[Federal Register Volume 63, Number 101 (Wednesday, May 27, 1998)]
[Notices]
[Pages 29014-29016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13952]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[INFO-98-19]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call the CDC Reports 
Clearance Officer on (404) 639-7090.
    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; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques for other 
forms of information technology. Send comments to Seleda Perryman, CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, 
Atlanta, GA 30333. Written comments should be received within 60 days 
of this notice.

Proposed Projects

    1. Surveillance for Bloodstream and Vascular Access Infections in 
Outpatient Hemodialysis Centers--New--National Center for Infectious 
Diseases (NCID). The Hospital Infections Program, NCID is proposing a 
study of bloodstream infections, vascular access infections, 
hospitalizations, and antimicrobial starts at U.S. outpatient 
hemodialysis centers. Although bloodstream and vascular access 
infections are common in hemodialysis patients, there is no existing 
system to record and track these complications. Participation in the 
proposed project is voluntary; it is estimated that 100 of the 
approximately 3,000 U.S. outpatient hemodialysis centers will 
participate. Participating centers may collect data continuously, or 
may discontinue participation at any time; we estimate that the average 
center will participate for six months. Each month, participating 
centers will record the number of hemodialysis patients they treat and 
maintain a log of all hospitalizations and intravenous (IV) 
antimicrobial starts. For each hospitalization or IV antimicrobial 
start, further information (e.g., type of vascular access, clinical 
symptoms, presence of a vascular access infection, and blood culture 
results) will be collected. A computer program will be developed to 
allow dialysis center personnel to enter and analyze their own data; 
they will also transmit the data to CDC with all patient identifiers 
removed. CDC will aggregate this data and generate reports which will 
be sent to participating dialysis centers. Rates of bloodstream 
infection, vascular access infection, and antimicrobial use per 1000 
patient-days will be calculated. Also, the percentage of antimicrobial 
starts for which a blood culture is performed will be calculated. 
Through use of these data, dialysis centers will be able to track rates 
of key infectious complications of hemodialysis. This will facilitate 
quality control improvements to reduce the incidence of infections, and 
clinical practice guidelines to improve use of antimicrobials. The 
total cost to the respondents is $78,000.

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                                                                    Number of    Average burden/                
                      Form                          Number of      responses/      response (in    Total burden 
                                                   respondents     respondent         hours)        (in hours)  
----------------------------------------------------------------------------------------------------------------
Agreement to Participate.......................             100               1              1               100
Census Form....................................             100               1              1               100
Log............................................             100          \1\ 10              1             1,000
Incident Form..................................             100         \1\ 200              0.2           4,000
                                                                                                 ---------------

[[Page 29015]]

                                                                                                                
      Total....................................  ..............  ..............  ...............          5,200 
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\1\ Estimated mean.                                                                                             

    2. Pulmonary Function Testing Course Approval Program, 29 CFR 
1910.1043 (0920-0138)--Extension--The National Institute for 
Occupational Safety and Health (NIOSH) has responsibility under the 
Cotton Dust Standard, 29 CFR 1910.1043, for approving courses to train 
technicians to perform pulmonary function testing. Successful 
completion of a NIOSH approved course is mandatory under the Standard. 
To carry out its responsibility, NIOSH maintains a Pulmonary Function 
Testing Course Approval Program. The program consists of an application 
submitted by potential sponsors who seek NIOSH approval to conduct 
courses, and if approved, notification to NIOSH of any course or 
faculty changes during the period of approval. The application form and 
addended materials including agenda, vitae and course materials are 
reviewed by NIOSH to determine if the applicant has developed a program 
which adheres to the criteria required in the Standard. The letter 
seeking approval for subsequent changes is reviewed to assure that 
changes in faculty or course content continue to meet course 
requirements. Applications to be a course sponsor and carry out 
training are submitted voluntarily by institutions and organizations 
from throughout the country. If an application is not submitted for 
review, NIOSH is unable to evaluate a course to determine whether it 
meets the criteria in the Cotton Dust Standard and whether technicians 
will be adequately trained as mandated under the Standard. The total 
cost to respondents for the three year period is $1,851.00.

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                                                                     Number of    Average burden/               
                   Respondents                       Number of      responses/     response  (in   Total burden 
                                                    respondents     respondent        hours)        (in hours)  
----------------------------------------------------------------------------------------------------------------
Sponsoring organizations........................              66               1            .614            40.5
      Total.....................................  ..............  ..............  ..............            40.5
                                                                                                 ---------------
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    3. Measurement of Stress and Stressful Life Events in Black Women 
of Reproductive Age (0920-0356)--Reinstatement--National Center for 
Chronic Disease Prevention and Health Promotion. A review of studies of 
psycho-social factors and adverse pregnancy outcome supports the 
hypothesis that high levels of exposure to stressful life experiences 
put black women at increased risk for adverse reproductive outcome, 
particularly Pre-term Delivery (PTD) and Very Low Birth Weight (VLBW). 
The purpose of this study is to evaluate the reliability and validity 
of existing instruments that measure stress and stressful life events 
in black women of reproductive age. Eligible subjects will be black 
women who live in the Atlanta metropolitan area. Subjects will be 
recruited from flyers, newspaper announcements, hospitals and clinics 
in the metropolitan Atlanta area. Subjects will be screened and 
selected based on age (18-30 or 31-45 years), years of education (12, 
13-15, 16 or more), and pregnancy status (pregnant, not pregnant). A 
maximum of thirty women will be selected for each combination of age, 
education and pregnancy status. The minimum age for participation will 
be 18 to avoid the complications due to requirement of parental 
consent. Women will be excluded if they use illicit drugs, such as 
heroin, cocaine and marijuana because these substances may alter the 
metabolism of cortisol. The contact, timing and spacing of the 
interviews and laboratory collection are based on the methodology 
developed and used for conducting reliability and validity tests. 
Approximately one half of the women will be pregnant at the time of 
data collection.
    Women enrolled in the study respond to a series of face-to-face and 
self-administered demographic and psycho-social questionnaires. Women 
are also asked to provide a saliva sample so that we can correlate 
reported levels of stress with biological measures of stress.
    Participation in this study is voluntary and participants will 
receive compensation for their time. A written informed consent will be 
obtained and oversight will be provided by local institutional review 
board.
    This project should take two years. One hundred fifteen (115) women 
will participate only in the validity study and thirty-nine (39) women 
will participate in the validity and reliability study. The validity 
study requires one interview and one salivary sample. The reliability 
study requires a second interview and a second salivary specimen, 
approximately two weeks after the first interview.
    During the first three months of the study, the Project Director 
will set up the office, hire staff and student assistants and provide 
interviewer and data entry training. The Project Director will also 
make contacts and explore potential sites for recruiting women for the 
study. During the next nine months, all of the interviews 
(approximately 115 validity subjects and 39 reliability subjects 
remaining) will be conducted and data entry of the quantitative 
instruments (i.e Demographic Lifestyle Questionnaire, Cohen Perceived 
Stress Scale, Life Experience Survey (LES), ARIC/BAECKE Questionnaire 
of Habitual Physical Activity, Center for Epidemiologic Studies 
Depression Scale (CES-D), Profile of Mood States, Multiple Affect 
Adjustive Checklist, Speilberger Trait Anxiety Inventory--Self 
Evaluation Questionnaire) will be completed. Scoring for the 
qualitative instruments (i.e. Structured Event Probe and Narrative 
Rating Method (SEPRATE) and Life Events and Difficulties Schedule 
(LEDS) will be initiated during year 1, but the bulk of the qualitative 
scoring will be completed during Year 2. The data entry of the 
qualitative date will be completed during Year 2. Preliminary analyzes 
will be conducted during Year 2, with the technical assistance of CDC. 
The total estimated cost to respondents is $6,755.

[[Page 29016]]



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                                                                     Number of    Average burden/               
                   Respondents                       Number of      responses/     response  (in   Total burden 
                                                    respondents     respondent        hours)        (in hours)  
----------------------------------------------------------------------------------------------------------------
Reliability Study Group.........................              39               2               3             234
Validity Study Group............................             115               1               3             345
                                                                                                 ---------------
      Total.....................................  ..............  ..............  ..............             579
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    4. The National Death Index (NDI) (0920-0215)--Extension--A service 
of the National Center for Health Statistics (NCHS), that assists 
health and medical researchers to determine the vital status of their 
study subjects. The NDI is a national data base containing identifying 
death record information submitted annually to NCHS by all the state 
vital statistics offices, beginning with deaths in 1979. Searches 
against the NDI file provide the states and dates of death and the 
death certificate numbers of deceased study subjects. With the recent 
implementation of the NDI Plus service, researchers now have the option 
of also receiving cause of death information for deceased subjects, 
thus reducing the need to request copies of death certificates from the 
states. The NDI Plus option currently provides the ICD-9 codes for the 
underlying and multiple causes of death for the years 1979-1996. The 
five administrative forms are completed by health researchers in 
government, universities, and private industry in order to apply for 
NDI services and to submit records of study subjects for computer 
matching against the NDI file. The total cost to respondents is 
estimated at $5,685.

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                                                                     Number of    Average burden/               
                   Respondents                       Number of      responses/     response  (in   Total burden 
                                                    respondents     respondents       hours)        (in hours)  
----------------------------------------------------------------------------------------------------------------
Government researchers..........................              48               1            1.89            90.8
University researchers..........................              60               1            1.89           113.5
Private industry researchers....................              12               1            1.89            22.7
                                                                                                 ---------------
      Total.....................................  ..............  ..............  ..............           227.0
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Charles W. Gollmar,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 98-13952 Filed 5-26-98; 8:45 am]
BILLING CODE 4163-18-P