[Federal Register Volume 77, Number 9 (Friday, January 13, 2012)]
[Notices]
[Pages 2066-2067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-605]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-12-0740]
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) 639-7570
and send comments to Kimberly Lane, CDC Reports Clearance Officer, 1600
Clifton Road, MS-D74, Atlanta, GA 30333 or send an email 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
Medical Monitoring Project (MMP)--(OMB No. 0920-0740 Exp: 5/31/
2012)--Revision--National Center for HIV/AIDS, Viral 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.
through in-person or telephone interviews and abstraction of medical
records. Information is also extracted from HIV case surveillance
records for a dataset, referred to as the minimum dataset, which is
used to assess non-response bias, for quality control, to improve the
ability of MMP to monitor ongoing care and treatment of HIV-infected
persons, and to make inferences from the MMP sample to HIV-infected
persons in care nationally. No other Federal agency collects nationally
representative 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 request approval for
a
[[Page 2067]]
revision and 3-year approval for the previously approved Medical
Monitoring Project (MMP) 0920-0740 exp. 5/31/2012). The interview and
minimum dataset 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. The number of sampled
patients has increased by 62 patients compared to the previously
approved information collection; thereby increasing the total burden
hours by 37 hours, from 8,500 to 8,537.
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), through medical record and abstraction by
trained abstractors and through extraction of information from HIV
surveillance case records. The project activities and methods will
remain the same as those used in the previously approved data
collection period.
Interviews with HIV-infected patients provide 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.
The minimum dataset contains demographic and HIV-related laboratory
test information extracted from an existing HIV case surveillance
database, the national HIV/AIDS Reporting System.
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 on all eligible
participants. Minimal data on all sampled patients will be extracted
from the national HIV/AIDS Reporting System.
Participation of respondents is voluntary. There is no cost to the
respondents other than their time.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
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Sampled, Eligible HIV-Infected Standard 7219 1 45/60 5,414
Patients. interview.
Sampled, Eligible HIV-Infected Short interview. 301 1 20/60 100
Patients Unable to Complete
the Standard Interview.
Facility office staff pulling ................ 7,520 1 3/60 376
medical records.
Facility office staff ................ 936 1 2 1,872
providing Estimated Patient
Loads.
Facility office staff ................ 1,030 1 30/60 515
providing patient lists.
Facility office staff ................ 3,120 1 5/60 260
approaching participants for
enrollment.
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Total..................... ................ .............. .............. .............. 8,537
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Kimberly Lane,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2012-605 Filed 1-12-12; 8:45 am]
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