[Federal Register Volume 63, Number 86 (Tuesday, May 5, 1998)]
[Notices]
[Pages 24810-24812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11823]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[INFO-98-18]


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 on or before 
July 6, 1998.

Proposed Projects

    1. 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 of $35 for their time. A

[[Page 24811]]

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 (SEPARATE) 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 analyses 
will be conducted during Year 2, with the technical assistance of CDC. 
The total estimated cost to respondents is $6,755 (39 reliability 
participants @ $70 and 115 validity participants @ $35).

----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden/               
                   Respondents                       Number of      responses/     response (in    Total burden 
                                                    respondents     respondent         hrs.)         (in hrs.)  
----------------------------------------------------------------------------------------------------------------
Reliability Study Group:                                                                                        
    African-American women for the ages of 18 to                                                                
     45.........................................              39               2               3             234
Validity Study Group:                                                                                           
    African-American women for the ages of 18 to                                                                
     45.........................................             115               1               3             345
                                                 ---------------------------------------------------------------
      Total.....................................  ..............  ..............  ..............             579
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    2. Expanded National Surveillance for Antimicrobial Resistance, 
Pilot. The Hospital Infections Program, National Center for Infectious 
Diseases, Centers for Disease Control and Prevention (CDC), is 
proposing a surveillance system to identify patients with infections 
with antimicrobial resistant pathogens of critical public health 
importance. As a pilot project, we will first study glycopeptide 
intermediate-resistant Staphylococcus aureus. Approximately \1/3\ of S. 
aureus infections are now resistant to multiple antibiotics leaving 
only vancomycin, the only Food and Drug Administration (FDA) approved 
glycopeptide antibiotic available in the United States, for treatment 
of these infected patients. CDC's Hospital Infections Program 
recommended that all staphylococci possibly resistant to glycopeptides 
(minimum inhibitory concentration [MIC] <gr-thn-eq> 4 <greek-m>g/mL) be 
sent to CDC if the MIC is unchanged or higher. The incidence of these 
resistant pathogens is thought to be rare, and to date only one 
additional glycopeptide intermediate-resistant S. aureus (GRS) has been 
identified. Clinicians caring for patients with infections due to GRS 
have extremely limited treatment options for their patients, and 
scientists are in need of adequate clinical specimens to create 
informed hypotheses about mechanisms of resistance to aid in drug 
discovery and treatment options.
    To confirm and characterize GRS, we propose building on the 
existing Emerging Infections Network of the Infectious Disease Society 
of America (IDSA EIN, a pool of approximately 200 infectious disease 
specialists), clinical microbiologists participating in CLINMICRONET (a 
pool of approximately 100 microbiologists), the infection control 
community, and industry, and CDC will serve as a reference laboratory. 
The objectives of this surveillance system are to (1) obtain 
epidemiologic and clinical data on patients with GRS infections so that 
risk factors for infection and clinical impact of infection can be 
studied, and (2) obtain GRS isolates to confirm identity and 
susceptibility, create library of molecular fingerprints (pulsed field 
gel electrophoresis [PFGE]), and study resistance mechanisms.
    Number of respondents and burden to complete forms for possible 
isolates (number of respondents is estimated since the actual incidence 
of these pathogens is thought to be very low).

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                                                                     Number of    Average burden/               
                      Form                           Number of      responses/    respondent (in   Total burden 
                                                    respondents     respondent         hrs.)         (in hrs.)  
----------------------------------------------------------------------------------------------------------------
Emerging Infections Network.....................              20               1            0.50              10
ClinMicronet....................................              20               1            0.50              10
Industry/infection control community............              40               1            0.50              20
                                                 ---------------------------------------------------------------
      Total.....................................  ..............  ..............  ..............              40
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[[Page 24812]]

Charles W. Gollmar,
Acting Associate Director for Policy Planning and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 98-11823 Filed 5-4-98; 8:45 am]
BILLING CODE 4163-18-P