[Federal Register Volume 61, Number 56 (Thursday, March 21, 1996)]
[Notices]
[Pages 11640-11642]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6792]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[INFO-96-12]
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 for opportunity for public comment on
proposed data collection projects, the
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Centers for Disease Control and Prevention (CDC) will publish periodic
summaries of proposed 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 Wilma Johnson, CDC
Reports Clearance Officer, 1600 Clifton Road, MS-D24, Atlanta, GA
30333. Written comments should be received within 60 days of this
notice.
Proposed Project
1. Vibrio Illness Investigation Report Form--(0920-0322)--
Extension--The purpose of the Cholera and other Vibrio Illness
Investigation Report Form is to collect information on illness
occurring as a result of infection with Vibrio species. Vibrios are
important pathogens in the United States, and primary septicemia,
gastroenteritis, and wound infections have been associated with various
species. In particular, gastroenteritis and primary septicemia have
been associated with the consumption of undercooked shellfish, and
particularly with raw Gulf Coast oysters. Associations have also been
linked to wound infections with exposure of broken skin to seawater.
Most importantly, Vibrio cholerae 01 is the organism responsible for
cholera, a severe, dehydrating diarrheal illness. Although infections
with Vibrio cholerae 01 are notifiable in all states, an official
report form for this illness did not previously exist. The Vibrio
Illness Investigation Report Form is used to record information on all
Vibrio-related illness, as well as more detailed information on cholera
illness, which is currently a reportable disease in all states. The
form has a separate optional Seafood Investigation section to be
completed when applicable. The form provides a consolidated, systematic
method by which health departments can report such information, which
is then used to gain a better understanding of the incidence, etiology,
and epidemiology of all Vibrio-related illness occurring in the United
States.
Data columns have been added to, and comments space reduced on, the
form to facilitate data entry and reduce the burden. No change in the
frequency of reporting has occurred or is projected.
Most respondents are epidemiologists or nurses in the local health
department, but in some instances infection control nurses or
physicians might complete the form. The total cost per respondent is
estimated at $11.00. This is primarily salary, but also includes
postage and telephone calls.
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No. of Avg. burden/ Total
Respondents No. of responses/ response burden (in
respondents respondent (in hrs.) hrs.)
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Local health department staff............................... 90 1 0.33 30
Health care facility staff.................................. 45 1 0.33 15
Physicians.................................................. 15 1 0.33 5
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Total................................................... ........... ........... ........... 50
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2. Prospective Evaluation of Health-Care Workers Exposed to Blood
From Patients Infected with HIV--(0920-0131)--Extension--The HIV
Infections Branch, Hospital Infections Program (HIP), Centers for
Disease Control and Prevention (CDC) plans to continue surveillance of
health-care workers (HCWs) exposed to the blood of persons infected
with human immunodeficiency virus (HIV). This prospective evaluation,
initiated in August 1983, provides essential scientific information on
the risk of HIV transmission in the health care setting. The objectives
of the project are to: (1) estimate the risk of HIV infection in HCWs
exposed via the percutaneous, mucous-membrane, or skin route to HIV
infected blood, according to type of exposure; (2) describe the type of
devices and circumstances of the exposures sustained by HCWs; (3)
describe the clinical natural history and development of laboratory
markers of HIV infection in HCWs enrolled in this project who
seroconvert to HIV; and, (4) describe the use of post-exposure
chemoprophylaxis by HCWs exposed to HIV infected blood.
The design of this voluntary surveillance includes enrollment of
participating institutions (respondents) throughout the United States.
In the event that an HCW employed at the facility sustains an eligible
exposure to HIV infected blood, the HCW is enrolled and followed
prospectively. Epidemiologic data and serum for HIV antibody testing
are collected within 30 days after the exposure with follow-up visits
and serum samples collected at 6 weeks, 3, 6, and 12 months from the
date of the exposure.
The number of respondents is the expected number of institutions
participating in the project annually. The number of responses is based
on the average number of forms which will be completed during each
year. The 250 HCWs enrolled each year will each need four Follow-up
forms completed. The number of Reports of Antiviral Prophylaxis is
based on the proportion of HCWs expected to be prescribed antiviral
prophylaxis (approximately 40%). The total cost to respondents is
estimated at $10,525.
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No. of Avg. burden/ Total
Respondents No. of responses/ response burden (in
respondents respondent (in hrs.) hrs.)
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Initial Case Report Form.................................... 250 1 0.33 83
Confidential Report Form.................................... 250 1 0.25 63
Follow-up Form.............................................. 250 4 0.25 250
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Antiviral Prophylaxis Rpt................................... 100 1 0.25 25
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Total................................................... ........... ........... ........... 421
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Dated: March 15, 1996.
Wilma G. Johnson,
Acting Associate Director for Policy Planning and Evaluation, Centers
for Disease Control and Prevention (CDC).
[FR Doc. 96-6792 Filed 3-20-96; 8:45 am]
BILLING CODE 4163-18-P
