[Federal Register: December 14, 2006 (Volume 71, Number 240)]
[Notices]
[Page 75255-75256]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14de06-62]
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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
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.
[[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)
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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