05-4683. 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 [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).

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.

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:

Respondents	Number of respondents	Number of responses per respondent	Average burden per response	Total burden
Pulmonary History Questionnaire	5	1	20/60	2
Spirometry	25	6	20/60	50
Nasal exudates collection/Nasal wash	25	6	10/60	25
Symptom Questionnaire	25	6	5/60	13
Hearing test	25	6	15/60	38
Beach Survey	5	160	5/60	67
Total				195

Dated: March 3, 2005.

Betsey Dunaway,

Acting Reports Clearance Officer, Office of the Chief Science Officer, Centers for Disease Control and Prevention.