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

Forms and Documents

Document Name	Status
Form 2 Clinical Exam Form	New
Form 1 Follow-up Telephone Questionaire Form and Instruction	New
Form 1 Supplemental Mental Health Telephone Questionaire Form and Instruction	New
Form 1 Annual Recontact Questionaire Form and Instruction	Modified
GuLF Supporting Statement B 102213.docx Supporting Statement B	2014-01-29
Att_35 IRB Approval Suppl Mental Health Questionnaire.pdf Supplementary Document	2014-01-27
Att_34 IRB Approval Biomedical Exams.pdf Supplementary Document	2014-01-27
Att_33 IRB Approval Followup Telephone Interviews.pdf Supplementary Document	2014-01-27
Att_32 IRB Approval Annual Recontact.pdf Supplementary Document	2014-01-27
Att_31 IRB Approval 2013 Continuing Review.pdf Supplementary Document	2014-01-27
Att_29 Certificate of Confidentiality.pdf Supplementary Document	2014-01-27
Att_30 HHS Privacy Impact Assessment.pdf Supplementary Document	2014-01-27
Att_01 GuLF STUDY Protocol V20.0_07192013.pdf Supplementary Document	2014-01-27
Att_23 Clinic Exam Saliva Collection General Instructions.pdf Supplementary Document	2014-01-29
Att_22 Clinic Exam Pulmonary Function Result Form.pdf Supplementary Document	2014-01-29
Att_21 Clinic Exam Heart Rate Results Form.pdf Supplementary Document	2014-01-29
Att_20 Clinic Exam Hemoglobin Results Form.pdf Supplementary Document	2014-01-29
Att_19 Clinic Exam Cholesterol Results Form.pdf Supplementary Document	2014-01-29
Att_18 Clinic Exam Body Mass Index Results Form.pdf Supplementary Document	2014-01-29
Att_17 Clinic Exam Blood Pressure Results Form.pdf Supplementary Document	2014-01-29
Att_14 Clinic Exam Frequently Asked Questions.pdf Supplementary Document	2014-01-29
Att_13 Clnic Exam Informed Consent Summary.pdf Supplementary Document	2014-01-29
Att_12 Clinic Exam Visit Confirmation Letter.pdf Supplementary Document	2014-01-29
Att_11 Clinic Exam Scheduling Script.pdf Supplementary Document	2014-01-29
Att_10 Clinic Exam Invitation Letter.pdf Supplementary Document	2014-01-29
Att_04 Follow-up Questionnaire Summary of Changes.pdf Supplementary Document	2014-01-29
Att_02 Follow-up Lead Letter.pdf Supplementary Document	2014-01-29
Att_07 Supplemental Mental Health Questionnaire Thank You Letter.pdf Supplementary Document	2014-01-29
Att_05 Supplemental Mental Health Telephone Script.pdf Supplementary Document	2014-01-29
Att_08 Annual Recontact Request Letter.pdf Supplementary Document	2014-01-29
GuLF Supporting Statement A 20140326.doc Supporting Statement A	2014-03-27

IC Document Collections

IC ID	Document Title	Status
210241	Clinical Exam Form	New
210240	Follow-up Telephone Questionaire Form and Instruction	New
210239	Supplemental Mental Health Telephone Questionaire Form and Instruction	New
195744	Annual Recontact Questionaire Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0626	ICR Reference No: 201401-0925-009
Status: Historical Active	Previous ICR Reference No: 201012-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No: 21343
Title: Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers (NIEHS)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/07/2014
	Date Received in OIRA: 01/31/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2017	36 Months From Approved	04/30/2014
Responses	160,686	0	55,000
Time Burden (Hours)	65,172	0	52,000
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 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 four times 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.

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Authorizing Statute(s): US Code: 42 USC 281 Name of Law: Public Health Service Act
  

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:
	78 FR 66945	11/07/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 3391	01/21/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Annual Recontact Questionaire	1	Annual Recontact Questionaire
Supplemental Mental Health Telephone Questionaire	1	Supplemental Mental Health Questionnaire
Follow-up Telephone Questionaire	1	Active Follow-up Sub-cohort
Clinical Exam	1, 2, 3, 4	Clinical Exam Saliva Collection Log ,   Clinical Exam Questioniare ,   Clinical Exam Mental Health Questionnaire ,   INFORMED CONSENT FORM

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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	160,686	55,000	0	62,400	43,286	0
Annual Time Burden (Hours)	65,172	52,000	0	40,600	-27,428	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 revision and continuation is a program change due to agency discretion and represents the estimated burden for the first three years of the follow-up phase of the GuLF STUDY. The primary objectives of the GuLF STUDY continue to be the assessment of a wide range of potential short- and long-term human health effects associated with clean-up and disposal activities surrounding the Deepwater Horizon oil spill in the Gulf of Mexico.

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Annual Cost to Federal Government: $5,838,740

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: 01/31/2014

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