Proposed Data Collections Submitted for Public Comment and Recommendations, 75256-75257 [E6-21269]
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75256
Federal Register / Vol. 71, No. 240 / Thursday, December 14, 2006 / Notices
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
Number of
respondents
Number of
responses per
respondent
Average
burden
(hours)
per response
Total
burden
(hours)
Respondents
Form name
Director, State Newborn Screening
Laboratory.
State Form ..........................................
25
1
3/60
1.3
Case
State
Case
State
Case
Case
Case
25
25
25
60
60
5
20
1
1
1
1
1
1
1
10/60
3/60
10/60
3/60
10/60
10/60
10/60
4.2
1.3
4.2
3
10
0.8
3.3
Follow-up State Coordinator ...............
Metabolic Clinic Employee .................
Parent Advocate .................................
Parent .................................................
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-07–05AJ]
rwilkins on PROD1PC63 with NOTICES
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
VerDate Aug<31>2005
17:54 Dec 13, 2006
Jkt 211000
Report Form ..............................
Form ..........................................
Report Form ..............................
Form ..........................................
Report Form ..............................
Report Form ..............................
Report Form ..............................
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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
be received within 60 days of this
notice.
Proposed Project
National Surveillance for Severe
Adverse Events Associated with
Treatment of Latent Tuberculosis
Infection—New—Division of
Tuberculosis Elimination (DTBE),
National Center for HIV, STD, and TB
Prevention (NCHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
As part of the national TB elimination
strategy, the American Thoracic Society
and CDC have published
recommendations for targeted testing for
TB and treatment for latent TB infection
(LTBI). However, between October 2000
and September 2004, the CDC received
reports of 50 patients with severe
adverse events associated with the use
of the two or three-month regimen of
rifampin and pyrazinamide (RZ) for the
treatment of LTBI; 12 (24%) patients
E:\FR\FM\14DEN1.SGM
14DEN1
75257
Federal Register / Vol. 71, No. 240 / Thursday, December 14, 2006 / Notices
died (Morbidity and Mortality Weekly
Report 2003;52[31]:735–9). A severe
adverse event is defined as
hospitalization or death of a person
receiving treatment for LTBI. On the
basis of these data, the American
Thoracic Society and CDC
recommended that RZ should generally
not be offered for treatment of persons
with LTBI, regardless of HIV status.
Rifampin and pyrazinamide should
continue to be administered in
multidrug regimens for the treatment of
persons with active TB disease.
Reports of severe adverse events
related to RZ and other older LTBI
regimens have prompted a need for this
three year project—a national
surveillance system of such events. The
objective of the project is to determine
the annual number and temporal trends
of severe adverse events (hospitalization
or death) associated with any treatment
for LTBI in the United States.
treatment of LTBI and contains
demographic, clinical, and laboratory
information. CDC will analyze and
periodically publish reports
summarizing national LTBI treatment
adverse events statistics and also will
conduct special analyses for publication
in peer-reviewed scientific journals to
further describe and interpret these
data.
The Food and Drug Administration
(FDA) collects data on adverse events
related to drugs through the FDA
MedWatch Program. CDC is planning to
collaborate with FDA in developing the
national surveillance system for adverse
events associated with treatment for
LTBI. Reporting will be conducted
through telephone, e-mail, or during
CDC site visits. The only cost to
respondents is their time to gather
medical records to complete the form.
Surveillance of such events will provide
data to support periodic evaluation of
guidelines for treatment of persons with
LTBI and revision, as needed.
This project will set up a passive
reporting system for severe adverse
events (death or hospitalization) to
therapy for LTBI. The system will rely
on medical chart review of already
existing data by TB control staff.
Potential respondents are any of the
60 reporting areas for the national TB
surveillance system (the 50 states, the
District of Columbia, New York City,
Puerto Rico, and 8 jurisdictions in the
Pacific and Caribbean). Data will be
collected using the data collection form
for adverse events associated with LTBI
treatment (AELT). Based on previous
reporting, CDC anticipates receiving an
average of 3 responses per year from the
60 reporting areas. The AELT form is
completed for each reported
hospitalization or death related to
ESTIMATE OF ANNUALIZED BURDEN HOURS
Average burden per response
(in hours)
Number of respondents
Number of responses per
respondent
Physicians ........................................................................................................
Nurses ..............................................................................................................
Medical Clerk ...................................................................................................
3
3
3
1
1
1
3
4
1
9
12
3
Total ..........................................................................................................
........................
........................
........................
24
Type of respondents
Dated: December 8, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–21269 Filed 12–13–06; 8:45 am]
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.
BILLING CODE 4163–18–P
Proposed Project
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–07–0128]
rwilkins on PROD1PC63 with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
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) 639–5960 or send an email to omb@cdc.gov. Send written
VerDate Aug<31>2005
17:54 Dec 13, 2006
Jkt 211000
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
investigations under the ‘‘Congenital
Syphilis (CS) Case Investigation and
Report Form’’ (CDC73.126, REV 10–
2003). This form is currently approved
under OMB No. 0920–0128, and is due
to expire on 12/31/2006. This request is
for a 3-year extension of OMB approval.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Total burden
(in hours)
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 response for those who
provide data electronically and 30
minutes per response for those who
provide data via hard copy. The
estimated annual number of cases
expected to be reported using the
current case definition is approximately
500. There are no costs to the
respondents other than their time. The
total estimated annual burden hours are
160.
E:\FR\FM\14DEN1.SGM
14DEN1
]]>Agencies
[Federal Register Volume 71, Number 240 (Thursday, December 14, 2006)]
[Notices]
[Pages 75256-75257]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-21269]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-07-05AJ]
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
National Surveillance for Severe Adverse Events Associated with
Treatment of Latent Tuberculosis Infection--New--Division of
Tuberculosis Elimination (DTBE), National Center for HIV, STD, and TB
Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
As part of the national TB elimination strategy, the American
Thoracic Society and CDC have published recommendations for targeted
testing for TB and treatment for latent TB infection (LTBI). However,
between October 2000 and September 2004, the CDC received reports of 50
patients with severe adverse events associated with the use of the two
or three-month regimen of rifampin and pyrazinamide (RZ) for the
treatment of LTBI; 12 (24%) patients
[[Page 75257]]
died (Morbidity and Mortality Weekly Report 2003;52[31]:735-9). A
severe adverse event is defined as hospitalization or death of a person
receiving treatment for LTBI. On the basis of these data, the American
Thoracic Society and CDC recommended that RZ should generally not be
offered for treatment of persons with LTBI, regardless of HIV status.
Rifampin and pyrazinamide should continue to be administered in
multidrug regimens for the treatment of persons with active TB disease.
Reports of severe adverse events related to RZ and other older LTBI
regimens have prompted a need for this three year project--a national
surveillance system of such events. The objective of the project is to
determine the annual number and temporal trends of severe adverse
events (hospitalization or death) associated with any treatment for
LTBI in the United States. Surveillance of such events will provide
data to support periodic evaluation of guidelines for treatment of
persons with LTBI and revision, as needed.
This project will set up a passive reporting system for severe
adverse events (death or hospitalization) to therapy for LTBI. The
system will rely on medical chart review of already existing data by TB
control staff.
Potential respondents are any of the 60 reporting areas for the
national TB surveillance system (the 50 states, the District of
Columbia, New York City, Puerto Rico, and 8 jurisdictions in the
Pacific and Caribbean). Data will be collected using the data
collection form for adverse events associated with LTBI treatment
(AELT). Based on previous reporting, CDC anticipates receiving an
average of 3 responses per year from the 60 reporting areas. The AELT
form is completed for each reported hospitalization or death related to
treatment of LTBI and contains demographic, clinical, and laboratory
information. CDC will analyze and periodically publish reports
summarizing national LTBI treatment adverse events statistics and also
will conduct special analyses for publication in peer-reviewed
scientific journals to further describe and interpret these data.
The Food and Drug Administration (FDA) collects data on adverse
events related to drugs through the FDA MedWatch Program. CDC is
planning to collaborate with FDA in developing the national
surveillance system for adverse events associated with treatment for
LTBI. Reporting will be conducted through telephone, e-mail, or during
CDC site visits. The only cost to respondents is their time to gather
medical records to complete the form.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Physicians...................................... 3 1 3 9
Nurses.......................................... 3 1 4 12
Medical Clerk................................... 3 1 1 3
---------------
Total....................................... .............. .............. .............. 24
----------------------------------------------------------------------------------------------------------------
Dated: December 8, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E6-21269 Filed 12-13-06; 8:45 am]
BILLING CODE 4163-18-P
