[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77880-77881]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31377]


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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: 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

[[Page 77881]]

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.

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

    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.
    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, [email protected] 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 
[email protected]. 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.
[FR Doc. 2010-31377 Filed 12-13-10; 8:45 am]
BILLING CODE 4140-01-P