OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 202602-0920-001 · OMB 0920-1313 · Active

Forms and Documents
DocumentTypeStatusAvailability
Form 0920-1313 Att5b Test Kit Qs Int Labs (Word) 20221202 Form and Instruction Unchanged Available
Form 0920-1313 Att5a Test Kit Applctn Qs US Labs (Word) 20221202 Form and Instruction Unchanged Repair queued
Form 0920-1313 Att5a Test Kit Applctn Qs US Labs (Word) 20221202 Form and Instruction Unchanged Repair queued
Form 0920-1313 Test Kit Application and Questions for US Laboratories (online) Form and Instruction Unchanged Repair queued
Att 7 TOM Kits STARS Determination.pdf Supplementary Document Uploaded 2026-02-03 Repair queued
Att6 TOM Kits PIA 20251217 signed.pdf Supplementary Document Uploaded 2026-02-03 Repair queued
Att3 TOM Kits Factsheet.pdf Supplementary Document Uploaded 2026-02-03 Repair queued
Att2a TOM Kits CR 60-Day FRN Public Comment Summary.docx Public Comments Uploaded 2025-11-04 Repair queued
Att2 0920–1313_60-day FRN.pdf Supplementary Document Uploaded 2026-02-03 Available
1 - SS-B TOM Kits_03FEB2026.docx Supporting Statement B Uploaded 2026-02-03 Available
1 - SS-A TOM Kits_03FEB2026.docx Supporting Statement A Uploaded 2026-02-03 Repair queued
0920-1313 Nonmaterial Change Justification.docx Justification for No Material/Nonsubstantive Change Uploaded 2024-01-29 Repair queued
0920-1313 Nonmaterial Change Justification.docx Justification for No Material/Nonsubstantive Change Uploaded 2023-04-18 Repair queued
30 Day FRN 0920-1313.pdf Supplementary Document Uploaded 2022-12-28 Repair queued
Att4c TOM Kits 0920-1313 NOA 20201203.pdf Supplementary Document Uploaded 2022-12-13 Repair queued
Att4b TOM Kits GenIC 0923-0047 NOA 20190510.pdf Supplementary Document Uploaded 2022-12-13 Repair queued
Att4a TOM Kits PHE PRA Waiver and Notice 20190320.pdf Supplementary Document Uploaded 2022-12-13 Repair queued
Att3 CDC TOM Kits Factsheet.pdf Supplementary Document Uploaded 2022-12-13 Repair queued
0 - Privacy Act Checklist.docx Supplementary Document Uploaded 2022-12-13 Available
Att1 Legislative Authority.pdf Supplementary Document Uploaded 2022-12-13 Repair queued
Att8 TOM Kits Privacy Impact Assessment Form.pdf Supplementary Document Uploaded 2020-05-21 Repair queued
Att7 TOM Kits Research Determination Form.pdf Supplementary Document Uploaded 2020-05-21 Repair queued
Att5 TOM Kits GenIC 0923-0047 NOA 20190510.pdf Supplementary Document Uploaded 2020-05-21 Repair queued
Att4 TOM Kits PHE PRA Waiver and Notice 20190320.pdf Supplementary Document Uploaded 2020-05-21 Repair queued
Att3 CDC TOM Kits Factsheet.pdf Supplementary Document Uploaded 2020-05-21 Repair queued
Att2 TOM Kits 60-day FRN.pdf Supplementary Document Uploaded 2020-05-21 Repair queued
Att1 Legislative Authority.pdf Supplementary Document Uploaded 2020-05-21 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
257355 International Laboratories Form and Instruction UnchangedAtt5b Test Kit Qs Int Labs (Word) 20221202
257355 International Laboratories Form and Instruction Unchanged
241928 Private or Not-for-Profit Institutions Form and Instruction UnchangedAtt5a Test Kit Applctn Qs US Labs (Word) 20221202
241928 Private or Not-for-Profit Institutions Form and Instruction Unchanged
241927 State, Local, and Tribal Government Laboratories Form and Instruction UnchangedAtt5a Test Kit Applctn Qs US Labs (Word) 20221202
241927 State, Local, and Tribal Government Laboratories Form and Instruction Unchanged
241926 Federal Laboratories Form and Instruction UnchangedTest Kit Application and Questions for US Laboratories (online)
241926 Federal Laboratories Form and Instruction Unchanged
ICR Details
0920-1313 202602-0920-001
Active 202401-0920-013
HHS/CDC 0920-1313
[NCEH] Distribution of Traceable Opioid Material* Kits (TOM Kits*) across U.S. and International Laboratories
Extension without change of a currently approved collection   Yes
Regular
Approved without change 03/23/2026
Retrieve Notice of Action (NOA) 02/17/2026
  Inventory as of this Action Requested Previously Approved
03/31/2029 36 Months From Approved 03/31/2026
900 0 900
80 0 80
0 0 0
The purpose of this information collection (IC) is for the CDC to assure that the Traceable Opioid Material* Kits (TOM Kits*) are being distributed to different types of laboratories in public, private, and non-profit sectors. The intended use is: 1) To gather information on the types of laboratories requesting the kits. 2) To determine the types of instrumentation, matrices, and sample size for those requesting kits. Data will be collected by online survey. This Extension ICR is submitted to renew the data collection for an additional three years. There is no change to the approved burden hours.
US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None
Not associated with rulemaking
  90 FR 42766 09/04/2025
91 FR 6218 02/11/2026
Yes
  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 900 900 0 0 0 0
Annual Time Burden (Hours) 80 80 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$1,010,623
No
    No
    No
No
No
No
No
Jeffrey Zirger 404 639-7118 [email protected]
  Yes
  No changes anticipated.
Agency/Sub Agency RCF ID RCF Title RCF Status IC Title
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
02/17/2026