Justification for Change

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; expiration date 1/31/2012. 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 are being sought include:

1. 2010 ABCs Case Report Form—(Attachment 2)

2. 2010 Invasive Methicillin-resistant Staphylococcus aureus ABCs Case Report Form—(Attachment 3)

3. 2010 Neonatal Infection Expanded Tracking Form (Attachment 4)

Previously OMB approved forms in this package include:

4. 2009 ABCs Case Report Form—OMB no. 0920-0802 (Attachment 5)

5. 2009 Invasive Methicillin-resistant Staphylococcus aureus ABCs Case Report Form—OMB no. 0920-0802 (Attachment 6)

6. 2009 Neonatal Infection Expanded Tracking Form—OMB no. 0920-0802 (Attachment 7)

Description of Changes

Minor changes are being requested for the 2010 ABCs Case Report Form, the 2010 Invasive Methicillin-resistant Staphylococcus aureus ABCs Case Report Form and the 2010 Neonatal Infection Expanded Tracking Form in order to streamline and enhance disease surveillance for the pathogens under surveillance. There are no changes to form respondents. The changes from the previously approved forms are minimal and will not result in a change to previously estimated burden hours, as per communication with surveillance officers (form respondents).

Detailed Description of Changes

1. 2010 ABCs Case Report Form changes include:

1. Indication of ICU admission during hospitalization (Question 6)

2. Expansion of patient residence options at time of initial culture- includes private residence, long term acute care facility, homeless incarcerated, and college dormitory. (Question 7a.)

3. Modification of question regarding fetal out come for pregnant and postpartum cases. Now includes ‘still pregnant’ as option. (Question17b.)

4. Removal of other non-sterile site from which organism was isolated. (Question 23)

5. Indication of a positive influenza test within 10 days of an ABCs culture. (Question 33)

6. Clarification of pneumococcal vaccine names (Question 29)

7. Moving autopsy question from second page to front page, near outcome question, as requested by surveillance officers (Question 16)

2. 2010 Invasive Methicillin-resistant Staphylococcus aureus changes include:

   1. Addition of option for Long Term Acute Care Hospital (Question 5)

   2. Addition of option for ICU for location of culture collection (Question 11a.)

   3. Addition of option ‘If survived, was patient transferred to a LTACF?’ for patient outcome (Question 12)

   4. Addition of option for ‘Chronic Ulcer/Wound (non-decubitis) under types of infection (Question 17)

   5. Slight modification of option for ‘Pressure Ulcer’ to ‘Decubitus/Pressure Ulcer’ (Question 17 and 18)

3. 2010 Neonatal Group B Streptococcal Disease Prevention Tracking Form changes include:

1. Addition of ‘unknown’ options for questions 7, 8, 20 and 21a.