Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices 35101 

Scientists at NIAID have developed 

novel topical formulations that promote 

the growth of health-associated strains 

of commensal bacteria and inhibit 

disease-associated bacteria, thereby 

enhancing skin health. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration. 

Potential Commercial Applications: 

• Over-the-counter formulations—this 

invention could be readily 

incorporated into popular body 

lotions or other skincare products to 

make ‘‘enhanced’’/‘‘microbiomefriendly’’ versions that promote the 

growth of health associated bacterial 

Competitive Advantages: 

• Benign safety profile with multiple 

mechanisms of action 

• Proven enhancement of beneficial 

microbiota 

• Can be readily incorporated into 

existing products 

Development Stage: 

• Pre-clinical 

Inventors: Carlos Castillo and Ian 

Myles, MD, MPH, both of NIAID. 

Publications: Castillo, Carlos, et al. 

‘‘Assessing the effects of common 

topical exposures on skin bacteria 

associated with atopic dermatitis’’, Skin 

Health and Disease, 2021.05.07. 

Intellectual Property: HHS Reference 

No. E–100–2021–0; US provisional 

application No. 63/175,368 filed on 

April 15, 2021. 

Licensing Contact: To license this 

technology, please contact David Yang 

at 240–695–6406 or yangp3@

mail.nih.gov and reference E–100– 

2021–0. 

Collaborative Research Opportunity: 

The National Institute of Allergy and 

Infectious Diseases is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate or 

commercialize this technology. For 

collaboration opportunities, please 

contact David Yang at 240–695–6406 or 

yangp3@mail.nih.gov. 

Dated: June 24, 2021. 

Surekha Vathyam, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2021–14129 Filed 6–30–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License, Inter-Institutional AgreementInstitution Lead: Biomarkers and 

Immunogenic Compositions for Filarial 

Parasites 

AGENCY: National Institutes of Health, 

National Institute of Allergy and 

Infectious Diseases, HHS. 

ACTION: Notice. 

SUMMARY: The National Institute of 

Allergy and Infectious Diseases, an 

institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an exclusive, sublicensable 

patent license to New York Blood 

Center, Inc. (‘‘NYBC’’), located in New 

York, New York, in its rights to the 

technologies and patent applications 

listed in the SUPPLEMENTARY

INFORMATION section of this notice. 

DATES: Only written comments and/or 

applications for a license which are 

received by the Technology Transfer 

and Intellectual Property Office, 

National Institute of Allergy and 

Infectious Diseases, on or before July 16, 

2021 will be considered. 

ADDRESSES: Requests for copies of the 

patent applications, inquiries, and 

comments relating to the contemplated 

Exclusive License should be directed to: 

Theodoric Mattes, Ph.D., Technology 

Transfer and Patent Specialist, 

Technology Transfer and Intellectual 

Property Office, National Institute of 

Allergy and Infectious Diseases, 5601 

Fishers Lane, Suite 6D, MSC9804, 

Rockville, MD 20852–9804, phone 

number 240–627–3827, or 

theodoric.mattes@nih.gov. 

SUPPLEMENTARY INFORMATION: The 

following and all continuing U.S. 

patents/patent applications thereof are 

the intellectual properties to be licensed 

under the prospective agreement to 

NYBC: United States Provisional Patent 

Application Number 62/317,342, filed 

May 1, 2016, the title of which is 

‘‘Biomarkers and Immunogenic 

Compositions for Filarial Parasites’’ 

(HHS Reference No. E–288–2016–0–US– 

01); PCT Patent Application Number 

PCT/US2017/025554, filed March 31, 

2017, the title of which is ‘‘Biomarkers 

and Immunogenic Compositions for 

Filarial Parasites’’ (HHS Reference No. 

E–288–2016–00–PCT–02); United States 

Patent Application Number 16/090,013, 

filed September 28, 2018, the title of 

which is ‘‘Biomarkers and Immunogenic 

Compositions for Filarial Parasites’’ 

(HHS Reference No. E–288–2016–0–US– 

03); and United States Patent 

Application Number 17/076,616, filed 

October 21, 2020, the title of which is 

‘‘Biomarkers and Immunogenic 

Compositions for Filarial Parasites’’ 

(HHS Reference No. E–288–2016–0–US– 

04). 

The patent rights to this technology 

have been assigned to New York Blood 

Center, Inc. and the Government of the 

United States of America as represented 

by the Secretary, Department of Health 

& Human Services, by each institution’s 

respective inventors. 

The prospective patent license will be 

for the purpose of consolidating the 

patent rights to New York Blood Center, 

Inc., for the development and 

commercialization of the technology. 

Consolidation of these co-owned 

rights is intended to expedite 

development of the technology, 

consistent with the goals of the BayhDole Act codified as 35 U.S.C. 200–212. 

The prospective interinstitutional 

agreement may include an exclusive 

license for NIAID’s rights in these 

jointly owned patents. It will be 

sublicensable, and any sublicenses 

granted by NYBC will be subject to the 

provisions of 37 CFR part 404. NIAID 

will retain its rights to non-exclusively 

license its rights to the patent 

applications to third parties for internal 

research use. 

In the subject technology, researchers 

at NIAID and NYBC isolated and 

analyzed the transcriptome and 

proteome of the parasite at various life 

stages as well as its Wolbachia sp. 

endosymbiont to identify potential 

biomarkers for diagnostic assays and 

vaccine candidates. In all, they 

identified forty-seven (47) biomarkers. 

The associated patents claim the use of 

two or more of these biomarkers in 

conjunction with an adjuvant as an 

immunological composition, or the 

detection of any of these biomarkers in 

a serological-type assay. 

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 may be granted 

unless within fifteen (15) days from the 

date of this published notice the 

National Institute of Allergy and 

Infectious Diseases 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 


khammond on DSKJM1Z7X2PROD with NOTICES
35102 Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices 

confidentially, and may be made 

publicly available. 

Complete license applications 

submitted in response to this Notice 

will be presumed to contain business 

confidential information and any release 

of information in 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: June 25, 2021. 

Surekha Vathyam, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2021–14128 Filed 6–30–21; 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 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; 240–276– 

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 

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 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 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– 

784–1190 (Formerly: GammaDynacare Medical Laboratories) 

HHS-Certified Laboratories 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 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.) 

Alere Toxicology Services, 450 

Southlake Blvd., Richmond, VA 

23236, 804–378–9130 (Formerly: 

Kroll Laboratory Specialists, Inc., 

Scientific Testing Laboratories, Inc.; 

Kroll Scientific Testing Laboratories, 

Inc.) 

Clinical Reference Laboratory, Inc., 8433 

Quivira Road, Lenexa, KS 66215– 

2802, 800–445–6917 

Cordant Health Solutions, 2617 East L 

Street, Tacoma, WA 98421, 800–442– 

0438 (Formerly: STERLING Reference 

Laboratories) 

Desert Tox, LLC, 5425 E Bell Rd., Suite 

125, Scottsdale, AZ 85254, 602–457– 

5411/623–748–5045 

DrugScan, Inc., 200 Precision Road, 

Suite 200, Horsham, PA 19044, 800– 

235–4890 

Dynacare *, 245 Pall Mall Street, 

London, ONT, Canada N6A 1P4, 519– 

679–1630 (Formerly: GammaDynacare Medical Laboratories) 


khammond on DSKJM1Z7X2PROD with NOTICES