Research determination

Att8a NCEH-ATSDR Research Determination Form.pdf

Behavioral Risk Factor Surveillance System (BRFSS) Asthma Call-back Survey (ACBS)

Research determination

OMB: 0920-1204

Document [pdf]
Download: pdf | pdf
Print Date: 5/5/20

Title:

OMB Renew Document of BRFSS Asthma Call-back Survey (ACBS)

Project Id:

0900f3eb81b0af81

Accession #:

NCEH-AST-3/26/20-0af81

Project Contact:

Qin_Xiaoting (csk5)

Organization:

NCEH/ATSDR/DEHSP/ACHB/AST

Status:

Pending Clearance

Intended Use:

Project Determination

Estimated Start Date:

03/26/2020

Estimated Completion Date:

05/06/2020

CDC/ATSDR HRPO/IRB Protocol #:

IRB excempt for BRFSS

OMB Control #:

OMB No. 920-1204

Determinations
Determination

Justification

Completed

Entered By & Role

HSC:
Does NOT Require HRPO
Review

Not Research

5/5/20

Davis_Stephanie I. (sgd8) CIO HSC

5/5/20

Davis_Stephanie I. (sgd8) CIO OMB / PRA

PRA:
PRA Applies

Description & Funding
Description
Priority:

Standard

Date Needed:

05/06/2020

Determination Start Date:

03/26/20

Description:

??This is a revision ICR for the Behavioral Risk Factor Surveillance System (BRFSS) Asthma Call-back Survey (ACBS). ACBS will
produce state- or jurisdiction-level data about asthma. The goal of this information collection is to add in-depth data about those with
asthma (e.g., symptoms, environmental factors, medication use etc.) and their experiences (e.g., activity limitation, health system
use, self-management education, etc.). ACBS in approved under OMB Control No. 0920-1204, expiration date 11/30/2020. CDC is
seeking PRA clearance to revise and to continue to collect state level asthma data for next three-year cycle. This package includes
Supporting Statements A and B, attachments, and other required supporting information. A new proposal has been made to revise
the survey protocol to improve ACBS response. The revisions include three significant changes: 1. To recommend the ACBS
interview be done within two days of the BRFSS interview, instead of two weeks; 2. Instead of identifying the most knowledge
person at beginning of ACBS, to identify the most knowledge person at the end of BRFSS, record it in the state-added questions
section, and not record it in the public release data; and 3. If both the randomly selected child and adult responding to the BRFSS
have a diagnosis of asthma, increasing the child proportion from 75% up to 100% in order to maximize child sample size.

IMS/CIO/Epi-Aid/Chemical Exposure Submission:

No

IMS Activation Name:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

CDC is requesting a three-year Paperwork Reduction Act (PRA) clearance to revise and to continue to collect information under the
Behavioral Risk Factor Surveillance System (BRFSS) Asthma Call-back Survey (ACBS) (OMB Control No. 0920-1204, expiration
date 11/30/2020)

Objective:

Current ACBS OMB number: 920-1204, expired at 11/30/2020. CDC is seeking PRA clearance to continue to collect state level
asthma data for next three year cycle.

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Surveys and Questionnaires

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided

Method Categories:

Survey
Data will be collected through a follow-up survey approximately two days after the Behavioral Risk Factor Surveillance System

Methods:

(BRFSS) survey is administered. The ACBS is an ongoing data collection administered, on behalf of NCEH, by CDC#s National
Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) through their BRFSS cooperative agreement under CDCRFA DP15-1513 (BRFSS, OMB Control No. 0920-1061, expiration date 3/31/2021). The ACBS is an in-depth asthma survey that
contains questions on asthma such as medication use, symptoms, health care use, and disease management. The respondent will
be either an adult (BRFSS respondent) or child (chosen using the Random Child Selection and Childhood Asthma Prevalence
module) who has ever had asthma. The ACBS sample includes all cases meeting the qualification criteria in BRFSS. ACBS will only
conduct one call-back interview per household. In order for a state to include children in the ACBS, it must have the Random Child
Selection and Childhood Asthma Prevalence modules in the BRFSS. If a randomly selected child with response on the BRFSS has
a diagnosis of asthma, then he/she is eligible for the ACBS. If both the randomly selected child and adult responding to the BRFSS
have a diagnosis of asthma, then one is eligible for the ACBS through a 75/25 split. NCEH/DEHSP/ACHB funds Behavioral Risk
Factors Surveillance System (BRFSS) for Asthma-Call-back Survey (ACBS) annually. The BRFSS provides funding to each
recipients/jurisdictions using cooperative agreement for them to conduct ACBS in their jurisdiction. Each recipient/jurisdiction has
their own methods of collecting data, whether to use contractor or not.

Collection of Info, Data or Biospecimen:

1. CDC annually provides the ACBS questionnaire and compiles requests regarding the questionnaire modifications from states and
sends the requests to the questionnaire work group. This work group is comprised of state epidemiologists and CDC Health
Scientists, who review and vote on proposed changes and new questions. Questionnaire revisions are described in the supporting
documents part A1. All states use the same ACBS questionnaire. CDC also produces data processing layouts. 2. Information
collection is conducted by telephone interview. CDC provides Computer-Assisted Telephone Interviewing (CATI) programming to
states for their use. States may also opt to use their own CATI programming software. 3. ACBS awardees are responsible for field
operations and to determine how their data will be collected within the BRFSS and ACBS guidelines. States may collect data using
in-house calling centers, hire vendors using RFP procedures, or contract with universities. The data collector is the same for BRFSS
and ACBS. Data collectors must develop and maintain procedures to ensure respondents# privacy, assure and document the
quality of the interviewing process, and supervise and monitor the interviewers. Files containing phone numbers must be maintained
separately from any files containing responses. 4. States submit de-identified data files to CDC on a monthly or quarterly basis for
cleaning and weighting. CDC returns clean, weighted data files to the state of origin for its use. Through the BRFSS ACBS website,
CDC also makes cleaned subsets of state data files available for public use, along with information about the source of sample
(landline or cell phone), weighting, and any restrictions on publication or use of the data (https://www.cdc.gov/brfss/acbs/index.htm).

Expected Use of Findings/Results:

CDC National Asthma Control Program (NACP) uses BRFSS ACBS data to plan for and evaluate public health programs at the
(sub) state level. Information collected will be used by asthma control programs located in state health departments and at the
federal level to improve tracking the disease, and for planning and evaluating interventions to reduce the disease burden. For most
states, ACBS data is the only source of asthma related health information that is targeted to state asthma prevention and
intervention and needs.

Could Individuals potentially be identified based on
Information Collected?

Yes

Will PII be captured (including coded data)?

Yes

Does CDC have access to the identifiers?

No

Is an assurance of confidentiality in place or
planned?

No

Is a certificate of confidentiality in place or planned? No
Is there a formal written agreement prohibiting the
release of identifiers?

No

Funding

Funding Type

Funding Title

CDC Cooperative Agreement

CDC-RFA DP15-1513

Funding #

Original Budget Yr

# Years Award

Review Attributes

Public Health Surveillance

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office

No

Estimated number of study participants

Population - Children

N/A

Population - Minors

N/A

Population - Prisoners

N/A

Population - Pregnant Women

N/A

Population - Emancipated Minors

N/A

Suggested level of risk to subjects Do you anticipate this project will be exempt research or non-exempt research
Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested documents of informed consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological

No Selection

specimens
Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Institutions yet to be added .....

Staff
Staff
Member

SIQT Exp.
Date

CITI Biomedical
Exp. Date

Hatice
Zahran

10/25/2021

11/28/2021

Xiaoting
Qin

12/12/2021

CITI Social & Behavioral
Exp. Date

09/14/2019

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

Principal
Investigator

hbz4@cdc.
gov

770-4881509

ASTHMA AND COMMUNITY
HEALTH BRANCH

Principal
Investigator

csk5@cdc.
gov

770-4880797

ASTHMA SURVEILLANCE TEAM

Data
DMP
Proposed Data Collection Start Date:

1/1/21

Proposed Data Collection End Date:

4/1/24

Proposed Public Access Level:

Public

Public Access Justification:

States submit de-identified data files to CDC on a monthly or quarterly basis for cleaning and weighting. CDC returns clean,
weighted data files to the state of origin for its use. Through the BRFSS ACBS website, CDC also makes cleaned subsets of state
data files available for public use, along with information about the source of sample (landline or cell phone), weighting, and any
restrictions on publication or use of the data (https://www.cdc.gov/brfss/acbs/index.htm).
ACBS sample files from BRFSS asthma eligible respondents, include phone numbers only. Since sample files are separate from

datasets, no phone numbers are included in the datasets. No dates of birth, last names, or email address are obtained. Information
that details race/ethnicity, occupation and small geographic residence (such as county or zip code) is transferred from BRFFS and
suppressed in the public use dataset based on BRFSS protocol. In order to determine which variables to suppress, the BRFSS
ACBS uses the HHS Safe Harbor guidelines (https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification
/index.html).

How Access Will Be Provided for Data:

Plans for Archival and Long Term Preservation:

Spatiality

Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset Title

Dataset yet to be
added...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External Access
URL

Download
URL

Type of Data
Released

Collection Start
Date

Collection End
Date


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