[Federal Register Volume 65, Number 122 (Friday, June 23, 2000)]
[Notices]
[Pages 39155-39169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-15889]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Federal Drug Testing Custody and Control Form

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

ACTION: Notice of final form.

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SUMMARY: The Substance Abuse and Mental Health Services Administration 
(SAMHSA) has revised the Federal Drug Testing Custody and Control Form 
(CCF). The current Federal CCF has a July 31, 2000, expiration date. 
The Office of Management and Budget (OMB) has approved the use of the 
new Federal CCF until June 30, 2003. OMB approval of the new Federal 
CCF allows Federal agencies and employers regulated by the Department 
of Transportation (DOT) to begin using the new Federal CCF on August 1, 
2000, for their workplace drug testing programs.

EFFECTIVE DATE: August 1, 2000.

FOR FURTHER INFORMATION CONTACT: Walter F. Vogl, Ph.D., Drug Testing 
Section, Division of Workplace Programs, CSAP, 5600 Fishers Lane, 
Rockwall II, Suite 815, Rockville, Maryland 20857, tel. (301) 443-6014, 
fax (301) 443-3031, or email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    All urine specimens must be collected using chain of custody 
procedures to document the integrity and security of the specimen from 
the time of collection until receipt by the laboratory. To ensure 
uniformity among all Federal agency and federally regulated workplace 
drug testing programs, the use of an OMB approved Federal CCF is 
required. Based on the experiences of using the current Federal CCF for 
the past several years, SAMHSA and DOT initiated a joint effort to 
develop a new Federal CCF that was easier to use and more accurately 
reflected both the collection process and how results were reported by 
the drug testing laboratories. This effort included scheduling two 
public meetings attended by over 35 industry representatives who 
recommended most of the changes to the current Federal CCF. As a result 
of these two meetings, SAMHSA published a proposed revised Federal CCF 
in a Federal Register notice (64 FR 61916) on November 15, 1999. A 
sample of the proposed form was included in that notice.
    The first major proposed change was to make the revised Federal CCF 
a six-part form by eliminating the split specimen copy. Since the split 
specimen copy is used only when the split specimen is tested (i.e., 
less than approximately 5 percent of split specimens are tested), it 
would be more efficient to have the split specimen test result reported 
on the original laboratory copy (Copy 1). When the split specimen is 
tested, the primary laboratory would need to make a photocopy of Copy 1 
of the Federal CCF and send it along with the split specimen to the 
second laboratory. Although this procedure requires the primary 
laboratory to make a photocopy, SAMHSA and DOT believe the cost saving 
associated with not including a separate split specimen copy with each 
Federal CCF outweighs the cost associated with the few times that Copy 
1 will need to be photocopied by the primary laboratory. Additionally, 
eliminating the split specimen copy will help make any handwritten 
information appear more legible on the later copies.
    The second major proposed change was to move the specimen bottle 
seal(s)/ label(s) from the right side of the form to the bottom of Copy 
1. This change would permit overprinting information on the form using 
standard width tractor feed printers rather than requiring more 
expensive wide carriage printers. In addition, the storage and handling 
requirements would be similar to other documents since the overall size 
of the new Federal CCF (including the tractor feed strips) is 
essentially the same as a standard sheet of paper.
    The third major proposed change involved simplifying the chain of 
custody step by requiring the collector to only sign the form once. 
SAMHSA and DOT believe the current requirement for the collector to 
sign the

[[Page 39156]]

form three times can be replaced with one signature because the 
certification statement signed by the collector clearly describes that 
the collector has possession of the specimen from the time the 
collector receives the specimen from the donor until the collector 
releases the specimen for shipment to the laboratory.
    The fourth major proposed change was to provide a wider choice of 
terms that a laboratory can use to report specimen test results. The 
current form uses the term ``Test Not Performed'' to report any result 
other than a negative or positive result. In fact, this term does not 
always reflect the actual handling of the specimen. SAMHSA and DOT 
believe it is more appropriate to provide a variety of terms on the 
Federal CCF that accurately reflect the different specimen test results 
that a laboratory may report, such as, invalid result, adulterated, 
substituted, or rejected for testing.
    The fifth major proposed change was to include a new step on the 
original laboratory copy (Copy 1) for reporting the result for the 
split specimen (Bottle B) since the split specimen copy was eliminated. 
This change ensures that the primary specimen and split specimen 
laboratory test results are recorded on the same copy that is provided 
to the Medical Review Officer if the split specimen is tested.
    The sixth major proposed change was to place the Medical Review 
Officer (MRO) steps for both the primary and split specimens on the MRO 
copy. This change permits the MRO to record the determination for both 
the primary specimen and the split specimen (if tested) on the same 
copy and to use this copy to report results to the employer.
    Other changes were considered to be minor changes and were 
discussed as each part of the proposed new form was described in the 
November 15, 1999, Federal Register notice.

Public Comments

    SAMHSA received thirty comments on the proposed changes from 
laboratories, printing firms, employers, organizations, and 
individuals. The majority of comments supported the proposed changes. 
All comments were reviewed and taken into consideration in preparing 
the new Federal CCF. The substantive comments submitted and SAMHSA's 
and DOT's response to those comments are discussed below as each step 
of the new Federal CCF is described.

New Federal CCF

    Appendix A is a sample of the new Federal CCF.

General Changes

    The new Federal CCF has the following 5 copies: Copy 1--Laboratory 
Copy, Copy 2--Medical Review Officer Copy, Copy 3--Collector Copy, Copy 
4--Employer Copy, and Copy 5--Donor Copy. The reverse side of each copy 
(i.e., Copy 1, Copy 2, Copy 3, Copy 4, and Copy 5) must have the 
``Paperwork Reduction Act Notice'' statement. The reverse side of Copy 
5 must also have the ``Privacy Act Statement (for Federal employees 
only)'' and the ``Instructions for Completing the Federal Drug Testing 
Custody and Control Form.'' The required statements and instructions 
for completing the Federal CCF are provided below.
    The second laboratory copy was eliminated from the proposed six-
part form when SAMHSA and DOT agreed to permit a certified laboratory 
to transmit a negative result to the Medical Review Officer (MRO) 
electronically (e.g., facsimile, computer). The only time that a hard 
copy of the Federal CCF must be sent to the MRO is when the laboratory 
is reporting either a positive for a specific drug, adulterated, 
substituted, rejected for testing, or invalid result. For these 
relatively few non-negative results, the laboratory is required to make 
and send a photocopy of Copy 1 to the MRO even if an electronic report 
was sent. SAMHSA and DOT believe the additional cost saving associated 
with not including the second laboratory copy with each Federal CCF 
outweighs the cost associated with the few times that Copy 1 will need 
to be photocopied by the primary laboratory.
    Each copy of the new Federal CCF will be on white paper. The 
proposed changes had required using paper with a different color border 
for the MRO, collector, employer, and donor copies as opposed to using 
a different color paper for each of these copies as used for the old 
form. Two comments supported using paper with different color borders 
while two comments opposed using color borders. SAMHSA and DOT have 
reevaluated the need to use either different color paper or paper with 
different color borders and believe that using white paper for each 
copy is sufficient to ensure that the copies will be distributed as 
required. Additionally, using white paper for all copies will reduce 
the cost to assemble the form and will make handwritten information 
more legible on all copies.
    The sequence of the copies for the new Federal CCF was changed to 
laboratory, MRO, collector, employer, and donor. Three comments 
suggested changing the sequence of the copies for the proposed revised 
form because of the concern with the legibility of the information on 
the latter copies, especially if a latter copy is needed to replace a 
lost copy. SAMHSA and DOT concur that legibility is a concern and the 
best copies, beside the laboratory copy, should be the MRO and 
collector copies. If the employer and donor copies are not entirely 
legible, the information can be obtained from the MRO or collector 
copies. In addition, placing the donor copy last, gives the donor the 
instructions for collecting the urine specimen and completing the 
Federal CCF. This may be useful if, at a later time, the donor claims 
that the collector did not follow the collection procedure.

Copy 1--Laboratory Copy

    Copy 1 has a one inch space at the top of the page reserved for the 
following items: the title ``Federal Drug Testing Custody and Control 
Form'' must be printed along the top edge, the OMB Number must appear 
in the right hand corner, name and street address of the certified 
laboratory that will test the specimen, a unique preprinted specimen 
identification number, an accession number after the specimen is 
received by the laboratory, and any other information (e.g., accounting 
code) the laboratory or user of the form may want to print on the form.
    Step 1 is completed by the collector or employer representative. A 
space is provided for the name, address, and identification number (if 
applicable) of the employer and the name and address of the MRO. The 
collector records the donor's social security number or other employee 
identification number after verifying the donor's identity. The 
collector marks the appropriate box to indicate the reason for the test 
and the appropriate box for the drug tests to be performed. The 
collector records the collection site address and the phone and fax 
numbers where the collector can be contacted.
    Four comments recommended that the we retain the same sequence for 
the reasons for the test as on the current CCF. SAMHSA and DOT concur 
with that recommendation and changed the sequence to coincide with that 
on the current CCF. Three comments were opposed to requiring the 
collector to indicate the acronym of the Federal agency for which the 
specimen was being collected because the collector did not always have 
that information. We agree that that information is not always known by 
the collector and deleted the acronym from the new Federal CCF.
    Step 2 is completed by the collector after receiving the specimen 
from the donor and measuring the temperature of

[[Page 39157]]

the specimen. This step requires the collector to mark the appropriate 
box to indicate if the temperature of the specimen was within the 
required temperature range, whether it is a split or single specimen 
collection, if no specimen was collected, and if it was an observed 
collection. A ``Remarks'' line is provided when the collector is 
required to provide a comment. One comment suggested placing the box 
for the split specimen collection before the box for the single 
specimen collection. SAMHSA and DOT agree with the comment because the 
vast majority of collections are split specimen collections rather than 
single specimen collections.
    Step 3 directs the collector to affix the seal(s)/label(s) to the 
specimen bottle(s), to date the seal(s) after being placed on the 
specimen bottle(s), to have the donor initial the seal(s) after being 
placed on the specimen bottle(s), and to instruct the donor to complete 
step 5 on the MRO copy (Copy 2). This is essentially the same 
instruction that appears on the current form.
    Step 4 is a revised chain of custody step that is initiated by the 
collector and completed by the laboratory after the specimen is 
accessioned by the laboratory. This step requires the collector to only 
sign the form once to certify that the specimen was collected, labeled, 
sealed, and released for shipment to the laboratory in accordance with 
Federal requirements. SAMHSA and DOT believe that one collector 
signature is sufficient to document chain of custody from this 
procedure. The collector is also required to note the time of the 
collection, the date of collection, and the specific name of the 
delivery service to whom the specimen is released for shipment to the 
laboratory. This is the same information that is required on the 
current Federal CCF. Since there is no requirement for delivery service 
personnel to document chain of custody during transit because they do 
not have access to the specimen bottle(s) or the Federal CCF, chain of 
custody annotations resume when the shipping container/package is 
opened and an individual at the laboratory has access to the specimen 
bottle(s) and the Federal CCF. We consider this individual to be the 
accessioner, and he or she is required to document the condition of the 
primary specimen bottle seal, sign the Federal CCF, print his/her name, 
the date the specimen was accessioned, and then to whom the specimen 
was released. The entry for the ``Specimen Bottle(s) Released To'' may 
include transfer to temporary storage or transfer to another 
individual. After this transfer, chain of custody for the specimen 
bottle(s) is documented by the laboratory using an internal chain of 
custody form. Two comments suggested deleting the requirement to record 
the delivery service since it was mentioned in the certification 
statement signed by the collector and one commenter suggested allowing 
preprinting a generic term for the delivery service. SAMHSA and DOT 
believe it is extremely important to document that the collector 
transferred the shipping container/package to a specific delivery 
service. It ensures that the collector knows that the specimen must be 
directly transferred to a specific delivery service rather than to 
another individual or to temporary storage.
    Step 5(a) is completed by a certifying scientist at the laboratory 
to document the test result for the primary specimen. The certifying 
scientist is required to provide a signature, print his or her name, 
and the date. This step has boxes to allow the certifying scientist to 
easily check whether the result is negative, positive for a specific 
drug, rejected for testing, adulterated, substituted, invalid result, 
and/or dilute. One comment suggested adding a box to check when a 
specimen was dilute rather than requiring a comment to written on the 
``Remarks'' line. SAMHSA and DOT concur with that recommendation and 
added a box to check when a specimen was dilute.
    Step 5(b) is used by a certifying scientist at the second certified 
laboratory to document the test result for the split specimen, if the 
split specimen is tested. This step has a space for the name and 
address of the second laboratory, a certification statement, 
appropriate boxes for the certifying scientist to report the test 
result for the split specimen, a signature line, a line to print his or 
her name, and the date. There were no comments submitted regarding this 
step.
    There must be two tamper-evident specimen bottle seal(s)/label(s) 
located in the bottom one and three-quarter inch space of Copy 1. One 
label must have the letter ``A'' on it to designate its use for sealing 
and labeling the primary specimen bottle and the other has the letter 
``B'' on it to designate its use for sealing and labeling the split 
specimen bottle. Each seal/label must have the same specimen 
identification number (either preprinted or overprinted before use) 
that appears at the top of the form, a place for the collector to 
annotate the date of the collection, and a place for the donor to 
initial each label after it is placed on the specimen bottle. If a 
single specimen collection procedure is used, the ``B'' label is 
discarded by the collector.
    It is also the responsibility of the supplier of the seals/labels 
to ensure that they are tamper-evident. Tamper-evident is defined as a 
seal/label that cannot be removed from the specimen bottle after 5 
minutes contact with the specimen bottle.
    Three comments supported locating the seals/labels at the bottom of 
the form and three comments were opposed and recommended leaving the 
seals/labels attached to the side of the form. They were concerned that 
placement of the seals/labels at the bottom of the form would jam the 
printers because of the thickness of the form. SAMHSA and DOT believe 
that reducing the number of copies to 5 from 7 and ensuring that a good 
quality tamper-evident seal/label is properly placed on the form that 
the seals/labels will not interfere with the printing or overprinting 
process. There are numerous examples of forms used with labels placed 
directly onto the forms that do not cause printing problems and we 
fully expect that to be the case when the new Federal CCF is printed 
and used.

Copy 2--Medical Review Officer Copy

    The Medical Review Officer copy is the same format as Copy 1 except 
that step 5(a) has been replace with step 5. This step 5 on Copy 2 is 
completed by the donor after the specimen bottle(s) are sealed, 
initialed by the donor, and dated. The donor is required to read the 
certification statement, provide a signature, printed name, date of 
collection, daytime phone number, evening phone number, and date of 
birth. This information will be used by the Medical Review Officer to 
contact the donor for results that require donor contact before making 
a determination.

Copy 3--Collector Copy

    Exactly the same as Copy 2.

Copy 4--Employer Copy

    Exactly the same as Copy 2.

Copy 5--Donor Copy

    Exactly the same as Copy 2.

Paperwork Reduction Act Notice

    The following Paperwork Reduction Act Notice must appear on the 
back of each copy (i.e, Copy 1, Copy 2, Copy 3, Copy 4, and Copy5) of 
the Federal CCF:

Paperwork Reduction Act Notice (as required by 5 CFR 1320.21)

    Public reporting burden for this collection of information, 
including the time for reviewing instructions, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information is estimated for each respondent to 
average: 5 minutes/donor; 4 minutes/collector; 3

[[Page 39158]]

minutes/laboratory; and 3 minutes/Medical Review Officer. Federal 
employees may send comments regarding these burden estimates, or any 
other aspect of this collection of information, including 
suggestions for reducing the burden, to the SAMHSA Reports Clearance 
Officer, Paperwork Reduction Project (0930-0158), Room 16-105, 
Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. 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.

    There were no comments submitted regarding this Paperwork Reduction 
Act Notice statement.

Privacy Act Statement

    The following Privacy Act Statement must appear on the back of the 
donor copy (Copy 5):

Privacy Act Statement (For Federal Employees Only)

    Submission of the information on the attached form is voluntary. 
However, incomplete submission of the 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 your removal from 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 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 specimen provided for urinalysis testing 
for illegal drugs. If you refuse to indicate your SSN, a substitute 
number or other identifier will be assigned, as required, to process 
the specimen.
    In the event laboratory analysis determines the presence of one 
or more illegal drugs in the specimen you provide, you will be 
contacted by an agency Medical Review Officer (MRO). The MRO will 
determine whether there is a legitimate medical explanation for the 
drug(s) identified by urinalysis.

    There were no comments submitted regarding this Privacy Act 
statement.

Instructions for Completing the Federal CCF

    The following instructions must appear on the back of the donor 
copy (Copy 5):

Instructions for Completing the Federal Drug Testing Custody and 
Control Form

    A. Collector ensures that the name and address of the drug 
testing laboratory appear on the top of the CCF and the Specimen 
I.D. number on the top of the CCF matches the Specimen I.D. number 
on the labels/seals.
    B. Collector provides the required information in STEP 1 on the 
CCF. The collector provides a remark in STEP 2 if the donor refuses 
to provide his/her SSN or Employee I.D. number.
    C. Collector gives a collection container to the donor for 
providing a specimen.
    D. After the donor gives the specimen to the collector, the 
collector checks the temperature of specimen within 4 minutes and 
marks the appropriate temperature box in STEP 2 on the CCF. The 
collector provides a remark if the temperature is outside the 
acceptable range.
    E. Collector checks the split or single specimen collection box. 
If no specimen is collected, that box is checked and a remark is 
provided. If it is an observed collection, that box is checked and a 
remark is provided. If no specimen is collected, Copy 1 is discarded 
and the remaining copies are distributed as required.
    F. Donor watches the collector pouring the specimen from the 
collection container into the specimen bottle(s), placing the cap(s) 
on the specimen bottle(s), and affixing the label(s)/seal(s) on the 
specimen bottle(s).
    G. Collector dates the specimen bottle label(s) after they are 
placed on the specimen bottle(s).
    H. Donor initials the specimen bottle label(s) after the 
label(s) have been placed on the specimen bottle(s).
    I. Collector turns to Copy 2 (MRO Copy) and instructs the donor 
to read the certification statement in STEP 5 and to sign, print 
name, date, provide phone numbers, and date of birth after reading 
the certification statement. If the donor refuses to sign the 
certification statement, the collector provides a remark in STEP 2 
on Copy 1.
    J. Collector completes STEP 4 (i.e., provides signature, printed 
name, date, time of collection, and name of delivery service), 
immediately places the sealed specimen bottle(s) and Copy 1 of the 
CCF in a leak-proof plastic bag, releases specimen package to the 
delivery service, and distributes the other copies as required.

List of Acceptable Modifications

    SAMHSA recognizes that different hardware and software are used to 
prepare and print forms and this will create minor differences in the 
appearance between forms. The following is a list of acceptable 
differences and modifications when printing the Federal CCF:
    (1) The OMB number may appear either vertically or horizontally in 
the upper right hand corner of the form.
    (2) The name and address of the testing laboratory and the unique 
specimen identification number at the top of the form and on the 
specimen bottle seal(s)/label(s) may be printed during the original 
printing and form assembly process or added by ``overprinting'' after 
the form is assembled.
    (3) Preprinting and/or overprinting the employer name and address, 
MRO name and address, and collection site information is permitted.
    (4) The spaces for the employer name and address, MRO name and 
address, and the collection site address may have lines.
    (5) The unique specimen identification number at the top of the 
form and on the tamper-evident seal(s)/label(s) may be either a bar 
code with an associated human readable number or only a human readable 
number.
    (6) A laboratory does not need to assign and record a separate 
laboratory accession number in the one inch space at the top of the 
form if it uses the unique specimen identification number to track the 
specimen after receipt. When this is the case, the form may be printed 
without the words ``LAB ACCESSION NO.'' appearing on the top of the 
form.
    (7) The size of each ``check'' box may vary slightly.
    (8) The font size and style used for letters may vary to enhance 
readability.
    (9) The ``exact'' location for each item on the printed form may 
vary slightly from the location indicated on the sample form provided 
in Appendix A.
    (10) The data entry/information fields may be highlighted using 
different colors to show where the collector, donor, and laboratory 
would be providing information. The colors used to highlight the fields 
may be different for different fields, but must not prevent making 
clear facsimiles and photocopies of the information that is printed or 
handwritten in these fields.
    (11) The space for the donor's SSN or Employee I.D. No. may have 
combs, boxes, or a single line.
    (12) The legend at the bottom of copies 2 through 5 may be printed 
using different colors or a different color stripe may be printed at 
the bottom of copies 2 through 5. To ensure consistency and correct 
distribution of the copies, if different color stripes or legends are 
used at the bottom of each copy, the following colors must be used: MRO 
copy--pink, Collector copy--yellow, Employer copy--blue, Donor copy--
green.
    (13) A reference mark(s) may be used to position the form in a 
printer to overprint information in the correct

[[Page 39159]]

location or to optically scan the information in the various fields.
    (14) The size of the two tamper-evident seals/labels may vary, but 
must be placed within the space provided at the bottom of Copy 1.
    (15) The color of the preprinted information on the ``A'' specimen 
bottle tamper-evident seal/label may be different than the color of the 
preprinted information on the ``B'' specimen bottle tamper-evident 
seal/label.

Availability of Federal CCF

    The new Federal CCF is available on the SAMHSA website 
(www.health.org/workpl.htm) as an electronic ``.pdf'' file that can be 
opened, saved, and printed.

Use of Expired Federal CCF

    SAMHSA and DOT recognize that there may be a large supply of old 
forms at collection sites after the August 1, 2000, implementation date 
for the new Federal CCF. To avoid discarding these forms, OMB is 
permitting the use of the old Federal CCF until supplies are exhausted, 
but not to be used beyond July 31, 2001. After that date, remaining 
copies of the old Federal CCF should be destroyed.

Richard Kopanda,
Executive Officer, Substance Abuse and Mental Health Services 
Administration.

BILLING CODE 4162-20-P

[[Page 39160]]

Appendix A
[GRAPHIC] [TIFF OMITTED] TN23JN00.000


[[Page 39161]]



Paperwork Reduction Act Notice (As Required by 5 CFR 1320.21)

    Public reporting burden for this collection of information, 
including the time for reviewing instructions, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information is estimated for each respondent to 
average: 5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; 
and 3 minutes/Medical Review Officer. Federal employees may send 
comments regarding these burden estimates, or any other aspect of 
this collection of information, including suggestions for reducing 
the burden, to the SAMHSA Reports Clearance Officer, Paperwork 
Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 
Fishers Lane, Rockville, MD 20857. 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.

[[Page 39162]]

[GRAPHIC] [TIFF OMITTED] TN23JN00.001


[[Page 39163]]



Paperwork Reduction Act Notice (As Required by 5 CFR 1320.21)

    Public reporting burden for this collection of information, 
including the time for reviewing instructions, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information is estimated for each respondent to 
average: 5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; 
and 3 minutes/Medical Review Officer. Federal employees may send 
comments regarding these burden estimates, or any other aspect of 
this collection of information, including suggestions for reducing 
the burden, to the SAMHSA Reports Clearance Officer, Paperwork 
Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 
Fishers Lane, Rockville, MD 20857. 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.

[[Page 39164]]

[GRAPHIC] [TIFF OMITTED] TN23JN00.002


[[Page 39165]]



Paperwork Reduction Act Notice (As Required by 5 CFR 1320.21)

    Public reporting burden for this collection of information, 
including the time for reviewing instructions, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information is estimated for each respondent to 
average: 5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; 
and 3 minutes/Medical Review Officer. Federal employees may send 
comments regarding these burden estimates, or any other aspect of 
this collection of information, including suggestions for reducing 
the burden, to the SAMHSA Reports Clearance Officer, Paperwork 
Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 
Fishers Lane, Rockville, MD 20857. 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.

[[Page 39166]]

[GRAPHIC] [TIFF OMITTED] TN23JN00.003


[[Page 39167]]



Paperwork Reduction Act Notice (As Required by 5 CFR 1320.21)

    Public reporting burden for this collection of information, 
including the time for reviewing instructions, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information is estimated for each respondent to 
average: 5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; 
and 3 minutes/Medical Review Officer. Federal employees may send 
comments regarding these burden estimates, or any other aspect of 
this collection of information, including suggestions for reducing 
the burden, to the SAMHSA Reports Clearance Officer, Paperwork 
Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 
Fishers Lane, Rockville, MD 20857. 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.

[[Page 39168]]

[GRAPHIC] [TIFF OMITTED] TN23JN00.004

BILLING CODE 4162-20-C

[[Page 39169]]

Instructions for Completing the Federal Drug Testing Custody and 
Control Form

    A. Collector ensures that the name and address of the drug 
testing laboratory appear on the top of the CCF and the Specimen 
I.D. number on the top of the CCF matches the Specimen I.D. number 
on the labels/seals.
    B. Collector provides the required information in STEP 1 on the 
CCF. The collector provides a remark in STEP 2 if the donor refuses 
to provide his/her SSN or Employee I.D. number.
    C. Collector gives a collection container to the donor for 
providing a specimen.
    D. After the donor gives the specimen to the collector, the 
collector checks the temperature of specimen within 4 minutes and 
marks the appropriate temperature box in STEP 2 on the CCF. The 
collector provides a remark if the temperature is outside the 
acceptable range.
    E. Collector checks the split or single specimen collection box. 
If no specimen is collected, that box is checked and a remark is 
provided. If it is an observed collection, that box is checked and a 
remark is provided. If no specimen is collected, Copy 1 is discarded 
and the remaining copies are distributed as required.
    F. Donor watches the collector pouring the specimen from the 
collection container into the specimen bottle(s), placing the cap(s) 
on the specimen bottle(s), and affixing the label(s)/seal(s) on the 
specimen bottle(s).
    G. Collector dates the specimen bottle label(s) after they are 
placed on the specimen bottle(s).
    H. Donor initials the specimen bottle label(s) after the 
label(s) have been placed on the specimen bottle(s).
    I. Collector turns to Copy 2 (MRO Copy) and instructs the donor 
to read the certification statement in STEP 5 and to sign, print 
name, date, provide phone numbers, and date of birth after reading 
the certification statement. If the donor refuses to sign the 
certification statement, the collector provides a remark in STEP 2 
on Copy 1.
    J. Collector completes STEP 4 (i.e., provides signature, printed 
name, date, time of collection, and name of delivery service), 
immediately places the sealed specimen bottle(s) and Copy 1 of the 
CCF in a leak-proof plastic bag, releases specimen package to the 
delivery service, and distributes the other copies as required.

Privacy Act Statement: (For Federal Employees Only)

    Submission of the information on the attached form is voluntary. 
However, incomplete submission of the 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 specimen provided for urinalysis testing 
for illegal drugs. If you refuse to indicate your SSN, a substitute 
number or other identifier will be assigned, as required, to process 
the specimen.
    In the event laboratory analysis determines the presence of one 
or more illegal drugs in the specimen you provide, you will be 
contacted by an agency Medical Review Officer (MRO). The MRO will 
determine whether there is a legitimate medical explanation for the 
drug(s) identified by urinalysis.

Paperwork Reduction Act Notice (as Required by 5 CFR 1320.21)

    Public reporting burden for this collection of information, 
including the time for reviewing instructions, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information is estimated for each respondent to 
average: 5 minutes/donor; 4 minutes/collector; 3 minutes/laboratory; 
and 3 minutes/Medical Review Officer. Federal employees may send 
comments regarding these burden estimates, or any other aspect of 
this collection of information, including suggestions for reducing 
the burden, to the SAMHSA Reports Clearance Officer, Paperwork 
Reduction Project (0930-0158), Room 16-105, Parklawn Building, 5600 
Fishers Lane, Rockville, MD 20857. 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.

[FR Doc. 00-15889 Filed 6-22-00; 8:45 am]
BILLING CODE 4162-20-P