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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920-1313 Att5b Test Kit Qs Int Labs (Word) 20221202	Form and Instruction	New	Available
Form 0920-1313 International Laboratories	Form and Instruction	New	Repair queued
Form 0920-1313 Att5a Test Kit Applctn Qs US Labs (Word) 20221202	Form and Instruction	Modified	Available
Form 0920-1313 Private or Not-for-Profit Institutions	Form and Instruction	Modified	Repair queued
Form 0920-1313 Att5a Test Kit Applctn Qs US Labs (Word) 20221202	Form and Instruction	Modified	Available
Form 0920-1313 State, Local, and Tribal Government Laboratories	Form and Instruction	Modified	Repair queued
Form 0920-1313 Test Kit Application and Questions for US Laboratories (online)	Form and Instruction	Modified	Available
Form 0920-1313 Federal Laboratories	Form and Instruction	Modified	Repair queued
30 Day FRN 0920-1313.pdf	Supplementary Document	Uploaded 2022-12-28	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	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	Repair queued
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
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	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
257355	International Laboratories	Form and Instruction	New	Att5b Test Kit Qs Int Labs (Word) 20221202
257355	International Laboratories	Form and Instruction	New
241928	Private or Not-for-Profit Institutions	Form and Instruction	Modified	Att5a Test Kit Applctn Qs US Labs (Word) 20221202
241928	Private or Not-for-Profit Institutions	Form and Instruction	Modified
241927	State, Local, and Tribal Government Laboratories	Form and Instruction	Modified	Att5a Test Kit Applctn Qs US Labs (Word) 20221202
241927	State, Local, and Tribal Government Laboratories	Form and Instruction	Modified
241926	Federal Laboratories	Form and Instruction	Modified	Test Kit Application and Questions for US Laboratories (online)
241926	Federal Laboratories	Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1313	ICR Reference No: 202212-0920-010
Status: Historical Active	Previous ICR Reference No: 202005-0920-006
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1313
Title: [NCEH] Distribution of Traceable Opioid Material* Kits (TOM Kits*) across U.S. Laboratories
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  Yes
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/28/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/29/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2026	36 Months From Approved	03/31/2023
Responses	900	0	1,200
Time Burden (Hours)	80	0	120
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 56957	09/16/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 79890	12/28/2022
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
Federal Laboratories	0920-1313	Test Kit Application and Questions for US Laboratories (online)
International Laboratories	0920-1313	Att5b Test Kit Qs Int Labs (Word) 20221202
Private or Not-for-Profit Institutions	0920-1313	Att5a Test Kit Applctn Qs US Labs (Word) 20221202
State, Local, and Tribal Government Laboratories	0920-1313	Att5a Test Kit Applctn Qs US Labs (Word) 20221202

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ICR Summary of Burden

table that charts list of burden

	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	1,200	0	-500	200	0
Annual Time Burden (Hours)	80	120	0	-60	20	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: CDC is requesting approval for a total time burden of 80 hours per year, which is a decrease of 40 hours over the previously approved 120 hours. We estimate a total number of 900 responses per year which is a decrease of 300 over the previously approved 1,200 responses.

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Annual Cost to Federal Government: $4,737,737

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  Yes

Description/Changes for Common Form Usage:  As part of this revision, CDC is changing the title of this ICR from “Distribution of Traceable Opioid Material* Kits (TOM Kits*) across U.S. Laboratories” to “Distribution of Traceable Opioid Material* Kits (TOM Kits*) across U.S. and International Laboratories.” The title change is necessary due to the expansion of test kit distribution to international customers. Additional revisions include the following: • CDC is adding their new line of TOM Kits*, Emergent Drug Panel (EDP) Kits, for distribution. The EDP compounds are identified by doing a search of recent lists put out by the DEA and the Center for Forensic Science Research and Education (CFSRE). These lists provide data on all classes of drugs that were recently identified in the field and provide recommendations on which drugs should be included in testing. These classes of drugs may be found mixed with opioids and contribute to the opioid epidemic. These lists are updated several times a year and keep up with the changing drug landscape in the United States. • CDC will continue to distribute TOM Kits*, including the new EDP Kits, through a single vendor instead of two.

Approved RCFs using this ICR

table that charts list of RCF

Agency/Sub Agency	RCF ID	RCF Title	RCF Status	IC Title

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 12/29/2022

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