Exhibit 11 - HHS List of Certified Laboratories.pdf

53754 Federal Register / Vol. 87, No. 169 / Thursday, September 1, 2022 / Notices

ESTIMATED ANNUALIZED BURDEN HOURS—Continued

Form name Type of respondent Number of respondents

Number of responses per respondent

Average burden per response (in hours)

Total annual burden hours

Annual Principal Investigator Worksheet About Local Context (Attachment B41).

Health Care Practitioner .. 1,800 1 20/60 600

Study-Specific Worksheet About Local Context (At-tachment B42).

Health Care Practitioner .. 4,800 1 15/60 1,200

Study Closure or Transfer of Study Review Respon-sibility (Attachment B43).

Health Care Practitioner .. 1,680 1 15/60 420

Unanticipated Problem or Serious or Continuing Noncompliance Reporting Form (Attachment B44).

Health Care Practitioner .. 360 1 20/60 120

Change of Signatory Institution PI Form (Attachment B45).

Health Care Practitioner .. 120 1 20/60 40

Request Waiver of Assent Form (Attachment B46) .. Health Care Practitioner .. 35 1 20/60 12 CIRB Waiver of Consent Request Supplemental

Form (Attachment B47).

Health Care Practitioner .. 20 1 15/60 5

Review Worksheet CIRB Review for Inclusion of In-carcerated Participants (Attachment B48).

Board Members ............... 20 1 60/60 20

Notification of Incarcerated Participant Form (Attach-ment B49).

Health Care Practitioner .. 20 1 20/60 7

CTSU OPEN Survey (Attachment C03) .................... Health Care Practitioner .. 10 1 15/60 3 CIRB Customer Satisfaction Survey (Attachment

C04).

Participants ...................... 600 1 15/60 150

Follow-up Survey (Communication Audit) (Attach-ment C05).

Participants/ Board Members

300 1 15/60 75

CIRB Board Member Annual Assessment Survey (Attachment C07).

Board Members ............... 60 1 15/60 15

PIO Customer Satisfaction Survey (Attachment C08) Health Care Practitioner .. 60 1 5/60 5 Audit Scheduling Form (Attachment D01) ................. Health Care Practitioner .. 152 5 21/60 266 Preliminary Audit Finding Form (Attachment D02) .... Health Care Practitioner .. 152 5 10/60 127 Audit Maintenance Form (Attachment D03) .............. Health Care Practitioner .. 152 5 9/60 114 Final Audit finding Report Form (Attachment D04) ... Health Care Practitioner .. 75 11 1,098/60 15,098 Follow-up Form (Attachment D05) ............................. Health Care Practitioner .. 75 7 27/60 236 Roster Maintenance Form (Attachment D06) ............ Health Care Practitioner .. 5 1 18/60 2 Final Report and CAPA Request Form (Attachment

D07).

Health Care Practitioner .. 12 9 1,800/60 3,240

NCI/DCTD/CTEP FDA Form 1572 for Annual Sub-mission (Attachment E01).

Physician ......................... 26,500 1 15/60 6,625

NCI/DCTD/CTE Biosketch (Attachment E02) ............ Physician; Health Care Practitioner.

48,000 1 120/60 96,000

NCI/DCTD/CTEP Financial Disclosure Form (Attach-ment E03).

Physician; Health Care Practitioner.

48,000 1 15/60 12,000

NCI/DCTD/CTEP Agent Shipment Form (ASF) (At-tachment E04).

Physician ......................... 24,000 1 10/60 4,000

Totals .................................................................. .......................................... 167,545 235,510 .................... 151,769

Dated: August 26, 2022.

Diane Kreinbrink, Project Clearance Liaison, National Cancer Institute, National Institutes of Health.

[FR Doc. 2022–18853 Filed 8–31–22; 8:45 am]

BILLING CODE 4140–01–P

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 and Oral Fluid 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 (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

FOR FURTHER INFORMATION CONTACT:

Anastasia Donovan, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N06B, Rockville, Maryland 20857; 240–276– 2600 (voice); Anastasia.Donovan@ samhsa.hhs.gov (email).

SUPPLEMENTARY INFORMATION: In accordance with Section 9.19 of the 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

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53755 Federal Register / Vol. 87, No. 169 / Thursday, September 1, 2022 / Notices 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/resources/drug-testing/ certified-lab-list.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and of the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.

The Mandatory Guidelines using Urine 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 using Oral Fluid were first published in the Federal Register on October 25, 2019 (84 FR 57554) with an effective date of January 1, 2020.

The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Public Law 100–71 and allowed urine drug testing only. The Mandatory Guidelines using Urine have since been revised, and new Mandatory Guidelines allowing for oral fluid drug testing have been published. The Mandatory Guidelines require strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on specimens for federal agencies. HHS does not allow IITFs to conduct oral fluid testing.

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 using Urine and/ or Oral Fluid. An HHS-certified laboratory or IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), which attests that the test facility has met minimum standards. HHS does not allow IITFs to conduct oral fluid testing.

HHS-Certified Laboratories Approved To Conduct Oral Fluid Drug Testing

In accordance with the Mandatory Guidelines using Oral Fluid dated October 25, 2019 (84 FR 57554), the following HHS-certified laboratories meet the minimum standards to conduct drug and specimen validity tests on oral fluid specimens:

At this time, there are no laboratories certified to conduct drug and specimen validity tests on oral fluid specimens.

HHS-Certified Instrumented Initial Testing Facilities Approved To Conduct Urine Drug Testing

In accordance with the Mandatory Guidelines using Urine dated January 23, 2017 (82 FR 7920), the following HHS-certified IITFs meet the minimum standards to conduct drug and specimen validity tests on urine specimens:

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

HHS-Certified Laboratories Approved To Conduct Urine Drug Testing

In accordance with the Mandatory Guidelines using Urine dated January 23, 2017 (82 FR 7920), the following HHS-certified laboratories meet the minimum standards to conduct drug and specimen validity tests on urine specimens:

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.)

Clinical Reference Laboratory, Inc., 8433 Quivira Road, Lenexa, KS 66215– 2802, 800–445–6917

Desert Tox, LLC, 5425 E Bell Rd., Suite 125, Scottsdale, AZ 85254, 602– 457–5411/623–748–5045

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.)

Legacy Laboratory Services Toxicology, 1225 NE 2nd Ave., Portland, OR 97232, 503–413–5295/800–950–

MedTox Laboratories, Inc., 402 W County Road D, St. Paul, MN 55112, 651–636–7466/800–832–3244

Minneapolis Veterans Affairs Medical Center, Forensic Toxicology Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612–725– 2088. Testing for Veterans Affairs (VA) Employees Only

Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 91311, 800–328–6942, (Formerly:

Centinela Hospital Airport Toxicology Laboratory)

Phamatech, Inc., 15175 Innovation Drive, San Diego, CA 92128, 888– 635–5840

Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403, 610–631–4600/877–642–2216, (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories)

US Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., Fort George G. Meade, MD 20755–5235, 301–677–7085, VerDate Sep<11>2014 17:15 Aug 31, 2022 Jkt 256001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\01SEN1.SGM 01SEN1js pe ar s on D

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53756 Federal Register / Vol. 87, No. 169 / Thursday, September 1, 2022 / Notices

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 on 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.

Anastasia M. Donovan, Public Health Advisor, Division of Workplace Programs.

[FR Doc. 2022–18876 Filed 8–31–22; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF HOMELAND

SECURITY

Federal Emergency Management Agency

[Docket ID FEMA–2022–0002]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland Security.

ACTION: Notice.

SUMMARY: New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized.

Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports, currently in effect for the listed communities.

DATES: Each LOMR was finalized as in the table below.

ADDRESSES: Each LOMR is available for inspection at both the respective Community Map Repository address listed in the table below and online through the FEMA Map Service Center at https://msc.fema.gov.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472,

(202) 646–7659, or (email) patrick.sacbibit@fema.dhs.gov; or visit the FEMA Mapping and Insurance eXchange (FMIX) online at https:// www.floodmaps.fema.gov/fhm/fmx_ main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.

The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C.

4001 et seq., and with 44 CFR part 65.

The currently effective community number is shown and must be used for all new policies and renewals.

The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program

(NFIP).

This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements.

The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.

This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP. The changes in flood hazard determinations are in accordance with

44 CFR 65.4.

Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at https:// msc.fema.gov.

(Catalog of Federal Domestic Assistance No.

97.022, ‘‘Flood Insurance.’’)

Michael M. Grimm, Assistant Administrator for Risk Management, Federal Emergency Management Agency, Department of Homeland Security.

State and county Location and case No.

Chief executive officer of community

Community map repository

Date of modification

Community No.

Colorado: Arapahoe (FEMA Docket No.: B–2232).

City of Aurora (21– 08–0396P).

The Honorable Mike Coffman, Mayor, City of Aurora, 15151 East Alameda Parkway, Au-rora, CO 80012.

Public Works Department, 15151 East Al-ameda Parkway, Aurora, CO 80012.

Jul. 29, 2022

Florida:

Manatee (FEMA

Docket No.:

B–2232)

Unincorporated areas of Manatee County (21–04– 3451P)

The Honorable Kevin Van Ostenbridge, Chair, Manatee County Board of Commis-sioners, P.O. Box 1000, Bra-denton, FL 34206.

Manatee County Building and Develop-ment Services Department, 1112 Man-atee Avenue West, Bradenton, FL 34205.

Aug. 2, 2022

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