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]

Download as PDF 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 http://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 http:// 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: http:// 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 Fmt 4703 Sfmt 4703 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 http://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: http://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