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 the CDC Reports Clearance Officer on (404) 498-1210.
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. Send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-E11, Atlanta, GA 30333. Written comments should be received within 60 days of this notice.
Proposed Project
Environmental Monitoring of Persistent Organic Pollutants and Metals: A Multi-Center Study to Determine Population Exposure to Environmental Toxins in North America—New—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).
Persistent organic pollutants (POPs) are a group of man-made chemicals that can stay in the environment for long periods of time and can be transported long distances in the environment. Heavy metals such as lead and mercury are naturally found substances that can also be released into the environment as a result of human activities (e.g., smelting). Exposure to these contaminants, even at low levels, may lead to adverse health effects, particularly in high-risk groups such as the unborn child. However, before we attempt to determine if these contaminants are associated with health effects, we have to find out if these contaminants are present in our blood and in what amounts. The Arctic Monitoring and Assessment Program (AMAP), established in 1991 under the Arctic Environmental Protection Strategy (AEPS), has the responsibility to monitor levels and assess effects of selected pollutants (i.e., POPs and heavy metals) in all Arctic locations. To our knowledge, a similar integrated program for monitoring exposure to POPs and metals does not exist in North America.
The proposed program will monitor levels of POPs and heavy metals in first-time pregnant women. The program will help determine geographical and temporal trends of these exposures in selected cities within the United States, Canada, and Mexico. CDC will be responsible for the investigation in the United States; Canada and Mexico will be responsible for the investigation in their countries. The findings will inform first-time pregnant women in the vicinity of the study sites of their exposure to selected POPs and heavy metals. This program will also provide unique information regarding accumulation of POPs and heavy metals in relation to dietary patterns, and will allow assessment of trends in diet, which is critical public health information. Biomonitoring for POPs and metals will enhance awareness among this vulnerable population of the risks posed by these chemicals in various regions of North America and help identify ways to reduce exposure. The program will enroll 25 pregnant women (20-25 years of age) per site (United States: 5 sites; Canada: 5 sites; Mexico: 10 sites). Data from previous projects in the United States and Canada will be used for comparing results of the current project. As there has been little national or regional monitoring in Mexico, more sites will be selected in Mexico than in the United States and Canada.
In collaboration with obstetricians at the local sites, study participants will be recruited during their prenatal clinic visit, after their 36th week of pregnancy but prior to delivery. One person from the study team will approach the mother during a routine prenatal visit, explain the project, and obtain signed consent if the mother is willing to participate. The study will involve administering an exposure questionnaire and collection of blood and urine samples during the 3rd trimester of the pregnancy. This is only a one-time study; blood collection and administration of the questionnaire will only be done once. All samples will be analyzed at a single laboratory in each country, and the results will be distributed to the study participants and their physicians prior to publication. There are no costs to respondents.
Respondents | Number of respondents | Number of responses per respondent | Average burden per response (in hrs.) | Total burden (in hrs.) |
---|---|---|---|---|
U.S. Primiparous Pregnant Women | 125 | 1 | 30/60 | 63 |
Total | 63 |
Dated: April 13, 2004.
Alvin Hall,
Director, Management Analysis and Services Office, Centers for Disease Control and Prevention.
[FR Doc. 04-9212 Filed 4-22-04; 8:45 am]
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