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 Department of Health and Human Services Centers for Disease  Control and Prevention [30 Day-07-0641]
 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 
                    *omb@cdc.gov*. 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.
                    ( print 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
Respondents
Form name
Number of 
                             respondents
Number of 
                             responses per respondent
Average 
                             burden  
                             (hours)  
                             per response
Total 
                             burden  
                             (hours)Director, State Newborn Screening Laboratory
State Form
25
1
3/60
1.3Case Report Form
25
1
10/60
4.2Follow-up State Coordinator
State Form
25
1
3/60
1.3Case Report Form
25
1
10/60
4.2Metabolic Clinic Employee
State Form
60
1
3/60
3Case Report Form
60
1
10/60
10Parent Advocate
Case Report Form
5
1
10/60
0.8Parent
Case Report Form
20
1
10/60
3.3
 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