[Federal Register: March 10, 2005 (Volume 70, Number 46)]
[Notices]
[Page 11983-11984]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr05-85]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-05-0494]
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 404-371-5973 or
send comments to Seleda Perryman, CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
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. Written comments should be received
within 60 days of this notice.
Proposed Project
Exposure to Aerosolized Brevetoxins during Red Tide Events (OMB No.
0920-0494)--Revision--National Center for Environmental Health (NCEH),
Centers for Disease Control and Prevention (CDC).
Karenia brevis (formerly Gymnodinium breve) is the marine
dinoflagellate responsible for extensive blooms (called red tides) that
form in the Gulf of Mexico. K. brevis produces potent toxins, called
brevetoxins, that have been responsible for killing millions of fish
and other marine organisms. The biochemical activity of brevetoxins is
not completely understood and there is very little information
regarding human health effects from environmental exposures, such as
inhaling brevetoxin that has been aerosolized and swept onto the coast
by offshore winds. The National Center for Environmental Health (NCEH),
Centers for Disease Control and Prevention (CDC) has recruited people
who work along the coast of Florida and who are periodically
occupationally exposed to aerosolized red tide toxins.
We have administered a base-line respiratory health questionnaire
and conducted pre- and post-shift pulmonary function tests during a
time when there is no red tide reported near the area. When a red tide
developed, we administered a symptom survey and conducted pulmonary
function testing (PFT). We compared (1) symptom reports before and
during the red tide and (2) the changes in baseline PFT values during
the work shift (differences between pre- and post-shift PFT results)
without exposure to red tide with the changes in PFT values during the
work shift when individuals are exposed to red tide.
Unfortunately, the exposures experienced by our study cohort have
been minimal, and we plan to conduct another study (using the same
symptom questionnaires and spirometry tests) during a more severe red
tide event.
[[Page 11984]]
In addition, we are now planning to quantify the levels of
cytokines in nasal exudates to assess whether they can be used to
verify exposure and to demonstrate a biological effect (i.e., allergic
response) following inhalation of aerosolized brevetoxins. We plan to
include not only the study subjects who have been involved in our
earlier studies, but also any new individuals who are hired to work at
the relevant beaches. As mentioned above, we have collected part data
on occupational exposure to red tides. However, because we are dealing
with natural phenomena and are subject literally to the tides, and
because the scientific questions are evolving as we learn more, we must
extend our data collection time for an additional three years. There
are no costs to respondents except for their time.
Annualized Burden Table:
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Number of Average
Respondents Number of responses per burden per Total burden
respondents respondent response
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Pulmonary History Questionnaire... 5 1 20/60 2
Spirometry........................ 25 6 20/60 50
Nasal exudates collection/Nasal 25 6 10/60 25
wash.............................
Symptom Questionnaire............. 25 6 5/60 13
Hearing test...................... 25 6 15/60 38
Beach Survey...................... 5 160 5/60 67
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Total......................... .............. .............. .............. 195
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Dated: March 3, 2005.
Betsey Dunaway,
Acting Reports Clearance Officer, Office of the Chief Science Officer,
Centers for Disease Control and Prevention.
[FR Doc. 05-4683 Filed 3-9-05; 8:45 am]
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