Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information Regarding Specific Issues Related to the Use of the Oral Fluid Specimen for Drug Testing, 34086-34087 [2011-14092]
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Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
Dated: June 6, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–14343 Filed 6–9–11; 8:45 am]
[FR Doc. 2011–14441 Filed 6–9–11; 8:45 am]
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Dated: June 6, 2011.
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Dated: June 6, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–14440 Filed 6–9–11; 8:45 am]
BILLING CODE 4140–01–P
Mandatory Guidelines for Federal
Workplace Drug Testing Programs;
Request for Information Regarding
Specific Issues Related to the Use of
the Oral Fluid Specimen for Drug
Testing
Substance Abuse and Mental
Health Services Administration
(SAMHSA), HHS.
ACTION: Request for Information.
AGENCY:
This document is a request for
information regarding specific aspects of
the regulatory policies and standards
that may be applied to the Mandatory
Guidelines for Federal Workplace Drug
Testing Programs (oral fluid specimen).
DATES: Comment Close Date: To be
assured consideration, comments must
be received at one of the addresses
provided below on or before August 9,
2011.
ADDRESSES: Because of staff and
resource limitations, we cannot accept
comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
• Electronically. You may submit
electronic comments to https://
www.regulations.gov. Follow ‘‘Submit a
comment’’ instructions.
• By regular mail. You may mail
written comments to the following
address only: Substance Abuse and
Mental Health Services Administration,
Attention: Division of Workplace
Programs, 1 Choke Cherry Road, Room
2–1049, Rockville, MD 20857. Please
allow sufficient time for mailed
comments to be received before the
close of the comment period.
• By express or overnight mail. You
may send written comments to the
following address only: Substance
Abuse and Mental Health Services
Administration, Attention: Division of
Workplace Programs, 1 Choke Cherry
SUMMARY:
E:\FR\FM\10JNN1.SGM
10JNN1
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Federal Register / Vol. 76, No. 112 / Friday, June 10, 2011 / Notices
Road, Room 2–1049, Rockville, MD
20850.
• By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments only to the
following address prior to the close of
the comment period:
• For delivery in Rockville, MD:
Substance Abuse and Mental Health
Services Administration, Attention:
Division of Workplace Programs, 1
Choke Cherry Road, Room 2–1049,
Rockville, MD 20850. To deliver your
comments to the Rockville address, call
telephone number (240) 276–2600 in
advance to schedule your delivery with
one of our staff members. Because
access to the interior of the Substance
Abuse and Mental Health Services
Administration Building is not readily
available to persons without Federal
government identification, commenters
are encouraged to either schedule your
drop off or leave your comments with
the security guard in the main lobby of
the building.
FOR FURTHER INFORMATION CONTACT: LT
Eugene Hayes, Division of Workplace
Programs, CSAP, SAMHSA, 1 Choke
Cherry Road, Room 2–1033, Rockville,
Maryland 20857, (240) 276–1459
(phone), (240) 276–2610 (Fax), or e-mail
at eugene.hayes@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION: Inspection
of Public Comments: All comments
received before the close of the
comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments. Comments received
by the deadline will also be available for
public inspection at the Substance
Abuse and Mental Health Services
Administration, Division of Workplace
Programs, 1 Choke Cherry Road,
Rockville, MD 20850, Monday through
Friday of each week from 8:30 a.m. to
4 p.m. To schedule an appointment to
view public comments, phone (240)
276–1459.
I. Background: The Department of
Health and Human Services (HHS)
establishes the standards for Federal
workplace drug testing programs under
the 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
VerDate Mar<15>2010
14:33 Jun 09, 2011
Jkt 223001
Federal Register on April 11, 1988 [53
FR 11979]. SAMHSA subsequently
revised the Guidelines on June 9, 1994
[59 FR 29908], September 30, 1997 [62
FR 51118], November 13, 1998 [63 FR
63483], April 13, 2004 [69 FR 19644],
and on November 25, 2008 [73 FR
71858]. If there is an adequate scientific
basis, HHS anticipates issuing further
revisions to the Mandatory Guidelines
to address the use of oral fluid
specimen.
Section 503 of Public Law 100–71, 5
U.S.C. Section 7301 note, required the
Department to establish scientific and
technical guidelines and amendments in
accordance with Executive Order 12564
and to publish Mandatory Guidelines
which establish comprehensive
standards for all aspects of laboratory
drug testing and procedures, including
standards that require the use of the best
available technology for ensuring the
full reliability and accuracy of drug tests
and strict procedures governing the
chain of custody of specimens collected
for drug testing. These revisions to the
Mandatory Guidelines promote and
establish standards that use the best
available technology for ensuring the
full reliability and accuracy of urine
drug tests, while reflecting the ongoing
process of review and evaluation of
legal, scientific, and societal concerns.
SAMHSA’s chartered CSAP Drug
Testing Advisory Board (DTAB) will be
the vehicle to provide recommendations
for including alternative specimens (oral
fluid) in the Mandatory Guidelines for
Federal Workplace Drug Testing
Programs. The overall intent of this
effort will be publication of the
proposed revisions to the Mandatory
Guidelines in the Federal Register for
public comment and the development of
the Final Notice.
To assist the DTAB, we are soliciting
written comments and statements from
the general public and industry
stakeholders regarding a variety of
issues related to oral fluid specimen
drug testing, including analytes, cutoffs,
specimen validity, collection, collection
devices, and testing.
II. Solicitation of Comments: As we
develop our initial outline for the
Mandatory Guidelines, we are seeking
additional information that is current,
scientific, and peer reviewed in
reference to oral fluid specimen drug
testing, specifically on the following
questions:
• Analytes/Cutoffs: What analytes
should be measured in oral fluid for the
initial and confirmatory tests? What
initial and confirmation cutoffs should
be used for the oral fluid drug tests?
Should the oral fluid drug testing panel
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
34087
be expanded to include schedule II
prescription medications?
• Specimen Validity: Are bio-markers
needed to validate the oral fluid
specimen? Are there appropriate biomarkers or tests for the oral fluid
specimen that would reveal
adulteration, substitution, and/or
dilution?
• Collection: How should an oral
fluid specimen be collected? For an oral
fluid split specimen collection, how
should the collection of the two
specimens be performed? As a donor,
would you prefer to provide an oral
fluid or a urine specimen?
• Collection Devices: What should be
the technical requirements for an oral
fluid specimen collection device?
• Testing: What technologies are
available to perform initial and
confirmatory testing on oral fluid
specimens?
Dated: June 6, 2011.
Elaine Parry,
Director, Office of Management, Technology
and Operations.
[FR Doc. 2011–14092 Filed 6–9–11; 8:45 am]
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SECURITY
[Docket No. DHS–2011–0027]
Broad Stakeholder Survey
National Protection and
Programs Directorate, DHS.
ACTION: 60-day notice and request for
comments; New Information Collection
Request: 1670–NEW.
AGENCY:
The Department of Homeland
Security (DHS), National Protection and
Programs Directorate (NPPD), Office of
Cybersecurity and Communications
(CS&C), Office of Emergency
Communications (OEC), has submitted
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and Budget (OMB) for review and
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Paperwork Reduction Act of 1995 (Pub.
L. 104–13, 44 U.S.C. Chapter 35). NPPD
is soliciting comments concerning the
Broad Stakeholder Survey.
DATES: Comments are encouraged and
will be accepted until August 9, 2011.
This process is conducted in accordance
with 5 CFR 1320.1.
ADDRESSES: Written comments and
questions about this Information
Collection Request should be forwarded
to DHS/NPPD/CS&C/OEC, Attn.:
Richard Reed, 202–343–1666,
Richard.E.Reed@dhs.gov. Written
comments should reach the contact
SUMMARY:
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 76, Number 112 (Friday, June 10, 2011)]
[Notices]
[Pages 34086-34087]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-14092]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration
Mandatory Guidelines for Federal Workplace Drug Testing Programs;
Request for Information Regarding Specific Issues Related to the Use of
the Oral Fluid Specimen for Drug Testing
AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), HHS.
ACTION: Request for Information.
-----------------------------------------------------------------------
SUMMARY: This document is a request for information regarding specific
aspects of the regulatory policies and standards that may be applied to
the Mandatory Guidelines for Federal Workplace Drug Testing Programs
(oral fluid specimen).
DATES: Comment Close Date: To be assured consideration, comments must
be received at one of the addresses provided below on or before August
9, 2011.
ADDRESSES: Because of staff and resource limitations, we cannot accept
comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
Electronically. You may submit electronic comments to
https://www.regulations.gov. Follow ``Submit a comment'' instructions.
By regular mail. You may mail written comments to the
following address only: Substance Abuse and Mental Health Services
Administration, Attention: Division of Workplace Programs, 1 Choke
Cherry Road, Room 2-1049, Rockville, MD 20857. Please allow sufficient
time for mailed comments to be received before the close of the comment
period.
By express or overnight mail. You may send written
comments to the following address only: Substance Abuse and Mental
Health Services Administration, Attention: Division of Workplace
Programs, 1 Choke Cherry
[[Page 34087]]
Road, Room 2-1049, Rockville, MD 20850.
By hand or courier. Alternatively, you may deliver (by
hand or courier) your written comments only to the following address
prior to the close of the comment period:
For delivery in Rockville, MD: Substance Abuse and Mental
Health Services Administration, Attention: Division of Workplace
Programs, 1 Choke Cherry Road, Room 2-1049, Rockville, MD 20850. To
deliver your comments to the Rockville address, call telephone number
(240) 276-2600 in advance to schedule your delivery with one of our
staff members. Because access to the interior of the Substance Abuse
and Mental Health Services Administration Building is not readily
available to persons without Federal government identification,
commenters are encouraged to either schedule your drop off or leave
your comments with the security guard in the main lobby of the
building.
FOR FURTHER INFORMATION CONTACT: LT Eugene Hayes, Division of Workplace
Programs, CSAP, SAMHSA, 1 Choke Cherry Road, Room 2-1033, Rockville,
Maryland 20857, (240) 276-1459 (phone), (240) 276-2610 (Fax), or e-mail
at eugene.hayes@samhsa.hhs.gov.
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following Web site as soon as possible after they have been
received: https://www.regulations.gov. Follow the search instructions on
that Web site to view public comments. Comments received by the
deadline will also be available for public inspection at the Substance
Abuse and Mental Health Services Administration, Division of Workplace
Programs, 1 Choke Cherry Road, Rockville, MD 20850, Monday through
Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment
to view public comments, phone (240) 276-1459.
I. Background: The Department of Health and Human Services (HHS)
establishes the standards for Federal workplace drug testing programs
under the 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].
SAMHSA subsequently revised the Guidelines on June 9, 1994 [59 FR
29908], September 30, 1997 [62 FR 51118], November 13, 1998 [63 FR
63483], April 13, 2004 [69 FR 19644], and on November 25, 2008 [73 FR
71858]. If there is an adequate scientific basis, HHS anticipates
issuing further revisions to the Mandatory Guidelines to address the
use of oral fluid specimen.
Section 503 of Public Law 100-71, 5 U.S.C. Section 7301 note,
required the Department to establish scientific and technical
guidelines and amendments in accordance with Executive Order 12564 and
to publish Mandatory Guidelines which establish comprehensive standards
for all aspects of laboratory drug testing and procedures, including
standards that require the use of the best available technology for
ensuring the full reliability and accuracy of drug tests and strict
procedures governing the chain of custody of specimens collected for
drug testing. These revisions to the Mandatory Guidelines promote and
establish standards that use the best available technology for ensuring
the full reliability and accuracy of urine drug tests, while reflecting
the ongoing process of review and evaluation of legal, scientific, and
societal concerns.
SAMHSA's chartered CSAP Drug Testing Advisory Board (DTAB) will be
the vehicle to provide recommendations for including alternative
specimens (oral fluid) in the Mandatory Guidelines for Federal
Workplace Drug Testing Programs. The overall intent of this effort will
be publication of the proposed revisions to the Mandatory Guidelines in
the Federal Register for public comment and the development of the
Final Notice.
To assist the DTAB, we are soliciting written comments and
statements from the general public and industry stakeholders regarding
a variety of issues related to oral fluid specimen drug testing,
including analytes, cutoffs, specimen validity, collection, collection
devices, and testing.
II. Solicitation of Comments: As we develop our initial outline for
the Mandatory Guidelines, we are seeking additional information that is
current, scientific, and peer reviewed in reference to oral fluid
specimen drug testing, specifically on the following questions:
Analytes/Cutoffs: What analytes should be measured in oral
fluid for the initial and confirmatory tests? What initial and
confirmation cutoffs should be used for the oral fluid drug tests?
Should the oral fluid drug testing panel be expanded to include
schedule II prescription medications?
Specimen Validity: Are bio-markers needed to validate the
oral fluid specimen? Are there appropriate bio-markers or tests for the
oral fluid specimen that would reveal adulteration, substitution, and/
or dilution?
Collection: How should an oral fluid specimen be
collected? For an oral fluid split specimen collection, how should the
collection of the two specimens be performed? As a donor, would you
prefer to provide an oral fluid or a urine specimen?
Collection Devices: What should be the technical
requirements for an oral fluid specimen collection device?
Testing: What technologies are available to perform
initial and confirmatory testing on oral fluid specimens?
Dated: June 6, 2011.
Elaine Parry,
Director, Office of Management, Technology and Operations.
[FR Doc. 2011-14092 Filed 6-9-11; 8:45 am]
BILLING CODE 4162-20-P
