[Federal Register Volume 65, Number 86 (Wednesday, May 3, 2000)]
[Notices]
[Pages 25731-25732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10978]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 DAY-24-00]


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 Officer at (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.

Proposed Projects

    1. Surveillance and Evaluation of Plasma Donors for the Human 
Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)--New--National 
Center for HIV, STD, and TB Prevention (NCHSTP). 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) was 
present in various segments of the population. In response, the 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extensive review of published and unpublished data led to the 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 was 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. Research has also indicated that similar 
studies are needed to determine the incidence and prevalence of 
hepatitis C (HCV) infection.
    A complementary family of surveys and studies, organized by the 
CDC, provides empirical estimates of the extent of the epidemic of the 
human immunodeficiency virus (HIV) in the United States. The national 
surveillance system of HIV infection in the United States includes 
monitoring incidence and prevalence rates of HIV-infection among first 
time and repeat whole blood donors. Although this surveillance system 
has been in place for several years to monitor HIV trends in the United 
States blood supply, such a

[[Page 25732]]

system does not exist for the source plasma industry for either HIV or 
hepatitis C (HCV).
    The source plasma industry collects approximately 14 million of 
plasma each year. The majority of source plasma is used to produce 
immune globulins, albumin and other blood products utilized in the 
United States and in other countries. Donors may donate up to two times 
per week and are remunerated for each donation. Although the source 
collection industry plays an important role in the production of blood 
products, little information regarding HIV or HCV rates within the 
industry has been published to date.
    The objectives of this study of HIV and HCV in plasma donors are 
to:
    1. Analyze the risk behavior characteristics of infected donors to 
assess distribution and trends of HIV and HCV;
    2. Study the motivations and risk factors of HIV and HCV infected 
deferred donors in order to improve the donor screening and deferral 
processes;
    3. Monitor additional human immunodeficiency and hepatitis viruses, 
HIV and HCV genetic variation, and other infections relevant to the 
epidemiology of HIV and HCV among U.S. plasma donors;
    4. Evaluate the laboratory characteristics of plasma from infected 
donors to determine the effectiveness of current and anticipated test 
modalities; and
    5. Evaluate risk factors for transmission of HCV among recently 
infected individuals.
    The above objectives will be attained though a questionnaire 
designed to evaluate demographic information, knowledge of HIV and HCV, 
risks for HIV and HCV and motivations for donating plasma. In order to 
elucidate risks for transmission among this population, a group of HIV 
and HCV negative persons will also be given the questionnaire. 
Respondents will be interviewed with the aid of a computer assisted 
telephone interview (CATI) and respondents will receive a stipend for 
their time and travel expenses. Participation is voluntary, and all 
information will be gathered only after written informed consent has 
been obtained.
    The CDC anticipates 430 individuals will be enrolled annually in 
this study (based upon combined estimates obtained from the plasma 
companies regarding the number of HIV and HCV positive donors 
identified per year, plus the number of HIV and HCV negative 
individuals enrolled as comparisons). It has been estimated that the 
interview will take approximately 20 minutes to complete; therefore, 
the response burden will be 143 hours. The approximate hourly wage 
earned per respondent is $10.00/hour. The total cost to the respondents 
would be $1430.00. The Annual Burden hours are 218.

----------------------------------------------------------------------------------------------------------------
                                                                                      No. of        Avg. burden
                           Respondents                                No. of        responses/     per response
                                                                    respondents     respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Questionnaire...................................................             430               1           20/60
Form............................................................              90               5           10/60
----------------------------------------------------------------------------------------------------------------


    Dated: April 26, 2000.
Charles W. Gollmar,
Acting Associate Director for Policy, Planning, and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 00-10978 Filed 5-2-00; 8:45 am]
BILLING CODE 4163-18-P