[Federal Register Volume 76, Number 225 (Tuesday, November 22, 2011)]
[Notices]
[Pages 72206-72207]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-30103]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-12-12AM]
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 (404) 639-5960
and send comments to Daniel Holcomb, CDC Reports Clearance Officer,
1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to
[email protected].
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. Written comments should be received
within 60 days of this notice.
Proposed Project
Prospective Birth Cohort Study Involving Environmental Uranium
Exposure in the Navajo Nation (U01)--New--National Center for
Environmental Health (NCEH) and Agency for Toxic Substances and Disease
Registry (ATSDR), 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/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 U.S. 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
[[Page 72207]]
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 survey instruments for pregnant mothers include the following:
Enrollment Survey, Nutritional Assessment/Food Intake Questionnaire,
Ages and Stages Questionnaire (ASQ-I), Mullen Stages of Early
Development (MSEL), and Postpartum Surveys. 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
equals 3550.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per response Total burden
respondents respondent (hours) (hours)
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Mother........................ Enrollment 550 1 2 1100
Survey.
Ages and Stages 500 4 15/60 500
Questionnaire
(2,6,9 12
months).
Mullen Stages of 500 1 15/60 125
Early
Development.
Postpartum 500 1 1 500
Survey (0
months).
Post-partum 500 4 15/60 500
Survey (2, 6,
9, 12 months).
Father........................ Enrollment 550 1 90/60 825
Survey.
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Total..................... ................ .............. .............. .............. 3550
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Dated: November 16, 2011.
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-30103 Filed 11-21-11; 8:45 am]
BILLING CODE 4163-18-P