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Medical Monitoring Project (MMP)—0920-0740, exp. 5/31/2012—Extension with change—National Center for HIV, Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
This proposed data collection supplements the HIV/AIDS surveillance programs in 23 selected state and local health departments, which collect information on persons diagnosed with, living with, and dying from HIV infection and AIDS and will incorporate data elements from two data collections: Supplement to HIV/AIDS Surveillance (SHAS) project (0920-0262) and the Adult/Adolescent Spectrum of HIV Disease (ASD). Both projects stopped data collection in 2004.
Although CDC receives surveillance data from all U.S. states, these supplemental surveillance data are needed to make population-based national estimates of key indicators, related to the quality of HIV-related ambulatory care, the severity of need for HIV-related care and services, and HIV-related behaviors and clinical outcomes.
This project collects data on behaviors and clinical outcomes from a probability sample of HIV-infected adults receiving care in the U.S. Collection of data from interviews with HIV-infected patients provides information on patient demographics, and the current levels of behaviors that may facilitate HIV transmission: Sexual and drug use behaviors; patients' access to, use of and barriers to receiving HIV-related secondary prevention services; utilization of HIV-related medical services; and adherence to drug regimens. Collection of data from patient medical records provides information on: Demographics and insurance status; the prevalence and incidence of AIDS-defining opportunistic illnesses and co-morbidities related to HIV disease; the receipt of prophylactic and antiretroviral medications; and whether patients are receiving screening and treatment according to Public Health Service guidelines. No other Federal agency collects national population-based behavioral and clinical information from HIV-infected adults in care. The data are expected to have significant implications for policy, program development, and resource allocation at the state/local and national levels.
The Centers for Disease Control and Prevention requests approval for a 3-year extension with change for the previously approved Medical Monitoring Project (MMP) 0920-0740 exp. 5/31/2012). Data will be collected through in-person and telephone-administered, computer-assisted interviews conducted by trained interviewers in 23 Reporting Areas (16 states, Puerto Rico and 6 separately funded cities), and through medical record abstraction by trained abstractors. The methods for the project have been updated to include telephone interviews as an interviewing option. Otherwise, the project activities and methods will remain the same as those used in the previously approved data collection period.
A standard interview will be conducted with approximately 96% of patients, and will take 45 minutes. A short interview will be conducted with patients who are too ill to complete the standard interview or when the interview must be translated. The short interview, which will be conducted with approximately 4% of patients, will take approximately 20 minutes.
Medical record abstractions will be completed for on all eligible participants. Minimal data on all sampled patients will be extracted from an existing HIV case surveillance database, the national HIV/AIDS Reporting System [HARS]. These data will be used for quality control (to ensure patients were not sampled for participation in MMP more than once), to assess nonresponse bias, to prospectively monitor respondents' care utilization and treatment, and to make inference to the population of persons living with HIV in the United States.
The interview and minimum data set data collection instruments have been revised based on experience in previous data collection cycles, but these changes will not affect the burden per respondent. The medical record abstraction forms have not changed. CDC's current goal is to interview 80% of 9,400 patients or 7,520, 96% of whom (a total of 7,219 patients) will complete the standard interview and 4% of whom (a total of 301 patients) will complete the short interview. Because the number of sampled patients is greater (by 62 patients) than for the previously approved information collection, the total burden (in hours) will increase by 37 hours, from 8,500 to 8,537.
Participation of respondents is voluntary and there is no cost to the respondents other than their time.
The estimated annualized burden hours are 8,537.
|Type of respondent||Form name||Number of respondents||Number of responses per respondent||Average burden per response (in hours)|
|Sampled, Eligible HIV-Infected Patients||Standard interview||7,219||1||45/60|
|Sampled, Eligible HIV-Infected Patients Unable to Complete the Standard Interview||Short interview||301||1||20/60|
|Facility office staff pulling medical records||7,520||1||3/60|
|Facility office staff providing Estimated Patient Loads||936||1||2|
|Facility office staff providing patient lists||1,030||1||30/60|
|Facility office staff approaching participants for enrollment||3,120||1||5/60|
Dated: March 19, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate Director for Science (OADS), Office of the Director, Centers for Disease Control and Prevention.
[FR Doc. 2012-7028 Filed 3-22-12; 8:45 am]
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