Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Notices 15211 

context can demonstrate which 

oncogene derived neoepitopes are 

presented by common HLA alleles, and 

can provide the data necessary to 

rapidly develop TCRs against the 

desired antigens. 

Using the MS approach, inventors at 

the National Cancer Institute (NCI) have 

identified neoepitopes derived from a 

mutated isoform of Epithelial Growth 

Factor Receptor (EGFR) presented by 

HLA A*11:01 across multiple biological 

replicates. From this MS data, the 

inventors were able to successfully 

isolate murine TCRs that specifically 

recognize HLA A*11:01 restricted 

neoepitopes targeting EGFR L858R. 

According to various cancer genome 

databases, EGFR L858R is highly 

prevalent in lung adenocarcinoma, nonsmall cell lung carcinoma, and nonsquamous non-small cell lung 

carcinoma, making this driver mutation 

an excellent target to develop off-theshelf cellular therapies. The clinical 

potential of these TCRs has not been 

explored. 

Therapeutic Area(s): Cancer. 

Research uses include: TCRs may be 

used as positive controls to identify 

HLA–A*11:01 EGFR L858R reactive T 

cells from different sources such as 

patients or animal models; TCRs 

recognize the common EGFR L858R 

driver mutation in the context of HLA– 

A*11:01; EGFR; the prevalence of EGFR 

L858R substitutions, relative to the 

overall EGFR mutation population, 

ranges from 27.7% to 41.1% in nonsmall cell lung cancer patients; HLA– 

A*11:01 allele frequency is particularly 

high (up to 60%) in Asian and Oceanian 

populations. This research has validated 

the effectiveness of using mass 

spectrometry to detect amino acid 

sequences on specific HLA complexes. 

Achieving expeditious 

commercialization of federally funded 

research and development is consistent 

with the goals of the Bayh-Dole Act, 

codified as 35 U.S.C. 200–212 and 37 

CFR 404.4. 

Development Stage: Research Tool. 

Dated: February 26, 2024. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2024–04251 Filed 2–29–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Population Sciences 

and Epidemiology Integrated Review 

Group, Aging, Injury, Musculoskeletal, 

and Rheumatologic Disorders Study 

Section, March 14, 2024, 09:00 a.m. to 

March 15, 2024, 08:00 p.m., National 

Institutes of Health, Rockledge II, 6701 

Rockledge Drive, Bethesda, MD 20892 

which was published in the Federal 

Register on February 26, 2024, 89 FR 

14081, Doc 2024–03762. 

This meeting is being amended to 

change the location to Hilton 

Alexandria Old Town, 1767 King Street, 

Alexandria, VA 22314. The meeting 

time will remain the same. The meeting 

is closed to the public. 

Dated: February 26, 2024. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–04306 Filed 2–29–24; 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 (Mandatory Guidelines) using 

Urine and the laboratories currently 

certified to meet the standards of the 

Mandatory Guidelines using Oral Fluid. 

FOR FURTHER INFORMATION CONTACT: 

Anastasia Flanagan, Division of 

Workplace Programs, SAMHSA/CSAP, 

5600 Fishers Lane, Room 16N06B, 

Rockville, Maryland 20857; 240–276– 

2600 (voice); Anastasia.Flanagan@

samhsa.hhs.gov (email). 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) publishes a notice 

listing all HHS-certified laboratories and 

Instrumented Initial Testing Facilities 

(IITFs) in the Federal Register during 

the first week of each month, in 

accordance with Section 9.19 of the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(Mandatory Guidelines) using Urine and 

Section 9.17 of the Mandatory 

Guidelines using Oral Fluid. 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/drug-testing-resources/ 

certified-lab-list. 

HHS separately notifies Federal 

agencies of the laboratories and IITFs 

currently certified to meet the standards 

of the 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); January 23, 

2017 (82 FR 7920); and on October 12, 

2023 (88 FR 70768). 

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, and subsequently 

revised in the Federal Register on 

October 12, 2023 (88 FR 70814). 

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 


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