[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.
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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]
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