[Federal Register Volume 68, Number 103 (Thursday, May 29, 2003)]
[Notices]
[Pages 32056-32057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13374]


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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