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, Public Health Service, DHHS.

# ACTION:

Notice.

# SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license worldwide to practice the invention embodied in: US Patent Application Serial Number 08/548,159 filed 10/95 by McClaren, Notkins, Lan, and Li, and foreign counterparts, and US Patent Application Serial Number 08/514,213 filed 8/95, and foreign counterparts, by McClaren, Notkins, and Lan—both entitled “Methods and Compositions for the Detection and Treatment of Insulin Dependent Diabetes” to BioSeek Inc., of New York, NY. The United States of America is an assignee of the patent rights to these inventions.

# DATES:

Only written comments and/or application for a license which are received by the NIH Office of Technology Transfer on or before February 5, 2001 will be considered.

# ADDRESSES:

Requests for a copy of the patent applications, inquiries, comments and other materials relating to the contemplated license should be directed to: John Rambosek, Ph.D. Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Su9ite 325, Rockville, MD 20852-3804; Email:jr312d@nih.gov; Telephone: (301) 496-7056, ext. 270; Facsimile: (301) 402-0220.

# SUPPLEMENTARY INFORMATION:

Insulin-dependent diabetes mellitus (IDDM) affects close to one million people in the United States. It is autoimmune disease in which the immune system produces antibodies that attack the body's own insulin-manufacturing cells in the pancreas. Patients require daily injections of insulin to regulate blood sugar levels. The invention identifies two proteins, named IA-2 and IA-2β, that are important markers for type I (juvenile, insulin-dependent) diabetes. IA-2/IA-2β, when used in diagnostic tests, recognized autoantibodies in 70 percent of IDDM patients. Combining IA-2 and IA-2β with other known markers increased the level of identification to 90 percent of individuals with IDDM. Moreover, the presence of autoantiboides to IA-2 and IA-2β in otherwise normal individuals was highly predictive in identifying those at risk of ultimately developing clinical disease. It is now possible to develop a rapid and effective test that can screen large populations for IDDM. In addition, IA-2 and IA-2β are candidates for immune tolerance and prevention of disease development. The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective license may be limited to use of the invention for diagnostic and therapeutic uses in the detection and treatment of diabetes. The prospective exclusive license may be granted unless, within 60 days from the date of this published Notice, NIH 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 404.7

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Dated: November 30, 2000.

Jack Spiegel,

Director, Division of Technology Development and Transfer, Office of Technology Transfer.

[FR Doc. 00-31215 Filed 12-6-00; 8:45 am]

BILLING CODE 4140-01-M