80_FR_37390 80 FR 37265 - Proposed Data Collection Submitted for Public Comment and Recommendations

80 FR 37265 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 125 (June 30, 2015)

Page Range37265-37268
FR Document2015-16028

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the National Healthcare Safety Network (NHSN). 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 promote healthcare safety.

Federal Register, Volume 80 Issue 125 (Tuesday, June 30, 2015) 
[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37265-37268]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16028]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-0666; Docket No. CDC-2015-0048]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the National 
Healthcare Safety Network (NHSN). NHSN is a

[[Page 37266]]

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 promote 
healthcare safety.

DATES: Written comments must be received on or before August 31, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0048 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted 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 the 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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; (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; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    National Healthcare Safety Network (NHSN)--Revision--National 
Center for Emerging and Zoonotic Infection Diseases (NCEZID), 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 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. The NHSN currently consists of five components: Patient Safety, 
Healthcare Personnel Safety, Biovigilance, Long-Term Care Facility 
(LTCF), and Dialysis. The Outpatient Procedure Component is on track to 
be released in NHSN in 2016/2017. The development of this component has 
been previously delayed to obtain additional user feedback and support 
from outside partners.
    Changes were made to seven facility surveys. Based on user feedback 
and internal reviews of the annual facility surveys it was determined 
that questions and response options be amended, removed, or added to 
fit the evolving uses of the annual facility surveys. The surveys are 
being increasingly used to help intelligently interpret the other data 
elements reported into NHSN. Currently the surveys are used to 
appropriately risk adjust the numerator and denominator data entered 
into NHSN while also guiding decisions on future division priorities 
for prevention.
    Additionally, minor revisions have been made to 27 forms within the 
package to clarify and/or update surveillance definitions. Two forms 
are being removed as those forms will no longer be added to the NHSN 
system. The previously approved NHSN package included 54 individual 
collection forms; the current revision request removes two forms for a 
total of 52 forms. The reporting burden will increase by 583,825 hours, 
for a total of 4,861,542 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)
----------------------------------------------------------------------------------------------------------------
Registered Nurse (Infection     NHSN                       2,000               1            5/60             167
 Preventionist).                 Registration
                                 Form.
Registered Nurse (Infection     Facility Contact           2,000               1           10/60             333
 Preventionist).                 Information.
Registered Nurse (Infection     Patient Safety             5,000               1           50/60           4,167
 Preventionist).                 Component--Annu
                                 al Hospital
                                 Survey.

[[Page 37267]]

 
Registered Nurse (Infection     Group Contact              1,000               1            5/60              83
 Preventionist).                 Information.
Registered Nurse (Infection     Patient Safety             6,000              12           15/60          18,000
 Preventionist).                 Monthly
                                 Reporting Plan.
Registered Nurse (Infection     Primary                    6,000              44           30/60         132,000
 Preventionist).                 Bloodstream
                                 Infection (BSI).
Registered Nurse (Infection     Pneumonia (PNEU)           6,000              72           30/60         216,000
 Preventionist).
Registered Nurse (Infection     Ventilator-                6,000             144           25/60         360,000
 Preventionist).                 Associated
                                 Event.
Registered Nurse (Infection     Urinary Tract              6,000              40           20/60          80,000
 Preventionist).                 Infection (UTI).
Staff RN......................  Denominators for           6,000               9               3         162,000
                                 Neonatal
                                 Intensive Care
                                 Unit (NICU).
Staff RN......................  Denominators for           6,000               9               5         270,000
                                 Specialty Care
                                 Area (SCA)/
                                 Oncology (ONC).
Staff RN......................  Denominators for           6,000              60               5       1,800,000
                                 Intensive Care
                                 Unit (ICU)/
                                 Other locations
                                 (not NICU or
                                 SCA).
Registered Nurse (Infection     Surgical Site              6,000              36           35/60         126,000
 Preventionist).                 Infection (SSI).
Staff RN......................  Denominator for            6,000             540            5/60         270,000
                                 Procedure.
Laboratory Technician.........  Antimicrobial              6,000              12            5/60           6,000
                                 Use and
                                 Resistance
                                 (AUR)-
                                 Microbiology
                                 Data Electronic
                                 Upload
                                 Specification
                                 Tables.
Pharmacy Technician...........  Antimicrobial              6,000              12            5/60           6,000
                                 Use and
                                 Resistance
                                 (AUR)-Pharmacy
                                 Data Electronic
                                 Upload
                                 Specification
                                 Tables.
Registered Nurse (Infection     Central Line               1,000             100           25/60          41,667
 Preventionist).                 Insertion
                                 Practices
                                 Adherence
                                 Monitoring.
Registered Nurse (Infection     MDRO or CDI                6,000              72           30/60         216,000
 Preventionist).                 Infection Form.
Registered Nurse (Infection     MDRO and CDI               6,000              24           15/60          36,000
 Preventionist).                 Prevention
                                 Process and
                                 Outcome
                                 Measures
                                 Monthly
                                 Monitoring.
Registered Nurse (Infection     Laboratory-                6,000             240           30/60         720,000
 Preventionist).                 identified MDRO
                                 or CDI Event.
Registered Nurse (Infection     Long-Term Care               250               1               1             250
 Preventionist).                 Facility
                                 Component--Annu
                                 al Facility
                                 Survey.
Registered Nurse (Infection     Laboratory-                  250               8           15/60             500
 Preventionist).                 identified MDRO
                                 or CDI Event
                                 for LTCF.
Registered Nurse (Infection     MDRO and CDI                 250              12            5/60             250
 Preventionist).                 Prevention
                                 Process
                                 Measures
                                 Monthly
                                 Monitoring for
                                 LTCF.
Registered Nurse (Infection     Urinary Tract                250               9           30/60           1,125
 Preventionist).                 Infection (UTI)
                                 for LTCF.
Registered Nurse (Infection     Monthly                      250              12            5/60             250
 Preventionist).                 Reporting Plan
                                 for LTCF.
Registered Nurse (Infection     Denominators for             250              12            3.25           9,750
 Preventionist).                 LTCF Locations.
Registered Nurse (Infection     Prevention                   250              12            5/60             250
 Preventionist).                 Process
                                 Measures
                                 Monthly
                                 Monitoring for
                                 LTCF.
Registered Nurse (Infection     LTAC Annual                  400               1           50/60             333
 Preventionist).                 Survey.
Registered Nurse (Infection     Rehab Annual               1,000               1           50/60             833
 Preventionist).                 Survey.
Occupational Health RN/         Healthcare                    50               1               8             400
 Specialist.                     Personnel
                                 Safety
                                 Component
                                 Annual Facility
                                 Survey.
Occupational Health RN/         Healthcare                17,000               1            5/60           1,417
 Specialist.                     Personnel
                                 Safety Monthly
                                 Reporting Plan.
Occupational Health RN/         Healthcare                    50             200           20/60           3,333
 Specialist.                     Worker
                                 Demographic
                                 Data.
Occupational Health RN/         Exposure to                   50              50               1           2,500
 Specialist.                     Blood/Body
                                 Fluids.
Occupational Health RN/         Healthcare                    50              30           15/60             375
 Specialist.                     Worker
                                 Prophylaxis/
                                 Treatment.
Laboratory Technician.........  Follow-Up                     50              50           15/60             625
                                 Laboratory
                                 Testing.
Occupational Health RN/         Healthcare                    50              50           10/60             417
 Specialist.                     Worker
                                 Prophylaxis/
                                 Treatment-
                                 Influenza.

[[Page 37268]]

 
Medical/Clinical Laboratory     Hemovigilance                500               1               2           1,000
 Technologist.                   Module Annual
                                 Survey.
Medical/Clinical Laboratory     Hemovigilance                500              12            1/60             100
 Technologist.                   Module Monthly
                                 Reporting Plan.
Medical/Clinical Laboratory     Hemovigilance                500              12               1           6,000
 Technologist.                   Module Monthly
                                 Reporting
                                 Denominators.
Medical/Clinical Laboratory     Hemovigilance                500              48           15/60           6,000
 Technologist.                   Adverse
                                 Reaction.
Medical/Clinical Laboratory     Hemovigilance                500              10           10/60             833
 Technologist.                   Incident.
Staff RN......................  Patient Safety             5,000               1            5/60             417
                                 Component--Annu
                                 al Facility
                                 Survey for
                                 Ambulatory
                                 Surgery Center
                                 (ASC).
Staff RN......................  Outpatient                 5,000              12           15/60          15,000
                                 Procedure
                                 Component--Mont
                                 hly Reporting
                                 Plan.
Staff RN......................  Outpatient                 5,000              25           40/60          83,333
                                 Procedure
                                 Component Event.
Staff RN......................  Outpatient                 5,000              12           40/60          40,000
                                 Procedure
                                 Component--Mont
                                 hly
                                 Denominators
                                 and Summary.
Registered Nurse (Infection     Outpatient                 6,500               1             2.0          13,000
 Preventionist).                 Dialysis Center
                                 Practices
                                 Survey.
Staff RN......................  Dialysis Monthly           6,500              12            5/60           6,500
                                 Reporting Plan.
Staff RN......................  Dialysis Event..           6,500              60           25/60         162,500
Staff RN......................  Denominators for           6,500              12           10/60          13,000
                                 Dialysis Event
                                 Surveillance.
Staff RN......................  Prevention                 1,500              12            1.25          22,500
                                 Process
                                 Measures
                                 Monthly
                                 Monitoring for
                                 Dialysis.
Staff RN......................  Dialysis Patient             325              75           10/60           4,063
                                 Influenza
                                 Vaccination.
Staff RN......................  Dialysis Patient             325               5           10/60             271
                                 Influenza
                                 Vaccination
                                 Denominator.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............       4,861,542
----------------------------------------------------------------------------------------------------------------


Maryam I. Daneshvar,
Deputy Director, Office of Scientific Integrity, Office of the 
Associate Director for Science, Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2015-16028 Filed 6-29-15; 8:45 am]
 BILLING CODE 4163-18-P

Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices 37265 collecting, validating and verifying primary risk for acute hepatitis C. The primarily through drug treatment information, processing and prevention of HCV infection among programs and syringe exchange maintaining information, and disclosing PWIDs requires an integrated approach programs, as well as persons referred to and providing information; to train including harm reduction interventions, these sites as a result of referral from personnel and to be able to respond to substance abuse treatment, prevention other programs and respondent driven a collection of information, to search of other blood borne infections, and care sampling. Those who consent to data sources, to complete and review and treatment of HCV infection. participate will be administered an the collection of information; and to The purpose of the proposed study is eligibility interview questionnaire by transmit or otherwise disclose the to address the high prevalence of HCV trained field staff. If found eligible, the information. infection by developing and participant will take an interviewer- implementing an integrated approach administered survey that includes Proposed Project for detection, prevention, care and information on initiation of drug use, Prevent Hepatitis Transmission Among treatment of infection among persons injection practices, HCV and HIV Persons Who Inject Drugs—New— aged 18–30 years who reside in non- infection status, access to prevention National Center for HIV/AIDS, Viral urban counties. Awardees will develop and medical care, desire to receive and Hepatitis, STD, and TB Prevention and implement a comprehensive barriers to receiving HCV treatment, and (NCHHSTP), Centers for Disease strategy to enroll young non-urban missed opportunities for hepatitis Control and Prevention (CDC) PWID, collect epidemiological prevention. Participants will receive Background and Brief Description information, test for HCV infection and counselling regarding adherence to provide linkage to primary care services, medical and/or drug treatment services Hepatitis C virus (HCV) infection is prevention interventions, and treatment and prevention services. Participants the most common chronic blood borne for substance abuse and HCV infection. will be interviewed for a maximum of infection in the United States; In addition to providing HCV testing, 5 times within any 12-month interval approximately 3 million persons are participants will be offered testing for during the course of the study: Consent chronically infected. Identifying and the presence of co-infections with and interview at enrollment/baseline for reaching persons at risk for HCV hepatitis B virus (HBV) and HIV. Rates an estimated 60 minutes, and 30-minute infection is critical to prevent of HCV infection or re-infection will be follow-up interviews every 3 months transmission and treat and cure if evaluated through follow-up blood tests. thereafter. Participants who are infected. CDC monitors the national Furthermore, adherence to prevention recruited early in the study have more incidence of acute hepatitis C through services and retention in care will be follow-up interviews than those who are passive surveillance of acute, assessed through follow up interviews. recruited in the later part of the study symptomatic cases of laboratory The project will recruit an estimated during the 3-year project. However, confirmed hepatitis C cases. Since 2006, total of 1,500 young PWIDs to enroll recruitment will be spread over 2 years surveillance data have shown a trend 1,000. The participants will be recruited and on average, the duration of follow- toward reemergence of HCV infection from settings where young PWIDs up is estimated to be one year. mainly among young persons who inject obtain access to care and treatment Participation in interviews and drugs (PWID) in nonurban counties. Of services. Recruitment will be direct and responses to all study questions are the cases reported in 2013 with in-person by partnering with local harm totally voluntary and there is no cost to information on risk factors 62% reduction sites. Recruiters will enroll respondents other than their time. The indicated injection drug use as the subjects across recruitment sites maximum burden is 3,375 hours. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden Type of respondents Form name responses per respondents respondent response (in hrs.) (in hrs.) Young PWIDs ................................... Screener ........................................... 1500 1 15/60 375 Eligible young PWIDs ....................... Initial Survey ..................................... 1000 1 60/60 1000 Eligible young PWIDs ....................... Follow-up survey .............................. 1000 4 30/60 2000 Total ........................................... ........................................................... ........................ ........................ ........................ 3375 Maryam I. Daneshvar, DEPARTMENT OF HEALTH AND ACTION: Notice with comment period. Deputy Director, Office of Scientific Integrity, HUMAN SERVICES Office of the Associate Director for Science, SUMMARY: The Centers for Disease Office of the Director, Centers for Disease Centers for Disease Control and Control and Prevention (CDC), as part of Control and Prevention. Prevention its continuing efforts to reduce public [FR Doc. 2015–16027 Filed 6–29–15; 8:45 am] burden and maximize the utility of [60Day–15–0666; Docket No. CDC–2015– government information, invites the asabaliauskas on DSK5VPTVN1PROD with NOTICES BILLING CODE 4163–18–P 0048] general public and other Federal agencies to take this opportunity to Proposed Data Collection Submitted comment on proposed and/or for Public Comment and continuing information collections, as Recommendations required by the Paperwork Reduction AGENCY: Centers for Disease Control and Act of 1995. This notice invites Prevention (CDC), Department of Health comment on the National Healthcare and Human Services (HHS). Safety Network (NHSN). NHSN is a VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1

37266 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices system designed to accumulate, extension of existing collection of accumulate, exchange, and integrate exchange, and integrate relevant information, and each reinstatement of relevant information and resources information and resources among previously approved information among private and public stakeholders private and public stakeholders to collection before submitting the to support local and national efforts to support local and national efforts to collection to OMB for approval. To protect patients and promote healthcare protect patients and promote healthcare comply with this requirement, we are safety. Specifically, the data is used to safety. publishing this notice of a proposed determine the magnitude of various DATES: Written comments must be data collection as described below. healthcare-associated adverse events received on or before August 31, 2015. Comments are invited on: (a) Whether and trends in the rates of these events ADDRESSES: You may submit comments, the proposed collection of information among patients and healthcare workers identified by Docket No. CDC–2015– is necessary for the proper performance with similar risks. The data will be used 0048 by any of the following methods: of the functions of the agency, including to detect changes in the epidemiology of • Federal eRulemaking Portal: whether the information shall have adverse events resulting from new and Regulation.gov. Follow the instructions practical utility; (b) the accuracy of the current medical therapies and changing for submitting comments. agency’s estimate of the burden of the risks. The NHSN currently consists of • Mail: Leroy A. Richardson, proposed collection of information; (c) five components: Patient Safety, Information Collection Review Office, ways to enhance the quality, utility, and clarity of the information to be Healthcare Personnel Safety, Centers for Disease Control and Biovigilance, Long-Term Care Facility Prevention, 1600 Clifton Road NE., MS– collected; (d) ways to minimize the burden of the collection of information (LTCF), and Dialysis. The Outpatient D74, Atlanta, Georgia 30329. Procedure Component is on track to be Instructions: All submissions received on respondents, including through the use of automated collection techniques released in NHSN in 2016/2017. The must include the agency name and or other forms of information development of this component has Docket Number. All relevant comments received will be posted without change technology; and (e) estimates of capital been previously delayed to obtain to Regulations.gov, including any or start-up costs and costs of operation, additional user feedback and support personal information provided. For maintenance, and purchase of services from outside partners. access to the docket to read background to provide information. Burden means Changes were made to seven facility documents or comments received, go to the total time, effort, or financial surveys. Based on user feedback and Regulations.gov. resources expended by persons to internal reviews of the annual facility Please note: All public comment should be generate, maintain, retain, disclose or surveys it was determined that submitted through the Federal eRulemaking provide information to or for a Federal questions and response options be portal (Regulations.gov) or by U.S. mail to the agency. This includes the time needed amended, removed, or added to fit the address listed above. to review instructions; to develop, evolving uses of the annual facility acquire, install and utilize technology surveys. The surveys are being FOR FURTHER INFORMATION CONTACT: To and systems for the purpose of increasingly used to help intelligently request more information on the collecting, validating and verifying interpret the other data elements proposed project or to obtain a copy of information, processing and reported into NHSN. Currently the the information collection plan and maintaining information, and disclosing surveys are used to appropriately risk instruments, contact the Information and providing information; to train adjust the numerator and denominator Collection Review Office, Centers for personnel and to be able to respond to data entered into NHSN while also Disease Control and Prevention, 1600 a collection of information, to search guiding decisions on future division Clifton Road NE., MS–D74, Atlanta, data sources, to complete and review priorities for prevention. Georgia 30329; phone: 404–639–7570; the collection of information; and to Email: omb@cdc.gov. Additionally, minor revisions have transmit or otherwise disclose the SUPPLEMENTARY INFORMATION: Under the been made to 27 forms within the information. Paperwork Reduction Act of 1995 (PRA) package to clarify and/or update (44 U.S.C. 3501–3520), Federal agencies Proposed Project surveillance definitions. Two forms are must obtain approval from the Office of National Healthcare Safety Network being removed as those forms will no Management and Budget (OMB) for each (NHSN)—Revision—National Center for longer be added to the NHSN system. collection of information they conduct Emerging and Zoonotic Infection The previously approved NHSN or sponsor. In addition, the PRA also Diseases (NCEZID), Centers for Disease package included 54 individual requires Federal agencies to provide a Control and Prevention (CDC). collection forms; the current revision 60-day notice in the Federal Register request removes two forms for a total of concerning each proposed collection of Background and Brief Description 52 forms. The reporting burden will information, including each new The National Healthcare Safety increase by 583,825 hours, for a total of proposed collection, each proposed Network (NHSN) is a system designed to 4,861,542 hours. ESTIMATED ANNUALIZED BURDEN HOURS Average Number of Number of burden per Total burden asabaliauskas on DSK5VPTVN1PROD with NOTICES Type of respondents Form name responses per respondents response (in hours) respondent (in hours) Registered Nurse (Infection NHSN Registration Form ................. 2,000 1 5/60 167 Preventionist). Registered Nurse (Infection Facility Contact Information ............. 2,000 1 10/60 333 Preventionist). Registered Nurse (Infection Patient Safety Component—Annual 5,000 1 50/60 4,167 Preventionist). Hospital Survey. VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1

Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices 37267 ESTIMATED ANNUALIZED BURDEN HOURS—Continued Average Number of Number of burden per Total burden Type of respondents Form name responses per respondents response (in hours) respondent (in hours) Registered Nurse (Infection Group Contact Information ............... 1,000 1 5/60 83 Preventionist). Registered Nurse (Infection Patient Safety Monthly Reporting 6,000 12 15/60 18,000 Preventionist). Plan. Registered Nurse (Infection Primary Bloodstream Infection (BSI) 6,000 44 30/60 132,000 Preventionist). Registered Nurse (Infection Pneumonia (PNEU) .......................... 6,000 72 30/60 216,000 Preventionist). Registered Nurse (Infection Ventilator-Associated Event ............. 6,000 144 25/60 360,000 Preventionist). Registered Nurse (Infection Urinary Tract Infection (UTI) ............ 6,000 40 20/60 80,000 Preventionist). Staff RN ............................................ Denominators for Neonatal Intensive 6,000 9 3 162,000 Care Unit (NICU). Staff RN ............................................ Denominators for Specialty Care 6,000 9 5 270,000 Area (SCA)/Oncology (ONC). Staff RN ............................................ Denominators for Intensive Care 6,000 60 5 1,800,000 Unit (ICU)/Other locations (not NICU or SCA). Registered Nurse (Infection Surgical Site Infection (SSI) ............. 6,000 36 35/60 126,000 Preventionist). Staff RN ............................................ Denominator for Procedure .............. 6,000 540 5/60 270,000 Laboratory Technician ...................... Antimicrobial Use and Resistance 6,000 12 5/60 6,000 (AUR)-Microbiology Data Elec- tronic Upload Specification Tables. Pharmacy Technician ....................... Antimicrobial Use and Resistance 6,000 12 5/60 6,000 (AUR)-Pharmacy Data Electronic Upload Specification Tables. Registered Nurse (Infection Central Line Insertion Practices Ad- 1,000 100 25/60 41,667 Preventionist). herence Monitoring. Registered Nurse (Infection MDRO or CDI Infection Form .......... 6,000 72 30/60 216,000 Preventionist). Registered Nurse (Infection MDRO and CDI Prevention Process 6,000 24 15/60 36,000 Preventionist). and Outcome Measures Monthly Monitoring. Registered Nurse (Infection Laboratory-identified MDRO or CDI 6,000 240 30/60 720,000 Preventionist). Event. Registered Nurse (Infection Long-Term Care Facility Compo- 250 1 1 250 Preventionist). nent—Annual Facility Survey. Registered Nurse (Infection Laboratory-identified MDRO or CDI 250 8 15/60 500 Preventionist). Event for LTCF. Registered Nurse (Infection MDRO and CDI Prevention Process 250 12 5/60 250 Preventionist). Measures Monthly Monitoring for LTCF. Registered Nurse (Infection Urinary Tract Infection (UTI) for 250 9 30/60 1,125 Preventionist). LTCF. Registered Nurse (Infection Monthly Reporting Plan for LTCF .... 250 12 5/60 250 Preventionist). Registered Nurse (Infection Denominators for LTCF Locations ... 250 12 3.25 9,750 Preventionist). Registered Nurse (Infection Prevention Process Measures 250 12 5/60 250 Preventionist). Monthly Monitoring for LTCF. Registered Nurse (Infection LTAC Annual Survey ....................... 400 1 50/60 333 Preventionist). Registered Nurse (Infection Rehab Annual Survey ...................... 1,000 1 50/60 833 Preventionist). Occupational Health RN/Specialist ... Healthcare Personnel Safety Com- 50 1 8 400 ponent Annual Facility Survey. Occupational Health RN/Specialist ... Healthcare Personnel Safety Month- 17,000 1 5/60 1,417 asabaliauskas on DSK5VPTVN1PROD with NOTICES ly Reporting Plan. Occupational Health RN/Specialist ... Healthcare Worker Demographic 50 200 20/60 3,333 Data. Occupational Health RN/Specialist ... Exposure to Blood/Body Fluids ........ 50 50 1 2,500 Occupational Health RN/Specialist ... Healthcare Worker Prophylaxis/ 50 30 15/60 375 Treatment. Laboratory Technician ...................... Follow-Up Laboratory Testing .......... 50 50 15/60 625 Occupational Health RN/Specialist ... Healthcare Worker Prophylaxis/ 50 50 10/60 417 Treatment-Influenza. VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1

37268 Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Average Number of Number of burden per Total burden Type of respondents Form name responses per respondents response (in hours) respondent (in hours) Medical/Clinical Laboratory Tech- Hemovigilance Module Annual Sur- 500 1 2 1,000 nologist. vey. Medical/Clinical Laboratory Tech- Hemovigilance Module Monthly Re- 500 12 1/60 100 nologist. porting Plan. Medical/Clinical Laboratory Tech- Hemovigilance Module Monthly Re- 500 12 1 6,000 nologist. porting Denominators. Medical/Clinical Laboratory Tech- Hemovigilance Adverse Reaction .... 500 48 15/60 6,000 nologist. Medical/Clinical Laboratory Tech- Hemovigilance Incident .................... 500 10 10/60 833 nologist. Staff RN ............................................ Patient Safety Component—Annual 5,000 1 5/60 417 Facility Survey for Ambulatory Surgery Center (ASC). Staff RN ............................................ Outpatient Procedure Component— 5,000 12 15/60 15,000 Monthly Reporting Plan. Staff RN ............................................ Outpatient Procedure Component 5,000 25 40/60 83,333 Event. Staff RN ............................................ Outpatient Procedure Component— 5,000 12 40/60 40,000 Monthly Denominators and Sum- mary. Registered Nurse (Infection Outpatient Dialysis Center Practices 6,500 1 2.0 13,000 Preventionist). Survey. Staff RN ............................................ Dialysis Monthly Reporting Plan ...... 6,500 12 5/60 6,500 Staff RN ............................................ Dialysis Event ................................... 6,500 60 25/60 162,500 Staff RN ............................................ Denominators for Dialysis Event 6,500 12 10/60 13,000 Surveillance. Staff RN ............................................ Prevention Process Measures 1,500 12 1.25 22,500 Monthly Monitoring for Dialysis. Staff RN ............................................ Dialysis Patient Influenza Vaccina- 325 75 10/60 4,063 tion. Staff RN ............................................ Dialysis Patient Influenza Vaccina- 325 5 10/60 271 tion Denominator. Total ........................................... ........................................................... ........................ ........................ ........................ 4,861,542 Maryam I. Daneshvar, Health, Dallas Regional Office, 1301 dually-eligible for Medicare and Deputy Director, Office of Scientific Integrity, Young Street, Room 714, Dallas, TX Medicaid that exceeds the Medicaid Office of the Associate Director for Science, 75202, to reconsider CMS’ decision to allowable cost for the service provided Office of the Director, Centers for Disease disapprove Texas’ Medicaid SPA 14–25. to the recipient. This exclusion would Control and Prevention. Closing Date: Requests to participate permit the state to make Medicaid DSH [FR Doc. 2015–16028 Filed 6–29–15; 8:45 am] in the hearing as a party must be payments that are above and beyond BILLING CODE 4163–18–P received by the presiding officer by July hospitals’ reported uncompensated 15, 2015. costs of providing services to Medicaid FOR FURTHER INFORMATION CONTACT: and uninsured individuals. DEPARTMENT OF HEALTH AND Benjamin R. Cohen, Presiding Officer, The issue to be considered at the HUMAN SERVICES (HHS) CMS, 2520 Lord Baltimore Drive, Suite hearing is: L, Baltimore, Maryland 21244; Centers for Medicare and Medicaid • Whether Texas SPA 14–25 is Telephone: (410) 786–3169. inconsistent with Medicaid DSH Services SUPPLEMENTARY INFORMATION: This requirements of sections 1902(a)(13)(A)(iv) Notice of Hearing: Reconsideration of notice announces an administrative and 1923 of the Social Security Act (Act) Disapproval Texas Medicaid State Plan hearing to reconsider CMS’ decision to because it would provide for payment to Amendment (SPA) 14–25 disapprove Texas’ Medicaid SPA 14–25, disproportionate share hospitals of amounts which was submitted to the Centers for that exceed the hospital’s uncompensated AGENCY: Centers for Medicare and Medicare and Medicaid Services (CMS) costs which cannot be considered consistent Medicaid Services (CMS), HHS. with DSH requirements pursuant to the on August 26, 2014 and disapproved on hospital-specific limit under section April 7, 2015. In part, this SPA asabaliauskas on DSK5VPTVN1PROD with NOTICES ACTION: Notice of Hearing: 1923(g)(1) of the Act. Reconsideration of Disapproval. requested CMS approval to revise the methodology for calculating the Section 1116 of the Act and federal SUMMARY: This notice announces an hospital-specific limit for the regulations at 42 CFR part 430, establish administrative hearing to be held on Disproportionate Share Hospital (DSH) Department procedures that provide an August 6, 2015, at the Department of program. Specifically, SPA 14–25 administrative hearing for Health and Human Services, Centers for proposed to exclude from the reconsideration of a disapproval of a Medicare and Medicaid Services, calculation, the portion of a Medicare state plan or plan amendment. CMS is Division of Medicaid & Children’s payment for an individual who is required to publish a copy of the notice VerDate Sep<11>2014 17:34 Jun 29, 2015 Jkt 235001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\30JNN1.SGM 30JNN1


Document Created: 2018-02-22 11:17:05
Document Modified: 2018-02-22 11:17:05
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before August 31, 2015.
ContactTo request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the 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 Citation80 FR 37265 
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