# Proposed Data Collections Submitted for Public Comment and Recommendations > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3AE7-14432 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** July 26, 2007 - **Citation:** 72 FR 41077 ## Text 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 omb@cdc.gov. 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 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 Form Number of respondents Average number of responses per respondent Average burden per response (in hours) Total burden 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 Pneumonia Flow Diagram and Infant and Children Pneumonia Flow Diagram 1,500 72 30/60 54,000 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)—Microbiology Laboratory Data 1,500 45 3 202,500 Antimicrobial Use and Resistance—Pharmacy Data 1,500 36 2 108,000 Denominators for Intensive Care Unit (ICU)/Other locations (Not NICU or SCA) 1,500 18 5 135,000 Denominators for Specialty Care Area (SCA) 1,500 9 5 67,500 Denominators for Neonatal Intensive Care Unit (NICU) 1,500 9 4 54,000 Denominator for Procedure 1,500 540 8/60 108,000 Denominator for Outpatient Dialysis 80 9 5/60 60 Patient Safety Component—Outpatient Dialysis Center Practices Survey 80 1 1 80 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 Medication Administration Form 150 50 10/60 1,250 Pre-season Survey on Influenza Vaccination Programs for Healthcare Workers 150 1 10/60 25 Post-Season Survey on Influenza Vaccination Programs for Healthcare Workers 150 1 10/60 25 Central Line Insertion Practices Adherence Monitoring Form (CLIP) 1,500 100 5/60 12,500 Laboratory Testing 150 100 15/60 3,750 MDRO Prevention Process and Outcome Measures Monthly Monitoring Form 1,500 24 10/60 6,000 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 High Risk Inpatient Influenza Vaccine—Summary Form Method A 1,500 5 16 120,000 High Risk Inpatient Influenza Vaccine-Numerator Data Form Method B 500 250 10/60 20,833 High Risk Inpatient Influenza Vaccine—Summary Form Method B 500 5 4 10,000 High Risk Inpatient Influenza Vaccine—Denominator Data Form Method B 500 250 5/60 10,417 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 --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3AE7-14432. Public record. Not legal advice.