[Federal Register Volume 79, Number 13 (Tuesday, January 21, 2014)]
[Notices]
[Pages 3391-3392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-01038]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission For OMB Review; 30-Day Comment Request: Gulf Long-Term 
Follow-Up Study (GuLF STUDY)

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, 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 November 7, 2013 on pages 66945-66946 and allowed 60-days for public 
comment. No public comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment. The National 
Institute of Environmental Health Sciences (NIEHS), 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.
    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: NIH Desk Officer.
    Comment 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.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, 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.
    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.

[[Page 3392]]



                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cleanup & non-Cleanup Workers..........  Annual Recontact Questionnaire.          32,762               3           15/60          24,572           8,191
Cleanup & non-Cleanup Workers..........  Supplemental Mental Health                4,600               4           15/60           4,600           1,533
                                          Telephone Questionnaire.
Cleanup & non-Cleanup Workers..........  Follow-up Telephone                      20,000               2           30/60          20,000           6,667
                                          Questionnaire.
Cleanup & non-Cleanup Workers..........  Clinical Exam..................           4,000               1               4          16,000           5,333
--------------------------------------------------------------------------------------------------------------------------------------------------------


    Dated: January 9, 2014.
Joellen M. Austin,
Associate Director for Management.
[FR Doc. 2014-01038 Filed 1-17-14; 8:45 am]
BILLING CODE 4140-01-P