Proposed Data Collections Submitted for Public Comment and Recommendations

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

----------------------------------------------------------------------------------------------------------------

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] 4 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).

----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------

[[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