2013-16794. Agency Information Collection Activities: Submission for Office of Management and Budget (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 Government Paperwork Elimination Act (GPEA) 44 U.S.C. 3504. To request a copy of these documents, call the SAMHSA Reports Clearance Officer at [phone].

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

SAMHSA will request OMB approval for the Federal Drug Testing Custody and Control Form (Federal CCF) 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 OMB approval for the information provided by test facilities (i.e., laboratories and Instrumented Initial Test Facilities, IITFs) for the National Laboratory Certification Program (NLCP).

The Federal CCF is used by all federal agencies and employers regulated by the Department of Transportation (DOT) to document the collection and chain of custody of drug testing specimens at the collection site, for the test facility to report results, and for the Medical Review Officer (MRO) to make a determination. The current OMB-approved Federal CCF has an August 31, 2013 expiration date. In accordance with the GPEA, OMB set terms of clearance for the extension of the current Federal CCF as follows: Prior to the next approval of this package, the Agency (SAMHSA) 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.

In an effort to comply with the stated terms of the clearance requirement set forth by OMB, SAMHSA will authorize the use of an electronic Federal CCF. SAMHSA has resubmitted the Federal CCF with no content revisions to the form for OMB approval. The only revisions are to enable the form to be used as a paper form or as an electronic form.

• The first change to the Federal CCF is to allow the Public Burden Statement to be a separate page of an electronic Federal CCF. The Public Burden Statement must appear on all federal government forms that place a reporting burden on gathering information.
• The second change is to allow the Federal CCF instructions and the Privacy Act Statement to be on a separate page or pages of an electronic Federal CCF.
• The third change is to allow the bottle labels/seals to be printed separately, and not as a part of Copy 1 of the Federal CCF.
• The fourth change is to revise the Federal CCF Instructions to allow the use of an electronic form.

Below is a copy of the Federal CCF:

Paper CCF: Back of Copy 1-4

Electronic CCF: Separate Page

Public Burden Statement

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0158. Public reporting burden for this collection of information is estimated to average: 5 minutes/donor; 4 minutes/collector; 3 minutes/test facility; and 3 minutes/Medical Review Officer. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA Reports Clearance Officer, 1 Choke Cherry Road, Room 2-1057, Rockville, Maryland, 20857.

Paper CCF: Back of Copy 5

Electronic CCF: Separate Page

Instructions for Completing the Federal Drug Testing Custody and Control Form for Urine Specimen Collection

When Making Entries on a Paper CCF, use Black or Blue ink pen and Press Firmly

Collector ensures that the name and address of the HHS-certified Instrumented Initial Test Facility (IITF) or HHS-certified laboratory are on the top of the Federal CCF and the Specimen Identification (I.D.) number on the top of the Federal CCF matches the Specimen I.D. number on the labels/seals.

STEP 1:

• Collector ensures that the required information is in STEP 1. Collector enters a remark in STEP 2 if Donor refuses to provide his/her SSN or Employee I.D. number.
• Collector gives collection container to Donor and instructs Donor to provide a specimen. Collector notes any unusual behavior or appearance of Donor in the remarks line in STEP 2. If the Donor's conduct at any time during the collection process clearly indicates an attempt to tamper with the specimen, Collector notes the conduct in the remarks line in STEP 2 and takes action as required.

STEP 2:

• Collector checks specimen temperature within 4 minutes after receiving the specimen from Donor, and marks the appropriate temperature box in STEP 2. If the temperature is outside the acceptable range, Collector enters a remark in STEP 2 and takes action as required.
• Collector inspects the specimen and notes any unusual findings in the remarks line in STEP 2 and takes action as required. Any specimen with unusual physical characteristics (e.g., unusual color, presence of foreign objects or material, unusual odor) cannot be sent to an IITF and must be sent to an HHS-certified laboratory for testing, as required.
• Collector determines the volume of specimen in the collection container. If the volume is acceptable, Collector proceeds with the collection. If the volume is less than required by the federal agency, Collector takes action as required, and enters remarks in STEP 2. If no specimen is collected by the end of the collection process, Collector checks the None Provided box, enters a remark in STEP 2, discards Copy 1, and distributes remaining copies as required.
• Collector checks the Split or Single specimen collection box. If the collection is observed, Collector checks the Observed box and enters a remark in STEP 2.

STEP 3:

• Donor watches Collector pour the specimen from the collection container into the specimen bottle(s), place the cap(s) on the specimen bottle(s), and affix the label(s)/seal(s) on the specimen bottle(s).
• Collector dates the specimen bottle label(s) after placement on the specimen bottle(s).
• Donor initials the specimen bottle label(s) after placement on the specimen bottle(s).
• Collector instructs the Donor to read and complete the certification statement in STEP 5 on Copy 2 (signature, printed name, date, phone numbers, and date of birth). If Donor refuses to sign the certification statement, Collector enters a remark in STEP 2 on Copy 1.

STEP 4:

• Collector completes STEP 4 on Copy 1 (signature, printed name, date, time of collection, and name of delivery service) and places the sealed specimen bottle(s) in a leak-proof plastic bag.
• Paper CCF: Collector places Copy 1 in the leak-proof plastic bag. Electronic CCF: Collector places printed copy of Copy 1 in the leak-proof plastic bag and/or places package label (with Specimen I.D., test facility name and contact information, and collection site name and contact information) on the outside of the bag.
• Collector seals the bag, prepares the specimen package for shipment, and distributes the remaining CCF copies as required.

Privacy Act Statement: (For Federal Employees Only)

Submission of the information on the Federal Drug Testing Custody and Control Form is voluntary. However, incomplete submission of the information, refusal to provide a specimen, or substitution or adulteration of a specimen may result in delay or denial of your application for employment/appointment or may result in removal from the federal service or other disciplinary action.

The authority for obtaining the specimen and identifying information contained herein is Executive Order 12564 (“Drug-Free Federal Workplace”), 5 U.S.C. 3301 (2), 5 U.S.C. 7301, and Section 503 of Public Law 100-71, 5 U.S.C. 7301 note. Under provisions of Executive Order 12564 and 5 U.S.C. 7301, test results may only be disclosed to agency officials on a need-to-know basis. This may include the agency Medical Review Officer (MRO), the administrator of the Employee Assistance Program, and a supervisor with authority to take adverse personnel action. This information may also be disclosed to a court where necessary to defend against a challenge to an adverse personnel action.

Submission of your SSN is not required by law and is voluntary. Your refusal to furnish your number will not result in the denial of any right, benefit, or privilege provided by law. Your SSN is solicited, pursuant to Executive Order 9397, for purposes of associating information in agency files relating to you and for purposes of identifying the specimen provided for testing for the presence of illegal drugs. If you refuse to indicate your SSN, a substitute number or other identifier will be assigned, as required, to process the specimen.

Public Burden Statement

Public Burden Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0158. Public reporting burden for this collection of information is estimated to average: 5 minutes/donor; 4 minutes/collector; 3 minutes/test facility; and 3 minutes/Medical Review Officer. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to SAMHSA Reports Clearance Officer, 1 Choke Cherry Road, Room 2-1057, Rockville, Maryland, 20857.

The number of respondents has been reduced from 7.1 to a total of 6.1 million; which reduces the total burden hours of −240,480.

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

The NLCP application form has not been revised compared to the previous form.

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.

Number of form/respondents	Burden/responses (hours)	Responses/ respondent	Total burden hours
Custody and Control Form
Donor	.08	6,150,000	512,500
Collector	.07	6,150,000	410,000
Laboratory	.05	6,150,000	307,500
Medical Review Officer	.05	6,150,000	307,500
Laboratory Application	3.0	3	9
Laboratory Inspection Checklist	2.0	35	70
Laboratory Recordkeeping	250.0	35	8750
Total			1,546,329

Written comments and recommendations concerning the proposed information collection should be sent by August 14, 2013 to the SAMHSA Desk Officer at the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). To ensure timely receipt of comments, and to avoid potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, commenters are encouraged to submit their comments to OMB via email to: [e-mail]. Although commenters are encouraged to send their comments via email, commenters may also fax their comments to: 202-395-7285. Commenters may also mail them to: Office of Management and Budget, Office of Information and Regulatory Affairs, New Executive Office Building, Room 10102, Washington, DC 20503.

Summer King,

Statistician.