[Federal Register Volume 63, Number 77 (Wednesday, April 22, 1998)]
[Notices]
[Pages 19923-19924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10644]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30DAY-12-98]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 639-7090. Send written
comments to CDC, Desk Officer; Human Resources and Housing Branch, New
Executive Office Building, Room 10235; Washington, DC 20503. Written
comments should be received within 30 days of this notice.
Proposed Projects
1. Follow-Up Study of Children With Developmental Disabilities--
New--National Center for Environmental Health--In the mid-1980's, 10-
year-old children were identified as having one or more of five
developmental disabilities: mental retardation, cerebral palsy,
epilepsy, hearing impairment, or vision impairment. These children were
identified (mainly from special education records in the public
schools) in the metro-Atlanta area as part of a study to develop
surveillance methods for these conditions in school-age children. A
follow-up study is proposed to trace, locate, and interview these
children, who are now in their early twenties, to assess their status
with regard to educational attainment, employment, living arrangements,
services received, functional limitations, adaptive behavior, social
participation, health, and quality of life. Previous studies (published
mostly in the mid-1980's) on the post-secondary school experiences of
former recipients of special education services were either limited to
one type of impairment (e.g., mild mental retardation) or were
restricted to a narrow range of outcomes (e.g., employment and
education) or did not incorporate a comparison group of persons who
were not in special education. The proposed study is a one-time, in-
person interview and includes a contemporaneous comparison group of
persons who, at age 10 years, were in regular education classes in the
same schools as were the persons with developmental disabilities. A
base of 1,608 identified children and 650 comparison persons will be
used to find a total of 1,600 who will be interviewed. The data
generated from this study will be used to estimate the burden of
secondary health conditions, limited social participation, and economic
disadvantage among young adults with long-standing developmental
impairments. This information will be helpful to efforts aimed at the
prevention of various secondary problems in this population. Total
annual burden hours are 1,312.
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Number of Avg. burden/
Activity Number of responses/ responses (in Total burden
respondents respondent hrs.) (in hrs.)
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Contacting/Scheduling call...................... 1,290 1 0.166 215
Face-to-face Interview.......................... 1,097 1 1 1,097
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2. Model Performance Evaluation Program for Retroviral and AIDS-
Related Testing--(0920-0274)--Revision--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 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-/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
[[Page 19924]]
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. Total
annual burden hours are 668.
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Number of Average burden/
Type of respondents Number of respondents/ response (in Total burden
respondents response hrs) (in hrs)
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Enrollments (new)............................... 100 1 0.05 5
Retroviral Survey............................... 1,000 1 0.5 500
TLI Survey...................................... 350 1 0.5 163
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3. Evaluation of Educational Brochures on Opportunistic Infections
Affecting People with HIV/AIDS--New--The National Center for HIV, STD
and TB Prevention, Division of HIV/AIDS Prevention, Intervention
Research and Support proposes to conduct research to assure that
intended audiences (persons living with HIV/AIDS) find the brochures
clear, informative and useful. Specifically, the research will examine
perceptions of the appearance, quality, value, readability, and clarity
of the information provided. Attention will be focused on identifying
information, language and/or formatting issues which are confusing or
unclear. Further, although the intended audience of the brochure series
is all persons living with HIV/AIDS, we propose to use the limited
resources available to target those who are lower income. This is
warranted given their often more restricted access to reliable
information sources, making the brochures a more valuable resource for
them. In addition, the correlations between low socio-economic status
(SES) and low literacy warrant attention to assuring the readability
and comprehension of the materials among this group.
The information generated from this research will enable NCHSTP to
tailor materials to the needs, wants and preferences of individuals
living with HIV/AIDS. Additionally, the center is committed to
developing a standardized process for including such audience testing
in subsequent materials development projects. The proposed process will
provide the foundation for establishing a standardized process for such
assessment. Total annual burden hours are 275.
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Number of Average burden/
Form name Number of responses/ response (in Total burden
respondents respondent hrs.) (in hrs.)
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Form A \1\.................................. 550 1 0.5 275
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\1\ Estimated time includes 10-15 minutes for reading one of the 11 information brochures and 10-15 minutes to
complete the survey which will be administered orally.
Dated: April 16, 1998.
Kathy Cahill,
Associate Director for Policy Planning and Evaluation, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 98-10644 Filed 4-21-98; 8:45 am]
BILLING CODE 4163-18-P