Agency Forms Undergoing Paperwork Reduction Act Review, 13344-13345 [2013-04508]

Download as PDF 13344 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–13–0852] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 639–7570 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project Prevalence Survey of HealthcareAssociated Infections (HAIs) in Acute Care Hospitals in the United States— Extension—(0920–0852 exp.5/31/13)— National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC). Background and Brief Description Preventing healthcare-associated infections (HAIs) is a CDC priority. An essential step in reducing the occurrence of HAIs is to estimate accurately the burden of these infections in U.S. hospitals, and to describe the types of HAIs and causative organisms. The scope and magnitude of HAIs in the United States were last directly estimated in the 1970s by CDC’s Study on the Efficacy of Nosocomial Infection Control (SENIC), in which comprehensive data were collected from a sample of 338 hospitals; 5% of hospitalized patients acquired an infection not present at the time of admission. Because of the substantial resources necessary to conduct hospitalwide surveillance in an ongoing manner, most of the more than 4,500 hospitals now reporting to the CDC’s current HAI surveillance system, the National Healthcare Safety Network (NHSN 0920–0666 expires 1/31/15), focus instead on device-associated and procedure-associated infections in a selected patient locations, and do not report data on all types of HAIs occurring hospital-wide. Periodic assessments of the magnitude and types of HAIs occurring in all patient populations within acute care hospitals are needed to inform decisions by local and national policy makers and by hospital infection control personnel regarding appropriate targets and strategies for HAI prevention. Such assessments can be obtained in periodic national prevalence surveys, such as those that have been conducted in several European countries. In 2008–2009, CDC developed a pilot protocol for a HAI point prevalence survey, conducted over a 1-day period at each of 9 acute care hospitals in one U.S. city. This pilot phase was followed in 2010 by a phase 2, limited roll-out HAI and antimicrobial use prevalence survey, conducted during July and August in 22 hospitals across 10 Emerging Infections Program sites (in California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee). Experience gained in the phase 1 and phase 2 surveys was used to conduct a full-scale, phase 3 survey in 2011, involving 183 hospitals in the 10 EIP sites. Over 11,000 patients were surveyed, and analysis of HAI and antimicrobial use data is ongoing at this time. Preliminary HAI prevalence results were presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (San Francisco, CA, September 8–12, 2012) and preliminary antimicrobial use results were presented at the 2012 IDWeek conference (San Diego, CA, October 17–21, 2012). An extension of the prevalence survey’s existing OMB approval is sought, to allow a repeat HAI and antimicrobial use prevalence survey to be performed in 2014. A repeat survey will allow further refinement of survey methodology and assessment of changes over time in prevalence, HAI distribution, and pathogen distribution. It will also allow for a re-assessment of the burden of antimicrobial use, at a time when antimicrobial stewardship is an area of active engagement in many acute care hospitals. The 2014 survey will be performed in a sample of up to 500 acute care hospitals, drawn from the acute care hospital populations in each of the 10 EIP sites (and including participation from many hospitals that participated in prior phases of the survey). Infection prevention personnel in participating hospitals and EIP site personnel will collect demographic and clinical data from the medical records of a sample of eligible patients in their hospitals on a single day in 2014, to identify CDC-defined HAIs. The surveys will provide data for CDC to make estimates of the prevalence of HAIs across this sample of U.S. hospitals as well as the distribution of infection types and causative organisms. These data can be used to work toward reducing and eliminating healthcareassociated infections—a DHHS Healthy People 2020 objective (http:// www.healthypeople.gov/2020/ topicsobjectives2020/ overview.aspx?topicid=17). This survey project also supports the CDC Winnable Battle goal of improving national surveillance for healthcare-associated infections (http://www.cdc.gov/ winnablebattles/Goals.html). The total burden is 9,375 hours, which represents an increase of 250 hours over the previously approved burden. The increase is requested because the median number of responses per respondent in the 2011 phase 3 survey was 75. Previously, we had estimated 73 responses per respondent. There are no costs to respondents. The total estimated annualized burden is 9,375. ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response in hours Infection Prevention Personnel in Participating Hospitals ........................................................... erowe on DSK2VPTVN1PROD with NOTICES Respondents 500 75 15/60 VerDate Mar<15>2010 15:18 Feb 26, 2013 Jkt 229001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\27FEN1.SGM 27FEN1 13345 Federal Register / Vol. 78, No. 39 / Wednesday, February 27, 2013 / Notices *Assumptions: One respondent per hospital, collection of data on median of 75 patients per hospital, average data collection time of 15 minutes per patient. Kimberly S. Lane, 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. 2013–04508 Filed 2–26–13; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–13–0263] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Proposed Project Requirements for the Importation of Nonhuman Primates into the United States (formerly Requirements for a Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States) (OMB Control No. 0920–0263 Exp.6/30/2014)—Revision— National Center Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC). Background and Brief Description Since May 1990, CDC has monitored the arrival and/or uncrating of certain shipments of non-human primates imported into the United States under a special permit program specific to Cynomolgus, African Green, or Rhesus Monkeys. CDC has monitored compliance with this special permit through the collection of information focused on determining whether or not importers conduct adequate disease control practices. Importers were required to renew their special permit every 180 days. In February 2013, CDC promulgated two regulations pertaining to the importation of nonhuman primates. The first rule rule, Requirements for Importers of Nonhuman Primates (2/15/ 2013, Vol. 78, No. 32/p. 11522) consolidates into 42 CFR 71.53 the requirements previously found in 42 CFR part 71.53 with those found in the Special Permit to Import Cynomolgus, African Green, or Rhesus Monkeys into the United States. It also extended the time period for registration/permit renewal from 180 days to 2 years. The Special Permit has been withdrawn. The requirements found therein are now incorporated into the revised final rule for 42 CFR 71.53. The second rule, Establishment of User Fees for Filovirus Testing of Nonhuman Primate Liver Samples (2/12/2013, Vol.78, No. 29, p.9828), outlines a process by which importers can send liver tissues to CDC from primates that die during importation from reasons other than trauma. CDC performs these tests due to the absence of a private sector option. CDC feels these regulatory changes balance the public health risks posed by the importation of nonhuman primates with the burden imposed on regulating their importation. These rule changes have prompted CDC to modify how it administers the information collected from the public in the enforcement of nonhuman primate regulations. CDC is requesting the following changes: 1. CDC requests that this information collection request be re-named ‘‘Requirements for the Importation of Nonhuman Primates into the United States’’ to more accurately reflect the type of information that is requested from respondents. 2. To streamline administration of this information collection request, CDC requests that CDC form 75.10A Application for Registration as an Importer of Nonhuman Primates and the Recordkeeping requirement currently approved under OMB Control Number 0920–0134 Foreign Quarantine Regulations, be moved and included in this revision to OMB Control Number 0920–0263. This action places all nonhuman primate information collection requirements and requests into one information collection request administered by CDC. 3. CDC is renaming the different portions of the information collected in this information collection to more accurately list the types of forms and documentation CDC collects from importers of nonhuman primates. Therefore, the former information categories of Businesses (limited permit), Businesses (extended permit), and Organizations (extended permit) are being renamed and reorganized. The information contained in these categories will now be accounted for in the Documentation sections of the burden table. This categorization will more accurately reflect CDC’s interaction with the importers. 4. CDC also requests additional burden hours to account for notification to CDC from importers of shipment arrivals and requests for release from quarantine. 5. CDC further requests the addition of the Filovirus Diagnostic Specimen Submission Form for Non-human Primate Materials, which will be used to collect all of the necessary information from nonhuman primate importers to test nonhuman primate liver samples for filovirus and communicate the results of this test. This action adds approximately 50 hours of burden to this information collection request. This information collection involves minimal personally identifiable information and should have limited impact on an individual’s privacy. There are no costs to respondents other than their time. The total burden requested for this information collection is 146. erowe on DSK2VPTVN1PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Type of respondent Nonhuman Primate Importer .......................... Nonhuman Primate Importer .......................... VerDate Mar<15>2010 15:18 Feb 26, 2013 Jkt 229001 71.53(g) New Importer Nonhuman Primates. 71.53(g) Importer ReNonhuman Primates. PO 00000 Frm 00046 Fmt 4703 Number of responses per respondent Number of respondents Form name/CFR reference Average burden per response (in hours) Registration— 1 1 10/60 Registration— 12 1 10/60 Sfmt 4703 E:\FR\FM\27FEN1.SGM 27FEN1

Agencies

[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13344-13345]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04508]



[[Page 13344]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-13-0852]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review by the Office of 
Management and Budget (OMB) in compliance with the Paperwork Reduction 
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call 
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments 
to CDC Desk Officer, Office of Management and Budget, Washington, DC 
20503 or by fax to (202) 395-5806. Written comments should be received 
within 30 days of this notice.

Proposed Project

    Prevalence Survey of Healthcare-Associated Infections (HAIs) in 
Acute Care Hospitals in the United States--Extension--(0920-0852 exp.5/
31/13)--National Center for Emerging and Zoonotic Infectious Diseases, 
Centers for Disease Control and Prevention (CDC).

Background and Brief Description

    Preventing healthcare-associated infections (HAIs) is a CDC 
priority. An essential step in reducing the occurrence of HAIs is to 
estimate accurately the burden of these infections in U.S. hospitals, 
and to describe the types of HAIs and causative organisms. The scope 
and magnitude of HAIs in the United States were last directly estimated 
in the 1970s by CDC's Study on the Efficacy of Nosocomial Infection 
Control (SENIC), in which comprehensive data were collected from a 
sample of 338 hospitals; 5% of hospitalized patients acquired an 
infection not present at the time of admission. Because of the 
substantial resources necessary to conduct hospital-wide surveillance 
in an ongoing manner, most of the more than 4,500 hospitals now 
reporting to the CDC's current HAI surveillance system, the National 
Healthcare Safety Network (NHSN 0920-0666 expires 1/31/15), focus 
instead on device-associated and procedure-associated infections in a 
selected patient locations, and do not report data on all types of HAIs 
occurring hospital-wide. Periodic assessments of the magnitude and 
types of HAIs occurring in all patient populations within acute care 
hospitals are needed to inform decisions by local and national policy 
makers and by hospital infection control personnel regarding 
appropriate targets and strategies for HAI prevention. Such assessments 
can be obtained in periodic national prevalence surveys, such as those 
that have been conducted in several European countries.
    In 2008-2009, CDC developed a pilot protocol for a HAI point 
prevalence survey, conducted over a 1-day period at each of 9 acute 
care hospitals in one U.S. city. This pilot phase was followed in 2010 
by a phase 2, limited roll-out HAI and antimicrobial use prevalence 
survey, conducted during July and August in 22 hospitals across 10 
Emerging Infections Program sites (in California, Colorado, 
Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, 
Oregon, and Tennessee). Experience gained in the phase 1 and phase 2 
surveys was used to conduct a full-scale, phase 3 survey in 2011, 
involving 183 hospitals in the 10 EIP sites. Over 11,000 patients were 
surveyed, and analysis of HAI and antimicrobial use data is ongoing at 
this time. Preliminary HAI prevalence results were presented at the 
52nd Interscience Conference on Antimicrobial Agents and Chemotherapy 
(San Francisco, CA, September 8-12, 2012) and preliminary antimicrobial 
use results were presented at the 2012 IDWeek conference (San Diego, 
CA, October 17-21, 2012).
    An extension of the prevalence survey's existing OMB approval is 
sought, to allow a repeat HAI and antimicrobial use prevalence survey 
to be performed in 2014. A repeat survey will allow further refinement 
of survey methodology and assessment of changes over time in 
prevalence, HAI distribution, and pathogen distribution. It will also 
allow for a re-assessment of the burden of antimicrobial use, at a time 
when antimicrobial stewardship is an area of active engagement in many 
acute care hospitals. The 2014 survey will be performed in a sample of 
up to 500 acute care hospitals, drawn from the acute care hospital 
populations in each of the 10 EIP sites (and including participation 
from many hospitals that participated in prior phases of the survey). 
Infection prevention personnel in participating hospitals and EIP site 
personnel will collect demographic and clinical data from the medical 
records of a sample of eligible patients in their hospitals on a single 
day in 2014, to identify CDC-defined HAIs. The surveys will provide 
data for CDC to make estimates of the prevalence of HAIs across this 
sample of U.S. hospitals as well as the distribution of infection types 
and causative organisms. These data can be used to work toward reducing 
and eliminating healthcare-associated infections--a DHHS Healthy People 
2020 objective (http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=17). This survey project also supports the CDC 
Winnable Battle goal of improving national surveillance for healthcare-
associated infections (http://www.cdc.gov/winnablebattles/Goals.html).
    The total burden is 9,375 hours, which represents an increase of 
250 hours over the previously approved burden. The increase is 
requested because the median number of responses per respondent in the 
2011 phase 3 survey was 75. Previously, we had estimated 73 responses 
per respondent. There are no costs to respondents. The total estimated 
annualized burden is 9,375.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                   Number of     Average  burden
                         Respondents                              Number of      responses per    per  response
                                                                 respondents       respondent        in hours
----------------------------------------------------------------------------------------------------------------
Infection Prevention Personnel in Participating Hospitals....             500               75            15/60
----------------------------------------------------------------------------------------------------------------


[[Page 13345]]

    *Assumptions: One respondent per hospital, collection of data on 
median of 75 patients per hospital, average data collection time of 15 
minutes per patient.

Kimberly S. Lane,
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. 2013-04508 Filed 2-26-13; 8:45 am]
BILLING CODE 4163-18-P