80 FR 58733 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 80, Issue 189 (September 30, 2015)

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (PRA). This notice invites comment on the three- year extension of information collection clearance for the ``Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation'' project (OMB Control No. 0923-0046; expiration date 05/31/2016). The purpose of the study is to examine the potential association between environmental contaminants (i.e., uranium and other heavy metal exposures) and reproductive birth outcomes by recruiting Navajo mothers to assess and follow theirs and their children's uranium exposures at birth and at key developmental milestones.

[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Notices]
[Pages 58733-58734]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24718]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60Day-15-0046; Docket No. ATSDR-2015-0005]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), 
Department of Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR), 
as part of its continuing efforts to reduce public burden and maximize 
the utility of government information, invites the general public and 
other Federal agencies to take this opportunity to comment on proposed 
and/or continuing information collections, as required by the Paperwork 
Reduction Act of 1995 (PRA). This notice invites comment on the three-
year extension of information collection clearance for the 
``Prospective Birth Cohort Study Involving Environmental Uranium 
Exposure in the Navajo Nation'' project (OMB Control No. 0923-0046; 
expiration date 05/31/2016). The purpose of the study is to examine the 
potential association between environmental contaminants (i.e., uranium 
and other heavy metal exposures) and reproductive birth outcomes by 
recruiting Navajo mothers to assess and follow theirs and their 
children's uranium exposures at birth and at key developmental 
milestones.

DATES: Written comments must be received on or before November 30, 
2015.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2015-0005 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.


FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION:  Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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; (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; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review

[[Page 58734]]

the collection of information; and to transmit or otherwise disclose 
the information.

Proposed Project

    Prospective Birth Cohort Study Involving Environmental Uranium 
Exposure in the Navajo Nation (U01), (OMB Control No. 0923-0046, 
Expiration Date 02/29/2016)--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 Division 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. 0923-0048; 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 during 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) 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. 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: 
Enrollment Survey, Ages and Stages Questionnaire (ASQ-I), Mullen Stages 
of Early Development (MSEL), Postpartum Surveys, and Food Frequency 
Questionnaire/WIC Intake. 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.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in     (in hrs.)
                                                                    respondent         hrs.)
----------------------------------------------------------------------------------------------------------------
Mother........................  Eligibility Form             750               1            5/60              63
                                 (screening
                                 form).
                                Enrollment                   550               1               2           1,100
                                 Survey.
                                Home                         550               1               1             550
                                 Environmental
                                 Assessment.
                                Ages and Stages              500               4           15/60             500
                                 Questionnaire--
                                 (2, 6, 9, 12
                                 months).
                                Mullen Stages of             500               1           20/60             167
                                 Early
                                 Development.
                                Postpartum                   500               1               1             500
                                 Survey--(2
                                 months).
                                Postpartum                   500               3           15/60             375
                                 Survey--(6, 9,
                                 12 months).
                                Food Frequency               500               1           45/60             375
                                 Questionnaire/
                                 WIC Intake.
Father........................  Enrollment                   550               1           90/60             825
                                 Survey.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           4,455
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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. 2015-24718 Filed 9-29-15; 8:45 am]
 BILLING CODE 4163-18-P