[Federal Register Volume 67, Number 151 (Tuesday, August 6, 2002)]
[Notices]
[Pages 51058-51064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19897]



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Part V





Department of Health and Human Services





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Centers for Disease Control and Prevention



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OMB Approval of Data Collection; Notice

  Federal Register / Vol. 67, No. 151 / Tuesday, August 6, 2002 / 
Notices  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Notice of OMB Approval of Data Collection

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

ACTION: General notice.

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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: (404) 498-1210.

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

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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.]

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[FR Doc. 02-19897 Filed 8-2-02; 11:33 am]
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