Justification for Change

EIP 2015 Change Request_justification_revised 2-17-15.docx

Emerging Infections Program

Justification for Change

OMB: 0920-0978

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Emerging Infections Program (EIP)

Non-substantive Change Request

January 2015






















Amy McMillen, MPH

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases

Office of the Director

1600 Clifton Rd

Atlanta GA 30333

404-639-1045

[email protected]


Background

The National Center for National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) of the Centers for Disease Control and Prevention (CDC) is requesting approval of a non-substantive change to the approved package under OMB no. 0920-0978; expiration date 8/31/2016.

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, and Streptococcus pneumoniae., specific foodborne diseases that is captured within FoodNet, and Influenza (specifically for the All Age Influenza Hospitalization Surveillance (Flu Hosp) project).

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

  1. 2015 ABCs Case Report Form — (Attachment 1)

  2. 2015 ABCs Neonatal Infection Expanded Tracking Form — (Attachment 2 )

  3. New Form: 2014 ABCs Non Bacteremic Pneumococcal Disease— (Attachment 3)

  4. 2015 FoodNet Variable list — (Attachment 4)

  5. 2014-2015 FluSurv-NET Influenza Surveillance Project Case Report Form — (Attachment 5)

  6. 2014-2015 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey — (Attachment 6)

  7. 2014-2015 FluSurv-NET Influenza Surveillance Project Vaccination History Telephone Survey (Spanish) — (Attachment 7)

  8. 2014-2015 FluSurv-NET Influenza Surveillance Project Consent Form — (Attachment 8)

  9. 2014-2015 FluSurv-NET Influenza Surveillance Project Consent Form (Spanish) — (Attachment 9)


The changes in this package are minor, do not change the scope of a collection, and does not greatly impact the burden. The following will detail the changes to the EIP surveillance tools including description and crosswalk of changes.






Active Bacterial Core surveillance (ABCs) - Active population-based laboratory surveillance for invasive bacterial diseases


Detailed Description of Changes

  1. 2015 ABCs Case Report Form

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

    1. Question 32, Receipt of pneumococcal vaccine

      • Directions below checkboxes will be changed to ‘If between ≥ 3 months and <5 years of age and an isolate is available for serotyping, please complete the Invasive Pneumococcal Disease in Children expanded form’


  1. 2015 ABCs Invasive Pneumococcal Disease in Children Case Report Form

Burden is decreasing as data elements have been removed from the data collection tool

These changes include:

    1. Removed capture of manufacturer and vaccine name for Diptheria/Tetanus/Pertussis (DTP or DTaP)

    2. Removed capture of manufacturer and vaccine name for Haemophilis influenza type B (Hib)

    3. Removed rows capturing influenza immunizations

    4. Added section on data sources for vaccination history, including

      • What information source was used to identify the health provider

      • How many health providers were contacted

      • What information sources were used to obtain vaccination history


  1. 2015 ABCs Non-Bacteremic Case Report Form Active Bacterial Core surveillance (ABCs), a part of the Emerging Infections Program (EIP) network, is an active, laboratory, and population-based surveillance system. It is used to determine the incidence and epidemiological characteristics of invasive disease due to group A Streptococcus (GAS), group B Streptococcus (GBS), Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria meningitidis, at 10 sites located throughout the United States. Since ABCs surveillance began in 1995, a case of invasive bacterial disease has been defined as isolation from culture of one of these pathogens from a normally sterile site in a resident of the surveillance area. Data from ABCs have been used to inform the development of vaccines, to inform the Advisory Committee on Immunization Practices (ACIP) recommendations for their use and to evaluate their effectiveness after recommendations for use are in place.


On August 13, 2014, ACIP recommended routine use of 13-valent pneumococcal conjugate vaccine (PCV13) among adults aged ≥65 years in series with the 23-valent pneumococcal polysaccharide vaccine (PPSV23).1 Both vaccines have demonstrated efficacy against invasive pneumococcal disease (IPD) in placebo-controlled trials. One of the determining factors for recommending PCV13 to adults aged ≥65 years was its demonstrated 45% efficacy (95% confidence interval=14-65%) against vaccine-type non-bacteremic (i.e. non-invasive) pneumococcal pneumonia (NBPP) in a placebo-controlled trial conducted in the Netherlands.2 Evidence is less clear as to whether PPSV23 is effective against NBPP. The incidence of NBPP and the effectiveness of PCV13 vaccine against NBPP have a major influence on determining which vaccine or combination of vaccines would provide the greatest health benefits at the lowest costs. Given these and other considerations, ABCs Non-Bacteremic surveillance responds to the ACIP recommendations for the need to re-evaluate the pneumococcal vaccine policy for adults in 2018.



Cross walk of 2015 form changes


  1. 2015 ABCs Case Report Form


2014 form

2015 form

32. Did the patient receive pneumococcal vaccination?

1 □ Yes

2 □ No

9 □ Unknown


If YES, please note which pneumococcal vaccine was received (Check all that apply)

1 □ Prevnar®, 7-valent Pneumococcal Conjugate Vaccine (PCV7)

1 □ Prevnar-13®, 13-valent Pneumococcal Conjugate Vaccine (PCV13)

1 □ Pneumovax®, 23-valent Pneumococcal Polysaccharide Vaccine (PPV23)

1 □ Vaccine type not specified


If between ≥3 months and <18 years of age and an isolate is available for

serotyping, please complete the Invasive Pneumococcal Disease in

Children expanded form.


32. Did the patient receive pneumococcal vaccination?

1 □ Yes

2 □ No

9 □ Unknown


If YES, please note which pneumococcal vaccine was received (Check all that apply)

1 □ Prevnar®, 7-valent Pneumococcal Conjugate Vaccine (PCV7)

1 □ Prevnar-13®, 13-valent Pneumococcal Conjugate Vaccine (PCV13)

1 □ Pneumovax®, 23-valent Pneumococcal Polysaccharide Vaccine (PPV23)

1 □ Vaccine type not specified


If between ≥ 2 months and <5 years of age and an isolate is available for

serotyping, please complete the Invasive Pneumococcal Disease in

Children expanded form.




  1. 2015 ABCs Invasive Pneumococcal Disease Case Report Form


2014 form

2015 form

Title: Active Bacterial Core Surveillance (ABCs) Invasive Pneumococcal Disease in Children

Title: Active Bacterial Core Surveillance (ABCs) Invasive Pneumococcal Disease in Children (aged ≥2 months to <5 years)

Indicate manufacturer for Diptheria/Tetanus/Pertussis (DTP or DTap)

Removed

Indicate vaccine name for Diptheria/Tetanus/Pertussis (DTP or DTap)

Removed

Indicate manufacturer for Haemophilus influenzae type B (Hib)

Removed

Indicate vaccine name for Haemophilus influenzae type B (Hib)

Removed

Indicate dates of immunization for influenza vaccine

Removed

Indicate manufacturer for influenza vaccine

Removed

Indicate vaccine name for influenza vaccine

Removed


Was health care provider information available from the following sources?


Medical chart:

Yes

No

Did not check


Vaccine Registry:

Yes

No

Did not check


Parent/Guardian:

Yes

No

Did not check

Refused


If yes to any sources, how many providers were contacted?


What sources were used for vaccination history?


Medical chart:

Yes

No

Did not check


Vaccine Registry:

Yes

No

Did not check


Primary Care Provider:

Yes

No

Did not check


Other Provider:

Yes

No

Did not check





ABCs Change Estimates of Annualized Burden Hours from 2014 to 2015


Table A.1 Estimated Annualized Burden Hours(Highlighted forms below indicate a change in burden hours in 2015)



Type of Respondent

Form Name

No. of respondents

No. of responses per respondent

Avg. burden per response (in hours)

2015 Total burden (in hours)

State Health Department


ABCs Case Report Form

10

809

20/60

2697

Invasive Methicillin-resistant Staphylococcus aureus ABCs Case Report Form

10

609

20/60

2030

ABCs Invasive Pneumococcal Disease in Children Case Report Form

10

22

10/60

37

New Form: ABCs Non-Bacteremic Pneumococcal Disease Case Report Form

10

100

10/60

167

Neonatal Infection Expanded Tracking Form

10

37

20/60

123

ABCs Legionellosis Case Report Form

10

100

20/60

333







Foodborne Diseases Active Surveillance Network (FoodNet)

Minor revisions have been made to the FoodNet surveillance tool since the last change approval in 2014; however the changes did not result in a change to estimated burden hours for those forms.


Detailed Description of Changes

  • Expanded the list of responses for ‘AgClinicTestType’ to reflect new tests that are now being used in clinical labs.

  • Added two new variables related to culture-independent testing for STEC:

    • DXO157

    • DXO157TestType

  • Added the following new variables to capture case exposure information to be used for attribution estimates. These variables were developed by a working group consisting of CDC and state health department sites over a two-year period. Variables were pilot-tested in 4 sites for a three-month period for Salmonella and Campylobacter cases.


    • Meat and poultry

      • CEA_Beef

      • CEA_Beef_grnd

      • CEA_Beef_out

      • CEA_Beef_unckgrnd

      • CEA_Chicken

      • CEA_Chx_grnd

      • CEA_Chx_out

      • CEA_Pork

      • CEA_Turkey

      • CEA_Turkey_grnd

      • CEA_Turkey_out

    • Fish and seafood

      • CEA_Fish

      • CEA_Fish_unck

      • CEA_Seafd

      • CEA_Seafd_unck

    • Dairy

      • CEA_Dairy

      • CEA_Milk_raw

      • CEA_Odairy_raw

      • CEA_Softcheese

      • CEA_Softcheese_raw

    • Eggs

      • CEA_Eggs

      • CEA_Eggs_out

      • CEA_Eggs_unck

    • Fruits and vegetables

      • CEA_Berries

      • CEA_Cantaloupe

      • CEA_Herbs

      • CEA_Lettuce

      • CEA_Spinach

      • CEA_Sprouts

      • CEA_Raw_cider

      • CEA_Tomatoes

      • CEA_Watermelon

    • Water

      • CEA_Ountreat_water

      • CEA_Sewer_water

      • CEA_Swim_treat

      • CEA_Swim_untreat

      • CEA_Well_water

    • Person-to-person

      • CEA_Sick_contact

    • Environmental

      • CEA_Bird

      • CEA_Cat

      • CEA_Dog

      • CEA_Farm_ranch

      • CEA_Live_poultry


      • CEA_Pig

      • CEA_Pocketpet

      • CEA_Reptile_amphib

      • CEA_Ruminants

      • CEA_Sick_pet






Influenza - All Age Influenza Hospitalization Surveillance Project


Minor revisions have been made to the FluSurv-NET Influenza Surveillance tool since the last change approval in 2014; however the changes did not result in a change to estimated burden hours for those forms.


Detailed Description of Changes

  1. 2014-15 FluSurv-NET Influenza Surveillance Project_Case Report Form

  • A question was added to capture the type of address provided for the patient.

  • Additional questions were added to capture additional patient provider contact information.

  • To better capture information on where the patient resided at the time of, additional residence type options for question C13 were added.

  • Questions regarding Influenza testing results were updated to include new influenza testing types and corresponding result options.

  • To better capture information regarding signs/symptoms at the time of admission, question E2 was rephrased to list signs/symptoms as they appear in medical chart – but original intent of question was preserved.

  • The options for specifying location of consolidation was removed from questionnaire.

  • The section on vaccination status has now an option to record type of vaccination (injected or nasal spray) for children <9 years of age.



  1. 2014-2015 FluSurv-NET Influenza Surveillance Project_Vaccination History Telephone Survey

(Changes Account for the English and Spanish Version)

  • Addition of a question to capture the type of vaccination (injected or nasal spray) received by patients <9 years of age.


  1. 2014-2015 FluSurv-NET Influenza Surveillance Project_Consent Form

(Changes Account for the English and Spanish Version)

  • Location of reference material for continuation of interview was updated to reflect current location.



Cross walk of 2015 form changes

  1. 2014-15 FluSurv-NET Influenza Surveillance Project_Case Report Form

Question on 2013-14 Form

Question on 2014-15 Form

N/A

A10. Address Type: ___________

N/A

A16. Primary Provider (PCP) Name 2: ______________

N/A

A17. Primary Provider (PCP) Phone 2: ______________

N/A

A18. Primary Provider (PCP) Fax2: ______________

E13. Where did patient reside at the time of hospitalization?

Private residence

Rehabilitation facility

Group home/Retirement home

Assisted living/Residential care

Homeless/Shelter

Nursing home

Unknown

Other, specify: _____________________

E13. Where did patient reside at the time of hospitalization?

Private residence

Alcohol/Drug Abuse Treatment

Group home/Retirement home

Homeless/Shelter

Hospitalized at birth

Jail/Prison

LTACH/Transitional Care (TCU)

Mental Hospital

Nursing home

Rehabilitation facility

Hospice

Unknown

Other, specify: ___________________

D1-4. Test 1-4:

Rapid

RT-PCR

Viral Culture

Serology

Fluorescent Antibody

Method Unknown/Note Only

D1-4. Test 1-4:

Rapid

Molecular Assay

Viral Culture

Serology

Fluorescent Antibody

Method Unknown/Note Only

D1a-4a. Result:

Flu A (not subtyped)

Flu B

Flu A & B

Flu A/B (Not Distinguished)

2009 H1N1

H1, Seasonal

H1, Unspecified

H3

Flu A, Unsubtypable

Negative

Unknown

Other, specify: __________________________

D1a-4a. Result:

Flu A (no subtype)

Flu B(no genotype)

Flu A & B

Flu A/B (Not Distinguished)

2009 H1N1

H1, Unspecified

H3

Flu A, Unsubtypable

Flu B, Yamagata

Flu B, Victoria

Negative

Unknown Type

Other, specify: __________________________

E2. Acute conditions at admission (Check all that apply):

Acute respiratory illness

Asthma and/or COPD exacerbation

Fever

Pneumonia

Other respiratory or cardiac conditions

Other, neither respiratory nor cardiac conditions

Unknown


E2. Acute signs/symptoms at admission [within 2 weeks prior to positive flu test]:

Altered mental status/confusion

Chest pain

Congested/runny nose

Conjunctivitis/pink eye

Cough

Diarrhea

Fever/chills

Headache

Myalgia/muscle aches

Nausea/vomiting

Rash

Seizures

Shortness of breath/resp distress

Sore throat

Wheezing

Other, non-respiratory

E3. Date of onset of acute respiratory symptoms: ____/ ____/ ____ Unknown

E3. Date of onset of acute respiratory symptoms [within 2 weeks prior to positive flu test]: ____/ ____/ ____ Unknown

E3a. If no respiratory symptoms, date of onset of acute illness resulting in hospitalization:

____/ ____/ ____ Unknown

E4. Date of onset of acute condition resulting in current hospitalization:

____/ ____/ ____ Unknown

E9i. Immunocompromised Condition Yes No/Unknown

AIDS or CD4 count < 200

Cancer diagnosis in last 12 months

Complement deficiency

HIV Infection

Immunoglobulin deficiency

Immunosuppressive therapy

Organ transplant

Stem cell transplant (e.g., bone marrow transplant)

Steroid therapy (taken within 2 weeks of admission)

Other, specify__________________

E10i. Immunocompromised Condition

Yes No/Unknown

AIDS or CD4 count < 200

Cancer: current/in treatment or diagnosed in last 12 months

Complement deficiency

HIV Infection

Immunoglobulin deficiency

Immunosuppressive therapy

Organ transplant

Stem cell transplant (e.g., bone marrow transplant)

Steroid therapy (taken within 2 weeks of admission)

Other, specify__________________


E9k. Other Yes No/Unknown

Liver disease (e.g., cirrhosis, chronic hepatitis, hepatitis C)

Morbidly obese (ADULTS ONLY)

Obese

Pregnant

If pregnant, specify gestational age in weeks: ________

Unknown gestational age

Post-partum (two weeks or less)

Other, specify _______________

E10k. Other Yes No/Unknown

Intravenous drug use

Liver disease (e.g., cirrhosis, chronic hepatitis, hepatitis C)

Systemic lupus erythematosus/SLE/Lupus

Morbidly obese (ADULTS ONLY)

Obese

Pregnant

If pregnant, specify gestational age in weeks: ________

Unknown gestational age

Post-partum (two weeks or less)

Other, specify _______________

H1f. Human metapneumovirus

Yes, positive

Yes, negative

Not tested/Unknown

Date: ____/____/____

H1f. Parainfluenza 4

Yes, positive

Yes, negative

Not tested/Unknown

Date: ____/____/____

H1g. Rhinovirus

Yes, positive

Yes, negative

Not tested/Unknown

Date: ____/____/____

H1g. Human metapneumovirus

Yes, positive

Yes, negative

Not tested/Unknown

Date: ____/____/____

H1h. Other, specify: ______________

Yes, positive

Yes, negative

Not tested/Unknown

Date: ____/____/____

H1h. Rhinovirus/Enterovirus

Yes, positive

Yes, negative

Not tested/Unknown

Date: ____/____/____

N/A

H1i.Coronavirus (type):____________

Yes, positive

Yes, negative

Not tested/Unknown

Date: ____/____/____

J2c. Please specify location for bronchopneumonia/pneumonia/consolidation/lobar infiltrate/air space density/opacity:

Single lobar

Multiple lobar (unilateral)

Multiple lobar (bilateral)

Unknown

Removed

K2a. If discharged alive, please indicate to where:

Home

Other hospital

Hospice/Home hospice

Homeless/Shelter

Rehabilitation Facility

Group home/Retirement home

Assisted living/Residential Care

Home with Services

Nursing home

Unknown

Other, specify: _____________________

K2a. If discharged alive, please indicate to where:

Private residence

Alcohol/Drug Abuse Treatment

Assisted living/Residential Care

Group home/Retirement home

Home with Services

Homeless/Shelter

Jail/Prison

LTACH/Transitional Care (TCU)

Mental Hospital

Nursing home

Rehabilitation Facility

Hospice

Unknown

Other, specify: ________________

M1. Did patient receive the influenza vaccine for the current influenza season?

Yes

No

Unknown

Removed

M2-M6. [vaccination history source]

Yes

Yes, specific date unknown

No

Unknown

Not Checked

M1-M4. [vaccination history source]

Yes, full date known

Yes, specific date unknown

No

Unknown

Not Checked

N/A

M1b-M4b. If patient < 9 yrs, specify vaccine type:

Injected Vaccine

Nasal Spray/FluMist

Combination of both

Unknown type




  1. 2014-2015 FluSurv-NET Influenza Surveillance Project_Vaccination History Telephone Survey


Question on 2013-14 Survey

Question on 2014-15 Survey

N/A

1b) What type of flu vaccine did [you / child’s name] receive?

Injected Vaccine

Nasal Spray/FluMist

Combination of both

Unknown type




  1. 2014-2015 FluSurv-NET Influenza Surveillance Project_Consent Form


Question on 2013-14 Consent Form

Question on 2014-15 Consent Form

Hello. My name is __________ from the _____[state] Department of Public Health. May I speak to ______ [patient’s name /parent of [child’s name] ] . We are working with the Centers for Disease Control and Prevention and other health departments to learn more about influenza disease or the flu. To do this, we are talking to people who have been in the hospital with the flu. We want to look at things that may affect their illness and whether they were vaccinated against the flu.


Because you/your child [or NAME if speaking with proxy] were in the hospital for the flu beginning on _______[day admitted], I would like to ask you a few questions about whether you/your child [or NAME if speaking with proxy] received the flu vaccine this season. This will take about five minutes. Your participation is voluntary and if you choose to refuse it will not affect any medical care or benefits you receive. All of your responses will be kept confidential as much as the law allows. You may refuse to answer any questions and may stop at any time. This information will help [State/Local Health Department] and CDC better describe influenza-associated hospitalizations. Additionally, this information may help us improve vaccination recommendations for flu and better protect the public’s health. There is no other benefit to you for answering these questions. There is also no risk to you. If you have any questions about the study, you may call _____[state contact] at the Department of Public Health at XXX-XXX-XXXX. Do you have any questions before I begin?

May I continue with this interview?

Yes □ No

If YES, go to Appendix F.

If NO: Thank you for your time. Have a good day

Hello. My name is __________ from the _____[state] Department of Public Health. May I speak to ______ [patient’s name /parent of [child’s name] ] . We are working with the Centers for Disease Control and Prevention and other health departments to learn more about influenza disease or the flu. To do this, we are talking to people who have been in the hospital with the flu. We want to look at things that may affect their illness and whether they were vaccinated against the flu.


Because you/your child [or NAME if speaking with proxy] were in the hospital for the flu beginning on _______[day admitted], I would like to ask you a few questions about whether you/your child [or NAME if speaking with proxy] received the flu vaccine this season. This will take about five minutes. Your participation is voluntary and if you choose to refuse it will not affect any medical care or benefits you receive. All of your responses will be kept confidential as much as the law allows. You may refuse to answer any questions and may stop at any time. This information will help [State/Local Health Department] and CDC better describe influenza-associated hospitalizations. Additionally, this information may help us improve vaccination recommendations for flu and better protect the public’s health. There is no other benefit to you for answering these questions. There is also no risk to you. If you have any questions about the study, you may call _____[state contact] at the Department of Public Health at XXX-XXX-XXXX. Do you have any questions before I begin?

May I continue with this interview?

Yes □ No

If YES, go to Appendix 7.

If NO: Thank you for your time. Have a good day.



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