Non-Substantive Change Request Justification

0920-1313 Nonmaterial Change Justification.docx

[NCEH] Distribution of Traceable Opioid Material* Kits (TOM Kits*) across U.S. Laboratories

Non-Substantive Change Request Justification

OMB: 0920-1313

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Justification for Program Changes – 0920-1313, exp. date 03/31/2026

Date: 04/10/2023

The details of the proposed revisions to this ICR are summarized here:

  • CDC is requesting a nonmaterial/non-substantive change to Distribution of Traceable Opioid Material Kits across U.S. and International Laboratories survey questions (Attachments 5a and 5b). The requested change splits question 1 on both the domestic (Attachment 5a) and international (Attachment 5b) surveys into 2 questions for clarity. The vendor would like to use the responses received in the new question 1 of both surveys to determine which kits the requesting laboratory would like to order currently. The CDC program would like to know the summed answers to both new questions 1 and 2 to understand the TOM kits’ impact.

  • This change will not impact the annual burden hours or the method of deployment for the survey.



Table 1 : Changes to the Domestic Survey (Att. 5a)

Page Number

Section

Proposed Revision

1

Testing Information Question 1

1. Which test kit(s) are you requesting? (provide quantity)

Fentanyl Analog Screening (FAS) Quantity [___]

FAS Version 1 Quantity [___]

FAS Version 2 and 3 Quantity [___]

FAS Version 4 Quantity [___]

Emergent Drug Panel (EDP) Quantity [___]


2. Which test kit(s) have you previously received? (provide quantity)

Fentanyl Analog Screening (FAS) Quantity [___]

FAS Version 1 Quantity [___]

FAS Version 2 and 3 Quantity [___]

FAS Version 4 Quantity [___]

Emergent Drug Panel (EDP) Quantity [___]

2

Testing Information Question 2

Update numbering to Question 3

2

Testing Information Question 3

Update numbering to Question 4

2

Testing Information Question 4

Update numbering to Question 5

2

Testing Information Question 5

Update numbering to Question 6

2

Testing Information Question 6

Update numbering to Question 7

2

Testing Information Question 7

Update numbering to Question 8





Table 2: Changes to the International Survey (Att. 5b)

Page Number

Section

Proposed Revision

1

Testing Information Question 1

1. Which test kit(s) are you requesting? (provide quantity)

Fentanyl Analog Screening (FAS) Quantity [___]

FAS Version 1 Quantity [___]

FAS Version 2 and 3 Quantity [___]

FAS Version 4 Quantity [___]

2. Which test kit(s) have you previously received? (provide quantity)

Fentanyl Analog Screening (FAS) Quantity [___]

FAS Version 1 Quantity [___]

FAS Version 2 and 3 Quantity [___]

FAS Version 4 Quantity [___]

2

Testing Information Question 2

Update numbering to Question 3

2

Testing Information Question 3

Update numbering to Question 4

2

Testing Information Question 4

Update numbering to Question 5

2

Testing Information Question 5

Update numbering to Question 6

2

Testing Information Question 6

Update numbering to Question 7

2

Testing Information Question 7

Update numbering to Question 8



File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorSchondelmeyer, Rio (CDC/DDNID/NCEH/DEHSP)
File Modified0000-00-00
File Created2024-09-06

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