Prospective Grant of Co-Exclusive License: Developing, Manufacturing and Selling Instruments, Reagents and Related Products and Providing Services Involving Sequencing Nucleic Acids, Including Without Limitations Diagnostic Devices and Services, 30390-30391 [E7-10478]

Download as PDF 30390 Federal Register / Vol. 72, No. 104 / Thursday, May 31, 2007 / Notices Dated: May 22, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–10492 Filed 5–30–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; Comment Request; The Jackson Heart Study (JHS) Summary: Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on October 25, 2006, pages 62476–62477, and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: The Jackson Heart Study (JHS). Type of Information Collection Request: Extension of a currently approved collection (OMB NO. 0925–0491). Need and Use of Information Collection: This project involves annual follow-up by telephone of participants in the JHS, review of their medical records, and interviews with doctors and family to identify disease occurrence. Interviewers will contact doctors and hospitals to ascertain participants’ cardiovascular events. Information gathered will be used to further describe the risk factors, occurrence rates, and consequences of cardiovascular disease in African American men and women. Frequency of Response: One time. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; Businesses or other for profit; not-for-profit institutions. The annual reporting burden is as follows: Estimated Number of Respondents: 600; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: 0.5 and Estimated Total Annual Burden Hours Requested: 300. The annualized cost to respondents is estimated at $9,500. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. ESTIMATE OF ANNUAL HOUR BURDEN Number of respondents Type of response Frequency of response Average time per response Annual hour burden 300 300 1 1 0.5 0.5 150 150 Total .......................................................................................................... sroberts on PROD1PC70 with NOTICES Morbidity & Mortality AFU 3rd Party/Next-of-kin decedents ............................ Morbidity & Mortality AFU 3rd Party Physicians ............................................. 600 ........................ ........................ 300 Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, VerDate Aug<31>2005 16:01 May 30, 2007 Jkt 211001 Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Ms. Cheryl Nelson, Project Officer, NIH, NHLBI, 6701 Rockledge Drive, MSC 7934, Bethesda, MD 20892–7934, or call non-toll-free number 301–435–0451 or E-mail your request, including your address to: NelsonC@nhlbi.nih.gov. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication. Dated: May 22, 2007. Peter Savage, Acting Director. Dated: May 22, 2007. Suzanne A. Freeman, Project Clearance Officer. [FR Doc. 07–2698 Filed 5–30–07; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Co-Exclusive License: Developing, Manufacturing and Selling Instruments, Reagents and Related Products and Providing Services Involving Sequencing Nucleic Acids, Including Without Limitations Diagnostic Devices and Services National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of a coexclusive license to practice the invention embodied in Patent Applications U.S. 60/151,580, filed August 29, 1999; PCT/US00/23736, filed August 29, 2000, U.S. 6,982,146 issued January 3, 2006, and USSN 11/204,367, filed August 12, 2005; entitled ‘‘High Speed Parallel Molecular Nucleic Acid Sequencing’’, to Invitrogen Corporation having a place of business in Carlsbad, E:\FR\FM\31MYN1.SGM 31MYN1 Federal Register / Vol. 72, No. 104 / Thursday, May 31, 2007 / Notices California. The patent rights in this invention have been assigned to the United States of America. DATES: Only written comments and/or application for a license that are received by the NIH Office of Technology Transfer on or before July 30, 2007 will be considered. ADDRESSES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Cristina Thalhammer-Reyero, PhD, M.B.A., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; E-mail: ThalhamC@mail.nih.gov; Telephone: 301–435–4507; Facsimile: 301–402– 0220. The invention relates to a method and apparatus for high-speed, parallel molecular nucleic acid sequencing, also known as Two Dye Sequencing (TDS). This invention is based on Fluorescence Resonance Energy Transfer (FRET), a technology increasingly in use for several molecular analysis purposes. In particular, the method consists of: (1) Attachment of engineered DNA polymerases labeled with a donor fluorophore to the surface (chamber) of a microscope field of view, (2) addition to the chamber of DNA with an annealed oligonucleotide primer and template, which is bound by the polymerase, (3) further addition of four nucleotide triphosphates, each labeled on the base with a different fluorescent acceptor dye, (4) excitation of the donor fluorophore with light of a wavelength specific for the donor but not for any of the acceptors, resulting in the FRET transfer of the energy associated with the excited state of the donor to the acceptor fluorophore for a given nucleotide, which is then radiated, (5) identification of the nucleotides most recently added to the primer by recording the fluorescent spectrum of the individual dye molecules at specific locations in the microscope field, and (6) converting the sequential spectrum into a DNA sequence for each DNA molecule in the microscope field of view. The prospective co-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 co-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 sroberts on PROD1PC70 with NOTICES SUPPLEMENTARY INFORMATION: VerDate Aug<31>2005 16:01 May 30, 2007 Jkt 211001 requirements of 35 U.S.C. 209 and 37 CFR 404.7. The field of use may be limited to ‘‘Developing, manufacturing and selling instruments, reagents and related products and providing services involving sequencing nucleic acids, including without limitations diagnostic devices and services’’. 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: May 24, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7–10478 Filed 5–30–07; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institute of Environmental Health Sciences Office of the Director, Office of Translational Research; Availability of Report From Global Environmental Health Workshop: Request for Public Comments National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), HHS. ACTION: Request for comments. AGENCY: SUMMARY: The NIEHS vision is to prevent disease and improve human health by using environmental sciences to understand human biology and human disease. NIEHS has prioritized Global Environmental Health (GEH) as a major initiative of its new strategic plan to implement its vision. To obtain advice and guidance on potential research strategies for global environmental health, the NIEHS held the Global Environmental Health Workshop on January 10, 2007, and now invites public comments on the workshop report. DATES: The deadline for comments is July 1, 2007. ADDRESSES: Comments should preferably be submitted electronically at https://www.niehs.nih.gov/external/ geh.htm. Comments can also be submitted by e-mail to gehcomments@niehs.nih.gov or by mail PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 30391 to Dr. William J. Martin, NIEHS, P.O. Box 12233, MD B2–07, Research Triangle Park, NC 27709. Courier address: NIEHS, 111 TW Alexander Drive, Room B220, Research Triangle Park, NC 27709. SUPPLEMENTARY INFORMATION: Background The NIEHS vision is to prevent disease and improve human health by using environmental sciences to understand human biology and human disease. To achieve that vision and have the greatest impact on preventing disease and improving human health, the NIEHS focuses on basic science, disease-oriented research, global environmental health, and multidisciplinary training for researchers. The NIEHS has prioritized Global Environmental Health (GEH) as a major initiative of its new strategic plan. The NIEHS convened a distinguished panel of scientists on January 10, 2007, in San Francisco, California to participate in the NIEHS Global Environmental Health Workshop. The overall goal of this workshop was to provide advice and guidance to NIEHS senior staff on potential research strategies as the institute enters into this new arena of environmental health science. The workshop’s objectives were to: (1) Inform NIEHS of opportunities in global environmental health (GEH), (2) evaluate the opportunities in GEH within the context of NIEHS’s strategic priorities, (3) determine the current barriers for NIEHS/NIH to effectively conduct GEH research, and (4) determine the process for establishing effective strategic partnerships in GEH. The participants prepared a report that summarizes their discussion at the workshop and includes their recommendations on potential research strategies for GEH. The NIEHS invites public comments on the workshop report and will consider this input as senior staff reviews the recommendations in the workshop report and develops research plans for GEH. Request for Comments Comments on the report should be submitted preferably via the conference website or by e-mail or mail [see ‘‘ADDRESSES’’ above]. Persons submitting written comments are asked to include their name and contact information (affiliation, mailing address, telephone, e-mail, and sponsoring organization, if any). Comments should be received by July 1, 2007. E:\FR\FM\31MYN1.SGM 31MYN1

Agencies

[Federal Register Volume 72, Number 104 (Thursday, May 31, 2007)]
[Notices]
[Pages 30390-30391]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10478]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Co-Exclusive License: Developing, 
Manufacturing and Selling Instruments, Reagents and Related Products 
and Providing Services Involving Sequencing Nucleic Acids, Including 
Without Limitations Diagnostic Devices and Services

AGENCY: National Institutes of Health, Public Health Service, HHS.

ACTION: Notice.

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

SUMMARY: This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 
CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), 
Department of Health and Human Services, is contemplating the grant of 
a co-exclusive license to practice the invention embodied in Patent 
Applications U.S. 60/151,580, filed August 29, 1999; PCT/US00/23736, 
filed August 29, 2000, U.S. 6,982,146 issued January 3, 2006, and USSN 
11/204,367, filed August 12, 2005; entitled ``High Speed Parallel 
Molecular Nucleic Acid Sequencing'', to Invitrogen Corporation having a 
place of business in Carlsbad,

[[Page 30391]]

California. The patent rights in this invention have been assigned to 
the United States of America.

DATES: Only written comments and/or application for a license that are 
received by the NIH Office of Technology Transfer on or before July 30, 
2007 will be considered.

ADDRESSES: Requests for a copy of the patent application, inquiries, 
comments and other materials relating to the contemplated license 
should be directed to: Cristina Thalhammer-Reyero, PhD, M.B.A., Office 
of Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, MD 20852-3804; E-mail: 
ThalhamC@mail.nih.gov; Telephone: 301-435-4507; Facsimile: 301-402-
0220.

SUPPLEMENTARY INFORMATION: The invention relates to a method and 
apparatus for high-speed, parallel molecular nucleic acid sequencing, 
also known as Two Dye Sequencing (TDS). This invention is based on 
Fluorescence Resonance Energy Transfer (FRET), a technology 
increasingly in use for several molecular analysis purposes. In 
particular, the method consists of: (1) Attachment of engineered DNA 
polymerases labeled with a donor fluorophore to the surface (chamber) 
of a microscope field of view, (2) addition to the chamber of DNA with 
an annealed oligonucleotide primer and template, which is bound by the 
polymerase, (3) further addition of four nucleotide triphosphates, each 
labeled on the base with a different fluorescent acceptor dye, (4) 
excitation of the donor fluorophore with light of a wavelength specific 
for the donor but not for any of the acceptors, resulting in the FRET 
transfer of the energy associated with the excited state of the donor 
to the acceptor fluorophore for a given nucleotide, which is then 
radiated, (5) identification of the nucleotides most recently added to 
the primer by recording the fluorescent spectrum of the individual dye 
molecules at specific locations in the microscope field, and (6) 
converting the sequential spectrum into a DNA sequence for each DNA 
molecule in the microscope field of view.
    The prospective co-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 co-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.
    The field of use may be limited to ``Developing, manufacturing and 
selling instruments, reagents and related products and providing 
services involving sequencing nucleic acids, including without 
limitations diagnostic devices and services''.
    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: May 24, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-10478 Filed 5-30-07; 8:45 am]
BILLING CODE 4140-01-P

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