OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 202304-0920-004 · OMB 0920-1313 · Active

Forms and Documents
DocumentTypeStatusAvailability
Form 0920-1313 International Laboratories Form and Instruction Modified Available
Form 0920-1313 International Laboratories Form and Instruction Modified Repair queued
Form 0920-1313 Private or Not-for-Profit Institutions Form and Instruction Modified Available
Form 0920-1313 Private or Not-for-Profit Institutions Form and Instruction Modified Repair queued
Form 0920-1313 State, Local, and Tribal Government Laboratories Form and Instruction Modified Available
Form 0920-1313 State, Local, and Tribal Government Laboratories Form and Instruction Modified Missing upstream
Form 0920-1313 Federal Laboratories Form and Instruction Modified Available
Form 0920-1313 Federal Laboratories Form and Instruction Modified Repair queued
0920-1313 Nonmaterial Change Justification.docx Justification for No Material/Nonsubstantive Change Uploaded 2023-04-18 Available
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 Available
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 Available
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 Available
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 Available
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 Available
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
0 - Privacy Act Checklist.docx Supplementary Document Uploaded 2022-12-13 Missing upstream
Att1 Legislative Authority.pdf 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 Available
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
Att7 TOM Kits Research Determination Form.pdf Supplementary Document Uploaded 2020-05-21 Missing upstream
Att5 TOM Kits GenIC 0923-0047 NOA 20190510.pdf Supplementary Document Uploaded 2020-05-21 Available
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 Available
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 Available
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 Available
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 Available
Att1 Legislative Authority.pdf Supplementary Document Uploaded 2020-05-21 Repair queued
1 - SS-B TOM Kits.docx Supporting Statement B Uploaded 2022-12-13 Available
1 - SS-B TOM Kits.docx Supporting Statement B Uploaded 2022-12-13 Repair queued
1 - SS-A TOM Kits.docx Supporting Statement A Uploaded 2022-12-13 Available
1 - SS-A TOM Kits.docx Supporting Statement A Uploaded 2022-12-13 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
257355 International Laboratories Form and Instruction Modified
257355 International Laboratories Form and Instruction Modified
241928 Private or Not-for-Profit Institutions Form and Instruction Modified
241928 Private or Not-for-Profit Institutions Form and Instruction Modified
241927 State, Local, and Tribal Government Laboratories Form and Instruction Modified
241927 State, Local, and Tribal Government Laboratories Form and Instruction Modified
241926 Federal Laboratories Form and Instruction Modified
241926 Federal Laboratories Form and Instruction Modified
ICR Details
0920-1313 202304-0920-004
Historical Active 202212-0920-010
HHS/CDC 0920-1313
[NCEH] Distribution of Traceable Opioid Material* Kits (TOM Kits*) across U.S. Laboratories
No material or nonsubstantive change to a currently approved collection   Yes
Regular
Approved without change 04/21/2023
Retrieve Notice of Action (NOA) 04/19/2023
  Inventory as of this Action Requested Previously Approved
03/31/2026 03/31/2026 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 Non-Substantive Change Request is submitted to split Question #1 on both the Domestic (Attachment 5a) and International (Attachment 5b) surveys into two questions for clarity. 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
  87 FR 56957 09/16/2022
87 FR 79890 12/28/2022
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
$4,737,737
No
    No
    No
No
No
No
No
Jeffrey Zirger 404 639-7118 [email protected]
  Yes
  No changes to Common Forms.
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.
04/19/2023