Project Determination

Print Date: 4/18/24

Title:

Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

Project Id:

0900f3eb82368b15

Accession #:

-NCEZID-4/12/24-68b15

Project Contact:

Vice_Rudith (nhr9)

Organization:

NCEZID

Status:

Pending Clearance

Intended Use:

Project Determination

Estimated Start Date:

04/12/2024

Estimated Completion Date:

08/31/2027

CDC/ATSDR HRPO/IRB Protocol #:
0920-1071

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

4/18/24

Youngblood_Laura
L. (zfk9) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation
Other - This GenIC is for the collection of feedback on agency service delivery. Such projects are consistent with the
attributes of non-research program evaluation, as they are designed to gather feedback to improve agency service
delivery. They are not designed to develop or contribute to generalizable knowledge.

PRA:
PRA Applies

4/18/24

Vice_Rudith (nhr9)
OMB / PRA

Description & Funding
Description
Priority:

Standard

Determination Start Date:

04/15/24

Description:

NCEZID is seeking a three-year revision of Generic OMB control No. 0920-1071 (Generic Clearance for the Collection of Qualitative
Feedback on Agency Service Delivery) to continue collecting routine customer feedback on agency service delivery. This Generic
enables CDC to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to
improving service delivery. This Project Determination is for the overarching Service Delivery Generic Information Collection
Request (genICR). Any Generic Information Collections (GenICs) submitted under this genICR will require a separate STARS
Project Determination.

IMS/CIO/Epi-Aid/Lab-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

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The information collected from our customers and stakeholders will help ensure that users have an effective, efficient, and satisfying
experience with the Agency#s programs.

Objective:

The information collected 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.

Does your project measure health disparities among Yes
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?:

Yes

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

No

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Surveys and Questionnaires ; Focus Groups

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:

Focus Group; Survey

Methods:

This Project Determination is for the overarching Service Delivery Generic Information Collection Request (genICR). Any Generic
Information Collections (GenICs) submitted under this genICR will require a separate STARS Project Determination.

Collection of Info, Data or Biospecimen:

A variety of instruments and platforms will be used to collect information from respondents, including but not limited to online
surveys, in-person surveys, focus groups, usability testing, and customer comment cards. The Project Determination for each
GenIC will include specific details about how data or specimens will be collected.

Expected Use of Findings/Results and their impact:

Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to
the overall population. Findings will be used for general service improvement but are not for publication or other public release.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding yet to be added .....

HSC Review

HSC Attributes
Program Evaluation

Yes

Other - This GenIC is for the collection of feedback
on agency service delivery. Such projects are
consistent with the attributes of non-research
program evaluation, as they are designed to gather
feedback to improve agency service delivery. They
are not designed to develop or contribute to
generalizable knowledge.

Yes

Regulation and Policy
Do you anticipate this project will need IRB review
by the CDC IRB, NIOSH IRB, or through reliance on
an external IRB?

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
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

No Selection

exemption or Investigational Device Exemption

Institutions & Staff
Institutions

Will you be working with an outside Organization or Institution? No
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp.
Date

Rudith
Vice

06/27
/2026

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

Project
Coordinator

nhr9@cdc.
gov

4047187292

NATIONAL CENTER FOR EMERGING ZOONOTIC
AND INFECTIOUS DISEASES

Data
DMP
Proposed Data Collection Start Date:

4/15/24

Proposed Data Collection End Date:

4/16/27

Proposed Public Access Level:

Public

Public Access Justification:

Any Generic Information Collections (GenICs) submitted under this genICR will include specific information about public access.

How Access Will Be Provided for Data:

Any Generic Information Collections (GenICs) submitted under this genICR will include specific information about how access will
be provided to the data.

Plans for Archival and Long Term Preservation:

Spatiality

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

Dataset
Dataset
Title

Dataset
Description

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Dataset yet to be added...

Supporting Info
Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Current

Vice_Rudith
(nhr9)
Project Contact

04/15/2024

Supporting Statement A

Paperwork Reduction Act Form

SSA_0920-1071_Revision_STARS.docx

Current

Vice_Rudith
(nhr9)
Project Contact

04/15/2024

GenIC Request Form

Paperwork Reduction Act Form

Service Delivery Gen-IC Request.docx

Collection End
Date