Mandatory Guidelines for Federal Workplace Drug Testing Programs

Forms and Documents

Document Name	Status
Form Federal CCF Donor Form and Instruction	Modified
Form Urine Lab Appl. Fo Laboratory Recordkeeping Form and Instruction	New
Form Urine Lab Appl. Fo Laboratory Inspection Checklist Form and Instruction	New
Form Urine Lab Appl. Fo Laboratory Application Form and Instruction	New
Form Federal CCF Medical Review Officer Form and Instruction	New
Form Federal CCF Laboratory Form and Instruction	New
Form Federal CCF Collector Form and Instruction	New
Attachment C.pdf Supplementary Document	2010-07-15
Attachment B.pdf Supplementary Document	2010-07-15
Attachment A.pdf Supplementary Document	2010-07-15
OMB - Supporting Statement final.doc Supporting Statement A	2010-08-27

IC Document Collections

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

ICR Details

OMB Control No: 0930-0158	ICR Reference No: 201007-0930-002
Status: Historical Active	Previous ICR Reference No: 200908-0930-001
Agency/Subagency: HHS/SAMHSA	Agency Tracking No:
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: 08/29/2010
	Date Received in OIRA: 07/16/2010
Terms of Clearance: Approved consistent with the following terms of clearance: SAMHSA will work with OMB prior to release of any final notice announcing or providing guidance on the revised Federal Drug Testing Custody and Control Form. Documents published prior to OMB's review of this ICR under the Paperwork Reduction Act were confusing to the public and SAMHSA will work with OMB to prevent similar confusion in the future. Previous terms of clearance (Prior to the next approval of this package, the Agency shall provide a progress update on adoption of electronic forms in an effort to reduce burden. SAMHSA is encouraged to explore ways to convert the Federal Drug Testing Custody and Control Form (Federal CCF) into an electronic form.) remain in effect.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2013	36 Months From Approved	11/30/2011
Responses	28,384,153	0	28,384,168
Time Burden (Hours)	1,786,809	0	1,786,809
Cost Burden (Dollars)	2,212,000	0	2,090,000

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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: 5 USC 501 Name of Law: SAMHSA
  

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:
	74 FR 59196	11/17/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 41488	07/16/2010
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
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 Appl. Form, Urine IITF Info Checklist Form, Urine IITF Appl. Form, Urine Lab Info Checklist Form	Urine Lab Appl. Form ,   Urine IITF Info Checklist Form ,   Urine IITF Appl. Form ,   Urine Lab Info Checklist Form
Laboratory Inspection Checklist	Urine Lab Appl. Form, Urine Lab Info Checklist Form, Urine IITF Appl. Form, Urine IITF Info Checklist Form	Urine Lab Appl. Form ,   Urine Lab Info Checklist Form ,   Urine IITF Appl. Form ,   Urine IITF Info Checklist Form
Laboratory Recordkeeping	Urine Lab Appl. Form, Urine Lab Info Checklist Form, Urine IITF Appl. Form, Urine IITF Info Checklist Form	Urine Lab Appl. Form ,   Urine Lab Info Checklist Form ,   Urine IITF Appl. Form ,   Urine IITF Info Checklist 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	28,384,153	28,384,168	0	-15	0	0
Annual Time Burden (Hours)	1,786,809	1,786,809	0	0	0	0
Annual Cost Burden (Dollars)	2,212,000	2,090,000	0	122,000	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: Miscellaneous Actions

Short Statement: There is no burden change.

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Annual Cost to Federal Government: $11,745,000

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]? Uncollected

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: 07/16/2010

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