OMB approves the version of protocol,supporting documents, and ICs that were revised per IRB (December) and OMB (January) comments, with the exception of the consent form for the home visit. NIH should resubmit the consent form, responding to OMB concerns about clarity, as well as the translated versions of the study materials and the yet to be developed publicity materials, as non-substantive changes as soon as each are available. NIH should discuss with OMB whether additional projects (add-on studies including the bio-specimen cohort) are subject to approval under the PRA.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
01/31/2014
36 Months From Approved
55,000
0
0
52,000
0
0
0
0
0
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 secondarily 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 stress due to widespread economic and lifestyle disruption . Exposures range from negligible to potentially significant, however, the potential long-term human health consequences are largely unknown due to a dearth of 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 engaged in no clean-up-related work ("unexposed" controls), and followed in either an Active Follow-up Cohort (N~27,000) or a Passive Follow-up Cohort (N~28,000).
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Gulf Study Participants