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 Department of Health and Human Services Centers for Disease Control and Prevention [30Day-09-0666]
 The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these 
                    ( print page 35869)
                    requests, call the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail to 
                    *omb@cdc.gov*. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395-6974. Written comments should be received within 30 days of this notice. Proposed Project National Healthcare Safety Network (NHSN) (OMB No. 0920-0666)—Revision—National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), Centers for Disease Control and Prevention (CDC). Background and Brief Description The National Healthcare Safety Network (NHSN) is a system designed to accumulate, exchange, and integrate relevant information and resources among private and public stakeholders to support local and national efforts to protect patients and to promote healthcare safety. Specifically, the data is used to determine the magnitude of various healthcare-associated adverse events and trends in the rates of these events among patients and healthcare workers with similar risks. The data will be used to detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing risks. Healthcare institutions that participate in NHSN voluntarily report their data to CDC using a web browser-based technology for data entry and data management. Data are collected by trained surveillance personnel using written standardized protocols. This revision submission to OMB is a request to add a Hemovigilance module to the NHSN. This module is a response to a recommendation from HHS' Advisory Committee on Blood Safety and Availability (ACBSA) to develop a national system for outcome surveillance that includes recipients of blood and blood products. The module consists of 6 additional forms: (1) The Hemovigilance Module Annual Survey (1,000 annualized burden hours); (2) the Hemovigilance Module Monthly Reporting Plan (200 annualized burden hours); (3) Hemovigilance Module Blood Produce Incident Reporting—Summary Data (12,000 annualized burden hours); (4) Hemovigilance Module Monthly Reporting Denominators (3,000 annualized burden hours); (5) Hemovigilance Incident form (6,000 annualized burden hours); and (6) Hemovigilance Adverse Reaction form (10,000 annualized burden hours). The Hemovigilance Module totals an estimated 32,200 annualized burden hours Also in this submission, CDC is also requesting to delete two forms currently approved by OMB: Implementation of Engineering Controls (currently approved for 300 burden hours) and the Laboratory Identified Multi-drug Resistant Organism (MDRO) Event Summary Form (currently approved for 4,500 burden hours). These forms are no longer needed by the NHSN. These deletions total 4,800 burden hours. NHSN was first approved by OMB in 2005 and a revision request was approved by OMB in 2008. The 2008 revision request included modifications to approved forms, new modules, and an increase in the number of respondents. Later in 2008, CDC requested and received OMB approval to increase the number of respondents for the NHSN to 6,000 healthcare facilities. This change was a result of an increasing number of State legislatures requiring reporting of healthcare-acquired infections by healthcare facilities using the NHSN. Participating institutions must have a computer capable of supporting an Internet service provider (ISP) and access to an ISP. The only other cost to respondents is their time to complete the appropriate forms. OMB No. 0920-0666: National Healthcare Safety Network (NHSN) is currently approved for 5,144,844 annualized burden hours. This request includes a net increase of 27,400 burden hours (deletion of 2 forms: −4,800 burden hours; new Hemovigilance Module: +32,200 burden hours), bringing the total estimated annualized burden hours for the entire information collection request to 5,172,244 hours. There are no additional respondents for this request as they are already part of the respondent population. Estimate of Annualized Burden Hours
Respondents
Form
Number of 
                             respondents
Number of 
                             responses per respondent
Average 
                             burden per  
                             response (in hours)Infection Control Practitioner
Facility Contact Information
6,000
1
10/60Patient Safety Component Hospital Survey
6,000
1
30/60Agreement to Participate and Consent
6,000
1
15/60Group Contact Information
6,000
1
5/60Patient Safety Monthly Reporting Plan
6,000
9
35/60Healthcare Personnel Safety Reporting Plan
600
9
10/60Primary Bloodstream Infection (BSI)
6,000
36
30/60Pneumonia (PNEU)—also includes Any Patient Pneumonia Flow Diagram and Infant and Children Pneumonia Flow Diagram
6,000
72
30/60Urinary Tract Infection (UTI)
6,000
27
30/60Surgical Site Infection (SSI)
6,000
27
30/60.
Dialysis Event (DI)
225
200
15/60Antimicrobial Use and Resistance (AUR)—Microbiology Laboratory Data
6,000
45
3Antimicrobial Use and Resistance—Pharmacy Data
6,000
36
2Denominators for Intensive Care Unit (ICU)/Other locations (Not NICU or SCA)
6,000
18
5Denominators for Specialty Care Area (SCA)
6,000
9
5Denominators for Neonatal Intensive Care Unit (NICU)
6,000
9
4Denominator for Procedure
6,000
540
8/60Denominator for Outpatient Dialysis
225
9
5/60Dialysis Survey
225
1
1( print page 35870)List of Blood Isolates
6,000
1
1Manual Categorization of Positive Blood Cultures
6,000
1
1Exposures to Blood/Body Fluids
600
50
1Healthcare Personnel Post-exposure Prophylaxis
600
10
15/60Healthcare Personnel Demographic Data
600
200
20/60Healthcare Personnel Vaccination History
600
300
10/60Annual Facility Survey
600
1
8Healthcare Worker Survey
600
100
10/60Healthcare Personnel Influenza Vaccination Form
600
500
10/60Healthcare Personnel Influenza Antiviral Medication Administration Form
600
50
10/60Pre-season Survey on Influenza Vaccination Programs for Healthcare Workers
600
1
10/60Post-Season Survey on Influenza Vaccination Programs for Healthcare Workers
600
1
10/60Central Line Insertion Practices Adherence Monitoring Form (CLIP)
6,000
100
10/60Laboratory Testing
600
100
15/60MDRO Prevention Process and Outcome Measures Monthly Monitoring Form
6,000
24
10/60MDRO or CDAD Infection Event Form
6,000
72
30/60Laboratory Identified MDRO or CDAD Event Form (LabID)
6,000
240
30/60Registration Form
6,000
1
5/60High Risk Inpatient Influenza Vaccine—Summary Form Method A
6,000
5
16High Risk Inpatient Influenza Vaccine—Numerator Data Form Method B
2,000
250
10/60High Risk Inpatient Influenza Vaccine—Summary Form Method B
2,000
5
4High Risk Inpatient Influenza Vaccine—Denominator Data Form Method B
2,000
250
5/60Hemovigilance Module Annual Survey
500
1
2Hemovigilance Module Monthly Reporting Plan
500
12
2/60Hemovigilance Module Blood Product Incident Reporting—Summary Data
500
12
2Hemovigilance Module Monthly Reporting Denominators
500
12
30/60Hemovigilance Incident
500
72
10/60Hemovigilance Adverse Reaction
500
120
10/60
 Dated: July 13, 2009. Marilyn S. Radke, Reports Clearance Officer, Centers for Disease Control and Prevention.


[FR Doc. E9-17263 Filed 7-20-09; 8:45 am] BILLING CODE 4163-18-P