[Federal Register Volume 76, Number 6 (Monday, January 10, 2011)]
[Notices]
[Pages 1433-1434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-280]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-11-11BD]
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 Carol E. Walker, CDC Acting 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 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
Fetal-Infant Mortality Review--Human Immunodeficiency Virus
Prevention Methodology (FHPM)--New--National Center for HIV/AIDS, Viral
Hepatitis, Sexually Transmitted Diseases, and Tuberculosis Prevention
(NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
NCHHSTP has the primary responsibility within the CDC and the U.S.
Public Health Service for the prevention and control of HIV infection,
viral hepatitis, sexually transmitted diseases, and tuberculosis, as
well as for community-based HIV prevention activities, syphilis, and
tuberculosis elimination programs. Remarkable progress has been made in
preventing mother-to-child transmission of HIV in recent years,
following the introduction of antiretroviral therapy for the prevention
of mother-to-child transmission in 1994. The number of infants
perinatally infected with HIV has decreased dramatically: from 1,650
cases in 1991 to approximately 240-247 cases in 2005.
Despite advances in interventions for the prevention of mother-to-
child transmission of human immunodeficiency virus type 1, including
antiretroviral drugs, elective cesarean delivery, and avoidance of
breastfeeding, between 100 and 200 infants are perinatally infected
with HIV in the United States each year. Many of these cases result
from missed prevention opportunities, such as prenatal HIV testing,
prenatal care, or antiretroviral prophylaxis.
The Fetal-InfantMortality Review-HIV Prevention Methodology (FHPM)
is designed to identify and address missed prevention opportunities at
the community level. FHPM was first piloted at 3 sites, which developed
the data collection instruments collaboratively with CityMatCH and CDC;
CDC did not dictate the data collection method. FHPM is currently a CDC
NCHHSTP funded extramural project at 10 sites, conducted in partnership
with the National Fetal and Infant Mortality Review Program,
[[Page 1434]]
CityMatCH, and participating communities. This request is for 3-years.
The original Fetal-Infant Mortality Review (FIMR) methodology was
an approach designed to lead to community-level improvements in infant
health outcomes. The methodology consists of four steps: Data
gathering, case review, community action, and changes in community
systems.
The FHPM has adapted the steps of FIMR in order to evaluate and
address the causes of perinatal HIV transmission. This is the first
program to approach perinatal HIV prevention using a community-based
systems investigation and improvement strategy.
During FHPM's first step of the methodology, cases of perinatal HIV
will be identified based on a pre-established case definition, and will
be prioritized for community review.
Data for selected cases will be collected from a variety of
sources, including medical, public health, and case management records,
and then de-identified. A maternal interview will only be conducted if
consent is provided by the woman. Data collection can proceed using
hospital records if there is no consent for an interview. Data
collected during interviews with consenting women will be de-
identified. There will be no cost to participants beyond their time,
and women can decline to be interviewed.
The maternal interview is the only portion of the project which
interacts with individual patients. As is the case for all data
collected by FHPM, the intent for the data is for local use to
understand and improve local systems. Face-to-face interviews will
average 1.5 hours in duration and will not need to be repeated, unless
a woman has a second pregnancy and is selected for case review under
the priority assessment, and consents to participate a second time.
Each of the 10 FHPM sites will conduct 30 maternal interviews annually.
The number of elements in the interview is presently being reduced.
When the FIMR-HIV Data System (FHDS) is implemented (see below), each
of these 10 sites will be asked to send its data to the FHDS.
After the data collection phase, a multidisciplinary case review
team (CRT) will conduct a regularly scheduled case review session. The
recommendations and findings of the CRT will then be passed on to a
Community Action Team (CAT), a diverse, broad-based group of community
leaders and representatives capable of defining and initiating changes
in the local systems.
Since 2009, partner organizations have been funded to operate FHPM
in 10 sites. Sites have been collecting and evaluating data on mother-
to-child transmissions in their communities since 2010. Currently de-
identified FHPM data is stored electronically at participating sites.
This data has been collected by local health agencies for local public
health action and programming. NCHHSTP also plans to launch the FIMR-
HIV Data System (FHDS) in 2011, which would provide a centralized, Web-
based data system that could be accessed and utilized by all
participating sites and partner organizations. This Information
Collection Request is being submitted since the FHDS since FHDS will be
managed by CDC, thus centralizing the data and allowing aggregated
analysis.
NCHHSTP is considering ways to eliminate perinatal HIV transmission
in the U.S., and has incorporated FHPM into a framework to do so.
Data collected by FHPM will primarily serve to inform and improve
local health systems in order to prevent future perinatal HIV
transmissions. This data will provide a clearer picture of the systems-
level strengths and weaknesses in participating communities. There will
be no cost to participants other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Form name Respondents Number of responses per response (in Total burden
respondents respondent hours) (in hours)
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Face-to-Face Maternal Sites 10 30 1.5 450
Interview Form. participating
in FHPM.
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Dated: December 30, 2010.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2011-280 Filed 1-7-11; 8:45 am]
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