[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.)
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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
