95224 Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Notices 

meeting notes of the November 14–15, 

2024 ACMH open meeting; and (2) 

recommendations on the 

implementation of the updated Office of 

Management and Budget (OMB) Federal 

race and ethnicity data collection 

standards (SPD 15) that is focused on 

opportunities for engagement with 

racial, ethnic, and Tribal community 

level organizations to support increased 

awareness of OMB SPD 15 and their 

intended goals within their 

communities. The final 

recommendations will be given to the 

Deputy Assistant Secretary for Minority 

Health to inform efforts related to 

engagement with racial, ethnic, and 

Tribal community level organizations to 

support increased awareness of OMB 

SPD 15 and their intended goals within 

their communities. 

Any individual who wishes to attend 

the meeting must register via the Zoom 

registration link, https://

www.zoomgov.com/webinar/register/ 

WN_iZGnp8BWRQORITiqVcThzA, by 5 

p.m. EST on December 12, 2024. Each 

registrant should provide their name, 

affiliation, phone number, email 

address, if they plan to provide either 

written or verbal comment, and whether 

they have requests for special 

accommodations, including sign 

language interpretation. After 

registering, registrants will receive an 

automated email response with the 

meeting connection link. The meeting 

connection link is unique to each 

registrant and should not be shared. 

Members of the public will have an 

opportunity to provide comments at the 

meeting. Individuals should indicate 

during registration whether they intend 

to provide written or verbal comment. 

Public comments will be limited to two 

minutes per speaker during the time 

allotted. Individuals of the public may 

also submit and distribute electronic or 

printed statements or material(s) related 

to this meeting’s topic. Written 

statements or material(s) should be 

double-spaced with one-inch margins 

and not exceed two pages in length. Any 

content beyond the two-page limit will 

not be presented to the Committee. 

Registered members of the public who 

plan to submit electronic and distribute 

electronic or printed public statements 

or material(s) related to the meeting’s 

topic should email the material to OMHACMH@hhs.gov at least two (2) business 

days prior to the meeting. 

Violet Woo, 

Designated Federal Officer, Advisory 

Committee on Minority Health. 

[FR Doc. 2024–28167 Filed 11–29–24; 8:45 am] 

BILLING CODE 4150–29–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: Vaccine Augmented 

Tumor Infiltrating Lymphocytes for the 

Treatment of Cancer 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Cancer Institute, 

an institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an Exclusive Patent License to 

practice the inventions embodied in the 

Patents and Patent Applications listed 

in the Supplementary Information 

section of this Notice to Iovance 

Biotherapeutics, Inc. (‘‘Iovance’’), 

headquartered in San Carlos, CA. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Cancer 

Institute’s Technology Transfer Center 

on or before December 17, 2024 will be 

considered. 

ADDRESSES: Requests for copies of the 

patent applications, inquiries, and 

comments relating to the contemplated 

Exclusive Patent License should be 

directed to: Andrew Burke, Ph.D., 

Senior Technology Transfer Manager, 

NCI Technology Transfer Center, 

Telephone: (240)–276–5484; Email: 

andy.burke@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

1. United States Provisional Patent 

Application No. 63/295,762 filed 

December 31, 2021, entitled ‘‘T Cell 

Therapy with Vaccination as a 

Combination Immunotherapy Against 

Cancer’’ [HHS Reference No. E–046– 

2022–0–US–01]; 

2. International Patent Application 

No. PCT/US2022/082579 filed 

December 29, 2022, entitled ‘‘T Cell 

Therapy with Vaccination as a 

Combination Immunotherapy Against 

Cancer’’ [HHS Reference No. E–046– 

2022–0–PCT–02]; 

3. Australian Patent Application No. 

2022425620 filed June 25, 2024, entitled 

‘‘T Cell Therapy with Vaccination as a 

Combination Immunotherapy Against 

Cancer’’ [HHS Reference No. E–046– 

2022–0–AU–01]; 

4. Canadian Patent Application No. 

3241588 filed June 18, 2024, entitled ‘‘T 

Cell Therapy with Vaccination as a 

Combination Immunotherapy Against 

Cancer’’ [HHS Reference No. E–046– 

2022–0–CA–01]; 

5. Chinese Patent Application No. 

202280092973.5 filed August 30, 2024, 

entitled ‘‘T Cell Therapy with 

Vaccination as a Combination 

Immunotherapy Against Cancer’’ [HHS 

Reference No. E–046–2022–0–CN–01]; 

6. European Patent Application No. 

22854399.7 filed June 25, 2024, entitled 

‘‘T Cell Therapy with Vaccination as a 

Combination Immunotherapy Against 

Cancer’’ [HHS Reference No. E–046– 

2022–0–EP–01]; 

7. Japanese Patent Application No. 

2024–539628 filed June 28, 2024, 

entitled ‘‘T Cell Therapy with 

Vaccination as a Combination 

Immunotherapy Against Cancer’’ [HHS 

Reference No. E–046–2022–0–JP–01]; 

and 

8. United States Patent Application 

No. 18/720,347 filed June 14, 2024, 

entitled ‘‘T Cell Therapy with 

Vaccination as a Combination 

Immunotherapy Against Cancer’’ [HHS 

Reference No. E–046–2022–0–US–02]. 

The patent rights in these inventions 

have been assigned and/or exclusively 

licensed to the Government of the 

United States of America. 

The prospective exclusive license 

territory may be ‘‘worldwide’’, and the 

field of use may be limited to the 

following: 

‘‘Development, manufacture and 

commercialization of combination 

immunotherapies for the treatment of 

cancer in humans, comprising at least 

the following elements: 

1. An autologous tumor infiltrating 

lymphocyte (TIL) T cell product; and 

2. A neoantigen cancer vaccine.’’ 

The E–046–2022 patent family is 

primarily directed to a combination 

immunotherapy comprising a 

population of antigen-specific immune 

cells (e.g., T cells) and a vaccine 

targeting the same antigen(s). In 

oncology, many adoptive cell therapies 

rely on antigen-specific T cells isolated 

from the patient in need of treatment. 

However, these cells often exist in a 

terminally differentiated and exhausted 

state and are unable to mount a robust 

immune response following reinfusion. 

Recent evidence suggests that 

administration of a vaccine in parallel 

with the T cell product can ameliorate 

this performance defect when the 

vaccine targets antigen(s) recognized by 

the T cells. This two-part approach may 

enhance treatment efficacy. 

It is noted that the exclusive field of 

use which may be granted to Iovance 

applies to only certain autologous T cell 

products and vaccination strategies and 

does not include, for example, any nonTIL-based applications. Accordingly, 

the scope of rights which may be 

conveyed under the proposed license 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 231 / Monday, December 2, 2024 / Notices 95225 

covers a portion of the possible 

applications of E–046–2022. 

This Notice is made in accordance 

with 35 U.S.C. 209 and 37 CFR part 404. 

The prospective exclusive license will 

be royalty bearing, and the prospective 

exclusive license may be granted unless 

within fifteen (15) days from the date of 

this published Notice, the National 

Cancer Institute receives written 

evidence and argument that establishes 

that the grant of the license would not 

be consistent with the requirements of 

35 U.S.C. 209 and 37 CFR part 404. 

In response to this Notice, the public 

may file comments or objections. 

Comments and objections, other than 

those in the form of a license 

application, will not be treated 

confidentially and may be made 

publicly available. 

License applications submitted in 

response to this Notice will be 

presumed to contain business 

confidential information and any release 

of information from these license 

applications will be made only as 

required and upon a request under the 

Freedom of Information Act, 5 U.S.C. 

552. 

Dated: November 25, 2024. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2024–28081 Filed 11–29–24; 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 

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 effective 

October 10, 2023 (88 FR 70814), 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 effective 

February 1, 2024 (88 FR 70768), 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: GammaDynacare Medical Laboratories). 

HHS-Certified Laboratories Approved 

to Conduct Urine Drug Testing 

In accordance with the Mandatory 

Guidelines using Urine effective 

February 1, 2024 (88 FR 70768), 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.) 


ddrumheller on DSK120RN23PROD with NOTICES1