Supporting Statement B

Evaluation of a CDC Service Provided to Public Health Laboratories to Rapidly Identify Multidrug-Resistant Isolates of TB

OSTLTS Generic Information Collection Request

OMB No. 0920-0879

Supporting Statement – Section B

Submitted: January 3, 2011

Program Official/Project Officer

Mitchell Yakrus, MS, MPH

Microbiologist

National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)

Division of Tuberculosis Elimination

Laboratory Branch

1600 Clifton RD, MS F08, Atlanta, GA 30333

Phone: 404-639-1288

Fax: 404-639-1287

Email: [email protected]

Section B – Data Collection Procedures

Note: Statistical methods will not be used to select respondents. Section B describes data collection procedures.

1. Respondent Universe and Sampling Methods

The respondent universe will consist of 43 public health laboratories (PHL) representing 40 states, 2 cities, and Puerto Rico. To be eligible for participation, PHL must be funded by Division of Tuberculosis Elimination (DTBE) cooperative agreements and submitted isolates of Mycobacterium tuberculosis complex (MTBC) to the CDC molecular testing of drug resistance (MDDR) service. Eligible representatives include the Public Health Laboratory Director or their designee for each PHL. Due to the limited size of the potential respondent universe, it is preferable to survey all 43 potential respondents. This is the first time this data collection has been performed, but based on response rates from previous surveys of PHL, we anticipate a response rate of 80% or higher for this data collection.

Table B-1: Potential Respondent Universe

Entity	Potential Respondent	N
Public Health Laboratory	Public Health Laboratory Director or designee	43
Total Universe of Potential Respondents		43

2. Procedures for the Collection of Information

Data will be collected through both web-based survey and data collection instruments administered to the entire potential respondent universe. Respondents will also be given the choice of filling in Word versions of the instruments that can be returned by either email or fax. Eligible respondents include the State Health Laboratory Directors or their designees representing 43 PHL (N =43). PHL will be sent a data collection instrument for each isolate of MTBC submitted to the CDC MDDR service. The Reference Laboratory Team of LB will provide submitter identifier and CDC specimen identification numbers on each form to assist data collection. Respondents will need to use the electronic Laboratory Information Management System (LIMS) to obtain local DST and any other molecular results. An advance email notification (see Attachment H) will be sent to all Directors informing them of the planned survey and data collection with the the dates the instruments will be administered. A second email will be sent survey and data collection instruments attached along with instructions for completion. (See Attachment I). The survey and data collection instruments will remain open for 20 business days. Reminders will be emailed on day 10 and day 15 of the survey and data collection. Reminder phone calls will begin on day 18. Reminders will only be used for non-respondents (see Attachment J).

The survey and data collection instruments will be administered one time. Data will be collected and stored in Snap® Surveys software maintained by the LB of DTBE as respondents submit their completed surveys. Data will be transferred to Excel and SPSS for conducting basic descriptive analyses and producing data charts and tables for reporting.

3. Methods to Maximize Response Rates and Deal with Non-response

An advance survey notification email (Attachment H), survey notification email (Attachment I) and reminders by email and telephone (Attachment J) will be sent to each potential respondent to maximize response rates. Invitations to participate will stress the importance of partner participation to improve the MDDR service. The notification and emails will be sent by the Project Officer to the potential respondents. Lead staff will also make personal phone calls to non-respondents to encourage participation.

4. Test of Procedures or Methods to be Undertaken

The estimate for burden hours is based on a pilot test of both the survey and data collection instruments by nine randomly-selected Public Health Laboratory Directors or their designees from PHL who had previously submitted isolates to the MDDR testing service.

In the pilot test, the average time to complete the survey including time for reviewing instructions, gathering needed information and completing the survey, was approximately 10 minutes. Based on these results, the estimated time range for actual respondents to complete the survey is 10-15 minutes. For the purposes of estimating burden hours, the upper limit of this range (i.e., 15 minutes) is used for completion of the survey.

The estimated time to complete a data collection instrument for collecting local DST each isolate submitted to the MDDR testing service was approximately 5 minutes. Based on these results, the estimated time range for actual respondents to complete a data collection instrument for each isolate submitted to the MDDR testing service was 5-10 minutes. For purposes of estimating burden hours, the upper limit of this range (i.e., 10 minutes) is used for completion of a data collection instrument.

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

The data collection was designed by a project lead who will also collect and analyze the data. No other individuals were consulted on the statistical aspects or analysis of data from this sub-collection.

Mitchell A. Yakrus, MS, MPH

Microbiologist

CDC/OID/NCHHSTP/DTBE/LB

Phone: 404.639.1288

Email: [email protected]

LIST OF ATTACHMENTS – Section B

Note: Attachments are included as separate files as instructed.

H. Advance Survey Notification Email

I. Survey Notification Email

J. Reminders (Email and Telephone)