[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]
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs) hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
[[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