of Theft, Loss or Release	180	1	1
73.5 & 73.6(a)(b)	Report of Identification of Select Agent	320	9	1
73.5 & 73.6(d-e)	Request of Exemption	3	1	1
73.3 & 73.4(e)(1)	Request for Exclusions/Restricted	71	1	1
73.10(e)	Request for Expedited Review	1	1	1
73.20	Administrative Review	30	1	4
73.18	Inspections	320	1	8

Dated: September 30, 2011.

Daniel Holcomb,

Reports Clearance Officer, Centers for Disease Control and Prevention.