[Federal Register Volume 70, Number 109 (Wednesday, June 8, 2005)]
[Notices]
[Pages 33498-33499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-11371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-05-0445X]


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) 371-5983 or send an e-mail 
to [email protected]. 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

    A Multi-Center Study to Assess Exposure to Environmental Pollutants 
Among Primiparous Women in North America--New--National Center for 
Environmental Health (NCEH), Centers for Disease Control and Prevention 
(CDC).

[[Page 33499]]

Background and Brief Description

    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 (Primiparous) 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). The current protocol only describes and seeks approval for 
enrollment of 75 pregnant women from three of the five U.S. sites. Two 
U.S. sites have ongoing studies, in collaboration with CDC, where they 
are testing maternal blood for POPs and metals; these two sites are 
non-federal, academic institutions, and CDC does not have a formal 
funding agreement with these institutions. 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 other than their time. The estimated total annualized 
burden hours are 53 hours.
    Estimate of Annualized Burden Table:

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                                                                                   Number of     Average  burden
                     Type or respondents                          Number of      responses per    per  response
                                                                 respondents       respondent       (in hrs.)
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Screening First-time Pregnant Women..........................             106                1             5/60
Demographic and Health History Questionnaire.................              75                1            10/60
Food Frequency Questionnaire.................................              75                1            25/60
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    Dated: May 31, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and 
Prevention.
[FR Doc. 05-11371 Filed 6-7-05; 8:45 am]
BILLING CODE 4163-18-P