[Federal Register Volume 74, Number 138 (Tuesday, July 21, 2009)]
[Notices]
[Pages 35868-35870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17263]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-09-0666]


Agency Forms Undergoing Paperwork Reduction Act Review

    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

[[Page 35869]]

requests, call the CDC Reports Clearance Officer at (404) 639-5960 or 
send an e-mail to [email protected]. 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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
              Respondents                         Form              respondents    responses per   response (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Infection Control Practitioner........  Facility Contact                   6,000               1           10/60
                                         Information.
                                        Patient Safety Component           6,000               1           30/60
                                         Hospital Survey.
                                        Agreement to Participate           6,000               1           15/60
                                         and Consent.
                                        Group Contact                      6,000               1            5/60
                                         Information.
                                        Patient Safety Monthly             6,000               9           35/60
                                         Reporting Plan.
                                        Healthcare Personnel                 600               9           10/60
                                         Safety Reporting Plan.
                                        Primary Bloodstream                6,000              36           30/60
                                         Infection (BSI).
                                        Pneumonia (PNEU)--also             6,000              72           30/60
                                         includes Any Patient
                                         Pneumonia Flow Diagram
                                         and Infant and Children
                                         Pneumonia Flow Diagram.
                                        Urinary Tract Infection            6,000              27           30/60
                                         (UTI).
                                        Surgical Site Infection            6,000              27           30/60
                                         (SSI).
 .                                      Dialysis Event (DI).....             225             200           15/60
                                        Antimicrobial Use and              6,000              45               3
                                         Resistance (AUR)--
                                         Microbiology Laboratory
                                         Data.
                                        Antimicrobial Use and              6,000              36               2
                                         Resistance--Pharmacy
                                         Data.
                                        Denominators for                   6,000              18               5
                                         Intensive Care Unit
                                         (ICU)/Other locations
                                         (Not NICU or SCA).
                                        Denominators for                   6,000               9               5
                                         Specialty Care Area
                                         (SCA).
                                        Denominators for                   6,000               9               4
                                         Neonatal Intensive Care
                                         Unit (NICU).
                                        Denominator for                    6,000             540            8/60
                                         Procedure.
                                        Denominator for                      225               9            5/60
                                         Outpatient Dialysis.
                                        Dialysis Survey.........             225               1               1

[[Page 35870]]

 
                                        List of Blood Isolates..           6,000               1               1
                                        Manual Categorization of           6,000               1               1
                                         Positive Blood Cultures.
                                        Exposures to Blood/Body              600              50               1
                                         Fluids.
                                        Healthcare Personnel                 600              10           15/60
                                         Post-exposure
                                         Prophylaxis.
                                        Healthcare Personnel                 600             200           20/60
                                         Demographic Data.
                                        Healthcare Personnel                 600             300           10/60
                                         Vaccination History.
                                        Annual Facility Survey..             600               1               8
                                        Healthcare Worker Survey             600             100           10/60
                                        Healthcare Personnel                 600             500           10/60
                                         Influenza Vaccination
                                         Form.
                                        Healthcare Personnel                 600              50           10/60
                                         Influenza Antiviral
                                         Medication
                                         Administration Form.
                                        Pre-season Survey on                 600               1           10/60
                                         Influenza Vaccination
                                         Programs for Healthcare
                                         Workers.
                                        Post-Season Survey on                600               1           10/60
                                         Influenza Vaccination
                                         Programs for Healthcare
                                         Workers.
                                        Central Line Insertion             6,000             100           10/60
                                         Practices Adherence
                                         Monitoring Form (CLIP).
                                        Laboratory Testing......             600             100           15/60
                                        MDRO Prevention Process            6,000              24           10/60
                                         and Outcome Measures
                                         Monthly Monitoring Form.
                                        MDRO or CDAD Infection             6,000              72           30/60
                                         Event Form.
                                        Laboratory Identified              6,000             240           30/60
                                         MDRO or CDAD Event Form
                                         (LabID).
                                        Registration Form.......           6,000               1            5/60
                                        High Risk Inpatient                6,000               5              16
                                         Influenza Vaccine--
                                         Summary Form Method A.
                                        High Risk Inpatient                2,000             250           10/60
                                         Influenza Vaccine--
                                         Numerator Data Form
                                         Method B.
                                        High Risk Inpatient                2,000               5               4
                                         Influenza Vaccine--
                                         Summary Form Method B.
                                        High Risk Inpatient                2,000             250            5/60
                                         Influenza Vaccine--
                                         Denominator Data Form
                                         Method B.
                                        Hemovigilance Module                 500               1               2
                                         Annual Survey.
                                        Hemovigilance Module                 500              12            2/60
                                         Monthly Reporting Plan.
                                        Hemovigilance Module                 500              12               2
                                         Blood Product Incident
                                         Reporting--Summary Data.
                                        Hemovigilance Module                 500              12           30/60
                                         Monthly Reporting
                                         Denominators.
                                        Hemovigilance Incident..             500              72           10/60
                                        Hemovigilance Adverse                500             120           10/60
                                         Reaction.
----------------------------------------------------------------------------------------------------------------


    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