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

Forms and Documents

Document Name	Status
Form 0920-20JE Private or Not-for-Profit Institutions Form and Instruction	New
Form 0920-20JE State, Local, and Tribal Government Laboratories Form and Instruction	New
Form 0920-20JE Federal Laboratories Form and Instruction	New
Att8 TOM Kits Privacy Impact Assessment Form.pdf Supplementary Document	2020-05-21
Att7 TOM Kits Research Determination Form.pdf Supplementary Document	2020-05-21
Att5 TOM Kits GenIC 0923-0047 NOA 20190510.pdf Supplementary Document	2020-05-21
Att4 TOM Kits PHE PRA Waiver and Notice 20190320.pdf Supplementary Document	2020-05-21
Att3 CDC TOM Kits Factsheet.pdf Supplementary Document	2020-05-21
Att2 TOM Kits 60-day FRN.pdf Supplementary Document	2020-05-21
Att1 Legislative Authority.pdf Supplementary Document	2020-05-21
1 - SS-B TOM Kits_20200504 clean.docx Supporting Statement B	2020-05-21
1 - SS-A TOM Kits_20200504 clean final.docx Supporting Statement A	2020-05-21

IC Document Collections

IC ID	Document Title	Status
241928	Private or Not-for-Profit Institutions Form and Instruction	New
241927	State, Local, and Tribal Government Laboratories Form and Instruction	New
241926	Federal Laboratories Form and Instruction	New

ICR Details

OMB Control No: 0920-1313	ICR Reference No: 202005-0920-006
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20JE
Title: Distribution of Traceable Opioid Material* Kits (TOM Kits*) across U.S. Laboratories
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/03/2020
	Date Received in OIRA: 06/02/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2022	36 Months From Approved
Responses	1,200	0	0
Time Burden (Hours)	120	0	0
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:
	85 FR 11991	02/28/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 33678	06/02/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Federal Laboratories	0920-20JE	TOM Kits Questions
State, Local, and Tribal Government Laboratories	0920-20JE	TOM Kits Questions
Private or Not-for-Profit Institutions	0920-20JE	TOM Kits Quesitons

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ICR Summary 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	1,200	0	0	1,200	0	0
Annual Time Burden (Hours)	120	0	0	120	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a New Collection.

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Annual Cost to Federal Government: $4,737,736

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:  No

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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: 06/02/2020

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