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]
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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]
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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]
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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 https://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)
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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
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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]
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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]
-----------------------------------------------------------------------
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 https://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]
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