Final EIP Justification OMB 0920-0978 nonsubstantive ABCs only April262017 CLEAN

Emerging Infections Programs (EIP)

OMB Control Number 0920-0978

Expiration Date: 02/28/2019

Program Contact

Sonja Mali Nti-Berko

Emerging Infections Programs (EIP)

Division of Preparedness and Emerging Infections

National Center for Emerging and Zoonotic Infectious Diseases

Centers for Disease Control and Prevention

1600 Clifton Rd, MS-C18

Atlanta, GA 30329

Phone: (404) 488-4780

E-mail: [email protected]

Submission Date: April 26, 2017

Circumstances of Change Request for OMB 0920-0978

This is a nonmaterial/non-substantive change request for OMB No. 0920-0978, expiration date 02/28/2019, for the Emerging Infections Programs (EIP). The Emerging Infections Programs (EIPs) are population-based centers of excellence established through a network of state health departments collaborating with academic institutions, local health departments, public health and clinical laboratories, infection control professionals, and healthcare providers. EIPs assist in local, state, and national efforts to prevent, control, and monitor the public health impact of infectious diseases.

Activities of the EIPs fall into the following general categories: (1) active surveillance; (2) applied public health epidemiologic and laboratory activities; (3) implementation and evaluation of pilot prevention/intervention projects; and (4) flexible response to public health emergencies. Activities of the EIPs are designed to: (1) address issues that the EIP network is particularly suited to investigate; (2) maintain sufficient flexibility for emergency response and new problems as they arise; (3) develop and evaluate public health interventions to inform public health policy and treatment guidelines; (4) incorporate training as a key function; and (5) prioritize projects that lead directly to the prevention of disease.

Activities in the EIP Network to which all applicants must participate are:

• Active Bacterial Core surveillance (ABCs): active population-based laboratory surveillance for invasive bacterial diseases.

• Foodborne Diseases Active Surveillance Network (FoodNet): active population-based laboratory surveillance to monitor the incidence of select enteric diseases.

• Influenza: active population-based surveillance for laboratory confirmed influenza-related hospitalizations.

• Healthcare-Associated Infections-Community Interface (HAIC) surveillance: active population-based surveillance for healthcare-associated pathogens and infections.

This non-substantive change request is for changes to the disease-specific data elements for ABCs only. As a result of proposed changes, the estimated annualized burden is expected to decrease by 333 hours, from 22,806 to 22,473. The data elements and justifications are described below.

The forms for which approval for changes and additions are being sought include:

1. 2017 ABCs Case Report Form (Att. 1)

2. 2017 ABCs H. influenzae Neonatal Sepsis Expanded Surveillance Form (Att. 2)

3. 2017 Neonatal Infection Expanded Case Report Form (Att. 3)

4. 2017 ABCs Invasive Pneumococcal Disease in Children (SPN Expanded CRF) (Att. 4)

5. Legionellosis Expanded Case Report Form (discontinued)

Detailed Description of Changes

1. 2016 ABCs Case Report Form

There is no impact on burden due to the changes on this form. Changes include:

1. Question 3a – Adding question to ask if culture was performed

2. Question 3, number changed to Q3b

3. Question 3c, adding date field to collect date of culture independent diagnostic tests (CIDTs)

4. Question 3d – Asking for type of CIDT

5. Question 13b – Added question:

• CIDT STERILE SITE FROM WHICH ORGANISM WAS DETECTED: 1 CSF 1 Other _________________________

6. Question 27, Underlying Conditions – adding checkbox for ‘Eculizumab (Soliris)’ to be used for N. meningitidis cases only

7. Question 33 & 34 – adding ‘Unknown date’ check boxes for surgery and delivery dates

8. Question 35- adding ‘Unknown days’ check box

2. 2016 ABCs H. influenzae Neonatal Sepsis Expanded Surveillance Form

There is no impact on burden due to the changes on this form. Changes include:

1. Added space for name of person completing the form

2. Added State ID to the top of the form

3. Added options for pregnancy outcome (top of form)

4. Q5 added unknown for date of transfer and date of discharge

5. Q6 added unknown option for question regarding whether infant was discharged to home and readmitted to birth hospital.

6. Q6 added unknown option for date of discharge

7. Q7 added unknown option for date of discharge

8. Q8 added question on date of death, if patient died

9. Q8a changed the order of the options

10. Q9b. added unknown option

11. Q10b #1 and #2 added space for culture source specified

12. Q11a added an “other ICD9 codes” option

13. Q11a added a space to specify other ICD9 codes

14. Added ICD9 code to Q11a

15. Added ICD10 codes to Q11c

16. Q19 now Q24.

17. Q24 now Q23 and split into Q23, Q23a & Q23b

18. Q24a now Q23c and added unknown option

19. Q25 now Q30

20. Q25a now Q30a, slight change in wording

21. Q28 now Q29 added “other (specify)” option

22. Q29 now Q28, slight change in wording and added unknown option

23. Q30 now Q29, added unknown option

24. Q31d split into 2 questions, now Q31d and 31e, added ICD9 and ICD10 options

3. 2016 Neonatal Infection Expanded Tracking Form

There is no impact on burden due to the changes on this form. Changes include:

1. Add 2 ICD10 codes to Q9d:

a. ICD10_A408 Numeric 1=Yes/0=No; Description: A40.8: Other streptococcal sepsis

2. ICD10_A491 Numeric 1=Yes/0=No; Description: A49.1: Streptococcal infection, unspecified site

4. 2017 Expanded Surveillance for Children with Invasive Pneumococcal Disease Form

There is no impact on burden due to the changes on this form. Changes include:

1. Updated wording only under vaccines column to remove guidance for recording info for PCV7

2. Added ‘Pnuemovax23 (PPSV23)’ under pneumococcal polysaccharide vaccine section.

5. Legionellosis Expanded Case Report Form

This form has been discontinued. Justification: Outside of underlying conditions, the expanded form was not providing the program with the expected additional information being collected outside of NNDSS.

Justification for changes

The changes made to the ABCs forms under this non-substantive request will aid in clarifying the burden of disease and possible risk factors for disease.  This information can be used to inform strategies for preventing disease and negative outcomes.  Specifically, changes to the 2017 ABCs Case Report Form (Att. 1) include added questions to collect information on culture independent testing practices to better understand the changing testing landscape and how this impacts disease rates.  Check box was added to collect information on number of cases taking eculizumab/Soliris for meningococcal disease to track how many cases and vaccine failures in people taking this specific drug. The 2017 ABCs H. influenzae Neonatal Sepsis Expanded Surveillance Form (Att. 2) changes include the addition of several unknown check box options to characterize missing versus unknown data.  Other changes were made for clarification purposes. ICD10 codes were added to capture all codes associated with ABCs pathogens on the 2017 Neonatal Infection Expanded Case Report Form (Att. 3).  And PPSV23 was already collected as part of the 2017 ABCs Invasive Pneumococcal Disease in Children (SPN Expanded CRF) (Att. 4), the change in this submission clarifies the brand name for PPSV23 is Pneumovax.  The legionellosis Expanded Case report Form has been discontinued.

Cross walk of 2017 form changes

1. 2017 ABCs Case Report Form

2016 form	2017 form
	3a. Was a culture performed? 1 □ Yes, Positive 2 □ Yes, Negative 3 □ No
3. Date first positive culture collected	Now 3b, no change to wording
	3c. DATE FIRST POSITIVE Culture Independent Diagnostic Test (CIDT, e.g. PCR) COLLECTED ____/____/_______
	3d. Type of CIDT:  Biofire Meningitis Panel  Other ________________  Unknown
	13b. CIDT STERILE SITE FROM WHICH ORGANISM WAS DETECTED:  CSF  Other, _____________
27. Underlying causes or prior illnesses	27. Added Checkbox for specific drug, Eculizumab (Soliris) to Immunosuppressive Therapy, only valid for N.meningitidis cases.
33. Did the patient have surgery or any skin incision?  Yes  No  Unknown If YES, date of surgery or skin incision: ___/____/________	33. Did the patient have surgery or any skin incision?  Yes  No  Unknown If YES, date of surgery or skin incision: ___/____/________  Unknown date
34. Did the patient deliver a baby (vaginal or c-section)?  Yes  No  Unknown If YES, date of delivery: ___/____/________	34. Did the patient deliver a baby (vaginal or c-section)?  Yes  No  Unknown If YES, date of delivery: ___/____/________  Unknown date
35. Did patient have: □ Varicella □ Penetrating Trauma □ Blunt Trauma □ Surgical wound □ Burns If yes, record number of days prior to first positive culture: 1 □ 0-7 days 2 □ 8-14 days	35. Did patient have: □ Varicella □ Penetrating Trauma □ Blunt Trauma □ Surgical wound □ Burns If yes, record number of days prior to first positive culture: □ 0-7 days 2 □ 8-14 days 9 □ Unknown days

2. 2016 ABCs H. influenzae Neonatal Sepsis Expanded Surveillance Form

2016 form	2017 form
	Person Filling Out Form: __________________________________________
Pregnant or post-partum (if pregnant or post-partum, specify outcome of pregnancy): □ Live Birth - complete Q1-11, then skip to maternal section (Q12-30) □ Stillbirth - complete Q1-3, then skip to maternal section (Q12-30) □ Spontaneous Abortion- complete Q1-2b, then skip to maternal section (Q12-30) □ Induced Abortion (end form)	Pregnant or post-partum (specify outcome of pregnancy) □ Live Birth (hospitalized) - complete #1-29 □ Stillbirth (hospitalized)- complete #1-3, 12-29 □ Spontaneous Abortion - complete #1-2b, 12-18, and 28-29 □ Home delivery (live or still births) - end form □ Induced Abortion - end form □ Pregnancy outcome unknown - end form Other maternal cases (specify) □ Hi from a sterile site in stillbirth - complete # 1-3, 12-31 □ Fetal death associated with placenta/amniotic fluid - complete #1-3, 12-29
5. Was the infant transferred to another hospital following birth? Yes (1) No (0) Unknown (9) If YES, Hospital where infant was transferred__ __ __ __ __ ID date of transfer __ __ /__ __ /__ __ __ __ date of discharge __ __ /__ __ /__ __ __ __	5. Was the infant transferred to another hospital following birth? Yes (1) No (0) Unknown (9) If YES, Hospital where infant was transferred__ __ __ __ __ ID date of transfer __ __ /__ __ /__ __ __ __ Unknown (9) date of discharge __ __ /__ __ /__ __ __ __Unknown (9)
6. Was the infant discharged to home and readmitted to the birth hospital? Yes (1) No (0) IF YES, date & time of readmission: __ __ /__ __ /__ __ __ __ ___ ___ ___ Unknown Month day year time AND date of discharge __ __ /__ __ /__ __ __ __	6. Was the infant discharged to home and readmitted to the birth hospital? Yes (1) No (0) If YES, date & time of readmission: __ __ /__ __ /__ __ __ __ __ __ __ __ Unknown (9) month day year (4 digits) (times in military format) time AND date of discharge __ __ /__ __ /__ __ __ __ Unknown (9) month / day / year (4 digits)
7 . Was the infant discharge to home and readmitted to a different hospital ? Yes (1) No (0 ) If YES, hospital ID: __ __ __ __ __ AND date & time of admission: __ __ /__ __ /__ __ __ __ __ __ __ __ Unknown (9) month day year (4 digits) (times in military format) time	7 . Was the infant discharge to home and readmitted to a different hospital ? Yes (1) No (0 ) Unknown (9) If YES, hospital ID: __ __ __ __ __ AND date & time of admission: __ __ /__ __ /__ __ __ __ __ __ __ __ Unknown (9) month day year (4 digits) (times in military format) time AND date of discharge __ __ /__ __ /__ __ __ __ Unknown (9) month / day / year (4 digits)
8. Outcome of infant : Survived (1) Died (2) Unknown (9)	8. Outcome of infant : Survived (1) Died (2) Unknown (9) If infant Died, specify Date of Death _ _ / _ _/ _ _ _ _ Unknown (9) month / day / year
8a. If survived, did the infant have the following neurologic or medical sequelae evident on discharge (check all that apply) □ Seizure disorder □ Hearing impairment □ Requiring oxygen □ None	8a. If survived, did the infant have the following neurologic or medical sequelae evident on discharge (check all that apply) □ None □ Seizure disorder □ Hearing impairment □ Requiring oxygen
9b. If yes, to either 9 or 9a, total number of days in the NICU. __ __ __	9b. If yes, to either 9 or 9a, total number of days in the NICU. __ __ __ Unknown (9)
11a. IF YES, Were any of the following ICD-9 codes reported in the discharge diagnosis of the chart? (check all that apply) □ 771.81: Septicemia of newborn □ 995.91: Sepsis □ 038.41 Septicemia due to H. influenzae □ 482.2: Pneumonia due to H. influenzae □ 320.0: Haemophilus meningitis □ 762.7: Chorioamnionitis affecting fetus or newborn □ 670.22 Puerperal sepsis, delivered with mention of postpartum complication	11a. If YES, Were any of the following ICD-9 codes reported in the discharge diagnosis of the chart? □ None of the codes listed were found in chart □ 771.81: Septicemia of newborn □ 995.91: Sepsis □ 038.41 Septicemia due to H. influenzae □ 482.2: Pneumonia due to H. influenzae □ 320.0: Haemophilus meningitis □ 762.7: Chorioamnionitis affecting fetus or newborn □ 670.22 Puerperal sepsis, delivered w/ postpartum □ Other ICD-9 codes (specify) _________________
11c. IF YES, were any of the following ICD-10 codes reported in the discharge diagnosis of the chart? (Check all that apply) □ A41.3: Sepsis due to H. influenzae □ J14: Pneumonia due to H. influenzae □ G00.0: Haemophilus meningitis □ P36.8: Other bacterial sepsis of newborn □ P36.9: Bacterial sepsis of newborn, unspecified □ P02.7: Chorioamnionitis □ O85: Puerperal sepsis □ O75.3: Sepsis during labor	11c. IF YES, were any of the following ICD-10 codes reported in the discharge diagnosis of the chart? (Check all that apply) □ A41.3: Sepsis due to H. influenzae □ J14: Pneumonia due to H. influenzae □ G00.0: Haemophilus meningitis □ P36.8: Other bacterial sepsis of newborn □ P36.9: Bacterial sepsis of newborn, unspecified □ P02.7: Chorioamnionitis □ O85: Puerperal sepsis □ O75.3: Sepsis during labor □ B96.3 H. influenzae as cause of disease classd elswhr □ Other ICD-10 codes (specify) _________________
19. Did mother have a prior history of penicillin allergy?  Yes  No IF YES, was a previous maternal history of anaphylaxis noted?  Yes  No	Now Q24, no change to wording
24. Type of delivery: (Check all that apply)  Vaginal  Vaginal after previous C-section  Forceps  Vacuum  Primary C-section  Repeat C-section  Unknown If delivery was by C-section: Did labor begin before C-section?  Yes  No  Unknown Did membrane rupture happen before C-section?  Yes  No  Unknown	Now Q23, Q23a, Q23b and Q23c 23. Type of delivery: (Check all that apply)  Unknown (9)  Vaginal  Vaginal after previous C-section  Forceps (VBAC)  Vacuum  Primary C-section  Repeat C-section 23a. If delivery was by C-section: Did labor begin before C-section?  Yes  No  Unknown (9) 23b. If delivery was by C-section: Did membrane rupture happen before C-section?  Yes  No  Unknown (9) 23c. If delivery by C-section was it scheduled or emergency?  Yes  No  Unknown (9)
25. Intrapartum fever (T ≥ 100.4 F or 38.0 C):  Yes (1)  No (0)  Unknown If yes, 1st recorded T ≥ 100.4 F or 38.0 C at: __/__/____  Unknown	Now Q30, no change to wording
25a. If intrapartum fever present, were any bacterial cultures performed during labor?  Yes  No	30a. Were any bacterial cultures performed during labor?  Yes  No
28. What was the reason for administration of intrapartum antibiotics? (Check all that apply)  GBS prophylaxis  Suspected amnionitis/chorioamnionitis  Prolonged latency  C-section prophylaxis  Mitral valve prolapse prophylaxis  Other  Unknown	27. What was the reason for administration of intrapartum antibiotics? (Check all that apply)  Unknown (9)  Intrapartum fever (≥ 100.4 F/38 C)  Prolonged latency  C-section prophylaxis  GBS prophylaxis  Suspected amnionitis/chorioamnionitis  Mitral valve prolapse prophylaxis  Other (specify) _____________
29. Did mother have chorioamnionitis or suspected chorioamnionitis?  Yes  No	28. Did mother have chorioamnionitis or suspected chorioamnionitis during the intrapartum period or in the week prior to spontaneous abortion?  Yes (1)  No (0)  Unknown (9)
30. During the intrapartum period did the mother have any of the following symptoms or diagnoses? (check all that apply)  Uterine tenderness  Foul smelling amniotic fluid  Urinary tract infection  Maternal tachycardia (>100 beats/min)  Fetal tachycardia (>160 beats/min)  Maternal WBC >20 or 20,000	29. During the intrapartum period did the mother have any of the following symptoms or diagnoses? (check all that apply)  Uterine tenderness  Foul smelling amniotic fluid  Urinary tract infection  Maternal tachycardia (>100 beats/min)  Fetal tachycardia (>160 beats/min)  Intrapartum fever (≥ 100.4 F/38 C)  Maternal WBC >20 or 20,000  Unknown (9)
31d: Were any of the following ICD-9 or ICD-10 codes reported in the discharge diagnoses of the mother’s chart? ICD-9 995.91: Sepsis 038.41 Septicemia due to H. influenzae 482.2: Pneumonia due to H. influenzae 320.0: Haemophilus meningitis 762.7: Chorioamnionitis affecting fetus or newborn 670.22: Puerperal sepsis, delivered, with mention of postpartum complication 670.20: Puerperal sepsis, unspecified as to episode of care or not applicable 670.24: Puerperal sepsis, postpartum condition or complication ICD-10 A41.3: Sepsis due to H. influenzae J14: Pneumonia due to H. influenzae G00.0: Haemophilus meningitis P02.7: Chorioamnionitis O85: Puerperal sepsis O75.3: Sepsis during labor	31d. Were any ICD-9 or ICD-10 codes reported in the discharge diagnoses of the mother’s chart?  Yes (1)  No (0)  Unknown (9) 31e. If any ICD-9 or ICD-10 codes reported in the discharge diagnoses of the mother’s chart: (Check all that apply) ICD-9 None of the listed ICD-9 codes found in chart 995.91: Sepsis 038.41 Septicemia due to H. influenzae 482.2: Pneumonia due to H. influenzae 320.0: Haemophilus meningitis 762.7: Chorioamnionitis affecting fetus or newborn 670.22: Puerperal sepsis, delivered, w/ postpartum 670.20: Puerperal sepsis, unspecified 670.24: Puerperal sepsis, postpartum Other ICD-9 codes (specify)____________________ ICD-10 None of the listed ICD-10 codes found in chart A41.3: Sepsis due to H. influenzae J14: Pneumonia due to H. influenzae G00.0: Haemophilus meningitis P02.7: Chorioamnionitis O85: Puerperal sepsis O75.3: Sepsis during labor B96.3 H. influenzae as cause of disease classd elswhr Other ICD-10 codes (specify) _________________

3. 2017 Neonatal Infection Expanded Tracking Form

2016 form

2017 form

9d. IF YES, were any of the following ICD-10 codes reported in the discharge diagnosis of the chart? A40.1: Sepsis due to streptococcus, group B (1) A40.8: Other Streptococcal sepsis (1) (1) P36: Bacterial sepsis of newborn (1) P36.0: Sepsis of newborn due to streptococcus, group B (1) P36.1: Sepsis of newborn to other unspecified streptococci (1) B95.1: Streptococcus, group b as the cause of disease classified elsewhere (1) B95.5: Unspecified streptococcus as the cause of disease classified elsewhere (1) G00.2: Streptococcal meningitis (1)

9d. IF YES, were any of the following ICD-10 codes reported in the discharge diagnosis of the chart? A40.1: Sepsis due to streptococcus, group B (1) A40.8: Other Streptococcal sepsis (1) A40.9: Streptococcus sepsis, unspecified (1) A49.1: Streptococcal infection, unspecified site (1) P36: Bacterial sepsis of newborn (1) P36.0: Sepsis of newborn due to streptococcus, group B (1) P36.1: Sepsis of newborn to other unspecified streptococci (1) B95.1: Streptococcus, group b as the cause of disease classified elsewhere (1) B95.5: Unspecified streptococcus as the cause of disease classified elsewhere (1) G00.2: Streptococcal meningitis (1)

4. 2017 Expanded Surveillance for Children with Invasive Pneumococcal Disease Form

2016 form		2017 form
Under Vaccines column in Table: Pneumococcal conjugate vaccine When recording pneumococcal conjugate vaccine information, please differentiate between Prevnar® (PCV7) and Prevnar13® (PCV13)	Under Vaccines Column in Table: Pneumococcal conjugate vaccine Prevnar13® (PCV13)
Under Vaccines column in Table: Pneumococcal polysaccharide vaccine	Under Vaccines column in Table: Pneumococcal polysaccharide vaccine Pnuemovax®23 (PPSV23)

Table A.1 Estimated Annualized Burden Hours

As a result of proposed changes, the estimated annualized burden is expected to decrease by 333 hours, from 22,806 to 22,473. The changes to the four amended forms has no impact on burden estimates. The discontinuation of the Legionellosis Expanded Case Report Form will result in a 333 hour reduction in annual burden.

The following table is updated for the entire 0920-0978 burden table. The five forms included in this change request are highlighted:

Type of Respondent	Form Name	No. of respondents	No. of responses per respondent	Avg. burden per response (in hours)	Total burden (in hours) - APPROVED	Total Burden (in hours) - REQUESTED
State Health Department	ABCs Case Report Form	10	809	20/60	2697	2697
	Invasive Methicillin-resistant Staphylococcus aureus ABCs Case Report Form	10	609	20/60	2030	2030
	ABCs Invasive Pneumococcal Disease in Children Case Report Form	10	22	10/60	37	37
	ABCs Non-Bacteremic Pneumococcal Disease Case Report Form	10	125	10/60	208	208
	Neonatal Infection Expanded Tracking Form	10	37	20/60	123	123
	ABCs Legionellosis Case Report Form (discontinued)	10	100	20/60	333	0
	Campylobacter	10	637	20/60	2123	2123
	Cryptosporidium	10	130	10/60	217	217
	Cyclospora	10	3	10/60	5	5
	Listeria monocytogenes	10	13	20/60	43	43
	Salmonella	10	827	20/60	2757	2757
	Shiga toxin producing E. coli	10	90	20/60	300	300
	Shigella	10	178	10/60	297	297
	Vibrio	10	20	10/60	33	33
	Yersinia	10	16	10/60	27	27
	Hemolytic Uremic Syndrome	10	10	1	100	100
	Influenza Hospitalization Surveillance Project Case Report Form	10	400	15/60	1000	1000
	Influenza Hospitalization Surveillance Project Vaccination Telephone Survey	10	100	5/60	83	83
	Influenza Hospitalization Surveillance Project Vaccination Telephone Survey Consent Form	10	100	5/60	83	83
	2015 ABCs H. influenza Neonatal Sepsis Expanded Surveillance Form	10	6	10/60	10	10
EIP site	CDI Case Report Form	10	1650	20/60	5500	5500
	CDI Treatment Form	10	1650	10/60	2750	2750
	Resistant Gram-Negative Bacilli Case Report Form	10	500	20/60	1667	1667
Person(s) in the community infected with C. difficile (CDI Cases)	Screening Form	600	1	5/60	50	50
	Telephone interview	500	1	40/60	333	333
Total					22,806	22,473

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