[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Notices]
[Pages 96454-96456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31738]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60Day-17-17IY; Docket No. ATSDR-2016-0122]


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. This notice invites comment on ``Biomonitoring 
of Great Lakes Populations Program III.'' The purpose of the proposed 
study is to evaluate body burden levels of priority contaminants in 
Great Lakes residents,

[[Page 96455]]

particularly those who are at high exposure risk, in the Milwaukee Bay 
Estuary Area of Concern (AOC) area that was not previously addressed in 
ATSDR's previous biomonitoring programs around the Great Lakes.

DATES: Written comments must be received on or before February 28, 
2017.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2016-0122 by any of the following methods:
     Federal eRulemaking Portal: Regulations.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 the 
collection of information; and to transmit or otherwise disclose the 
information.

Proposed Project

    Biomonitoring of Great Lakes Populations Program III--New--Agency 
for Toxic Substances and Disease Registry (ATSDR).

Background and Brief Description

    The Agency for Toxic Substances and Disease Registry (ATSDR) is 
requesting a three-year Paperwork Reduction Act (PRA) clearance for a 
new information collection request (ICR) titled ``Biomonitoring of 
Great Lakes Populations Program III.'' ATSDR awarded funds to the 
Wisconsin Department of Health Services (WIDHS) to conduct this 
information collection under cooperative agreement #NU61TS000269-01-00. 
The purpose of the current program is to evaluate body burden levels of 
legacy and emerging contaminants in susceptible Great Lakes populations 
in the Milwaukee Estuary Area of Concern (AOC) in Wisconsin, an area 
that has not been previously covered by other Great Lakes initiatives.
    The Great Lakes Basin has suffered decades of pollution and 
ecosystem damage. Many chemicals persist in Great Lakes waters and 
sediments, as well as in wildlife. These chemicals can build up in the 
aquatic food chain, and eating contaminated fish is a known route of 
human exposure.
    In 2009, the Great Lakes Restoration Initiative (GLRI) was enacted 
by Public Law 111-88 to make restoration and protection of the Great 
Lakes a national priority. The GLRI is led by the U.S. Environmental 
Protection Agency (US EPA). Under a 2015 interagency agreement with the 
US EPA, ATSDR initiated the Biomonitoring of Great Lakes Populations 
Program III program. This project will provide additional public health 
information to supplement the previous cooperative agreement programs 
CDC-RFA-TS10-1001 ``Biomonitoring of Great Lakes Populations'' 
(hereafter referred to as ``Program I,'' OMB Control Number 0923-0044) 
and CDC-RFA-TS13-1302 ``Biomonitoring of Great Lakes Populations-II'' 
(hereafter referred to as ``Program II,'' OMB Control Number 0923-0052) 
initiated in FY2010 and FY2013, respectively.
    WIDHS received funding for the current program. WIDHS will recruit 
and enroll two subpopulations of adults in the Milwaukee Bay Estuary 
Area of Concern (AOC) who are known to eat fish from the Milwaukee 
River Basin and Lake Michigan. This study will not include pregnant 
women.
    The target populations are: (1) Licensed anglers living in 
proximity to the Milwaukee Estuary AOC and (2) Burmese refugees who are 
known to eat a substantial amount of fish from this area. WIDHS study 
staff will work closely with local refugee and citizen support 
organizations on participant recruitment.
    The aims of the information collection in this surveillance project 
are:
    1. Assess levels of contaminants (metals, polychlorinated 
biphenyls, chlorinated pesticides, perfluorinated compounds, and 
polyaromatic hydrocarbons) in blood and urine of residents who consume 
fish from contaminated areas that had not been studied in previous 
Programs I and II;
    2. Use the project findings to inform public health officials and 
offer guidance on public health actions to reduce exposure to Great 
Lakes contaminants.
    This applied public health program aims to measure contaminants in 
biological samples (blood, urine and hair) from people who may be at 
high risk of chemical exposure in the Great Lakes area. These 
measurements will provide a baseline for current and future restoration 
activities. The results will be compared to available national 
estimates, such as those reported by the National Health and Nutrition 
Examination Survey (NHANES).
    Respondents will be screened for eligibility and consent will be 
obtained. Participants who consent will respond to a questionnaire and 
participate in

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clinic visits for body measurements and biological specimen collection 
(blood, urine, and hair). Their blood will be tested for 
polychlorinated biphenyls, metals, perfluorinated compounds, persistent 
pesticides, and lipids. Urine will be tested for polycyclic aromatic 
hydrocarbons and creatinine. The hair samples (optional) will be saved 
for a later analysis.
    Respondents will also be interviewed. They will be asked about 
demographic and lifestyle factors, hobbies, health conditions that may 
affect fish consumption and fishing habits, and types of jobs which can 
contribute to chemical exposure. Some dietary questions will be asked 
with a focus on consumption of Great Lakes fish.
    Participation in the study is voluntary and there is no cost to 
respondents other than their time. The estimated annualized burden for 
the program averaged over the three-year study period is 231 hours 
among 166 respondents. There is no cost to respondents other than their 
time spent in the study.

                                                            Estimated Annualized Burden Hours
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                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
              Type of respondents                               Form name                   respondents    responses per   response  (in    (in hours)
                                                                                                            respondent        hours)
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Licensed Anglers...............................  Eligibility Screening Survey (paper)...             156               1            5/60              13
                                                 Eligibility Screening Survey (online)..              28               1            5/60               2
                                                 Study Questionnaire (paper)............              58               1           30/60              29
                                                 Study Questionnaire (online)...........              87               1           30/60              44
                                                 Clinic Visit Checklist and Body                     133               1           35/60              78
                                                  Measurements.
                                                 Follow-up Survey.......................             133               1            5/60              11
Burmese Refugees...............................  Eligibility Screening Survey...........              42               1            5/60               4
                                                 Contact Information Form...............              33               1            5/60               3
                                                 Study Questionnaire....................              33               1           40/60              22
                                                 Clinic Visit Checklist and Body                      33               1           35/60              19
                                                  Measurements.
                                                 Network Size Questions.................              33               1            5/60               3
                                                 Follow-up Survey.......................              33               1            5/60               3
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............             231
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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. 2016-31738 Filed 12-29-16; 8:45 am]
BILLING CODE 4163-18-P