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Subpart D - Procedures for Review of Suspension or Proposed
Revocation of a Certified Laboratory.
Section 4.1 Applicability.
These procedures apply when:
(a) The Secretary has notified a laboratory in writing that its
certification to perform urine drug testing under these Mandatory
Guidelines for Federal Workplace Drug Testing Programs has been
suspended or that the Secretary proposes to revoke such certification.
(b) The laboratory has, within 30 days of the date of such notification
or within 3 days of the date of such notification when seeking
an expedited review of a suspension, requested in writing an opportunity
for an informal review of the suspension or proposed revocation.
Section 4.2 Definitions.
Appellant Means the laboratory which has been notified of its
suspension or proposed revocation of its certification to perform
urine drug testing and has requested an informal review thereof.
Respondent Means the person or persons designated by the Secretary
in implementing these Guidelines (currently the National Laboratory
Certification Program is located in the Division of Workplace
Programs, Substance Abuse and Mental Health Services Administration).
Reviewing Official Means the person or persons designated by
the Secretary who will review the suspension or proposed revocation.
The reviewing official may be assisted by one or more of his or
her employees or consultants in assessing and weighing the scientific
and technical evidence and other information submitted by the
appellant and respondent on the reasons for the suspension and
Section 4.3 Limitation on Issues Subject to Review.
The scope of review shall be limited to the facts relevant to
any suspension or proposed revocation, the necessary interpretations
of those facts, the Mandatory Guidelines for Federal Workplace
Drug Testing Programs, and other relevant law. The legal validity
of the Mandatory Guidelines shall not be subject to review under
Section 4.4 Specifying Who Represents the Parties.
The appellant's request for review shall specify the name, address,
and phone number of the appellant's representative. In its first
written submission to the reviewing official, the respondent shall
specify the name, address, and phone number of the respondent's
Section 4.5 The Request for Informal Review and the Reviewing
(a) Within 30 days of the date of the notice of the suspension
or proposed revocation, the appellant must submit a written request
to the reviewing official seeking review, unless some other time
period is agreed to by the parties. A copy must also be sent to
the respondent. The request for review must include a copy of
the notice of suspension or proposed revocation, a brief statement
of why the decision to suspend or propose revocation is wrong,
and the appellant's request for an oral presentation, if desired.
(b) Within 5 days after receiving the request for review, the
reviewing official will send an acknowledgment and advise the
appellant of the next steps. The reviewing official will also
send a copy of the acknowledgment to the respondent.
Section 4.6 Abeyance Agreement.
Upon mutual agreement of the parties to hold these procedures
in abeyance, the reviewing official will stay these procedures
for a reasonable time while the laboratory attempts to regain
compliance with the Mandatory Guidelines for Federal Workplace
Drug Testing Programs or the parties otherwise attempt to settle
the dispute. As part of an abeyance agreement, the parties can
agree to extend the time period for requesting review of the suspension
or proposed revocation. If abeyance begins after a request for
review has been filed, the appellant shall notify the reviewing
official at the end of the abeyance period advising whether the
dispute has been resolved. If the dispute has been resolved, the
request for review will be dismissed. If the dispute has not been
resolved, the review procedures will begin at the point at which
they were interrupted by the abeyance agreement with such modifications
to the procedures as the reviewing official deems appropriate.
Section 4.7 Preparation of the Review File and Written
The appellant and the respondent each participate in developing
the file for the reviewing official and in submitting written
arguments. The procedures for development of the review file and
submission of written argument are:
(a) Appellant's Documents and Brief. Within 15 days after receiving
the acknowledgment of the request for review, the appellant shall
submit to the reviewing official the following (with a copy to
(1) A review file containing the documents supporting appellant's
argument, tabbed and organized chronologically, and accompanied
by an index identifying each document. Only essential documents
should be submitted to the reviewing official.
(2) A written statement, not to exceed 20 double-spaced pages,
explaining why respon- dent's decision to suspend or propose revocation
of appellant's certification is wrong (appellant's brief).
(b) Respondent's Documents and Brief. Within 15 days after receiving
a copy of the acknowledgment of the request for review, the respondent
shall submit to the reviewing official the following (with a copy
to the appellant):
(1) A review file containing documents supporting respondent's
decision to suspend or revoke appellant's certification to perform
urine drug testing, tabbed and organized chronologically, and
accompanied by an index identifying each document. Only essential
documents should be submitted to the reviewing official.
(2) A written statement, not exceeding 20 double-spaced pages
in length, explaining the basis for suspension or proposed revocation
(c) Reply Briefs. Within 5 days after receiving the opposing
party's submission, or 20 days after receiving acknowledgment
of the request for review, whichever is later, each party may
submit a short reply not to exceed 10 double-spaced pages.
(d) Cooperative Efforts. Whenever feasible, the parties should
attempt to develop a joint review file.
(e) Excessive Documentation. The reviewing official may take
any appropriate step to reduce excessive documentation, including
the return of or refusal to consider documentation found to be
irrelevant, redundant, or unnecessary.
Section 4.8 Opportunity for Oral Presentation.
(a) Electing Oral Presentation. If an opportunity for an oral
presentation is desired, the appellant shall request it at the
time it submits its written request for review to the reviewing
official. The reviewing official will grant the request if the
official determines that the decision- making process will be
substantially aided by oral presentations and arguments. The reviewing
official may also provide for an oral presentation at the official's
own initiative or at the request of the respondent.
(b) Presiding Official. The reviewing official or designee will
be the presiding official responsible for conducting the oral
(c) Preliminary Conference. The presiding official may hold
a prehearing conference (usually a telephone conference call)
to consider any of the following: simplifying and clarifying issues;
stipulations and admissions; limitations on evidence and witnesses
that will be presented at the hearing; time allotted for each
witness and the hearing altogether; scheduling the hearing; and
any other matter that will assist in the review process. Normally,
this conference will be conducted informally and off the record;
however, the presiding official may, at his or her discre- tion,
produce a written document summarizing the conference or transcribe
the conference, either of which will be made a part of the record.
(d) Time and Place of Oral Presentation. The presiding official
will attempt to schedule the oral presentation within 30 days
of the date appellant's request for review is received or within
10 days of submission of the last reply brief, whichever is later.
The oral presentation will be held at a time and place determined
by the presiding official following consultation with the parties.
(e) Conduct of the Oral Presentation.
(1) General. The presiding official is responsible for conducting
the oral presentation. The presiding official may be assisted
by one or more of his or her employees or consultants in conducting
the oral presentation and reviewing the evidence. While the oral
presentation will be kept as informal as possible, the presiding
official may take all necessary steps to ensure an orderly proceeding.
(2) Burden of Proof/Standard of Proof. In all cases, the respondent
bears the burden of proving by a preponderance of the evidence
that its decision to suspend or propose revocation is appropriate.
The appellant, however, has a responsibility to respond to the
respondent's allegations with evidence and argument to show that
the respondent is wrong.
(3) Admission of Evidence. The rules of evidence do not apply
and the presiding official will generally admit all testimonial
evidence unless it is clearly irrelevant, immaterial, or unduly
repetitious. Each party may make an opening and closing statement,
may present witnesses as agreed upon in the prehearing conference
or otherwise, and may question the opposing party's witnesses.
Since the parties have ample opportunity to prepare the review
file, a party may introduce additional documentation during the
oral presentation only with the permission of the presiding official.
The presiding official may question witnesses directly and take
such other steps necessary to ensure an effective and efficient
consideration of the evidence, including setting time limitations
on direct and cross-examinations.
(4) Motions. The presiding official may rule on motions including,
for example, motions to exclude or strike redundant or immaterial
evidence, motions to dismiss the case for insufficient evidence,
or motions for summary judgment. Except for those made during
the hearing, all motions and opposition to motions, including
argument, must be in writing and be no more than 10 double-spaced
pages in length. The presiding official will set a reasonable
time for the party opposing the motion to reply.
(5) Transcripts. The presiding official shall have the oral presentation
transcribed and the transcript shall be made a part of the record.
Either party may request a copy of the transcript and the requesting
party shall be responsible for paying for its copy of the transcript.
(f) Obstruction of Justice or Making of False Statements. Obstruction
of justice or the making of false statements by a witness or any
other person may be the basis for a criminal prosecution under
18 U.S.C. 1505 or 1001.
(g) Post-hearing Procedures. At his or her discretion, the presiding
official may require or permit the parties to submit post-hearing
briefs or proposed findings and conclusions. Each party may submit
comments on any major prejudicial errors in the transcript.
Section 4.9 Expedited Procedures for Review of Immediate
(a) Applicability. When the Secretary notifies a laboratory in
writing that its certification to perform urine drug testing has
been immediately suspended, the appellant may request an expedited
review of the suspension and any proposed revocation. The appellant
must submit this request in writing to the reviewing official
within 3 days of the date the laboratory received notice of the
suspension. The request for review must include a copy of the
suspension and any proposed revocation, a brief statement of why
the decision to suspend and propose revocation is wrong, and the
appellant's request for an oral presentation, if desired. A copy
of the request for review must also be sent to the respondent.
(b) Reviewing Official's Response. As soon as practicable after
the request for review is received, the reviewing official will
send an acknowledgment with a copy to the respondent.
(c) Review File and Briefs. Within 7 days of the date the request
for review is received, but no later than 2 days before an oral
presentation, each party shall submit to the reviewing official
the following: (1) a review file containing essential documents
relevant to the review, tabbed, indexed, and organized chronologically,
and (2) a written statement, not to exceed 20 double-spaced pages,
explaining the party's position concerning the suspension and
any proposed revocation. No reply brief is permitted.
(d) Oral Presentation. If an oral presentation is requested
by the appellant or otherwise granted by the reviewing official,
the presiding official will attempt to schedule the oral presentation
within 7-10 days of the date of appellant's request for review
at a time and place determined by the presiding official following
consultation with the parties. The presiding official may hold
a pre-hearing conference in accordance with section 4.8(c) and
will conduct the oral presentation in accordance with the procedures
of sections 4.8(e),(f),and (g).
(e) Written Decision. The reviewing official shall issue a written
decision upholding or denying the suspension or proposed revocation
and will attempt to issue the decision within 7-10 days of the
date of the oral presentation or within 3 days of the date on
which the transcript is received or the date of the last submission
by either party, whichever is later. All other provisions set
forth in section 4.14 will apply.
(f) Transmission of Written Communications. Because of the importance
of timeliness for these expedited procedures, all written communications
between the parties and between either party and the reviewing
official shall be by facsimile or overnight mail.
Section 4.10 Ex parte Communications.
Except for routine administrative and procedural matters, a party
shall not communicate with the reviewing or presiding official
without notice to the other party.
Section 4.11 Transmission of Written Communications by Reviewing
Official and Calculation of Deadlines.
(a) Because of the importance of a timely review, the reviewing
official should normally transmit written communications to either
party by facsimile or overnight mail in which case the date of
transmission or day following mailing will be considered the date
of receipt. In the case of communications sent by regular mail,
the date of receipt will be considered 3 days after the date of
(b) In counting days, include Saturdays, Sundays, and holidays.
However, if a due date falls on a Saturday, Sunday, or Federal
holiday, then the due date is the next Federal working day.
Section 4.12 Authority and Responsibilities of Reviewing Official.
In addition to any other authority specified in these procedures,
the reviewing official and the presiding official, with respect
to those authorities involving the oral presentation, shall have
the authority to issue orders; examine witnesses; take all steps
necessary for the conduct of an orderly hearing; rule on requests
and motions; grant extensions of time for good reasons; dismiss
for failure to meet deadlines or other requirements; order the
parties to submit relevant information or witnesses; remand a
case for further action by the respondent; waive or modify these
procedures in a specific case, usually with notice to the parties;
reconsider a decision of the reviewing official where a party
promptly alleges a clear error of fact or law; and to take any
other action necessary to resolve disputes in accordance with
the objectives of these procedures.
Section 4.13 Administrative Record.
The administrative record of review consists of the review file;
other submissions by the parties; transcripts or other records
of any meetings, conference calls, or oral presentation; evidence
submitted at the oral presentation; and orders and other documents
issued by the reviewing and presiding officials.
Section 4.14 Written Decision.
(a) Issuance of Decision. The reviewing official shall issue a
written decision upholding or denying the suspension or proposed
revocation. The decision will set forth the reasons for the decision
and describe the basis therefor in the record. Furthermore, the
reviewing official may remand the matter to the respondent for
such further action as the reviewing official deems appropriate.
(b) Date of Decision. The reviewing official will attempt to
issue his or her decision within 15 days of the date of the oral
presentation, the date on which the transcript is received, or
the date of the last submission by either party, whichever is
later. If there is no oral presentation, the decision will normally
be issued within 15 days of the date of receipt of the last reply
brief. Once issued, the reviewing official will immediately communicate
the decision to each party.
(c) Public Notice. If the suspension and proposed revocation
are upheld, the revocation will become effective immediately and
the public will be notified by publication of a notice in the
Federal Register. If the suspension and proposed revocation are
denied, the revocation will not take effect and the suspension
will be lifted immediately. Public notice will be given by publication
in the Federal Register.
Section 4.15 Court Review of Final Administrative Action;
Exhaustion of Administrative Remedies.
Before any legal action is filed in court challenging the suspension
or proposed revocation, respondent shall exhaust administrative
remedies provided under this subpart, unless otherwise provided
by Federal Law. The reviewing official's decision, under section
4.9(e) or 4.14(a), constitutes final agency action and is ripe
for judicial review as of the date of the decision.
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