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 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

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, 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