Proposed Data Collections Submitted for Public Comment and Recommendations, 38938-38939 [05-13246]
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38938
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Notices
provisions of this act, CDC funded 5
CADDRE centers including the
California Department of Health and
Human Services, Colorado Department
of Public Health and Environment,
Johns Hopkins University, the
University of Pennsylvania, and the
University of North Carolina at Chapel
Hill. CDC National Center for Birth
Defect and Developmental Disabilities
will participate as the 6th site. The
multi-site, collaborative study will be an
epidemiological investigation of
possible causes for the autism spectrum
disorders.
developmental and physical exam of the
child participant; (7) biological
sampling of the child participant (blood
and hair); and, (8) biological sampling of
the biological parents of the child
participant (blood only). OMB clearance
is requested for the self administered
questionnaires and buccal swab kit, the
primary caregiver interview, and the
child development interview. There is
no cost to respondents other than their
time.
Data collection methods will consist
of the following: (1) Medical and
educational record review of the child
participant; (2) medical record review of
the biological mother of the child
participant; (3) a packet sent to the
participants with self-administered
questionnaires and a buccal swab kit; (4)
a telephone interview focusing on
pregnancy-related events and early life
history (biological mother and/or
primary caregiver interview); (5) a child
development interview (for case
participants only) administered over the
telephone or in-person; (6) a
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents
Survey
Number of
responses per
respondent
Average
burden per
response
(in hrs.)
Total burden
(in hrs.)
Cases:
—Self administered questionnaires and buccal swab kit .........................
—Primary caregiver interview ...................................................................
—Child development interview .................................................................
Controls:
—Self administered questionnaires and buccal swab kit .........................
—Primary caregiver interview ...................................................................
—Child development interview .................................................................
644
644
644
1
1
1
3.0
40/60
3.0
1932
429
1932
1288
1288
1288
1
1
1
3.0
40/60
1.0
3864
859
1288
Total ...................................................................................................
........................
........................
........................
10,304
Dated: June 21, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 05–13245 Filed 7–5–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–05–0010]
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 404–371–5983 and
send comments to Seleda Perryman,
VerDate jul<14>2003
16:35 Jul 05, 2005
Jkt 205001
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
The National Birth Defects Prevention
Study (OMB 0920–0010)—Extension—
The Division of Birth Defects and
Developmental Disabilities (DBDDD),
National Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
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Fmt 4703
Sfmt 4703
Background and Brief Description
CDC has been monitoring the
occurrence of serious birth defects and
genetic diseases in Atlanta since 1967
through the Metropolitan Atlanta
Congenital Defects Program (MACDP).
The MACDP is a population-based
surveillance system for birth defects in
the 5 counties of Metropolitan Atlanta.
Its primary purpose is to describe the
spatial and temporal patterns of birth
defects occurrence and serve as an early
warning system for new teratogens.
From 1993 to 1996, the Division of Birth
Defects and Developmental Disabilities
(DBDDD) conducted the Birth Defects
Risk Factor Surveillance (BDRFS) study,
a case-control study of risk factors for
selected birth defects. Infants with birth
defects were identified through MACDP
and maternal interviews and clinical/
laboratory tests were conducted on
approximately 300 cases and 100
controls per year. Controls were selected
from among normal births in the same
population. In 1997 the BDRFS became
the National Birth Defects Prevention
Study (NBDPS). The major components
of the study did not change.
The NBDPS is a case-control study of
major birth defects that includes cases
identified from existing birth defect
E:\FR\FM\06JYN1.SGM
06JYN1
38939
Federal Register / Vol. 70, No. 128 / Wednesday, July 6, 2005 / Notices
surveillance registries in ten states
(including metropolitan Atlanta).
Control infants are randomly selected
from birth certificates or birth hospital
records. Mothers of case and control
infants are interviewed using a
computer-assisted telephone interview.
Parents are asked to collect cheek cells
from themselves and their infants for
DNA testing. Information gathered from
both the interviews and the DNA
specimens will be used to study
independent genetic and environmental
factors as well as gene-environment
interactions for a broad range of
carefully classified birth defects.
This request is submitted to obtain
OMB clearance for three additional
years. There is no cost to respondents
other than their time.
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents
Type of burden
Frequency of
response
Average burden/response
(in hours)
Annual burden
(in hours)
NBDPS case/control interview .........................................................................
Biologic specimen collection ............................................................................
400
1,200
1
1
1
10/60
400
200
Total ..........................................................................................................
........................
........................
........................
600
Dated: June 21, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 05–13246 Filed 7–5–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Augmenting Laboratory Outcomes in
HIV Assessment (ALOHA)
Announcement Type: Supplemental
(04017).
Funding Opportunity Number:
AA120.
Catalog of Federal Domestic
Assistance Number: 93.944.
Key Dates:
Application Deadline: August 5, 2005.
I. Funding Opportunity Description
Authority: This program is authorized
under sections 317(k)(2) and 318b of the
Public Health Service Act (42 U.S.C.
Sections 247b(k)(2) and 247c), as
amended.
Purpose: CD4+ T-lymphocyte (CD4)
and viral load (VL) tests are used to
stage disease and, when opportunistic
infections (OI) are present, to guide
therapeutic decisions. Because CD4 and
VL testing should be performed
throughout the course of HIV disease,
reporting of these lab tests has been
used as a marker for whether HIVinfected persons are receiving
healthcare. Augmenting Laboratory
Outcomes in HIV Assessment (ALOHA)
will augment routine HIV/AIDS
surveillance data collection for the
purpose of assessing the completeness
and validity of laboratory (i.e., CD4
count and VL) and OI information. This
will be accomplished by the following:
VerDate jul<14>2003
16:35 Jul 05, 2005
Jkt 205001
1. Assessing the stage of HIV disease
at initial diagnosis among a cohort of
newly diagnosed HIV-infected persons,
over the age of 13, using routine and
augmented laboratory and clinical
information.
2. Better characterizing CD4 count
and VL, and correlating this laboratory
information with available data on OIs.
If, after complete enumeration of lab
and OI information, OIs add little to
nothing to help stage HIV disease, then
future surveillance practices may be
streamlined.
3. Identifying surveillance practices
(e.g., laboratory reporting requirements,
electronic lab reporting, and program
policies or organization) that affect the
completeness and accuracy of
surveillance laboratory data.
4. Assessing lab reporting as a marker
for access and adherence to care
following HIV diagnosis.
5. Identifying correlates for not being
in care, as indicated by the presence or
absence of laboratory reports.
6. Systematically evaluating the
availability of clinical and laboratory
data on the prevalence of common comorbid conditions (e.g., hepatitis B,
hepatitis C, tuberculosis, and cancer)
that are associated with risk factors for
HIV infection and influence the clinical
course of HIV disease. Data on these
conditions will be compared to levels of
CD4 and VL to assess the effects of comorbid conditions on levels of
immunosuppression at the time of HIV
diagnosis.
A variety of HIV/AIDS reporting areas
with different surveillance practices and
procedures will be sought for ALOHA.
This project will attempt to include an
area that currently warehouses lab
results, specifically CD4, in a separate
lab results database, and does not report
this information to the national HIV/
AIDS surveillance system. The
completeness of reporting for CD4
results will be assessed to determine if
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Frm 00078
Fmt 4703
Sfmt 4703
these reports truly indicate access to
care. This proportion has not been
reliably estimated by national
surveillance data. Some reporting areas
report a high proportion (greater than 75
percent) of newly diagnosed cases with
CD4 and/or VL results within 12 months
of diagnosis.
The factors that contribute to the
ability of lower morbidity areas to report
completely has not been fully examined,
but may be due to their ability to
conduct active case finding and medical
record abstraction. These practices may
have national surveillance policy
implications. Since lab reporting data is
critical to the expectations of the
Morbidity Monitoring Project (MMP), an
area will be sought to provide validation
of lab reporting as a marker for receiving
health care, and to collect information
about reasons for no lab testing and the
inability to link a person to care.
Lastly, ALOHA will include at least
one area that will match its HIV/AIDS
case registry to infectious disease
databases to identify, apart from
medical record review, OIs that
occurred six months before and after
HIV diagnosis. Examples of these
databases include the National
Electronic Disease Surveillance System
(NEDSS); cancer, hepatitis or
tuberculosis registries; or prescription
medication databases (e.g., Medicaid or
AIDS Drug Assistance Program).
As part of this project, participating
areas will conduct their usual
surveillance activities for information
on CD4 and VL lab results and OIs.
These activities include active case
surveillance, medical record review and
data extraction for newly diagnosed
cases (over the age of 13). When no lab
result is received by the HIV/AIDS
surveillance program, ongoing active
case follow-up will be needed to
determine case disposition and record
specific categorical information, such as
E:\FR\FM\06JYN1.SGM
06JYN1
]]>Agencies
[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Notices]
[Pages 38938-38939]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13246]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-05-0010]
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 404-371-5983
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
The National Birth Defects Prevention Study (OMB 0920-0010)--
Extension--The Division of Birth Defects and Developmental Disabilities
(DBDDD), National Center on Birth Defects and Developmental
Disabilities (NCBDDD), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
CDC has been monitoring the occurrence of serious birth defects and
genetic diseases in Atlanta since 1967 through the Metropolitan Atlanta
Congenital Defects Program (MACDP). The MACDP is a population-based
surveillance system for birth defects in the 5 counties of Metropolitan
Atlanta. Its primary purpose is to describe the spatial and temporal
patterns of birth defects occurrence and serve as an early warning
system for new teratogens. From 1993 to 1996, the Division of Birth
Defects and Developmental Disabilities (DBDDD) conducted the Birth
Defects Risk Factor Surveillance (BDRFS) study, a case-control study of
risk factors for selected birth defects. Infants with birth defects
were identified through MACDP and maternal interviews and clinical/
laboratory tests were conducted on approximately 300 cases and 100
controls per year. Controls were selected from among normal births in
the same population. In 1997 the BDRFS became the National Birth
Defects Prevention Study (NBDPS). The major components of the study did
not change.
The NBDPS is a case-control study of major birth defects that
includes cases identified from existing birth defect
[[Page 38939]]
surveillance registries in ten states (including metropolitan Atlanta).
Control infants are randomly selected from birth certificates or birth
hospital records. Mothers of case and control infants are interviewed
using a computer-assisted telephone interview. Parents are asked to
collect cheek cells from themselves and their infants for DNA testing.
Information gathered from both the interviews and the DNA specimens
will be used to study independent genetic and environmental factors as
well as gene-environment interactions for a broad range of carefully
classified birth defects.
This request is submitted to obtain OMB clearance for three
additional years. There is no cost to respondents other than their
time.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average burden/
Type of burden Number of Frequency of response (in Annual burden
respondents response hours) (in hours)
----------------------------------------------------------------------------------------------------------------
NBDPS case/control interview.................... 400 1 1 400
Biologic specimen collection.................... 1,200 1 10/60 200
-----------------
Total....................................... .............. .............. .............. 600
----------------------------------------------------------------------------------------------------------------
Dated: June 21, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 05-13246 Filed 7-5-05; 8:45 am]
BILLING CODE 4163-18-P
