Justification for Non-Substantive Change

0920-1190_Change_Request_Justification_092717 JZ.docx

ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia

Justification for Non-Substantive Change

OMB: 0920-1190

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Change Request

Sept 28, 2017

Information Collection Request: “ZEN Colombia Study: Zika in Pregnant Women and Children in Colombia”

(OMB no. 0920-1190, exp. date 07/31/19)

Background and Justification

CDC is approved to collect information needed to better understand the adverse pregnancy, maternal and infant health outcomes associated with Zika Virus (ZIKV) during pregnancy and/or early infancy. This information includes multiple clinic visits to collect blood and urine, as well as interview administered questionnaires at every visit.

CDC obtained approval for information collection in July 2017 and is requesting a non-substantive modification request to add a 4 month Ages and Stages Questionnaire. This questionnaire would be in lieu of the 6 month Ages and Stages Questionnaire for infants born premature as they would not be able to meet the milestones indicated in the 6 month questionnaire. Therefore, there is no change to the estimated burden per response. CDC plans to begin administering the revised instruments as soon as we receive approval. 

In addition, minor changes have been made to the Supporting Statement A to more accurately reflect activities.

An updated Supporting Statement Part A and the 4 Month Ages and Stages Questionnaire is attached.

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