[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]


=======================================================================
-----------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondent            Form name        Number of     responses per     response      Total burden
                                                    respondents     respondent        (hours)         (hours)
----------------------------------------------------------------------------------------------------------------
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.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............            3550
----------------------------------------------------------------------------------------------------------------


    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