[Federal Register Volume 75, Number 194 (Thursday, October 7, 2010)]
[Notices]
[Pages 62132-62133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-25293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for opportunity for public comment 
on proposed data collection projects, the National Institute of 
Environmental Health Sciences (NIEHS), the National Institutes of 
Health (NIH) will publish periodic summaries of proposed projects to be 
submitted to the Office of Management and Budget (OMB) for review and 
approval.
    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

[[Page 62133]]

(``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.

----------------------------------------------------------------------------------------------------------------
                                     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).......................
 
 
    Passive Cohort Total          ..............               4  ..............            1.25  ..............
     responses & hrs............
    Active Cohort Total           ..............               5  ..............            4.25  ..............
     responses & hrs............
                                 -------------------------------------------------------------------------------
    Total responses & avg hrs     ..............               9  ..............            0.58         156,000
     per response...............
                                 -------------------------------------------------------------------------------
        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 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 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.

FOR FURTHER INFORMATION CONTACT: 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 
<a href="/cdn-cgi/l/email-protection#c3b0a2ada7afa6b183adaaa6abb0edadaaabeda4acb5"><span class="__cf_email__" data-cfemail="f182909f959d9483b19f98949982df9f9899df969e87">[email protected]</span></a>. Include your address.
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.

    Dated: September 29, 2010.
W. Christopher Long,
NIEHS, Acting Associate Director for Management, National Institutes of 
Health.
[FR Doc. 2010-25293 Filed 10-6-10; 8:45 am]
BILLING CODE 4140-01-P


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