Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information Regarding Specific Issues Related to the Use of the Hair Specimen for Drug Testing, 30689-30691 [2015-12743]
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Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices
30689
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
21 CFR Section
Total ..............................................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
........................
........................
........................
........................
Total hours
26,020
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
21 CFR Section
Number of disclosures per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
208.24(c) ................................................................................
Distributing and Dispensing a Medication Guide—208.24(e)
191
88,736
9,000
5,000
1,719,000
443,680,000
1.25 .............
0.05 (3 minutes).
2,148,750
22,184,000
Total ................................................................................
........................
........................
........................
.....................
24,332,750
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: May 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–12976 Filed 5–28–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1081]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on
Postmarketing Adverse Event
Reporting for Medical Products and
Dietary Supplements During an
Influenza Pandemic
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Dated: May 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–12977 Filed 5–28–15; 8:45 am]
BILLING CODE 4164–01–P
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled,
‘‘Guidance for Industry on
Postmarketing Adverse Event Reporting
for Medical Products and Dietary
Supplements During an Influenza
Pandemic’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUMMARY:
Lhorne on DSK2VPTVN1PROD with NOTICES
entitled, ‘‘Guidance for Industry on
Postmarketing Adverse Event Reporting
for Medical Products and Dietary
Supplements During an Influenza
Pandemic’’ to OMB for review and
clearance under 44 U.S.C. 3507. 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. OMB has now approved the
information collection and has assigned
OMB control number 0910–0701. The
approval expires on April 30, 2018. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
On
January 8, 2015, the Agency submitted
a proposed collection of information
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
15:17 May 28, 2015
Jkt 235001
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 Hair Specimen for Drug Testing
Substance Abuse and Mental
Health Services Administration
(SAMHSA), Department of Health and
Human Services (DHHS).
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
SUMMARY:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Guidelines for Federal Workplace Drug
Testing Programs (hair specimen).
DATES: Comment Close Date: To be
assured consideration, comments must
be received at one of the addresses
provided below on or before June 29,
2015.
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 7–1029,
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
Road, Room 7–1029, 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 7–1029,
Rockville, MD 20850. To deliver your
ADDRESSES:
E:\FR\FM\29MYN1.SGM
29MYN1
30690
Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices
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:
Sean Belouin, Division of Workplace
Programs, Center for Substance Abuse
Prevention (CSAP), SAMHSA, 1 Choke
Cherry Road, Room 7–1029, Rockville,
Maryland 20857, (240) 276–2716
(phone), (240) 276–2610 (Fax), or email
at sean.belouin@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)
276–2716.
Lhorne on DSK2VPTVN1PROD with NOTICES
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.
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]. On May 15, 2015, HHS
published a notice of proposed revisions
to the mandatory guidelines which
would provide federal executive branch
VerDate Sep<11>2014
15:17 May 28, 2015
Jkt 235001
agencies with the option of collecting
and testing an oral fluid specimen in
addition to urine specimen. The
comment period concludes on July 14,
2015.
Section 503 of Public Law 100–71, 5
U.S.C. 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 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) is the
vehicle to provide recommendations to
the SAMHSA Administrator for
proposed changes to the Mandatory
Guidelines for Federal Workplace Drug
Testing Programs. The DTAB process
involves evaluating the scientific
supportability of any considered
change. 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 hair
specimen drug testing, including the
hair specimen, its collection, specimen
preparation, analytes/cutoffs, specimen
validity, and initial and confirmatory
testing.
II. Solicitation of Comments
We are seeking additional information
to inform potential use of hair
specimens for drug testing, specifically
on the following questions:
Hair Specimen:
• What are the acceptable body
locations from which to collect hair for
workplace drug testing? What should be
done if head hair is not available for
collection?
• What hair treatments (i.e., shampoo,
conditioning, perm, relaxers, coloring,
bleaching, straightening, hair transplant)
influence drug concentration in hair and
to what degree?
• What are the acceptable reasons for
hair testing (i.e., pre-employment,
random, reasonable suspicion, postaccident, other (fitness for duty, return
to duty, etc.))?
Collection:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
• What training should a collector
receive prior to collecting the hair
specimen?
• What is the best protocol to collect
the hair specimen?
• Should the hair collection protocol
be standardized, including specific
instructions on how close to cut the hair
specimen to the skin, how to determine
the authenticity of the hair specimen,
what cutting instruments to use, how to
ensure the cutting instruments are
decontaminated, and whether the use of
collection kits should be required?
• What is the minimum amount of
hair that should be collected?
Specimen Preparation:
• What are acceptable protocols for
hair specimen preparation, such as
cutting/powdering, initial washing,
decontamination, and pre-extraction
(i.e., digestion, micro pulverization,
etc.)?
• Should the washing and
decontamination procedures be analyte
specific?
• What criteria should be used to
determine the acceptability of a specific
wash and decontamination procedure?
Are there published research studies,
with experimental data included, that
demonstrate that a particular wash
procedure is effective at removing
external contaminants while not
significantly affecting the amount of
incorporated drug related to drug use?
• If washing steps are used for
decontamination, should adjustments be
made for drug concentrations detected
in the wash fluids? What calculations
are recommended for these
adjustments?
Analytes/Cutoffs:
• What analytes should be measured
in hair by the initial and confirmatory
tests?
• What initial and confirmation
cutoffs should be used for the various
hair drug testing analytes?
• For each analyte/drug, what criteria
(cutoff) should be used to distinguish
external contamination from drug use?
• What unique metabolites or other
biomarkers exist to confirm use and to
distinguish drug use from external
contamination for which the drugs are
currently tested?
Specimen Validity:
• Are biomarkers or tests needed to
verify that the specimen is authentic
human hair?
• Are there appropriate biomarkers or
tests for the hair specimen that would
reveal adulteration and/or substitution?
What are the acceptability criteria for
these biomarkers or tests?
• Is the ‘‘invalid’’ result category
reasonable for hair testing? If so, what
criteria are acceptable to classify a
specimen result as invalid?
E:\FR\FM\29MYN1.SGM
29MYN1
Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Notices
Testing:
• What technologies are available to
perform initial and confirmatory testing
on hair specimens?
• What is the best sample for valid
quality control/proficiency testing
material? How should this quality
control/proficiency testing material be
prepared? What is the best method to
prepare a contaminated hair sample
versus a sample that represents drug
use?
Janine Cook,
Chemist, Division of Workplace Programs,
Center for Substance Abuse and Prevention,
SAMHSA.
[FR Doc. 2015–12743 Filed 5–28–15; 8:45 am]
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2015–0455]
Certificates of Alternative Compliance
2010 .......
ALLISON CROSBY .......
2010 .......
BEE HIVE .....................
2010 .......
2010 .......
BETTY PFANKUCH ......
BETTY PFANKUCH ......
2010 .......
2010 .......
C–COURAGEOUS ........
DWIGHT S. RAMSAY ...
2010 .......
FAST GIANT .................
2010 .......
FAST TITAN .................
2010 .......
JOHN W. JOHNSON ....
2010 .......
KELLIE CHOUEST .......
2010 .......
2010 .......
M/V ANNA G .................
M/V CHARLEVOIX .......
2010 .......
M/V JODY MCMINN .....
2010 .......
2010 .......
M/V JOE GRIFFIN ........
M/V NICHOLAS P
CALLAIS.
M/V QUEEN BEE .........
Lhorne on DSK2VPTVN1PROD with NOTICES
2010 .......
1 33
M/V RAYMOND C.
PERCOR, JR.
15:17 May 28, 2015
The Coast Guard announces
that the Coast Guard District Prevention
Divisions have issued certificates of
alternative compliance to vessels of
special construction or purpose that
cannot fully comply with the light,
shape, and sound signal provisions of
the International Regulations for
Preventing Collisions at Sea (72
COLREGS) and/or Inland Navigation
Rules without interfering with their
special function. This notice promotes
the Coast Guard’s maritime safety and
stewardship missions.
SUMMARY:
For
information about this document call or
email LCDR Megan Cull, Coast Guard
Navigation Standards Division;
telephone (202) 372–1565, email
megan.l.cull@uscg.mil. For information
about viewing or submitting material to
the docket, call Cheryl Collins, Program
Manager, Docket Operations, telephone
202–366–9826, toll free 1–800–647–
5527.
The special construction or purpose
of some vessels makes them unable to
comply with the light, shape, and sound
signal provisions of the 72 COLREGS
and/or Inland Navigation Rules. Under
72 COLREGS, statutory law and Coast
Guard regulations, a vessel may instead
meet alternative requirements and the
vessel’s owner, builder, operator, or
agent may apply for a certificate of
alternative compliance (COAC). The
Chief of the Inspections and
Investigations Branch in each Coast
Guard District office determines
whether the vessel for which the COAC
is sought complies as closely as possible
with the 72 COLREGS and/or Inland
Navigation Rules, and decides whether
to issue the COAC. Once issued, a
COAC remains valid until information
supplied in the application for the
COAC, or the terms of the COAC
becomes inapplicable to the vessel.
Under the governing statute 1 and
regulation,2 the Coast Guard must
publish notice of each COAC.
The Coast Guard issued COACs to the
following vessels between 2010 and
2014:
Sidelights on the outboard edges of the superstructure 6′ 8″ from the centerline. Restricted in ability to
maneuver/not under command lights may be installed 1 foot below each masthead light on either side
of mast.
Forward masthead light 38′ 21⁄4″ above main deck; aft masthead light 18′ 109⁄16″ aft of forward masthead
light; aft anchor light 25′ 15⁄16″ off center to starboard side, just forward of the stern; sidelights on the
side of the pilothouse 12′ 41⁄4″ inboard of the greatest breadth.
Aft masthead light on the main mast above pilothouse, 20′ 5″ aft of the forward masthead light.
Duplicate COAC with addition of allowing two 360° restricted in ability to maneuver/not under command
lights on aft mast to allow 360° visibility.
Aft masthead light on the main mast above the pilothouse, 21′ 83⁄4″ aft of the forward masthead light.
Aft masthead light on the main mast above the pilothouse, 20′ 5″ aft of the forward masthead light. Two
360° restricted in ability to maneuver/not under command lights on aft mast to allow 360° visibility.
Forward masthead light above the pilothouse 18.92′ above the hull, and its aft masthead light on the
main mast above the pilothouse, 16.83′ aft and 14.76′ above the forward masthead light.
Forward masthead light above the pilothouse 18.92′ above the hull, and its aft masthead light on the
main mast above the pilothouse, 16.83′ aft and 14.76′ above the forward masthead light.
Aft masthead lights on the main mast atop of each pilothouse 115″ aft of each forward masthead light located atop the opposing pilothouse. Sidelights located on the side of the pilothouse.
Aft masthead light on main mast above pilothouse, 25′ 55⁄16″ aft of forward masthead light; sidelights 15′
8″ inboard from greatest breadth; two sets of 360° restricted in ability to maneuver/not under command
lights on the aft mast, one set on each side of the mast, 1′ 1″ from the centerline.
Sidelights on the top of the pilothouse, 8′ 1″ inboard from the greatest breadth of the vessel.
Reduce the intensity of the required sound signal to 85 decibel when leaving the dock/berth during normal operations.
Sidelights placed forward of the masthead light and located on the outermost edge of the pilothouse
more than 10% inboard of the greatest breadth of the vessel.
Aft masthead light on the main mast above the pilothouse, 21′ 10″ aft of the forward masthead light.
Aft masthead light on the main mast above the pilothouse, 24′ 4″ aft of the forward masthead light.
Forward masthead light on top of the pilothouse 38′ 21⁄4″ above main deck and aft masthead light on
main mast above pilothouse, 18′ 109⁄16″ aft of the forward masthead light, and its aft anchor light 25′
15⁄16″ off center to the starboard side, just forward of the stern. In addition, the sidelights may be
placed on the side of the pilothouse 12′ 41⁄2″ inboard of the greatest breadth of the vessel.
Single Voyage COAC horizontal separation between forward and aft masthead light, 84′. Height of forward masthead light, 29′ 10″. Vertical separation of forward and aft masthead light, 6′ 11″. Sidelights
placed 26′ 4″ above main deck. Vertical separation between sidelights and forward masthead light 3′
6″. Sidelights placed on outside edge of pilothouse symmetric about the axis line of the masthead
lights.
U.S.C. 1605(c).
VerDate Sep<11>2014
Discussion
SUPPLEMENTARY INFORMATION:
Coast Guard, DHS.
2010 .......
Notice.
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4162–20–P
AGENCY:
ACTION:
30691
2 33
Jkt 235001
PO 00000
CFR 81.18.
Frm 00041
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E:\FR\FM\29MYN1.SGM
29MYN1
]]>Agencies
[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Notices]
[Pages 30689-30691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12743]
-----------------------------------------------------------------------
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 Hair Specimen for Drug Testing
AGENCY: Substance Abuse and Mental Health Services Administration
(SAMHSA), Department of Health and Human Services (DHHS).
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
(hair specimen).
DATES: Comment Close Date: To be assured consideration, comments must
be received at one of the addresses provided below on or before June
29, 2015.
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 7-1029, 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 Road, Room 7-1029, 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 7-1029, Rockville, MD 20850. To deliver your
[[Page 30690]]
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: Sean Belouin, Division of Workplace
Programs, Center for Substance Abuse Prevention (CSAP), SAMHSA, 1 Choke
Cherry Road, Room 7-1029, Rockville, Maryland 20857, (240) 276-2716
(phone), (240) 276-2610 (Fax), or email at sean.belouin@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) 276-2716.
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. 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].
On May 15, 2015, HHS published a notice of proposed revisions to the
mandatory guidelines which would provide federal executive branch
agencies with the option of collecting and testing an oral fluid
specimen in addition to urine specimen. The comment period concludes on
July 14, 2015.
Section 503 of Public Law 100-71, 5 U.S.C. 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 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) is the
vehicle to provide recommendations to the SAMHSA Administrator for
proposed changes to the Mandatory Guidelines for Federal Workplace Drug
Testing Programs. The DTAB process involves evaluating the scientific
supportability of any considered change. 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 hair
specimen drug testing, including the hair specimen, its collection,
specimen preparation, analytes/cutoffs, specimen validity, and initial
and confirmatory testing.
II. Solicitation of Comments
We are seeking additional information to inform potential use of
hair specimens for drug testing, specifically on the following
questions:
Hair Specimen:
What are the acceptable body locations from which to
collect hair for workplace drug testing? What should be done if head
hair is not available for collection?
What hair treatments (i.e., shampoo, conditioning, perm,
relaxers, coloring, bleaching, straightening, hair transplant)
influence drug concentration in hair and to what degree?
What are the acceptable reasons for hair testing (i.e.,
pre-employment, random, reasonable suspicion, post-accident, other
(fitness for duty, return to duty, etc.))?
Collection:
What training should a collector receive prior to
collecting the hair specimen?
What is the best protocol to collect the hair specimen?
Should the hair collection protocol be standardized,
including specific instructions on how close to cut the hair specimen
to the skin, how to determine the authenticity of the hair specimen,
what cutting instruments to use, how to ensure the cutting instruments
are decontaminated, and whether the use of collection kits should be
required?
What is the minimum amount of hair that should be
collected?
Specimen Preparation:
What are acceptable protocols for hair specimen
preparation, such as cutting/powdering, initial washing,
decontamination, and pre-extraction (i.e., digestion, micro
pulverization, etc.)?
Should the washing and decontamination procedures be
analyte specific?
What criteria should be used to determine the
acceptability of a specific wash and decontamination procedure? Are
there published research studies, with experimental data included, that
demonstrate that a particular wash procedure is effective at removing
external contaminants while not significantly affecting the amount of
incorporated drug related to drug use?
If washing steps are used for decontamination, should
adjustments be made for drug concentrations detected in the wash
fluids? What calculations are recommended for these adjustments?
Analytes/Cutoffs:
What analytes should be measured in hair by the initial
and confirmatory tests?
What initial and confirmation cutoffs should be used for
the various hair drug testing analytes?
For each analyte/drug, what criteria (cutoff) should be
used to distinguish external contamination from drug use?
What unique metabolites or other biomarkers exist to
confirm use and to distinguish drug use from external contamination for
which the drugs are currently tested?
Specimen Validity:
Are biomarkers or tests needed to verify that the specimen
is authentic human hair?
Are there appropriate biomarkers or tests for the hair
specimen that would reveal adulteration and/or substitution? What are
the acceptability criteria for these biomarkers or tests?
Is the ``invalid'' result category reasonable for hair
testing? If so, what criteria are acceptable to classify a specimen
result as invalid?
[[Page 30691]]
Testing:
What technologies are available to perform initial and
confirmatory testing on hair specimens?
What is the best sample for valid quality control/
proficiency testing material? How should this quality control/
proficiency testing material be prepared? What is the best method to
prepare a contaminated hair sample versus a sample that represents drug
use?
Janine Cook,
Chemist, Division of Workplace Programs, Center for Substance Abuse and
Prevention, SAMHSA.
[FR Doc. 2015-12743 Filed 5-28-15; 8:45 am]
BILLING CODE 4162-20-P
