[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66945-66946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment request: Gulf Long-Term 
Follow-Up Study (GuLF STUDY)

    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), 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.
    Written comments and/or suggestions from the public and affected 
agencies are invited to address 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) 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.
    To Submit Comments and for Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: Dr. Dale 
P. Sandler, Chief, Epidemiology Branch, NIEHS, Rall Building A3-05, 
P.O. Box 12233, Research Triangle Park, NC 27709 or call non-toll-free 
number 919-541-4668 or Email your request, including your address to: 
[email protected]. Formal requests for additional plans and 
instruments must be requested in writing.
    Comment 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.
    Proposed Collection: Gulf Long-Term Follow-Up Study (GuLF STUDY), 
0925-0626, Expiration Date 01/31/2014--REVISION, National Institute of 
Environmental Health Sciences (NIEHS), National Institutes of Health 
(NIH).
    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 related to the Deepwater Horizon disaster, and 
to create a resource for additional collaborative research on focused 
hypotheses or subgroups. Exposures range from negligible to potentially 
significant; however, potential long-term human health consequences are 
largely unknown due to insufficient research in this area.
    The study has enrolled 32,762 participants with a range of jobs/
exposures, including participants who performed various types of clean-
up-related work (``exposed'') and other who did not (``unexposed'' 
controls). Of the 32,762 enrolled into the Full Cohort, 20,000 have 
been assigned to the Active Follow-up Sub-cohort, and 6,000 of these 
have been assigned to the Biomedical Surveillance Sub-cohort.
    In order to minimize loss to follow-up, updated contact information 
will be collected yearly for the Full Cohort. Follow-up questionnaires 
will be administered biennially to the Active Follow-up Sub-cohort to 
assess changes in health status and factors that could confound 
associations between exposures and outcomes. A supplemental mental 
health questionnaire will be administered repeatedly over a 2-year 
period to a subset of 4,600 participants in the Active Follow-up Sub-
cohort to assess mental health trajectories among those affected by the 
oil spill and utilization of mental health services in the Gulf region. 
Participants in the Biomedical Surveillance Sub-cohort will be invited 
to take part in a comprehensive research-based clinical examination. 
The clinical exam provides an opportunity to carry out more 
comprehensive clinical testing and mental health evaluations than could 
be completed during the baseline home visit. The exams will allow for a 
much more in-depth assessment of pulmonary, neurological, and mental 
health outcomes that may be associated with the Deepwater Horizon oil 
spill exposures and experiences.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 21,724.

                                                            Estimated Annualized Burden Hours
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                                                                                             Number of     Average time    Total burden
            Type of respondent                      Form/activity            Number of     responses per   per response    hour  (for 3     Annualized
                                                                            respondents     respondent      (in hours)        years)        burden hour
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Cleanup and non-Cleanup Workers...........  Annual Recontact                      32,762               3           15/60          24,572           8,191
                                             Questionnaire.
Cleanup and non-Cleanup Workers...........  Supplemental Mental Health             4,600               4           15/60           4,600           1,533
                                             Telephone Questionnaire.
Cleanup and non-Cleanup Workers...........  Follow-up Telephone                   20,000               2           30/60          20,000           6,667
                                             Questionnaire.
Cleanup and non-Cleanup Workers...........  Clinical Exam...............           4,000               1               4          16,000           5,333
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[[Page 66946]]

    Dated: October 30, 2013.
Joellen M. Austin,
Associate Director for Management.
[FR Doc. 2013-26647 Filed 11-6-13; 8:45 am]
BILLING CODE 4140-01-P