Justification for Change

Justification for Change.docx

Gonococcal Isolate Surveillance Project

Justification for Change

OMB: 0920-0307

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Justification for the Change

OMB 0920-0307

Requested change: The variable SPC on Forms 2 and 3 (and SPCTINO in the data dictionary) will be changed to GEN and the response codes will change.

Form

Current Item

Requested Change

2

SPC

This variable name will be changed to GEN


The response codes will change from “1” or “2” to “1.0”, “2.0”, “4.0”, “8.0”, “16.0”, or “32.0”

3

SPC

This variable name will be changed to GEN


The response codes will change from “1” or “2” to “1.0”, “2.0”, “4.0”, “8.0”, “16.0”, or “32.0”



Justification for the Change: The Gonococcal Isolate Surveillance Project conducts public health surveillance on antimicrobial susceptibility of Neisseria gonorrhoeae. To provide the most useful and actionable surveillance data and to keep pace with changes in gonorrhea treatment practices, the Gonococcal Isolate Surveillance Project (GISP) occasionally has to update the antimicrobial agents tested in GISP. N. gonorrhoeae susceptibility to spectinomycin has been tested in GISP since 1987. However, spectinomycin is no longer available in the United States. An antibiotic regimen that includes gentamicin, an antimicrobial similar to spectinomycin but that is widely available in the United States, was recently found to be effective for gonorrhea treatment and is likely to be recommended as alternative therapy in the upcoming CDC STD Treatment Guidelines update. In GISP, we will replace testing for spectinomycin (SPC) susceptibility with testing for gentamicin (GEN) susceptibility. Thus, the variable SPC on Forms 2 and 3 will be changed to GEN. Spectinomycin susceptibility is coded as SPCTINO in the data dictionary – this will be also be changed to GEN. The response codes will also need to change to reflect the possible gentamicin susceptibility results: rather than 1=sensitive or 2=resistant, the acceptable response codes will be 1.0, 2.0, 4.0, 8.0, 16.0, or 32.0.

Effect of proposed change on the burden and/or respondents: None.

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorBob Kirkcaldy
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File Created2021-01-27

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