2014-08168. 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 [phone] or send an email 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

Select Agent Distribution Activity (SADA): Request for Select Agent (OMB Control No. 0920-0591 exp. 7/31/2014)—Extension—National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The Centers for Disease Control and Prevention is requesting approval to continue data collection under the Select Agent Distribution Activity (SADA). The purpose of this data collection is to provide a systematic and consistent mechanism to review requests that come to CDC for Select Agents. The term select agents is used to describe a limited group of viruses, bacteria, rickettsia, and toxins that have the potential for use as agents of bioterrorism, inflicting significant morbidity and mortality on susceptible populations. The SADA form is scheduled to expire on 07/31/2014.

SADA was originally created for the anticipated large number of requests for select agents by investigators seeking National Institutes of Health grants. The process was established to lessen the burden on CDC Subject Matter Experts (SMEs) who would be receiving requests for access to select agents housed within NCEZID. The SADA application is a Material Transfer Agreement that is specific to select agent requests. Although the SADA Office has not received a new application since the last OMB request, they have received several inquiries and provided assistance to both internal SMEs as well as outside requestors.

CDC has deposited a variety of strains into the BEI Resources repository and requestors now have the option of requesting materials using this mechanism. However, CDC would like to maintain the ability to process requests if they receive them and is therefore making a request to use the SADA application indefinitely.

The number of potential respondents in a given year is unknown. The estimates below are based on if they were to receive requests from 900 respondents.

A user fee will be collected to recover costs for materials, handling and shipping (except for public health laboratories). The cost to the respondent will vary based on which agent is requested. The total hour burden is 450 hours.

Estimated Annualized Burden Hours

Type of respondents	Form name	Number of respondents	Number of responses per respondent	Avg. burden per response (in hrs.)
Researcher	SADA Request for Select Agent	900	1	30/60
	Total

LeRoy Richardson

Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.