[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 An extensive review of published and unpublished 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
------------------------------------------------------------------------

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

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

    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