Justification for Change

Justification for Request for Approval of Non-Substantive Changes to OMB-PRA package 0923-0042 “Morbidity Study of Former Marines, Dependents, and Employees Potentially Exposed to Contaminated Drinking Water at USMC Base Camp Lejeune”

February 2012

One component of this project involves sending the health survey to people who register with the Marine Corps to receive information about the exposure to contaminated water at Camp Lejeune, referred to in the OMB-PRA package and IRB protocol as the “Registered Group”. The responses from this group will be compiled into a descriptive report, but are not part of the research component of this project. At the time the contract request and OMB package were prepared, an estimate was made of the number of people expected to register with the Marine Corps to receive the health survey. This estimate was incorrect. The number of people who registered with the Marines by June 30, 2011 and to whom ATSDR agreed to send a survey exceeded the original estimate by approximately 66,000 people.

Including these additional people in the survey is not expected to result in more respondents than previously approved by OMB for this information collection package. The response rate for the survey participants is lower than was anticipated. The actual response rate is estimated to be 27-28% when late responders are included, compared to the response rate of 40% noted in the PRA package.

ATSDR is authorized to collect 142,803 responses over the life of this package. The number of surveys received to date is approximately 77,100.If the response rate of these additional people is 40%, the total number of respondents will be approximately 103,500 which does not exceed the total number of respondents authorized by OMB for this information collection package.

ATSDR is requesting to use a modified process and modified consent document in surveying these additional registrants.

1. There will only be one mailing instead of also sending a pre-survey letter notifying them to expect the survey. Only the survey packet containing the letter of invitation, the consent document, and the survey questions will be sent.

2. The consent document and the survey instructions will be modified. The help desk and web-based survey were staffed by Westat and are no longer active, thus for these survey participants, the number to call for information about the survey will be changed to a number staffed by CDC and the web-based survey option will not be available.

The estimated cost to the government for surveying these additional people is $268,000 ($218,000 for the contractor and $50,000 for ATSDR personnel costs). This represents an increase of 1.82% in the original budget of $14,700,000.