E8-20913. 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 404-639-5960 and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to [e-mail].

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.)

Background and Brief Description

Karenia brevis (formerly Gymnodinium breve) is the marine dinoflagellate responsible for extensive blooms (called Florida red tides) that forms 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 revision of data collection procedures for the currently approved project and an additional three year extension. 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.

NCEH plans to include the study subjects who have been involved in the earlier studies and any new individuals (n=25) who have been hired to work at the relevant beaches.

There is no cost to respondents other than their time.

Estimated Annualized Burden Hours

Instrument type	Number of respondents	Number of responses per respondent	Average burden per response (in hours)	Total burden (in hours)
Pulmonary History Survey	10	1	20/60	3
Symptom survey	25	6	5/60	13
Total				16

Catina Conner,

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