30dy0808AB draft

Billing Code: 4163-18-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-08-08AB]

Agency Forms Undergoing Paperwork Reduction Act Review

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639-5960 or send an email to omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 395-6974. Written comments should be received within 30 days of this notice.

Proposed Project

All Age Influenza Hospitalization Surveillance (Flu Hosp)– New - National Center for Immunization and Respiratory Diseases (NCIRD) Centers for Disease Control and Prevention (CDC).

Background and Brief Description

The data collection network is an established CDC-state-academic institution collaborative network, the Emerging Infections Program (EIP) which includes defined catchment areas in the states of California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee. From October 1 through April 30(flu season), Flu Hosp sites will collect data in selected catchment areas using case report forms. Participating sites will also complete discharge audit forms following flu season.

A standardized case report form will be completed for all persons meeting the case definition and inclusion criteria in the selected catchment areas. Most of the case report forms can be completed using data obtained from the laboratory and medical chart review. If the medical chart is not available, or the necessary information is not included in the medical record, the patient or their proxy may be interviewed.

To address any limitation in completeness of case identification, a retrospective discharge audit will be conducted by each participating site following flu season. Based on a range of discharge diagnoses, persons aged ≥ 18 years who are residents of a geographically-defined area and who were admitted to hospitals during October 1, 2007 through April 30, 2008, will have their medical chart examined to identify whether they had an influenza positive test result at the beginning of their hospitalization. The discharge audit will determine if cases were missed by usual case ascertainment methods. The completeness evaluation is a matching (or linking) project, followed by chart abstraction of missed cases.

The need for the information and proposed use(s) of the information are necessary because currently there is no national surveillance system in place that is able to estimate the burden of laboratory-confirmed adult hospitalizations during seasonal or pandemic influenza within a given season. Additionally, because influenza is often underreported, including a retrospective discharge audit in addition to conducting prospective surveillance is needed to identify limitations in current surveillance efforts.

The ”respondents” for each of the forms are the 10 state health departments who submit biweekly case report forms for pediatric and adult influenza surveillance, and who submit discharge audit forms to CDC. “Responses” for the case report forms indicate the number of cases that are identified. The number of “responses” for all case report forms must be estimated as we do not know before hand how many cases will occur. Respondents are required to submit data for the Adult Flu Hosp project and the Pediatric Influenza Project to the CDC bi-weekly during flu season.

“Responses” for Discharge Audit forms A-D indicate the number of times each site is required to fill out the respective form. Data for the Discharge audit will be a one-time data collection for each case. Although 10 states participate in Flu Hosp, because New York includes two functionally and geographically different catchment areas, those two areas will submit individual discharge audit data, to make a total of 11 respondents.

There are no costs to respondents other than their time. The total estimated annualized burden is 508 hours.

Estimated Annualized Burden Hours

Form Name	Type of Respondent	No. of respondents	Number of responses per respondent	Avg. burden per response (in hours)
Pediatric Influenza Hospitalization Surveillance Project Case Report Form	Health Department	10	75	15/60
Adult Influenza Hospitalization Surveillance Project Case Report Form	Health Department	10	120	15/60
Adult Discharge Audit Case Report Form	Health Department	11	3	15/60
Adult Discharge Audit Form A: Description of Matching Method	Health Department	11	1	15/60
Adult Discharge Audit Form B: Sampling Strategy	Health Department	11	1	15/60
Adult Discharge Audit Form C: Summary	Health Department	11	1	15/60
Adult Discharge Audit Form D: Future	Health Department	11	1	15/60

DATE:

______________________________________

Maryam I. Daneshvar, PhD

Acting Reports Clearance Officer

Centers for Disease Control and Prevention