Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers (NIEHS)

Forms and Documents

Document Name	Status
Form 1 Gulf Study Participants Form and Instruction	New
GuLFOMBpart1wkshtREVISEDfinal20110114.doc Supplementary Document	2011-01-21
GuLFOMBattachment22NEWQuestionnaire_Sources20110120.xls Supplementary Document	2011-01-21
GuLFOMBattachment21NEWAppendix_V_-_Participant_Remuneration_Receipt_Form.pdf Supplementary Document	2011-01-21
GuLFOMBattachment20NEWAppendix_U_-_Environmental_Monitoring_Data.pdf Supplementary Document	2011-01-21
GuLFOMBattachment19NEWAppendix_T_-_Active_Follow-up_Sub-cohort_Home_Visit_Instructions_for_Urine_Collection.pdf Supplementary Document	2011-01-21
GuLFOMBattachment18NEWAppendix_S_-_Active_Follow-up_Sub-cohort_Home_Visit_Instructions.pdf Supplementary Document	2011-01-21
GuLFOMBattachment17NEWAppendix_R_-_Active_Follow-up_Sub-cohort_Pre-visit_Appointment_Cover_Letter.pdf Supplementary Document	2011-01-21
GuLFOMBattachment16DELETED.pdf Supplementary Document	2011-01-21
GuLFOMBattachment15REVISEDAppendix_Q_-_Report_to_Participants_-_Abnormal_Mailed_Follow-up.pdf Supplementary Document	2011-01-21
GuLFOMBattachment14REVISEDAppendix_P_-_Report_to_Participants_-_Normal_Mailed_Follow-up.pdf Supplementary Document	2011-01-21
GuLFOMBattachment13REVISEDAppendix_O_-_Physician_Notification_Letter.pdf Supplementary Document	2011-01-21
GuLFOMBattachment12REVISEDAppendix_N_-_Report_to_Participants_-_Referral_Guide.pdf Supplementary Document	2011-01-21
GuLFOMBattachment11REVISEDAppendix_M_-_Participant_Blood_Pressure_Report_-_In-Home.pdf Supplementary Document	2011-01-21
GuLFOMBattachment10REVISEDAppendix_L_-_Report_to_Participants_-_In-Home.pdf Supplementary Document	2011-01-21
GuLFOMBattachment9REVISEDAppendix_K_-_Oil_Spill_Work_History_Form.pdf Supplementary Document	2011-01-21
GuLFOMBattachment6REVISEDAppendix_H_-_Frequently_Asked_Questions.pdf Supplementary Document	2011-01-21
GuLFOMBattachment5REVISEDAppendix_G_-_Brochure.pdf Supplementary Document	2011-01-21
GuLFOMBattachment4REVISEDAppendix_F_-_Lead_Letter_-v2.pdf Supplementary Document	2011-01-21
GuLFOMBattachment3REVISEDAppendix_E_-_Informed_Consent_Quick_Reference_Guide_-_Post_Dec_IRB.pdf Supplementary Document	2011-01-21
GuLFOMBattachment2REVISEDAppendix_D_-_Informed_Consent_Form-Post_Dec_IRB-v2.pdf Supplementary Document	2011-01-21
GuLFOMBattachment1SUPP-Appendix_C_-_Lab_Processing_Flow_Sheet_and_Template_for_Specimen_Collection.pdf Supplementary Document	2011-01-21
GuLFOMBattachment1SUPP-Appendix_B_-_Schedule_of_Procedures_and_Evaluations.pdf Supplementary Document	2011-01-21
GuLFOMBattachment1SUPP-Appendix_A_Scientific_References.pdf Supplementary Document	2011-01-21
GuLFOMBattachment1REVISEDProtocol_-_Post_Dec_IRB_-_Final20101221.pdf Supplementary Document	2011-01-21
GuLFOMBsuppstBrevised20110120.pdf Supporting Statement B	2011-01-21
GuLFOMBattachment13physicianV2.pdf Supplementary Document	2010-12-09
GuLFOMBattachment12referralV2.pdf Supplementary Document	2010-12-09
GuLFOMBattachment2consentV2.pdf Supplementary Document	2010-12-09
GuLFOMBattachment16protocolVer2appABC.pdf Supplementary Document	2010-12-08
GuLFOMBattachment15abnormal.pdf Supplementary Document	2010-12-08
GuLFOMBattachment14normal.pdf Supplementary Document	2010-12-08
GuLFOMBattachment11bp.pdf Supplementary Document	2010-12-08
GuLFOMBattachment10homerep.pdf Supplementary Document	2010-12-08
GuLFOMBattachment7enrollqx.pdf Supplementary Document	2010-12-08
GuLFOMBattachment6faq.pdf Supplementary Document	2010-12-08
GuLFOMBattachment5brochure.pdf Supplementary Document	2010-12-08
GuLFOMBattachment4leadletter.pdf Supplementary Document	2010-12-08
GuLFOMBattachment3consentguide.pdf Supplementary Document	2010-12-08
GuLFOMBattachment1protocolVer1.pdf Supplementary Document	2010-12-08
GuLFOMBsuppstArevised20110120.pdf Supporting Statement A	2011-01-21

IC Document Collections

IC ID	Document Title	Status
195744	Gulf Study Participants Form and Instruction	New

ICR Details

OMB Control No: 0925-0626	ICR Reference No: 201012-0925-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers (NIEHS)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/21/2011
	Date Received in OIRA: 12/17/2010
Terms of Clearance: 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.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2014	36 Months From Approved
Responses	55,000	0	0
Time Burden (Hours)	52,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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).

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 62132	10/07/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 77880	12/14/2010
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Gulf Study Participants	1, 2	Enrollment ,   Baseline

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	55,000	0	0	55,000	0	0
Annual Time Burden (Hours)	52,000	0	0	52,000	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new ICR.

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Annual Cost to Federal Government: $6,800,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 12/17/2010

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