[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
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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)
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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
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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