Human Subjects Determination: IRB Approval is Not Required

Print Date: 3/11/21

Title:

NCEHATSDR Service Delivery (Generic Clearance)

Project Id:

0900f3eb81cc43d8

Accession #:

-NCEH-3/10/21-c43d8

Project Contact:

Abel_Jason A. (jza5)

Organization:

NCEH/ATSDR

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

02/01/2022

Estimated Completion Date:

01/31/2025

CDC/ATSDR HRPO/IRB Protocol #:

NA

OMB Control #:

0923-0047

Determinations
Determination

Justification

Completed

Entered By & Role

3/11/21

Davis_Stephanie I. (sgd8) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation
Quality Assurance / Improvement
Other - Service Delivery and Program Improvement

PRA:
PRA Applies

3/11/21

Davis_Stephanie I. (sgd8) CIO OMB / PRA

Description & Funding
Description
Priority:

Standard

Determination Start Date:

03/10/21

Description:

This is a request to publish the 60-day Federal Register Notice for ATSDR #Generic Clearance for the Collection of Qualitative
Feedback on Agency Service Delivery# (OMB Control No. 0923-0047; expiration date 01/31/2022). The information collection
activity provides a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with
the Federal government#s commitment to improving service delivery. By qualitative feedback we mean information that provides
useful insights on perceptions and opinions, but are not statistical surveys that yield quantitative results that can be generalized to
the population of study.

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

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

This feedback will provide insights into customer or stakeholder perceptions, experiences and expectations, provide an early
warning of issues with service, or focus attention on areas where communication, training or changes in operations might improve
delivery of products or services. These collections will allow for ongoing, collaborative and actionable communications between the
Agency and its customers and stakeholders. It will also allow feedback to contribute directly to the improvement of program
management.

Objective:

The solicitation of feedback will target areas such as: timeliness, appropriateness, accuracy of information, courtesy, efficiency of
service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or
maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and
stakeholders on the Agency#s services will be unavailable.

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Feedback

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, CDC employees or agents will obtain data by intervening or interacting
with participants, CDC employees or agents will obtain or use anonymous or unlinked data or biological specimens, CDC
employees or agents will obtain or use identifiable (including coded) private data or biological specimens, CDC employees will
participate as co-authors in presentation(s) or publication(s), CDC employees will provide substantial technical assistance or
oversight

Method Categories:

Discussion Group; Focus Group; Individual Interviews (Qualitative); Needs Assessment; QA/QI

Methods:

ATSDR will only submit a collection for approval under this generic clearance if it meets the following conditions: # The collections
are voluntary; # The collections are low-burden for respondents (based on considerations of total burden hours, total number of
respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government; # The
collections are noncontroversial and do not raise issues of concern to other Federal agencies; # Any collection is targeted to the
solicitation of opinions from respondents who have experience with the program or may have experience with the program in the
near future; # Personally identifiable information (PII) is collected only to the extent necessary and is not retained; # Information
gathered is intended to be used only internally for general service improvement and program management purposes and is not
intended for release outside of the agency (if released, the agency must indicate the qualitative nature of the information); #
Information gathered will not be used for the purpose of substantially informing influential policy decisions; and # Information
gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used
as though the results are generalizable to the population of study.

Collection of Info, Data or Biospecimen:

The types of collections that this generic clearance covers include, but are not limited to: # Customer comment cards/complaint
forms # Small discussion groups # Focus Groups of customers, potential customers, delivery partners, or other stakeholders #
Cognitive laboratory studies, such as those used to refine questions or assess usability of a website; # Qualitative customer
satisfaction surveys (e.g., post-transaction surveys; opt-out web surveys) # In-person observation testing (e.g., website or software
usability tests)

Expected Use of Findings/Results:

The solicitation of feedback will target areas such as: timeliness, appropriateness, accuracy of information, courtesy, efficiency of
service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or
maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and
stakeholders on the Agency#s services will be unavailable.

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?

Yes

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

Other-Staff time only - $0

Staff time only - $0

HSC Review

HSC Attributes
Program Evaluation

Yes

Quality Assurance / Improvement

Yes

Other - Service Delivery and Program Improvement

Yes

Additional Ethical Considerations
Resulting data collected are not published but will be
used to improve agency products.

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office
Estimated number of study participants

Population - Children
Population - Minors
Population - Prisoners
Population - Pregnant Women

No

Funding #

Original Budget Yr

# Years Award

Population - Emancipated Minors

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 Waivers of Documentation 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
specimens

No Selection

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

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Stephanie
Davis

02/22
/2024

10/24/2021

08/03/2021

08/15/2014

Data
DMP
Proposed Data Collection Start Date:

2/1/22

Proposed Data Collection End Date:

1/31/25

Proposed Public Access Level:

Non-Public

Staff Role

Email

Phone

Organization

Data Use
Contact

sgd8@cdc.
gov

770-4883676

NATIONAL CENTER FOR
ENVIRONMENTAL HEALTH

Non-Public Details:
Reason For Not Releasing Data:

Other - Quality improvement for ATSDR services

Public Access Justification:

This is a generic IC request to allow gathering of feedback on services provided by ATSDR for the purposes of quality improvement.

How Access Will Be Provided for Data:

Data will be used by ATSDR to evaluate and improve services.

Plans for Archival and Long Term Preservation:

Spatiality

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

Dataset
Dataset
Title

Dataset
Description

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