[Federal Register Volume 78, Number 135 (Monday, July 15, 2013)]
[Notices]
[Pages 42091-42099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16794]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


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 (240) 
276-1243.

[[Page 42092]]

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:
BILLING CODE 4162-20-P

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[GRAPHIC] [TIFF OMITTED] TN15JY13.000

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

[[Page 42094]]

collection of information, including suggestions for reducing this 
burden, to SAMHSA Reports Clearance Officer, 1 Choke Cherry Road, Room 
2-1057, Rockville, Maryland, 20857.
[GRAPHIC] [TIFF OMITTED] TN15JY13.001


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[[Page 42098]]


BILLING CODE 4162-20-C

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

[[Page 42099]]

recordkeeping requirements are shown in the following table.

----------------------------------------------------------------------------------------------------------------
                                                                      Burden/
                   Number of form/respondents                        responses      Responses/     Total burden
                                                                      (hours)       respondent         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: [email protected]. 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.
[FR Doc. 2013-16794 Filed 7-12-13; 8:45 am]
BILLING CODE 4162-20-P