[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73112-73114]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29944]
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HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Environmental Health Sciences; Notification
of Request for Emergency Clearance; GuLF Study: Gulf Long-term Follow-
up Study for Oil Spill Clean-Up Workers and Volunteers
In accordance with Section 3507(j) of the Paperwork Reduction Act
of 1995, the National Institutes of Health (NIH) hereby publishes
notification of request for Emergency Clearance for the information
collection related to the GuLF Study: Gulf Long-term Follow-up Study
for Oil Spill Clean-Up Workers and Volunteers.
This information collection is essential to the mission of NIEHS
(42 U.S.C. 285l), which is to conduct and support research, training,
health information dissemination, and other programs with respect to
factors in the environment that affect human health, directly or
indirectly. Through this mission, the NIEHS has a mandate to study the
environmental impact on individuals of natural and man-made
catastrophes and the long term health effects of these incidents. The
Deepwater Horizon disaster, with its release of approximately 5 million
barrels (~ 680,000 tons) of crude oil into the Gulf of Mexico,
represents the largest oil spill in U.S. history. Given the magnitude
of this spill and the scope of the potential exposures--over 100,000
persons have completed safety training in preparation for participation
[[Page 73113]]
in clean-up activities related to the spill--study of the human health
effects of this spill is urgently needed to monitor gulf clean-up
workers and to understand the adverse consequences of oil spills in
general.
Close ongoing community engagement will enhance scientific validity
of the study, make it more broadly relevant from a public health
perspective, and expand its benefits to the affected communities. We
have established contacts with community organizations, representative
worker organizations, advocacy groups, and State and local governments
to identify the primary health issues of concern locally and to discuss
study implementation issues across the five State area. Further, we
will identify Community Outreach Coordinators to organize and implement
outreach activities in each of the Gulf States. In addition to the
continuing efforts with public health and community group
representatives, we have been conducting and will continue webinars,
dockside chats, and phone and in-person briefings with key stakeholder
groups and health departments.
NIEHS cannot reasonably comply with the normal clearance procedures
to initiate this information collection, because the use of normal
procedures will delay the collection and hinder the agency in
accomplishing its mission, to the detriment of the public good.
Compelling reason exists to collect the required information at the
earliest opportunity in order to capture information that may be lost
with passage of time and to initiate contact with the workers and
populations exposed to the effects of the spill.
The information to be obtained by this survey will provide the
NIEHS, the U.S. government and the private sector with information on
potential short- and long-term human health effects associated with
clean-up and disposal activities surrounding the Deepwater Horizon oil
spill in the Gulf of Mexico. Health areas of interest include, but are
not limited to, respiratory, cardiovascular, hematologic, dermatologic,
neurologic, cancer, reproductive, mental health, substance abuse,
immunologic, hepatic, and renal effects. The study will investigate
biomarkers of potentially adverse biological effect, including DNA
damage, aberrant epigenetic profiles, and alterations in gene
expression, some of which have been observed in previous studies of oil
spill clean-up workers. The study will create a resource for additional
collaborative research on specific scientific hypotheses or on
subgroups of interest, and work with external scientists to facilitate
nested sub-studies within the existing cohort to examine outcomes and
exposure subgroups of interest; and create a resource to better
understand the short and long-term human health effects of oil and oil
dispersants in the environment.
Proposed Collection: Title: GuLF Study: Gulf Long-term Follow-up
Study for Oil Spill Clean-Up Workers and Volunteers. Type of
Information Collection Request: Emergency. Need and Use of Information
Collection: The purpose of the GuLF Study is to investigate potential
short- and long-term health effects associated with oil spill clean-up
activities and exposures surrounding the Deepwater Horizon disaster;
and to create a resource for additional collaborative research on
focused hypotheses or subgroups. Over 55,000 persons participating in
oil-spill clean-up activities have been exposed to a range of known and
suspected toxins in crude oil, burning oil, and dispersants, to
excessive heat, and possibly to stress due to widespread economic and
lifestyle disruption. Exposures range from negligible to potentially
significant, however, potential long-term human health consequences are
largely unknown due to insufficient research in this area. Participants
will be recruited from across job/exposure groups of primarily English,
Spanish, or Vietnamese speaking adults (accommodations for other
languages developed as appropriate) who performed oil-spill clean-up-
related work (``exposed'') and similar persons who did not
(``unexposed'' controls), and followed in either an Active Follow-up
Cohort (N~27,000) or a Passive Follow-up Cohort (N~28,000). Exposures
will be estimated using detailed job-exposure matrices developed from
data from monitoring performed by different agencies and organizations
during the crisis, information obtained by interview, and the available
scientific literature. We will investigate acute health effects among
all cohort members via self-report from the enrollment interview, and
via clinical measures and biological samples from Active Follow-up
Cohort members only. All cohort members will be followed for
development of a range of health outcomes through record linkage (e.g.,
cancer, mortality) and possibly through linkage with routinely
collected health surveillance data (collected by health departments and
the CDC) or with electronic medical records. Recruitment of subjects
should begin in late 2010, with telephone interviews and the baseline
home visits conducted within 18 months.
Frequency of Response: Participation will include one enrollment
telephone interview (0.5 hr); collection of biological and
environmental samples, basic clinical measurements, and GPS coordinates
(2.75 hr) from the Active Follow-up Cohort only; annual contact
information update (0.25; Active and Passive) or biennial follow-up
telephone or Web interviews (0.5 hr; Active only) for 10 years or more.
We also anticipate screening 25,000 ineligible respondents. Affected
Public: Individuals or households. Type of Respondents: Workers
involved in Deepwater Horizon disaster clean-up, and similar
individuals not involved in clean-up effort. The annual reporting
burden is as follows: Estimated Number of Respondents: Active Follow-up
Cohort (N~27,000) and Passive Follow-up Cohort (N~28,000). Estimated
Number of Responses per Respondent: See table.
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Estimated Estimated Total burden Estimated
Activity (3-yrs) number of responses per Burden hours hours per total burden
respondents respondent per response respondent hours
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Ineligible respondents.......... 25,000 1 0.25 0.25 6,250
Enrollment interview (All)...... 55,000 1 0.50 0.50 27,500
Home Visit (Active)............. 27,000 1 2.75 2.75 74,250
Annual Contact Info Update 28,000 3 0.25 0.75 21,000
(Passive)......................
Annual Contact Info Update 27,000 2 0.25 0.50 13,500
(Active).......................
Biennial interview (Active)..... 27,000 1 0.50 0.50 13,500
Passive Cohort Total .............. 4 .............. 1.25 ..............
responses & hrs............
Active Cohort Total .............. 5 .............. 4.25 ..............
responses & hrs............
Total responses & avg .............. 9 .............. 0.58 156,000
hrs per response.......
Average per year.... .............. .............. .............. .............. 52,000
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[[Page 73114]]
Average Burden Hours per Response: 0.58 hour; and Estimated Total
Burden Hours Requested: 156,000 (over 3 years). The average annual
burden hours requested is 52,000. The annualized cost to respondents is
estimated at $11.60 (assuming $20 hourly wage x 0.58 hour). There are
no Capital Costs to report. There are no Operating or Maintenance Costs
to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address one or more of the
following points: (1) Evaluate whether the proposed collection of
information is necessary for the proper performance of the function of
the agency, including whether the information will have practical
utility; (2) Evaluate the accuracy of the agency's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) Enhance the
quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who
are to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, New Executive Office Building, Room 10235, Washington, DC
20503, Attention: Desk Officer for NIH. To request more information on
the proposed project or to obtain a copy of the data collection plans
and instruments, contact: Dr. Dale P. Sandler, Chief, Epidemiology
Branch, NIEHS, Rall Building A3-05, PO Box 12233, Research Triangle
Park, NC 27709; non-toll-free number 919-541-4668 or E-mail
[email protected]. Include your address.
By publication of this request of this request for emergency
review, the NIEHS is requesting the approval for this collection. In
view of the urgent public priority to initiate the study at the
earliest opportunity in the wake of a public emergency, NIEHS requests
that the collection of information be approved within 14 days of the
publication of the Federal Register notice. This will allow sufficient
time for public comment.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 10 days
of the date of this publication.
Dated: November 18, 2010.
W. Christopher Long,
NIEHS, Acting Associate Director for Management, National Institutes of
Health.
[FR Doc. 2010-29944 Filed 11-26-10; 8:45 am]
BILLING CODE 4140-01-P