[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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