[Federal Register Volume 64, Number 203 (Thursday, October 21, 1999)]
[Notices]
[Pages 56794-56795]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27467]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control And Prevention
[60Day-00-03]
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, the Center for Disease Control and
Prevention is providing opportunity for public comment on proposed data
collection projects. To request more information on the proposed
projects or to obtain a copy of the data collection plans and
instruments, call the CDC Reports Clearance Officer on (404) 639-7090.
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 for other
forms of information technology. Send comments to Seleda Perryman, CDC
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24,
Atlanta, GA 30333. Written comments should be received within 60 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extensive review of published and unpublished data led to the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 system does not exist for the source
[[Page 56795]]
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.
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Number of Avg. burden per
Form name Number of responses/ response (in Total Burden
respondents respondent hrs.) (in hrs.)
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Questionnaire............................... 430 1 20/60 143
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Date: October 14, 1999.
Nancy Cheal,
Acting Associate Director for Policy, Planning, and Evaluation, Centers
for Disease Control and Prevention (CDC).
[FR Doc. 99-27467 Filed 10-20-99; 8:45 am]
BILLING CODE 4163-18-P