0920-0641 Attachment 2 60day FRN

54086

Federal Register / Vol. 71, No. 177 / Wednesday, September 13, 2006 / Notices

all comments received, which will
become a matter of public record.
Approved: September 6, 2006.
Robert I. Cusick,
Director, Office of Government Ethics.
[FR Doc. E6–15129 Filed 9–12–06; 8:45 am]

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, specialists at metabolic
clinics and parent groups with an
interest in newborn screening for
information regarding missed cases. An
estimated 100 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.
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. There are
no costs to respondents except their
time to participate in the survey.

on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project

BILLING CODE 6345–02–P

Descriptive Epidemiology of Missed
or Delayed Diagnoses for Conditions
Detected by Newborn Screening—(OMB
No. 0920–0641)—Extension-National
Center for Environmental Health
(NCEH), Centers for Disease Control and
Prevention (CDC).

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–06–0641]

Background and Brief Description

Proposed Data Collections Submitted
for Public Comment and
Recommendations

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 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. 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

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 404–639–5960 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Atlanta, GA 30333 or send an e-mail to
[email protected].
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

ESTIMATED ANNUALIZED BURDEN HOURS
Respondents

Number of respondents

Number of responses per
respondent

100

1

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Average burden per response
(in hours)
10/60

Total burden
(hours)

17