[Federal Register Volume 72, Number 143 (Thursday, July 26, 2007)]
[Notices]
[Pages 41077-41079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14432]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-07-0666]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-5960 
and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance 
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail 
to [email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology. Written comments should be received 
within 60 days of this notice.

Proposed Project

    National Healthcare Safety Network (NHSN) (OMB Control 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 application to OMB 
includes a significant increase in the number of burden hours to the 
previously approved data collection. The increase is due to inclusion 
of new forms and an increased number of respondents.
    NHSN was first approved by OMB in 2005 and CDC proposes to revise 
this data collection by adding new modules to the NHSN as well as 
modifying currently approved forms. Four new forms are proposed: (1) 
Healthcare Worker Influenza Vaccination form; (2) Healthcare Worker 
Influenza Antiviral Medication Administration form; (3) Pre-season 
survey on Influenza Vaccination Programs for Healthcare Workers; and 
(4) Post-season Survey on Influenza Vaccination Programs for Healthcare 
Workers. The purpose of these new forms is to help participating 
healthcare institutions and CDC to: (1) Monitor influenza vaccination 
coverage among healthcare personnel at individual facilities and to 
provide aggregate coverage estimates for all participating facilities; 
(2) monitor progress towards attaining the Healthy People 2010 goal of 
60% vaccination coverage among healthcare personnel; (3) monitor 
influenza vaccination coverage by ward/unit of the facility or 
occupational group so that areas or groups with low vaccination rates 
can be targeted for interventions; (4) monitor adverse reactions 
related to receipt of the vaccine or receipt of antiviral medications; 
and (5) assess the characteristics of influenza vaccination programs 
pre- and post-influenza season to identify practices associated with 
high immunization rates. The total estimated annual burden for these 
forms is 13,800 hours.
    CDC is proposing to add an additional form, Central Line Insertion 
Practices Monitoring Form, to the Patient Safety Component Device 
Associated Module. This new form will enable participating facilities 
and CDC to (1) monitor central line insertion practices in individual 
patient care units and facilities and provide aggregate data for all 
participating facilities (facilities have the option of recording 
inserter-specific adherence data); (2) link gaps in recommended 
practice with the clinical outcome both in individual facilities and 
for all participating facilities; (3) facilitate quality improvement by 
identifying specific gaps in adherence to recommended prevention 
practices, thereby helping to target intervention strategies for 
reducing central line infection rates. The total estimated annual 
burden for this form is 12,500 hours.
    CDC proposes to add the Multi-Drug Resistant Organism (MDRO) 
Prevention Process Monitoring Module to the Patient Safety Component. 
This module consists of four forms: (1) MDRO Prevention Process 
Monitoring Form; (2) MDRO Infection Event Form; (3) Laboratory-
identified MDRO Event Form; and (4) Laboratory-identified MDRO Event 
Summary Form. The purpose of these forms is to: (1) Monitor processes 
and practices in individual patient care units and facilities and to 
provide aggregate adherence data for all participating facilities; (2) 
link gaps in recommended practice with the clinical outcome (i.e., MDRO 
infection) both in individual facilities and for all participating 
facilities; (3) facilitate quality improvement by identifying specific 
gaps in adherence to

[[Page 41078]]

recommended prevention practices, thereby helping to target 
intervention strategies for reducing MDRO infection rates. The total 
estimated annual burden for these forms is 244,500 hours.
    The fourth new proposed collection to the NHSN is the High Risk 
Inpatient Influenza Vaccination Module. This module consists of four 
forms: (1) Influenza High Risk Inpatient Influenza Vaccine Summary 
Form--Method A; (2) Influenza High Risk Inpatient Influenza Vaccine 
Summary Form--Numerator Data Form Method B; (3) Influenza High Risk 
Inpatient Influenza Vaccine Summary Form--Method B; and (4) Influenza 
High Risk Inpatient Influenza Vaccine--Denominator Form Method B. The 
purpose of these forms is to: (1) Monitor influenza vaccination 
practices for high risk patients and provide aggregate data in regard 
to the number of high risk patients receiving vaccination, those 
already vaccinated, and those who decline due to medical 
contraindications or other reasons; and (2) to identify reasons that 
high risk patients are not receiving influenza vaccination. The total 
estimated annual burden of these forms is 161,250 hours.
    CDC is also proposing to open enrollment to any healthcare 
facility; therefore this submission includes a registration form 
(Registration Form) to collect necessary registration information. The 
total estimated annual burden for this form is 125 hours.
    A Long Term Acute Care Hospital (LTACH) survey form is included in 
this submission. This survey will allow long term acute care hospitals 
and CDC to collect information on LTACH characteristics, infection 
control practices, and microbiology laboratory practices. This data 
will provide CDC with more comprehensive information on all of the 
types of facilities that utilize the NHSN. The total estimated annual 
burden for this form is 38 hours.
    Finally, CDC also proposes to make minor edits and modifications to 
currently approved forms.
    CDC is also adding an increased number of participating healthcare 
institutions from a wide spectrum of settings. Part of this increase in 
burden hours is due to the passage of legislation in many states 
requiring mandatory reporting of healthcare-associated infections. Some 
states plan to use or are using NHSN as their data collection system to 
meet this mandate.
    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.

                                       Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                      Average         Average
                                                     Number of       number of      burden per     Total burden
                      Form                          respondents    responses per   response  (in       hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Facility Contact Information....................           1,500               1           10/60             250
Patient Safety Component Hospital Survey........           1,500               1           30/60             750
Agreement to Participate and Consent............           1,500               1           15/60             375
Group Contact Information.......................           1,500               1            5/60             125
Patient Safety Monthly Reporting Plan...........           1,500               9           35/60           7,875
Healthcare Personnel Safety Reporting Plan......             150               9           10/60             225
Primary Bloodstream Infection (BSI).............           1,500              36           30/60          27,000
Pneumonia (PNEU)--also includes Any Patient                1,500              72           30/60          54,000
 Pneumonia Flow Diagram and Infant and Children
 Pneumonia Flow Diagram.........................
Urinary Tract Infection (UTI)...................           1,500              27           30/60          20,250
Surgical Site Infection (SSI)...................           1,500              27           30/60          20,250
Dialysis (DI)...................................              80              90           15/60           1,800
Antimicrobial Use and Resistance (AUR)--                   1,500              45               3         202,500
 Microbiology Laboratory Data...................
Antimicrobial Use and Resistance--Pharmacy Data.           1,500              36               2         108,000
Denominators for Intensive Care Unit (ICU)/Other           1,500              18               5         135,000
 locations (Not NICU or SCA)....................
Denominators for Specialty Care Area (SCA)......           1,500               9               5          67,500
Denominators for Neonatal Intensive Care Unit              1,500               9               4          54,000
 (NICU).........................................
Denominator for Procedure.......................           1,500             540            8/60         108,000
Denominator for Outpatient Dialysis.............              80               9            5/60              60
Patient Safety Component--Outpatient Dialysis                 80               1               1              80
 Center Practices Survey........................
List of Blood Isolates..........................           1,500               1               1           1,500
Manual Categorization of Positive Blood Cultures           1,500               1               1           1,500
Exposures to Blood/Body Fluids..................             150              50               1           7,500
Healthcare Personnel Post-exposure Prophylaxis..             150              10           15/60             375
Healthcare Personnel Demographic Data...........             150             200           20/60          10,000
Healthcare Personnel Vaccination History........             150             300           10/60           7,500
Annual Facility Survey..........................             150               1               8           1,200
Implementation of Engineering Controls..........             150               1           30/60              75
Healthcare Worker Survey........................             150             100           10/60           2,500
Healthcare Personnel Influenza Vaccination Form.             150             500           10/60          12,500
Healthcare Personnel Influenza Antiviral                     150              50           10/60           1,250
 Medication Administration Form.................
Pre-season Survey on Influenza Vaccination                   150               1           10/60              25
 Programs for Healthcare Workers................
Post-Season Survey on Influenza Vaccination                  150               1           10/60              25
 Programs for Healthcare Workers................
Central Line Insertion Practices Adherence                 1,500             100            5/60          12,500
 Monitoring Form (CLIP).........................
Laboratory Testing..............................             150             100           15/60           3,750
MDRO Prevention Process and Outcome Measures               1,500              24           10/60           6,000
 Monthly Monitoring Form........................
MDRO Infection Event Form.......................           1,500              72           30/60          54,000
Laboratory Identified MDRO Event Form (LIME)....           1,500             240           30/60         180,000
Registration Form...............................           1,500               1            5/60             125

[[Page 41079]]

 
High Risk Inpatient Influenza Vaccine--Summary             1,500               5              16         120,000
 Form Method A..................................
High Risk Inpatient Influenza Vaccine-Numerator              500             250           10/60          20,833
 Data Form Method B.............................
High Risk Inpatient Influenza Vaccine--Summary               500               5               4          10,000
 Form Method B..................................
High Risk Inpatient Influenza Vaccine--                      500             250            5/60          10,417
 Denominator Data Form Method B.................
Laboratory Identified MDRO Event--Summary Form..           1,500               3               1           4,500
Long-term Acute Care Hospital Survey............              75               1           30/60              38
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............       1,276,153
----------------------------------------------------------------------------------------------------------------


    Dated: July 19, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E7-14432 Filed 7-25-07; 8:45 am]
BILLING CODE 4163-18-P