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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 1 Registered Group	Form and Instruction	New	Repair queued
Form 1 Former Civilian Workers--Camp Pendleton	Form and Instruction	New	Repair queued
Form 1 Former Active Duty Marines and Navy Personnel--Camp Lejeune	Form and Instruction	New	Repair queued
Form 1 Former Dependents (now all adults) and former Marines Who Lived at Camp Lejeune 1999-2002	Form and Instruction	New	Repair queued
Form 1 Former Civilian Workers--Camp Lejeune	Form and Instruction	New	Repair queued
Form 1 Health Survey--Former Active Duty Marines and Navy Personnel-Camp Lejeune	Form and Instruction	New	Repair queued
support stateB OMB 4_10.doc	Supporting Statement B	Uploaded 2010-05-10	Available
Attachment A legislation.pdf	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment S IRB amendment.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment R IRB approval.htm	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment Q med rec release.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment P protocol.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment O consent reg.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment N consent.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment M invite reg.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment L prenotice reg.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment K telephone.docx	Supplementary Document	Uploaded 2010-05-10	Available
Attachment J email reminder.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment I reminder.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment H email thank you.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment G postcard.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment F email invite.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment E ltr of invitation.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment D prenotice.docx	Supplementary Document	Uploaded 2010-05-10	Available
Attachment S IRB amendment.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment R IRB approval.htm	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment Q med rec release.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment P protocol.docx	Supplementary Document	Uploaded 2010-05-10	Available
Attachment O consent reg.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment N consent.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment M invite reg.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment L prenotice reg.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment K telephone.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment J email reminder.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment I reminder.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment H email thank you.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment G postcard.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment F email invite.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment E ltr of invitation.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment D prenotice.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment S IRB amendment.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment R IRB approval.htm	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment Q med rec release.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment P protocol.docx	Supplementary Document	Uploaded 2010-05-10	Available
Attachment O consent reg.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment N consent.doc	Supplementary Document	Uploaded 2010-05-10	Available
Attachment M invite reg.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment L prenotice reg.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment K telephone.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment J email reminder.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment I reminder.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment H email thank you.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment G postcard.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment F email invite.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment E ltr of invitation.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment D prenotice.docx	Supplementary Document	Uploaded 2010-05-10	Available
Attachment S IRB amendment.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment R IRB approval.htm	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment Q med rec release.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment P protocol.docx	Supplementary Document	Uploaded 2010-05-10	Available
Attachment O consent reg.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment N consent.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment M invite reg.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment L prenotice reg.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment K telephone.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment J email reminder.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment I reminder.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment H email thank you.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment G postcard.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment F email invite.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment E ltr of invitation.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment D prenotice.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment S IRB amendment.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment R IRB approval.htm	Supplementary Document	Uploaded 2010-05-10	Available
Attachment Q med rec release.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment P protocol.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment O consent reg.doc	Supplementary Document	Uploaded 2010-05-10	Available
Attachment N consent.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment M invite reg.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment L prenotice reg.docx	Supplementary Document	Uploaded 2010-05-10	Available
Attachment K telephone.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment J email reminder.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment I reminder.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment H email thank you.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment G postcard.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment F email invite.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment E ltr of invitation.docx	Supplementary Document	Uploaded 2010-05-10	Available
Attachment D prenotice.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment S IRB amendment.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment R IRB approval.htm	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment Q med rec release.doc	Supplementary Document	Uploaded 2010-05-10	Available
Attachment P protocol.docx	Supplementary Document	Uploaded 2010-05-10	Available
Attachment O consent reg.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment N consent.doc	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment M invite reg.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment L prenotice reg.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment K telephone.docx	Supplementary Document	Uploaded 2010-05-10	Available
Attachment J email reminder.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment I reminder.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment H email thank you.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment G postcard.docx	Supplementary Document	Uploaded 2010-05-10	Available
Attachment F email invite.docx	Supplementary Document	Uploaded 2010-05-10	Available
Attachment E ltr of invitation.docx	Supplementary Document	Uploaded 2010-05-10	Repair queued
Attachment D prenotice.docx	Supplementary Document	Uploaded 2010-05-10	Available
support stateA OMB 4_10.doc	Supporting Statement A	Uploaded 2010-05-10	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
192937	Registered Group	Form and Instruction	New
192936	Former Civilian Workers--Camp Pendleton	Form and Instruction	New
192935	Former Active Duty Marines and Navy Personnel--Camp Lejeune	Form and Instruction	New
192934	Former Dependents (now all adults) and former Marines Who Lived at Camp Lejeune 1999-2002	Form and Instruction	New
192933	Former Civilian Workers--Camp Lejeune	Form and Instruction	New
192932	Health Survey--Former Active Duty Marines and Navy Personnel-Camp Lejeune	Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 201005-0923-001
Status: Historical Inactive	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 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: Withdrawn	Conclusion Date: 09/23/2010
	Date Received in OIRA: 05/18/2010
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: On January 28, 2008, President Bush signed H.R. 4986: National Defense Authorization Act for Fiscal Year 2008 requiring ATSDR to develop a health survey of individuals possibly exposed to contaminated drinking water at Camp Lejeune. The Act requires the survey to be developed within 120 days of enactment and to be conducted within one year of enactment. The health survey instrument will include questions on cancers and non-fatal diseases that can be confirmed by medical records and are known or suspected of being associated with solvent exposures (Parkinson's disease, kidney failure and other severe kidney diseases, severe liver diseases, lupus, scleroderma, multiple sclerosis, motor neuron disease/amyotrophic lateral sclerosis, infertility, endometriosis, and miscarriages). The survey will also collect information on potential risk factors. A space will also be provided so that the respondent can report other disease conditions. The collected information will be used to assign exposure status and to assess potential confounding. ATSDR plans to contact 210,000 former active duty Marines and Navy personnel; 8,000 former civilian workers; approximately 29,000 former Marines and Navy personnel and their dependents who were included in the 1999-2002 ATSDR survey; 50,000 Marines and 10,000 civilians stationed or employed at Camp Pendleton anytime during the period 1975-1985 who were never stationed at Camp Lejeune during the period of drinking water contamination; and about 50,000 who registered with the USMC who are not included in these other databases. To improve the credibility of the study, an external, unexposed comparison group, similar in all respects to the Marines and civilian workers at Camp Lejeune except for exposure to VOC-contaminated drinking water, will be included. We expect at least a 65% participation rate.

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Authorizing Statute(s): PL: Pub.L. 110 - 181 315 Name of Law: National Defense Authorization Act for Fiscal Year 2008
  

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:
	73 FR 40876	07/16/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 25859	05/10/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

table that charts list of burden

IC Title	Form No.	Form Name
Former Active Duty Marines and Navy Personnel--Camp Lejeune	1	Health Survey
Health Survey--Former Active Duty Marines and Navy Personnel-Camp Lejeune	1	Health Survey
Former Civilian Workers--Camp Lejeune	1	Health Survey
Former Dependents (now all adults) and former Marines Who Lived at Camp Lejeune 1999-2002	1	Health Survey
Former Civilian Workers--Camp Pendleton	1	Health Survey
Registered Group	1	Health Survey

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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: $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]? Uncollected

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: 05/18/2010

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