15210 Federal Register / Vol. 89, No. 42 / Friday, March 1, 2024 / Notices 

pertaining to current good 

manufacturing practice requirements 

have been approved under OMB control 

number 0910–0139. The collections of 

information in 21 CFR part 58 

pertaining to good laboratory practice 

for nonclinical laboratory studies have 

been approved under OMB control 

number 0910–0119. 

III. Electronic Access

Persons with access to the internet

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, https://

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://

www.regulations.gov. 

Dated: February 26, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–04375 Filed 2–29–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Secretary’s Advisory 

Committee on Human Research 

Protections 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: Pursuant to section 10(a) of 

the Federal Advisory Committee Act, 

U.S.C. Appendix 2, notice is hereby 

given that the Secretary’s Advisory 

Committee on Human Research 

Protections (SACHRP) will hold a 

meeting that will be open to the public. 

Information about SACHRP, the full 

meeting agenda, and instructions for 

linking to public access will be posted 

on the SACHRP website at https://

www.hhs.gov/ohrp/sachrp-committee/ 

meetings/index.html. 

DATES: The meeting will be held on 

Wednesday, March 20, 2024 from 11:00 

a.m. until 4:30 p.m., and Thursday,

March 21, 2024, from 11:00 a.m. until

4:00 p.m. (times are tentative and

subject to change). The confirmed times

and agenda will be posted on the

SACHRP website as this information

becomes available.

ADDRESSES: This meeting will be held

via webcast. Members of the public may

also attend the meeting via webcast.

Instructions for attending via webcast

will be posted at least one week prior 

to the meeting at https://www.hhs.gov/ 

ohrp/sachrp-committee/meetings/ 

index.html. 

FOR FURTHER INFORMATION CONTACT: Julia 

Gorey, J.D., Executive Director, 

SACHRP; U.S. Department of Health 

and Human Services, 1101 Wootton 

Parkway, Suite 200, Rockville, 

Maryland 20852; telephone: 240–453– 

8141; fax: 240–453–6909; email address: 

SACHRP@hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authority of 42 U.S.C. 217a, section 222 

of the Public Health Service Act, as 

amended, SACHRP was established to 

provide expert advice and 

recommendations to the Secretary of 

Health and Human Services, through 

the Assistant Secretary for Health, on 

issues and topics pertaining to or 

associated with the protection of human 

research subjects. 

The Subpart A Subcommittee (SAS) 

was established by SACHRP in October 

2006 and is charged with developing 

recommendations for consideration by 

SACHRP regarding the application of 

subpart A of 45 CFR part 46 in the 

current research environment. 

The Subcommittee on Harmonization 

(SOH) was established by SACHRP at its 

July 2009 meeting and charged with 

identifying and prioritizing areas in 

which regulations and/or guidelines for 

human subjects research adopted by 

various agencies or offices within HHS 

would benefit from harmonization, 

consistency, clarity, simplification and/ 

or coordination. The SACHRP meeting 

will open to the public at 11:00 a.m., on 

Wednesday, March 20, 2023, followed 

by opening remarks from Julie 

Kaneshiro, Acting Director of OHRP and 

Dr. Douglas Diekema, SACHRP Chair. 

The meeting will begin with a 

discussion of the draft recommendation, 

Ethical and Regulatory Considerations 

for the Inclusion of LGBTQI+ 

Populations in HHS Human Subjects 

Research. This topic is a continuation of 

the discussion and speaker panel 

presented at the October 2023 SACHRP. 

This will be followed by discussion of 

Considerations for Uninformative 

Research. The first day will adjourn at 

approximately 4:30 p.m. The second 

day of the meeting, March 21st, will 

begin at 11:00 with a discussion of 

Interpretation of the Best-interests 

Standard for the Retention of Subjects in 

Human Subjects Research that Has Been 

Halted or Suspended. Other topics may 

be added; for the full and updated 

meeting agenda, see http://

www.dhhs.gov/ohrp/sachrp-committee/ 

meetings/index.html. The meeting will 

adjourn by 4:00 p.m., March 21, 2024. 

Time will be allotted for public 

comment on both days of the meeting. 

The public may submit written public 

comment in advance to SACHRP@

hhs.gov no later than midnight March 

14th, 2023, ET. Written comments will 

be shared with SACHRP members and 

may read aloud during the meeting. 

Comments which are read aloud are 

limited to three minutes each. Public 

comment must be relevant to topics 

being addressed by the SACHRP. 

Dated: February 23, 2024. 

Julia G. Gorey, 

Executive Director, SACHRP, Office for 

Human Research Protections. 

[FR Doc. 2024–04343 Filed 2–29–24; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government Owned Inventions 

Available for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Inquiries related to this licensing 

opportunity should be directed to: 

Andrew Burke Ph.D., Technology 

Transfer Manager, NCI, Technology 

Transfer Center, email: burkear@

mail.nih.gov or phone: (240) 276–5484. 

SUPPLEMENTARY INFORMATION: 

NIH Reference Number: E–251–2023– 

0. 

Title: T Cell Receptors Targeting 

EGFR L858R mutation on HLA– 

A*11:01 + Tumors. 

Tumor-specific mutated proteins can 

create neoepitopes, mutation-derived 

antigens that distinguish tumor cells 

from healthy cells, which are attractive 

targets for adoptive cell therapies. 

However, the process of precisely 

identifying the neoepitopes to target is 

complex and challenging. One method 

to identify such neoepitopes is Mass 

Spectrometry (MS) when used in 

conjunction with elution of peptides 

bound to a specific Human Leukocyte 

Antigen (HLA) allele. Using MS in this 


ddrumheller on DSK120RN23PROD with NOTICES1
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 


ddrumheller on DSK120RN23PROD with NOTICES1