GuLFOMBpart1wkshtREVISEDfinal20110114

PAPERWORK REDUCTION ACT SUBMISSION WORKSHEET

Part I: Information Collection Request

This template is intended for staff without an ICRAS account. Please fill out and submit to the appropriate Operating Division to enter into ICRAS. The form mirrors the screens available in the ICRAS 4 system. To request an account to log into ICRAS.

Instructions for filling out the form are available at www.paperworkreduction.gov.

1. Agency/Subagency originating request

NIH/NIEHS

2. Title:

GuLF Study: Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers

3. Type of information collection (check one)

(See instructions)

X New collection (Request for a new OMB Control Number)

Extension without change of a currently approved collection

Revision of a currently approved collection

Reinstatement without change of a previously approved collection

Reinstatement with change of a previously approved collection

Nonmaterial or nonsubstantive change to a currently approved collection (formerly 83C)

Existing collection in use without and OMB Control Number

4. OCN: ____________

5. Type of review requested (check one)

a. X Regular

b. __ Emergency - Approval requested by:

c. Delegated

If Emergency, please attach justification.( 4000 characters maximum)

6. Requested expiration date (check one)

a. X Three years from approval date

b. __ Six Months from approval date (Maximum for Emergency reviews)

3. Other
   

Specify: / (mm/yy)
or Number of Months from Approval Date

7. Abstract (2000 characters maximum, attach additional sheets as necessary)

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~24,000) or a Passive Follow-up Cohort (N~31,000). Exposures will be estimated using detailed job-exposure matrices developed from data from monitoring performed by different agencies and organizations during the crisis, information obtained by interview, and the available scientific literature. We will investigate acute health effects via self-report from the enrollment interview among all cohort members, and via clinical measures and biological samples from Active Follow-up Cohort members. All cohort members will be followed for development of a range of health outcomes through record linkage (cancer, mortality) and possibly through linkage with routinely collected health surveillance data (collected by health departments and the CDC) or linkage to electronic medical records that may become available during the course of follow-up. Recruitment of subjects should begin in late 2011, with the telephone interviews and the baseline home visits within 24 months.

8. Authorizing Statute(s)

Public Law:

Congress Number	Sequence Number	Section	Name

US Code:

Title	Section	Name
42	281	PUBLIC HEALTH SERVICE

Executive Order:

Number	Name

Statute:

Title	Subtitle

9. Associated Rulemaking Information Stage of Rulemaking (check one) Federal Register Citation

RIN: - a. Proposed Rule Volume Page number ____________
Publication Date / /____

b. Interim Final or Final Rule

For a Proposed Rule, OMB will not consider an ICR complete until the Notice of Proposed Rulemaking has been published.

For a Final Rule, please put the ICR reference number for the ICR reviewed at the proposed rule stage in Box 4.

For ICRs associated with Interim Final or Final rules that are not significant under EO

10. Federal Register Notices & Comments

Federal Register Citation

60-day Notice: Volume 7 5 Page number 6 2 1 3 2 Publication Date 10 / 07 / 2010

30-day Notice: Volume Page number Publication Date / /

Did the Agency receive public comments on this ICR? _Yes XNo

Unless submitted as an Emergency or Associated with Rulemaking, OMB will not consider an ICR complete until the 30-day notice has been published.
12866, please attach a draft of the Federal Register document.

11. Annual Cost to Federal Gov:

$ $6,800,000

14. Agency contact: LEAVE BLANK

Name:

Phone:

E-mail:

12. Does this ICR contain surveys, censuses, or employ statistical methods?

X Yes No

13. Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?

Yes X No

PAPERWORK REDUCTION ACT SUBMISSION WORKSHEET

Part I: Information Collection Request (continued)

Information Collection Budget (ICB)

If a change in burden is due to a Program Change Due to New Statute, identify the Citations for New Statutory Requirements:

Public Law:

Congress Number	Sequence Number	Section	Name

US Code:

Title	Section	Name

Executive Order:

Number	Name

Statute:

Title	Subtitle

If Program Change is due to Agency Discretion, please categorize the reduction. Burden reduction from (select one):

a. Cutting Redundancy
b. Using Information Technology
c. Changing Regulations
d. Changing Forms
e. Miscellaneous Actions

If Program Change is due to Agency Discretion, please categorize the increase in burden. Burden increase caused by (select one):
a. Changing Regulations
b. Miscellaneous Actions

Explain the reasons for any program changes or adjustments reported; that is, provide a short statement how the reduction in burden was achieved or why the increase in burden occurred. (If you need more space, please provide a short summary here and elaborate in the Supporting Statement.)

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