2010-31377. Proposed Collection; Comment Request; GuLF Worker Study: Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers

SUMMARY:

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on 7 October 2010 on pages 62132-3 and allowed 60-days for public comment. One public comment was received and addressed regarding the appropriateness and sources for funding the survey. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

5 CFR 1320.5: Reporting and Recordkeeping Requirements: Final Rule: Respondents to this collection of information are not required to respond unless the data collection instruments display a currently valid OMB control number.

Proposed Collection

Title: GuLF Worker Study: Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers. Type of Information Collection Request: New. 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.

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

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.

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 are invited on one or more of the following points: (1) 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) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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, [e-mail] or by fax to 202-395-6974, Attention: Desk Officer for NIH. To request more information on the 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.

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

Dated: December 9, 2010.

W. Christopher Long,

NIEHS, Acting Associate Director for Management, National Institutes of Health.