Submission for OMB Review; Emergency Clearance Request Human Influenza Surveillance of Health Care Centers in the United States and Taiwan

SUMMARY:

In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for emergency review and processing of this information collection by March 7, 2015. NIAID is requesting emergency processing of this information collection, pursuant to 5 CFR 1320.13, because NIAID cannot reasonably comply with the normal clearance procedures which would cause a delay and likely prevent or substantially disrupt the collection of information. A delay in starting the information collection would hinder the agency in accomplishing its mission to the detriment of the public good. Public harm could result through the loss of critically needed information to understand the causes of severity of influenza and associated morbidity and mortality during the Northern hemisphere 2014-15 influenza season. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) 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) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.

DATES:

Comment due date: Comments regarding this information collection are best assured of having their full effect if received within 7 days of the date of this publication.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Diane Post, Program Officer, Respiratory Diseases Branch, NIAID, NIH 5601 Fishers Lane, Bethesda, MD or call non-toll-free number at 240-627-3348 or email your request, including your address to: postd@niaid.nih.gov

SUPPLEMENTARY INFORMATION:

Proposed Collection: Human Influenza Surveillance of Health Care Centers in the United States and Taiwan, (NIAID), 0925—NEW, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH).

Need and Use of Information Collection: This study will identify individuals with influenza through focused surveillance in key regions of the United States and Taiwan, rapidly identify circulating influenza strains to identify those with pandemic potential and create an invaluable bank of human samples from patients with influenza to characterize the basis of severe disease—a critical knowledge gap impacting effectiveness of decision-making around patient care. The 2014-15 influenza season is unique because the dominant circulating strain is an H3N2 strain that is not sensitive to the immunity induced by the influenza vaccine formulation administered to the general public. Our study will provide insight into viral determinants that may be contributing to the severity of influenza and associated morbidity and mortality this season. Capturing samples from this influenza season is essential for understanding the public health implications the virus may have in the future, and discerning the reasons behind the severity of the disease it causes.

OMB approval is requested for 6 months. There are no costs to respondents other than their time. The total estimated annualized burden hours are 500.