[Federal Register Volume 69, Number 63 (Thursday, April 1, 2004)]
[Notices]
[Pages 17157-17158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7311]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-23-04]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    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) 498-1210. Send written 
comments to CDC, Desk Officer, Human Resources and Housing Branch, New 
Executive Office Building, Room 10235, Washington, DC 20503 or by fax 
to (202) 395-6974. Written comments should be received within 30 days 
of this notice.
    Proposed Project: Descriptive Epidemiology of Missed or Delayed 
Diagnoses for Conditions Detected by Newborn Screening--New--National 
Center for Environmental Health (NCEH), Centers for Disease Control and 
Prevention (CDC).
    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 for between 4 and 30 different conditions including 
phenylketonuria (PKU) and congenital hypothyroidism, 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, and 
the reasons for the missed and legal outcomes, if any. The reasons for 
the missed 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, specialists at metabolic clinics and 
parent groups with an interest in newborn screening, for information 
regarding missed cases. An estimated 269 subjects (with an expected 
response rate of 80% from metabolic clinics, Lab Directors and 
Coordinators) will be requested to complete a short questionnaire that 
asks for information regarding the details of any missed cases of which 
they are aware.
    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. Furthermore, it is not clear that there is a systematic

[[Page 17158]]

assessment of missed cases on a population basis; this project will 
seek to identify procedures for routine surveillance of missed cases. 
The estimated annualized burden is 36 hours.

------------------------------------------------------------------------
                                                Number of      Average
                                  Number of     responses    burden per
          Respondents            respondents       per      response (in
                                               respondent      hours)
------------------------------------------------------------------------
Lab Directors.................            42             1         10/60
Follow-up Coordinators........            42             1         10/60
Metabolic Clinic Employee.....           120             1         10/60
Parent Advocate...............            13             1         10/60
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    Dated: March 25, 2004.
Joe E. Salter,
Acting Director, Management Analysis and Services Office, Centers for 
Disease Control and Prevention.
[FR Doc. 04-7311 Filed 3-31-04; 8:45 am]
BILLING CODE 4163-18-P