Office of the Director, National Institutes of Health; Notice of Meeting, 18415-18416 [05-7241]

Download as PDF Federal Register / Vol. 70, No. 68 / Monday, April 11, 2005 / Notices in Sharing Biomedical Research Resources (https://ott.od.nih.gov/ NewPages/RTguide_final.html) and Developing Sponsored Research Agreements (https://ott.od.nih.gov/ spons_research.html). Patent Protection Like other emerging technology areas, patents directed to genomic inventions tend to issue with claims that are broad in scope. Public health-oriented technology transfer must balance the rewards of broad intellectual property protection afforded to founders of enabling genomic inventions with the benefits of fostering opportunities for those striving to improve upon those innovations. Therefore, in considering whether to seek patent protection on genomic inventions, institutional officials should consider whether significant further research and development by the private sector is required to bring the invention to practical and commercial application. Intellectual property protection should be sought when it is clear that private sector investment will be necessary to develop and make the invention widely available. By contrast, when significant further research and development investment is not required, such as with many research material and research tool technologies, best practices dictate that patent protection rarely should be sought. Best Licensing Practices The optimal strategy to transfer and commercialize many genomic inventions is not always apparent at early stages of technology development. As an initial step in these instances, it may be prudent to protect the intellectual property rights to the invention. As definitive commercial pathways unfold, those embodiments of an invention requiring exclusive licensing as an incentive for commercial development of products or services can be distinguished from those that would best be disseminated non-exclusively in the marketplace. Whenever possible, non-exclusive licensing should be pursued as a best practice. A non-exclusive licensing approach favors and facilitates making broad enabling technologies and research uses of inventions widely available and accessible to the scientific community. When a genomic invention represents a component part or background to a commercial development, non-exclusive freedom-tooperate licensing may provide an appropriate and sufficient complement to existing exclusive intellectual property rights. VerDate jul<14>2003 17:45 Apr 08, 2005 Jkt 205001 In those cases where exclusive licensing is necessary to encourage research and development by private partners, best practices dictate that exclusive licenses should be appropriately tailored to ensure expeditious development of as many aspects of the technology as possible. Specific indications, fields of use, and territories should be limited to be commensurate with the abilities and commitment of licensees to bring the technology to market expeditiously. For example, patent claims to gene sequences could be licensed exclusively in a limited field of use drawn to development of antisense molecules in therapeutic protocols. Independent of such exclusive consideration, the same intellectual property rights could be licensed non-exclusively for diagnostic testing or as a research probe to study gene expression under varying physiological conditions. License agreements should be written with developmental milestones and benchmarks to ensure that the technology is fully developed by the licensee. The timely completion of milestones and benchmarks should be monitored and enforced. Best practices provide for modification or termination of licenses when progress toward commercialization is inadequate. Negotiated sublicensing terms and provisions optimally permit fair and appropriate participation of additional parties in the technology development process. Funding recipients and the intramural technology transfer community may find these recommendations helpful in achieving the universal goal of ensuring that public health consequences are considered when negotiating licenses for genomic technologies. PHS encourages licensing policies and strategies that maximize access, as well as commercial and research utilization of the technology to benefit the public health. For this reason, PHS believes that it is important for funding recipients and the intramural technology transfer community to reserve in their license agreements the right to use the licensed technologies for their own research and educational uses, and to allow other institutions to do the same, consistent with the Research Tools Guidelines. Conclusion PHS recognizes that these recommendations generally reflect practices that may already be followed by most funding recipients and the intramural technology transfer community with regard to licensing of genomic and other technologies. PHS PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 18415 also acknowledges the need for flexibility in the licensing negotiation process as the requirements of individual license negotiations may vary and may not always be adaptable to these best practices. Dated: April 5, 2005. Mark L. Rohrbaugh, Director, Office of Technology Transfer, National Institutes of Health. [FR Doc. 05–7247 Filed 4–8–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Office of the Director, National Institutes of Health; Notice of Meeting Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the Director’s Council of Public Representatives. The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. Name of Committee: Director’s Council of Public Representatives. Date: April 28, 2005. Time: 8:30 a.m. to 4:30 p.m. Agenda: Among the topics proposed for discussion are: (1) NIH Director’s update; (2) update on conflict of interest; (3) update on public access; (4) NIH response to COPR’s recommendations and formal reports to the NIH Director; and (5) discussion and public comment. Place: National Institutes of Health, Building 31, C–Wing, Conference Room 6, 9000 Rockville Pike, Bethesda, MD 20852. Contact Person: Jennifer E. Gorman Vetter, NIH Public Liaison/COPR Coordinator, Office of Communications and Public Liaison, Office of the Director, National Institutes of Health, 9000 Rockville Pike, Building 1, Room 344, Bethesda, MD 20892, (301) 435– 4448, gormanj@od.nih.gov. Any member of the public interested in presenting oral comments to the committee may notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person E:\FR\FM\11APN1.SGM 11APN1 18416 Federal Register / Vol. 70, No. 68 / Monday, April 11, 2005 / Notices may file written comments with the committee by forwarding their statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance into the building by non-government employees. Persons without a government I.D. will need to show a photo I.D. and signin at the security desk upon entering the building. Information is also available on the Institute’s/Center’s Home page: https:// www.copr.nih.gov, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. 17:45 Apr 08, 2005 Jkt 205001 Dated: April 4, 2005. LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–7242 Filed 4–8–05; 8:45 am] National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting BILLING CODE 4140–01–M VerDate jul<14>2003 (Catalogue of Federal Domestic Assistance Program Nos. 93.855, Allergy, Immunology, and Transplantation Research; 93.856, Microbiology and Infectious Diseases Research, National Institutes of Health, HHS) National Institutes of Health Dated: April 4, 2005. LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–7241 Filed 4–8–05; 8:45 am] Name of Committee: National Cancer Institute Special Emphasis Panel, Patient Navigator Research Program. Date: May 5–6, 2005. Time: 8 a.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: Holiday Inn Select Bethesda, 8120 Wisconsin Ave., Bethesda, MD 20814. Contact Person: Joyce C. Pegues, PhD, Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Blvd. 7149, Bethesda, MD 20892, 301/594–1286, peguesj@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, NIH Malaria Research & Reference Reagent Resource Center (MR4). Date: May 4, 2005. Time: 3 p.m. to 5 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, Rockledge 7600, 6700B Rockledge Drive, Bethesda, MD 20817. (Telephone conference call). Contact Person: Adriana Costero, PhD, Scientific Review Administrator, Scientific Review Program, DEA/NIAID/DHHS, 6700B Rockledge Drive, MSC–7616, Bethesda, MD 20892. 301–451–4573. acostero@niaid.nih.gov. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 Dated: April 4, 2005. LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–7234 Filed 4–8–05; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant application, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Challenge Grants: Biodefense Product Development. Date: April 27, 2005. Time: 8 a.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. Place: Double Tree Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Mary J. Homer, PhD, Scientific Review Administrator, Scientific Review program, Division of Extramural Activities, NIAID/NIH/DHHS, Room 3255, 6700–B Rockledge Drive, MSC 7616, Bethesda, MD 20892. (301) 496–7042. mjhomer@niaid.nih.gov. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Challenge Grants: Biodefense Product Development RFA–AI– 04–029. Date: April 29, 2005. Time: 8:30 a.m. to 6:30 p.m. Agenda: To review and evaluate grant applications. Place: Double Tree Rockville, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Tracy A. Shahan, PhD, Scientific Review Administrator, Scientific Review Program, Division of Extramural Activities, NIAID/NIH/DHHS, Room 3121, E:\FR\FM\11APN1.SGM 11APN1

Agencies

[Federal Register Volume 70, Number 68 (Monday, April 11, 2005)]
[Notices]
[Pages 18415-18416]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-7241]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Office of the Director, National Institutes of Health; Notice of 
Meeting

    Pursuant to section 10(a) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of 
the Director's Council of Public Representatives.
    The meeting will be open to the public, with attendance limited to 
space available. Individuals who plan to attend and need special 
assistance, such as sign language interpretation or other reasonable 
accommodations, should notify the Contact Person listed below in 
advance of the meeting.

    Name of Committee: Director's Council of Public Representatives.
    Date: April 28, 2005.
    Time: 8:30 a.m. to 4:30 p.m.
    Agenda: Among the topics proposed for discussion are: (1) NIH 
Director's update; (2) update on conflict of interest; (3) update on 
public access; (4) NIH response to COPR's recommendations and formal 
reports to the NIH Director; and (5) discussion and public comment.
    Place: National Institutes of Health, Building 31, C-Wing, 
Conference Room 6, 9000 Rockville Pike, Bethesda, MD 20852.
    Contact Person: Jennifer E. Gorman Vetter, NIH Public Liaison/
COPR Coordinator, Office of Communications and Public Liaison, 
Office of the Director, National Institutes of Health, 9000 
Rockville Pike, Building 1, Room 344, Bethesda, MD 20892, (301) 435-
4448, gormanj@od.nih.gov.
    Any member of the public interested in presenting oral comments 
to the committee may notify the Contact Person listed on this notice 
at least 10 days in advance of the meeting. Interested individuals 
and representatives of organizations may submit a letter of intent, 
a brief description of the organization represented, and a short 
description of the oral presentation. Only one representative of an 
organization may be allowed to present oral comments and if accepted 
by the committee, presentations may be limited to five minutes. Both 
printed and electronic copies are requested for the record. In 
addition, any interested person

[[Page 18416]]

may file written comments with the committee by forwarding their 
statement to the Contact Person listed on this notice. The statement 
should include the name, address, telephone number and when 
applicable, the business or professional affiliation of the 
interested person.
    In the interest of security, NIH has instituted stringent 
procedures for entrance into the building by non-government 
employees. Persons without a government I.D. will need to show a 
photo I.D. and sign-in at the security desk upon entering the 
building.
    Information is also available on the Institute's/Center's Home 
page: https://www.copr.nih.gov, where an agenda and any additional 
information for the meeting will be posted when available.

(Catalogue of Federal Domestic Assistance Program Nos. 93.14, 
Intramural Research Training Award; 93.22, Clinical Research Loan 
Repayment Program for Individuals from Disadvantaged Backgrounds; 
93.232, Loan Repayment Program for Research Generally; 93.39, 
Academic Research Enhancement Award; 93.936, NIH Acquired 
Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, 
Undergraduate Scholarship Program for Individuals from Disadvantaged 
Backgrounds, National Institutes of Health, HHS)

    Dated: April 4, 2005.
LaVerne Y. Stringfield,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 05-7241 Filed 4-8-05; 8:45 am]
BILLING CODE 4140-01-M

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