[Federal Register Volume 85, Number 28 (Tuesday, February 11, 2020)]
[Notices]
[Pages 7776-7778]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Proposed Collection; 
Comment Request

    In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction 
Act of 1995 concerning the opportunity for public comment on proposed 
collections of information, the Substance Abuse and Mental Health 
Services Administration (SAMHSA) will publish periodic summaries of 
proposed projects. To request more information on the proposed projects 
or to obtain a copy of the information collection plans, call the 
SAMHSA Reports Clearance Officer at (240) 276-0361.
    Comments are invited on: (a) Whether the proposed collections of 
information are necessary for the proper performance of the functions 
of the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use

[[Page 7777]]

of automated collection techniques or other forms of information 
technology.

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

    SAMHSA will request OMB approval for a revision of the Federal Drug 
Testing Custody and Control Form (CCF) for federal agency and federally 
regulated drug testing programs which must comply with the HHS 
Mandatory Guidelines for Federal Workplace Drug Testing Programs using 
Urine (UrMG) dated January 23, 2017 (82 FR 7920) and using Oral Fluid 
(OFMG) dated October 25, 2019, and OMB approval for information 
provided by test facilities (laboratories and Instrumented Initial Test 
Facilities, IITFs) for the National Laboratory Certification Program 
(NLCP).
    The CCF is used by all federal agencies and employers regulated by 
the Department of Transportation (DOT) and the Nuclear Regulatory 
Commission (NRC) to document the collection and chain of custody of 
urine specimens at the collection site, for HHS-certified test 
facilities to report results, and for Medical Review Officers (MROs) to 
document and report a verified result. SAMHSA allows the use of the CCF 
as a paper or electronic form.
    The current OMB-approved CCF has an August 31, 2020 expiration 
date. SAMHSA has resubmitted the CCF with major content revisions to 
the form for OMB approval. These revisions are:

Copies 1-5

Revised Step 1
1. Added ``Collector Contact Info:'' and ``Other'' line (e.g., email)
Revised Step 2
1. Put Urine and Oral Fluid checkboxes above Step 2 for collector to 
annotate
2. Expanded to 4 lines for collector entries:
    --General entry for Split, Single, or None Provided (same as 
current)
    --Entries specific to urine collection (moved ``Collector reads 
urine temperature within 4 minutes'' here; other entries same as 
current)
    --Entries specific to oral fluid collection: added ``Split Type'' 
with checkboxes for Serial, Concurrent, and Subdivided; ``Each Device 
Within Expiration Date?'' with checkboxes Yes or No; and Volume 
Indicator(s) Observed checkbox)
    --Remarks (same as current)
Revised Step 3
1. Edited instruction to state ``collector affixes seal(s) to 
bottle(s)/tube(s)''
Revised Step 4 (Collector Section)
1. Edited ``Specimen Bottle(s) Released To'' box to state ``Specimen 
Bottle(s)/Tubes(s) Released To''

Copy 1 (Test Facility Copy)

Revised Step 4 (Accessioner Section)
1. Edited ``Specimen Bottle(s) Released To'' box to state ``Specimen 
Bottle(s)/Tubes(s) Released To''
2. Added ``Primary/Single Specimen Device Expiration Date'' and ``Split 
Specimen Device Expiration Date'' fields for accessioner to annotate 
expiration dates of oral fluid collection devices
Revised Step 5a (Certification and Reporting Section)
1. Removed analyte names and checkboxes
2. Repositioned results and checkboxes: Moved REJECTED FOR TESTING, 
ADULTERATED, SUBSTITUTED and INVALID RESULT checkboxes; moved POSITIVE 
checkbox to be under DILUTE
3. Added line for certifying scientist to record positive analytes and 
concentrations, and added ``Analyte(s) in ng/mL'' instruction (aligned 
under ``POSITIVE for:'')

Copy 2 (Medical Review Officer Copy)

Revised Step 6 (Donor Section)
1. Edited donor certification statement to state ``specimen bottle/
tubes''
Revised Step 7 (MRO Section--Primary Specimen)
1. Put Urine and Oral Fluid checkboxes above Step 6 for MRO to annotate

Bottom of Copies

Revised Copy 1
1. Edited label/seal at bottom of Copy 1 to allow for modification 
(e.g., perforations, label with transparent seal on one side, and 
separate label and seal)
Revised Copies 3-5
1. Removed Steps 6 and 7 (MRO sections)
2. Moved Public Burden Statement from the back to the front of the 
copies
Additional Edits to Copy 5
1. Moved Privacy Act Statement (for federal employees) from the back to 
the front of the copy
2. Removed Instructions for Completing the CCF from the back. SAMHSA 
will post instructions for completing the Federal CCF for urine and 
oral fluid on their website.
    Based upon information from federal agencies and from DOT 
concerning their regulated industries, the number of respondents has 
increased from 5.4 million to 6.7 million, which increases the total 
burden hours by 170,701.8.
    Laboratories and IITFs seeking HHS certification under the NLCP 
must complete and submit the NLCP application form. The NLCP 
application form has not been revised compared to the previous form.
    Prior to an inspection, an HHS-certified laboratory or IITF 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 for the onsite inspection. The NLCP information 
checklist has not been revised compared to the previous form.
    The annual total burden estimates for the CCF, the NLCP 
application, the NLCP information checklist, and the NLCP recordkeeping 
requirements are shown in the following table.

----------------------------------------------------------------------------------------------------------------
                                                                                    Burden per
         Form/respondent             Number of     Responses per   Total number      response      Annual burden
                                    respondents     respondent     of responses       (hours)         (hours)
----------------------------------------------------------------------------------------------------------------
Custody and Control Form: \1\
    Donor.......................       6,726,610               1       6,726,610            0.08       538,128.8
    Collector...................       6,726,610               1       6,726,610            0.07         378,000
    Laboratory..................       6,726,610               1       6,726,610            0.05         336,330
    IITF........................               1               0               0            0.05               0
    Medical Review Officer......       6,726,610               1       6,726,610            0.05         270,000
NLCP Application Form: \2\
    Laboratory..................               5               5               5               3              15

[[Page 7778]]

 
    IITF........................               0               0               0               3               0
Sections B and C--NLCP
 Inspection Checklist:
    Laboratory..................              29               1              29               1              29
    IITF........................               0               0               0               1               0
Record Keeping:
    Laboratory..................              29               1              29             250           7,250
    IITF........................               0               0               0             250               0
                                 -------------------------------------------------------------------------------
        Total...................       6,726,673  ..............      26,906,503  ..............       1,529,753
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    Send comments to Carlos Graham, SAMHSA Reports Clearance Officer, 
Room 15-E-57-A, 5600 Fishers Lane, Rockville, MD 20857 OR email a copy 
to [email protected]. Written comments should be received by 
April 13, 2020.

Jennifer Wilson,
Budget Analyst.
[FR Doc. 2020-02671 Filed 2-10-20; 8:45 am]
BILLING CODE 4162-20-P