E9-3651. 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 [phone] or send an e-mail to [e-mail]. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to [phone]. Written comments should be received within 30 days of this notice.

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

Type of respondents	Instrument type	No. of respondents	No. of responses per respondent	Average burden per response (in hours)
New study participants	Pulmonary Health Questionnaire	10	1	20/60
Lifeguards (previous participants and new)	Pre- and Post-Shift Red Tide Questionnaire	25	6	5/60

Dated: February 12, 2009.

Maryam I. Daneshvar,

Acting Reports Clearance Officer, Centers for Disease Control and Prevention.