[Federal Register Volume 85, Number 126 (Tuesday, June 30, 2020)]
[Notices]
[Pages 39204-39206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13986]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


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 (240) 276-0361.

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 revisions to the form for OMB 
approval. During 60-day public comment 7 commenter's submitted comments 
on the proposed changes to the CCF. These commenters were comprised of 
individuals, organizations, and private sector companies. All comments 
were reviewed and taken into consideration in the preparation of the 
revised CCF. The issues and concerns raised in the public comments for 
the CCF are set out www.reginfo.gov/public/do/PRAMain.
    These revisions are listed below:

[[Page 39205]]

Copies 1-5

Revised Step 1
1. Added ``CDL State and No.'' to donor identification types
2. 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 5 (Donor Section)
1. Added line for donor email address
2. Edited donor certification statement to state ``specimen bottle/
tubes''
Revised Step 6 (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 Copy 5
1. 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-C;.
    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.

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                                                                                    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
    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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    Written comments and recommendations for the proposed information 
collection should be sent within 30 days of publication of this notice 
to www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under 30-day Review--Open

[[Page 39206]]

for Public Comments'' or by using the search function.

Carlos Graham,
Social Science Analyst.
[FR Doc. 2020-13986 Filed 6-29-20; 8:45 am]
BILLING CODE 4162-20-P