[Federal Register:
May 6, 1999 (Volume 64, Number 87)]
[Notices]
[Pages 24396-24398]
Billing Code: 4163-18-P
DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Centers for Disease Control and Prevention
National
Institute for Occupational Safety and Health
[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
- 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.
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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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- 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/
Respondent Number of responses/ response Total burden
Respondents respondent (in hrs.) (in hrs.)
--------------------------------------------------------------------------------------
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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- 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/
Respondent Number of responses/ response Total burden
Respondents respondent (in hrs.) (in hrs.)
--------------------------------------------------------------------------------------
Carpenters.................... 150 2 .33 99
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- 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 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:
-----------------------------------
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.
-----------------------------------
- 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.
- 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.
- 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:
- A nationwide survey of blood collection establishments.
- A nationwide survey of transfusion services.
- 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.
- 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/
Respondent Number of responses/ response Total burden
Respondents respondent (in hrs.) (in hrs.)
--------------------------------------------------------------------------------------
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
tested at ARC/ABC............ 500 1 0.2 100
Transfusion recipients (follow-
up interview and study of
recipients tested at ARC/ABC) 100 3 0.5 150
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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)
CERTIFIED TO BE A TRUE COPY OF THE ORIGINAL
Certifying Officer
[FR Doc. 99-11339 Filed 5-5-99; 8:45 am]
This page was last updated on May 6, 1999
