2010-17400. Agency Information Collection Activities: Submission for OMB Review; Comment Request

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on [phone].

Project: Mandatory Guidelines for Federal Workplace Drug Testing Programs (OMB No. 0930-0158)—Revision

SAMHSA's Mandatory Guidelines for Federal Workplace Drug Testing Programs will request OMB approval for the Federal Drug Testing Custody and Control Form for Federal agency and federally regulated drug testing programs which must comply with the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (73 FR 71858) dated November 25, 2008, and for the information provided by laboratories for the National Laboratory Certification Program (NLCP).

The Federal Drug Testing Custody and Control Form (Federal CCF) is used by all Federal agencies and employers regulated by the Department of Transportation to document the collection and chain of custody of urine specimens at the collection site, for laboratories to report results, and for Medical Review Officers to make a determination. The current Federal CCF approved by OMB has a November 30, 2011 expiration date. SAMHSA has resubmitted the Federal CCF with revisions to the form for OMB approval.

• The first change is to add a new item in Step 1 of Copy 1, which lists the acronyms for the Federal testing authorities under which the specimen is collected. The new Step 1 (d) would read as follows: “D. Specify Testing Authority: HHS, NRC, DOT—Specify DOT Agency: FMCSA, FAA, FRA, FTA, PHMSA, USCG” with a checkbox beside each agency name.
• The second change is to revise the Federal CCF Copy 1 to permit use by Instrumented Initial Test Facility (IITF), in addition to laboratories.
• The third change is to add the new drug analytes required by the revised Guidelines to the Primary Specimen Report section in Step 5(a) on Copy 1. The new drug analytes are methylenedioxymethamphetamine (MDMA), commonly known as “ecstasy”; methyleneamphetamine (MDA), and methylenedioxyethylamphetamine (MDEA). MDA and MDEA are both close chemical analogues of MDMA.
• The fourth change is to revise the Medical Review Officer (MRO) reporting sections on Copy 2 for primary specimens (Step 6) and for split specimens (Step 7) to facilitate reporting in accordance with the Guidelines.

Below is a copy of the revised Federal CCF:

 

Prior to an inspection, a laboratory is required to submit specific information regarding its laboratory procedures. Collecting this information prior to an inspection allows the inspectors to thoroughly review and understand the laboratory's testing procedures before arriving at the laboratory.

The annual total burden estimates for the Federal Drug Testing Custody and Control Form, the NLCP application, the NLCP inspection checklist, and NLCP recordkeeping requirements are shown in the following table.

Form/respondent	Burden/ response (hrs.)	Number of responses	Total annual burden (hrs.)
Custody and Control Form:
Donor	.08	7,096,000	567,680
Collector	.07	7,096,000	496,720
Laboratory	.05	7,096,000	354,800
Medical Review Officer	.05	7,096,000	354,800
Laboratory Application	3.00	3	9
Laboratory Inspection Checklist	3.00	100	300
Laboratory Recordkeeping	250.00	50	12,500
Total			1,786,809

Written comments and recommendations concerning the proposed information collection should be sent by August 16, 2010 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202-395-6974.

Dated: July 12, 2010.

Dennis O. Romero,

Deputy Director, Office of Program Services.