[Federal Register Volume 64, Number 219 (Monday, November 15, 1999)]
[Notices]
[Pages 61916-61930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29609]


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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 proposed revision.

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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 Public Law 100-71 and Executive Order No. 12564. As a 
result of the Executive Order and Public Law, HHS published the 
Mandatory Guidelines for Federal Workplace Drug Testing Programs in the 
Federal Register on April 11, 1988 (53 FR 11979), which were revised on 
June 9, 1994 (59 FR 29908), to establish comprehensive standards for 
all aspects of the Federal workplace drug testing program. The 
Mandatory Guidelines require all urine specimens to 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 workplace 
drug testing programs, the Mandatory Guidelines require agencies to use 
an Office of Management and Budget (OMB) approved Federal drug testing 
custody and control form (Federal CCF) for their programs. 
Additionally, the Department of Transportation (DOT) has required its 
regulated industries to use the Federal CCF. The current Federal CCF 
has been approved for use by OMB until July 31, 2000, for all Federal 
agency and federally regulated drug testing programs which must comply 
with the HHS Mandatory Guidelines.
    The current Federal CCF is a seven-part form that consists of the 
following copies: Copy 1 (Original--Must Accompany Specimen to 
Laboratory (White)), Copy 2 (Second Original--Must Accompany Specimen 
to Laboratory (White)), Copy 3 (Split Specimen--Must Accompany Split 
Specimen to Laboratory (White)), Copy 4 (Medical Review Officer Copy 
(Pink)), Copy 5 (Donor Copy (Green)), Copy 6 (Collector Copy (Yellow)), 
and Copy 7 (Employer Copy (Blue)). The reverse side of copies 1, 2, 3, 
4, 5, and 6 have a Paperwork Reduction Act Notice statement, the 
reverse side of Copy 5 has a Privacy Act Statement (for Federal 
employees only), and the reverse side of Copy 7 has instructions for 
completing the CCF. Additionally, the tamper-evident specimen bottle 
seal(s)/label(s) are attached to the right side of Copy 1.
    This notice provides proposed changes to the current Federal CCF. 
It incorporates changes based on the HHS and DOT experiences during the 
past several years as well as many of the recommendations developed by 
industry representatives (i.e., users and suppliers of the Federal CCF) 
at two working group meetings held in January and March 1999. The 
Substance Abuse and Mental Health Services Administration (SAMHSA) 
believes the proposed changes will make the Federal CCF easier to use 
and will more accurately reflect the collection process and how results 
are reported by the drug testing laboratories. The proposed form is 
provided in Appendix A.

DATES: Written comments on the proposed draft should be submitted by 
January 14, 2000.

ADDRESSES: Written comments should be addressed to Robert L. Stephenson 
II, M.P.H., Director (Acting), Division of Workplace Programs, CSAP, 
5600 Fishers Lane, Rockwall II, Suite 815, Rockville, Maryland 20857.

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].

Discussion

    SAMHSA is proposing the following major changes to the Federal CCF. 
The first major change is to make the revised Federal CCF a six-part 
form by eliminating the split specimen copy (current Copy 3). 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 second laboratory 
report the split specimen test result on Copy 1. For those instances 
when the split specimen is tested, the primary laboratory will 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 believes 
saving the costs for printing a separate split specimen copy for each 
Federal CCF outweighs the costs associated with the few times that Copy 
1 will need to be photocopied by the primary laboratory. In addition, 
eliminating the split specimen copy will help make the information that 
appears on later pages more legible.
    The second major change is locating the specimen bottle seal(s)/
label(s) on the bottom of Copy 1 rather than attaching them to the 
right side of the form. This change will eliminate the need to have 
special and expensive wide carriage printers and equipment to handle 
the automatic processing of the Federal CCF and will standardize the 
storage and handling requirements to match those for other documents. 
We believe this change will increase the number of suppliers printing 
the Federal CCF, will reduce the cost to print the Federal CCF, and 
reduce the cost of the forms for the user.
    The third major change involves simplifying the chain of custody 
step by requiring the collector to only sign the form once. SAMHSA 
believes the current requirement for the collector to sign the form 
three times can be replaced by using one signature because the 
certification statement signed by the collector clearly describes that 
the collector had possession of the specimen from the time collector 
received the specimen from the donor until the collector released the 
specimen for shipment to the laboratory.
    The fourth major change is to provide additional choices for the 
laboratory to report specimen test results. The current form uses 
``Test Not Performed'' to report anything other than a negative or 
positive result. SAMHSA believes it is more appropriate to provide 
choices on the form that accurately reflect the handling and reporting 
of specimen test results, such as, invalid result, adulterated, 
substituted, or rejected for testing.
    The fifth major change is to include a new step on Copy 1 to allow 
the secondary laboratory to document a result for the split specimen 
(Bottle B). 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 change is placing the Medical Review Officer steps 
for the primary and split specimens on Copy 2. This change permits the 
MRO to record the determination for both the primary specimen and the 
split specimen (if tested) on the same copy (Copy 2).
    Appendix A presents the required format and appearance for each 
copy of

[[Page 61917]]

the 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 ``check'' box 
appearing 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 varies slightly from the location indicated on the sample 
provided in Appendix A. These minor changes in appearance are permitted 
since they do not impact on the required format. Other changes 
permitted on the printed copies 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 SSN 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 these highlighted 
fields. Other required information (e.g., the name and address of the 
testing laboratory, 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 six-part printed form after it 
is assembled.
    A detailed discussion of other proposed changes is as follows:

Copy 1

    Copy 1 (Laboratory Copy) 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 OMB Number that must 
appear in the upper right hand corner (the OMB Number may be placed 
vertical or horizontal), the name and street address of the laboratory 
that will receive and test the specimen, a unique preprinted specimen 
identification number (it may be a bar code with an associated human 
readable number or only a human readable number), space for the 
laboratory to assign an accession number after the specimen is 
received, and any other information (e.g., accounting) the laboratory 
or user of the form may want to document on the form. There are no 
restrictions on the font size used for the information appearing in 
this one inch space.
    Step 1 is completed by the collector or employer representative. 
The employer name and address, the acronym of the Federal Agency under 
which the specimen is being collected and tested (e.g., DOD, DOI, FRA, 
FAA), and the MRO name and address may be preprinted or handwritten. 
The collector will normally enter the donor's social security number 
after verifying the donor's identity. The collector also marks the 
appropriate box to indicate the reason for the test and the appropriate 
box for the drug tests to be performed. The collector then enters the 
information required for the collection site. This step is essentially 
the same as for the current Federal CCF except the collection site 
information has been moved from step 5 on the current form to step 1 on 
this proposed form.
    Step 2 is completed by the collector after receiving the specimen 
from the donor and measuring the temperature of the specimen. As on the 
current form, this step requires the collector to mark the appropriate 
box to indicate if the temperature of the specimen was within the 
required temperature range; but also requires the collector to indicate 
whether it is a single or split specimen collection, to indicate if no 
specimen was collected and why, or to indicate if it was an observed 
collection and why. SAMHSA believes the additional information is 
needed to ensure that the collector documents why a specimen was not 
collected or the reason an observed collection was conducted.
    Step 3, as on the current form, instructs the collector to seal the 
specimen bottle(s), have the donor initial the bottle seal(s), and then 
instruct the donor to complete step 5 on the MRO copy (Copy 3). This is 
essentially the same instruction that appears on the current form.
    Step 4 is a totally revised chain of custody step that is initiated 
by the collector and then 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 believes that one 
collector signature is sufficient to document the chain of custody from 
the time the collector receives the specimen from the donor and 
prepares the specimen bottle(s) and Federal CCF for shipment to the 
laboratory. 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, but the format has changed. Since there is no 
requirement for couriers, express carriers, or postal service personnel 
to document chain of custody for the specimens during transit because 
they do not have access to the specimen(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 of the specimen 
bottle(s) is documented by the laboratory on an internal chain of 
custody form.
    Step 5(a) is completed by the laboratory to document the test 
results on the primary specimen. This step has been expanded compared 
to the current Federal CCF to allow the laboratory to more easily 
report a specimen for which there may have been an invalid result, the 
specimen was adulterated or substituted, or rejected for testing. An 
additional box has been included for 6-acetylmorphine since the 
required testing for this analyte began December 1, 1998.
    Step 5(b) has been added for reporting the split specimen result if 
the split specimen is tested. This new step gives the secondary 
laboratory an area to report the result for the split specimen, a line 
to indicate the laboratory's name and address, a certification 
statement, and a space for the secondary laboratory's certifying 
scientist to sign and date the form.
    The bottom area of copy 1 is reserved for the tamper-evident 
specimen bottle seal(s)/label(s). There must be two labels (i.e., one 
marked with the letter ``A'' to designate the primary specimen and the 
other marked with the letter ``B'' to designate the split specimen) to 
accommodate collecting split specimens and each must have the same 
preprinted specimen identification number that appears at the top of 
the Federal CCF. Each label must also have 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 second label (i.e., 
the ``B'' label) is discarded by the collector.

Copy 2

    Copy 2 (Laboratory Copy) is similar to Copy 1 except that step 5(b) 
and the

[[Page 61918]]

space where the labels are located has been replaced with step 6 
(Medical Officer Review step used to make a determination on the 
primary specimen) and step 7 (Medical Officer Review step used to make 
a determination on the split specimen). Step 6 has been changed from 
the current Federal CCF to allow the MRO to record a ``Refusal To 
Test'' when the primary specimen is ``Adulterated'' or ``Substituted.'' 
Step 7 is used to record the determination for the split specimen (if 
tested).

Copy 3

    Copy 3 (Medical Review Officer Copy) is the same format as Copy 2 
except that step 5(a) has been replaced with step 5. This step 5 on 
Copy 3 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. Additionally, Copy 3 must have a pink 
border (approximately \1/4\ inch width) rather than using a pink sheet 
of paper to allow easy photocopying, if needed.

Copy 4, Copy 5, Copy 6

    Copy 4 (Collector Copy), Copy 5 (Donor Copy), and Copy 6 (Employer 
Copy) are exactly the same as Copy 3 with the following exceptions. 
Copy 4 must have a yellow border, Copy 5 must have a green border, and 
Copy 6 must have a blue border. These borders will allow photocopying, 
if necessary. As with Copy 3, the color borders should be approximately 
\1/4\ inch width.

Paperwork Reduction Act Notice

    The Paperwork Reduction Act Notice in Appendix A must appear on all 
Federal government forms that place a reporting burden on gathering 
information. This notice is the same as that appearing on the current 
OMB approved Federal CCF; however, SAMHSA is specifically interested in 
receiving comments for the estimated average times it will take the 
collector to complete the form, the donor to complete the form, the 
laboratory to complete the form, and the Medical Review Officer to 
complete the form. Please assume that completing the form will include 
reviewing printed information and/or reading certification statements.

Privacy Act Statement

    The Privacy Act Statement in Appendix A must appear on the back of 
the donor copy (Copy 4). It applies to all donors who are Federal 
employees. It is the same statement that appears on the current Federal 
CCF.

Tamper-Evident Labels

    The size of the two tamper-evident seal(s)/label(s) may vary, but 
must be placed within the space provided at the bottom of Copy 1. It is 
also the responsibility of the supplier of the specimen bottle seal(s)/
label(s) 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. SAMHSA believes this 
single requirement is sufficient to ensure that the seal(s)/label(s) 
provided with the Federal CCF are tamper-evident; however, we invite 
comments to recommend other specifications/requirements that should be 
considered.

Availability of CCF

    The proposed Federal CCF, once approved by OMB, will be available 
on the SAMHSA website as an electronic file (using several different 
formats) that can be downloaded. Photocopies will also be available 
from the Division of Workplace Programs. SAMHSA believes making the 
Federal CCF available using this approach will ensure that the form is 
readily available from different sources.
Richard Kopanda,
Executive Officer, Substance Abuse and Mental Health Services 
Administration.

BILLING CODE 4162-20-P

[[Page 61919]]

Appendix A
[GRAPHIC] [TIFF OMITTED] TN15NO99.016


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Back of Copy 1

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 16-106, 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.

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[GRAPHIC] [TIFF OMITTED] TN15NO99.017



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Back of Copy 2

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 16-106, 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.

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[GRAPHIC] [TIFF OMITTED] TN15NO99.018



[[Page 61924]]

Back of Copy 3

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 16-106, 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.

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[GRAPHIC] [TIFF OMITTED] TN15NO99.019



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Back of Copy 4

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 16-106, 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.

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.

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[GRAPHIC] [TIFF OMITTED] TN15NO99.020



[[Page 61928]]

Back of Copy 5

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 16-106, 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.

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[GRAPHIC] [TIFF OMITTED] TN15NO99.021



BILLING CODE 4162-20-C

[[Page 61930]]

Back of Copy 6

Instructions for Completing the Federal Drug Testing Custody and 
Control Form

    Note: Use ballpoint pen, press hard, and check all copies for 
legibility.
    Procedure:
    1. Collector ensures that the name and address of the drug testing 
laboratory appear on the top of the form and that the preprinted 
Specimen I.D. number on the top of the form is identical to the 
preprinted Specimen I.D. number appearing on the specimen bottle 
labels/seals.
    2. Collector ensures the required information is provided in STEP 1 
on the CCF.

    Note: If the donor refuses to provide his/her SSN or Employee 
I.D. number, the collector must provide an appropriate comment on 
the REMARKS line in STEP 4.

    3. Collector gives the collection container/specimen bottle to the 
donor for providing a specimen.
    4. Upon receiving the specimen from the donor, the collector checks 
the temperature of specimen within 4 minutes.
    5. Collector marks appropriate temperature box (if outside the 
temperature range, provides a remark in STEP 4).
    6. Collector marks the appropriate box to indicate whether it is a 
single or split specimen collection. If no specimen is collected, the 
box is checked and a remark is provided in STEP 4. If it is an observed 
collection, the box is checked and a remark is provided in STEP 4.

    Note: If no specimen is collected, Copies 1 and 2 are discarded, 
but the remaining copies are distributed as indicated below.

    7. Collector secures cap(s) on specimen bottle(s) and affixes 
seal(s).
    8. Collector dates the specimen bottle label(s).
    9. Donor initials the specimen bottle label(s) after the label(s) 
have been placed on the specimen bottle(s).
    10. Collector turns to Copy 3 (MRO Copy--pink border) and instructs 
the donor to read the certification statement in STEP 5 (Copy 3) and to 
sign, print name, date, provide phone numbers, and date of birth after 
reading the certification statement.

    Note: If the donor refuses to sign the certification statement, 
the collector must provide an appropriate comment on the REMARKS 
line in STEP 4 on Copy 1.

    11. Collector completes STEP 4 (i.e., provides signature, printed 
name, date, time of collection, and specific name of delivery service).

    Note: Collector records any comments concerning the collection 
on the REMARKS line in STEP 4.

    12. Collector immediately places and seals the specimen bottle(s) 
and Copy 1 and Copy 2 of the CCF in an appropriate leak-proof plastic 
bag.

    Note: If the plastic bag containing the specimen bottle(s) is 
not immediately placed in a shipping container and sealed because 
several collections will be placed in the same shipping container, 
the Collector must maintain visual control of the specimens or place 
them in secured temporary storage.

    13. Collector sends Copy 3 to the MRO, gives Copy 4 to the donor, 
retains Copy 5, and sends Copy 6 to the Employer.

[FR Doc. 99-29609 Filed 11-12-99; 8:45 am]
BILLING CODE 4162-20-P