Proposed Data Collections Submitted for Public Comment and Recommendations, 54086-54087 [E6-15151]
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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
omb@cdc.gov.
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
Number of respondents
Respondents
Number of responses per
respondent
100
1
hsrobinson on PROD1PC61 with NOTICES
State laboratory directors, screening laboratory managers, follow-up coordinators, metabolic clinic specialists, and parent groups ...............................
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16:19 Sep 12, 2006
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Average burden per response
(in hours)
10/60
Total burden
(hours)
17
Federal Register / Vol. 71, No. 177 / Wednesday, September 13, 2006 / Notices
Dated: September 7, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–15151 Filed 9–12–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–06–0128]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
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,
54087
investigations under the ‘‘Congenital
Syphilis (CS) Case Investigation and
Report Form’’ (CDC73.126, REV 11–98);
this form is currently approved under
OMB No. 0920–0128, and is due to
expire on 9/30/2006. This request is for
a 3-year extension of OMB approval.
Reducing congenital syphilis is a
national objective in the DHHS Report
entitled Healthy People 2010 (Vol. I and
II). Objective 25–9 of this document
states the goal: ‘‘Reduce congenital
syphilis to 1 new case per 100,000 live
births’’. In order to meet this national
objective, an effective surveillance
system for congenital syphilis must be
continued to monitor current levels of
disease and progress towards the year
2010 objective. This data will also be
used to develop intervention strategies
and to evaluate ongoing control efforts.
Respondent burden is approximately
15 minutes per reported case. The
estimated annual number of cases
expected to be reported using the
current case definition is 500 or less.
Therefore, the total number of hours for
congenital syphilis reporting required
will be approximately 130 hours per
year. There are no costs to the
respondents other than their time.
Atlanta, GA 30333 or send an e-mail to
omb@cdc.gov.
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
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
Congenital Syphilis (CS) Case
Investigation and Report Form
(CDC73.126)—OMB No. 0920–0128—
Extension—National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Coordinating
Center for Infectious Diseases (CCID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
CDC proposes to continue data
collection for congenital syphilis case
ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents
Average number of responses per
respondent
Clerical and Hospital staff of state and local health department STD project
areas ............................................................................................................
65
8
15/60
130
Total ..........................................................................................................
........................
........................
........................
130
Respondents
Dated: September 6, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–15184 Filed 9–12–06; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
hsrobinson on PROD1PC61 with NOTICES
Food and Drug Administration
Cooperative Agreement to Support the
Shellfish and Seafood Safety
Assistance Project; Announcement
Type: Single Source Application;
Agency Funding Opportunity Number:
RFA–FDA–CFSAN–2006–1
AGENCY:
Food and Drug Administration,
HHS.
VerDate Aug<31>2005
16:19 Sep 12, 2006
Jkt 208001
ACTION:
Notice.
I. Funding Opportunity Description
The Food and Drug Administration
(FDA), Center for Food Safety and
Applied Nutrition (CFSAN), Office of
Seafood is announcing its intent to
award, noncompetitively, a cooperative
agreement to the Interstate Shellfish
Sanitation Conference (ISSC) in the
amount of $320,500 for fiscal year 2006,
for direct and indirect costs combined.
Subject to the availability of Federal
funds and successful performance, 4
additional years of support will be
available. FDA will support the research
covered by this notice under the
authority of section 301 of the Public
Health Service Act (the PHS act) (42
U.S.C. 241). FDA’s research program is
PO 00000
Frm 00070
Fmt 4703
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Average burden per response
(in hours)
Total burden
(hours)
described in the Catalog of Federal
Domestic Assistance No. 93.103. Before
entering into cooperative agreements,
FDA carefully considers the benefits
such agreements will provide to the
public. This effort will enhance FDA’s
molluscan shellfish sanitation program
and provide the public greater assurance
of the quality and safety of these
products.
II. Eligibility Information
Competition is limited to ISSC
because ISSC is the only organization
that has the established formal
structure, procedures, and expertise to
direct all components (public health,
environmental, resource management,
and enforcement) of an effective
shellfish sanitation program.
E:\FR\FM\13SEN1.SGM
13SEN1
]]>Agencies
[Federal Register Volume 71, Number 177 (Wednesday, September 13, 2006)]
[Notices]
[Pages 54086-54087]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-15151]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-06-0641]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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 omb@cdc.gov.
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 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
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).
Background and Brief Description
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
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.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response Total burden
respondents respondent (in hours) (hours)
----------------------------------------------------------------------------------------------------------------
State laboratory directors, screening laboratory 100 1 10/60 17
managers, follow-up coordinators, metabolic
clinic specialists, and parent groups..........
----------------------------------------------------------------------------------------------------------------
[[Page 54087]]
Dated: September 7, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E6-15151 Filed 9-12-06; 8:45 am]
BILLING CODE 4163-18-P
