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]

Download as PDF 34086 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] BILLING CODE 4160–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings DEPARTMENT OF HEALTH AND HUMAN SERVICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. WReier-Aviles on DSKGBLS3C1PROD with NOTICES Dated: June 6, 2011. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Substance Abuse and Mental Health Services Administration Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, NIH Support for Conferences and Scientific Meetings. Date: July 25–28, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6700B Rockledge Drive, 3201, Bethesda, MD 20817 (Virtual Meeting). Contact Person: Brandt R. Burgess, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/NIAID, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892–7616, 301–451–2584, bburgess@niaid.nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, NIAID Peer Review Meeting. Date: July 28, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate contract proposals. Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814. Contact Person: Dharmendar Rathore, PhD, Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institutes of Health/NIAID, 6700B Rockledge Drive, MSC 7616, Rm 3134, Bethesda, MD 20892–7616, 301–435–2766, rathored@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, NIDDK Telephone SEP. Date: July 6, 2011. Time: 10 to 11 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Xiaodu Guo, MD, PhD, Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 761, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–4719, guox@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, Nephrotic Syndrome Ancillary Studies. Date: July 13, 2011. Time: 2 to 2:45 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Lakshmanan Sankaran, PhD, Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 755, 6707 Democracy Boulevard, Bethesda, MD 20892–5452, (301) 594–7799, ls38z@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, VerDate Mar<15>2010 14:33 Jun 09, 2011 Jkt 223001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) 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] BILLING CODE 4162–20–P DEPARTMENT OF HOMELAND 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 the following Information Collection Request to the Office of Management and Budget (OMB) for review and clearance in accordance with the 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]


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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