Morbidity Study of Former Marines, Dependents, and Employees Potentially Exposed to Contaminated Drinking Water at USMC Base Camp Lejeune

Forms and Documents

Document Name	Status
Health Survey Form	New
attachment C survey 11_10 clean.docx Supplementary Document	2010-11-22
Supporting Statement B.11.3.10.doc Supporting Statement B	2010-11-04
Attachment Q IRB amendment.docx Supplementary Document	2010-11-04
Attachment P IRB approval.htm Supplementary Document	2010-11-04
Attachment O med rec release.doc Supplementary Document	2010-11-04
Attachment N protocol.docx Supplementary Document	2010-11-04
Attachment M consent reg.doc Supplementary Document	2010-11-04
Attachment L consent.doc Supplementary Document	2010-11-04
Attachment K telephone.docx Supplementary Document	2010-11-04
Attachment J email reminder.docx Supplementary Document	2010-11-04
Attachment H email thank you.docx Supplementary Document	2010-11-04
Attachment G postcard.docx Supplementary Document	2010-11-04
Attachment F email invite.docx Supplementary Document	2010-11-04
Attachment D prenotice.docx Supplementary Document	2010-11-04
Attachment E ltr of invitation.docx Supplementary Document	2010-11-04
Attachment B 60 day FRN.pdf Supplementary Document	2010-11-04
Attachment I reminder.docx Supplementary Document	2010-11-04
Attachment A legislation.pdf Supplementary Document	2010-11-04
Supporting statement A 11.3.10.doc Supporting Statement A	2010-11-04

IC Document Collections

IC ID	Document Title	Status
195214	Health Survey Form	New

ICR Details

OMB Control No: 0923-0042	ICR Reference No: 201011-0923-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/TSDR	Agency Tracking No:
Title: Morbidity Study of Former Marines, Dependents, and Employees Potentially Exposed to Contaminated Drinking Water at USMC Base Camp Lejeune
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: 11/22/2010
	Date Received in OIRA: 11/09/2010
Terms of Clearance: OMB approval for this collection is granted contingent upon ATSDR/CDC agreement to share the reports from the expert advisory committee with OMB and to notify OMB of ATSDR’s determination regarding how to proceed with the completion of the study (see Supporting Statement, Section B.4).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2013	36 Months From Approved
Responses	47,601	0	0
Time Burden (Hours)	35,701	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: On Jan. 28, 2008, President Bush signed H.R. 4986: National Defense Authorization Act for FY 2008 which requires ATSDR to develop a health survey of individuals possibly exposed to contaminated drinking water at Camp Lejeune that would collect: "...personal health information that may lead to scientifically useful health information associated with exposure to trichloroethylene (TCE), [tetrachloroethylene or perchloroethylene] (PCE), vinyl chloride, and the other contaminants identified in the ATSDR studies that may provide a basis for further reliable scientific studies of potentially adverse health impacts of exposure to contaminated water at Camp Lejeune." The health survey will be mailed to everyone identified as having lived or worked at Camp Lejeune during the period of drinking water contamination. This includes anyone who registers with the US Marine Corps or ATSDR and those identified by computerized databases from the Defense Manpower Data Center or ATSDR. To have an unbiased sampling frame, the morbidity study population will consist of those identified by computerized databases who lived or worked at Camp Lejeune during the period of drinking water contamination. A comparison group is randomly sampled from Marines and civilian employees who were stationed at Camp Pendleton and not at Camp Lejeune during the period of water contamination.

---

Authorizing Statute(s): PL: Pub.L. 110 - 181 315 Name of Law: National Defense Authorization Act
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 40876	07/16/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 810	01/08/2009
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Health Survey	none, None	Health Survey ,   Health Survey

---

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	47,601	0	0	47,601	0	0
Annual Time Burden (Hours)	35,701	0	0	35,701	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. Federal Register Notices were previously published for earlier versions of the study; new FRN publication was waived by OMB.

---

Annual Cost to Federal Government: $4,900,000

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? Yes

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

---

Common Form ICR:  No

---

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: 11/09/2010

---