[Federal Register Volume 78, Number 67 (Monday, April 8, 2013)]
[Notices]
[Pages 20920-20921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-08067]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-13-0040]
Agency Forms Undergoing Paperwork Reduction Act Review
The Agency for Toxic Substances and Disease Registry (ATSDR)
publishes a list of information collection requests under review by the
Office of Management and Budget (OMB) in compliance with the Paperwork
Reduction Act (44 U.S.C. Chapter 35). To request a copy of these
requests, call (404) 639-7570 or send an email to [email protected]. Send
written comments to CDC Desk Officer, Office of Management and Budget,
Washington, DC 20503 or by fax to (202) 395-5806. Written comments
should be received within 30 days of this notice.
Proposed Project
Generic Clearance of ATSDR Exposure Investigations (EI) [OMB
Control No: 0923-0040, Expiration Date 11/30/2012]--Reinstatement with
Change--Agency for Toxic Substances and Disease Registry (ATSDR).
Background and Brief Description
The Agency for Toxic Substances and Disease Registry (ATSDR)
requests a change to a three-year ``generic clearance''. The title has
changed since publication of the 60-day Federal Register Notice to
read--Generic Clearance of ATSDR Exposure Investigations (EI). The
goals remain the same but ATSDR believes the change will allow the
Agency to carry out its public health activities in a more timely and
efficient manner. The benefits to using the EI Generic Clearance
include submission of a standardized OMB review package for each EI
Generic Information Collection (GenIC).
The ATSDR Division of Community Health and Investigation (DCHI)
conducts public health assessments (PHAs) at sites when requested by
the U.S. EPA, states, organizations, or individual petitioners. The
purpose of the agency's PHA process is to find out whether people have
been, are being, or may be exposed to hazardous substances and, if so
whether that exposure is harmful, or potentially harmful, and should
therefore be stopped or reduced. The process also serves as a mechanism
through which the agency responds to specific community health concerns
related to hazardous waste sites.
Exposure assessment is the hallmark of the PHA process. ATSDR
scientists review environmental data to see how much contamination is
at a site, where it is, and how people might come into contact with it.
Generally, ATSDR does not collect its own environmental sampling data
but reviews information provided by federal and state government
agencies and/or their contractors, potentially responsible parties, and
the public. When adequate environmental or exposure information does
not exist to assess human exposures and possible related health
effects, ATSDR will indicate what further environmental sampling may be
needed and may collect environmental and biological samples, when
appropriate.
Therefore, as part of the PHA process, the DCHI Science Support
Branch (SSB) uses EIs to fill data gaps that are essential for
evaluating whether communities are exposed to contaminants and whether
a health hazard is present. The EI team conducts point of human-contact
sampling focused on geographic areas where exposures are expected to be
high. EIs may include environmental (ambient air, personal air, indoor
air, dust, soil, sediment, biota, ground water, tap water and surface
water sampling) or biological sampling (blood and urine sampling), or
both. Most EIs sampling events are completed over a period of days to
months and are a one-time occurrence.
An EI aims to identify the most highly exposed individuals and
measure their exposure. The results of the investigation are site-
specific and apply only to the participants from the site. An EI is not
considered a health study. The participants' results are not intended
to be generalized to other populations and other communities. No
participants from external comparison groups are included in the data
collection. As a public service, EIs provide individual exposure
information back to the participants. EIs are also used as the basis to
implement appropriate public health actions that reduce exposure to
communities.
Information obtained from the participants assists the team in
determining if exposure has occurred or is occurring. For each EI, a
data collection system will include all of the measurements and
procedures that are proposed to address data gaps in biological and
environmental sampling.
ATSDR collects contact information (e.g., name, address, phone
number) to provide the participant with their individual results.
General information, which includes height, weight, age, race, gender,
etc., is also collected primarily in biological investigations to
assist with results interpretation. Some of this information is
investigation-specific; not all of these data are collected for every
investigation.
ATSDR also collects information on other possible confounding
sources of chemical(s) exposure such as medicines taken, food eaten,
hobbies, jobs, etc. In addition, ATSDR asks questions on recreational
or occupational activities that could increase a participant's
[[Page 20921]]
exposure potential. That information represents an individual's
exposure history. With these data, we can assess the presence or
absence of a specific exposure and estimate how long and how frequently
people have had contact with the chemical(s) of interest. The responses
also provide data about exposure to other sources of the chemical(s).
Participation in an EI is completely voluntary and requires
participants' written consent. To assist in interpreting the sampling
results, a survey questionnaire appropriate to the specific contaminant
is administered to participants. Information is generally gathered in a
face-to-face interview with potentially exposed participants, but could
occasionally be administered by phone or mail. All information is
usually collected and recorded electronically and, on occasion, hard
copy forms will be used.
ATSDR uses approximately 12-20 questions about environmental
exposures per investigation. This number can vary depending on the
number of chemicals being investigated the route of exposure (e.g.,
breathing, eating, touching), and number of other sources of the
chemical(s) (e.g., products used, jobs).
Typically, the number of participants in an individual EI ranges
from 10 to 100. Questionnaires are generally needed in less than half
of the EIs (approximately than 12 per year).
The DCHI SSB EI team and the ATSDR staff and partners in the DCHI
cooperative agreement program will use the EI Generic Clearance for OMB
submittals for each EI. EIs are usually nonresearch investigations, but
occasionally may be classified as research. The DCHI cooperative
agreement operates across ten ATSDR regions across the nation. In 2012,
ATSDR was functionally reorganized and DCHI was divided into three
functional units that administer its ten regions and its cooperative
agreement program: Eastern Branch, Central Branch and Western Branch.
The DCHI SSB supports all three DCHI branches. It is uncertain at this
time how many EIs across the states, regions, and branches will require
an expedited approval at the same time.
EI participants will likely include community members that are
concerned about being exposed to environmental contamination.
Investigations tend to focus on the most highly exposed at the site,
such as those living in proximity to the site. On occasion, small
businesses may be included as EI participants.
The estimated annual burden hours are 600, which is an increase
from the previously approved burden hours of 375 hours. The increase is
due to the addition of EIs conducted by cooperative agreement states
requiring a survey each year. There are no costs to the respondents
other than their time.
EIs are performed under the authority of the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980
(CERCLA), commonly known as the ``Superfund'' Act, as amended by the
Superfund Amendments and Reauthorization Act (SARA) of 1986.
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
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Exposure Investigation Participants. Chemical Exposure 1,200 1 30/60
Questions.
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Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013-08067 Filed 4-5-13; 8:45 am]
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