Emergency Request Memo

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
_______________________________________________________________________________________
Centers for Disease Control
and Prevention (CDC)
Atlanta GA 30341-3724

Dominic Mancini
Deputy Director
Office of Information and Regulatory Affairs
Office of Management and Budget
Washington, DC

July 14, 2017

Subject: Request for Emergency Review and Clearance
Dear Mr. Mancini:
Pursuant to Office of Management and Budget (OMB) procedures established at 5 CFR Part
1320, Controlling Paperwork Burdens on the Public, the Centers for Disease Control and
Prevention (CDC) requests that the proposed information collection project, “Zika Outcomes and
Development of Infants and Children (ZODIAC)” be processed in accordance with section
1320.13, Emergency Processing.
I have determined that this information must be collected prior to the expiration of time periods
established under Part 1320, and that this information is essential to the CDC’s mission to protect
America from health, safety and security threats, both foreign and in the U.S.
The current Zika virus disease outbreak in the Americas, first identified in March 2015 in Brazil,
has established causal links between congenital infection with Zika virus (ZIKV) and a number
of major birth defects. The unanticipated event that prompted this emergency request is the
finding that some neurologic problems associated with congenital ZIKV infection may not be
apparent at birth. Questions remain about these delayed effects and about progressive neurologic
damage in affected children. New or modified assessment tools and/or methods may be needed
to identify these sequelae of congenital ZIKV infection; specialized medical or social services
may be needed to mitigate their effect on the developing child. The proposed ZODIAC
information collection in Brazil is designed to investigate these questions, and is expected to be
completed in 3 months. The goal of this information collection is to field test new assessment
tools, adaptations of existing tools, and new methods to improve understanding of the longerterm health and developmental consequences of congenital ZIKV infection, the impact on
affected families, and their care needs.
Early intervention is critical to ensure that children with disabilities achieve their full potential.
However, to date, recommendations for care related to congenital ZIKV infection pertain to
infants only. There is no recommended set of health and developmental assessments to evaluate
children with congenital ZIKV infection older than 12 months, and to identify delayed
consequences. Some existing clinical assessment tools may be adequate for evaluating these
children, and others may not, or may have to be adapted to be clinically useful in this population
of older children with congenital ZIKV infection. In addition, parents should be assessed for
depression and stress, and field-tested data collection instruments that specifically relate to
caregivers and families of children who have been living with congenital ZIKV infection for 1224 months are not available. Assessing and quantifying the level of need for these services is a
high priority, not only for Brazil, but for other countries in the Americas, including the United
States, where ZIKV arrived later than it did in Brazil, and where the consequences for children