80 FR 75865 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry

Federal Register Volume 80, Issue 233 (December 4, 2015)

[Federal Register Volume 80, Number 233 (Friday, December 4, 2015)]
[Notices]
[Pages 75865-75866]
From the Federal Register Online  [www.thefederalregister.org]
[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)
----------------------------------------------------------------------------------------------------------------
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