[Federal Register Volume 61, Number 96 (Thursday, May 16, 1996)]
[Notices]
[Pages 24799-24800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12329]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 DAY-11]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) publishes a 
list of information collection requests under review, 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 Office on (404) 
639-7090.
    The following requests have been submitted for review since the 
last publication date on May 9, 1996.

Proposed Project

    1. Intensive-Care Antimicrobial Resistance Epidemiology (Project 
ICARE), Phase II--NEW--Antibiotic resistance is estimated to cost as 
much as 4 billion dollars a year to the health care system in the 
United States and the number of resistant microorganisms is increasing. 
For example, data reported to the National Nosocomial Infections 
Surveillance (NNIS) system demonstrated a 20-fold increase, between 
January 1989 and March 1993, in the percentage of enterococci 
associated with nosocomial infections that are resistant to vancomycin 
(VRE). Additional analysis of NNIS data has demonstrated that other 
antibiotic resistant nosocomial pathogens have also increased in recent 
years. One of the major factors limiting the understanding of 
antibiotic resistance among nosocomial pathogens is the lack of 
information on the relationship between the amount and kind of 
antibiotic used in hospitals and the emergence of resistance.
    This proposed one year study, called Project ICARE, will collect 
data on the amount of antibiotics used in 50 NNIS hospitals and the 
antibiotic susceptibility patterns found in certain bacterial pathogens 
isolated in these hospitals' microbiology laboratories between June 
1996 and June 1997. Further, new mechanisms of resistance will be 
studied on specific antibiotic-resistant isolates that will be sent to 
CDC from these laboratories. A successful pilot study involving eight 
NNIS hospitals was conducted between August 1994 and January 1995 to 
study the feasibility of collecting such information.
    After initially setting up the project with information on the 
different intensive care units (ICUs) and wards, the hospital will 
provide three different types of data each month: (1) Summary of the 
amount of parenteral and oral antibiotics, by generic group, reported 
by the pharmacy, (2) summary of the number of isolates, by species, 
susceptible, intermediate or resistant to various antibiotics reported 
by the microbiology laboratory, and (3) actual isolates of resistant 
pathogens to be sent to by the microbiology laboratory to CDC. For 
antibiotics used and number of isolates in each of the susceptibility 
categories, separate data are to be reported for each ICU, all other 
inpatients, and outpatients (antibiotic use among outpatients is not 
collected). Data collection forms for summary data from the 
microbiology laboratory and pharmacy have been created to assist in 
recording the data; however, the data will be entered into a computer 
software created by CDC specifically for Project ICARE. The software 
will be provided to the hospitals at no cost. Data will be transmitted 
to CDC by floppy disk or by electronic transfer when it become 
available in the NNIS system in 1996.

[[Page 24800]]



------------------------------------------------------------------------
                                                No. of      Avg. burden/
         Respondents              No. of      responses/   response  (in
                                respondents   respondent        hrs)    
------------------------------------------------------------------------
Primary Contact..............            50            12           1   
Pharmacist...................            50            60           1.8 
Microbiologist...............            50            60           0.35
                              ------------------------------------------
      Total..................  ............  ............  .............
------------------------------------------------------------------------

    The total burden hours is 7050. Send comments to Desk Officer, CDC; 
Human Resources and Housing Branch, New Executive Office Building, Room 
10235; Washington, DC 20503.
    4. National Nosocomial Infections Surveillance (NNIS) System--
(0920-0012)--Extension--The National Nosocomial Infections Surveillance 
(NNIS) system is currently the only source for national data on 
nosocomial (hospital-associated) infections in the United States. It 
first began collecting data in 1970. It is a collaborative project 
between the Hospital Infections Program of the Centers for Disease 
Control and Prevention (CDC) and voluntarily participating hospitals in 
the United States. The goals of the system are to: (1) develop 
comparative nosocomial infection rates that can be used by hospitals to 
assess quality of care, (2) describe the scope and magnitude, including 
trends, of the nosocomial infection problem in the U.S., (3) identify 
risk factors associated with these infections, (4) assist hospitals in 
the effective use of surveillance data to improve the quality of 
patient care, and (5) conduct collaborative research studies. Data are 
collected using protocols developed by CDC that define the specific 
populations of patients at risk, risk factors, and outcomes. The 
decision about which component(s) to use is made by each hospital 
depending on its own needs for surveillance data. The data are 
collected by trained surveillance personnel, assisted by hospital 
personnel, and are entered into IDEAS, a surveillance software which 
makes the data available for analysis at the hospital's convenience. 
The data are currently transmitted to CDC by floppy disk, then 
aggregated into a national database. During 1996, it will become 
possible for some hospitals to transmit the data to CDC through the 
NNIS telecommunications system. This system is expected to be used by 
all participating hospitals by 1997, resulting in reduced response 
time. NNIS methodology, which has been published, is the standard 
nosocomial infection surveillance methodology and is used at least in 
part by most U.S. hospitals.

------------------------------------------------------------------------
                                                 No. of     Avg. burden/
          Respondents              No. of      responses/   response (in
                                 respondents   respondent      hours)   
------------------------------------------------------------------------
Hospitals.....................           251            12          0.16
------------------------------------------------------------------------

    The total burden hours is 481. Send comments to Desk Officer, CDC; 
Human Resources and Housing Branch, New Executive Office Building, Room 
10235; Washington, DC 20503.

    Dated: May 10, 1996.
[FR Doc. 96-12329 Filed 5-15-96; 8:45 am]
BILLING CODE 4163-18-P