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:
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 with laboratory evidence of Zika virus infection who do not meet the current CSTE definition of Zika virus disease, and infants who do not meet the current definition of congenital Zika virus infection and 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
Public Health Service Act (42 USC 241)
Draft 60-day FRN
Website information - Zika Virus Disease and Pregnancy Registry (changes requested)
Overview letter (changes requested)
Maternal Health History Form (changes requested)
Assessment at Delivery Form (changes requested)
Infant Health Follow-Up Form (changes requested)
Specimen Collection Form
Domestic ZIKA Clinical Inquiries Database
Survey of county-level surveillance records of Aedes aegypti and Aedes albopictus from 2000 to present
IRB Approval – EOC call center
IRB Approval – Mosquito surveillance survey
IRB Approval – Pregnancy Register (updated)
Pregnancy Registry Information Sheet (changes requested)
Developmental Milestones for Infant (new)
Fact Sheet for Obstetric Healthcare Providers (new)
Fact Sheet for Pediatric Healthcare Providers (new)
Fact sheet for Health Departments (new)
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 cases of zika virus infection among pregnant women with laboratory evidence of infection but no reported symptoms.
To clarify that CDC plans to collect information from health departments and clinicians about pregnant women and pre- or perinatally exposed infants, whether or not they meet the case definition for confirmed or probable 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.
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
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Requested Change |
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Maternal Health History Form (Att. E) |
Mother’s name: ____________
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Mother’s name: _____Last _______First ____MI Maiden name (if applicable) _______________ State/Territory ID:_______________
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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 |
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Indication for maternal serum Zika virus testing: ___________________
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Indication for maternal Zika virus testing: Exposure history, no known fetal concerns Exposure history and fetal concerns |
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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 |
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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 _________________
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N/A |
Was Zika virus infection acquired in place of residence No Yes, if yes, skip to the section on Mother’s pregnancy |
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Countr(ies) of exposure: _________ Date of travel1:________ _________ Date of travel2:________ _________ Date of travel3:________
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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 __/__/____
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N/A |
Mother’s sexual partner(s)? please check all that apply Male Female |
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N/A |
Did any male sexual partner(s) travel on this trip? No Yes |
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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 |
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N/A |
If male partner(s) travelled, did he have a test that showed lab evidence of Zika? No Yes |
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Mother agrees to participate in this Pregnancy Registry |
N/A [Removed] |
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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
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N/A |
Last menstrual period (LMP): __/__/____ |
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N/A |
Estimated delivery date based on (check all that apply): LMP __/__/____ U/S (1st trimester) U/S (2nd trimester) U/S (3rd trimester) |
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N/A |
History: # pregnancies ___ # living children ___ # miscarriages ___ # elective terminations ___
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N/A |
Prior fetus/infant with microcephaly: No Yes If yes, genetic cause: No Yes |
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Current gestation: Single Twins Triplets |
Gestation: Single Twins Triplets+ |
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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: _________________
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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 ________________
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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__________________________
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N/A |
Did this pregnancy end in miscarriage or intrauterine fetal demise (IUFD)? No Yes Date: __/__/____ Gestational age____ weeks |
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N/A |
Was this pregnancy terminated? No Yes Date:__/__/____ Gestational age ____ weeks |
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N/A |
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Assessment at Delivery Form (Att. F)
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N/A |
Birth Certificate ID: ________________ |
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N/A |
Infant’s State/Territory ID ________________ |
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N/A |
Mother’s State/Territory ID _______________ |
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Sex: Male Female |
Sex: Male Female Ambiguous/undetermined |
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Gestational age at delivery:___ weeks
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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 _____ |
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Delivery type: Vaginal Forceps/suction Caesarean section |
Delivery type: Vaginal Caesarean section Delivery complication: No Yes If yes, ______
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N/A |
Arterial Cord blood pH: if performed _______ Venous Cord blood pH: if performed _______ |
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Placental exam (pathologist): No Yes |
Placental exam (based on path report): No Yes If yes, Normal Abruption Inflammation Other abnormality (please describe)
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N/A |
Apgar score: 1 min______/5 min_______ |
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Infant temp at delivery: ________ oF |
Infant temp (if abnormal): ________ oF |
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Head circumference: cm in |
Birth head circumference: ____cm ___in molding present |
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N/A |
Repeat head circumference: ______cm _______in <24 hours 24-35hrs 36-48 hr 48+hr |
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Admitted to NICU: No Yes |
Admitted to Neonatal Intensive Care Unit: ______ No Yes, If yes, reason__________ |
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Microcephaly No Yes |
Microcephaly (head circumference <3%ile): No Yes |
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N/A |
Seizures: No Yes |
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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)
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Splenomegaly: No Yes (please describe) |
Splenomegaly by physical exam: No Yes Unknown (please describe) |
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Hepatomegaly: No Yes (please describe) |
Hepatomegaly by physical exam: No Yes Unknown (please describe) |
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Skin rash: No Yes (please describe) |
Skin rash by physical exam: No Yes Unknown (please describe) |
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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) |
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Hearing evaluation performed: Normal Abnormal (please describe) Not done |
Hearing screening: (date:__/__/____) Pass Fail or referred Not performed (please describe below) |
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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) |
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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) |
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Lumbar puncture performed: No Yes If yes, Normal Abnormal (please describe) |
Was a lumbar puncture performed: Yes No Unknown (date:__/__/____) |
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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)
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Other tests/results: |
Other tests/results/diagnosis (include dates):
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Provider name Dr. PA RN Mr. Ms. __________________ Phone:_________________ Email: _________________ |
Neonatal Provider name: Dr. PA RN Mr. Ms. __________________ Phone:_________________ Email: _________________ Date of form completion __/__/____ |
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N/A |
Pediatric Provider Name: Dr. PA RN Mr. Ms. __________________ Phone:_________________ Email: _________________ Date of form completion __/__/____
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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 __/__/____ |
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N/A |
Health Department Information Name of person completing form:______________ Phone:________ Email:_______ Date of form completion __/__/____ |
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Infant Health Follow-up Form (Att. G)
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N/A |
DOB: ______________ |
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N/A |
Infant’s State/Territory ID: Mother’s State/Territory ID: |
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N/A |
Sex: Male Female Ambiguous/undetermined |
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N/A |
Infant death: No Yes, date __/__/____ Unknown |
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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: |
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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
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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)
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Hearing evaluation performed: Yes No |
Hearing screening or re-screening: Not performed Unknown If performed: (date:__/__/____) Pass Fail or referred, please describe
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Dysmorphology exam: Yes No |
Audiological evaluation: Not performed Unknown If performed: (date:__/__/____) Normal Abnormal, please describe
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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) |
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Other (please describe): Yes No |
Other abnormal tests/results/diagnosis (include dates): No Yes (date: __/__/____) Please describe |
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Provider name Dr. PA RN Mr. Ms. __________________ Phone:_________________ Email: _________________ |
Neonatal Provider name: Dr. PA RN Mr. Ms. __________________ Phone:_________________ Email: _________________ Date of form completion __/__/____ |
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N/A |
Pediatric Provider Name: Dr. PA RN Mr. Ms. __________________ Phone:_________________ Email: _________________ Date of form completion __/__/____
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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 __/__/____ |
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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 |
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
Author | Samuel, Lee (CDC/OID/NCEZID) |
File Modified | 0000-00-00 |
File Created | 2021-01-24 |