[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.)  
----------------------------------------------------------------------------------------------------------------
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)   
----------------------------------------------------------------------------------------------------------------
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.

----------------------------------------------------------------------------------------------------------------
                                                                  Number of     Average burden/                 
                  Form name                      Number of        responses/     response  (in     Total burden 
                                                respondents       respondent         hrs.)          (in hrs.)   
----------------------------------------------------------------------------------------------------------------
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