[Federal Register Volume 64, Number 39 (Monday, March 1, 1999)]
[Notices]
[Pages 10000-10002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4925]


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

----------------------------------------------------------------------------------------------------------------
                                                                     Number of      Avg burden/   Total response
                   Respondents                       Number of      responses/     response (In     burden (In
                                                    respondents     respondent         hrs.)           hrs.)
----------------------------------------------------------------------------------------------------------------
Individual......................................           1,300               1             .33             429
                                                                                                 ---------------
    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