[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]


-----------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
           Form name               Respondents       Number of     responses per   response  (in   Total burden
                                                    respondents     respondent        hours)        (in hours)
----------------------------------------------------------------------------------------------------------------
Face-to-Face Maternal           Sites                         10              30             1.5             450
 Interview Form.                 participating
                                 in FHPM.
----------------------------------------------------------------------------------------------------------------


    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]
BILLING CODE 4163-18-P