85894 Federal Register / Vol. 88, No. 236 / Monday, December 11, 2023 / Notices 

verified the applicant’s claim that NDA 

215383 was approved on August 13, 

2021. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 342 days of patent 

term extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: December 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27044 Filed 12–8–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability 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: 

Theodoric Mattes at 240–627–3827, or 

theodoric.mattes@nih.gov. Licensing 

information may be obtained by 

communicating with the Technology 

Transfer and Intellectual Property 

Office, National Institute of Allergy and 

Infectious Diseases, 5601 Fishers Lane, 

Rockville, MD 20852; tel. 301–496– 

2644. A signed Confidential Disclosure 

Agreement will be required to receive 

copies of unpublished information 

related to the invention. 

SUPPLEMENTARY INFORMATION: 

Technology description follows: 

Vaccine for Cats To Block Toxoplasma 

Gondii Oocyst Shedding and 

Transmission 

Description of Technology: 

Toxoplasma gondii is the zoonotic 

causative agent of toxoplasmosis, a 

disease of significant concern for 

pregnant persons and livestock. A 

member of the phylum Apicomplexa, 

Toxoplasma gondii can infect almost 

any cell type found in mammals and 

birds. There are multiple transmission 

pathways, including consumption of 

undercooked meat from infected 

animals, consumption of unwashed 

plants, contaminated water supplies, 

blood transfers, and congenital transfer. 

Felines are considered the definitive 

host of Toxoplasma gondii. Direct or 

indirect transmission can occur via 

contact with the stool of infected 

felines. 

Researchers at the National Institute 

of Allergy and Infectious Diseases 

(NIAID), the U.S. Department of 

Agriculture (USDA), and the University 

of South Bohemia (Cˇ eske ́ Budeˇjovice, 

Czechia) have demonstrated that T. 

gondii strains lacking expression of 

either the intracellular transport protein 

IFT88 or the CYS–6-type surface antigen 

SRS15B prevent the formation of 

oocysts and have potential for broad 

immunity to T. gondii. The inventors 

propose that mass inoculation of felines, 

specifically wild or feral felines, with a 

live vaccine developed from these 

strains could result in a significant 

reduction in oocyst production and 

environment contamination, reducing 

further infection in a geographical area. 

It is also proposed that loss of IFT88 or 

SRS15B homologs in other 

Apicomplexa parasites, like Neospora, 

Sarcocystis, or Cryptosporidium could 

have a similar impact. 

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: 

• Live vaccine for felines against 

Toxoplasma gondii infection 

• Reduction in environmental 

Toxoplasma gondii oocysts 

Competitive Advantages: 

• 100% blocked Toxoplasma gondii 

oocyst shedding in felines 

• Detectable seroconversion protective 

against future Toxoplasma gondii 

infection 

• Scalable production strain with 

predictable inactivation of IFT88 or 

SRS15B gene 

• Materials available for development 

or licensing 

Development Stage: 

• Pre-Clinical 

Inventors: Michael Grigg (NIAID), 

Aline Sardinha da Silva (NIAID), 

Viviana Pszenny (NIAID), Jitender 

Dubey (USDA), and Julius Lukesˇ

(University of South Bohemia, Czechia). 

Intellectual Property: HHS Reference 

No. E–118–2023–2. U.S. Provisional 

Patent Application No. 63/470,773 filed 

June 4, 2023. 

Licensing Contact: To license this 

technology, please contact Theodoric 

Mattes at 240–627–3827, or 

theodoric.mattes@nih.gov., and 

reference E–118–2023–2. 

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 Theodoric Mattes at 240–627– 

3827, or theodoric.mattes@nih.gov. 

Dated: December 5, 2023. 

Surekha Vathyam, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2023–27113 Filed 12–8–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 


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