Att H_NonRearch Determination Form

CSTLTS Data Collection Determination Form
Public health research / Non-research & Paperwork Reduction Act

Purpose and Instructions
The purpose of this form is to learn about upcoming CSTLTS data collections to ensure compliance with human
subjects research and Paperwork Reduction Act (PRA) regulations. Complete this form when planning:
•

Data collection activities involving non-Federal respondents

•

Research that is conducted or supported by CDC

In other words, this form should be completed well before any data collection activities begin. Contact Cori
Wigington ([email protected]) with questions.

Section 1: Program Information
1. Date of Form Completion: December 3, 2018
2. Project Officer / Investigator / Point of Contact Name: Dianne Strozier
3. CDC Email: [email protected]
4. Phone: 404-498-3037
5. Organizational Unit (e.g., OSTLTS/DPHPI/ASREB): CSTLTS/DPPS/HDPB
6. Data Collection Project Title: Preventative Health and Health Services Block Grant
7. Funding mechanism (select all that apply):

☐ Contract; announcement number: Click here to enter text.
☐ Cooperative Agreement; announcement number: Click here to enter text.
☒ Grant; announcement number: CDC-RFA-OT18-1805.
☐ Task Order/Purchase Order; announcement number: Click here to enter text.
☐ Other: Click here to enter text.

Section 2: Data Collection Summary
8. Purpose:

☐ The purpose of this project is to develop or contribute to the generalizable knowledge to improve
public health practice related to Click here to enter text.

☒ The purpose of this project is to assess and / or improve the following public health service

program/ service by allowing grantees to address locally-defined public health needs by funding
programs that deal with the leading causes of death and disability.

☐ The purpose of this project is to prevent or control disease or injury by Click here to enter text.

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CSTLTS Data Collection Determination Form
Public health research / Non-research & Paperwork Reduction Act

9. Brief description of the data collection: CDC currently collects information from Block Grant
awardees to monitor their objectives and activities (Preventive Health and Health Services Block
Grant, OMB No. 0920-0106, exp. 7/31/2019 ). Each awardee is required to submit an annual
application for funding (Work Plan) that describes its objectives and the populations to be addressed,
and an Annual Report that describes activities, progress toward objectives, and Success Stories which
highlight the improvements Block Grant programs have made and the value of program activities.
Information is submitted electronically through the web-based Block Grant Information
Management System (BGMIS).
10. Estimated number of respondents: 61
11. Respondent population / study participants: (check all that apply)
Federal employees
Contractors to the federal government (e.g., Northrop Grumman, Deloitte)
State health department staff
Local health department staff
Tribal governmental / coalitions staff
Territorial health department staff
State elected or appointed official (e.g., governor)
Local elected or appointed official
Legislative staff
Clinical practitioner and/or healthcare staff (e.g., physician, hospital administrator, etc.)
Community member
Partner organization staff
University faculty / staff
Study/program participant
Other individual, please specify: Click here to enter text.

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12. Data collection methods: (check all that apply)
Questionnaire / Survey Instrument
Interim and/or Annual Progress Report
Focus Group
Key Informant Interview
Other, please specify: Click here to enter text.

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13. Intended use: (check all that apply)
On-going data collection for program management and involving the collection of minimal,
standard data elements of all sites receiving CDC funds for program implementation
Provide formative information before implementing a new, modified, or previously untested
intervention

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CSTLTS Data Collection Determination Form
Public health research / Non-research & Paperwork Reduction Act

☐ Provide formative information on how to tailor a proven-effective intervention, service or
program in a specific setting or context
☒ Assess the success of an established program in achieving its objectives in a specific population
where information gained will be used to provide feedback to that program
☐ Test a new, modified, or previously untested intervention, service, or program to determine if it
is effective
☐ Manage public health program through regular, ongoing collection and analysis of health-related
data for disease or event notification, please specify program:
☐ Longitudinal data collection allowing for hypothesis testing
☐ Identify, characterize, and/or solve an immediate health problem which will benefit those
participants involved in the investigation or their communities
☐ Systematic investigation of a non-standard intervention or a systematic comparison of standard
interventions occurs
☐ Other, please specify: Click here to enter text.
14. Will the data collection be conducted by CDC/ATSDR?
Yes

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☐ No

15. Will the data collection be sponsored by CDC/ATSDR? For more information visit: Internal CDC
Guidance on Sponsorship Determination
Yes

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☐ No

16. Briefly describe CDC/ATSDR’s role: CDC currently collects information from Block Grant awardees to
monitor their objectives and activities (Preventive Health and Health Services Block Grant, this
information is submitted electronically through the web-based Block Grant Information
Management System (BGMIS).
17. Anticipated start date of data collection: This is an ongoing effort.

Section 3: Self-Determination of Research & Paperwork Reduction Act Applicability
In the following section, identify if you think this data collection is a) research or non-research and b) subject
to the paperwork reduction act. All self-determinations will be reviewed by the OSTLTS Human Subjects
Contact and Paperwork Reduction Act (PRA) Contact for official determinations.
Research / Non-Research
45 CFR 46.102(d) regulations state “research means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to generalizable knowledge” where
“generalizable knowledge” is defined as new information that has relevance beyond the population or
program from with it was collected, or information that is added to the scientific literature), then the project
is considered to be research. For more information, visit: Human Research Protection Office’s.
Research / Non-research Self Determination

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CSTLTS Data Collection Determination Form
Public health research / Non-research & Paperwork Reduction Act

☒ Non-research
☐ Research
a. Is this activity research involving human participants?
No
Yes

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Paperwork Reduction Act
The Paperwork Reduction Act (PRA) requires that Federal agencies submit Information Collection Requests
to the Office of Management and Budget (OMB) for approval for federally sponsored data collections
involving ten (10) or more respondents. For more information visit: Information Collection Review Office.
PRA Self Determination:
PRA does not apply
PRA does apply

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Send Completed form to Cori Wigington ([email protected]), PRA Contact / Human Subjects Contact

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CSTLTS Data Collection Determination Form
Public health research / Non-research & Paperwork Reduction Act

To be completed by the OSTLTS PRA Contact & Human Subjects Contact only

Official Research Determination:
Non-research
Research

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a. Is this activity research involving human participants?
No
Yes

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Official PRA Determination:
PRA does not apply
PRA does apply

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NOTES:
Program seeking extension of an already approved ICR. Non-research.

Corinne Wigington
PRA Contact (or designee)

12.07.18
Date

Corinne Wigington
Human Subjects Contact (or designee)

12.07.18
Date

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