[Federal Register Volume 64, Number 87 (Thursday, May 6, 1999)]
[Notices]
[Pages 24396-24398]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11339]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[INFO-99-16]


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 Centers 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 with 60 days of 
this notice.

Proposed Projects

    1. Diffusion of Needle-stick Prevention Strategies--NEW--National 
Institute for Occupational Safety and Health (NIOSH)--Occupational 
exposure to bloodborne pathogens (including the hepatitis B and C 
viruses and the human immunodeficiency virus) poses a risk to workers 
in the health care industry and related occupations. The primary route 
of exposure to bloodborne pathogens is accidental percutaneous injury 
by a needle or similar sharp object.
    In 1991 the Occupational Safety and Health Administration (OSHA) 
enacted the final Bloodborne Pathogen Standard. Although the OSHA 
standard has increased compliance and awareness of needle-stick injury 
prevention strategies, needle-stick injuries are still occurring.
    Studies have demonstrated that the use of safer needle-stick 
prevention devices can reduce the incidence of needle-stick injuries 
and resulting costs. Little is known however, about how many hospitals 
have adopted devices such as, safer blood collection needles (SBCN) 
designed to prevent percutaneous injuries, and the variables that can 
influence their adoption by hospitals.
    This study will conduct a random sample national survey of 960 
infection control practitioners to evaluate how widespread the adoption 
of SBCN and other needle-stick prevention devices is in hospitals; and 
some of the internal and external environmental variables that can 
influence their adoption. The survey data may be used to indicate a 
hospital's readiness to adopt SBCN, to assess the extent of the 
diffusion of SBCN, and to cluster hospitals according to their stage of 
adoption for SBCN.
    The goal of this study is to (1) inform future NIOSH communication/
dissemination strategies to promote safer blood collection and related 
medical devices in hospitals, (2) inform policy makers about variables 
that can influence the adoption of safer blood collection devices, and 
(3) provide data that reveals national trends for the adoption of safer 
needles-tick prevention devices in hospitals. There cost to the 
respondents is $0.00.

[[Page 24397]]



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                                                                          Number of   Avg. Burden/
                       Respondent                           Number of    responses/     response    Total burden
                                                           Respondents   respondent     (in hrs.)     (in hrs.)
----------------------------------------------------------------------------------------------------------------
Infection control nurses................................           960             1         .1166           112
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    2. PHS Supplements to the Application for Federal Assistance SF 424 
(0920-0428)--Extension--The Centers for Disease Control and Prevention 
(CDC) is requesting a three-year extension of the currently approved 
OMB forms that are Supplements to the Request for Federal Assistance 
Application (SF-424). The Checklist, Program Narrative, the Public 
Health System Impact Statement (third party notification) (PHSIS), a 
new Substance Abuse and Mental Health Services Administration (SAMHSA) 
form and a new CDC form are a part of the standard application for 
state and local governments and for private non-profit and for-profit 
organizations when applying for financial assistance from PHS grant 
programs. The Checklist assists applicants to ensure that they have 
included all required information necessary to process the application. 
The Checklist data helps to reduce the time required to process and 
review grant applications, expediting the issuance of grant awards. The 
PHSIS Third Party Notification Form is used to inform State and local 
health agencies of community-based proposals submitted by non-
governmental applicants for Federal funding. SAMHSA's new form will be 
used in lieu of the PHSIS in specific instances. CDC's new forms will 
be used in lieu of the 5161-1 form for state and local governments 
requesting federal funding that is limited to state and local 
governments only.
    The current OMB approval for the supplements was previously 
submitted and approved as an emergency clearance and we are asking for 
a full three clearance to continue data collection The total annual 
cost to the respondents is estimated to be $1,184,452.

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                                                                          Number of   Avg. burden/
                       Respondents                          Number of    responses/   response (in  Total burden
                                                           respondents   respondent       hrs.)       (in hrs.)
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Program Narrative and Checklist.........................         6,231             1             4        24,924
CDC Form 0.0126 (E).....................................           990             1             4         3,960
Public Health Impact Statement (PHSIS)..................         2,845           2.5         .1666         1,185
SSA (SAMHSA)............................................         1,125             1         .1666           187
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    Total...............................................  ............  ............  ............        30,256
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    3. Safety for Workers' Eyes: Testing the Effectiveness of 
Theoretically-Based Eye Injury Prevention Messages--NEW--National 
Institute for Occupational Safety and Health (NIOSH) -Despite evidence 
that at least 90% of workplace eye injuries are preventable, safety eye 
wear use among workers is disappointingly low. According to the 
National Institute for Occupational Safety and Health (NIOSH) and 
results from the 1988 National Health Interview Survey Occupation 
Health Supplement, more than 600,000 occupational eye injuries occur 
annually. Sixteen percent of eye injuries occur among construction with 
carpenters being at particular risk given the nature of their work.
    Research has been conducted on the nature and extent of eye 
injuries among workers, but few studies have explored the behavioral 
aspects of the use of safety eye wear. To date, no one has used 
behavioral theory to examine the use of safety eye wear among union 
carpenters or develop a program that would increase safety eye wear 
use.
    The goals of this investigation are to: (1) Estimate the number of 
carpenters who are currently wearing protective eye wear by direct 
observation and pre-intervention survey in the study sample; (2) 
develop an eye wear safety promotion campaign geared toward carpenters, 
their first-line supervisors, and contractors based on results from 
focus groups and using the theory of planned behavior; (3) increase the 
use of protective eye wear among carpenters by administering the eye 
safety messages to carpenters, their first-line supervisors, and 
contractors; and (4) determine the effectiveness of the messages by 
comparing the use of safety eye wear among carpenters before and after 
the campaign by direct observation, post-intervention survey, and focus 
groups.
    The pre- and post-intervention survey instruments will assess 
carpenters' use of eye wear before and after the health communication 
message. In addition, based on the theory of planned behavior, the 
questionnaire will address workers behavioral intentions, attitudes, 
subjective norms, and perceived behavioral control.
    Using a quasi-experimental design, the data collected in this study 
will assess the effectiveness of theory-based messages to increase the 
use of safety eye wear when compared to a control group. This 
information will provide public health investigators as well as 
carpenter safety officers with a theory-driven effective eye injury 
prevention program and the tools to implement it. The total cost to 
respondents is $2,257.00.

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                                                                          Number of   Avg. burden/
                       Respondents                          Number of    responses/   response (in  Total burden
                                                           respondents   respondent       hrs.)       (in hrs.)
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Carpenters..............................................           150             2           .33            99
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    4. Hepatitis C Virus Lookback Evaluation -NEW- National Center for 
Infectious Disease (NCID)--The Food and Drug Administration (FDA) has 
recently issued guidelines for notification of persons who received

[[Page 24398]]

blood or blood components from donors who subsequently tested positive 
for antibody to hepatitis C virus (anti-HCV) using a licensed 
multiantigen assay.1 Blood collection establishments will 
identify potentially HCV-contaminated blood products and inform 
transfusion services of these units. The transfusion services will then 
attempt to notify the recipients of these products and encourage these 
recipients to be tested for HCV infection. CDC, in collaboration with 
the Agency for Health Care Policy and Research (AHCPR) and the FDA, has 
been charged with the responsibility of evaluating this nationwide 
notification process. The objective of this study is to evaluate the 
effectiveness of the targeted lookback for identifying persons infected 
with HCV, obtaining appropriate medical follow-up, and promoting 
healthy lifestyles and behaviors. The evaluation has three specific 
aims:
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    \1\ Food and Drug Administration. Guidance For Industry. Current 
Good Manufacturing Practice for Blood and Blood Components: (1) 
Quarantine and Disposition of Units from Prior Collections from 
Donors with Repeatedly Reactive Screening Tests for Antibody to 
Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the 
Notification of Consignees and Blood Recipients of Donor Test 
Results for Anti-HCV. Rockville, MD: Center for Biologics Evaluation 
and Research, FDA; September 1998.
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    1. Determine the effectiveness of targeted lookback for identifying 
prior transfusion recipients with HCV infection, including the 
proportion of recipients identified who are ultimately tested, the 
proportion of those tested who are HCV positive, the reasons persons do 
not receive notification, and the reasons persons do not avail 
themselves of testing.
    2. Determine the effectiveness of targeted lookback for encouraging 
and obtaining appropriate medical follow-up and promoting healthy 
lifestyles and behaviors among persons found positive for HCV 
infection, including proportion of HCV-positive persons who seek 
medical evaluation and outcome of that evaluation (severity of liver 
disease, anti-viral therapy, quality of counseling), and reactions/
impact of notification on HCV-negative persons.
    3. Determine the cost-effectiveness of targeted lookback, including 
resources (cost, personnel, etc.) utilized by blood collection groups 
and transfusion services for implementation and costs of medical 
evaluation and management.
    The evaluation will comprise the following components:
    1. A nationwide survey of blood collection establishments.
    2. A nationwide survey of transfusion services.
    3. A follow-up study of transfusion recipients presumed to have 
been notified of their potential HCV exposure. This detailed study will 
involve contacting and interviewing transfusion recipients from a 
sample of transfusion services in defined geographic areas.
    4. A follow-up study of notified transfusion recipients who obtain 
HCV testing offered by blood collection centers.
    The total cost to respondents is estimated to be $346,063.

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                                                                          Number of   Avg. burden/
                       Respondents                          Number of    responses/     response    Total burden
                                                           respondents   respondents   (in hours)    (in hours)
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Blood collection establishments.........................           140             1             5           700
Transfusion services....................................         5,000             1             5        25,000
Transfusion recipients (first telephone contact)........         5,000             1           0.2         1,000
Transfusion recipients (second telephone contact).......         2,000             1           0.5         1,000
Transfusion recipients (follow-up interview and study)..           200             3           0.5           300
Transfusion recipients (first interview of recipients              500             1           0.2           100
 tested at ARC/ABC......................................
Transfusion recipients (follow-up interview and study of           100             3           0.5           150
 recipients tested at ARC/ABC)..........................
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    Total...............................................  ............  ............  ............        28,250
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    Dated: April 30, 1999.
Nancy Cheal,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention (CDC).
[FR Doc. 99-11339 Filed 5-5-99; 8:45 am]
BILLING CODE 4163-18-P