[Federal Register: November 17, 2009 (Volume 74, Number 220)]
[Notices]
[Page 59196-59205]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17no09-75]
[[Page 59196]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 http://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 http://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