Proposed Data Collections Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Info-99-10]

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. 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 with 60 days of

this notice.

Proposed Project

1. National Surveillance of Dialysis-Associated Diseases (0920-

0009)--Reinstatement--National Center for Infectious Diseases (NCID).

The Hospital Infectious Program, NCID is proposing renewal of a yearly

mail survey of dialysis practices and dialysis-associated diseases at

U.S. outpatient hemodialysis centers. The rehabilitation of individuals

in the United States who suffer from chronic renal failure has been

identified as an important national priority; and since 1973, chronic

hemodialysis patients have been provided financial support by the

Federal Government. The Hospital Infections Program and the Hepatitis

Branch, Division of Viral and Rickettsial Diseases, Centers for Disease

Control and Prevention, have responsibility for formulating strategies

for the control of hepatitis, bacteremia, pyrogenic reactions, and

other hemodialysis-associated disease.

In order to devise such control measures, it is necessary to

determine the extent to which the incidence of these dialysis-

associated diseases changes over time. This request is to continue

surveillance activities among chronic hemodialysis centers nationwide.

In addition, once control measures are recommended it is essential that

such measures be monitored to determine their effectiveness. The survey

is conducted once a year by mailing it to all chronic hemodialysis

centers licensed by the Health Care Financing Administration (HCFA).

Dialysis practices surveyed include the use of hepatitis B vaccine in

patients and staff members, whether isolation rooms are used to treat

hepatitis B surface antigen-positive patients, the types of vascular

access and dialyzers used, whether certain dialysis items are

disinfected for reuse, and whether the dialysis center has any policy

for insuring judicious use of antimicrobial agents. Among dialysis-

associated diseases, the survey includes hepatitis B virus infection,

antibody to hepatitis C virus, antibody to human immunodeficiency

virus, pyrogenic reactions, and vancomycin-resistant enterococci. The

total cost of the respondents is $128,000.

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Number of Avg. burden/ Total response

Respondents Number of responses/ response (In burden (In

respondents respondent hrs.) hrs.)

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Chronic Hemodialysis Centers.................... 3,200 1 1 3,200

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Total....................................... .............. .............. .............. 3,200

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2. Survey of Private Industry Users of Data from the National

Health and Nutrition Examination Survey--NEW--The National Health and

Nutrition Examination Survey (NHANES) has been conducted periodically

since 1970 by the National Center for Health Statistics (NCHS), CDC.

NHANES data are collected in two phases, a household

[[Page 10001]]

interview and an examination in mobile examination centers that travel

throughout the country. The survey is the only source of nationally

representative examination and biological specimen data for many

important diseases and has often provided useful information on new

technologies such as Dual Energy X-ray Absorptiometry, a method used to

diagnose osteoporosis. NHANES has been extensively used by the public

health and medical research communities to address a wide range of

public health problems, including hypertension, diabetes, cholesterol,

obesity, lead exposure, and sexually transmitted diseases. Most of our

users appear to be based in traditional academic and public health

settings. However, many important efforts to promote public health

occur in the private sector, whether in the direct delivery of services

or in the development of new treatment and diagnostic modalities. Based

on inquiries received by the division, the NHANES data are used by

private industry, including the pharmaceutical industry and the health

care delivery industry, for a variety of purposes. However, little is

known of the extent of use of the data for these industries and for the

related biotechnology industries and how the data are used.

The objectives of the proposed survey are to (1) describe the

extent of use of the NHANES data by the private health care delivery,

pharmaceutical, and biotechnology industries, (2) describe the purpose

for which the data are used by these industries, and (3) explore ways

to improve the use of these data by private industry to improve the

health of the population.

Although similar questions are appropriate for other NCHS

administered data collection efforts, NHANES data are unique among NCHS

data efforts in its reliance on biological measurements and its direct

clinical relevance. This survey will focus specifically on the unique

relevance of NHANES examination and biologic specimen data but will

include collection of data on general awareness of NCHS data collection

efforts. The results may be used to determine the feasibility of

collecting data targeted to other NCHS data collection efforts.

Survey respondents will be identified through a range of mechanisms

including identifying names of public health, epidemiology, and health

services research unit directors at major pharmaceutical, health care

delivery organizations (including HMOs), and biotechnology companies

through industry organizations and by referral. The goal is to identify

both current users and non-users of the data. The survey will be

voluntary and confidential. The survey will use an interview format

with open-ended questions to address the proposed study objectives.

Primarily qualitative survey methods will be used to evaluate the data.

The total cost to respondents is estimated to be $10,000.

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Number of Avg burden/ Total response

Respondents Number of responses/ response (In burden (In

respondents respondent hrs.) hrs.)

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

Private Industry NHANES Data Users.............. 200 1 1 200

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Total....................................... .............. .............. .............. 200

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3. Evaluation of NCIPC Recommendations on Bicycle Helmet Use--

Reinstatement--The National Center for Injury Prevention and Control's

(NCIPC), Division of Unintentional Injury Prevention (DUIP) intends to

continue to conduct a survey of 1,300 persons from its mailing lists

and lists of recipients of recommendations on the use of bicycle

helmets in preventing head injuries. These recommendations were

published in the Morbidity and Mortality Weekly Report of February 17,

1995.

The purpose of this survey is to determine:

I. The penetration of the recommendations distribution,

II. The usefulness of the bicycle helmet recommendations,

III. How to improve the recommendations' content and format,

IV. Potential future DUIP bicycle helmet promotional activities,

V. Information needs and access points of DUIP's ``customers''

Results from this research will be used to (1) assist DUIP in

producing an updated version of the helmet recommendations; (2)

identify new helmet promotion programmatic directions; and (3) develop

future materials that meet the needs of DUIP ``customers.''

The study will be done by telephone.

The total cost to respondents is $0.00.

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Number of Avg burden/ Total response

Respondents Number of responses/ response (In burden (In

respondents respondent hrs.) hrs.)

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

Individual...................................... 1,300 1 .33 429

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Total....................................... .............. .............. .............. 429

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[[Page 10002]]

Nancy Cheal,

Acting Associate Director for Policy, Planning and Evaluation Centers

for Disease Control and Prevention (CDC).

[FR Doc. 99-4925 Filed 2-26-99; 8:45 am]

BILLING CODE 4163-18-P