Proposed Data Collections Submitted for Public Comment and Recommendations

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)

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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

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[[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)

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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

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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

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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