CDC_PRA Determination Form

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PAPERWORK REDUCTION ACT DETERMINATION FORM
AUTHORITY: The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), 5 Code of Federal Regulations (CFR) Part 1320
PRINCIPAL PURPOSES: To determine applicability of Centers for Disease Control and Prevention (CDC) proposed projects for Paperwork Reduction Act
(PRA) compliance. Proper completion of this form will prevent both illegal information collections and PRA violations.
ROUTINE USES: Information is disclosed to the Information Collection Review Office (ICRO) for auditing and quality assurance purposes.
MANDATORY DISCLOSURE: Failure to provide complete information and the necessary supporting documents may delay proposed project activities.
As a Federal Government agency, CDC is subject to the PRA. The information on this form is required to make a project’s PRA applicability
determination. This form (pages 1 and 2) must be completed by the Center, Institute, Office (CIO) PRA Contact. A copy of the related supporting
documents that identify all proposed project collection of information (reporting), retention of information (recordkeeping), and disclosure of
information (disclosing) activities must accompany this form upon submittal to ICRO via [email protected].
I. Center, Institute, Office (CIO) Information
CIO Abbreviation: NCHHSTP
CIO PRA Contact: Name (Last, First)

CDC E-mail:

Phone No.:

Bonds, Constance
Project Officer/Investigator/Point of Contact: Name (Last, First)

[email protected]
CDC E-mail:

404-718-8548
Phone No.:

Johnston, Stephanie
[email protected]
Project Title: Assessment of the Model Performance Evaluation Program

404-639-5019

Funding Mechanism Type: ☐ Contract
Announcement #:

☐ Cooperative Agreement

☐ Grant

☐ Task/Purchase Order

☐ Other

II. Determination Conditions
To determine a project’s PRA applicability, record responses to the below conditions (Please Check).
1. Does the proposed activity obtain, cause to be obtained, solicit, or require the disclosure to CDC/ATSDR or a third party information by or for
CDC/ATSDR? In other words, will CDC/ATSDR require the collection, retention, or disclosure of information? ☐ Yes ☐ No
2. Does the proposed collection entail identical questions posed to, or identical reporting, recordkeeping, or
☐ Yes ☐ No
disclosure requirements imposed on or requesting the same information from ten (10) or more persons?
☐ Yes ☐ No
3. Is the collection of information conducted by CDC/ATSDR (will CDC/ATSDR collect the information)?
☐
Yes ☐ No
4. Is the collection of information sponsored by CDC/ATSDR?
5. If applicable, is this collection of information waived by the
National Childhood Vaccine Injury Act [Public Law 99-660, section 321-Title III]?
☐ Yes ☐ No
III. CIO Determination Decision (Please Check)
☐
OMB/PRA Clearance Required, as proposed activity constitutes a collection of information - (If “Yes” response provided for items 1-2 and for
either item 3 or 4 in the previous section)
☐
OMB/PRA Clearance Not Required – Per 5. C.F.R. 1320.3(h), the following PRA exemption/exclusion category applies to this collection of
information:
OMB/PRA Clearance Not Required – An active Information Collection Request for this activity has already been approved by OMB.
Title:
OMB Number:
Expiration Date:
☐
OMB/PRA Clearance Not Required – (If a “No” response provided for items 1 or 2 or if a “No” response for items 3 and 4 in the previous section)
☐
OMB/PRA Clearance Not Required – The PRA requirement waived by the National Childhood Vaccine Injury Act [Public Law 99-660, section 321Title III].
IV. Proposed Project Dates: 09/01/2017
to 09/01/2021
☐

V. Proposed Project Activities
If applicable, indicate the type of Information Collection Instrument/Activity proposed for use (Check all that apply):
☐ Mail-back Questionnaire ☐ On-site Questionnaire ☐ Personal Interview ☐ Telephone Survey ☐ Testing/Assessment Form
☐ Web-based Survey ☐ Focus Groups ☐ Record Abstractions ☐ Performance Report ☐ Evaluation ☐ Observation
☐ Application ☐ Comment Card ☐ Discussion Group ☐ Eligibility Form ☐ Audit Form ☐ Workshop ☐ Peer Review
☐ Report ☐ Reporting Form ☐ Diary ☐ Log ☐ Journal ☐ Inspection Form ☐ Usability Test ☐ Consents
☐ Acknowledgments ☐ Card Sorts ☐ Any other means of requesting information from 10 or more respondents (Explain):

☐ N/A
CDC 0.1490 (E), May 2014, CDC Adobe Acrobat 10.1, S508 Electronic Version, May 2014

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VI. Project Abstract/Summary (Provide justification by describing project’s purpose, objectives, funding conditions/intent, and
scope of Federal involvement):
The CDC Model Performance Evaluation Program (MPEP) was established to analyze the performance and practices of all known
clinical and public health laboratories in the United States that perform drug susceptibility testing of isolates belonging to the
Mycobacterium tuberculosis complex (MTBC). To participate in the program, laboratories must follow recommended biosafety guidelines
for working with MTBC, perform MTBC drug susceptibility testing , and submit a signed Participant Biosafety Compliance Letter of
Agreement. The Division of Tuberculosis Elimination Laboratory Branch sends MTBC cultures twice a year to participating laboratories
along with a link to enter their testing results online. The Laboratory Branch compiles the results into a report that allows enrollees to
compare their results with those expected and thus provides a self-assessment tool for monitoring their ability to perform drug
susceptibilty testing of MTBC. In addition, the report contains information about participating laboratories such as their classification
(public health, hospital, independent, reference), number of tests performed, testing methods, and drugs tested against MTBC. Annually,
the Laboratory Capacity Team of the Laboratory Branch invites all participants to attend a webinar to cover information in the report.
The purpose of this information collection is to collect customer feedback from stakeholders to incorporate improvements in MPEP
service delivery. Information from this assessment will be used to measure the value of the MPEP to each laboratory program,
satisfaction with the online collection instrument, and whether information provided in the MPEP report is clear and understandable.
A web-based questionnaire will be designed and administered by the Laboratory Capacity Team using SurveyMonkey software. The
questionnaire contains 19 rating scale, multiple choice or fill in the blank questions (Appendix 1). The questionnaire link will be emailed to
TB laboratory supervisors or their designees of who are currently participating in the MPEP program. Responses will be automatically
compiled by SurveyMonkey and then exported to Excel for detailed analysis. Data will be analyzed by CDC project officer and/or CDC
project team members and discussed internally within Laboratory Branch and DTBE.

VII. For determinations of “PRA Not Applicable” and “PRA Exemption/Exclusion Requested”, please provide a brief summary to
support the decision:

VIII. CIO-PRA Oversight Official/Representative Certification Statement

On behalf of this project, I certify that this determination decision is in accordance with 5 CFR Part 1320.

Signature
(FOR ICRO USE ONLY)
Audit Findings:

02/05/2018
Date

Title
Selected for Audit?:

☐ OMB/PRA Clearance Not Required

☐ Yes

☐ OMB/PRA Clearance Required

ICRO Desk Officer: Name (Last, First)
ICRO Chief

Signature

☐ No

CDC ID No. 0920-17

CDC E-mail:
☐ Concur

Phone No.:

☐ Non-concur

03/29/2014
Date

CDC 0.1490 (E), May 2014, CDC Adobe Acrobat 10.1, S508 Electronic Version, May 2014

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