[Federal Register: April 23, 2004 (Volume 69, Number 79)]
[Notices]
[Page 22047-22048]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ap04-77]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-04-45]
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 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
[[Page 22048]]
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.
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response Total burden
respondents respondent (in hrs.) (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]
BILLING CODE 4163-18-P