Non-Substantive Change Request Justification 07APR2016_FINAL

Non-Substantive Change Request to OMB Control Number 0920-1101; CDC Emergency Operations Center Zika Related Clinical Inquiries and Surveillance

Program Contact

Lee Samuel

National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)

Office of Policy

1600 Clifton Rd, C-12

Atlanta GA 30333

Submission Date: January 24, 2021

Circumstances of Change Request for OMB 0920-1101

CDC requests approval for a non-substantive change to OMB Control No. 0920-1101: CDC Emergency Operations Center Zika Related Clinical Inquiries and Surveillance.

All of the proposed changes are being made to information collection instruments and supporting tools associated with the domestic pregnancy registry. These changes are being made because of the updated Council of State and Territorial Epidemiologists (CSTE) case definitions for confirmed and probable Zika virus disease and congenital Zika virus infection. Because of the updated CSTE case definitions, participation in the pregnancy registry is no longer voluntary. State laws mandate reporting of arboviral diseases when identified by a health care provider, hospital, or laboratory. Now that there are specific case definitions for Zika virus disease and congenital Zika virus infection, state and territorial health departments are responsible for determining which reported cases meet the case definitions and notifying CDC of these cases. For an emerging infection like Zika virus, little is known about the spectrum of disease. Case definitions may need to change as more information becomes available about the spectrum of Zika virus disease and congenital infection. The US Zika Pregnancy Registry is designed to allow collection of the clinical and epidemiologic information required to determine whether reported cases meet the case definitions and whether the case definitions accurately capture the spectrum of Zika virus disease. Therefore, the Registry includes pregnant women and infants who do not meet the current CSTE definitions, i.e.:

• Pregnant women with laboratory evidence of Zika infection or unspecified flavivirus infection but without symptoms of Zika virus disease;

• Symptomatic pregnant women with unspecified flavivirus infection; and

• Infants exposed to the mother’s Zika or unspecified flavivirus infection before or during birth who do not meet the case definition for congenital Zika virus infection.

It also allows mother-infant pairs to be linked, all of which is critical for both fully understanding and responding appropriately to the public health threat from Zika virus.

NCEZID’s human subjects advisor reviewed the proposed changes to the project and determined that it still does not met the definition of research (Attachment M). IRB review is not required.

Estimates of annualized burden hours for this change request remain the same. The burden estimate for the forms included in OMB Control No. 0920-1101 is 705 hours.

Attachments

1. Public Health Service Act (42 USC 241)

2. Draft 60-day FRN

3. Website information - Zika Virus Disease and Pregnancy Registry (changes requested)

4. Overview letter (changes requested)

5. Maternal Health History Form (changes requested)

6. Assessment at Delivery Form (changes requested)

7. Infant Health Follow-Up Form (changes requested)

8. Specimen Collection Form

9. Domestic ZIKA Clinical Inquiries Database

10. Survey of county-level surveillance records of Aedes aegypti and Aedes albopictus from 2000 to present

11. IRB Approval – EOC call center

12. IRB Approval – Mosquito surveillance survey

13. IRB Approval – Pregnancy Register (updated)

14. Pregnancy Registry Information Sheet (changes requested)

15. Developmental Milestones for Infant (new)

16. Fact Sheet for Obstetric Healthcare Providers (new)

17. Fact Sheet for Pediatric Healthcare Providers (new)

18. Fact sheet for Health Departments (new)

19. CSTE Case Definition (new)

Description and Justification of Changes

Supporting Statement A
1. Circumstances making the Collection of Information Necessary

• Updated territories with local Zika transmission to be consistent with current situation; added that local transmission may occur in U.S. states.

• Added the critical information gaps that the data collection is designed to address

• Added respondents for registry

• Updated description of pregnancy registry

  • To reflect case definitions (confirmed and probable for Zika virus disease and congenital zika virus infection) released by the Council of State and Territorial Epidemiologists on February 26, 2016 and add the case definitions as an attachment.

  • To clarify that, in addition to cases meeting the CSTE case definition, the registry will include the following cases:

    • Pregnant women with laboratory evidence of Zika infection or unspecified flavivirus infection but without symptoms of Zika virus disease;

    • Symptomatic pregnant women with unspecified flavivirus infection; and

    • Infants exposed to the mother’s Zika or unspecified flavivirus infection before or during birth who do not meet the case definition for congenital Zika virus infection.

  • To replace language about voluntary participation with “The provider will notify pregnant or postpartum women that they have a notifiable disease and that their information will be included in the registry” and discussion of the patients’ rights concerning disclosure of their protected health information as established by the HIPAA Privacy Rule.

  • To add that “The provider will document in the woman’s medical record that information was provided…”

  • To clarify that information collected on the Maternal Health History Form (Attachment E) may be provided in written or electronic form, or verbally.

  • To replace language about obtaining consent for participation in the registry with a statement that the Overview Letter (Attachment D) will instruct the health care provider to inform the patient about inclusion in the registry and the patient’s rights as established by the HIPAA Privacy Rule.

  • To clarify that information will be requested during pregnancy and that information on infant health (Attachments F, G) will be transmitted in the same manner as for the Maternal History Form.

  • To add that the proposed data collection is consistent with efforts to strengthen surveillance in the context of severe disease and emerging infections, which involve working closely with clinicians who diagnose and treat patients.

10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

• Added (HIPAA Privacy Rule) for collecting personally identified medical information from health care providers.

• Added that application for an Assurance of Confidentiality is in process

• Added that only de-identified data will be presented in case reports and in aggregate form, and that data that could indirectly identify an individual will be suppressed.

Attachment C: Website

• Changes: Removed letter to Health Care Provider (HCP) link and added Fact Sheet for Health Care Providers (Attachment P).

• Justification: Aligns better with web content format.

Attachment D: Overview Letter

• Changes: Clarified how health care providers can report cases and that as a nationally notifiable condition, consent from patients will not be solicited.

• Justification: New CSTE case definition, approved February 26, 2016, includes national notification for pregnant women and infants.

Attachment E: Maternal Health History Form

• Changes: New variables added: maternal hospitalization and death, sexual transmission questions, method to derive estimated delivery date, cocaine use, HC measurement, growth restriction, and prenatal ultrasound findings (was free text, now more text boxes).

• Removed voluntary participation checkbox, not requested for information needed to apply case definitions for a nationally notifiable disease.

• Justification: New findings associated with Zika virus.

Attachment F: Assessment at Delivery Form

• Changes: New variables added: delivery complications, imaging findings, neonatal diagnoses.

• Justification: Information needed to interpret reporting of neonatal outcomes.

Attachment G: Infant Health Follow-Up Form

• Changes: Added infant date of birth, added instruction sheet for developmental interpretation.

• Justification: Ensure appropriate tracking of infant, ensure appropriate surveillance of birth defects and developmental delays.

Attachment N: Pregnancy Registry Information Sheet

• Changes: Removed references to voluntary participation and removed information about specimen collection.

• Justification: Nationally notifiable disease and new CSTE case definition.

Attachment O: Developmental Milestones for Infant

• Changes: Added to provide HCP with information that will allow them to complete information on infant form related to developmental outcomes.

Attachment P: Fact Sheet for Obstetric Health Care Providers

• Changes: Added to provide HCP with information. This will be posted on the website.

Attachment Q: Fact Sheet for Pediatric Health Care Providers

• Changes: Added to provide HCP with information. This will be posted on the website.

Attachment R: Fact Sheet for Health Departments

• Changes: Added to provide health departments with information. This will be posted on the website.

Form

Current Question

Requested Change

Maternal Health History Form (Att. E)

Mother’s name: ____________

Mother’s name: _____Last _______First ____MI

Maiden name (if applicable) _______________

State/Territory ID:_______________

Race (Please ask the patient to self-identify as): American Indian or Alaska Native Asian Black or African-American Native Hawaiian or other Pacific Islander White

Race (check all that apply): American Indian or Alaska Native Asian Black or African-American Native Hawaiian or other Pacific Islander White

Indication for maternal serum Zika virus testing: ___________________

Indication for maternal Zika virus testing: Exposure history, no known fetal concerns Exposure history and fetal concerns

Date of Zika virus disease onset: _____/_____/_____ -OR-  Asymptomatic

Date of Zika virus symptom onset: _____/_____/_____ -OR-  Asymptomatic

If date not known, trimester of symptom onset __________

Hospitalized for Zika virus disease  No  Yes Maternal Death  No  Yes

Symptoms of mother’s Zika virus disease: (check all that apply) Fever ______ ^oF Rash Arthralgia Conjunctivitis Other Clinical Presentation_________________

Gestational age at onset: ________ weeks

Symptoms of mother’s Zika virus disease: (check all that apply) Fever ______ ^oF (if measured) Rash Arthralgia Conjunctivitis Other Clinical Presentation_________________

If symptomatic, gestational age at onset: ________ weeks

If gestational age not known, trimester of symptom onset _________________

N/A

Was Zika virus infection acquired in place of residence No Yes, if yes, skip to the section on Mother’s pregnancy

Countr(ies) of exposure:

_________ Date of travel1:________

_________ Date of travel2:________

_________ Date of travel3:________

IF TRAVEL DURING PREGNANCY, answer questions below. If not, skip to non-traveling woman

Country of exposure (1)______________

Travel Start __/__/____

Travel End __/__/____

Country of exposure (2)______________

Travel Start __/__/____

Travel End __/__/____

Country of exposure (3)______________

Travel Start __/__/____

Travel End __/__/____

N/A

Mother’s sexual partner(s)? please check all that apply Male Female

N/A

Did any male sexual partner(s) travel on this trip?  No  Yes

N/A

If yes, did any male partner(s) have an illness that included fever, rash, joint pain, or pink eye within 2 weeks of travel?  No  Yes

If yes, was there unprotected sexual contact while male partner(s) had illness? No Yes

N/A

If male partner(s) travelled, did he have a test that showed lab evidence of Zika?  No  Yes

 Mother agrees to participate in this Pregnancy Registry

N/A [Removed]

N/A

NON-TRAVELLING WOMAN: other possible exposures? Sexual partner w/travel history, symptomatic, lab evidence of Zika Sexual partner w/travel history, symptomatic, no test results Sexual partner w/travel history, asymptomatic lab evidence of Zika

Other, please describe____________ Unknown

N/A

Last menstrual period (LMP): __/__/____

N/A

Estimated delivery date based on (check all that apply):  LMP __/__/____  U/S (1^st trimester)  U/S (2^nd trimester)  U/S (3^rd trimester)

N/A

History: # pregnancies ___ # living children ___ # miscarriages ___ # elective terminations ___

N/A

Prior fetus/infant with microcephaly:  No  Yes If yes, genetic cause:  No  Yes

Current gestation: Single Twins Triplets

Gestation: Single Twins Triplets+

Underlying maternal illness:

Diabetes  No  Yes  Maternal PKU  No  Yes Hypothyroidism  No  Yes Hypertension  No  Yes Alcohol use  No  Yes Other underlying illness:  _________________

Underlying maternal illness:

Diabetes  No  Yes  Maternal PKU  No  Yes Hypothyroidism  No  Yes Hypertension  No  Yes Substance use during this pregnancy: Alcohol use  No  Yes Cocaine use No Yes Smoking No Yes Other underlying illness:  _________________

Complications of pregnancy: TORCH infection  No  Yes Gestational diabetes  No  Yes Death of a monozygote twin  No  Yes Pregnancy-related HTN  No  Yes Other  No  Yes ________________

Complications of pregnancy:

Toxoplasmosis positive No Yes Unknown

Herpes Simplex positive No Yes Unknown

Syphilis positive No Yes Unknown

Cytomegalovirus positive No Yes Unknown

Rubella positive No Yes Unknown

Fetal genetic abnormality No Yes, diagnosis_______ Unknown

Gestational diabetes No Yes Pregnancy-related HTN No Yes Intrauterine death of a twin No Yes Other__________________________

N/A

Did this pregnancy end in miscarriage or intrauterine fetal demise (IUFD)? No Yes Date: __/__/____ Gestational age____ weeks

N/A

Was this pregnancy terminated? No Yes Date:__/__/____ Gestational age ____ weeks

N/A

Maternal Prenatal Imaging and Diagnostics
Date(s) of Ultrasound(s):
__/__/____ Check if date approximated If date not known, gestational age ____ weeks	Overall Fetal Ultrasound Results: Normal Abnormal Check if reported by patient/healthcare provider  ultrasound report Head Circumference _______cm  Normal  Abnormal (by physician report) Biparietal diameter ___ cm Femur Length___ ___cm Abdominal Circumference _________cm  Symmetrical intrauterine growth restriction IUGR (<5% EFW) Asymmetrical IUGR (HC<FL or HC<AC)
	Intracranial calcifications  No  Yes Ventriculomegaly  No  Yes
	Cerebral atrophy  No  Yes Ocular anomalies  No  Yes
	Cerebellar abnormalities  No  Yes Arthrogryposis  No  Yes
	Corpus callosum abnormalities  No  Yes Hydrops  No  Yes
	Ascites  No  Yes Other  No  Yes, describe
Description of abnormal ultrasound findings:
Fetal MRI performed:  No  Yes (please answer questions below)
__/__/____ Check if date approximated If date not known, gestational age ____ weeks	Overall fetal MRI Results: Normal Abnormal Check if report by patient/healthcare provder Head Circumference ___cm  Normal  Abnormal Biparietal diameter ___ cm Femur Length _______cm  Symmetrical IUGR (<5% EFW)  Asymmetrical IUGR (HC<FL or HC <AC)
	Intracranial calcifications  No  Yes Ventriculomegaly  No  Yes
	Cerebral atrophy  No  Yes Ocular anomalies  No  Yes
	Cerebellar abnormalities  No  Yes Arthrogryposis  No  Yes
	Corpus callosum abnormalities  No  Yes Lissencephaly No Yes Pachygyria No Yes Hydranencephaly No Yes Porencephaly No Yes Hydrops  No  Yes
	Ascites  No  Yes Other No Yes, describe
Description of abnormal MRI findings:
	Amniocentesis performed:  No  Yes (date: __/__/____) Zika virus testing: Not performed Yes, if yes test results: lab evidence of Zika negative for Zika Non-Zika infection detected No Yes if yes, what infection was detected________________ Genetic abnormality detected No Yes Please describe:
Provider Information
Provider name:  Dr.  PA  RN  Mr.  Ms. ______________ Phone: ____________ Email: _____________ Date of form completion __/__/____
Name of person completing form (if different from provider): _________________ Hospital/facility:_________________ Phone:__________________ Email:_______ Date of form completion __/__/____
Provider Information
Name of person completing form:______________ Phone: ______ Email:_______ Date of form completion __/__/____
FOR INTERNAL CDC USE ONLY Mother ID:_______ State ID:________ Zika T ID:________
R number: __________ Mother infection type:  Confirmed  Probable  Possible

Assessment at Delivery Form (Att. F)

N/A

Birth Certificate ID: ________________

N/A

Infant’s State/Territory ID ________________

N/A

Mother’s State/Territory ID _______________

Sex: Male Female

Sex: Male Female Ambiguous/undetermined

Gestational age at delivery:___ weeks

Gestational age at delivery:___ weeks

Based on: (check all that apply) LMP __/__/____ U/S (1^st trimester) U/S (2^nd trimester) U/S (3^rd trimester Other _____

Delivery type:  Vaginal  Forceps/suction  Caesarean section

Delivery type:  Vaginal  Caesarean section Delivery complication:  No  Yes If yes, ______

N/A

Arterial Cord blood pH: if performed _______

Venous Cord blood pH: if performed _______

Placental exam (pathologist): No Yes

Placental exam (based on path report): No Yes

If yes, Normal Abruption Inflammation Other abnormality (please describe)

N/A

Apgar score: 1 min______/5 min_______

Infant temp at delivery: ________ ^oF

Infant temp (if abnormal): ________ ^oF

Head circumference: cm in

Birth head circumference: ____cm ___in

molding present

N/A

Repeat head circumference: ______cm _______in

<24 hours 24-35hrs 36-48 hr 48+hr

Admitted to NICU: No Yes

Admitted to Neonatal Intensive Care Unit: ______ No Yes, If yes, reason­__________

Microcephaly No Yes

Microcephaly (head circumference <3%ile): No Yes

N/A

Seizures: No Yes

Neurologic abnormalities: No Yes (please describe)

Neurologic exam: check all that apply Nor performed Unknown Normal Hypertonia/Spasticity Hyperreflexia Irritability Tremors Other Neurologic abnormalities (please describe below)

Splenomegaly: No Yes (please describe)

Splenomegaly by physical exam: No Yes Unknown (please describe)

Hepatomegaly: No Yes (please describe)

Hepatomegaly by physical exam: No Yes Unknown (please describe)

Skin rash: No Yes (please describe)

Skin rash by physical exam: No Yes Unknown (please describe)

Other abnormalities identified: No Yes (please provide clinical descriptions from medical records)

Other abnormalities identified: (please provide clinical description from medical records and include chromosomal abnormalities and syndromes); please check all that apply

None Microphthalmia Absent red reflex Excessive and redundant scalp skin Arthrogryposis (congenital joint contractures) Congenital Talipes Equinovarus (clubfoot) Other abnormalities (please describe below)

Hearing evaluation performed: Normal Abnormal (please describe) Not done

Hearing screening: (date:__/__/____) Pass Fail or referred Not performed (please describe below)

Ophthalmologic evaluation performed: Normal Abnormal (please describe) Not done

Retinal exam (with dilation): Not Performed Unknown If performed: (date:__/__/____) please check all that apply: Microphthalmia Chorioretinitis Macular pallor Other retinal abnormalities (please describe below)

Imaging study result: N/A Normal Abnormal (please list type, date, and describe)

Imaging study: Cranial ultrasound (date:__/__/____) MRI (date:__/__/____) CT (date:__/__/____) Not performed

Findings: check all that apply Microcephaly Cerebral (brain) atrophy Intracranial calcification Ventricular enlargement Lissencephaly Pachygyria Hydranencephaly Porencephaly Abnormality of corpus callosum Other abnormalities (please describe below)

Lumbar puncture performed: No Yes If yes, Normal Abnormal (please describe)

Was a lumbar puncture performed: Yes No Unknown (date:__/__/____)

TORCH testing result:  Not done  Negative  Positive (if positive, please specify pathogen and test (e.g., PCR, IgG, IgM))

Congenital infection testing: if performed, please specify test (i.e. PCR, IgG, IgM)

	Toxoplasmosis	Cytomegalovirus	Herpes Simplex	Rubella	Other
Positive
Negative
Not Done
Date

Other tests/results:

Other tests/results/diagnosis (include dates):

Provider name Dr. PA RN Mr. Ms. __________________ Phone:_________________

Email: _________________

Neonatal Provider name: Dr. PA RN Mr. Ms. __________________ Phone:_________________ Email: _________________ Date of form completion __/__/____

N/A

Pediatric Provider Name: Dr. PA RN Mr. Ms. __________________ Phone:_________________ Email: _________________ Date of form completion __/__/____

Name of person completing form: (if different from provider): Hospital/facility:________ Phone:_______

Name of person completing form: (if different from provider)______ Hospital/facility:______ Phone:_____ Name of Infant Pediatrician:________ Phone:______ Email:________ Date of form completion __/__/____

N/A

Health Department Information

Name of person completing form:______________

Phone:________ Email:_______ Date of form completion __/__/____

Infant Health Follow-up Form (Att. G)

N/A

DOB: ______________

N/A

Infant’s State/Territory ID:

Mother’s State/Territory ID:

N/A

Sex: Male Female Ambiguous/undetermined

N/A

Infant death: No Yes, date __/__/____ Unknown

Infant physical exam: Normal Abnormal (please describe)

Infant findings for corrected age at examination: (For infants born preterm, please account for corrected age: chronological age minus weeks born before 40 weeks gestation)

Check all that apply: Microcephaly (head circumference <3%ile) Arthrogryposis (congenital joint contractures) Hypertonia/Spasticity Splenomegaly Absent red reflex Congenital Talipes Equinovarus (clubfoot) Hyperreflexia Hepatomegaly Excessive and redundant scalp skin Irritability Tremors Skin rash Microphthalmia Swallowing/feeding difficulties Please list other abnormal findings:

Infant development: Normal Abnormal (please describe)

Development assessment for corrected age at examination: (For infants born preterm, please account for corrected age: chronological age minus weeks born before 40 weeks gestation) Normal Abnormal Unknown

If developmental delay, in what area? Please check all that apply Gross motor Fine motor Cognitive, linguistic and communication Socio-Emotional

CT/other imagine scan: Yes No

Imaging study: Cranial ultrasound (date:__/__/____) MRI (date:__/__/____) CT (date:__/__/____) Other _________ Not Performed

Findings: check all that apply Microcephaly Cerebral (brain) atrophy Intracranial calcification Ventricular enlargement Lissencephaly Pachygyria Hydranencephaly Porencephaly Abnormality of corpus callosum Other abnormalities (please describe below)

Hearing evaluation performed: Yes No

Hearing screening or re-screening: Not performed Unknown If performed: (date:__/__/____) Pass Fail or referred, please describe

Dysmorphology exam: Yes No

Audiological evaluation: Not performed Unknown If performed: (date:__/__/____) Normal Abnormal, please describe

Ophthalmologic exam: Yes No

Retinal exam (with dilation): Not Performed Unknown If performed: (date:__/__/____) please check all that apply: Microphthalmia Chorioretinitis Macular pallor Other retinal abnormalities (please describe below)

Other (please describe): Yes No

Other abnormal tests/results/diagnosis (include dates): No  Yes (date: __/__/____) Please describe

Provider name Dr. PA RN Mr. Ms. __________________ Phone:_________________

Email: _________________

Neonatal Provider name: Dr. PA RN Mr. Ms. __________________ Phone:_________________ Email: _________________ Date of form completion __/__/____

N/A

Pediatric Provider Name: Dr. PA RN Mr. Ms. __________________ Phone:_________________ Email: _________________ Date of form completion __/__/____

Name of person completing form: (if different from provider): Hospital/facility:________ Phone:_______

Name of person completing form: (if different from provider)______ Hospital/facility:______ Phone:_____ Name of Infant Pediatrician:________ Phone:______ Email:________ Date of form completion __/__/____

N/A

Health Department Information

Name of person completing form:______________

Phone:________ Email:_______ Date of form completion __/__/____

Estimates of Annualized Burden hours (unchanged from approved ICR)

Type of Respondent	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
State and Local Health Departments	Clinical Inquiries Database	420	1	15/60	105
	Maternal Health History Form	100	5	30/60	250
	Specimen Collection Form	100	1	15/60	25
Clinicians and Other Providers	Clinical Inquiries Database	800	1	15/60	200
	Assessment at Delivery Form	100	1	30/60	50
	Infant Health Follow-Up Form at 2 months of age	100	1	30/60	50
Vector control professionals, entomologists, and Public health biologists	Survey of county-level surveillance records of Aedes aegypti and Aedes albopictus	500	1	3/60	25
Total					705

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