Proposed Revisions to Federal Drug Testing Custody and Control Form, 59196-59205 [E9-27371]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Substance Abuse and Mental Health Services Administration

[Federal Register Volume 74, Number 220 (Tuesday, November 17, 2009)]
[Notices]
[Pages 59196-59205]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27371]



[[Page 59196]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Proposed Revisions to Federal Drug Testing Custody and Control 
Form

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Notice of Proposed Revisions to the Federal Custody and Control 
Form.

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SUMMARY: The Department of Health and Human Services (HHS) establishes 
the standards for Federal workplace drug testing programs under 
authority of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301 
and Executive Order No. 12564. As required, HHS published the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs (Guidelines) in 
the Federal Register on April 11, 1988 (53 FR 11979). The Substance 
Abuse and Mental Health Services Administration (SAMHSA) subsequently 
revised the Guidelines on June 9, 1994 (59 FR 29908), on September 30, 
1997 (62 FR 51118), on November 13, 1998 (63 FR 63483), on April 13, 
2004 (69 FR 19644) and on November 25, 2008 (73 FR 71858) with an 
effective date of May 1, 2010 (correct effective date published on 
December 10, 2008; 73 FR 75122). The Guidelines establish comprehensive 
standards for all aspects of the Federal workplace drug testing 
program, including the requirement for all urine specimens to be 
collected using chain of custody procedures to document specimen 
integrity and security from the time of collection until receipt by the 
``test facility.'' To ensure uniformity among all Federal agency 
workplace drug testing programs and procedures, the Guidelines require 
agencies to use an Office of Management and Budget (OMB) approved 
Federal Custody and Control Form (Federal CCF) for their programs. 
Additionally, the Department of Transportation (DOT) requires its 
regulated industries to use the Federal CCF.
    The current Federal CCF is a five-part form that consists of the 
following copies: Copy 1--Laboratory Copy, with the tamper-evident 
specimen bottle seal(s)/label(s) that are attached to the bottom of 
Copy 1, Copy 2--Medical Review Officer (MRO) Copy, Copy 3--Collector 
Copy, Copy 4--Employer Copy, and Copy 5--Donor Copy. The reverse side 
of each copy has a Public Burden Statement. The reverse side of Copy 5 
also has a Privacy Act Statement (for Federal employees only) and 
instructions for completing the Federal CCF. The current Federal CCF 
has been approved for use by OMB until September 1, 2012 for all 
Federal agency and federally-regulated drug testing programs that must 
comply with the Guidelines.
    In the latest revision to the Guidelines, dated November 25, 2008 
(73 FR 71858 with an effective date of May 1, 2010), the new 
regulations will permit the certification of Instrumented Initial Test 
Facilities (IITF) and will expand the drug testing profile to include 
new drug analytes: methylenedioxymethamphetamine (MDMA) commonly known 
as ``ecstasy,'' methylenedioxyamphetamine (MDA), and 
methylenedioxyethylamphetamine (MDEA) which are close chemical 
analogues of MDMA. These new regulatory actions will require that the 
Federal CCF be modified to accommodate the new rule changes.
    This notice provides proposed changes to the current Federal CCF. 
It incorporates changes in accordance with the latest revisions to the 
Guidelines (published November 25, 2008; 73 FR 71858; effective May 1, 
2010) and recommendations developed in a collaborative effort involving 
HHS and DOT. The proposed form is provided in Appendix A.

DATES: Written comments on the proposed draft should be submitted by 
January 19, 2010.

ADDRESSES: Written comments should be addressed to Robert L. Stephenson 
II, M.P.H., Director, Division of Workplace Programs (DWP), Center for 
Substance Abuse Prevention (CSAP), 1 Choke Cherry Road, Room 2-1035, 
Rockville, MD 20857. The public may also send comments by e-mail to 
charles.lodico@samhsa.hhs.gov. All comments received will be posted 
without change to https://www.drugfreeworkplace.gov.

FOR FURTHER INFORMATION CONTACT: Charles LoDico, M.S., D-ABFT, Drug 
Testing Team, DWP, CSAP, 1 Choke Cherry Road, Room 2-1039, Rockville, 
MD 20857, telephone (240) 276-2600, fax (240) 276-2610, or e-mail: 
charles.lodico@samhsa.hhs.gov.

Discussion

    SAMHSA is proposing several major changes to the Federal CCF. The 
first major change is to revise Copy 1 to permit use by IITFs, in 
addition to laboratories. This is in accordance with the latest 
revisions to the Guidelines (published November 25, 2008; effective May 
1, 2010), which allow certification of IITFs to perform federally-
regulated drug testing. A chain of custody section was added in Step 4 
of Copy 1 for the IITF to document receipt of the specimen and, as 
needed, to document subsequent transfer of the specimen to an HHS-
certified laboratory for testing. The second major change is to add the 
new drug analytes required by the revised Guidelines to the Primary 
Specimen Report section in Step 5a of Copy 1. The new drug analytes are 
MDMA, MDA and MDEA. The third major change is to discontinue recording 
split specimen test results on Copy 1 of the Federal CCF. Instead, Step 
5b of Copy 1 will be used to identify the split testing laboratory 
(i.e., laboratory name, city, and State), to indicate that the split 
specimen was tested, and to refer to a separate laboratory report for 
the split specimen test results. The fourth major change is to revise 
the 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 and DOT Regulations. Revisions to Copy 2, Step 6 
include the addition of lines for the MRO to specify positive drug 
analyte(s), to specify the adulterant/reason for reporting a specimen 
as adulterated, and to report other reasons for reporting a Refusal to 
Test (in addition to Adulteration and Substitution). Revisions to Copy 
2, Step 7 include the addition of lines for the MRO to specify drug 
analyte(s), substitution, or adulteration for ``Reconfirmed'' or 
``Failed to Reconfirm'' split specimens, and the addition of a checkbox 
to report a cancelled test.
    A desired outcome from the proposed Federal CCF revision process 
was to maintain the same form size (8.5 inch by 11 inch) as the current 
Federal CCF. The content and format was redrawn for conciseness, to 
conserve space, and to allow for the needed additional content while 
maintaining the overall familiarity to which collectors, laboratories 
and MROs were accustomed to using.
    Appendix A presents the required format and appearance for each 
copy of the proposed Federal CCF. SAMHSA recognizes that suppliers use 
different hardware and software to print forms and minor differences in 
appearance will occur. For example, the size of each checkbox on the 
form may be different, the font sizes and styles used for letters may 
be different, or the exact location of an item on a printed form may 
vary slightly from the location indicated on the sample provided in 
Appendix A. These minor changes in appearance are permitted since they 
do not significantly impact on the required format. Other changes 
permitted on the printed copies

[[Page 59197]]

include highlighting data entry/information fields where the collector 
and donor would be providing information and using combs/boxes (rather 
than a single line) for the donor's identification, to facilitate using 
optical readers for transferring that information. The colors used to 
highlight the fields may be different for different fields but must not 
prevent making clear photocopies of the information that is printed or 
handwritten in the highlighted fields. Other required information 
(e.g., the name and address of the test facility, the specimen 
identification number appearing on the top of the form and on the 
specimen bottle seal(s)/label(s)) may be printed on the Federal CCF 
during the original printing and assembly process or added by 
overprinting the five-part printed form after assembly.
    A detailed discussion of other proposed changes follows:

Copy 1

    To reflect use of the Federal CCF by IITFs as well as laboratories, 
Copy 1 has been redesignated as the Test Facility Copy (changed from 
Laboratory Copy). As on the current form, Copy 1 has a one-inch space 
at the top of the page reserved for: the title of the form (``Federal 
Custody and Control Form'') that must be printed along the top edge, 
the name and street address of the test facility, the unique preprinted 
specimen identification number (i.e., a barcode with an associated 
human readable number or only a human readable number), the test 
facility accession number (if used), and other information (e.g., 
accounting) that the test facility or user of the Federal CCF may want 
to include. There are no restrictions on the font size used for the 
information appearing in this one-inch space. Also as on the current 
form, the OMB number must be included, either vertically or 
horizontally, in the upper right-hand corner.
    The collector or employer representative completes Step 1. The 
items in Step 1(a), (b), and (c) are essentially the same as on the 
current Federal CCF. Step 1(d) is a new proposed item to list the 
acronyms for the Federal testing authority under which the specimen is 
being 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 DOT-regulated testing program applies to more than 6 million 
individuals. Some of the DOT agencies and the United States Coast Guard 
(USCG) have or anticipate having reporting requirements for test 
results. For example, the Federal Aviation Administration (FAA) 
requires the reporting of test results for pilots and mechanics, while 
the USCG requires the reporting of test results for mariners. We also 
expect other DOT agencies (e.g., FMCSA) may in the future require the 
identification of the ``testing authority'' in reporting of positive 
and refusal to test results which will be entered into a database. 
Identifying the Federal testing authority will facilitate reporting 
results to DOT agencies when their regulations require it and will 
assist HHS in identifying the Federal testing authority when it 
receives laboratory data. The information identifying the specific 
Federal testing authority captured on the Federal CCF will make it 
simpler for the entity reporting the result to the DOT agency (usually 
the employer or other program participant) to gather the information to 
satisfy the DOT agency reporting requirement. Knowing which data 
belongs to HHS, NRC, the USCG and the DOT agencies will prove helpful 
to each of these entities.
    The collector or employer should not find it difficult or 
impossible to complete this new step. HHS and DOT experience is that 
employers and Consortium/Third Party Administration (C/TPA) currently 
provide specific instructions to the collector or collection site in 
order to conduct the collection. For example, C/TPA would provide the 
name of the employer, the date of the collection, the test reason, 
whether the test is to be conducted under direct observation, and 
employee information (e.g., name and ID number). Therefore, we would 
expect the employers and C/TPAs to simply add another data element to 
what they already provide. In the event the information in Step 1(d) is 
not completed the test facility must not hold up processing, or testing 
the specimen. Similarly, the MRO must not hold up reporting a verified 
result. We believe this is something the test facility or MRO should 
just note and continue with processing, testing, and reporting of the 
specimen result.
    Step 1(e) contains the item ``Reason for Test,'' with the reasons 
consolidated on a single line to conserve space on the proposed Federal 
CCF. Items in Steps 1(f) and (g) are essentially the same as on the 
current Federal CCF.
    The collector completes Step 2 after he/she has received the 
specimen from the donor and has read the temperature of the specimen. 
The changes proposed for Step 2 are intended to gain more space on the 
proposed Federal CCF and to allow more space for the collector's 
Remarks. One proposed change is to move the instructions for Step 2 
[i.e., ``(make remarks when appropriate)'' and ``Collector reads 
specimen temperature within 4 minutes''] to the same line as 
``Completed by Collector.'' Another proposed change is to revise the 
sentence ``Is temperature between 90 [deg] and 100 [deg]F?'' to 
``Temperature between 90 [deg] and 100 [deg]F?'' This will reduce the 
space required for the three sections in Step 2 [i.e., for recording 
specimen temperature (Yes/No, Enter Remark) and collection type (Split/
Single/None Provided, Enter Remark), and to indicate an observed 
collection (Observed, Enter Remark)]. We are proposing to increase the 
space for collector comments in the ``Remarks'' section to allow 
additional explanation and to improve legibility of handwritten 
remarks.
    Step 3 instructs the collector to seal the specimen bottle(s), the 
donor to initial the bottle seal(s), and the donor to then complete 
Step 5 on Copy 2 (the MRO copy). These are the same instructions as on 
the current Federal CCF.
    Step 4 is the chain of custody section initiated by the collector 
and completed by the test facility. The major changes proposed for Step 
4 are to permit use of the Federal CCF by IITFs, as well as by 
laboratories, in accordance with the revised Guidelines. We are also 
proposing format changes to improve legibility of handwritten entries 
and facilitate form completion, while allowing all required information 
to be included. In the collector's chain of custody section, we propose 
to enlarge the block for the collector's signature while reducing the 
width of the ``Specimen Bottle(s) Released to:'' block. We also propose 
changing ``Initiated by Collector and Completed by Laboratory'' to 
``Initiated by Collector and Completed by Test Facility''. The 
``Received at IITF'' chain of custody section includes lines/checkboxes 
for the accessioner at the IITF to sign and print his/her name on the 
Federal CCF, record the date of specimen receipt, document the name and 
address of the IITF (if different from that printed on the Federal 
CCF), document the condition of the primary specimen bottle seal, and 
document the transfer of specimen custody. If a specimen received at 
the IITF cannot be reported (i.e., as rejected for testing, negative, 
or negative and dilute), the remaining specimen will be resealed using 
tamper-evident tape and forwarded to an HHS-certified laboratory for 
testing. This handling will be documented in the ``Transfer from IITF 
to Lab'' section of

[[Page 59198]]

the proposed Federal CCF. The laboratory chain of custody section in 
Step 4 is essentially the same as on the current Federal CCF. We are 
proposing changes similar to those for the collector's chain of custody 
section: to enlarge the block for the laboratory accessioner's 
signature while reducing the width of both the ``Specimen Bottle(s) 
Released to:'' block and the block for documenting condition of the 
primary specimen bottle seal.
    Step 5(a) is completed by the test facility to report the test 
results of the primary specimen. Changes are proposed for this section 
in accordance with the revised Guidelines, including: changing 
``Primary Specimen Test Results--Completed by Primary Laboratory'' to 
``Primary Specimen Report--Completed by Test Facility''; adding the new 
drug analytes (MDMA, MDA, and MDEA); changing ``Test Lab (if different 
from above)'' to ``Test Facility (if different from above)''; and 
changing ``Certifying Scientist'' to ``Certifying Technician/
Scientist'' on both signature and printed name lines. In addition, for 
clarity and to facilitate form completion, we propose to reposition 
drug/metabolite names and checkboxes, and to change the term ``Rejected 
for Testing'' to ``Rejected.'' We also propose to add ``[Delta]9-THCA'' 
after ``Marijuana Metabolite'' and ``BZE'' after ``Cocaine Metabolite'' 
to specify the drug analytes.
    We are proposing major changes to Step 5(b) of the current Federal 
CCF to accommodate the additional information needed on Copy 1 to 
address revised Guidelines requirements as described above. 
Laboratories will no longer record split specimen test results on Copy 
1 of the proposed Federal CCF and be moved to Copy 2 (Medical Review 
Officer Copy). This change is justified by National Laboratory 
Certification Program (NLCP) data obtained from HHS-certified 
laboratories in 2008. These data indicate that only 0.07% of federally-
regulated split specimens were tested (i.e., 3.7% of the total reported 
positives). Also, in many cases, the ``Remarks'' line of the current 
Federal CCF is insufficient to document all required comments for 
reporting split specimen test results. Laboratories often use a 
separate laboratory report to report split specimen results to the MRO. 
Therefore, in Step 5(b) of the proposed Federal CCF, the split 
laboratory will record its name and location (city and State), indicate 
that the split specimen was tested, and reference the separate 
laboratory report for the split specimen test results.
    At the bottom of Copy 1, we propose to reduce the area available 
for tamper-evident labels/seals to conserve space. The proposed Federal 
CCF in Appendix A shows two \1/2\-inch wide labels (i.e., reduced from 
\3/4\-inch on the current Federal CCF). The reduced size is sufficient 
for the required specimen identification number and should not affect 
the legibility of information printed on the labels/seals. We are also 
proposing to change the designation ``Copy 1--Laboratory'' printed on 
the bottom of Copy 1 to ``Copy 1--Test Facility Copy''.

Copy 2

    Steps 1 through 4 of Copy 2 (Medical Review Officer Copy) will be 
the same as Steps 1 through 4 of Copy 1 (Test Facility Copy) through 
the collector chain of custody section. The changes to the proposed 
Federal CCF begin in Step 4 of Copy 2. We propose to delete the 
``Received at Lab'' section in Step 4 of Copy 2 of the current Federal 
CCF. The collector separates the copies of the Federal CCF and sends 
Copy 1 to the test facility with the specimen. At that time, the test 
facility resumes chain of custody documentation. Therefore, chain of 
custody sections beyond the collector section are not completed on 
Copies 2 through 5.
    The collector instructs the donor to read the donor certification 
statement in Step 5 of Copy 2 and to complete the entries (signature, 
printed name, date, daytime telephone number, evening telephone number, 
and date of birth) in this section. The MRO uses this information to 
contact the donor as necessary during the verification process. We 
propose to revise the instructions to the donor at the bottom of the 
section to be consistent with current Guidelines requirements. The 
current statement ``Should the results of the laboratory tests for the 
specimen identified by this form be confirmed positive, the Medical 
Review Officer will contact you * * *'' will be changed to ``After the 
Medical Review Officer receives the test results for the specimen 
identified by this form, he/she may contact you * * *.'' Also, for 
clarity and ease of viewing, we propose to bold the lines on the 
proposed Federal CCF above and below Step 5 to provide visual 
separation of the section completed by the donor and the rest of the 
form.
    Step 6 on Copy 2 is used by the MRO to report the primary specimen 
test results to the employer after completing the verification. The 
proposed changes to this section are intended to facilitate form 
completion in accordance with MRO reporting requirements in the 
Guidelines and in DOT Regulations. The proposed changes include: 
changing the term ``determination/verification'' to ``verification'', 
repositioning results and checkboxes, adding a line after ``Positive'' 
for the MRO to specify the positive drug analyte(s), adding a line 
after ``Adulterated'' for the MRO to specify the adulterant/reason, 
adding ``Other'' under the ``Refusal to Test'' grouping to allow 
additional reasons for this result, and adding another ``Remarks'' line 
for the MRO's explanatory comments.
    Step 7 is used by the MRO to report the split specimen test results 
to the employer after completing the verification. The proposed changes 
to this section are intended to facilitate form completion in 
accordance with MRO reporting requirements in the Guidelines and in DOT 
Regulations. The proposed changes include: changing the term 
``determination/verification'' to ``verification'', adding a line after 
``Reconfirmed'' for the MRO to specify the reconfirmed test results 
(i.e., drug analytes, substitution, adulteration), adding the result 
and checkbox to report ``Test Cancelled'', adding a line after ``Failed 
to Reconfirm'' for the MRO to specify the test results that were not 
reconfirmed (i.e., drug analytes, substitution, adulteration), and 
adding another ``Remarks'' line for the MRO's explanatory comments.

Copy 3, Copy 4, Copy 5

    Copy 3 (Collector Copy), Copy 4 (Employer Copy), and Copy 5 (Donor 
Copy) will be the same as Copy 2 (Medical Review Officer Copy).

Instructions for Completing the Federal Custody and Control Form

    As on the current Federal CCF, instructions for completing the form 
are included on the back of Copy 5 (Donor Copy). The purpose of these 
instructions is to provide the donor with an overview of the specimen 
collection process. We propose to revise and update the instructions 
for clarity and for consistency with the revised Guidelines.
Public Burden Statement
    The Public Burden Statement in Appendix A must appear on all 
Federal Government forms that place a reporting burden on gathering 
information. This statement must be included on the back of each copy 
of the Federal CCF (i.e., Copies 1 through 5). The reporting address in 
this notice has been updated on the proposed revised Federal CCF and 
the word ``laboratory'' has been changed to ``test facility''. 
Otherwise, the statement is the same as the

[[Page 59199]]

``Paperwork Reduction Act Notice'' on the current OMB-approved Federal 
CCF. However, SAMHSA is interested in receiving public comments 
concerning the estimated average times for the collector, the donor, 
the test facility, and the MRO to complete the form. Individuals 
commenting on these topics should include in their estimates the time 
to review, print information, and/or read certification statements on 
the form.
Privacy Act Statement
    The Privacy Act Statement in Appendix A must appear on the back of 
Copy 5 (Donor Copy). It applies to all donors who are Federal 
employees. The statement is the same as that on the current Federal 
CCF.
Tamper-Evident Labels/Seals
    The size of the two tamper-evident labels/seals may vary, but they 
must be placed within the space provided at the bottom of Copy 1. It is 
the responsibility of the supplier of the specimen bottle labels/seals 
to ensure that they are tamper-evident. Tamper-evident tape is a tape 
that is placed on a specimen bottle which cannot be removed and be 
replaced without visible evidence that tampering has occurred. SAMHSA 
believes this single requirement is sufficient to ensure that the 
labels/seals provided with the Federal CCF are tamper-evident; however, 
comments are welcome on recommending other specifications/requirements 
that should be considered.
Availability of the Federal CCF
    The proposed Federal CCF, once approved by OMB, will be available 
on the SAMHSA Web site at https://www.drugfreeworkplace.gov/as an 
electronic file (using several different formats) that can be 
downloaded. Photocopies will also be available from the Division of 
Workplace Programs (DWP). SAMHSA believes making the Federal CCF 
available using this approach will ensure that the form is readily 
available from different sources.

Elaine Parry,
Director, Office of Program Services, SAMHSA.

APPENDIX A--Federal Drug Testing Custody and Control Forms

BILLING CODE 4162-20-P

[[Page 59200]]

[GRAPHIC] [TIFF OMITTED] TN17NO09.005

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 59201]]

collection information, including suggestions for reducing this burden, 
to SAMHSA Reports Clearance Officer, 1 Choke Cherry Road, Room 7-1044, 
Rockville, Maryland 20857.
[GRAPHIC] [TIFF OMITTED] TN17NO09.006

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/

[[Page 59202]]

Medical Review Officer. Send comments regarding this burden estimate or 
any other aspect of this collection information, including suggestions 
for reducing this burden, to SAMHSA Reports Clearance Officer, 1 Choke 
Cherry Road, Room 7-1044, Rockville, Maryland 20857.
[GRAPHIC] [TIFF OMITTED] TN17NO09.007

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/

[[Page 59203]]

Medical Review Officer. Send comments regarding this burden estimate or 
any other aspect of this collection information, including suggestions 
for reducing this burden, to SAMHSA Reports Clearance Officer, 1 Choke 
Cherry Road, Room 7-1044, Rockville, Maryland 20857.
[GRAPHIC] [TIFF OMITTED] TN17NO09.008

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/

[[Page 59204]]

Medical Review Officer. Send comments regarding this burden estimate or 
any other aspect of this collection information, including suggestions 
for reducing this burden, to SAMHSA Reports Clearance Officer, 1 Choke 
Cherry Road, Room 7-1044, Rockville, Maryland 20857.
[GRAPHIC] [TIFF OMITTED] TN17NO09.009


[[Page 59205]]


BILLING CODE 4162-20-C

Instructions for Completing the Federal Drug Testing Custody and 
Control Form

When Making Entries 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 label(s)/seal(s).
    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 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 turns to Copy 2 (Medical Review Officer Copy) 
and instructs the Donor to read and complete the certification 
statement in STEP 5 (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), places 
the sealed specimen bottle(s) and Copy 1 in a leak-proof plastic bag, 
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 requested information on the attached form is 
voluntary. However, incomplete submission of the requested information, 
refusal to provide a urine 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 urine specimen and identifying 
information contained herein is Executive Order 12564 (``Drug-Free 
Federal Workplace''), 5 U.S.C. Sec. 3301 (2), 5 U.S.C. Sec. 7301, and 
Section 503 of Public Law 100-71, 5 U.S.C. Sec. 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, 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 urine 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 information, including suggestions 
for reducing this burden, to SAMHSA Reports Clearance Officer, 1 Choke 
Cherry Road, Room 7-1044, Rockville, Maryland 20857.

[FR Doc. E9-27371 Filed 11-16-09; 8:45 am]
BILLING CODE 4162-20-P