[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
----------------------------------------------------------------------------------------------------------------
                                                                                  Number of
       Type of respondent                 Form name             Number of       responses per    Average burden
                                                               respondents       respondent     response (hours)
----------------------------------------------------------------------------------------------------------------
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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[[Page 18250]]

    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]
BILLING CODE 4163-18-P