00-10981. 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 [phone]. 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 Blood Donors Positive for Human Immunodeficiency Virus (HIV) Antibody or HIV Antigen (0920-0329)—Extension—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) is present in various segments of our population. In response, CDC formed an epidemiological 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 An extensive review of published and unpublished data led to the conclusion that even though there is information suggesting a very large number of Americans were infected, there was no substitute for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, 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 that involved interaction with individuals (non-blinded surveys). One of these surveys was the surveillance and evaluation of blood donors.

The objectives of this study are to: (1) Estimate the prevalence and incidence of HIV infection among blood donors at participating blood centers; (2) evaluate the characteristics of infected donors to strengthen the effectiveness of the donor screening and deferral processes; (3) analyze the risk behavior characteristics of infected donors to assess distribution and trends of HIV; (4) monitor additional human immunodeficiency viruses, HIV genetic variation, and other infections relevant to the epidemiology of HIV among U.S. blood donors and seroconverted recipients; (5) estimate the risk of HIV transmission from screened blood; (6) and evaluate new tests to decrease transmission by window period donors.

In 1993 and 1996, OMB again approved for 3 years each, 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 CDC anticipates 125 positive donors will enroll annually in this study (based upon previous 3 year enrollment rates and epidemiological progress of the disease). The interview takes approximately 1 hour to complete for those who agree to the interview and 10 minutes to complete for those who refuse to enroll. The Annual Burden is 140.

Respondents	No. of respondents	No. of responses/respondent	Avg. burden response (in hours)
Blood donors (interviewed)	125	1	1.0
Blood donors (refuse interview)	92	1	10/60

Dated: April 26, 2000.

Charles W. Gollmar,

Acting Associate Director for Policy, Planning, and Evaluation, Centers for Disease Control and Prevention (CDC).