[Federal Register Volume 62, Number 11 (Thursday, January 16, 1997)]
[Notices]
[Pages 2368-2369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-1064]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30DAY-25]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Office on (404) 639-7090. Send written
comments to CDC, Desk Officer; Human Resources and Housing Branch, New
Executive Office Building, Room 10235; Washington, DC 20503. Written
comments should be received within 30 days of this notice.
The following requests have been submitted for review since the
last publication date on December 11, 1996.
Proposed Projects
1. Surveillance and Evaluation of Blood Donors Positive for Human
Immunodeficiency Virus (HIV) Antibody or HIV Antigen (0920-0329)--
Reinstatement--In 1987, the President directed the Department of Health
and Human Services (DHHS) to determine the nationwide incidence of, to
predict the future of, and to determine the extent to which human
immunodeficiency virus (HIV) is present in various segments of our
population. In response, CDC formed an epidemiologic team to summarize
existing information. An extensive review of published and unpublished
data led to the conclusion that even though there is information
suggesting a very large number of Americans were infected, there was no
substitute for carefully and scientifically obtained incidence and
prevalence data. The need to monitor HIV seroprevalence existed on the
national and at the state and local levels for public health
management: targeting and evaluating prevention programs, planning
future health care needs and determining health policy.
On a national basis, HIV seroprevalence projects in 1987 consisted
of monitoring the HIV status of: civilian applicants for military
service; blood donors, including follow-up risk factor evaluation in
seropositives; and Job Corps entrants. HIV prevalence was studied in
settings of special public health interest including selected colleges
and prisons,
[[Page 2369]]
among health care workers in hospital emergency rooms and among Native
Americans and homeless persons. Other national data sources were
examined, such as cohort studies of groups at risk, including
homosexual and bisexual men and IV drug users, providing information on
knowledge of AIDS and risk behaviors, changes in behavior, and
incidence of HIV infection.
In 1987, OMB approved the ``Family of HIV Seroprevalence Surveys''
(0920-0232). These surveys included seven seroprevalence surveys which
involved interaction with individuals (non-blinded surveys). One of
these surveys was the surveillance and evaluation of blood donors
positive for Human Immunodeficiency Virus (HIV) Antibody.
In 1993, OMB again approved for 3 years the surveillance and
evaluation of blood donors who test positive for Human Immunodeficiency
Virus (HIV) Antibody and their needle-sharing and sexual partners
(0920-0329). This request is for an additional 3-year approval. The
total annual burden is 172.
------------------------------------------------------------------------
Average
Number of burden/
Respondents Number of responses/ response
respondents respondent (in
hours)
------------------------------------------------------------------------
Blood donors (interviews)............ 160 1 1.0
Blood donors (refuse interview)...... 120 1 0.1
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2. A CLIA Comprehension Survey and Information Program for
Physicians--New--The purpose of this contract is to enable the Centers
for Disease Control and Prevention (CDC) to assess the depth and
accuracy of the knowledge base of clinicians regarding the Clinical
Laboratory Improvement Amendments of 1988 (CLIA '88) regulations as
they relate to physicians' office laboratories (POLs), and to provide
specific information and training to practitioners based on this
assessment. In 1990, CDC was designated by the Department of Health and
Human Services to assist in the implementation of CLIA '88; this
project is a direct response to that mandate.
Through contact with the laboratory and physician communities, CDC
has become aware of gaps in information and understanding about the
CLIA '88 regulations, especially as they relate to physicians'' office
laboratories. Misconceptions regarding the CLIA '88 regulations in the
community may be impeding successful implementation of the regulations
and causing unnecessary and inappropriate responses in POL testing
sites. Therefore, CDC is proposing a survey of practicing physicians to
assess the depth and accuracy of the knowledge base of clinicians
regarding the CLIA '88 regulations as they relate to POLs, and to
provide specific information and training to practitioners based on
this assessment. The total annual burden is 896.
------------------------------------------------------------------------
Average
Number of burden/
Respondents Number of responses/ response
respondents respondent (in
hours)
------------------------------------------------------------------------
Laboratories......................... 4479 1 .2
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3. Development and Implementation of a Comprehensive Evaluation for
Project DIRECT (Diabetes Intervention: Reaching and Educating
Communities Together)--New--Diabetes mellitus is more prevalent among
African-Americans than whites, and African-Americans with diabetes are
more likely to suffer its devastating complications. Compared to
whites, African-Americans are more likely to develop blindness and end-
stage renal disease and are more likely to have amputations. In
addition, cardiovascular risk factors are more prevalent among African-
Americans than whites and African-Americans are more likely to die with
diabetes than are whites. In response to this disparity, the Centers
for Disease Control and Prevention (CDC) has launched a large-scale
community intervention trial known as Project DIRECT (Diabetes
Intervention: Reaching and Educating Communities Together). Based in
Raleigh, North Carolina, and sponsored by CDC's Division of Diabetes
Translation, Project DIRECT will serve as a model for multilevel
community-based diabetes prevention and control programs for urban
African-Americans.
This evaluation will determine the effect of (1) diabetes care; (2)
outreach, and (3) health promotion interventions in the targeted
community and compare this effect to a control community. The
intervention activities focus on the African-American population of a
geographically defined area of southeast Raleigh, North Carolina. The
control community is Greensboro, North Carolina. The populations
consist primarily of African-Americans. Health care providers will be
identified and solicited from practicing physicians in Raleigh and
Greensboro.
The survey will be conducted in four phases. Phase I will randomly
identify and solicit participation from household members with and
without diabetes from the control and intervention communities. In
Phase II, participants with and without diabetes will be randomly
selected and administered the survey questionnaire upon granting
informed consent. During Phase III, persons with diabetes will undergo
a brief physical exam that will consist of physical measures for
height, weight, blood pressure, and body mass index. In addition,
collection of a venous blood sample and urine sample will be performed.
In Phase IV, interviewers will administer a questionnaire to primary
care physicians about their knowledge, attitude and practice patterns
for caring for persons with diabetes. This study will undergo
Institutional Review Board reviews and comply with human subject
assurances in accordance with federal regulations. The total annual
burden is 3,148.
------------------------------------------------------------------------
Average
Number of burden/
Respondents Number of responses/ response
respondents respondent (in
hours)
------------------------------------------------------------------------
Households.......................... 7,182 1 .1666
General Population Questionnaire.... 2,516 1 0.5
Diabetes Module..................... 580 1 0.5
Laboratory Specimen Component....... 580 10.5
Provider Survey..................... 150 1 0.75
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Dated: January 10, 1997.
Wilma G. Johnson,
Acting Associate Director for Policy Planning and Evaluation, Centers
for Disease Control and Prevention (CDC).
[FR Doc. 97-1064 Filed 1-15-97; 8:45 am]
BILLING CODE 4163-18-P