Non-Substantive Change Request Memo July2022

Non-Substantive Change Request to OMB Control Number 0920-0009

Submission Date: 07/29/2022

CDC requests approval for a non-substantive change to OMB Control No. 0920-00009:

National Disease Surveillance Program - I. Case Reports.

The current ICR covers surveillance activities for Creutzfeldt-Jakob Disease (CJD), Reye Syndrome, Kawasaki syndrome and Acute Flaccid Myelitis (AFM). CDC is requesting a non-substantive change request for the Acute Flaccid Myelitis Patient Summary Form only. The overall changes to the form are minimal, therefore the estimates of annualized burden hours remain the same.

Justification for changes:

The enteroviruses responsible for acute flaccid myelitis (AFM) are different from poliovirus but are within the same virus family (Picornaviridae). Both AFM and polio can cause acute flaccid weakness that appears clinically similar and initially hard to distinguish without the additional data such as travel and polio vaccination history and testing of clinical specimens.

Wild poliovirus was eliminated in the United States in 1979, and the last imported case occurred in 1993; however with disruptions and temporary suspension of many routine vaccination programs worldwide during the COVID-19 pandemic, ongoing challenges to public health and health care infrastructure, and international travel restrictions lifted, polio remains a threat in other parts of the world and an increased vigilance for possible cases of polio and rapid detection of polio into the US is critical.

On July 21, 2022 NYS Health Department confirmed a case of polio in an unvaccinated individual.  This case was initially reported through the national AFM surveillance system which underscores the importance of collecting travel history and polio vaccination history in any suspected AFM case.

Paralytic polio has been classified as “Immediately notifiable, Extremely Urgent,” which requires that local and state health departments contact CDC within 4 hours.

Non-paralytic polio has been classified as “Immediately notifiable, Urgent,” which requires that local and state health departments contact CDC within 24 hours.

Burden:

The overall changes to the form are minimal, therefore the estimates of annualized burden hours for this change request will remain the same as the current OMB approval.

The burden estimate for the Acute Flaccid Myelitis (AFM) Patient Summary Form included in OMB Control No. 0920-0009 is 80 hours.

Type of Respondents	Form Name	No. of Respondents	No. of Responses per Respondent	Avg. Burden per Response (Hours)	Total Burden (Hours)
Epidemiologist	Acute Flaccid Myelitis (AFM) Patient Summary Form	100	4	12/60	80
Total (Hours)					80

Description of Changes to forms that do not pose burden to the public

• New questions have been added (Question 28 and 28a) to collect information on patient travel history 30 days before the onset of limb weakness.

• New questions have been added (questions 29, 29a, 29b, and 29c) to collect information on patient polio vaccination history including the number of doses.

• Original questions 28-43 have been renumbered to reflect the addition of new questions (questions: 28, 28a, 29, 29a, 29b, and 29c)

• The instruction for Acute Flaccid Myelitis outcome follow-up for 6 months and 12 months have been deleted. The follow-up form will only need to be completed at 60 days.  

• The websites for “CSTE’s Revision to the Standardized Case Definition, Case Classification, and Public Health Reporting for Acute Flaccid Myelitis” has been updated with the correct web link.