Determination

AttF Research and PRA Determination.pdf

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

Determination

OMB: 0923-0047

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Title:

CSPECE Resources Survey

Project Id:

0900f3eb81aa78ca

Accession #:

NCEH-DCHI-1/9/20-a78ca

Project Contact:

Hall_Elisha (nyu2)

Organization:

NCEH/ATSDR/DCHI

Status:

Pending Regulatory Clearance

Intended Use:

Project Determination

Estimated Start Date:

02/03/2020

Estimated Completion Date:

02/17/2020

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

0923-0047

Determinations
Determination

Justification

Completed

Entered By & Role

HSC:
Does NOT Require HRPO
Review

Not Research

2/19/20

Davis_Stephanie I. (sgd8) CIO H

2/19/20

Davis_Stephanie I. (sgd8) CIO O

PRA:
PRA Applies

Description & Funding
Description
Priority:

Standard

Date Needed:

01/20/2020

Determination Start Date:

01/14/20

Description:

The following project is to conduct a online survey (Survey M
feedback from Agency for Toxic Substances and Disease Reg
on: 1) the utility of the resources and support APPLETREE p
for resources in the future. CSPECE is a new initiative for co
childcare centers to prevent exposures to toxic substances.
survey cooperative agreement partners to understand the u
resources to plan relevant future guidance, resources, and technica

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Goals/Purpose

1) Understand the utility of the resources and support APPLE
Understand the APPLETREE partners need for resources in the futur

Objective:

1) Measure helpfulness of specific resources, assistance, and
scale to inform future resources. 2) Collect data on commun
communications. 3) Collect data on state needs and suggest

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be
Included/Represented:

Other

Tags/Keywords:

Surveys and Questionnaires, Environment and Public Health, Public

CDC's Role:

Activity originated and designed by CDC staff, or conducted
approve study design and data collection as a condition of a
conducting activity

Method Categories:

Survey

Methods:

ATSDR will submit this activity for Paperwork Reduction Act
Delivery Generic Clearance (OMB Control Number 0923-004
maintains a contact list for the staff member(s) in each Coo
program of interest, which includes staff name and official e
member(s) managing the CSPECE program from each state
(Attachment A). In the case of staff turnover or vacancy, th
they would be the next most informed. The recipients will be
Study Design: An observational design will be used to condu
Agreement Partner feedback on past resources and needs fo
technical assistance. Data collection instrument: One survey
reviewed by topic-area SMEs. Estimated average time to com
usefulness of resources provided and use and preferences fo
questions with one open-ended question. It also measures n
sensitive or personal questions are included. Data collection
Agreement Partners will be invited via email to participate in
above. Data will be collected via Survey Monkey (screensho
week, a reminder (Att D) will be sent to original contacts tha
day before the survey close, a final reminder (Att E) will be
responded to the survey.

Collection of Info, Data or Biospecimen:

Participants: ATSDR maintains a contact list for the staff me
manage CSPECE--the program of interest, which includes st
mailing list, the staff member(s) managing the CSPECE prog
survey via email (Attachment A). In the case of staff turnov
be invited, as they would be the next most informed. The re
viewable. Data collection procedures: No PII will be collected
email to participate in a voluntary survey using the methods
Monkey (screenshots in Att B) and available for two weeks.
original contacts that have not yet responded to the survey.
reminder (Att E) will be sent to the remaining contacts that have no

Expected Use of Findings/Results:

Results will inform future technical assistance and production of res

Could Individuals potentially be identified
based on Information Collected?

No

Funding
Funding yet to be added .....

Review Attributes

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Page 3 of 5

Quality Assurance / Improvement

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
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 documents 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

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Page 4 of 5
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

Elisha Hall

01/13/2023

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

CITI Good
Clinical Practice
Exp. Date

Staff Role

Email

Principal
Investigator

nyu2@cdc

Data
DMP
Proposed Data Collection Start Date:

2/3/20

Proposed Data Collection End Date:

2/14/20

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - Internal customer service data

Public Access Justification:

Data is for the purpose of informing internal customer servic
Partners. It does not have a public interest and is not necessary to s

How Access Will Be Provided for Data:

N/A. Data are not intended to be released to the public. Dat
identified by the state name.

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Plans for Archival and Long Term
Preservation:

We do not have plans for archiving or preserving the data. T
and support and use of the data are for a short term need.

Spatiality

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

Dataset
Dataset Title

Data
Publisher/Owner

Public
Access
Level

Public Access
Justification

External
Access URL

Download
URL

Dataset yet to
be added...

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