[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]


-----------------------------------------------------------------------

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.

----------------------------------------------------------------------------------------------------------------
                                     Estimated       Estimated                     Total burden      Estimated
        Activity (3-yrs)             number of     responses per   Burden hours      hours per     total burden
                                    respondents     respondent     per response     respondent         hours
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------


[[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