[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

[[Page 2983]]

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
                                                 ---------------------------------------------------------------
    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)   
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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

[[Page 2984]]

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