[Federal Register Volume 82, Number 1 (Tuesday, January 3, 2017)]
[Notices]
[Pages 124-126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31772]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60Day-17-17IY; Docket No. ATSDR-2016-0007]


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, 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 March 6, 2017.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2016-0007 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

[[Page 125]]

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 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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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
Licensed Anglers..............  Eligibility                  156               1            5/60              13
                                 Screening
                                 Survey (paper).
                                Eligibility                   28               1            5/60               2
                                 Screening
                                 Survey (online).
                                Study                         58               1           30/60              29
                                 Questionnaire
                                 (paper).
                                Study                         87               1           30/60              44
                                 Questionnaire
                                 online).
                                Clinic Visit                 133               1           35/60              78
                                 Checklist and
                                 Body
                                 Measurements.

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                                Follow-up Survey             133               1            5/60              11
Burmese Refugees..............  Eligibility                   42               1            5/60               4
                                 Screening
                                 Survey.
                                Contact                       33               1            5/60               3
                                 Information
                                 Form.
                                Study                         33               1           40/60              22
                                 Questionnaire.
                                Clinic Visit                  33               1           35/60              19
                                 Checklist and
                                 Body
                                 Measurements.
                                Network Size                  33               1            5/60               3
                                 Questions.
                                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. 2016-31772 Filed 12-30-16; 8:45 am]
 BILLING CODE 4163-18-P