2010-29944. 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 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.

Activity (3-yrs)	Estimated number of respondents	Estimated responses per respondent	Burden hours per response	Total burden hours per respondent	Estimated total burden 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 (Passive)	28,000	3	0.25	0.75	21,000
Annual Contact Info Update (Active)	27,000	2	0.25	0.50	13,500
Biennial interview (Active)	27,000	1	0.50	0.50	13,500
Passive Cohort Total responses & hrs		4		1.25
Active Cohort Total responses & hrs		5		4.25
Total responses & avg hrs per response		9		0.58	156,000
Average per year					52,000

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 × 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 [e-mail]. 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.