Mandatory Guidelines for Federal Workplace Drug Testing Programs

Forms and Documents

Document Name	Status
Form Federal CCF Donor Form and Instruction	Modified
Form IITF a_b_c Checkli Laboratory Recordkeeping Form and Instruction	Modified
Form Urine Lab a_b_c Ch Laboratory Inspection Checklist Form and Instruction	Modified
Form Urine Lab App Form Laboratory Application Form and Instruction	Modified
Form Federal CCF Medical Review Officer Form and Instruction	Modified
Form Federal CCF Laboratory Form and Instruction	Modified
Form Federal CCF Collector Form and Instruction	Modified
Guidance_2014_CCF_15 August2013_final.docx Supplementary Document	2014-05-28
eCCF_WhitePaper_April 30 without Attch.docx Supplementary Document	2014-05-28
PIA eCCF 5-21-2014_draft.pdf Supplementary Document	2014-05-28
DOT PIA signed.pdf Supplementary Document	2014-05-28
ECCF 12.13.2013.pdf Supplementary Document	2014-01-08
Att B FR MG 2008.pdf Supplementary Document	2013-07-16
Att A Executive Order 12564.pdf Supplementary Document	2013-07-16
Att C FR MG effective date final.pdf Supplementary Document	2013-07-16
Supporting Statement final 5-26-14.docx Supporting Statement A	2014-05-28

IC Document Collections

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

ICR Details

OMB Control No: 0930-0158	ICR Reference No: 201307-0930-003
Status: Historical Active	Previous ICR Reference No: 201007-0930-002
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 with change	Conclusion Date: 05/28/2014
	Date Received in OIRA: 07/24/2013
Terms of Clearance: HHS/SAMHSA shall update this docket with a final, signed version of the PIA, and it shall post the PIA for the general public. HHS/SAMHSA shall finalize and post all guidance documents.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2017	36 Months From Approved	05/31/2014
Responses	24,600,108	0	28,384,153
Time Burden (Hours)	1,546,329	0	1,786,809
Cost Burden (Dollars)	0	0	2,212,000

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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:
	78 FR 25282	04/30/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 42091	07/15/2013
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Laboratory Recordkeeping	IITF a_b_c Checklist	IITF a_b_c Checklist
Donor	Federal CCF	Federal CCF
Collector	Federal CCF	Federal CCF
Laboratory	Federal CCF	Federal CCF
Medical Review Officer	Federal CCF	Federal CCF
Laboratory Application	Urine Lab App Form	Urine Lab App Form
Laboratory Inspection Checklist	Urine Lab a_b_c Checklist, IITF App Form	Urine Lab a_b_c Checklist ,   IITF App Form

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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	24,600,108	28,384,153	0	0	-3,784,045	0
Annual Time Burden (Hours)	1,546,329	1,786,809	0	0	-240,480	0
Annual Cost Burden (Dollars)	0	2,212,000	0	0	-2,212,000	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: No

Burden Reduction Due to:

Short Statement: Currently there are 1,786,809 burden hours in the OMB inventory. SAMHSA is requesting 1,546,329. The adjustment of -240,480 is due to the reduced number of respondents of 1 million.

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

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 07/24/2013

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