98-1206. Proposed Data Collections Submitted for Public Comment and Recommendations  

  • [Federal Register Volume 63, Number 12 (Tuesday, January 20, 1998)]
    [Notices]
    [Pages 2982-2984]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-1206]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Centers for Disease Control and Prevention
    [INFO-98-08]
    
    
    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) and the Agency for Toxic Substances and Disease 
    Registry (ATSDR) 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/ATSDR 
    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 Wilma Johnson, CDC/
    ATSDR 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. Model Performance Evaluation Program for Retroviral and AIDS-
    Related Testing--(0920-0274)--Extension--Public Health Practice Program 
    Office (PHPPO). The CDC Model Performance Evaluation Program (MPEP) 
    currently assesses the performance of laboratories that test for human 
    immunodeficiency virus type 1 (HIV-1) antibody, human T-lymphotropic 
    virus types I and II (HTLV-I/II) antibody, perform CD4 T-cell testing 
    or T-lymphocyte immunophenotyping (TLI) by flow cytometry or alternate 
    methods, perform HIV-1 ribonucleic acid (RNA) determinations (viral 
    load), and test for HIV-1 p24 antigen through the use of mailed sample 
    panels. The CDC MPEP is proposing to use annual data collection 
    documents to gain updated information on the characteristics of testing 
    laboratories and their testing practices. Two data collection 
    instruments, or survey questionnaires, will be used. The first data 
    collection instrument will be concerned with laboratories that perform 
    HIV-1 antibody (Ab) testing, HTLV-I/II Ab testing, HIV-1 viral RNA 
    determinations, and HIV-1 p24 antigen (Ag) testing. Laboratories 
    enrolled in the MPEP will be mailed a survey questionnaire and be asked 
    to complete the sections pertinent to their laboratory's testing. The 
    survey instrument will collect demographic information related to 
    laboratory type, primary purpose for testing, types of specimens 
    tested, minimum education requirements of testing personnel, laboratory 
    director, and laboratory
    
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    supervisor, and training required of testing personnel. The demographic 
    section will be followed by more specific sections related directly to 
    HIV-1 Ab testing, HTLV-I/II Ab testing, HIV-1 RNA, and HIV-1 p24 Ag 
    testing. Included in the latter sections will be questions related to 
    the types of tests performed, the algorithm of testing, how test 
    results are interpreted, how results are reported, how specimens may be 
    rejected for testing, if some testing is referred to other 
    laboratories, and what quality control and quality assurance procedures 
    are conducted by the laboratory. Similarly, the TLI survey 
    questionnaire will also collect demographic information about each 
    laboratory, as well as, the type(s) of flow cytometer used, educational 
    and training requirements of testing personnel, the types of monoclonal 
    antibodies used in testing, how specimens are received, prepared, and 
    stored, how test results are recorded and reported to the test 
    requestor, and what quality control and quality assurance procedures 
    are practiced. Information collected through the use of these 
    instruments will enable CDC to determine if laboratories are conforming 
    to published recommendations and guidelines, whether education and 
    training requirements of testing personnel are conforming to current 
    legislative requirements, and whether problems in testing can be 
    identified through the collection of information. Information collected 
    through the survey instruments will then be compared statistically with 
    the performance evaluation results reported by the enrolled 
    laboratories to determine if characteristics of laboratories that 
    perform well can be distinguished from laboratories not performing as 
    well. Upon enrolling in the MPEP, participants are assigned an MPEP 
    number used to report testing results and survey questionnaire 
    responses allowing the individual responses of each laboratory 
    participant to be treated in confidence. When participants respond to 
    the surveys by sending CDC completed questionnaires, the collected 
    information is developed into aggregate reports. A copy of the 
    completed report is provided to each participating laboratory. Other 
    than their time, there will be no cost to the respondents.
    
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                                                                          No. of      Average burden/               
                       Respondents                       Number of     respondents/    response (in    Total burden 
                                                        respondents      response          hrs)          (in hrs)   
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    MPEP Enrollment Form............................             100               1             0.1              10
    Retroviral Survey...............................           1,000               1             0.5             500
    TLI Survey......................................             350               1             0.5             175
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        Total.......................................                                                             685
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        2. Prostate and Colorectal Cancer Screening in the Managed Care 
    Environment--New--National Center for Chronic Disease Prevention and 
    Health Promotion (NCCDPHP). Prostate and colorectal cancer are among 
    the leading causes of cancer deaths in the U.S. Prostate cancer 
    screening has increased rapidly during the past few years; however, 
    little is known about actual rates of screening, or the proportion of 
    men screened who present with symptoms or who are at high risk for 
    prostate cancer. Evidence suggests that colorectal cancer screening can 
    save lives and efforts are under way to increase participation in 
    screening. However, little information is available to monitor 
    screening rates. It is also unknown how well self-reported prostate and 
    colorectal cancer screening rates, which are often used in population 
    surveys, compare to actual screening rates. Therefore, the Centers for 
    Disease Control and Prevention (CDC), National Center for Chronic 
    Disease Prevention and Health Promotion, Division of Cancer Prevention 
    and Control, intends to conduct a survey of prostate and colorectal 
    cancer screening test utilization. As an increasing number of people 
    are served by managed care organizations where they may receive cancer 
    screening tests, the proposed study population are members of managed 
    care organizations.
        A sample of members (men aged 40 years and older and women 50 years 
    and older) of 3 managed care organizations will be interviewed over the 
    telephone, and the medical charts of the participants will be 
    abstracted. The information collected will include demographic 
    information, prostate and colorectal cancer screening tests received 
    within the past 5 years, and the reasons and outcomes of the tests. The 
    total cost estimate is: $400,000.
    
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                                                                        No. of       Average burden                 
                     Respondents                       No. of         responses/    of response (in    Total burden 
                                                    respondents       respondent          hrs)           (in hrs)   
    ----------------------------------------------------------------------------------------------------------------
    Members of Prepaid Health Plans.............            2200                1             0.25              550 
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        3. Substance Specific Applied Research Program (AMHPS) [King/Drew 
    Lead Study in-Person Interview, Lead and Hypertension Screening 
    Questionnaire/Risk Factor Questionnaire]--(0923-0015)--EXTENSION--The 
    Agency for Toxic Substances and Disease Registry (ATSDR) is mandated 
    pursuant to the 1980 Comprehensive Environmental Response Compensation 
    and Liability Act (CERCLA), and its 1986 Amendments, The Superfund 
    Amendments and Reauthorization Act (SARA), to prevent or mitigate 
    adverse human health effects and diminished quality of life resulting 
    from the exposure to hazardous substances into the environment. 
    Disadvantaged minorities in large urban areas have higher than national 
    blood lead levels. Some of these groups also suffer from 
    disproportionately high rates of hypertension. Previous data shows a 
    relationship between higher blood lead levels and higher blood 
    pressure, even at the lowest lead exposure. To facilitate this effort, 
    this study examines the relationship between lead exposure history in 
    inner city minorities and blood pressure, using a group at special risk 
    for elevated blood pressure, pregnant women. Elevated blood lead
    
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    and elevated blood pressure are two problems that disproportionately 
    affect minority groups. Establishing a link between blood pressure and 
    lead exposure, especially utilizing two new biomarkers of lead 
    exposure, bone lead and serum lead, can provide a new tool for dealing 
    with elevated blood pressure nationwide.
        This request is for a 3-year extension. Two previously approved 
    questionnaires will continue to be used to collect socioeconomic data, 
    and data pertaining to risk factors for elevated blood pressure and 
    lead exposure. A new questionnaire assessing social stress (Scale of 
    Chronic Social Role Stressors) and a 16 item, four response choice 
    scale will be added to better control for social stress factors 
    affecting blood pressure. There is no cost to respondents.
    
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                                                          No. of          No. of        Avg. burden                 
                   Type of respondent                   respondents     responses/     per response    Total burden 
                                                         per year       respondent       (in hrs)        (in hrs)   
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    Screening Questionnaire.........................             880               1             .5              440
    Social Role Stressors...........................             880               1             .08              70
    Risk Questionnaire..............................             330               2             .75             495
                                                     ---------------------------------------------------------------
        Total.......................................  ..............  ..............  ..............            1005
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        Dated: January 13, 1998.
    Wilma G. Johnson,
    Acting Associate Director for Policy Planning and Evaluation, Centers 
    for Disease Control and Prevention (CDC).
    [FR Doc. 98-1206 Filed 1-16-98; 8:45 am]
    BILLING CODE 4163-18-P
    
    
    

Document Information

Published:
01/20/1998
Department:
Centers for Disease Control and Prevention
Entry Type:
Notice
Document Number:
98-1206
Pages:
2982-2984 (3 pages)
Docket Numbers:
INFO-98-08
PDF File:
98-1206.pdf