Mandatory Guidelines for Federal Workplace Drug Testing Programs

Forms and Documents

Document Name	Status
Form 2020 Proposed Fed Donor Form and Instruction	Modified
Form Urine Lab App form Laboratory Application Form and Instruction	Modified
Supporting Statement_5.22.2020 final.docx Supporting Statement A	2020-06-30
CCF Table of Comments Received_FINAL.xlsx Supplementary Document	2020-06-30

IC Document Collections

IC ID	Document Title	Status
43644	Donor Form and Instruction	Modified
193838	Laboratory Recordkeeping Instruction	Modified
193837	Laboratory Inspection Checklist Instruction	Modified
193836	Laboratory Application Form and Instruction	Modified
193835	Medical Review Officer Instruction	Modified
193834	Laboratory Instruction	Modified
193833	Collector Instruction	Modified

ICR Details

OMB Control No: 0930-0158	ICR Reference No: 202006-0930-004
Status: Active	Previous ICR Reference No: 201704-0930-001
Agency/Subagency: HHS/SAMHSA	Agency Tracking No: 20007
Title: Mandatory Guidelines for Federal Workplace Drug Testing Programs
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/17/2020
	Date Received in OIRA: 07/01/2020
Terms of Clearance: OMB approves the revised Federal Drug Testing Custody and Control Form (CCF). In addition, the previous version of the CCF (the CCF with the four new analytes - oxycodone, oxymorphone, hydrocodone, and hydromorphone - listed in Step 5A) is authorized for use until August 30, 2021.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved	08/31/2020
Responses	26,906,503	0	21,600,061
Time Burden (Hours)	1,688,948	0	1,350,283
Cost Burden (Dollars)	0	0	0

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Abstract: The Federal Drug Testing Custody and Control Form is used for the Mandatory Guidelines required to in the chain of custody procedures to document the integrity and security of a urine specimen from the time it is collected until it is received by the laboratory.

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Authorizing Statute(s): US Code: 42 USC 290 Name of Law: Data Collection
  

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 7776	02/11/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 39204	06/30/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Laboratory Recordkeeping
Donor	2020 Proposed Fed CCF Proof Changes Highlighted	2020 Proposed Fed CCF Proof Changes Highlighted
Collector
Laboratory
Medical Review Officer
Laboratory Application	Urine Lab a_b_c Checklist, Urine Lab App form	2018 Urine Lab App form ,   2018 Urine Lab a_b_c Checklist
Laboratory Inspection Checklist

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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	26,906,503	21,600,061	0	5,306,442	0	0
Annual Time Burden (Hours)	1,688,948	1,350,283	0	338,665	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: Yes

Burden Reduction Due to: Cutting Redundancy

Short Statement: To ensure uniformity among all federally regulated workplace drug testing programs, the UrMG and OFMG require using an OMB-approved Federal CCF (Federal CCF - Attachment F). To facilitate ease of use and uniform reporting, the UrMG and OFMG will use a combined format to streamline the Federal CCF. The combined form will collect all information required by both Mandatory Guidelines and minimize duplication and cost to the users.

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Annual Cost to Federal Government: $18,400,000

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: 07/01/2020

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