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 × 0.25hr × 1500 respondents). There are no Capital 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: dkatz@niaid.nih.gov.

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.