[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]


-----------------------------------------------------------------------

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