[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.)   
----------------------------------------------------------------------------------------------------------------
Local health department staff...............................           90            1         0.33           30
Health care facility staff..................................           45            1         0.33           15
Physicians..................................................           15            1         0.33            5
                                                             ---------------------------------------------------
    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.)   
----------------------------------------------------------------------------------------------------------------
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
                                                             ---------------------------------------------------
    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