[Federal Register Volume 63, Number 83 (Thursday, April 30, 1998)]
[Notices]
[Pages 23789-23790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11479]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[30DAY-14-98]


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. Long-Term Health Effects of Methyl Parathion in Children--A 
Follow-Up Study--New--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. Children were exposed to Methyl 
Parathion (MP) via illegal indoor residential spraying of MP for pest 
control in nine states. All of these sprayed areas have been designated 
as CERCLA sites and placed on the National Priorities List (NPL) for 
conducting remedial actions. The MP sites consist of contaminated 
residences and businesses spread over several counties and states, 
intermingled with other building structures that were never sprayed 
with MP, making targeted remedial actions more challenging.
    This study of children exposed to MP and children not exposed, but 
matched on age, sex, and race will provide critical public health 
information for the gap in data regarding the effects of lower dose, 
sub-acute exposure on neurobehavioral and respiratory development. The 
study population will consist of children under 6 years of age at the 
time of exposure (exposed group), whose residences in Ohio and 
Mississippi were illegally sprayed with MP since 1994, and matched with 
unexposed children (unexposed group). No data exist regarding low dose, 
sub-acute exposure to MP in children. The goal of this study is to 
examine the association between lower dose, sub-acute MP exposure in 
children, specifically from indoor spraying, and the risk of adversely 
affecting normal neurobehavioral and respiratory development.
    The questionnaire will be administered in person by trained 
interviewers to the mothers (fathers or other guardians, if the mother 
is not available) of the exposed and unexposed children. The Pediatric 
Environmental Neurobehavioral Test Battery (PENTB) will be administered 
by personnel trained in the neurobehavioral assessment of children at 
annual intervals for the three study years. The total annual burden 
hours are 1,208.

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                                                                                          Average       Total   
                                                              Number of    Number of      burden/       annual  
                  Respondent questionnaire                   respondents   responses/  response (in  burden  (in
                                                                           respondent     hours)        hours)  
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Parent/Child (general).....................................          537            1          1             537
(PENTB) Test Battery Questionnaires........................          537            1          1.25          671
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    2. Survey of Assisted Reproductive Technology Embryo Laboratory 
Procedures and Practices--New--Public Health Practice Program Office--
In October 1992, Congress passed the Fertility Clinic Success Rate and 
Certification Act of 1992 (FCSRCA). In accordance with this statute, 
the CDC has been tasked with developing a model certification program 
for assisted reproductive technologies (ART) embryo laboratories that 
are providing services to human fertility specialists in the U.S. This 
model certification program is to be voluntarily implemented by States 
or by independent certifying agencies such as the College of American 
Pathologists (CAP), which are approved by the State. The model 
certification program is to include a set of quality standards for the 
performance of laboratory procedures, maintenance of records, 
qualifications of laboratory personnel, and criteria for the inspection 
and certification of embryo laboratories. Other than a General 
Accounting Office Survey conducted in 1988, no current survey of ART 
laboratory procedures and practices is available. The proposed 
information collection will use a paper survey to provide an 
enumeration of these ART laboratory procedures, equipment maintenance 
practices, and personnel qualifications. This information is required 
to finalize the development of the model certification program and also 
provide a baseline study for evaluating its impact and effectiveness.
    The intended population is ART laboratory directors at all 
facilities with human embryo laboratories in the U.S. The estimated 
time for completion of this survey is expected to be approximately one 
hour per response. This estimate includes the time needed to review 
instructions, gather the relevant information, complete the form, and 
review the collected data. The total annual burden hours are 488.

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                                                                                         Average                
                                                            Number of     Number of      burden/    Total burden
                       Respondents                         respondents   responses/     response       (hours)  
                                                                         respondent    (in hours)               
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ART Laboratory Directors................................          325             1           1.5           488 
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[[Page 23790]]

    Dated: April 24, 1998.
Kathy Cahill,
Associate Director for Policy Planning and Evaluation, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 98-11479 Filed 4-29-98; 8:45 am]
BILLING CODE 4163-18-P