[Federal Register Volume 67, Number 143 (Thursday, July 25, 2002)]
[Notices]
[Pages 48661-48662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18781]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-02-70]


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 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed 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) 498-1210.
    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 or other 
forms of information technology. Send comments to Anne O'Connor, CDC 
Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D24, 
Atlanta, GA 30333. Written comments should be received within 60 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

[[Page 48662]]

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.
    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. There are no costs to respondents.

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                                                                     Number of    Average burden/
                     Survey                          Number of      responses/     response  (in   Total burden
                                                    respondents     respondent        hours)        (in hours)
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Genotoxicity Immunotocixicity Study*............             150               1               1             150
Reproductive Health Study[dagger]...............             150               1          225/60           562.5
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............         714.50
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\*\ This part of the study involves the participant, after informed consent, voluntarily providing blood and
  urine samples and responding to a questionnaire concerning medical history, work history, and work practices
  to identify study eligibility, past exposures, and confounders.
[dagger] In the reproductive health part of the study and after informed consent, women are being 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 is given to each participant to determine eligibility
  for inclusion into the study and confounders of hormone analysis.


    Dated: July 18, 2002.
Nancy E. Cheal,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control and Prevention.
[FR Doc. 02-18781 Filed 7-24-02; 8:45 am]
BILLING CODE 4163-18-P