| Page Range | 56477-56478 | |
| FR Document | 2015-23479 |
[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)] [Notices] [Pages 56477-56478] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-23479] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request; United States and Global Human Influenza Surveillance in At-Risk Settings (NIAID) SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on April 9, 2015, page 19090 and allowed 60-days for public comment. One comment was received. However, it was not applicable to this data collection. The purpose of this notice is to allow an additional 30 days for public comment. The National Institute of Allergy and Infectious Diseases (NIAID), 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. 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, [email protected] or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, 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: [email protected]. Formal requests for additional plans and instruments must be requested in writing. Proposed Collection: United States and Global Human Influenza Surveillance in at-Risk Settings, 0925--NEW, National Institute of Allergies and Infectious Diseases (NIAID), National Institutes of Health (NIH). Need and Use of Information Collection: These studies will identify individuals with or at risk for influenza through focused surveillance in at-risk settings within the United States and internationally, rapidly identify circulating influenza strains to identify those with pandemic potential and create an invaluable bank of human samples from influenza patients to allow the characterization of the determinants of influenza transmission to and among humans, the immune response to influenza, and the basis of severe disease--critical knowledge gaps impacting effectiveness of decision-making around patient care and [[Page 56478]] pandemic preparedness. These studies will provide insight into viral and host determinants that may be contributing to the transmission of influenza, immune response to influenza, and severity of influenza and associated morbidity and mortality. OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours for the entire 3 year request are 17334. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Estimates of hour burden --------------------------------------------------------------------------------- Type of respondents Number of Frequency of Average time Annual hour Form name respondents response per response burden ---------------------------------------------------------------------------------------------------------------- Hospital/care setting patients Informed Consent 1600 1 10/60 267 Form. Form 1a .............. 1 10/60 267 Screening and enrollment log (Attachment 3). Form 2a .............. 1 10/60 267 Eligibility Checklist (Attachment 4). Form 3a Subject .............. 1 10/60 267 Identification (Attachment 5). Form 4a .............. 1 10/60 267 Demographic and Exposure Information (Attachment 6). Form 5a Current .............. 1 10/60 267 Symptoms (Attachment 7). Form 6a Medical .............. 1 10/60 267 History (Attachment 8). Form 8a Follow .............. 4 10/60 1,067 Up Assessment (Attachment 10). Human Animal-interface Informed Consent 900 1 10/60 150 patients. Form. Form 1a .............. 1 10/60 150 Screening and enrollment log (Attachment 3). Form 2a .............. 1 10/60 150 Eligibility Checklist (Attachment 4). Form 3a Subject .............. 1 10/60 150 Identification (Attachment 5). Form 4a .............. 1 10/60 150 Demographic and Exposure Information (Attachment 6). Form 5a Current .............. 25 10/60 3,750 Symptoms (Attachment 7). Form 6a Medical .............. 1 10/60 150 History (Attachment 8). Form 8a Follow .............. 25 10/60 3,750 Up Assessment (Attachment 10). Household Surveillance Informed Consent 500 1 10/60 83 patients. Form. Form 1a .............. 1 10/60 83 Screening and enrollment log (Attachment 3). Form 2a .............. 1 10/60 83 Eligibility Checklist (Attachment 4). Form 3a Subject .............. 1 10/60 83 Identification (Attachment 5). Form 4a .............. 1 10/60 83 Demographic and Exposure Information (Attachment 6). Form 5a Current .............. 6 10/60 500 Symptoms (Attachment 7). Form 6a Medical .............. 1 10/60 83 History (Attachment 8). Form 8a Follow .............. 6 10/60 500 Up Assessment (Attachment 10). Study Staff................... Informed Consent 5 600 10/60 500 Form. Form 7a .............. 600 10/60 500 Enrollment Specimen Collection (Attachment 9). Form 9a ED Chart .............. 600 10/60 500 Review (Attachment 11). Form 10a Chart .............. 600 10/60 500 Review--Inpatie nt Hospitalization (Attachment 12). Form 11a Subject .............. 600 10/60 500 Withdrawal Form (Attachment 13). Form 12a Subject .............. 600 10/60 500 checklist (Attachment 14). Form 13A .............. 600 10/60 500 Enrollment Report (Attachment 15). Form 14A 10% .............. 600 10/60 500 Data accuracy report (Attachment 16). Form 15A--QC .............. 600 10/60 500 Checklist (Attachment 17). --------------------------------------------------------------- Totals.................... ................ 3,005 .............. .............. 17,334 ---------------------------------------------------------------------------------------------------------------- Dated: September 10, 2015. Dione Washington, Project Clearance Liaison, NIAID, NIH. [FR Doc. 2015-23479 Filed 9-17-15; 8:45 am] BILLING CODE 4140-01-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Dates | Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. | |
| Contact | To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, 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 | |
| FR Citation | 80 FR 56477 |