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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1
Number of respondents
21 CFR section/activity
Total annual responses
Average burden per response
Total hours
610.2, Requests for Samples and Protocols; Official Release
660.6b, Protocols
660.36a2 and b, Samples and Protocols
660.46b, Protocols

72
3 1
1

82.972
4 1
1

5,974
12
1 1

3
5 6
5

17,922
60
6 5

Total

77

5,988

17,993

1 There
are no capital costs or operating and maintenance costs associated with this collection of information.

Our estimated burden for the information collection reflects an overall decrease of 1,463 hours and a corresponding decrease of 491
responses. We attribute this adjustment to a decrease in the number of submissions we received over the last few years.
Dated: July 27, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202116384 Filed 73021; 8:45 am BILLING CODE 416401P

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

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; 240276
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 SUMMARY:

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Number of responses per respondent
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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/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 Pubic Law 10071 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
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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
7841190 Formerly: GammaDynacare Medical Laboratories
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