Attachement J-4 - 88 FR 70768 - 5-8-2024 (44 Pages).pdf

70768 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

42 CFR Chapter I

Mandatory Guidelines for Federal Workplace Drug Testing Programs

AGENCY: Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Health and Human Services (HHS).

ACTION: Issuance of mandatory guidelines.

SUMMARY: The Department of Health and Human Services (‘‘HHS’’ or ‘‘Department’’) has revised the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), which published in the Federal Register of January 23, 2017.

DATES: The mandatory guidelines are effective February 1, 2024.

FOR FURTHER INFORMATION CONTACT:

Eugene D. Hayes, Ph.D., MBA, SAMHSA, CSAP, DWP; 5600 Fishers Lane, Room 16N02, Rockville, MD 20857, by telephone (240) 276–1459 or by email at Eugene.Hayes@ samhsa.hhs.gov.

SUPPLEMENTARY INFORMATION:

Executive Summary

These revised Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) establish a process whereby the Department annually publishes the authorized drug testing panel (i.e., drugs, analytes, or cutoffs) to be used for Federal workplace drug testing programs; revise the definition of a substituted specimen to include specimens with a biomarker concentration inconsistent with that established for a human specimen, establish a process whereby the Department publishes an authorized biomarker testing panel (i.e., biomarker analytes and cutoffs) for Federal workplace drug testing programs;

update and clarify the oral fluid collection procedures; revise the confirmatory test cutoff for morphine;

revise the Medical Review Officer (MRO) verification process for positive codeine and morphine specimens; and require MROs to submit semiannual reports to the Secretary or designated HHS representative on Federal agency specimens that were reported as positive for a drug or drug metabolite by a laboratory and verified as negative by the MRO. In addition, some wording changes have been made for clarity and for consistency with the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid

(OFMG) or to apply to any authorized specimen type.

The Department is publishing a separate Federal Register Notification (FRN) elsewhere in this issue of the Federal Register with the revised OFMG, which include the same or similar revisions as the UrMG, where appropriate.

Background Pursuant to its authority under section 503 of Public Law 100–71, 5 U.S.C. 7301, and Executive Order 12564, HHS establishes the scientific and technical guidelines for Federal workplace drug testing programs and establishes standards for certification of laboratories engaged in drug testing for Federal agencies.

Using data obtained from the Federal Workplace Drug Testing Programs and HHS-certified laboratories, the Department estimates that 275,000 urine specimens are tested annually by Federal agencies. No Federal agencies are testing hair or oral fluid specimens at this time.

HHS originally published the Mandatory Guidelines for Federal Workplace Drug Testing Programs (hereinafter referred to as Guidelines or Mandatory Guidelines) in the Federal Register (FR) on April 11, 1988 (53 FR 11979). The Substance Abuse and Mental Health Services Administration (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 November 25, 2008 (73 FR 71858).

SAMHSA published the current Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) on January 23, 2017 (82 FR 7920), and published the current Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) on October 25, 2019 (84 FR 57554). SAMHSA published proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs using Hair (HMG) on September 10, 2020 (85 FR 56108), and proposed revisions to the UrMG (87 FR 20560) and OFMG (87 FR 20522) on April 7, 2022.

There was a 60-day public comment period following publication of the proposed UrMG, during which 22 commenters submitted 93 comments on the UrMG. These commenters were comprised of individuals, organizations, and private sector companies. The comments are available for public view at https://www.regulations.gov/. All comments were reviewed and taken into consideration in the preparation of the

Guidelines. The issues and concerns raised in the public comments for the UrMG are set forth below. Similar comments are considered together in the discussion.

Summary of Public Comments and HHS’s Response

The following comments were directed to the information and questions in the preamble.

Authorized Drug Testing Panel

The Department requested comments on its proposal to publish the drug testing panel separately from the UrMG in a Federal Register Notification (FRN) each year. Sixteen commenters submitted a total of 35 comments on this topic for the UrMG.

Eight commenters disagreed with publishing a revised drug testing panel without a public comment period, expressing concerns that stakeholders including individuals subject to federally regulated drug testing would not be given the opportunity to provide comment and that the Department would miss valuable input including information on costs and burden. Some of these commenters suggested alternate ways to permit public comment while enabling a quicker response to testing panel changes (e.g., setting a shorter comment period, publishing the Guidelines as an interim final rule or issuing an advance notice of proposed rulemaking). The Department has reviewed these comments and suggestions and determined that no changes to the proposed Guidelines are needed. The Department has developed procedures which will allow review and comment before testing panel changes are published, as described below.

Consistent with current procedures, prior to making a change to the drug or biomarker testing panel, the Department will conduct a thorough review of the scientific and medical literature, and will solicit review and input from subject matter experts such as Responsible Persons (RPs) of HHS-certified laboratories, Medical Review Officers (MROs), research scientists, manufacturers of collection devices and/or immunoassay kits, as well as Federal partners such as the Department of Transportation (DOT), the Food and Drug Administration (FDA), and the Drug Enforcement Administration (DEA). Further, the Department plans to provide notice and opportunity for public comment regarding any proposed changes to the drug and biomarker testing panels as part of Drug Testing Advisory Board (DTAB) meetings and procedures.

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Information regarding any proposed changes to the drug analyte and biomarker testing panels and a request for public comment will be included in an advance notice of the DTAB meeting published in the Federal Register, along with the timeframe and method(s) for comment submission. During the meeting, the Department will present the basis for adding or removing analytes (i.e., including technical and scientific support for the proposed changes), as well as a discussion of related costs and benefits. This information will be provided in advance to DTAB members. The Department will review all submitted public comments and will share information during a DTAB session prior to DTAB’s review of SAMHSA’s recommendation to the Secretary regarding each proposed change.

The Department will make the final decision on any panel changes and include the effective date(s) in the annual Notification, to allow time for drug testing service providers (e.g., immunoassay kit manufacturers, oral fluid collection device manufacturers) to develop or revise their products, and for HHS-certified laboratories to develop or revise assays, complete validation studies, and revise procedures.

Four commenters disagreed that HHS is exempt from the Administrative Procedure Act (APA) requirements. Two of these specifically stated that the Guidelines are subject to APA requirements because DOT is required to use the Guidelines for their transportation industry drug testing programs. The Department explained why the APA does not apply under the Regulatory Impact and Notices section of the current UrMG (82 FR 7920) and has repeated the same information in that section below.

Ten commenters were concerned that the Department will not allow sufficient time for stakeholders to implement changes (e.g., time for Food and Drug Administration [FDA] clearance for new or revised products, information technology [IT] changes, process development and/or changes, contractual changes, and training).

Some of these commenters suggested that the Department set a standard time period (e.g., 90 days) for implementation of changes or based on the complexity of the change (e.g., between 90 and 365 days). The Department will establish a reasonable time for implementation based on the change, rather than setting a standard time period for all changes. As noted above, the Department will solicit information from stakeholders to assist in decision making.

In regard to the use of FDA-cleared immunoassay initial tests, two commenters suggested that federally regulated drug testing could fall under what they referred to as the FDA’s Employment and Insurance exemption.

The Department notes that, while some drugs of abuse test systems intended for employment and insurance testing are, under certain circumstances, exempt from the premarket notification procedures in 21 CFR part 807, subpart E, such exemptions do not apply to test systems intended for Federal drug testing programs. See 21 CFR part 862, subpart D. Applicant and HHS-certified test facilities must verify that test systems subject to FDA regulations are approved or otherwise cleared by FDA and, in addition, must validate test systems prior to use in accordance with requirements specified in the National Laboratory Certification Program (NLCP) Manuals for Urine Laboratories and Initial Instrumented Test Facilities (IITFs).

One commenter appeared to misinterpret the Department’s testing panel proposal, objecting to the Department making changes to the testing panels each year. The Department plans to issue an annual Notification with the current testing panels and required nomenclature, but will make changes only when needed to ensure the continued effectiveness of Federal workplace drug testing programs, which may not be every year.

Four commenters specifically agreed with the need to streamline and improve processes for making changes to the testing panels. Three of these commenters expressed concern over the process for testing panel review and who would be involved, and suggested involving other stakeholders (e.g., HHS-certified laboratories, DTAB, FDA). As noted above, the Department will use multiple methods and involve subject matter experts from various stakeholder groups to determine testing panel changes, and will provide opportunity for public review and comment before changes are made. FDA, DOT, and other Federal partners will also have opportunities to review and provide input.

The other commenter suggested that the Department include additional prescriptive language in each annual Notification (e.g., street names, detection times, pharmacological information on added drugs for MROs;

Custody and Control Form (CCF) instructions for collectors). The Department has determined that no changes to the proposed Guidelines are needed. Relevant information and guidance will be included in the MRO

Guidance Manual, Case Studies, Guidance for Using the Federal Custody and Control Form (CCF), and Specimen Collection Handbook. These documents are posted on SAMHSA’s website, https://www.samhsa.gov/workplace.

One commenter stated that testing panel changes would lead to an increase in incorrect information on the Federal CCF. The Department disagrees, noting that the Federal CCF does not include preprinted analyte names.

One of the commenters agreed with posting a Notification without a public comment period for added drugs, but disagreed with removing drugs from the testing panel without public comment.

The commenter noted that entities (e.g., DOT, some states) are required by law to use the Guidelines testing panel should be able to continue testing those drugs, even if Federal agencies will not.

The Department has determined that no changes to the proposed Guidelines are needed to address these concerns.

See additional comments under Section 3.4 below.

Authorized Biomarker Testing Panel The Department requested comments on its proposal to publish the biomarker testing panel separately from the UrMG in the Federal Register each year. Five commenters submitted a total of 12 comments on this topic for the UrMG.

Two commenters disagreed with publishing a biomarker testing panel without a public comment period, expressing concerns that stakeholders would not be given the opportunity to provide comment and that the Department would miss valuable input including information on costs and burden.

Two other commenters specifically agreed with the need to streamline and improve processes for making changes to the testing panels, but suggested involving other stakeholders (e.g., HHS-certified laboratories, DTAB). The Department has reviewed these comments and determined that no changes to the proposed Guidelines are needed. The Department has developed procedures which will allow review and comment before testing panel changes are published, as described under Authorized drug testing panel above.

One commenter disagreed that HHS is exempt from the APA requirements. The Department has reviewed the comment and determined that no change is needed to the proposed Guidelines. The Department explained why the APA does not apply under the Regulatory Impact and Notices section of the current UrMG (82 FR 7920) and has repeated the same information in that section below.

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Two commenters were concerned that the Department will not allow sufficient time for stakeholders to implement changes (e.g., time for information technology [IT] changes, process development and/or changes, training).

The commenters suggested that the Department set a standard time for implementation of all changes (e.g., 90 days, six months). As noted under Authorized drug testing panel above, the Department will establish a reasonable time for implementation based on the change, rather than setting a standard time period for all changes, and will solicit information from multiple sources to assist in decision making.

Two commenters suggested that the Department require all HHS-certified laboratories to perform standardized specimen validity and biomarker tests on all federally regulated specimens, and allow laboratories to choose whether to offer additional specialized tests upon MRO request on a case-by-case basis. This is consistent with current UrMG requirements for specimen validity testing. The Department is not requiring all certified laboratories to conduct biomarker testing at this time. However, if the drug testing industry identifies a need for such tests and an HHS-certified laboratory chooses to offer a biomarker test to their regulated clients, the Department will ensure that the tests provide scientifically valid and forensically defensible results and will revisit the need for requiring the test on all specimens.

Medical Review Officer (MRO) Verification of Codeine and Morphine Test Results

The Department removed the additional decision point for codeine and morphine, adjusted the confirmatory test cutoff for morphine from 2,000 to 4,000 ng/mL, and removed the additional requirement for clinical evidence of illegal opioid use.

The Department received one comment agreeing with these changes to the UrMG.

Medical Review Officer (MRO) Semiannual Reports

In Section 13.11, the Department added requirements for each MRO performing medical review services for Federal agencies to submit semiannual reports, in January and July of each year, of Federal agency specimens that were reported as positive for a drug or drug metabolite by the laboratory and verified as negative by the MRO, along with the reason for the negative verification (e.g., a valid prescription for a drug). Six commenters submitted six comments on this topic for the UrMG.

Four commenters disagreed, stating that HHS had not clearly described the reason and the process for such reports.

One commenter noted that the Department had not presented data documenting that MROs were incorrectly reporting specimens, and it was unclear how the reports could be matched to laboratory report information submitted to the National Laboratory Certification Program (NLCP). Another commenter was concerned that donors would be identifiable, and that ‘‘a database of legal drug use’’ would violate donor privacy. One of the commenters expressed concern over ‘‘unintended consequences’’ for DOT and state workplace drug testing programs, without further explanation.

One commenter disagreed on the basis of added costs and burden to MROs (e.g., system revisions, increased staff workload).

One commenter agreed that such reports could be beneficial, but suggested that MROs provide the same information as provided by laboratories to the NLCP. The commenter incorrectly stated that laboratories do not provide specimen identification numbers to the

NLCP.

The Department has reviewed the comments and determined that no change is needed to the proposed Guidelines. To clarify, this reporting policy is only for Federal agency specimens, not DOT-regulated specimens. Further, the reports are not for all positive specimens, only for those specimens that were reported as positive by the laboratory and verified as negative by the MRO. The requested MRO information is sufficient to enable matching to HHS-certified laboratory information provided to the NLCP without identifying the donor. At this time, there is no system-wide mechanism for identifying MRO verification practices for Federal agency specimens that are inconsistent with the Mandatory Guidelines, so data on incorrect reporting is not available. The Department is not planning to share MRO-specific information, but may share statistical information and deidentified examples of incorrect reporting by various means (e.g., DTAB meeting presentations, revisions to the MRO Guidance Manual and/or Case Studies). The Department will also provide this information to HHS-approved MRO certification organizations to share with their certified MROs and to update training materials and examinations as needed.

Marijuana Testing The Department did not propose any changes to the UrMG in regard to marijuana testing, but received three comments from three commenters disagreeing with the current requirements. Two commenters supported medical use of marijuana.

One commenter supported legalization of marijuana in general.

Current Federal law requires Federal agencies to test for marijuana under E.O.

12564 in their workplace drug testing programs. The Department also edited Section 13.5(c) to clarify that only prescription medications can be offered as a legitimate medical explanation for a positive drug test (as described under Section 13.5 below). No further edits are required at this time.

Discussion of Sections The Department has not included a discussion in the preamble of any sections for which public comments were not submitted or for minor wording changes (e.g., edits for clarity, typographical or grammatical corrections).

Subpart A—Applicability

Section 1.5 What do the terms used in these Guidelines mean?

Two commenters agreed and one disagreed with the Department’s proposed revision to the Substituted Specimen definition in Section 1.5 to include specimens tested for a biomarker. The commenter who disagreed stated that there are situations in which a legitimate specimen may be reported as outside the standards for human specimens, and these should be reported as invalid. The Department has reviewed the comment and determined that no change is needed to the proposed Guidelines. The Department will follow the procedures summarized under Authorized drug testing panel above to enable public comment and review, and will ensure that a biomarker test is scientifically supported and forensically sound to identify specimens as substituted before allowing its use with federally regulated drug testing.

Specimens that do not meet established criteria for the biomarker test will not be reported as substituted.

Section 1.7 What is a refusal to take a federally regulated drug test?

In Section 1.7(a), the Department proposed to remove two exceptions for reporting a refusal to test for a pre-employment test: a donor who fails to appear in a reasonable time and a donor who leaves the collection site before the collection process begins. Seven

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70771 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations commenters submitted seven comments on this proposal.

Five commenters disagreed with the changes, noting that an applicant may fail to appear because they have taken a different job offer. The commenters noted that a refusal to test in the individual’s record could prevent individuals from taking other job offers and/or require them to undergo unnecessary return-to-duty testing. The Department has reviewed the comments and determined that no change is needed. As stated in this section, the Federal agency determines a reasonable time for the donor to take the test, consistent with applicable agency regulations, and directs the individual accordingly. At the time an applicant is scheduled for a pre-employment drug test, or before, Federal agencies should provide the applicant with instructions on how to notify the agency in the event that they decide to withdraw their application or to not accept a job offer.

Such instructions will allow the agency to cancel the drug test and help applicants avoid a refusal to test result.

One commenter noted that the Guidelines should state that the designated employer representative (DER) makes the determination of a refusal to test. The Department has reviewed the comment and determined that no change is needed. As stated in this section, the Federal agency takes action consistent with applicable agency regulations.

Subpart C—Urine Specimen Tests

Section 3.4 What are the drug and biomarker test analytes and cutoffs for urine?

The Department revised Section 3.4 to describe the annual publication of the drug testing and biomarker testing panels and the nomenclature required for laboratory and MRO reports. Three commenters submitted four comments on the required nomenclature required for laboratory and MRO reports, which are addressed below. Comments on the testing panels are addressed under Authorized drug testing panel and Authorized biomarker testing panel above.

In regard to the required nomenclature specified in the annual Federal Register Notification, two commenters noted it is difficult and requires substantial effort for stakeholders to make such changes to their information technology (IT) systems. These commenters suggested that HHS convene a working group for review and input on nomenclature changes, to include employers, third party administrators, providers of electronic Federal Custody and Control Forms (ECCF providers), laboratories, and MROs. One commenter agreed with publishing the required nomenclature for each change to the testing panel, but suggested that nomenclature not be changed after publication to avoid increased costs and confusion. One commenter recommended a minimum of one-year implementation period after nomenclature changes are published.

The Department will establish required terminology based on correct scientific nomenclature for added analytes. As described under Authorized drug testing panel above, the Department has developed procedures to allow public notice and comment on proposed drug analyte changes through DTAB meetings and procedures. The Department will publish separate nomenclature lists for urine and oral fluid analytes.

Subpart F—Federal Drug Testing Custody and Control Form

Section 6.2 What happens if the correct Office of Management and Budget (OMB)-approved Federal CCF is not available or is not used?

One commenter stated that the Department should specify what constitutes an incorrect form, how a collector’s signed memorandum must be submitted to correct submission of an incorrect CCF, and what actions an HHS-certified laboratory must take in response to an incorrect CCF. The Department has determined that no changes to the Guidelines are needed.

The Department issues Guidance for Using the Federal CCF as part of the OMB-approved package and provides information and guidance specific to the current and expired versions of the Federal CCF, rather than including them in these Guidelines.

Subpart H—Urine Specimen Collection Procedure

8.3 What are the preliminary steps in

the urine specimen collection procedure?

There were no comments on this section; however, the Department added a sentence in item h stating that a donor is not required to remove any items worn for faith-based reasons. This requirement will be specified for all authorized specimen types.

Subpart K—Laboratory

Section 11.20 How long must an HHS-certified laboratory retain specimens?

The Department did not propose any changes to this section. One commenter submitted a comment specifically agreeing with the existing UrMG requirement for laboratories to maintain substituted urine specimens for a period of one year after reporting. The comment appeared to be in response to DOT’s February 28, 2022 notice of proposed rulemaking (NPRM) for transportation industry drug testing programs.

Subpart M—Medical Review Officer

(MRO)

Section 13.3 What training is required before a physician may serve as an

MRO?

The Department did not propose any changes to this section; however, one commenter indicated that this section is unclear and needs substantial clarification regarding additional MRO training (e.g., what must training consist of, must the MRO take another certification exam, would this be required for annual panel changes). The commenter also suggested that MROs register with SAMHSA to get updates/ announcements and acknowledge review of that information.

The Department has reviewed these comments and edited item b of this section to clarify that MROs must be trained on any revisions to the drug and biomarker testing panels. In regard to training, SAMHSA relies on the approved MRO certification entities to ensure that MROs certified by their organizations meet Guidelines requirements. Current documents on the SAMHSA website https:// www.samhsa.gov/workplace include the HHS Medical Review Officer Guidance Manual, MRO Cases Studies for Urine, and MRO Case Studies for Urine which address most of the suggested topics.

The Department does not maintain an email list, but sends a notice through the NLCP to HHS-approved MRO certification organizations for dissemination to their certified MROs.

The Department also sends additional guidance to HHS-certified laboratories to share with MROs, clients, and collectors as applicable.

Section 13.5 What must an MRO do when reviewing a urine specimen’s test results?

The Department revised Section 13.5(d)(2) to clarify that passive exposure to any drug (not just marijuana smoke) and ingestion of food products containing a drug (not just those containing marijuana) are not acceptable medical explanations for a positive drug test. The Department also added Section 13.5(d)(2)(iii) to clarify that only prescription medications can be offered as a legitimate medical explanation for

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70772 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations a positive drug test. Two commenters disagreed with the addition of Section 13.5(d)(2)(iii), maintaining that a physician’s recommendation for medical marijuana should be considered a legitimate medical explanation for a positive test. The Department has evaluated these comments and determined that no change is needed at this time. Although an increased number of States have authorized marijuana use for medical purposes, marijuana remains a Schedule I controlled substance and cannot be prescribed under Federal law. For purposes of the Federal drug free workplace program, Federal law pertaining to marijuana control supersedes State marijuana laws, and therefore, a physician’s recommendation for marijuana use is not a legitimate medical explanation for a positive marijuana test. Also see comments under Marijuana testing above.

In addition to the changes described above, the Department reordered UrMG Sections 13.8 and 13.9 to reflect the procedural order (i.e., requirements for an MRO to report a primary specimen test result are now in Section 13.8, and requests for a test of the split specimen are addressed in Section 13.9).

Regulatory Impact and Notices The potential impact that these

Guidelines have on the Department of Transportation (DOT) and/or Nuclear Regulatory Commission (NRC) regulated industries depends on the extent to which these agencies incorporate the UrMG revisions into their regulatory programs. Therefore, analysis of the potential impact of these Guidelines on such programs falls under the regulatory purview of DOT and NRC.

Executive Order 14094, 13563, and 12866

Executive Order 14094 of April 6, 2023 (Modernizing Regulatory Review) reaffirms the statement set forth in 13563 of January 18, 2011 (Improving Regulation and Regulatory Review) that ‘‘Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.’’ Consistent with this mandate, Executive Order 13563 requires agencies to tailor ‘‘regulations to impose the least burden on society, consistent with obtaining regulatory objectives.’’ Executive Order 13563 also requires agencies to ‘‘identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice’’ while selecting ‘‘those approaches that maximize net benefits.’’ The regulatory approach in this document will reduce burdens to providers and to consumers while continuing to provide adequate protections for public health and welfare.

The Secretary has examined the impact of the Guidelines under Executive Order 12866, as amended by Executive Order 14094, which directs Federal agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity).

According to Executive Order 12866, as amended by Executive Order 14094, defines a ‘‘significant regulatory action’’ as one that is likely to result in a rule that may meet any one of a number of specified conditions, including: (1) have an annual effect on the economy of $200 million or more in any one year (adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise legal or policy issues for which centralized review would meaningfully further the President’s priorities or the principles set forth in the Executive order, as specifically authorized in a timely manner by the Administrator of OIRA in each case. The Administrative Procedure Act (APA) delineates an exception to its rulemaking procedures for ‘‘a matter relating to agency management or personnel’’ 5 U.S.C.

553(a)(2). Because the Guidelines issued by the Secretary govern Federal workplace drug testing programs, HHS has taken the position that the Guidelines are a ‘‘matter relating to agency management or personnel’’ and, thus, are not subject to the APA’s requirements for notice and comment rulemaking. This position is consistent with Executive Order 12564 regarding Drug-Free Workplaces, which directs the Secretary to promulgate scientific and technical guidelines for executive agency drug testing programs.

Costs and Benefits

The Department included a Regulatory Impact and Notices section with cost and benefits analysis and burden estimates in the April 7, 2022 Federal Register Notification for the proposed UrMG (87 FR 20560), and requested public comment on all estimates and assumptions. Two commenters submitted comments concerning the Department’s costs and benefits analysis.

One commenter noted that the Department did not consider the application of the Guidelines to DOT testing, and recommended reanalysis of the costs and burden of the proposed changes with consideration of the impact on testing by the transportation industry. Please see the first paragraph of the Regulatory Impact and Notices section above.

The other commenter disagreed with the Department’s statement in the preamble to the proposed UrMG that ‘‘implementation costs would be lower for laboratories that already offer the drug test’’ compared to those laboratories that do not test for the added drug. The commenter indicated that the list of cost impacts for any change should include the laboratory’s assay validation, materials management, and updates to IT systems (e.g., laboratory information management system [LIMS], recipient systems, and electronic ordering systems). This commenter indicated that these additional costs should be considered, and that they will be dependent on the complexity and adaptability of these systems. The Department agrees that costs will depend on the change and noted that in the preamble to the proposed UrMG. The Department will continue to proactively solicit cost information from stakeholders when conducting a cost analysis. As described under Authorized drug testing panel above, the Department will include a discussion of related costs and benefits when presenting a proposed panel change during a DTAB meeting.

Information Collection/Record Keeping Requirements

The information collection requirements (i.e., reporting and recordkeeping) in the current Guidelines, which establish the scientific and technical guidelines for Federal workplace drug testing programs and establish standards for certification of laboratories engaged in urine drug testing for Federal agencies under authority of 5 U.S.C. 7301 and Executive Order 12564, are approved by the Office of Management and Budget

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(OMB) under control number 0930– 0158. The Federal Drug Testing Custody and Control Form (Federal CCF) used to document the collection and chain of custody of urine and oral fluid specimens at the collection site, for laboratories to report results, and for Medical Review Officers to make a determination; the National Laboratory Certification Program (NLCP) application; the NLCP Laboratory Information Checklist; and recordkeeping requirements in the current Guidelines, as approved under control number 0930–0158, will remain in effect.

In support of the Government Paperwork Reduction Act (PRA), the Department revised the Federal CCF to enable its use as an electronic form (78 FR 42091, July 15, 2013) and developed requirements and oversight procedures to ensure that HHS-certified test facilities and other service providers (e.g., collection sites, MROs) using an electronic version of the Federal CCF (ECCF) maintain the accuracy, security, and confidentiality of electronic drug test information. Before a Federal ECCF can be used for Federal agency specimens, HHS-certified test facilities must submit detailed information and proposed standard operating procedures (SOPs) to the NLCP for SAMHSA review and approval, and undergo an NLCP inspection focused on the proposed

ECCF.

Since 2013, SAMHSA has encouraged the use of Federal ECCFs and other electronic processes in HHS-certified test facilities, when practicable, for federally regulated testing operations. In accordance with section 8108(a) of the SUPPORT for Patients and Communities Act, SAMHSA originally set a deadline of August 31, 2023 for all HHS-certified laboratories to submit a request for approval of a digital (paperless) electronic Federal CCF. The Department subsequently extended the deadline to August 31, 2026, to enable sufficient time for all HHS-certified laboratories to identify and contract with an ECCF supplier or to develop an ECCF.

The title and description of the information collected and respondent description are shown in the following paragraphs with an estimate of the annual reporting, disclosure, and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Title: The Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine.

Description: The Mandatory Guidelines establish the scientific and technical guidelines for Federal drug testing programs and establish standards for certification of laboratories engaged in drug testing for Federal agencies under authority of Public Law 100–71, 5 U.S.C. 7301 note, and Executive Order 12564. Federal drug testing programs test applicants to sensitive positions, individuals involved in accidents, individuals for cause, and random testing of persons in sensitive positions.

Description of Respondents:

Individuals or households, businesses, or other-for-profit and not-for-profit institutions.

The burden estimates in the tables below are based on the following number of respondents: 38,000 donors who apply for employment or are employed in testing designated positions, 100 collectors, 25 urine specimen testing laboratories, 1 IITF, and 100 MROs.

ESTIMATE OF ANNUAL REPORTING BURDEN

Section Purpose Number of respondents

Responses/ respondent

Hours/ response Total hours

9.2(a)(1) ......................... Laboratory or IITF required to submit application for certification.

10 1 3 30

9.12(a)(3) ....................... Materials to submit to become an HHS inspec-tor.

10 1 2 20

11.3 ................................ Laboratory submits qualifications of responsible person (RP) to HHS.

10 1 2 20

11.4(c) ............................ Laboratory submits information to HHS on new RP or alternate RP.

10 1 2 20

11.22 .............................. Specifications for laboratory semiannual statis-tical report of test results to each Federal agency.

10 5 0.5 25

12.3(a) ........................... IITF 1 submits qualifications of RT to HHS ......... 1 1 1 1 12.4(c) ............................ IITF 1 submits information to HHS on new RT or alternate RT.

1 1 1 1

12.19 .............................. Specifications for IITF 1 semiannual statistical report of test results to each Federal agency.

1 1 1 1

13.8 and 14.7 ................ Specifies that MRO must report all verified pri-mary and split specimen test results to the Federal agency.

100 14 0.05 (3 min) 70

13.11 .............................. Specifications for MRO semiannual report to the Secretary or designated representative for Federal agency specimen results that were laboratory-positive and MRO-verified negative.

100 2 0.5 100

16.1(b) & 16.5(a) ........... Specifies content of request for informal review of suspension/proposed revocation of certifi-cation.

1 1 3 3

16.4 ................................ Specifies information appellant provides in first written submission when laboratory suspen-sion/revocation is proposed.

1 1 0.5 0.5

16.6 ................................ Requires appellant to notify reviewing official of resolution status at end of abeyance period.

1 1 0.5 0.5

16.7(a) ........................... Specifies contents of appellant submission for review.

1 1 50 50

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ESTIMATE OF ANNUAL REPORTING BURDEN—Continued

Section Purpose Number of respondents

Responses/ respondent

Hours/ response Total hours

16.9(a) ........................... Specifies content of appellant request for expe-dited review of suspension or proposed rev-ocation.

1 1 3 3

16.9(c) ............................ Specifies contents of review file and briefs ......... 1 1 50 50

Total ........................ .............................................................................. 259

1 Although IITFs are allowed under the UrMG, SAMHSA has not received any IITF application for certification to test federally regulated speci-mens. IITF numbers are provided in this analysis as placeholders for administrative purposes.

The following reporting requirements are also in the Guidelines, but have not been addressed in the above reporting burden table: collector must report any unusual donor behavior or refusal to participate in the collection process on the Federal CCF (Sections 1.8, 8.9);

collector annotates the Federal CCF when a sample is a blind sample (Section 10.3(a)); MRO notifies the Federal agency and HHS when an error occurs on a blind sample (Section 10.4(d)); and Sections 13.6 and 13.7 describe the actions an MRO takes for the medical evaluation of a donor who cannot provide a urine specimen.

SAMHSA has not calculated a separate reporting burden for these requirements because they are included in the burden hours estimated for collectors to complete Federal CCFs and for MROs to report results to Federal agencies.

ESTIMATE OF ANNUAL DISCLOSURE BURDEN

Section Purpose Number of respondents

Responses/ respondent

Hours/ response

Total hours

8.3(a), 8.5(f)(2)(iii), 8.6(b)(2).

Collector must contact Federal agency point of contact.

100 1 0.05 (3 min) 5

11.23, 11.24 ................... Information on drug test that laboratory must provide to Federal agency upon request or to donor through MRO.

25 10 3 750

12.20, 12.21 ................... Information on drug test that IITF must provide to Federal agency upon request or to donor through MRO.

1 1 1 1

13.9(b) ........................... MRO must inform donor of right to request split specimen test when a positive, adulterated, or substituted result is reported.

100 14 3 4,200

Total ........................ .............................................................................. 226

The following disclosure requirements are also included in the Guidelines, but have not been addressed in the above disclosure burden table: the collector must explain the basic collection procedure to the donor and answer any questions (Section 8.3(e) and (g)). SAMHSA believes having the collector explain the collection procedure to the donor and answer any questions is a standard business practice and not a disclosure burden.

ESTIMATE OF ANNUAL RECORDKEEPING BURDEN

Section Purpose Number of respondents

Responses/ respondent

Hours/ response

Total hours

8.3, 8.5, 8.8 ................... Collector completes Federal CCF for specimen collected.

100 380 0.07 (4 min) 2,660

8.8(d) & (f) ..................... Donor initials specimen labels/seals and signs statement on the Federal CCF.

38,000 1 0.08 (5 min) 3,040

11.8(a) & 11.19 .............. Laboratory completes Federal CCF upon receipt of specimen and before reporting result.

25 1,520 0.05 (3 min) 1,900

12.8(a) & 12.15 .............. IITF completes Federal CCF upon receipt of specimen and before reporting result.

1 1 1 1

13.4(d)(4), 13.8(c), 14.7(c).

MRO completes Federal CCF before reporting the primary or split specimen result.

100 380 0.05 (3 min) 1,900

14.1(b) ........................... MRO documents donor’s request to have split specimen tested.

100 2 0.05 (3 min) 10

Total ........................ .............................................................................. 38,326 ........................ ........................ 9,511

The Guidelines contain several recordkeeping requirements that

SAMHSA considers not to be an additional recordkeeping burden. In subpart D, a trainer is required to document the training of an individual

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70775 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Rules and Regulations to be a collector (Section 4.3(a)(3)) and the documentation must be maintained in the collector’s training file (Section 4.3(c)). SAMHSA believes this training documentation is common practice and is not considered an additional burden.

In subpart F, if a collector uses an incorrect form to collect a Federal agency specimen, the collector is required to provide a statement (Section 6.2(b)) explaining why an incorrect form was used to document collecting the specimen. SAMHSA believes this is an extremely infrequent occurrence and does not create a significant additional recordkeeping burden. Subpart H (Sections 8.4(c), 8.5(d)(2) and (e)(1) and (2)) requires collectors to enter any information on the Federal CCF of any unusual findings during the urine specimen collection procedure. These recordkeeping requirements are an integral part of the collection procedure and are essential to documenting the chain of custody for the specimens collected. The burden for these entries is included in the recordkeeping burden estimated to complete the Federal CCF and is, therefore, not considered an additional recordkeeping burden.

Subpart K describes a number of recordkeeping requirements for laboratories associated with their testing procedures, maintaining chain of custody, and keeping records (i.e., Sections 11.1(a) and (d); 11.2(b), (c), and (d); 11.6(b); 11.7(c); 11.8; 11.11(a);

11.14(a); 11.17; 11.21(a), (b), and (c);

11.22; 11.23(a); and 11.24). These recordkeeping requirements are necessary for any laboratory to conduct forensic drug testing and to ensure the scientific supportability of the test results. These practices are integrated in the current processes and, therefore, SAMHSA does not consider these standard business practices to be an additional burden for disclosure. Thus, the total annual response burden associated with the testing of urine specimens by the laboratories and IITFs is estimated to be 14,862 hours (that is, the sum of the total hours from the above tables). This is in addition to the 1,788,809 hours currently approved by OMB under control number 0930–0158 for urine testing under the current Guidelines.

As required by section 3507(d) of the PRA, the Secretary submitted a copy of the proposed Guidelines to OMB for its review. Comments on the information collection requirements were specifically solicited in order to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of HHS’s functions, including whether the information will have practical utility;

(2) evaluate the accuracy of HHS’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Dated: September 27, 2023.

Xavier Becerra, Secretary, Department of Health and Human Services.

Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine Specimens

Subpart A—Applicability

1.1 To whom do these Guidelines apply?

1.2 Who is responsible for developing and

implementing these Guidelines?

1.3 How does a Federal agency request a

change from these Guidelines?

1.4 How are these Guidelines revised?

1.5 What do the terms used in these

Guidelines mean?

1.6 What is an agency required to do to

protect employee records?

1.7 What is a refusal to take a federally

regulated drug test?

1.8 What are the potential consequences for

refusing to take a federally regulated drug test?

Subpart B—Urine Specimens

2.1 What type of specimen may be

collected?

2.2 Under what circumstances may a urine

specimen be collected?

2.3 How is each urine specimen collected?

2.4 What volume of urine is collected?

2.5 How does the collector split the urine

specimen?

2.6 When may…