Proposed Data Collections Submitted for Public Comment and Recommendations, 48551-48553 [05-16370]
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48551
Federal Register / Vol. 70, No. 159 / Thursday, August 18, 2005 / Notices
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
Nurse-Delivered Risk Reduction
Intervention for HIV–Infected WomenNew-National Center for HIV, STD, and
TB Prevention (NCHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description:
CDC is requesting a 3-year approval
from the Office of Management and
Budget (OMB) to administer a
questionnaire and a one-on-one
qualitative interview to HIV-infected
women in the southern United States
who are at risk for further transmission
of the disease. This study is designed to
adapt and evaluate an HIV transmission
prevention intervention for the growing
population of HIV-infected women in
the South and to study factors
associated with risk among women. The
primary outcome will be a reduction in
months a follow-up assessment will be
conducted to compare behavior change.
Six months after the intervention group
has been provided the intervention and
follow-up, women in the comparison
group will receive the intervention. The
assessments will capture information on
demographics, risk behaviors, attitudes,
and knowledge related to HIV/STD
transmission and prevention. Semistructured qualitative interviews will be
conducted with a subgroup of 25–30
young, recently-diagnosed participants
following their participation in the
intervention study. These interviews
will explore behavioral, social, and
contextual conditions that may have
contributed to the women’s risk for HIV
infection and ideas about preventing
other women from becoming infected.
The two behavioral assessments will
take about 1 hour each to complete, the
nurse-delivered intervention will take
about 1 hour to complete, and the
qualitative interviews will take about 2
hours to complete. The screening
interview will take about 10 minutes to
complete. There is no cost to
respondents other than the time it takes
them to participate.
sexual risk behavior as a result of a
brief, nurse-delivered prevention
intervention adapted for use with HIVinfected women in the South. The
project will also conduct in-depth
qualitative interviews of young, recently
HIV-infected women to assess social
and environmental factors that
contribute to behavioral risk for HIV
infection. The project addresses goals of
the CDC HIV Prevention Strategic Plan,
specifically the goal of increasing the
number of HIV-infected persons who are
linked to appropriate prevention, care,
and treatment services. In addition,
information from this research will
inform future prevention interventions
that encompass individual and
contextual factors.
Approximately 550 women will be
screened for eligibility to participate in
the study, and a minimum of 330
women from one or two sites will be
recruited and administered baseline and
follow-up behavioral risk assessments in
a randomized wait-list comparison
design with a 6-month follow-up period.
That is, the intervention and
comparison group will complete an
assessment at the baseline and in 6
ESTIMATE OF ANNUALIZED BURDEN TABLE
Number of
respondents
Respondents
Number of responses per
respondent
Burden per
response
(in hours)
Total burden
(in hours)
Women—screening interview ..........................................................................
Women—assessment interviews .....................................................................
Women—intervention ......................................................................................
Women—qualitative interviews ........................................................................
550
330
330
30
1
2
1
1
10/60
1
1
2
92
660
330
60
Total ..........................................................................................................
........................
........................
........................
1142
Dated: August 11, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 05–16369 Filed 8–17–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–05–0573]
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
VerDate jul<14>2003
12:20 Aug 17, 2005
Jkt 205001
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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Adult and Pediatric HIV/AIDS
Confidential Case Reports (OMB Control
No. 0920–0573)—Revision-National
Center for HIV, STD, and TB Prevention
(NCHSTP), Divisions of HIV/AIDS
Prevention, Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
CDC is seeking a 3-year approval from
the Office of Management and Budget
(OMB) to continue data collection of the
HIV/AIDS case reports. CDC is
proposing to collect additional data on
testing history for improved monitoring
of HIV incidence (HIV testing history
pre-test and post-test data collection
forms), on specimen quality and
E:\FR\FM\18AUN1.SGM
18AUN1
48552
Federal Register / Vol. 70, No. 159 / Thursday, August 18, 2005 / Notices
sequence information for drug
resistance and HIV–1 subtype
surveillance.
The National Adult and Pediatric
HIV/AIDS Confidential Case Reports are
collected as part of the HIV/AIDS
Surveillance System. CDC in
collaboration with health departments
in the states, territories, and the District
of Columbia, conducts national
surveillance for cases of HIV infection
and AIDS, the end-stage of disease
caused by infection with HIV. HIV/AIDS
surveillance data collection by CDC is
authorized under Sections 301 and 306
of the Public Health Service Act (42
U.S.C. 241 and 242k).
Currently, 59 areas (states/territories/
possessions) mandate and collect AIDS
surveillance data. In addition, 43 areas
currently mandate and collect
confidential name-based surveillance
data on HIV cases which have not
progressed to AIDS in adults/
adolescents and/or children using the
HIV case report forms. We anticipate
that over the next 3 years additional
areas will mandate collection of namebased HIV surveillance data. Therefore,
the estimated burden for the next 3
years is based on HIV case reporting in
59 areas. Respondents in this data
collection are state, local, and territorial
health departments. The purpose of
HIV/AIDS surveillance data is to
monitor trends in HIV/AIDS and
describe the characteristics of infected
persons (e.g., demographics, modes of
exposure to HIV, clinical and laboratory
markers of HIV disease, manifestations
of severe HIV disease, and deaths due to
AIDS). Because HIV infection results in
untimely death and most often infects
younger adults in the prime years of life,
large amounts of federal, state, and local
government funding have been allocated
to address all aspects of HIV infection,
including prevention and treatment.
HIV/AIDS surveillance data are widely
used at all government levels to assess
the impact of HIV infection on
morbidity and mortality, to allocate
medical care resources and services, and
to guide prevention and disease control
activities.
HIV/AIDS reports are sent to state/
local health departments by
laboratories, physicians, hospitals,
clinics, and other health care providers
using standard adult and pediatric case
report forms. Areas use a
microcomputer system developed by
CDC (the HIV/AIDS Reporting System,
HARS) to store and analyze data, as well
as transmit encrypted data to CDC. A
Public Health Information Network
(PHIN) compliant HIV reporting system
is currently in development and is
scheduled to replace HARS by 2007.
This request to OMB includes one
modification to both the Adult/
Adolescent and Pediatric HIV/AIDS
confidential case report forms. The
forms to be used during this period will
include an additional blank space in the
top and bottom portions of the forms.
Areas could then have the option of
using this space to assign a form
number. This form number would be for
local use only and not be reported to
CDC.
The burden estimate for this renewal
includes estimated burden for
evaluations of HIV/AIDS surveillance
based on these forms. In addition, the
burden estimate also includes forms that
will be used to collect additional data
on testing history for the purpose of
estimating HIV incidence. The
availability of a serologic testing
algorithm for recent HIV seroconversion
(STARHS) allows surveillance systems
to determine how many among a group
of new diagnoses are from new
infections. In order to derive a
population-based estimate of HIV
incidence based on data from those
individuals who choose to have an HIV
antibody test and who test positive
(those reported to HIV surveillance
systems), additional data are needed to
assign statistical weights to individual
STARHS results. These additional data
include information on individual’s
reason for testing, the frequency with
which he/she tests, place where he/she
was tested, when he/she was most
recently tested, when he/she was first
tested, whether he/she has ever tested
negative, and questions regarding use of
HIV-related medicines.
The table also includes burden
estimates of additional information on
specimen quality and genotyping test
results for drug resistance and HIV–1
subtypes as part of variant, atypical and
resistant HIV surveillance (VARHS).
These data will be reported to CDC by
participating health departments for the
purpose of calculating population-based
estimates of prevalence of HIV drug
resistance and HIV–1 subtypes among
individuals with newly diagnosed HIV.
These data are provided routinely by the
testing laboratory to health departments
requiring no additional data collection
form.
No other Federal agency collects this
type of national HIV/AIDS data. In
addition to providing technical
assistance for use of the case report
forms, CDC also provides reporting
areas with technical support for the
HARS software. There is no cost to
respondents other than their time.
ESTIMATE OF ANNUALIZED BURDEN TABLE
Number of
respondents
Form
Number of
responses
Burden per response (in
hours)
Total burden
(in hours)
Adult Case Report: AIDS .................................................................................
Adult Case Report: HIV ...................................................................................
Peds Case Report: AIDS .................................................................................
Peds Case Report: HIV ...................................................................................
HIV Testing History Form Pre-test version ......................................................
HIV Testing History Form Post-test version ....................................................
VARHS .............................................................................................................
59
59
59
59
6
24
24
814
809
2
9
1,577
1,577
1,577
10/60
10/60
10/60
10/60
2/60
2/60
0.5/60
8,004
7,955
20
89
315
1,262
315
Total ..........................................................................................................
........................
........................
........................
17,960
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18AUN1
Federal Register / Vol. 70, No. 159 / Thursday, August 18, 2005 / Notices
Dated: August 11, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 05–16370 Filed 8–17–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Technical Assistance to Rwandan
Healthy Schools Initiative
Announcement Type: New.
Funding Opportunity Number: CDC–
RFA–AA105.
Catalog of Federal Domestic
Assistance Number: 93.067.
Key Dates: Application Deadline:
September 12, 2005.
I. Funding Opportunity Description
Authority: This program is authorized
under Sections 301(a) and 307 of the Public
Health Service Act [42 U.S.C. 241 and 242l],
as amended, and under Public Law 108–25
(United States Leadership Against HIV/AIDS,
Tuberculosis and Malaria Act of 2003)
[U.S.C. 7601].
Background: Data from the 2000
Behavioral Surveillance Survey in
Rwanda suggests that in-school youth
are more likely to engage in early sexual
activity than out-of-school youth, which
makes secondary schools a natural and
important focus for age-appropriate
prevention and confidential, voluntary
counseling and testing (CT) activities. In
addition, behavior change messages or
CT services have not yet systematically
reached secondary-school students in
Rwanda; while science lessons at the
secondary level in Rwanda generally
cover HIV/AIDS-related subject matter,
content and presentation vary from
school to school.
At present, confidential CT services in
Rwanda are restricted primarily to
health facilities, with limited
availability in non-clinical settings.
Schools have great potential to function
as community resource centers for HIV/
AIDS, particularly in those cases where,
for multiple reasons, individuals are not
presenting themselves for HIV testing at
hospitals or health centers. When it has
been used, mobile, confidential CT has
proven to be a very effective approach
in Rwanda; single-day testing
campaigns have yielded as many as
12,000 persons tested.
With assistance from the World Bank,
the United Kingdom, Department for
International Development (DFID), the
United Nations Children’s Fund
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(UNICEF) and other donors, the
Rwandan Ministry of Education
(MINEDUC) has recently completed the
development of primary- and
secondary-school curricula that
integrate HIV/AIDS and life-skills
lessons at each level of instruction. The
Rwandan National Curriculum
Development Center has approved the
curricula and incorporated them into
the training modules at Rwanda’s
teacher training colleges (TTC). The new
textbooks will be distributed to schools
in the near future. This is a valuable
first step in ensuring that all students in
Rwanda have an adequate knowledge
base appropriate to their stage of
physical, intellectual, and emotional
development, with respect to HIV/AIDS
prevention.
Purpose: As part of the President’s
Emergency Plan for AIDS Relief, HHS
announces the availability of Fiscal Year
(FY) 2005 funds for technical assistance
to Rwanda’s MINEDUC in launching a
pilot initiative to develop secondary
schools into community resources for
confidential CT and the prevention of
HIV/AIDS. The initiative, tentatively
named the Healthy Schools Initiative,
will take in two main interventions: (1)
School-based, community, confidential
CT offered via mobile testing units to
secondary-school students, their parents
and teachers, and surrounding
communities; and (2) an innovative,
age-appropriate prevention/behavior
change campaign to focus on abstinence
and parent-child communication. The
grantee, to be selected on a competitive
basis, will be responsible for
collaborating closely with MINEDUC,
HHS, the U.S. Agency for International
Development (USAID), and other local
agencies to ensure the successful
planning, coordination, implementation
and monitoring of the initiative.
Intervention 1: Counseling and Testing
Under the Healthy Schools Initiative,
HHS will introduce free, confidential
mobile HIV testing to secondary schools
through a culturally appropriate public
campaign to target teachers, upper level
secondary-school students, their
families and community members.
Building on the enthusiasm expressed
by the Rwandan Minister of Education
about a sector-wide confidential CT
campaign, the mobile testing
intervention will roll out in a top-down
fashion, by starting with public HIV
tests for the Minister and other
MINEDUC officials and then branching
out to secondary schools through Free
CT days. Free CT days will involve
dispatching a mobile CT unit to
secondary schools to provide free,
confidential testing for teachers,
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48553
students, their families and community
members. Prior to offering confidential
CT at secondary schools, community
preparation campaigns in school
catchment areas will foster acceptance
of community- and youth-centered
confidential CT, and for people living
with HIV/AIDS (PLWHA).
Both a ‘‘prevention for negatives’’
component and linkages to the national
care and treatment program for HIV
infected persons will facilitate
appropriate follow-up for all individuals
tested through the initiative. Ageappropriate information, Education, and
Communication (IEC) materials that
emphasize behavior change will go out
to all individuals who test negative in
an effort to encourage abstinence and
faithfulness as the best means of
prevention. The program will forge
linkages with the Rwandan national
care and treatment program to ensure
access to care and treatment for
individuals who test positive.
Specifically, local referrals to clinics
providing care and treatment to HIV
infected individuals, and anti-retroviral
therapy (ART) to those who are eligible,
will be provided to any individual who
tests positive for HIV at any testing site.
In addition, educational materials on
HIV, ARTs, and strategies for reducing
transmission of HIV will be provided to
individuals testing positive.
Given that Rwandan law and
government policy currently require
parental consent for the testing of youth
under the age of 18, it is crucial that the
program develop appropriate linkages
between the initiative’s prevention and
confidential CT interventions to
engender parental support for youth CT.
Such linkages might include the
integration of a module on confidential
CT into the parent-child communication
curriculum, extracurricular sensitization
activities with parents about the
importance of knowing one’s serostatus
at any age, or national advocacy
activities coordinated with MINEDUC’s
HIV/AIDS unit.
Intervention 2: Prevention
As part of the President’s Emergency
Plan, HHS seeks to build on MINEDUC’s
achievements in developing primary
and secondary HIV curricula by
introducing a culturally and ageappropriate competence-based behaviorchange curriculum to emphasize
abstinence and parent-child
communication about HIV/AIDS. The
curriculum will be founded on the
conviction that the key to behavior
change lies in: (1) The delivery of
innovative, age- and culturally
appropriate messages about HIV/AIDS
behavior change; (2) the continual
E:\FR\FM\18AUN1.SGM
18AUN1
]]>Agencies
[Federal Register Volume 70, Number 159 (Thursday, August 18, 2005)]
[Notices]
[Pages 48551-48553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16370]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-05-0573]
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
Adult and Pediatric HIV/AIDS Confidential Case Reports (OMB Control
No. 0920-0573)--Revision-National Center for HIV, STD, and TB
Prevention (NCHSTP), Divisions of HIV/AIDS Prevention, Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC is seeking a 3-year approval from the Office of Management and
Budget (OMB) to continue data collection of the HIV/AIDS case reports.
CDC is proposing to collect additional data on testing history for
improved monitoring of HIV incidence (HIV testing history pre-test and
post-test data collection forms), on specimen quality and
[[Page 48552]]
sequence information for drug resistance and HIV-1 subtype
surveillance.
The National Adult and Pediatric HIV/AIDS Confidential Case Reports
are collected as part of the HIV/AIDS Surveillance System. CDC in
collaboration with health departments in the states, territories, and
the District of Columbia, conducts national surveillance for cases of
HIV infection and AIDS, the end-stage of disease caused by infection
with HIV. HIV/AIDS surveillance data collection by CDC is authorized
under Sections 301 and 306 of the Public Health Service Act (42 U.S.C.
241 and 242k).
Currently, 59 areas (states/territories/possessions) mandate and
collect AIDS surveillance data. In addition, 43 areas currently mandate
and collect confidential name-based surveillance data on HIV cases
which have not progressed to AIDS in adults/adolescents and/or children
using the HIV case report forms. We anticipate that over the next 3
years additional areas will mandate collection of name-based HIV
surveillance data. Therefore, the estimated burden for the next 3 years
is based on HIV case reporting in 59 areas. Respondents in this data
collection are state, local, and territorial health departments. The
purpose of HIV/AIDS surveillance data is to monitor trends in HIV/AIDS
and describe the characteristics of infected persons (e.g.,
demographics, modes of exposure to HIV, clinical and laboratory markers
of HIV disease, manifestations of severe HIV disease, and deaths due to
AIDS). Because HIV infection results in untimely death and most often
infects younger adults in the prime years of life, large amounts of
federal, state, and local government funding have been allocated to
address all aspects of HIV infection, including prevention and
treatment. HIV/AIDS surveillance data are widely used at all government
levels to assess the impact of HIV infection on morbidity and
mortality, to allocate medical care resources and services, and to
guide prevention and disease control activities.
HIV/AIDS reports are sent to state/local health departments by
laboratories, physicians, hospitals, clinics, and other health care
providers using standard adult and pediatric case report forms. Areas
use a microcomputer system developed by CDC (the HIV/AIDS Reporting
System, HARS) to store and analyze data, as well as transmit encrypted
data to CDC. A Public Health Information Network (PHIN) compliant HIV
reporting system is currently in development and is scheduled to
replace HARS by 2007.
This request to OMB includes one modification to both the Adult/
Adolescent and Pediatric HIV/AIDS confidential case report forms. The
forms to be used during this period will include an additional blank
space in the top and bottom portions of the forms. Areas could then
have the option of using this space to assign a form number. This form
number would be for local use only and not be reported to CDC.
The burden estimate for this renewal includes estimated burden for
evaluations of HIV/AIDS surveillance based on these forms. In addition,
the burden estimate also includes forms that will be used to collect
additional data on testing history for the purpose of estimating HIV
incidence. The availability of a serologic testing algorithm for recent
HIV seroconversion (STARHS) allows surveillance systems to determine
how many among a group of new diagnoses are from new infections. In
order to derive a population-based estimate of HIV incidence based on
data from those individuals who choose to have an HIV antibody test and
who test positive (those reported to HIV surveillance systems),
additional data are needed to assign statistical weights to individual
STARHS results. These additional data include information on
individual's reason for testing, the frequency with which he/she tests,
place where he/she was tested, when he/she was most recently tested,
when he/she was first tested, whether he/she has ever tested negative,
and questions regarding use of HIV-related medicines.
The table also includes burden estimates of additional information
on specimen quality and genotyping test results for drug resistance and
HIV-1 subtypes as part of variant, atypical and resistant HIV
surveillance (VARHS). These data will be reported to CDC by
participating health departments for the purpose of calculating
population-based estimates of prevalence of HIV drug resistance and
HIV-1 subtypes among individuals with newly diagnosed HIV. These data
are provided routinely by the testing laboratory to health departments
requiring no additional data collection form.
No other Federal agency collects this type of national HIV/AIDS
data. In addition to providing technical assistance for use of the case
report forms, CDC also provides reporting areas with technical support
for the HARS software. There is no cost to respondents other than their
time.
Estimate of Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Burden per
Form Number of Number of response (in Total burden
respondents responses hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Adult Case Report: AIDS......................... 59 814 10/60 8,004
Adult Case Report: HIV.......................... 59 809 10/60 7,955
Peds Case Report: AIDS.......................... 59 2 10/60 20
Peds Case Report: HIV........................... 59 9 10/60 89
HIV Testing History Form Pre-test version....... 6 1,577 2/60 315
HIV Testing History Form Post-test version...... 24 1,577 2/60 1,262
VARHS........................................... 24 1,577 0.5/60 315
-----------------
Total....................................... .............. .............. .............. 17,960
----------------------------------------------------------------------------------------------------------------
[[Page 48553]]
Dated: August 11, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 05-16370 Filed 8-17-05; 8:45 am]
BILLING CODE 4163-18-P
