Non-Substantive Change Request Justification 07APR2016_FINAL

0920-1101 Non-sub Change Request_4_7_16 FINAL.docx

CDC Emergency Operations Center Zika Related Clinical Inquiries and Surveillance

Non-Substantive Change Request Justification 07APR2016_FINAL

OMB: 0920-1101

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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.


  1. 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 (1st trimester) U/S (2nd trimester) U/S (3rd 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 (1st trimester) U/S (2nd trimester) U/S (3rd 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





16


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorSamuel, Lee (CDC/OID/NCEZID)
File Modified0000-00-00
File Created2021-01-24

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