[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Notices]
[Pages 75865-75866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30595]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[30Day-16-0046]
Agency Forms Undergoing Paperwork Reduction Act Review
The Agency for Toxic Substances and Disease Registry (ATSDR) has
submitted the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget,
Washington, DC 20503 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 (OMB Control No. 0923-0046, Expiration,
2/29/2016)--Extension--Agency for Toxic Substances and Disease Registry
(ATSDR).
Background and Brief Description
The Navajo Nation 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. 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 in 2013, ATSDR and its research partners (University of
New Mexico Community Environmental Health Program [UNM-CEHP], Navajo
Area Indian Health Service [NAIHS], Navajo Nation Department of Health
[NNDOH], Navajo Nation Environmental Protection Agency [NNEPA], and
Navajo culture and language specialists) initiated a research study
titled ``Prospective Birth Cohort Study Involving Environmental Uranium
Exposure in the Navajo Nation'' (OMB Control No. 0923-0046; expiration
date 02/29/2016). The goal of the research is to better understand and
prevent unfavorable child and maternal health outcomes potentially
related to prenatal exposures to uranium. As
ATSDR has received supplemental funding to continue the study, a
three year extension for PRA clearance is requested to allow further
recruitment of mother-infant pairs.
Participants 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.
Since 2013, over 525 mother-infant pairs and over 160 fathers have
been enrolled. Biological sample analysis, surveys, and developmental
screenings are performed for each participant. An estimated 675
biomonitoring samples have been analyzed for 36 metals/metalloids
including uranium, arsenic, lead and mercury. Home environmental
assessments (HEAs), conducted by field research staff, consist of gamma
radiation surveys, indoor air radon tests, and dust sample analysis of
the participants' primary residence during pregnancy, and over 400 HEAs
have been completed to date. Mothers must be present at home when field
research staff conduct the HEA. Study participants receive report back
letters on their biomonitoring and HEA results to inform them of
uranium and other heavy metals in their bodies and in and around their
home environment.
The survey instruments for pregnant mothers include the following:
Eligibility Form, Mother Enrollment Survey, Ages and Stages
Questionnaire (ASQ), Mullen Scales for Early Learning (MSEL),
Postpartum Survey (2 months), Postpartum Survey (6,9,12 months), Food
Frequency Questionnaire/WIC Intake Form, and Home Environmental
Assessments. An enrollment survey for fathers who agree to participate
is also administered. Follow-up assessments including the Ages & Stages
Questionnaire and biomonitoring at 2, 6, 9 and 12 months are currently
being conducted for the 387 infants delivered to date.
Community Health and Environmental Research Specialists (CHERS)
administer the surveys using a CDC-approved electronic data entry
system. Survey instruments are used to collect demographic information
and to assess potential environmental health risks and mother-child
interactions. The final format of the survey instruments is 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 4,455.
[[Page 75866]]
Estimated Annualized Burden Hours
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Average
Number of Number of burden
Type of respondents Form name respondents responses per response
respondent (hours)
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Mothers............................... Eligibility Form........ 750 1 5/60
Mother Enrollment Survey 550 1 2
Ages and Stages 500 4 15/60
Questionnaire (2,6,9,12
months).
Mullen Scales of Early 500 1 20/60
Learning.
Postpartum Survey (2 500 1 1
months).
Post-partum Survey (6, 500 3 15/60
9, 12 months).
Food Frequency 500 1 45/60
Questionnaire/WIC
Intake Form.
Home Environmental 550 1 1
Assessment.
Fathers............................... Father Enrollment Survey 550 1 90/60
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-30595 Filed 12-3-15; 8:45 am]
BILLING CODE 4163-18-P