| Page Range | 45444-45447 | |
| FR Document | 2018-19382 |
[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)] [Notices] [Pages 45444-45447] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19382] ----------------------------------------------------------------------- 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 November 6, 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 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 [[Page 45445]] 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 2,000 1 5/60 167 Registration Form. 57.101 Facility 2,000 1 10/60 333 Contact Information. 57.103 Patient 6,000 1 1.17 7,500 Safety Component-- Annual Hospital Survey. 57.105 Group 1,000 1 5/60 83 Contact Information. 57.106 Patient 6,000 12 15/60 18,000 Safety Monthly Reporting Plan. 57.108 Primary 6,000 44 33/60 145,200 Bloodstream Infection (BSI). 57.111 Pneumonia 1,800 72 30/60 64,800 (PNEU). 57.112 Ventilator-- 6,000 144 28/60 403,200 Associated Event. 57.113 Pediatric 100 120 30/60 6,000 Ventilator--Assoc iated Event (PedVAE). 57.114 Urinary 6,000 40 20/60 80,000 Tract Infection (UTI). 57.115 Custom 600 91 35/60 31,850 Event. 57.116 6,000 12 4 288,000 Denominators for Neonatal Intensive Care Unit (NICU). 57.117 2,000 9 5.03 90,600 Denominators for Specialty Care Area (SCA)/ Oncology (ONC). 57.118 6,000 60 5.03 1,812,000 Denominators for Intensive Care Unit (ICU)/Other locations (not NICU or SCA). 57.120 Surgical 6,000 36 35/60 126,000 Site Infection (SSI). 57.121 Denominator 6,000 540 10/60 540,000 for Procedure. 57.122 HAI 55 1 45/60 41 Progress Report State Health Department Survey. 57.123 1,000 12 5/60 1,000 Antimicrobial Use and Resistance (AUR)--Microbiolo gy Data Electronic Upload Specification Tables. [[Page 45446]] 57.124 2,000 12 5/60 2,000 Antimicrobial Use and Resistance (AUR)--Pharmacy Data Electronic Upload Specification Tables. 57.125 Central 100 100 25/60 4,167 Line Insertion Practices Adherence Monitoring. 57.126 MDRO or CDI 6,000 72 30/60 216,000 Infection Form. 57.127 MDRO and 6,000 24 15/60 36,000 CDI Prevention Process and Outcome Measures Monthly Monitoring. 57.128 Laboratory- 6,000 240 20/60 480,000 identified MDRO or CDI Event. 57.129 Adult 50 250 25/60 5,208 Sepsis. 57.137 Long-Term 2,600 1 2 5,200 Care Facility Component--Annual Facility Survey. 57.138 Laboratory- 2,600 12 20/60 10,400 identified MDRO or CDI Event for LTCF. 57.139 MDRO and 2,600 12 20/60 10,400 CDI Prevention Process Measures Monthly Monitoring for LTCF. 57.140 Urinary 2,600 14 35/60 18,200 Tract Infection (UTI) for LTCF. 57.141 Monthly 2,600 12 5/60 2,600 Reporting Plan for LTCF. 57.142 2,600 12 4.17 130,000 Denominators for LTCF Locations. 57.143 Prevention 2,600 12 5/60 2,600 Process Measures Monthly Monitoring for LTCF. 57.150 LTAC Annual 400 1 1.17 467 Survey. 57.151 Rehab 1,000 1 1.17 1,167 Annual Survey. 57.200 Healthcare 50 1 8 400 Personnel Safety Component Annual Facility Survey. 57.203 Healthcare 19,500 1 5/60 1,625 Personnel Safety Monthly Reporting Plan. 57.204 Healthcare 50 200 20/60 3,333 Worker Demographic Data. 57.205 Exposure to 50 50 1 2,500 Blood/Body Fluids. 57.206 Healthcare 50 30 15/60 375 Worker Prophylaxis/ Treatment. 57.207 Follow-Up 50 50 15/60 625 Laboratory Testing. 57.210 Healthcare 50 50 10/60 417 Worker Prophylaxis/ Treatment--Influe nza. 57.300 500 1 1.42 708 Hemovigilance Module Annual Survey. 57.301 500 12 1/60 100 Hemovigilance Module Monthly Reporting Plan. 57.303 500 12 1.17 7,000 Hemovigilance Module Monthly Reporting Denominators. 57.305 500 10 10/60 833 Hemovigilance Incident. 57.306 200 1 35/60 117 Hemovigilance Module Annual Survey--Non-acute care facility. 57.307 500 4 20/60 667 Hemovigilance Adverse Reaction-- Acute Hemolytic Transfusion Reaction. 57.308 500 4 20/60 667 Hemovigilance Adverse Reaction-- Allergic Transfusion Reaction. 57.309 500 1 20/60 167 Hemovigilance Adverse Reaction-- Delayed Hemolytic Transfusion Reaction. 57.310 500 2 20/60 333 Hemovigilance Adverse Reaction-- Delayed Serologic Transfusion Reaction. 57.311 500 4 20/60 667 Hemovigilance Adverse Reaction-- Febrile Non- hemolytic Transfusion Reaction. 57.312 500 1 20/60 167 Hemovigilance Adverse Reaction-- Hypotensive Transfusion Reaction. 57.313 500 1 20/60 167 Hemovigilance Adverse Reaction-- Infection. 57.314 500 1 20/60 167 Hemovigilance Adverse Reaction-- Post Transfusion Purpura. 57.315 500 1 20/60 167 Hemovigilance Adverse Reaction-- Transfusion Associated Dyspnea. 57.316 500 1 20/60 167 Hemovigilance Adverse Reaction-- Transfusion Associated Graft vs. Host Disease. 57.317 500 1 20/60 167 Hemovigilance Adverse Reaction-- Transfusion Related Acute Lung Injury. 57.318 500 2 20/60 333 Hemovigilance Adverse Reaction-- Transfusion Associated Circulatory Overload. 57.319 500 1 20/60 167 Hemovigilance Adverse Reaction-- Unknown Transfusion Reaction. 57.320 500 1 20/60 167 Hemovigilance Adverse Reaction-- Other Transfusion Reaction. [[Page 45447]] 57.400 Outpatient 5,000 1 10/60 417 Procedure Component--Annual Facility Survey. 57.401 Outpatient 5,000 12 20/60 15,000 Procedure Component--Monthl y Reporting Plan. 57.402 Outpatient 1,200 25 40/60 20,000 Procedure Component Same Day Outcome Measures. 57.403 Outpatient 1,200 12 40/60 9,600 Procedure Component--Monthl y Denominators for Same Day Outcome Measures. 57.404 Outpatient 5,000 540 10/60 450,000 Procedure Component--SSI Denominator. 57.405 Outpatient 5,000 36 35/60 105,000 Procedure Component--Surgic al Site (SSI) Event. 57.500 Outpatient 7,000 1 2.12 14,817 Dialysis Center Practices Survey. 57.501 Dialysis 7,000 12 5/60 7,000 Monthly Reporting Plan. 57.502 Dialysis 7,000 60 25/60 175,000 Event. 57.503 Denominator 7,000 12 10/60 14,000 for Outpatient Dialysis. 57.504 Prevention 2,000 12 1.42 17,000 Process Measures Monthly Monitoring for Dialysis. 57.505 Dialysis 325 75 10/60 4,063 Patient Influenza Vaccination. 57.506 Dialysis 325 5 10/60 271 Patient Influenza Vaccination Denominator. 57.507 Home 350 1 30/60 175 Dialysis Center 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. 2018-19382 Filed 9-6-18; 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 November 6, 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 45444 |