[Federal Register: October 3, 2003 (Volume 68, Number 192)]
[Notices]               
[Page 57464]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03oc03-80]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-75-03]

 
Proposed Data Collections Submitted for Public Comment and 
Recommendations

    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) 498-1210. Send written 
comments to CDC, Desk Officer, Human Resources and Housing Branch, New 
Executive Office Building, Room 10235, Washington, DC 20503 or by fax 
to (202) 395-6974. Written comments should be received within 30 days 
of this notice.
    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 
the occupational exposure to acrylamide. 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, 
postual 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 workers, and if 
preclinical neurobehavioral deficits are present at acrylamide doses 
currently considered to be within safe limits. This study is scheduled 
for implementation in late 2003 and 2004. The annualized estimated 
burden for this data collection is 87 hours.

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                                                                                     Number of    Average burden/
                      Survey questionnaire                           Number of      responses/     response (in
                                                                    respondents     respondent        hours)
----------------------------------------------------------------------------------------------------------------
Medical & Reproductive History Questionnaire....................             100               1           13/60
Occupational History Questionnaire..............................             100               1           34/60
Non-participant Questionnaire...................................             250               1            2/60
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    Dated: September 29, 2003.
Nancy E. Cheal,
Acting Associate Director for Policy, Planning and Evaluation, Centers 
for Disease Control Prevention.
[FR Doc. 03-25084 Filed 10-2-03; 8:45 am]

BILLING CODE 4163-18-P