[Federal Register Volume 71, Number 240 (Thursday, December 14, 2006)]
[Notices]
[Pages 75255-75256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-9723]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-07-0641]


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 404-639-4604 or send a e-mail to 
[email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 days of this notice.

[[Page 75256]]

Background and Brief Description

    Descriptive Epidemiology of Missed or Delayed Diagnoses for 
Conditions Detected by Newborn Screening--(OMB No. 0920-0641)--
Revision--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 four and 36 
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. 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 continue to collect information about 
missed or delayed diagnoses in order to 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 potential reasons for the miss and legal outcomes. 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 135 
remaining respondents will participate in our study by completing one 
or two short questionnaires that ask for information regarding the 
details of any missed or delayed 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.
    Respondent burden is approximately 3 minutes for the State Form and 
10 minutes for the Case Report Form. There are no costs to the 
respondents other than their time. The total estimated annual burden 
hours are 28.

                                        Estimated Annualized Burden Hours
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                                                                                         Average
                                                        Number of       Number of        burden         Total
          Respondents                 Form name        respondents    responses per   (hours)  per      burden
                                                                       respondent       response       (hours)
----------------------------------------------------------------------------------------------------------------
Director, State Newborn          State Form........              25               1            3/60          1.3
 Screening Laboratory.
                                 Case Report Form..              25               1           10/60          4.2
Follow-up State Coordinator....  State Form........              25               1            3/60          1.3
                                 Case Report Form..              25               1           10/60          4.2
Metabolic Clinic Employee......  State Form........              60               1            3/60          3
                                 Case Report Form..              60               1           10/60         10
Parent Advocate................  Case Report Form..               5               1           10/60          0.8
Parent.........................  Case Report Form..              20               1           10/60          3.3
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    Dated: December 8, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 06-9723 Filed 12-13-06; 8:45 am]
BILLING CODE 4163-18-M