Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### National Institutes of Health

# AGENCY:

National Institutes of Health.

# 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, sublicensable, patent license to Georgetown University “Georgetown”, a private university located in Washington DC, to its rights to the invention embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice.

      ( print page 21893)    

# 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 April 28, 2022 will be considered.

# ADDRESSES:

                        Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Whitney Hastings, Ph.D., Senior Technology Transfer Manager at                         *whitney.hastings2@nih.gov.*

# SUPPLEMENTARY INFORMATION:

## Intellectual Property

United States Provisional Patent Application No. 63/030,815, filed May 27, 2020, entitled “TARGETING THE CHOLECYSTOKININ-B RECEPTOR FOR IMAGING AND EARLY DETECTION OF PANCREATIC CANCER AND PRE-CANCEROUS LESIONS,” [HHS Ref. No. E—184-2020-0].

The patent rights in these inventions have been assigned to the Government of the United States of America and Georgetown University. The prospective patent license will be for the purpose of consolidating the patent rights to Georgetown, the co-owner of said rights, for commercial development and marketing. Consolidation of these co-owned rights is intended to expedite development of the invention, consistent with the goals of the Bayh-Dole Act codified as 35 U.S.C. 200-212.

The prospective patent license will be worldwide, exclusive, and may be limited to those fields of use commensurate in scope with the patent rights. It will be sublicensable, and any sublicenses granted by Georgetown will be subject to the provisions of 37 CFR part 401 and 404.

                    This technology discloses a method of detecting the presence of a pancreatic intraepithelial neoplasia lesion                     *in vivo*                     via administering to the subject a construct, or a pharmaceutically acceptable salt thereof, wherein the construct is comprised of siRNA-polymer nanoparticle complex that selectively bind to cholecystokinin-B receptors. The nanoparticle can be conjugated with a fluorophore or radioactive molecule (                    *e.g.,*                     technetium). In conjunction with an imaging device, the polyplex nanoparticle could be used to detect the presence of precancerous pancreatic intraepithelial neoplasia (PanIN) lesions.                

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 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: April 7, 2022.

Richard U. Rodriguez,

Associate Director, Technology Transfer Center, National Cancer Institute.

[FR Doc. 2022-07866 Filed 4-12-22; 8:45 am]

BILLING CODE 4140-01-P