Human Subjects Determination: IRB Approval is Not Required

Print Date: 11/5/24

Title:

NCEHATSDR Service Delivery (Generic Clearance)

Project Id:

0900f3eb81cc43d8

Accession #:

-NCEH-3/10/21-c43d8

Project Contact:

Yan S Ding

Organization:

NCEH/ATSDR

Status:

Project In Progress

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

8/5/24

Dignam_Timothy A. (ted9) CIO HSC

8/5/24

Dignam_Timothy A. (ted9) CIO OMB / PRA

8/5/24

Zirger_Jeffrey (wtj5) ICRO Reviewer

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation
Quality Assurance / Improvement

PRA:
PRA Applies

ICRO:
PRA Applies

OMB Approval date: 2/17/22
OMB Expiration date: 2/28/25

Description & Funding
Description
Priority:

Standard

Priority Justification:
CDC Priority Area for this Project:

Not selected

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/Lab-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Submitted through IMS Clearance Matrix:

Not selected

Primary Scientific Priority:

Not selected

Secondary Scientific Priority (s):

Not selected

Task Force Responsible:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Lab-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.

Does your project measure health disparities among Not Selected
populations/groups experiencing social, economic,
geographic, and/or environmental disadvantages?:
Does your project investigate underlying
contributors to health inequities among populations
/groups experiencing social, economic, geographic,
and/or environmental disadvantages?:

Not Selected

Does your project propose, implement, or evaluate
an action to move towards eliminating health
inequities?:

Not Selected

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
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.

Methods:

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 and their impact:

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 (including
coded data)?:

Yes

Is this project covered by an Assurance of
Confidentiality?

No

Does this activity meet the criteria for a Certificate
of Confidentiality (CoC)?

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

Funding #

Original Budget Yr

# Years Award

Budget Amount

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 require review by
a CDC IRB or HRPO?

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

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 HIPAA 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

No Selection

future
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

Will you be working with an outside Organization or Institution? Yes
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp.
Date

CITI
Biomedical
Exp. Date

Sharon
Flores

09/01
/2026

06/07/2027

Yan
Ding

06/26
/2026

06/26/2027

CITI Social &
Behavioral Exp.
Date

CITI Good Clinical
Practice Exp. Date

12/01/2026

Data
DMP
Proposed Data Collection Start Date:

2/1/22

Proposed Data Collection End Date:

1/31/25

Proposed Public Access Level:

Non-Public

CITI Good Laboratory
Practice Exp. Date

Staff Role

Email

Phone

Organization

CoInvestigator

fil4@cdc.
gov

7704884182

NATIONAL CENTER FOR
ENVIRONMENTAL HEALTH

Principal
Investigator

yad6@cdc.
gov

7704887934

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...

Supporting Info

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

08/05/2024

NOA 0923-0047 (2022)

Notice of Action

NOA 0923-0047_2022.pdf

Current

Ding_Yan
(Shirley) (yad6)
Project Contact

08/05/2024

60D FRN ATSDR

Paperwork Reduction Act Form

0 - 60-day_FRN_ATSDR_0923-0047 Generic Service
Delivery.docx

Current

Ding_Yan
(Shirley) (yad6)
Project Contact

08/05/2024

60D FRN request

Paperwork Reduction Act Form

0 - 60-day FRN Request 0923-0047 Generic Service
Delivery.docx

Davis_Stephanie
I. (sgd8)
CIO OMB / PRA

03/11/2021

60D Federal Register Notice
package for OMB Control No.
0923-0047; expiration date 01/31
/2022

Other

0923-0047 Final 60 day 2021 Extension to ICRO.zip

Abel_Jason A.
(jza5)
CIO HSC

03/11/2021

Updated 60 day package

Other

0923-0047 60 day 2021 Extension Updated per OS review.
zip

Davis_Stephanie
I. (sgd8)
CIO HSC

03/11/2021

Zipfile of 60-day Files with
comments and edits

Other

0923-0047 60D 2021 Extnsn rev OS.zip

Abel_Jason A.
(jza5)
Project Contact

03/10/2021

60 day PRA package

Other-60 day PRA package

0923-0047 60 day 2021 Extension.zip