[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]
-----------------------------------------------------------------------
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