[Federal Register Volume 69, Number 137 (Monday, July 19, 2004)]
[Notices]
[Pages 43004-43005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16317]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Notification of Request for Emergency Clearance; ``Determination
of Location, Capacity, and Status of Existing and Operating BSL-3
Laboratory Facilities Within the United States''
In accordance with section 3507(j) of the Paperwork Reduction Act
of 1995, the National Institutes of Health hereby publishes
notification of request for Emergency Clearance for the information
collection related to ``Determination of Location, Capacity, and Status
of Existing and Operating BSL-3 Laboratory Facilities within the United
States.''
This information collection is essential to the mission of NIAID/
NIH (42 U.S.C. 241, 284, and 285f) and is critical to meeting the
NIAID's role in the national biodefense effort (42 U.S.C. 285f).
Our nation's ability to detect and counter bioterrorism depends to
a large degree on the information generated by biomedical research on
dangerous, disease-causing microbes and on the immune system response
to these pathogens. Much of this research is supported by the NIH and
NIAID. The role of NIAID biodefense research is to develop
countermeasures, including vaccines, drugs, and diagnostic tests,
necessary to protect civilians from potential agents of bioterrorism.
Since the fall of 2001, the NIAID has moved quickly to accelerate basic
and clinical research related to the prevention, diagnosis and
treatment of diseases caused by potential agents of bioterrorism.
Responsible stewardship of Federal funds in support of the national
biodefense effort requires information on the existing capacity of the
nation's biosafety level three (BSL-3) laboratories so that informed
funding decisions can be made to enhance this national resource. NIAID
plans to issue additional awards to develop and to expand the national
capacity for biodefense-related research in meeting the objectives of
the FY 2005 Presidential Budget (http://www.whitehouse.gov/omb/budget/fy2005/appendix.html, pg. 436). Reliable information on the location,
size, and operational status of existing facilities is essential for
making sound funding decisions. Without this information, NIAID may not
be able to ensure appropriate distribution of BSL-3 laboratories when
it awards future construction grants.
NIH cannot reasonably comply with the normal clearance procedures
for information collection, because the use of normal procedures will
delay the collection and hinder the agency in accomplishing its
mission, to the detriment of the public good. Compelling reason exists
to collect the required information for successful planning and
implementation of the national priority to expand BSL-3 capacity, as
described in the FY 2005 Presidential Budget.
This information collection is essential to the effective
stewardship of Federal funds. After consultation with scientific
experts in the field, other government agencies, and other NIH
components, NIAID has determined that the information is not currently
available in any single, reliable, accessible source.
The information to be obtained by this survey will provide the
NIAID with reliable and current information on the location, size, and
operational status of existing BSL-3 laboratory facilities within the
United States. This information will enable NIAID to predict the
number, size and geographic requirements for additional biosafety
laboratories.
Proposed Collection: Title: ``Determination of Location, Capacity,
and Status of Existing and Operating BSL-3 Laboratory Facilities within
the United States.'' Type of Information Collection Request: EMERGENCY.
Need and Use of Information Collection: To determine the location,
capacity, and status of existing and operating BSL-3 laboratory
facilities within the United States, in order to make informed funding
decisions for awards in FY 2005. Frequency of Response: One time.
Affected Public: Universities, medical research institutions, other
Federal agencies, and the private sector (biotechnology and
pharmaceutical companies). Type of Respondent: Universities, research
facilities, other Federal agencies, and the private sector
(biotechnology and pharmacological organizations). The annual reporting
burden is as follows: Estimated Number of Respondents: 1500; Estimated
Number of Responses per Respondent: One; Average Burden Hours per
Response: 0.25 hours; and Estimated Total Annual Burden Hours
Requested: 375 hours. The annualized cost to respondents is estimated
at $20,625 total ($55/hr x 0.25hr x 1500 respondents). There are no
Capital
[[Page 43005]]
Costs, Operating Costs, or Maintenance Costs to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) Evaluate the accuracy of the agency's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for NIH. To request more information on
the proposed project or to obtain a copy of the data collection plans
and instruments, contact: Deborah Katz, NIAID Office of Biodefense
Research Affairs, 6610 Rockledge Drive, Room 5111, Bethesda, MD 20892.
Telephone: (301) 402-8539. E-mail: [email protected].
By publication of this request of this request for emergency
review, the NIH is requesting the approval for this collection. In view
of the urgent public priority to meet the required levels of
preparedness for possible bioterrorist actions against the United
States and its citizens, NIAID requests that the collection of
information be approved within 10 days of the publication of the
Federal Register notice. This will allow sufficient time for public
comment.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 10 days
of the date of this publication.
Dated: July 12, 2004.
Lynn C. Hellinger,
Associate Director for Management and Operations, NIAID (Executive
Officer), National Institutes of Health.
[FR Doc. 04-16317 Filed 7-16-04; 8:45 am]
BILLING CODE 4140-01-P