05-16367. Proposed Data Collections Submitted for Public Comment and Recommendations

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Proposed Project

Potential Reproductive and Neurological Effects of Exposure to Acrylamide—NEW—The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

The mission of the National Institute for Occupational Safety and Health (NIOSH) is to promote safety and health at work for all people through research and prevention. Consistent with this mission, NIOSH is undertaking a study of the reproductive and neurobehavioral effects of occupational exposure to acrylamide. Male acrylamide workers and control workers (N = 100 per group) will be recruited from manufacturing, end-user, and non-exposed settings. Exposure will be characterized by acrylamide hemoglobin, adduct and urinary metabolite levels, ambient area, personal air, and dermal sampling. Reproductive effects will be evaluated by examining semen quality, sperm DNA integrity, reproductive hormone levels, and prostate specific antigen (PSA) levels.

Neurobehavioral effects will be assessed using sensation-tactile, postural stability, grooved pegboard, and simple reaction time tests. Two questionnaires will be administered on one occasion. Questionnaire information will be collected concurrently to augment test interpretation, adjust for potential confounders and covariates during regression analysis, correlate specific jobs and job activities with exposure measurements, and for validation purposes. Findings from this study will clarify if the adverse reproductive effects observed in animal studies are also present in acrylamide-exposed male workers, and if preclinical neurobehavioral deficits are present at acrylamide doses currently considered to be within safe limits. This study is scheduled for implementation between 2005 and 2007. There is no cost to the respondent other than their time for participating. The annualized estimated burden for this data collection is 54 hours.

Estimate of Annualized Burden Table

Survey questionnaires	Number of respondents	Number of responses/respondent	Average burden/response (hours)
Medical & Reproductive History Questionnaire	67	1	13/60
Occupational History Questionnaire	67	1	34/60
Non-participant Questionnaire	17	1	2/60

Dated: August 11, 2005.

Joan F. Karr,

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