Justification for Change

Attachment 1_2009 OMB ABCs forms justification_KM_KAT.doc

Active Bacterial Core Surveillance (ABCs)

Justification for Change

OMB: 0920-0802

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Active Bacterial Core Surveillance (ABCs)



Background

The National Center for Immunization and Respiratory Diseases (NCIRD) of the Centers for Disease Control and Prevention (CDC) is requesting approval of changes to three data collection forms that have previously been approved under OMB no. 0920-0802. These forms are used to conduct surveillance to determine the incidence and epidemiologic characteristics of invasive disease due to Haemophilus influenzae, Neisseria meningitidis, group A Streptococcus, group B Streptococcus, Streptococcus pneumoniae, and methicillin-resistant Staphylococcus aureus.

The forms for which approval for changes is being sought include:

  1. 2009 ABCs Case Report Form—(Attachment 2)

  2. 2009 Invasive Methicillin-resistant Staphylococcus aureus ABCs Case Report Form—(Attachment 3)

  3. 2009 Neonatal Infection Expanded Tracking Form (Attachment 4)


Previously OMB approved forms in this package include:


  1. 2008 ABCs Case Report Form—OMB no. 0920-0802 (Attachment 5)

  2. 2008 Invasive Methicillin-resistant Staphylococcus aureus ABCs Case Report Form—OMB no. 0920-0802 (Attachment 6)

  3. 2008 Neonatal Group B Streptococcal Disease Prevention Tracking Form—OMB no. 0920-0802 (Attachment 7)


Description of Revisions

Minor changes are being requested for the 2009 Invasive Methicillin-resistant Staphylococcus aureus ABCs Case Report Form and the 2009 Neonatal Group B Streptococcal Disease Prevention Tracking Form in order to streamline and enhance disease surveillance for the pathogens under surveillance. The changes from the previously approved forms are minimal and will not result in a change to previously estimated burden hours.


Detailed Description of Revisions

  1. 2008 ABCs Case Report Form changes include:

    1. Option of ‘septic shock’ has been added to the under ‘Type of infection caused by organism’ question

    2. Three additional options (“Bone Marrow Transplant (BMT)”, “Premature Birth,” and “Chronic Skin Breakdown” have been added under “Underlying causes or prior illnesses” question..

    3. Questions aimed at collecting detailed Streptococcus pneumonia vaccination information (dates vaccines given, name, manufacturer and lot number) have been removed on the 2009 form.


  1. 2008 Invasive Methicillin-resistant Staphylococcus aureus changes include:

    1. Minor changes in wording for clarity

    2. Three additional checkbox questions related to patients undergoing current chronic dialysis treatment were added on the 2009 form. Communication with surveillance officers at several sites revealed that the addition of these questions would not result in an increased data collection burden.


  1. 2008 Neonatal Group B Streptococcal Disease Prevention Tracking Form changes include:

    1. Questions were reordered on the form for clarity and ease. No questions were added, deleted, or changed.

    2. The form has been renamed “Neonatal Infection Expanded Tracking Form.


File Typeapplication/msword
File TitleActive Bacterial Core Surveillance (ABCs)
AuthorHDN3
Last Modified Byshari steinberg
File Modified2009-02-25
File Created2009-02-10

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