| Page Range | 22074-22077 | |
| FR Document | 2018-10094 |
[Federal Register Volume 83, Number 92 (Friday, May 11, 2018)] [Notices] [Pages 22074-22077] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10094] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-18-0666; Docket No. CDC-2018-0042] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. ----------------------------------------------------------------------- SUMMARY: The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Healthcare Safety Network (NHSN). NHSN is a public health surveillance system that collects, analyzes, reports, and makes available data for monitoring, measuring, and responding to healthcare associated infections (HAIs), antimicrobial use and resistance, blood transfusion safety events, and the extent to which healthcare facilities adhere to infection prevention practices and antimicrobial stewardship. DATES: CDC must receive written comments on or before July 10, 2018. ADDRESSES: You may submit comments, identified by Docket No. CDC-2018- 0042 by any of the following methods:Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments. Mail: Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329. Instructions: All submissions received must include the agency name and Docket Number. CDC will post, without change, all relevant comments to Regulations.gov. Please note: Submit all comments through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the address listed above. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]. SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below. The OMB is particularly interested in comments that will help: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses. 5. Assess information collection costs. Proposed Project National Healthcare Safety Network (NHSN)--Revision--National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description NHSN is a public health surveillance system that collects, analyzes, reports, and makes available data for monitoring, measuring, and responding to healthcare associated infections (HAIs), antimicrobial use and resistance, blood transfusion safety events, and the extent to which healthcare facilities adhere to infection prevention practices and antimicrobial stewardship. The data collected will be used to inform and detect changes in the epidemiology of adverse events resulting from new and current medical therapies and changing risks. NHSN is comprised of six components: Patient Safety, Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility, Outpatient Procedure, and Dialysis. Changes were made to 33 data collection facility surveys with this new ICR. CDC revised three annual facility surveys for the Patient Safety component for Hospitals, Long-Term Acute Care Facilities, and Inpatient Rehabilitation Facilities. CDC's revisions clarify the reporting requirements for the data collected on fungal testing, facility locations, and laboratory testing locations. Additionally, corresponding response [[Page 22075]] options for these questions have been revised to include updated testing methods used by facilities to capture current HAI specific data specification requirements for NHSN. New required questions have been added to all Patient Safety component surveys. The new questions are designed to provide data on surveillance processes, policies, and standards that are used by reporting facilities to ensure that when an event is detected, the facility has the appropriate mechanism to conduct complete reporting. The Hospital Annual Survey added new required questions to provide data about neonatal antimicrobial stewardship practices because the focus of stewardship efforts in neonatology differ from the focus in adult and pediatric practice. Questions were removed and replaced on all three Patient Safety surveys to align better with the Core Elements of Hospital Antibiotic Stewardship Programs specified by CDC. The Core Elements defined by CDC are part of broad-based efforts by CDC and its healthcare and public health partners to combat the threat of antibiotic-resistant bacteria. The new Antibiotic Stewardship Program questions will provide additional data about operational features of the programs that hospitals have implemented, which in turn will enable CDC and its healthcare and public health partners to target their efforts to help invigorate and extend antibiotic stewardship. CDC is introducing a new optional survey form that is designed to be completed by state and local health departments that participate in HAI surveillance and prevention activities. This new form will provide data on legal and regulatory requirements that are pertinent to HAI reporting. CDC plans to include data the health department survey in its annual National and State Healthcare-Associated Infection Progress Report. The report helps identify the progress in HAI surveillance and prevention at the state and national levels. Data about the extent to which state health departments have validated HAI data that healthcare facilities in their jurisdiction report to NHSN and the extent of state and local health department HAI reporting requirements are important data for users of CDC's HAI Progress Report to consider when they are reviewing and interpreting data in the report. NHSN now includes a ventilator-associated event available for NICU locations, which requires additional denominator reporting, in which CDC has provided an option to accommodate facilities that are reporting requested data by updating the corresponding surveys. The Pediatric Ventilator-Associated Event (PedVAE) was removed from the survey because a single algorithm is used to detect PedVAE events. NHSN has made updates to the Antimicrobial Use and Resistance (AUR) data collection tools for the purposes of monitoring additional microorganisms and their antimicrobial susceptibility profiles. Use of these updates in AUR surveillance will provide important additional data for clinical and public health responses to mounting antibiotic resistance problems. The Long-term Care Facility Component (LTCF) will be updating three forms, two of which will include an update for facilities to document the ``CDI treatment start'' variable. Early CDI reporting data from nursing homes has shown exceptionally low event rates for many reporting facilities (e.g., zero events for six or more months). Since current CDI event detection is based on presence of a positive laboratory specimen, variability in the use of diagnostic testing as part of CDI management will have direct impact on the estimate of CDI burden in a facility (e.g., empiric treatment for CDI without confirmatory testing may result in the appearance of low disease burden). In order to determine whether low CDI event rates might be due to empiric CDI treatment practices, a new process measure will be incorporated into the monthly summary data on CDI for LTCFs. This measure, called ``CDI treatment starts,'' will allow providers to capture the number of residents started on antibiotic treatment for CDI that month based on clinical decisions (i.e., even those without a positive CDI test). This process measure should provide data on clinically-treated CDI in order to inform our understanding of CDI management practices and serve as a proxy for CDI burden in nursing homes. Overall, minor revisions have been made to a total of 33 forms within the package to clarify and/or update surveillance definitions, increase or decrease the number of reporting facilities, and add new forms. The previously approved NHSN package included 72 individual collection forms; the current revision request includes a total of 73 forms. The reporting burden will decrease by 109,745 hours, for a total of 5,393,725 hours. Estimated Annualized Burden Hours -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response Total burden respondents respondent (in hours) (in hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- Healthcare facility............................. 57.100 NHSN Registration Form......... 2,000 1 5/60 167 57.101 Facility Contact Information... 2,000 1 10/60 333 57.103 Patient Safety Component-- 6,000 1 1.17 7,500 Annual Hospital Survey. 57.105 Group Contact Information...... 1,000 1 5/60 83 57.106 Patient Safety Monthly 6,000 12 15/60 18,000 Reporting Plan. 57.108 Primary Bloodstream Infection 6,000 44 33/60 145,200 (BSI). 57.111 Pneumonia (PNEU)............... 1,800 72 30/60 64,800 57.112 Ventilator-Associated Event.... 6,000 144 28/60 403,200 57.113 Pediatric Ventilator-Associated 100 120 30/60 6,000 Event (PedVAE). 57.114 Urinary Tract Infection (UTI).. 6,000 40 20/60 80,000 57.115 Custom Event................... 600 91 35/60 31,850 57.116 Denominators for Neonatal 6,000 12 4 288,000 Intensive Care Unit (NICU). 57.117 Denominators for Specialty Care 2,000 9 5.03 90,600 Area (SCA)/Oncology (ONC). [[Page 22076]] 57.118 Denominators for Intensive Care 6,000 60 5.03 1,812,000 Unit (ICU)/Other locations (not NICU or SCA). 57.120 Surgical Site Infection (SSI).. 6,000 36 35/60 126,000 57.121 Denominator for Procedure...... 6,000 540 10/60 540,000 57.122 HAI Progress Report State 55 1 45/60 41 Health Department Survey. 57.123 Antimicrobial Use and 1,000 12 5/60 1,000 Resistance (AUR)-Microbiology Data Electronic Upload Specification Tables. 57.124 Antimicrobial Use and 2,000 12 5/60 2,000 Resistance (AUR)-Pharmacy Data Electronic Upload Specification Tables. 57.125 Central Line Insertion 100 100 25/60 4,167 Practices Adherence Monitoring. 57.126 MDRO or CDI Infection Form..... 6,000 72 30/60 216,000 57.127 MDRO and CDI Prevention Process 6,000 24 15/60 36,000 and Outcome Measures Monthly Monitoring. 57.128 Laboratory-identified MDRO or 6,000 240 20/60 480,000 CDI Event. 57.129 Adult Sepsis................... 50 250 25/60 5,208 57.137 Long-Term Care Facility 2,600 1 2 5,200 Component--Annual. Facility Survey: 57.138 Laboratory-identified MDRO 2,600 12 20/60 10,400 or CDI Event for LTCF. 57.139 MDRO and CDI Prevention 2,600 12 20/60 10,400 Process Measures Monthly Monitoring for LTCF. 57.140 Urinary Tract Infection 2,600 14 35/60 18,200 (UTI) for LTCF. 57.141 Monthly Reporting Plan for 2,600 12 5/60 2,600 LTCF. 57.142 Denominators for LTCF 2,600 12 4.17 130,000 Locations. 57.143 Prevention Process Measures 2,600 12 5/60 2,600 Monthly Monitoring for LTCF. 57.150 LTAC Annual Survey.......... 400 1 1.17 467 57.151 Rehab Annual Survey......... 1,000 1 1.17 1,167 57.200 Healthcare Personnel Safety 50 1 8 400 Component Annual Facility Survey. 57.203 Healthcare Personnel Safety 19,500 1 5/60 1,625 Monthly Reporting Plan. 57.204 Healthcare Worker 50 200 20/60 3,333 Demographic Data. 57.205 Exposure to Blood/Body 50 50 1 2,500 Fluids. 57.206 Healthcare Worker 50 30 15/60 375 Prophylaxis/Treatment. 57.207 Follow-Up Laboratory Testing 50 50 15/60 625 57.210 Healthcare Worker 50 50 10/60 417 Prophylaxis/Treatment-Influenza. 57.300 Hemovigilance Module Annual 500 1 1.42 708 Survey. 57.301 Hemovigilance Module Monthly 500 12 1/60 100 Reporting Plan. 57.303 Hemovigilance Module Monthly 500 12 1.17 7,000 Reporting Denominators. 57.305 Hemovigilance Incident...... 500 10 10/60 833 57.306 Hemovigilance Module Annual 200 1 35/60 117 Survey--Non-acute care facility. 57.307 Hemovigilance Adverse 500 4 20/60 667 Reaction--Acute Hemolytic Transfusion Reaction. 57.308 Hemovigilance Adverse 500 4 20/60 667 Reaction--Allergic Transfusion Reaction. 57.309 Hemovigilance Adverse 500 1 20/60 167 Reaction--Delayed Hemolytic Transfusion Reaction. 57.310 Hemovigilance Adverse 500 2 20/60 333 Reaction--Delayed Serologic Transfusion Reaction. [[Page 22077]] 57.311 Hemovigilance Adverse 500 4 20/60 667 Reaction--Febrile Non-hemolytic Transfusion Reaction. 57.312 Hemovigilance Adverse 500 1 20/60 167 Reaction--Hypotensive Transfusion Reaction. 57.313 Hemovigilance Adverse 500 1 20/60 167 Reaction--Infection. 57.314 Hemovigilance Adverse 500 1 20/60 167 Reaction--Post Transfusion Purpura. 57.315 Hemovigilance Adverse 500 1 20/60 167 Reaction--Transfusion Associated Dyspnea. 57.316 Hemovigilance Adverse 500 1 20/60 167 Reaction--Transfusion Associated Graft vs. Host Disease. 57.317 Hemovigilance Adverse 500 1 20/60 167 Reaction--Transfusion Related Acute Lung Injury. 57.318 Hemovigilance Adverse 500 2 20/60 333 Reaction--Transfusion Associated Circulatory Overload. 57.319 Hemovigilance Adverse 500 1 20/60 167 Reaction--Unknown Transfusion Reaction. 57.320 Hemovigilance Adverse 500 1 20/60 167 Reaction--Other Transfusion Reaction. 57.400 Outpatient Procedure 5,000 1 10/60 417 Component--Annual Facility Survey. 57.401 Outpatient Procedure 5,000 12 20/60 15,000 Component--Monthly Reporting Plan. 57.402 Outpatient Procedure 1,200 25 40/60 20,000 Component Same Day Outcome Measures. 57.403 Outpatient Procedure 1,200 12 40/60 9,600 Component--Monthly Denominators for Same Day Outcome Measures. 57.404 Outpatient Procedure 5,000 540 10/60 450,000 Component--SSI Denominator. 57.405 Outpatient Procedure 5,000 36 35/60 105,000 Component--Surgical Site (SSI) Event. 57.500 Outpatient Dialysis Center 7,000 1 2.12 14,817 Practices Survey. 57.501 Dialysis Monthly Reporting 7,000 12 5/60 7,000 Plan. 57.502 Dialysis Event.............. 7,000 60 25/60 175,000 57.503 Denominator for Outpatient 7,000 12 10/60 14,000 Dialysis. 57.504 Prevention Process Measures 2,000 12 1.42 17,000 Monthly Monitoring for Dialysis. 57.505 Dialysis Patient Influenza 325 75 10/60 4,063 Vaccination. 57.506 Dialysis Patient Influenza 325 5 10/60 271 Vaccination Denominator. 57.507 Home Dialysis Center 350 1 30/60 175 Practices Survey. --------------- Total................................... ...................................... .............. .............. .............. 5,393,725 -------------------------------------------------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Acting Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2018-10094 Filed 5-10-18; 8:45 am] BILLING CODE 4163-18-P
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with comment period. | |
| Dates | CDC must receive written comments on or before July 10, 2018. | |
| Contact | To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected] | |
| FR Citation | 83 FR 22074 |