02-19897. Notice of OMB Approval of Data Collection

AGENCY:

Centers for Disease Control and Prevention, Department of Health and Human Services.

ACTION:

General notice.

SUMMARY:

The purpose of this Notice is to announce OMB approval of data collection, “Notification of Possession of Select Agents,” under the Paperwork Reduction Act of 1995 (PRA). The OMB Control Number for this data collection is 0920-0561. The data collection will expire January 31, 2003.

FOR FURTHER INFORMATION CONTACT:

Anne O'Connor, Assistant Reports Clearance Officer, Centers for Disease Control and Prevention, Office of Program Planning and Evaluation, 1600 Clifton Road NE, Mailstop D-24, Atlanta, Georgia 30333. Telephone: [phone].

SUPPLEMENTARY INFORMATION:

Background

On June 12, 2002, the President signed the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Act). The Act requires that all persons in possession of any “Select Agent” notify the Secretary of the Department of Health and Human Services (DHHS) by September 10, 2002. Section 213(b) of The Act requires all persons in possession of any “High Consequence Livestock Pathogen or Toxin” notify the Secretary of the U.S. Department of Agriculture (USDA) by October 8, 2002. The Centers for Disease Control and Prevention (CDC) has been designated as the agency responsible for providing guidance on this notification to the Secretary, DHHS. The Animal and Plant Health Inspection Service (APHIS) has been designated as the agency responsible for providing guidance on this notification to the Secretary, USDA. In order to minimize the reporting burden to the public, CDC and APHIS created a common notification form.

In compliance with requirements of the Paperwork Reduction Act of 1995 (PRA), CDC published a notice in the Federal Register on July 2, 2002 inviting public comment on the proposed data collection regarding: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of the information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. The public was asked to submit their comments within 14 days of the publication of the notice.

Discussion of Comments

CDC received a number of comments to the Federal Register Notice regarding five issues related to the proposed data collection.

Comment: Many commenters requested a definition of the term ‘facility.’ CDC Response: The Guidance Document (see below) provides a definition of facility. For the purposes of this data collection, facility is defined as any individual, or government agency, university, corporation, company, partnership, society, association, firm or other legal entity located at a single geographic site. A single geographic site is a building or complex of buildings at a single mailing address.

Comment: A number of commenters were concerned that clinical and diagnostic laboratories were being required to submit the notification form because they interpreted sections of The Act as exempting these facilities from submitting the notification form. CDC Response: Although exemption of these laboratories was discussed during the development of this legislation, Congress explicitly rejected any broad exclusion of these facilities. A fuller explanation of Congressional intent on this subject is contained in the House Conference Report No. 107-481 to accompany H.R. 3448, May 21, 2002, at page 122. Congress permits exemption of such clinical and diagnostic laboratories from registration requirements, “* * * only if they report the identification of select agents to the Secretary and either promptly transfer the agent to a registered person or destroy the agent on site in accordance with regulations established by the Secretary.” The conference report further explains that laboratories which possess select agents for reference purposes must register and be subject to this full regulatory program. Although all clinical and diagnostic laboratories must participate in this initial notification phase under the legislation, DHHS and USDA will promptly develop, through rule-making, the regulations that will allow exemptions for those laboratories who only possess, use, or transfer select agents contained in specimens presented for diagnosis, verification, or proficiency testing. In order to comply with Congressional intent, CDC and APHIS are requiring all clinical and diagnostic laboratories that possess any agent or toxin listed on the notification form to submit a form to the address provided.

Comment: A number of commenters asked that CDC reconsider the requirement that facilities that do not possess a select agent complete and submit a declaration of non-possession. CDC response: CDC recognizes that The Act does not explicitly address this particular issue of a non-possession declaration. Asking respondents to declare non-possession is a critical means of ensuring that DHHS is knowledgeable of the potential universe of possessors of regulated agents and is necessary in order to effectively carry out the statutory intent of responsibly governing the transfer, possession, and use of biological agents or toxins.

Comment: Other commenters were concerned that CDC had underestimated the amount of time necessary to review instructions, gather the data, and enter it onto the form. CDC Response: CDC recognizes that many respondents will need less than two hours to complete the form and that other respondents will need more than two hours. However, given the vast universe of respondents, CDC feels that an average of two hours to review the instructions, gather the data, and complete the form is a reasonable estimate.

Comment: Several commenters asked about the list of Select Agents on the form. CDC Response: The notification form contains the list of Select Agents that was published in the Federal Register on October 24, 1996. As part of the rule-making process, CDC will publish another notice in the Federal Register requesting public comment on proposed changes to the list of select agents.

OMB Approved Guidance Document and Form

After considering the comments, CDC and APHIS submitted the Guidance Document and Notification Form (see below) to OMB for approval under the Paperwork Reduction Act. On July 31, 2002, OMB approved the Guidance Document and Notification Form under OMB Control No. 0920-0561. Upon OMB approval, CDC and APHIS plan to conduct a targeted mailing of the Guidance Document and form to approximately 190,000 facilities. If facilities have not received a copy of the Guidance Document and form within 10 days of publication of this notice, they should call 866-567-4232 to request a copy of the Guidance Document and form. The Guidance Document and form will also be available at both the CDC Web site (http://www.cdc.gov/​od/​ohs/​lrsat.htm) and the APHIS Web site (http://www.aphis.usda.gov/​vs/​ncie).

Dated: August 1, 2002.

Nancy E. Cheal,

Acting Associate Director for Policy, Planning and Evaluation, Centers for Disease Control and Prevention.

[Approved Guidance Document and Notification Form follow.]