[Federal Register Volume 67, Number 128 (Wednesday, July 3, 2002)]
[Notices]
[Pages 44609-44610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-16673]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-02-67]


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) 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 Reports 
Clearance Officer on (404) 498-1210.
    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 or other 
forms of information technology. Send comments to Seleda Perryman, CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, 
Atlanta, GA 30333. Written comments should be received within 60 days 
of this notice.
    Proposed Project: Descriptive Epidemiology of Missed or Delayed 
Diagnosis for Conditions Detected by Newborn Screening--New--National 
Center for Environmental Health (NCEH), Centers for Disease Control and 
Prevention (CDC).

Background

    Every state in the United States and Washington DC has a public 
health program to test newborn babies for congenital metabolic and 
other disorders through laboratory testing of dried blood spots. These 
programs screen between 4 and 30 different conditions including 
phenylketonuria (PKU) and congenital hypothroidism, with testing 
performed in both state laboratories and private laboratories 
contracted by state health departments. The screening process or system 
is broader than the state public health newborn screening program, 
which is composed only of the laboratory and follow-up personnel. It 
involves the collection of blood from a newborn, analysis of the sample 
in a screening laboratory, follow up of abnormal results, confirmatory 
testing and diagnostic work up.
    Parents, hospitals, medical providers including primary care 
providers and specialists, state laboratory and follow-up personnel, 
advocates, as well as other partners such as local health departments, 
police, child protection workers and courts play important roles in 
this process. Most children born with metabolic disease are identified 
in a timely manner and within the parameters defined by the newborn 
screening system of each state. These children are referred for 
diagnosis and treatment. However, some cases are not detected at all or 
the detection comes too late to prevent harm. These ``missed cases'' 
often result in severe morbidity such as mental retardation or death.
    In this project, we will update and expand a previous 
epidemiological study of missed cases of two disorders published in 
1986. We will assess the number of cases of each disorder missed, the 
reasons for the miss and legal outcomes, if any. The reasons for the 
miss will be tabulated according to which step or steps of the 
screening process it occurred. Data will be collected by asking state 
public health laboratory directors, newborn screening laboratory 
managers, follow up coordinators, lawyers and parent groups with an 
interest in newborn screening for information regarding missed cases. 
An estimated 250 subjects will be requested to complete a short 
questionnaire that asks for information regarding the details of any 
missed cases of which they are aware. Follow-up telephone calls may be 
necessary to clarify responses. There is no cost to the respondents.
    The survey will highlight procedures and actions taken by states 
and other participants in newborn screening systems to identify causes 
of missed cases and to modify policies and procedures to prevent or 
minimize recurrences. The information gleaned from this study may be 
used to help craft changes in the screening protocols that will make 
the process more organized and efficient and less likely to fail an 
affected child. Further, it is not clear that there is a systematic 
assessment of missed cases on a population basis; this project will 
seek to identify procedures for routine surveillance of missed cases.

 
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                                                                     Number of    Average burden/
                   Respondents                       Number of      responses/     response (in    Total burden
                                                    respondents     respondents       hours)        (in hours)
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Questionnaire...................................             125               2           15/60              62
Telephone Follow-up.............................              75               2           10/60              24
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    Total.......................................  ..............  ..............  ..............              86
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[[Page 44610]]

    Dated: June 26, 2002.
Nancy E. Cheal,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 02-16673 Filed 7-2-02; 8:45 am]
BILLING CODE 4163-18-P