Proposed Data Collections Submitted for Public Comment and Recommendations

Federal RegisterOct 21, 1999

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control And Prevention

[60Day-00-02]

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 Blood Donors Positive for Human

Immunodeficiency Virus (HIV) Antibody or HIV Antigen 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review of published and unpublished data led to the conclusion that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

[[Page 56796]]

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 total

cost to the respondent is $8,206.19 over the 3-year period.

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Number of Avg. burden

Respondents Number of responses/ response (in Total burden

respondents Respondent hours) (in hours)

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

Blood donors (interviewed)...................... 375 1 1.0 375

Blood donors (refuse interview)................. 275 1 0.16 44

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Total....................................... .............. .............. .............. 419.00

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Dated: October 14, 1999.

Nancy Cheal,

Acting Associate Director for Policy, Planning, and Evaluation, Centers

for Disease Control and Prevention (CDC).

[FR Doc. 99-27468 Filed 10-20-99; 8:45 am]

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Proposed Data Collections Submitted for Public Comment and Recommendations · 64 FR 56795 | Frix