[Federal Register Volume 77, Number 59 (Tuesday, March 27, 2012)]
[Notices]
[Pages 18248-18250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7351]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[30-Day-12-12BK]
Agency for Toxic Substances and Disease Registry; Agency Forms
Undergoing Paperwork Reduction Act Review
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
(404) 639-7570 or send an email to [email protected]. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC or
by fax to (202) 395-5806. Written comments should be received within 30
days of this notice.
Proposed Project
Prospective Birth Cohort Study Involving Environmental Uranium
Exposure in the Navajo Nation--New--Agency for Toxic Substances and
Disease Registry (ATSDR) and Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
The Navajo Nation includes 16 million acres of New Mexico, Utah and
Arizona. It is the largest Alaska Native/
[[Page 18249]]
American Indian Reservation in the United States. From 1948 to 1986,
many uranium mining and milling operations took place in the Navajo
Nation, leaving a large amount of uranium contamination on the
reservation. Several studies have reported that uranium mostly damages
the kidneys and urinary system. However, there is not much research
data on uranium exposure and poor birth and reproductive health
outcomes. Research involving prenatal exposure to uranium may help to
understand and prevent some unfavorable child and maternal health
outcomes.
There are important health differences concerning birth outcomes
and prenatal care in the Navajo Nation. According to the Indian Health
Service Regional Differences in Indian Health 2002-2003 Edition, the
infant death rate among the Navajo people is 8.5 deaths per 1000 live
births, compared to 6.9 deaths per 1000 live births among all races.
Only 61% of Navajo mothers with live births received prenatal care in
the first trimester as compared to 83% of all US mothers. Early and
regular prenatal care is a major predicator of positive birth outcomes.
Due to the health differences in birth outcomes and the chance for
environmental uranium exposure in the Navajo Nation, ATSDR decided that
the upcoming study must include education of women and their families
about the importance of prenatal care and the potential poor health
risks associated with exposure to uranium.
The House Committee on Oversight and Government Reform requested
that federal agencies develop a plan to address health and
environmental impacts of uranium contamination in the Navajo Nation. As
a result of this request, ATSDR awarded a research cooperative
agreement to University of New Mexico Community Environmental Health
Program (UNM-CEHP) entitled ``A Prospective Birth Cohort Study
Involving Environmental Uranium Exposure in the Navajo Nation (U01),''
in August 2010. ATSDR and UNM-CEHP are working with the Navajo Area
Indian Health Service (NAIHS), Navajo Nation Division of Health
(NNDOH), Navajo Nation Environmental Protection Agency (NNEPA), and
Navajo culture and language specialists to carry out the study. The
study will examine reproductive outcomes in pregnant women, follow and
assess their children from birth to 1 year of age, and create a system
to follow up the infants through childhood up to 6 years of age to
evaluate the impact of uranium exposure on biological and psychosocial
endpoints. Biological sample analysis, surveys, and developmental
screenings will be performed during this research period for each
participant.
In addition to investigating the role of uranium and other
chemicals in the environment on birth outcomes and development, the
prospective study may aid in understanding causes and prevention
measures of chronic conditions. Several research studies have shown
that exposure to chemicals in the environment during prenatal and
postnatal periods can affect the development of adult chronic diseases.
The study will also provide broad public health benefits for Navajo
communities through outreach and education on environmental prenatal
risks and early assessment. Referrals will also be provided for known
developmental delays.
Participants will include Native American mothers from age 14 to 45
with verification of pregnancy who have lived in the study area for at
least 5 years. Also, participants must consent to receive prenatal care
and deliver at one of the healthcare facilities that are taking part in
the study (Northern Navajo Medical Center, Chinle Comprehensive Health
Care Facility, Gallup Indian Medical Center, Tuba City Regional Health-
Care Corporation, or Ts[eacute]hootsoo[iacute] Medical Center). Fathers
will be included in the study with consent regardless of age or
residence. We estimate that 550 pregnant women and fathers per year
must be enrolled in the study to obtain adequate statistical power. A
10% pregnancy loss will be assumed, which would result in 500 live
births per year. Therefore, the total anticipated sample size is 1,500
mother-infant pairs over the three years of the study.
The data collection instruments for pregnant mothers include the
following: Enrollment Survey, Ages and Stages Questionnaire (ASQ-I),
Mullen Stages of Early Development (MSEL), Postpartum Surveys (12 month
Postpartum survey includes Nutritional Assessment/Food Intake
Questionnaire) and Eligibility Form. An enrollment survey for fathers
who agree to participate will also be administered. Community Health
and Environmental Research Specialists (CHERS) will administer surveys
using a CDC-approved electronic data entry system. Survey instruments
were designed to collect demographic information, assess potential
environmental health risks, and mother-child interactions. The survey
instruments were developed based on previous surveys conducted by Dine'
Network for Environmental Health (DiNEH) Project, the National
Children's Study, and by other birth cohort studies that have been
conducted among other indigenous populations. The final format of the
survey instruments was modified based on review and input from the
Navajo Nation community liaison group and associated Navajo staff to
address issues such as cultural sensitivity, comprehension and language
translation.
There is no cost to the respondents other than their time to
participate in the study. The total estimated annual burden hours are
3596.
Estimated Annualized Burden Hours
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Number of
Type of respondent Form name Number of responses per Average burden
respondents respondent response (hours)
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Mother.......................... Enrollment Survey....... 550 1 120/60
Ages and Stages 500 4 15/60
Questionnaire.
(2,6,9,12 months).......
Mullen Stages of Early.. 500 1 15/60
Development.............
Postpartum Survey (0 500 1 60/60
months).
Post-partum Survey...... 500 3 15/60
(2,6,9 months)..........
Postpartum Survey (12 500 1 15/60
months).
Eligibility Form........ 550 1 5/60
Father.......................... Enrollment Survey....... 550 1 90/60
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Dated: March 20, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science (OADS), Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2012-7351 Filed 3-26-12; 8:45 am]
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