[Federal Register Volume 74, Number 33 (Friday, February 20, 2009)]
[Notices]
[Pages 7904-7905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3651]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-08-0494]


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) 639-5960 or send an e-mail 
to [email protected]. Send written comments to CDC Desk Officer, Office of 
Management and Budget, Washington, DC or by fax to (202) 395-6974. 
Written comments should be received within 30 days of this notice.

[[Page 7905]]

Proposed Project

    Exposure to Aerosolized Brevetoxins during Red Tide Events (OMB No. 
0920-0494)--Reinstatement with change--National Center for 
Environmental Health (NCEH), Centers for Disease Control and Prevention 
(CDC).

Background and Brief Description

    Karenia brevis (formerly Gymnodinium breve) is the marine 
dinoflagellate responsible for extensive blooms (called Florida red 
tides) that form in the Gulf of Mexico. K. brevis produces potent 
toxins, called brevetoxins, which have been responsible for killing 
millions of fish and other marine organisms. The biochemical activity 
of brevetoxins is not completely understood and there is still 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.
    NCEH administered a baseline respiratory health survey and 
conducted pre- and post-shift pulmonary function tests (PFTs) during a 
time when there is no red tide reported near the area. When a red tide 
developed, NCEH administered a symptom survey and conducted PFTs. NCEH 
compared symptoms reported before the shift with symptoms reported 
after the shift. NCEH also examined changes in PFT test results (post-
shift values compared to pre-shift values). NCEH did these comparisons 
during a time when there was no red tide and during a time when there 
was a red tide and then examined the data to see if red tide exposure 
had an effect on symptom reports or PFT results.
    NCEH requests a reinstatement with change of data collection 
procedures for the previously approved project for an additional three 
years. The respondents for this reinstatement with change are a 
recruited group of approximately 25 lifeguards (aged >=18) who work 
along the coast of Florida and who periodically are occupationally 
exposed to aerosolized red tide toxins. The lifeguards and employees of 
the Department of Environmental Protection, (Sarasota County), Florida 
were recruited via a posted notice requesting volunteers. NCEH plans to 
re-contact study participants previously enrolled and add additional 
lifeguards hired previously to work at the relevant beaches.
    Unfortunately, the exposures experienced by the study cohort have 
been minimal, and NCEH plans to conduct another study (using the same 
symptom surveys and PFTs) during a more severe red tide event. First, 
NCEH wants 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. NCEH will collect nasal exudates at the same 
time the PFTs are done. We propose to add a component to this study to 
assess whether loratidine, an antihistamine available in over-the-
counter products, such as Claritin, can relieve the upper respiratory 
symptoms induced by inhaling aerosolized brevetoxins during Florida red 
tides.
    There is no cost to respondents other than their time. The total 
estimated annual burden hours are 16.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                                 Average burden
        Type of respondents             Instrument type          No. of       No. of responses  per response (in
                                                               respondents     per respondent        hours)
----------------------------------------------------------------------------------------------------------------
New study participants.............  Pulmonary Health                     10                 1             20/60
                                      Questionnaire.
Lifeguards (previous participants    Pre- and Post-Shift                  25                 6              5/60
 and new).                            Red Tide
                                      Questionnaire.
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    Dated: February 12, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. E9-3651 Filed 2-19-09; 8:45 am]
BILLING CODE 4163-18-P