Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies, 62595-62596 [2018-26279]

Download as PDF Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: November 28, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–26282 Filed 12–3–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Solicitation for Written Comments on Proposed Objectives for Healthy People 2030; Correction Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, Office of Disease Prevention and Health Promotion. ACTION: Notice; correction. AGENCY: The Department of Health and Human Services published a document in the Federal Register of November 27, 2018, concerning request for comments on the proposed Healthy People 2030 objectives. The document contained an incorrect date. FOR FURTHER INFORMATION CONTACT: Ayanna Johnson, HP2030@hhs.gov. SUMMARY: Correction In the Federal Register of November 27, 2018, in FR Doc. 2018–25836, on pages 60876–60877, correct the ‘‘Dates’’ caption to read: DATES: Written comments must be submitted by January 17, 2019. Dated: November 27, 2018. Don Wright, Deputy Assistant Secretary for Health (Disease Prevention and Health Promotion). [FR Doc. 2018–26299 Filed 12–3–18; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Substance Abuse and Mental Health Services Administration National Institute of General Medical Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, notice is hereby given of the following meeting. The meeting 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. Name of Committee: National Institute of General Medical Sciences Special Emphasis Panel; National Research Mentoring Network (NRMN) U24 Center Applications. Date: December 12, 2018. Time: 12:00 p.m. to 2:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Natcher Building, Room 3AN18, 45 Center Drive, Bethesda, MD 20892. Contact Person: Rebecca H. Johnson, Scientific Review Officer, Office of Scientific Review, National Institute of General Medical Sciences, National Institutes of Health, Natcher Building, Room 3AN18C, Bethesda, MD 20892, 301–594–2771, johnsonrh@ nigms.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.375, Minority Biomedical Research Support; 93.821, Cell Biology and Biophysics Research; 93.859, Pharmacology, Physiology, and Biological Chemistry Research; 93.862, Genetics and Developmental Biology Research; 93.88, Minority Access to Research Careers; 93.96, Special Minority Initiatives; 93.859, Biomedical Research and Research Training, National Institutes of Health, HHS) Dated: November 28, 2018. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018–26281 Filed 12–3–18; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4150–32–P VerDate Sep<11>2014 17:36 Dec 03, 2018 Jkt 247001 62595 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. AGENCY: The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHScertified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at http://www.samhsa.gov/ workplace. FOR FURTHER INFORMATION CONTACT: Charles LoDico, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N02C, Rockville, Maryland 20857; 240–276–2600 (voice). SUPPLEMENTARY INFORMATION: The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); April 30, 2010 (75 FR 22809); and on January 23, 2017 (82 FR 7920). The Mandatory Guidelines were initially developed in accordance with SUMMARY: E:\FR\FM\04DEN1.SGM 04DEN1 62596 Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices Executive Order 12564 and section 503 of Public Law 100–71. The ‘‘Mandatory uidelines for Federal Workplace Drug Testing Programs,’’ as amended in the revisions listed above, requires strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on urine specimens for federal agencies. To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory or IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections. Laboratories and IITFs in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A HHS-certified laboratory or IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), which attests that it has met minimum standards. In accordance with the Mandatory Guidelines dated January 23, 2017 (82 FR 7920), the following HHS-certified laboratories and IITFs meet the minimum standards to conduct drug and specimen validity tests on urine specimens: HHS-Certified Instrumented Initial Testing Facilities Dynacare, 6628 50th Street NW, Edmonton, AB Canada T6B 2N7, 780– 784–1190, (Formerly: GammaDynacare Medical Laboratories) HHS-Certified Laboratories ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624, 844–486–9226 Alere Toxicology Services, 1111 Newton St., Gretna, LA 70053, 504–361–8989/ 800–433–3823, (Formerly: Kroll Laboratory Specialists, Inc., Laboratory Specialists, Inc.) Alere Toxicology Services, 450 Southlake Blvd., Richmond, VA 23236, 804–378–9130, (Formerly: Kroll Laboratory Specialists, Inc., Scientific Testing Laboratories, Inc.; Kroll Scientific Testing Laboratories, Inc.) Baptist Medical Center-Toxicology Laboratory, 11401 I–30, Little Rock, AR 72209–7056, 501–202–2783, (Formerly: Forensic Toxicology Laboratory Baptist Medical Center) Clinical Reference Laboratory, Inc., 8433 Quivira Road, Lenexa, KS 66215– 2802, 800–445–6917 Cordant Health Solutions, 2617 East L Street, Tacoma, WA 98421, 800–442– 0438, (Formerly: STERLING Reference Laboratories) VerDate Sep<11>2014 17:36 Dec 03, 2018 Jkt 247001 DrugScan, Inc., 200 Precision Road, Suite 200, Horsham, PA 19044, 800– 235–4890 Dynacare,* 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519– 679–1630, (Formerly: GammaDynacare Medical Laboratories) ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655, 662– 236–2609 Laboratory Corporation of America Holdings, 7207 N Gessner Road, Houston, TX 77040, 713–856–8288/ 800–800–2387 Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ 08869, 908–526–2400/800–437–4986 (Formerly: Roche Biomedical Laboratories, Inc.) Laboratory Corporation of America Holdings, 1904 TW Alexander Drive, Research Triangle Park, NC 27709, 919–572–6900/800–833–3984 (Formerly: LabCorp Occupational Testing Services, Inc., CompuChem Laboratories, Inc.; CompuChem Laboratories, Inc., A Subsidiary of Roche Biomedical Laboratory; Roche CompuChem Laboratories, Inc., A Member of the Roche Group) Laboratory Corporation of America Holdings, 1120 Main Street, Southaven, MS 38671, 866–827–8042/ 800–233–6339 (Formerly: LabCorp Occupational Testing Services, Inc.; MedExpress/National Laboratory Center) LabOne, Inc. d/b/a Quest Diagnostics, 10101 Renner Blvd., Lenexa, KS 66219, 913–888–3927/800–873–8845 (Formerly: Quest Diagnostics Incorporated; LabOne, Inc.; Center for Laboratory Services, a Division of LabOne, Inc.) MedTox Laboratories, Inc., 402 W County Road D, St. Paul, MN 55112, 651–636–7466/800–832–3244 Legacy Laboratory Services—MetroLab, 1225 NE 2nd Ave., Portland, OR 97232, 503–413–5295/800–950–5295 Minneapolis Veterans Affairs Medical Center, Forensic Toxicology Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612–725– 2088, Testing for Veterans Affairs (VA) Employees Only National Toxicology Laboratories, Inc., 1100 California Ave., Bakersfield, CA 93304, 661–322–4250/800–350–3515 One Source Toxicology Laboratory, Inc., 1213 Genoa-Red Bluff, Pasadena, TX 77504, 888–747–3774 (Formerly: University of Texas Medical Branch, Clinical Chemistry Division; UTMB Pathology-Toxicology Laboratory) Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 91311, 800–328–6942 (Formerly: Centinela PO 00000 Frm 00037 Fmt 4703 Sfmt 9990 Hospital Airport Toxicology Laboratory) Pathology Associates Medical Laboratories, 110 West Cliff Dr., Spokane, WA 99204, 509–755–8991/ 800–541–7891x7 Phamatech, Inc., 15175 Innovation Drive, San Diego, CA 92128, 888– 635–5840 Quest Diagnostics Incorporated, 1777 Montreal Circle, Tucker, GA 30084, 800–729–6432 (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories) Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403, 610–631–4600/877–642–2216 (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline BioScience Laboratories) Redwood Toxicology Laboratory, 3700 Westwind Blvd., Santa Rosa, CA 95403, 800–255–2159 U.S. Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., Fort George G. Meade, MD 20755– 5235, 301–677–7085, Testing for Department of Defense (DoD) Employees Only —————— * The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with the HHS’ NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do. Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory (Federal Register, July 16, 1996) as meeting the minimum standards of the Mandatory Guidelines published in the Federal Register January 23, 2017 (82 FR 7920). After receiving DOT certification, the laboratory will be included in the monthly list of HHS-certified laboratories and participate in the NLCP certification maintenance program. Charles P. LoDico, Chemist. [FR Doc. 2018–26279 Filed 12–3–18; 8:45 am] BILLING CODE 4160–20–P E:\FR\FM\04DEN1.SGM 04DEN1

Agencies

[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62595-62596]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26279]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Current List of HHS-Certified Laboratories and Instrumented 
Initial Testing Facilities Which Meet Minimum Standards To Engage in 
Urine Drug Testing for Federal Agencies

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Department of Health and Human Services (HHS) notifies 
federal agencies of the laboratories and Instrumented Initial Testing 
Facilities (IITF) currently certified to meet the standards of the 
Mandatory Guidelines for Federal Workplace Drug Testing Programs 
(Mandatory Guidelines).
    A notice listing all currently HHS-certified laboratories and IITFs 
is published in the Federal Register during the first week of each 
month. If any laboratory or IITF certification is suspended or revoked, 
the laboratory or IITF will be omitted from subsequent lists until such 
time as it is restored to full certification under the Mandatory 
Guidelines.
    If any laboratory or IITF has withdrawn from the HHS National 
Laboratory Certification Program (NLCP) during the past month, it will 
be listed at the end and will be omitted from the monthly listing 
thereafter.
    This notice is also available on the internet at http://www.samhsa.gov/workplace.

FOR FURTHER INFORMATION CONTACT: Charles LoDico, Division of Workplace 
Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N02C, Rockville, 
Maryland 20857; 240-276-2600 (voice).

SUPPLEMENTARY INFORMATION: The Department of Health and Human Services 
(HHS) notifies federal agencies of the laboratories and Instrumented 
Initial Testing Facilities (IITF) currently certified to meet the 
standards of the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were 
first published in the Federal Register on April 11, 1988 (53 FR 
11970), and subsequently revised in the Federal Register on June 9, 
1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 
(69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 
FR 75122); April 30, 2010 (75 FR 22809); and on January 23, 2017 (82 FR 
7920).
    The Mandatory Guidelines were initially developed in accordance 
with

[[Page 62596]]

Executive Order 12564 and section 503 of Public Law 100-71. The 
``Mandatory uidelines for Federal Workplace Drug Testing Programs,'' as 
amended in the revisions listed above, requires strict standards that 
laboratories and IITFs must meet in order to conduct drug and specimen 
validity tests on urine specimens for federal agencies.
    To become certified, an applicant laboratory or IITF must undergo 
three rounds of performance testing plus an on-site inspection. To 
maintain that certification, a laboratory or IITF must participate in a 
quarterly performance testing program plus undergo periodic, on-site 
inspections.
    Laboratories and IITFs in the applicant stage of certification are 
not to be considered as meeting the minimum requirements described in 
the HHS Mandatory Guidelines. A HHS-certified laboratory or IITF must 
have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), 
which attests that it has met minimum standards.
    In accordance with the Mandatory Guidelines dated January 23, 2017 
(82 FR 7920), the following HHS-certified laboratories and IITFs meet 
the minimum standards to conduct drug and specimen validity tests on 
urine specimens:

HHS-Certified Instrumented Initial Testing Facilities

Dynacare, 6628 50th Street NW, Edmonton, AB Canada T6B 2N7, 780-784-
1190, (Formerly: Gamma-Dynacare Medical Laboratories)

HHS-Certified Laboratories

ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624, 
844-486-9226
Alere Toxicology Services, 1111 Newton St., Gretna, LA 70053, 504-361-
8989/800-433-3823, (Formerly: Kroll Laboratory Specialists, Inc., 
Laboratory Specialists, Inc.)
Alere Toxicology Services, 450 Southlake Blvd., Richmond, VA 23236, 
804-378-9130, (Formerly: Kroll Laboratory Specialists, Inc., Scientific 
Testing Laboratories, Inc.; Kroll Scientific Testing Laboratories, 
Inc.)
Baptist Medical Center-Toxicology Laboratory, 11401 I-30, Little Rock, 
AR 72209-7056, 501-202-2783, (Formerly: Forensic Toxicology Laboratory 
Baptist Medical Center)
Clinical Reference Laboratory, Inc., 8433 Quivira Road, Lenexa, KS 
66215-2802, 800-445-6917
Cordant Health Solutions, 2617 East L Street, Tacoma, WA 98421, 800-
442-0438, (Formerly: STERLING Reference Laboratories)
DrugScan, Inc., 200 Precision Road, Suite 200, Horsham, PA 19044, 800-
235-4890
Dynacare,* 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519-679-
1630, (Formerly: Gamma-Dynacare Medical Laboratories)
ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655, 
662-236-2609
Laboratory Corporation of America Holdings, 7207 N Gessner Road, 
Houston, TX 77040, 713-856-8288/800-800-2387
Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ 
08869, 908-526-2400/800-437-4986 (Formerly: Roche Biomedical 
Laboratories, Inc.)
Laboratory Corporation of America Holdings, 1904 TW Alexander Drive, 
Research Triangle Park, NC 27709, 919-572-6900/800-833-3984 (Formerly: 
LabCorp Occupational Testing Services, Inc., CompuChem Laboratories, 
Inc.; CompuChem Laboratories, Inc., A Subsidiary of Roche Biomedical 
Laboratory; Roche CompuChem Laboratories, Inc., A Member of the Roche 
Group)
Laboratory Corporation of America Holdings, 1120 Main Street, 
Southaven, MS 38671, 866-827-8042/800-233-6339 (Formerly: LabCorp 
Occupational Testing Services, Inc.; MedExpress/National Laboratory 
Center)
LabOne, Inc. d/b/a Quest Diagnostics, 10101 Renner Blvd., Lenexa, KS 
66219, 913-888-3927/800-873-8845 (Formerly: Quest Diagnostics 
Incorporated; LabOne, Inc.; Center for Laboratory Services, a Division 
of LabOne, Inc.)
MedTox Laboratories, Inc., 402 W County Road D, St. Paul, MN 55112, 
651-636-7466/800-832-3244
Legacy Laboratory Services--MetroLab, 1225 NE 2nd Ave., Portland, OR 
97232, 503-413-5295/800-950-5295
Minneapolis Veterans Affairs Medical Center, Forensic Toxicology 
Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612-725-2088, 
Testing for Veterans Affairs (VA) Employees Only
National Toxicology Laboratories, Inc., 1100 California Ave., 
Bakersfield, CA 93304, 661-322-4250/800-350-3515
One Source Toxicology Laboratory, Inc., 1213 Genoa-Red Bluff, Pasadena, 
TX 77504, 888-747-3774 (Formerly: University of Texas Medical Branch, 
Clinical Chemistry Division; UTMB Pathology-Toxicology Laboratory)
Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 
91311, 800-328-6942 (Formerly: Centinela Hospital Airport Toxicology 
Laboratory)
Pathology Associates Medical Laboratories, 110 West Cliff Dr., Spokane, 
WA 99204, 509-755-8991/800-541-7891x7
Phamatech, Inc., 15175 Innovation Drive, San Diego, CA 92128, 888-635-
5840
Quest Diagnostics Incorporated, 1777 Montreal Circle, Tucker, GA 30084, 
800-729-6432 (Formerly: SmithKline Beecham Clinical Laboratories; 
SmithKline Bio-Science Laboratories)
Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403, 
610-631-4600/877-642-2216 (Formerly: SmithKline Beecham Clinical 
Laboratories; SmithKline Bio-Science Laboratories)
Redwood Toxicology Laboratory, 3700 Westwind Blvd., Santa Rosa, CA 
95403, 800-255-2159
U.S. Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., 
Fort George G. Meade, MD 20755-5235, 301-677-7085, Testing for 
Department of Defense (DoD) Employees Only

------------
    * The Standards Council of Canada (SCC) voted to end its 
Laboratory Accreditation Program for Substance Abuse (LAPSA) 
effective May 12, 1998. Laboratories certified through that program 
were accredited to conduct forensic urine drug testing as required 
by U.S. Department of Transportation (DOT) regulations. As of that 
date, the certification of those accredited Canadian laboratories 
will continue under DOT authority. The responsibility for conducting 
quarterly performance testing plus periodic on-site inspections of 
those LAPSA-accredited laboratories was transferred to the U.S. HHS, 
with the HHS' NLCP contractor continuing to have an active role in 
the performance testing and laboratory inspection processes. Other 
Canadian laboratories wishing to be considered for the NLCP may 
apply directly to the NLCP contractor just as U.S. laboratories do.

    Upon finding a Canadian laboratory to be qualified, HHS will 
recommend that DOT certify the laboratory (Federal Register, July 16, 
1996) as meeting the minimum standards of the Mandatory Guidelines 
published in the Federal Register January 23, 2017 (82 FR 7920). After 
receiving DOT certification, the laboratory will be included in the 
monthly list of HHS-certified laboratories and participate in the NLCP 
certification maintenance program.

Charles P. LoDico,
Chemist.
[FR Doc. 2018-26279 Filed 12-3-18; 8:45 am]
BILLING CODE 4160-20-P