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View ICR - OIRA Conclusion

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:

	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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	900	1,200	-500	200
Annual Time Burden (Hours)	80	120	-60	20
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Odion Clunis 770 488-0045 lta2@cdc.gov

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

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