Research Determination

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Download: pdf

Print Date: 5/21/26

Title:

Performance Measures Project

Project Id:

0900f3eb826b2025

Accession #:

OPPE-EEU-5/18/26-b2025

Project Contact:

Clay Cooksey

Organization:

OPPE/PEO/PEOB/EEU

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

07/01/2026

Estimated Completion Date:

06/29/2029

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:
OMB Discontinuation Date:

Determinations

0920-1282

Determination

Justification

Completed

Entered By & Role

5/20/26

Chirila_Robert (uno4) CIO HSC

5/20/26

Zirger_Jeffrey (wtj5) OMB / PRA

5/20/26

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: 6/13/23
OMB Expiration date: 6/30/26

Description & Funding
Description
Priority:

Higher Priority

Date Needed:

05/27/2026

Priority Justification:

Current GenIC expires June 30,2026. ICRO needs research determination for processing new GenIC package

CDC Priority Area for this Project:

Other CDC Priority - Performance and Evaluation

Determination Start Date:

05/19/26

Description:

Generic Information Collection for NOFO program performance measures

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

To provide a flexible and timely approval framework that facilitates the collection of information needed to measure and improve the
performance of recipients of CDC/ATSDR funding. Through participation in the Performance Measures Project (PMP), CDC/ATSDR
programs and recipients will: 1) Develop strong performance measurement tools and practices; 2) define and operationalize priority
performance measures tailored to a specific public health initiative; and 3) establish common data collection and reporting
expectations across all recipients.

Objective:

CDC#s Performance Measures Project (PMP) will work with up to 40 new CDC programs. The number of recipients per CDC
/ATSDR program will vary dependent on program activity, and the expected average is approximately 35 recipients per program.

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Public Health

CDC's Role:

CDC employees will provide substantial technical assistance or oversight

Method Categories:

Technical Assistance

Methods:

Respondents will be recipients of CDC/ATSDR funding. CDC#s Performance Measures Project (PMP) will work with up to 40 new
CDC programs. The number of recipients per CDC/ATSDR program will vary dependent on program activity, and the expected
average is approximately 35 recipients per program. Data will be analyzed by the CDC/ATSDR program to assess recipient
progress toward the key outcomes defined by the public health initiative. The information collected is meant primarily for program
improvement and accountability; it is not intended to be used as the principal basis for policy decisions.

Collection of Info, Data or Biospecimen:

Participating CDC/ATSDR programs will provide the program-specific information collection forms to each recipient to facilitate
standardized performance data collection at the local level. Recipients will report these standardized performance data directly to
CDC/ATSDR programs on a periodic basis to assess progress toward achieving desired program outcomes as defined by the
program. The default periodic basis is annual reporting, but programs may propose alternate reporting schedules if needed.

Expected Use of Findings/Results and their impact:

The intended use of the resulting data is to generate general purpose statistics, to assess program progress (at both the local
recipient-specific and CDC/ATSDR program-wide levels), to provide data that can inform program evaluation, to assist with program
planning/management, and to improve the accountability of federal funds provided to recipients.

Could Individuals potentially be identified based on
Information Collected?

No

Dual Use Research potential?:

No

Funding

Funding yet to be added .....

HSC Review

HSC Attributes
Program Evaluation

Yes

Quality Assurance / Improvement

Yes

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
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

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

Staff
Staff
Member

SIQT
Exp.
Date

Destiny
Bruce

07/10
/2026

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

CITI Good Clinical
Practice Exp. Date

CITI Good Laboratory
Practice Exp. Date

Staff Role

Email

Phone

Organization

Project
Coordinator

rln0@cdc.
gov

4046390764

PERFORMANCE MONITORING
AND ACCOUNTABILITY UNIT

Data
DMP
Proposed Data Collection Start Date:

7/1/26

Proposed Data Collection End Date:

6/29/29

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

CIO conducting this project does not fund or own the data and is not responsible for making it available

Public Access Justification:

The data is managed by the CIO, not OPPE

How Access Will Be Provided for Data:

This is controlled by the CIO

Plans for Archival and Long Term Preservation:

This is managed by the CIO

Spatiality
Country

State/Province

County/Region

United States

Supporting Info
Current

Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

05/20/2026

NOA 0920-1282 (2023)

Notice of Action

NOA 0920-1282_2023.pdf

Cooksey_Clay
(zwx2)
Project Contact

05/19/2026

Current PMP Guidance that
demonstrates what is required of
participating programs

Other-Enter new type

PMP GenIC Package Guidance.docx