[Federal Register: May 29, 2003 (Volume 68, Number 103)]
[Notices]
[Page 32056-32057]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29my03-94]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30DAY-44-03]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. chapter 35). To request a copy of these requests, call
the CDC Reports Clearance Officer at (404) 498-1210. Send written
comments to CDC, Desk Officer, Human Resources and Housing Branch, New
Executive Office Building, Room 10235, Washington, DC 20503. Written
comments should be received within 30 days of this notice.
Proposed Project
Antineoplastic Drug Exposure: Effectiveness of Guidelines--New--The
National Institute for Occupational Safety and Health (NIOSH), Centers
for Disease Control and Prevention (CDC). Antineoplastic,
chemotherapeutic, or cytostatic drugs are widely used in the treatment
of cancer. These drugs possess mutagenic, teratogenic, and carcinogenic
properties, cause organ damage, and affect reproductive function.
Healthcare workers such as pharmacists and nurses who handle, prepare,
and administer these drugs are at increased risk of adverse health
effects from these agents, if exposed. The Occupational Safety and
Health Administration (OSHA) developed guidelines for healthcare
workers for the safe handling of antineoplastic drugs in 1986 and
revised those guidelines again in 1995. However, recent studies suggest
that the guidelines have not been effective in preventing exposure. A
1999 industrial hygiene evaluation of six cancer centers in the U.S.
and Canada reported that 75% of the wipe test samples in the pharmacy
were found to have detectable levels of antineoplastic drugs. Similar
findings were reported in the Netherlands, which has similar
guidelines. In addition, healthcare workers may assume that gloves
designed for bloodborne pathogen protection will also prevent drug
exposure which is often not the case. Since air concentrations of
antineoplastic drugs in many of the studies have been low to non-
detectable, it appears that the dermal route may be an important
consideration for internal absorption.
Numerous studies, including those after the OSHA guidelines were
revised in 1995, have demonstrated adverse health effects from
healthcare workers' exposure to antineoplastic agents. The most common
endpoints have been either markers of exposure, such as metabolites in
the urine, or genotoxic markers, such as micronuclei, sister chromatid
exchange, and chromosomal aberrations. Female reproductive adverse
effects have also been shown to occur with healthcare workers' exposure
to antineoplastic drugs. Not only have spontaneous abortion and
miscarriage been reported, but changes in the menstrual cycle have been
demonstrated as well. Based upon animal and human data, one study
estimated that exposure to cyclophosphamide by healthcare workers
increases the risk of leukemia cases by 17-100 new cases/million
workers/10 years.
This project addresses the continuing concern of healthcare
workers' exposure to antineoplastic agents. This is a multifaceted
project that involves environmental sampling of the workplace and the
collection of biological samples to determine how much of the agent is
absorbed and if there are any early biological effects from that
exposure. Biological measurements or biomarkers can detect effects of
exposure long before a disease can be diagnosed. A questionnaire will
be administered to determine confounders and other conditions that
might affect exposure such as work history and work practices. This
project will recruit oncology nurses, pharmacists, and pharmacy
technicians and will be conducted in collaboration with the University
of Maryland, the University of North Carolina, and the M.D. Anderson
Cancer Center.
In the biological effects part of the study, the participant, after
informed consent, will voluntarily provide blood and urine samples and
respond to a questionnaire concerning medical history, work history,
and work practices to identify study eligibility, past exposures, and
confounders.
In the reproductive health part of the study and after informed
consent, women will be asked to voluntarily give a daily urine sample
for approximately 45 days and keep track of their menstrual cycle by
entries into a diary. In addition, a short questionnaire will be given
to each participant to determine eligibility for inclusion into the
study and confounders of hormone analysis. By utilizing a battery of
sensitive biomarkers, the effects of low-level chronic exposure to
antineoplastic agents can be determined. Using the results of the
proposed study, exposures can be minimized or eliminated before adverse
health effects occur. Ultimately, the study will contribute to the
prevention of occupational disease from antineoplastic drug exposure.
The total annual burden for this data collection is 863 hours.
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Number of Average burden/
Survey Number of responses/ response (in
respondents respondent hours)
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Antineoplastic Handling Diary................................. 75 1 10/60
Biological Effects Study Questionnaire........................ 150 1 45/60
Reproductive Health Study Questionnaire....................... 100 1 15/60
Reproductive Health Diary..................................... 100 42 5/60
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[[Page 32057]]
Dated: May 21, 2003.
Thomas A. Bartenfeld,
Acting Deputy Director for Policy, Planning and Evaluation, Centers for
Disease Control and Prevention.
[FR Doc. 03-13374 Filed 5-28-03; 8:45 am]
BILLING CODE 4163-18-P