[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58394-58395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23203]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-12-12RO]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 
and send comments to Kimberly S. Lane, 1600 Clifton Road, MS-D74, 
Atlanta, GA 30333 or send an email to [email protected].
    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; and (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. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Anniston Community Health Survey: Follow-up and Dioxin Analyses 
(ACHS-II)--New--Agency for Toxic Substances and Disease Registry 
(ATSDR), Department of Health and Human Services (DHHS) Centers for 
Disease Control and Prevention (CDC).

Background and Brief Description

    In the past, polychlorinated biphenyls (PCBs) were used as coolants 
and lubricants in electrical equipment. They didn't burn easily and 
were good insulators. PCBs are no longer made in the U.S. They were 
banned in 1977 because they persist in the environment. Concerns grew 
about harm to health.
    The City of Anniston, AL, was the site of the former Monsanto 
facility. PCBs were made there from 1929 to 1971. For decades, PCBs 
were released into the local air, soil, and surface water. In 1996, 
residents found out they were exposed. Concerns grew and led to 
litigation. In 2003, a settlement in favor of the residents was reached 
in state and federal courts.
    The Anniston Environmental Health Research Consortium (AEHRC) was 
funded by the Agency for Toxic Substances and Disease Registry (ATSDR). 
The AEHRC conducted the Anniston Community Health Survey (ACHS) from 
2005 to 2007. Serum PCB levels in 766 Anniston adults were found to be 
three to seven times higher than in U.S. adults. Also, higher PCB 
levels were found in Anniston adults who had high blood pressure and 
diabetes.
    The ATSDR and the National Institutes of Health (NIH) plan to 
continue the work of the first ACHS. These agencies will conduct a 
follow-up study called the ACHS-II. It will be a repeated cross-
sectional study. Data collection will be managed by the University of 
Alabama at Birmingham (UAB) and the Calhoun County Health Department 
(CCHD).
    A sample of 500 adults will be selected from the first ACHS cohort. 
After informed consent, clinical assessments will be done. These will 
be for blood pressure, height, weight, and body girth. A questionnaire 
will be answered by computer-assisted personal interviews (CAPIs). 
Questions will be asked for health, demographic, diet, and lifestyle 
factors. The self-reported responses will be compared to laboratory 
analytes. For these, blood samples will be drawn and analyzed.
    The ACHS-II will measure the same serum PCBs as in the first 
Anniston survey. In this way, changes in PCB levels can be studied. The 
ACHS-II will also include serum analytes for dioxins, furans, dioxin-
like PCBs, and other similar chemicals. Additional analytes include 
blood measures of heavy metals. Clinical biomarkers will include 
measures for thyroid, diabetes, lipids, and immune function. This will 
give a more complete profile of human exposures and health in Anniston, 
AL.
    The ATSDR is requesting a two-year approval for this information 
collection.
    There are no costs to respondents other than their time. In total, 
they will spend 2 hours in the study.

                                  Exhibit 1--Estimated Annualized Burden Hours
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                                                                     Number of      Avg. burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs)          hours
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Adults who took part in first   Telephone                    333               1            2/60              11
 Anniston Community Health       Recruitment
 Survey.                         Script.
                                Survey for                   165               1            1/60               3
                                 Refusals.
                                Informed Consent             250               1            1/60               4
                                Update Contact               250               1            1/60               4
                                 Information
                                 Form.
                                Medications Form             250               1            3/60              12
                                Blood Draw Form.             250               1            2/60               8
                                Questionnaire...             250               1           45/60             188
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             230
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[[Page 58395]]

    Dated: September 14, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2012-23203 Filed 9-19-12; 8:45 am]
BILLING CODE 4163-18-P