Justification for Change

Biomonitoring of the Great Lakes Populations Program:

Circumstances of Change Request for OMB #0923-0044

This is a nonmaterial/non-substantive change request for OMB protocol #0923-0044 (expiration date: October 31, 2015). OMB approval was granted for data collection for a cooperative agreement program involving three state health departments (Michigan Department of Community Health, New York State Department of Health and Minnesota Department of Health).

We are requesting to increase the number of study participants from 100 to 200 only in the target population of refugees and immigrants from Burma and their descendants who live in the City of Buffalo, New York and who eat fish caught in local areas of concern.

In the Supporting Statement B, our enrollment goal for the Burmese target population was a minimum of 100 persons due to budgetary concerns. Burden estimates and sample, power calculations were based on 100 respondents. Now that data collection is in progress, the New York State Department of Health determined that an additional 100 respondents for the Burmese target population is feasible. This request to double the sample size will result in a methodological desirable increase in the power of the NYDOH program to detect a significant difference in contaminant levels between the Burmese target population and NHANES levels (Table 7).

Attached please find revised Supporting Statements A and B which incorporate the requested burden estimates, the requested burden costs, and new power calculations according to the requested target sample size of 200 Burmese respondents.

There is no requested change to the respondent driven sampling methodology or information collection instruments. The NYS DOH is in its data collection phase and rapidly moving towards the original enrollment goal of 100. The respondent driven sampling method would benefit from continuity in enrollment. As such, we would appreciate your expedited consideration of this request.