Determination of Non-applicability of Human Subjects Regulations

MAHC_STARS_03072024.pdf

[NCSTLTPHIW] Information Collections to Advance State, Tribal, Local and Territorial (STLT) Governmental Agency System Performance, Capacity, and Program Delivery

Determination of Non-applicability of Human Subjects Regulations

OMB: 0920-0879

Document [pdf]

Download: pdf | pdf

Print Date: 7/31/24

Title:

Use and Acceptability of the Model Aquatic Health Code (2023)

Project Id:

0900f3eb8231ffe5

Accession #:

NCEZID-DWASHEPI-2/29/24-1ffe5

Project Contact:

Pallavi A Kache

Organization:

NCEZID/DFWED/WDPB/DWASHEPI

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

05/01/2024

Estimated Completion Date:

06/30/2026

CDC/ATSDR HRPO/IRB Protocol #:
0920-0879

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

3/6/24

Peterson_James M. (iyr1) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation

PRA:

PRA Applies

ICRO:
PRA Applies

OMB Approval date: 8/29/23
OMB Expiration date: 8/31/26

3/7/24

Vice_Rudith (nhr9) OMB / PRA

3/7/24

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

03/15/2024

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

02/29/24

Description:

The Model Aquatic Health Code (MAHC) is a comprehensive guidance document that provides scientifically based
recommendations to help ensure healthy and safe experiences in pools, hot tubs, and splash pads. The MAHC was first released in
2014, and addresses the design, construction, operation, and management of aquatic facilities open to the public. State, tribal, local,
and territorial (STLT) public health partners can voluntarily use all or parts of the MAHC to create or update their codes to reduce
the risk of illness and injury at public aquatic facilities. Since the MAHC#s release, CDC has focused on developing and keeping the
MAHC current and in line with the scientific literature. As such, the document undergoes a thorough review and revision every 3
years. However, to date, CDC has not formally assessed jurisdictional use of the MAHC, and whether it meets the needs of aquaticfocused public health programs across the United States. Through focus groups and a quantitative survey of STLT partners, CDC
aims to characterize MAHC use, MAHC acceptability across the nation, and identify facilitators and barriers to MAHC utilization.
Results from this assessment will inform decision-making regarding MAHC activities and help optimize the MAHC as a resource for
STLT public health and environmental health partners.

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

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

The overarching goals of this project are to characterize MAHC use, MAHC acceptability, as well as facilitators and barriers to
MAHC use and implementation. Results from this assessment will inform decision making regarding MAHC activities and help
optimize the MAHC as a resource for STLT public health partners. For the purposes of this project, we define MAHC #use# as
MAHC language being incorporated into the jurisdiction#s pool code; or the MAHC being used as a reference to address a gap or
need that is not addressed directly in the jurisdiction#s code. #Implementation# is being defined as the operationalization of code
changes, once MAHC language has been incorporated into a jurisdiction#s pool code (e.g., training of pool inspectors and
operators; updating inspection forms; educating health officials and operators on new guidelines). In the 10 years since the
MAHC#s release, CDC has focused on developing and keeping the MAHC current and in line with the scientific literature. However,
the agency has thus far taken a passive approach to understanding stakeholder use of the MAHC. The MAHC is currently written in
#code language# so that individual jurisdictions can readily use all or parts of the MAHC language, revise the MAHC code as
needed to meet their unique needs, or choose not to use the MAHC at all. Based on anecdotal reports from across the United
States, CDC is aware of multiple states incorporating MAHC code into their pool regulations or using the MHAC or MAHC Annex as
reference. There is a need to characterize the use and acceptability of MAHC and assess the contextual factors that contribute to or
serve as barriers for MAHC use and implementation. This activity falls under Objective 1 of WDPB#s 2024 strategic objectives: to
prevent and control WASH-related outbreaks. Within NCEZID#s Domestic Water, Sanitation, and Hygiene Epidemiology
(DWASHE) Team, this work establishes a baseline understanding of partners# level of understanding or engagement with WASHrelated policies, regulations, and prevention behaviors.

Objective:

The primary objective of this project is to characterize the use and acceptability of the MAHC among state health department
partners and assess the facilitators and barriers to MAHC use and implementation. Within this broader objective, we outline several
sub-objectives: 1. Conduct key informant interviews/focus groups with aquatic-focused public health programs to explore MAHC
use, as well as key needs and perceptions across varying levels of MAHC use (e.g., STLT partners that do not use the MAHC;
STLT partners that are considering to use the MAHC; STLT partners that infrequently use the MAHC; and STLT partners that
frequently use the MAHC). 2. Conduct a quantitative survey to further explore overall MAHC use, as well as facilitators and barriers
to MAHC use and implementation. This will be done to capture a broader range of input from stakeholders that were not involved in
the more in-depth focus groups. 3. Use results to inform CDC decision-making regarding MAHC activities and help optimize the
MAHC as a more usable and widely accepted resource for STLT public health partners. 4. Develop case studies of jurisdictions to
model strategies for MAHC use and implementation. 5. Present results to MAHC stakeholders (e.g. CDC leadership and aquaticfocused public health officials and aquatics sector representatives) and publish results in peer-reviewed scientific literature.

Does your project measure health disparities among No
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?:

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

Activities or Tasks:

New Collection of Information, Data, or Biospecimens ; Programmatic Work

Target Populations to be Included/Represented:

Businesses

Tags/Keywords:

Public Health ; Policy ; Swimming ; Swimming Pools ; Needs Assessment

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 will participate as co-authors in presentation(s) or publication(s) ; CDC is the sole institution conducting activity

Method Categories:

Focus Group; Hybrid Study Design; Individual Interviews (Qualitative); Survey

Methods:

This investigation will use a two-phase, mixed-methods study design. In Phase I, we will conduct focus groups stratified across
levels of MAHC use and implementation and a quantitative survey (amongst both state/territorial and local-level STLT partners). In
Phase II, we will conduct an in-depth case study analysis for STLT partners. Across both phases, the respondent universe will
comprise of STLT government staff and delegates that act on behalf of an agency in providing essential public health services.
Phase I will allow us to capture information on MAHC use and implementation nationwide. Here, focus groups will be administered
among STLT public health programs with different levels of MAHC use and implementation. Surveys will be distributed to STLT
partners across 55 states and territories. To reach local level partners, we will distribute the survey via email lists administered by
the National Environmental Health Association and National Association of County and City Health Officials in a convenience
sampling approach. If response rates remain low one month after distribution, we will also explore a contact tracing approach, in
which STLT partners provide the contact information for other states that may be interested in participating. Survey results will be
analyzed through descriptive statistics and parametric/non-parametric statistical tests. Based on quantitative survey results, we will
conduct focus groups across three different levels of MAHC use (i.e., no use, infrequent use, and frequent use). We will recruit 3#6
STLT representatives per level. Partners will be recruited into each level based on survey responses, in which participants will be
asked to approximate the extent to which their jurisdiction#s public swimming pool regulations use MAHC language. Analytic
methods for the focus groups will include thematic analyses in MAXQDA to interpret key and emerging themes from the interviews
and to highlight illustrative quotes. Findings will be used to contextualize and support results from the survey. In Phase II, we
propose a [multi] case study design. This will offer rich, in-depth information about the interactions between MAHC use and
implementation and its socio-political context for #case# jurisdictions (Schoch). Cases will be bound by time and place (or setting),
and we will collect detailed information using a variety of data collection procedures over a sustained period# (Stake, et. al)
(Creswell). A descriptive [multi] case study approach will be used as opposed to an explanatory approach (looking to explain why or
how certain conditions have come to be); or an exploratory approach (identifying new ideas to be used in subsequent research
studies). This descriptive focus is essential, as it allows us to develop a deep, comprehensive understanding of the MAHC's impact.
The objective of case study analysis is transferability. Such transferability will allow us to make transferable claims about MAHC use
and implementation from insights gained from a few cases (i.e., jurisdictions). We assert that the understanding gathered from the
in-depth study of four local-level jurisdictions and how they interact with the MAHC will be transferable to other jurisdictions. The
[multi] case study analysis uses purposeful sampling of 1-4 units. By being specific about which jurisdictions select as cases, this
purposeful sampling will allow us to gather data from a variety of sources for a specific jurisdiction.

Collection of Info, Data or Biospecimen:

In Phase I, data collection methods will include focus groups and a quantitative survey. Focus group guides will be developed by
MAHC subject matter experts across NCEZID, NCEH, and NCIPC. Focus group facilitation will be led by experts with the
Behavioral Science Unit within the Health Promotion and Communication Team in the Waterborne Diseases Prevention Branch and
supported by co-investigators on the project. The survey instrument will comprise a series of Likert and #select all that apply#
questions to assess use, acceptability, and implementation of the MAHC and corresponding Annex. Select questions will be
adapted from previous MAHC questionnaires. New questions, and the resulting survey instrument will be distributed to a small
number of partners and validated with respect to content and construct validity. Content validity will ensure that the instrument
contains all essential questions and eliminates undesirable items within a construct domain (Lewis et al., 1995); while construct
validity will assess how well the intended concepts were operationalized within the questionnaire (Taherdoost 2016). In Phase II,
data collection will be conducted in the form of key-informant interviews across multiple stakeholders within a given jurisdiction (e.g.,
epidemiologists, environmental health professionals, policy specialists). Additional qualitative research methods may include policy
and legislative document analysis (i.e., local jurisdiction aquatic code review), as well as stakeholder and timeline mapping.
WDPB does not anticipate that this data collection will yield generalizable data. Rather, results will be used to better understand the

Expected Use of Findings/Results and their impact:

Could Individuals potentially be identified based on
Information Collected?

range of experiences among STLT participants, and serve as one of many data inputs into MAHC program management and
decision making. Specifically, we expect that results will indicate which sections of the MAHC are most useful to STLT partners
(including supplemental resources available on the CDC website including the MAHC Annex, mini-MAHCs, etc.). We aim to learn
where the MAHC could be streamlined or reformatted; and what further supporting resources may need to be developed to facilitate
MAHC use and implementation. Further, we will gain an understanding of why the MAHC may not be used or implemented by a
jurisdiction (e.g., the jurisdiction already has comprehensive code that is in agreement with the MAHC). Finally, we aim to put forth
case studies of jurisdictions to provide strategies for MAHC use and implementation.
No

Funding

Funding yet to be added .....

HSC Review

HSC Attributes
Program Evaluation

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?

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

Amy
Freeland

12/19
/2026

Brian
Hubbard

06/28
/2026

Candace
Rutt

06/26
/2026

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

09/08/2026

05/02/2025

CITI Good Clinical
Practice Exp. Date

Staff Role

Phone

Organization

Program
Lead

igc3@cdc.
gov

Waterborne Disease Prevention Branch

CoInvestigator

bnh5@cdc.
gov

770488-8

WATER FOOD AND ENVIRONMENTAL
HEALTH SERVICES BRANCH

CoInvestigator

awr8@cdc.
gov

Health Promotion & Communication Team

Joseph
Laco

08/18
/2026

Pallavi
Kache

08/02
/2026

Tessa
Clemens

08/28
/2026

07/16/2017

CoInvestigator

htr6@cdc.
gov

7704883955

SAFE WATER

07/11/2026

CoInvestigator

xlq2@cdc.
gov

4044718395

Domestic WASH Epi Team

01/07/2027

CoInvestigator

opr7@cdc.
gov

4044985997

SAFETY PROMOTION TEAM

Data
DMP
Proposed Data Collection Start Date:

4/1/24

Proposed Data Collection End Date:

12/31/25

Proposed Public Access Level:

Restricted

Restricted Details:
Data Use Type:

Data Sharing Agreement

Data Use Type URL:
Data Use Contact:

Public Access Justification:

How Access Will Be Provided for Data:

The primary objective of this project is to inform CDC decision-making regarding programmatic activities; therefore, we propose that
public access to this data remains restricted. Additionally, there could be political sensitivities around the MAHC for certain
jurisdictions and STLT public health partners, which would increase the importance of including a data request process in which
requestors identify their affiliation and the intended use of the data. To maintain transparency, we will publish our results in the
scientific literature and present findings at public health and aquatics conferences.
STLT government officials will be asked questions about only their professional duties as they relate to the MAHC. If asked to
provide any identifiable information, it will relate to their official duties (e.g., title, professional email address, number of months
/years that they have worked in their professional role). While quotes will be used in the manuscript, they will not be identifiable to
any individual. All identifiable information will be securely stored. All results will be reported in the aggregate with all identifiable
information excluded. Data may be linked to additional data sources by non-personal identifiers (state, county, city names, etc.) to
increase the overall utility of data collection. Survey results will be gathered electronically through a CDC-managed software
program, such as Epi Info# Web Survey System (Epi Info). Epi Info will allow our team to collect information from participants via the
internet. Survey forms will be published to the CDC web server. When published, Epi Info will create a survey-specific website

address. Our investigation team can distribute the URL over email. Participants will access the web survey and submit their
responses through a web browser or mobile device. After the participant submits the response, the survey designer downloads the
response directly into the original Epi Info# 7 project for analysis. Final research products will include a scientific manuscript
published in the Journal of Environmental Health or the Journal of Public Health Management. Results may also be shared with
STLT public health partners at conferences including the Council for State and Territorial Epidemiologists (CSTE).
Data will be securely imported onto the CDC server from the Epi Info web platform with the web survey key, organization key, and
security token. Within the Epi Info program, the #READ# command will allow us to save the survey results as an MS Excel 2007
Workbook. This datasheet will be saved within the project folder on the CDC securely stored on the CDC server in accordance with
federal standards found in the E-Government Act and the Paperwork Reduction Act. The Privacy Act does not apply to this data
collection. State government agency officials will be speaking from their official roles. If asked to provide any identifiable information,
it will relate to their official duties (e.g., title, professional email address). All identifiable information will be securely stored. All
results will be reported in the aggregate with all identifiable information removed. Audio files and transcripts of the in-depth
interviews will be also securely stored on the CDC server in accordance with federal privacy standards found in the E-Government
Act and the Paperwork Reduction Act. All results will be reported in the aggregate with all identifiable information removed.

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
Zirger_Jeffrey
(wtj5)

Date Added

Description

Supporting Info Type

Supporting Info

03/07/2024

NOA 0920-0879 (2023)

Notice of Action

NOA 0920-0879_2023.pdf

Collection End
Date

ICRO Reviewer
Peterson_James
M. (iyr1)
CIO HSC

03/06/2024

N/A

HS Research Determination Memo

030624PK-NR-signed.pdf