Prospective Grant of Exclusive License: Devices for Treating Dysphagia and Dysphonia, 76020-76021 [2010-30639]

Download as PDF 76020 Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices organizations are requested to notify Dr. Martin H. Goldrosen, National Center for Complementary and Alternative Medicine, NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland 20892, 301–594–2014, Fax: 301–480–9970. Letters of intent to present comments, along with a brief description of the organization represented, should be received no later than 5 p.m. on January 26, 2011. Only one representative of an organization may present oral comments. Any person attending the meeting who does not request an opportunity to speak in advance of the meeting may be considered for oral presentation, if time permits, and at the discretion of the Chairperson. In addition, written comments may be submitted to Dr. Martin H. Goldrosen at the address listed above up to ten calendar days (February 14, 2011) following the meeting. Copies of the meeting agenda and the roster of members will be furnished upon request by contacting Dr. Martin H. Goldrosen, Executive Secretary, NACCAM, National Center for Complementary and Alternative Medicine, National Institutes of Health, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland 20892, 301–594– 2014, Fax 301–480–9970, or via e-mail at naccames@mail.nih.gov. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: nccam.nih.gov/about/naccam, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.701, ARRA Related Biomedical Research and Research Support Awards; 93.213, Research and Training in Complementary and Alternative Medicine, National Institutes of Health, HHS) Dated: November 30, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Exclusive License: Devices for Treating Dysphagia and Dysphonia National Institutes of Health, Public Health Service, HHS AGENCY: ACTION: Notice. 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 (HHS), is contemplating the grant of an exclusive worldwide license to practice the invention embodied in: HHS Ref. No. E– 251–2005/0,/1,/2: SUMMARY: [FR Doc. 2010–30641 Filed 12–6–10; 8:45 am] BILLING CODE 4140–01–P Patent/application number Territory Filing date 60/695,424 ...................................................................... 60/787,215 ...................................................................... PCT/US2006/025535 ...................................................... PCT/US2007/007993 ...................................................... PCT/US2009/57158 ........................................................ 2006265985 .................................................................... 2,614,072 ........................................................................ 06785933.0 ..................................................................... 2008–520302 .................................................................. 11/993,094 ...................................................................... 08112281.5 ..................................................................... 12/240,398 ...................................................................... 12/211,633 ...................................................................... US .................... US .................... Intl .................... Intl .................... Intl .................... AU .................... CA .................... EP .................... JP ..................... US .................... HK .................... US .................... US .................... July 1, 2005 ................................................................... March 30, 2006 .............................................................. June 30, 2006 ................................................................ March 20, 2007 .............................................................. September 16, 2009 ...................................................... December 18, 2007 ....................................................... June 30, 2006 ................................................................ June 30, 2006 ................................................................ June 30, 2006 ................................................................ December 19, 2007 ....................................................... November 5, 2008 ......................................................... September 29, 2008 ...................................................... September 16, 2008 ...................................................... to Passy-Muir, Inc., a company incorporated under the laws of the State of California having its headquarters in Irvine, California. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to devices for treating dysphagia and dysphonia. Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before January 6, 2011 will be considered. DATES: Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael A. Shmilovich, Esq., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852–3804; Telephone: (301) 435– 5019; Facsimile: (301) 402–0220; E-mail: emcdonald on DSK2BSOYB1PROD with NOTICES ADDRESSES: VerDate Mar<15>2010 18:39 Dec 06, 2010 Jkt 223001 shmilovm@mail.nih.gov. A signed confidentiality nondisclosure agreement will be required to receive copies of any patent applications that have not been published by the United States Patent and Trademark Office or the World Intellectual Property Organization. SUPPLEMENTARY INFORMATION: The patents and patent applications intended for licensure disclose or cover a system, device and method for rehabilitating dysphagia due to stroke, ex-tubation or coronary bypass surgery. Swallowing recovery alleviates the risk of aspiration by augmenting volitional control using a simultaneous motor act (e.g., such as pressing a button to indicate when they are ready to swallow). It is believed that such motor training also initiates sensory stimulation, immediately preceding the motor act and that such sensory stimulation enhances excitation of a central pattern generator in the brain stem that augments the volitional PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 Status Expired. Expired. Expired. Expired. Expired. Pending. Pending. Pending. Pending. Pending. Pending. Pending. Pending. control of swallowing. This principle is applicable to other neurological impairments; their associated enhancement of voluntary motor act control by the patient initiating immediately concurrent and related sensory stimulations. Neurological impairments that are contemplated include reflex actions involving interactions between afferent and efferent paths (at the spinal cord or in the brain stem) as well as higher order interactions. This invention includes methods for treating neurologically impaired humans using devices such as those that produce vibratory stimulation, pressure stimulation, auditory stimulation, temperature stimulation, visual stimulation, olfactory stimulation, taste stimulation, or a combination of these. Upon activation a vibrator moves and vibrates the larynx. Patients can initiate sensory stimulation immediately prior to the patient’s own initiation of a swallow. E:\FR\FM\07DEN1.SGM 07DEN1 Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices Specifically, the device allows the patient coordinate muscular movement with a button press to permit volitional swallowing. In one aspect of the invention, the device comprises a connector for attaching the device to the patient’s neck, substantially over the patient’s larynx. The device also comprises a contact section for contacting the patient’s neck above the larynx. Additionally, the device also comprises a stimulator for applying at least one stimulus to the patient’s larynx. Also, the device comprises an adjustment mechanism for shifting the position of the device over the patient’s larynx. The device can also include a movement sensor for monitoring pressure on the patient’s larynx and a swallowing detector. The swallowing detector includes a piezoelectric stretch receptor and a stimulator, coupled to the movement sensor, for applying pressure to a patient’s larynx prior to swallowing. 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 exclusive license may be granted unless, within thirty (30) 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: December 1, 2010. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2010–30639 Filed 12–6–10; 8:45 am] emcdonald on DSK2BSOYB1PROD with NOTICES DEPARTMENT OF HOMELAND SECURITY This notice amends the notice of a major disaster declaration for the State of Arizona (FEMA–1940–DR), dated October 4, 2010, and related determinations. DATES: Effective Date: November 22, 2010. FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886. SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration for the State of Arizona is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 4, 2010. SUMMARY: The Hopi Tribe for Public Assistance. The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households in Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance— Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant. W. Craig Fugate, Administrator, Federal Emergency Management Agency. [FR Doc. 2010–30607 Filed 12–6–10; 8:45 am] BILLING CODE 9111–23–P DEPARTMENT OF HOMELAND SECURITY Customs and Border Protection [Internal Agency Docket No. FEMA–1940– DR; Docket ID FEMA–2010–0002] Arizona; Amendment No. 1 to Notice of a Major Disaster Declaration Federal Emergency Management Agency, DHS. AGENCY: Jkt 223001 U.S. Customs and Border Protection (CBP), Department of Homeland Security. ACTION: 60-Day notice and request for comments; Extension of an existing information collection: 1651–0103. AGENCY: Federal Emergency Management Agency 18:39 Dec 06, 2010 Notice. Agency Information Collection Activities: Passenger List/Crew List (CBP Form I–418) BILLING CODE 4140–01–P VerDate Mar<15>2010 ACTION: As part of its continuing effort to reduce paperwork and respondent burden, CBP invites the general public and other Federal agencies to comment on an information collection SUMMARY: PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 76021 requirement concerning the Passenger List/Crew List (CBP Form I–418). This request for comment is being made pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104–13; 44 U.S.C. 3505(c)(2)). DATES: Written comments should be received on or before February 7, 2011, to be assured of consideration. ADDRESSES: Direct all written comments to U.S. Customs and Border Protection, Attn: Tracey Denning, Regulations and Rulings, Office of International Trade, 799 9th Street, NW, 5th Floor, Washington, DC 20229–1177. FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to Tracey Denning, U.S. Customs and Border Protection, Regulations and Rulings, Office of International Trade, 799 9th Street, NW., 5th Floor, Washington, DC 20229– 1177, at 202–325–0265. SUPPLEMENTARY INFORMATION: CBP invites the general public and other Federal agencies to comment on proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104–13; 44 U.S.C. 3505(c)(2)). The comments should address: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimates of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden including the use of automated collection techniques or the use of other forms of information technology; and (e) estimates of capital or start-up costs and costs of operations, maintenance, and purchase of services to provide information. The comments that are submitted will be summarized and included in the request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record. In this document the CBP is soliciting comments concerning the following information collection: Title: Passenger List/Crew List. OMB Number: 1651–0103. Form Number: CBP Form I–418. Abstract: CBP Form I–418 is prescribed by the Department of Homeland Security, Customs and Border Protection (CBP), for use by masters, owners, or agents of vessels in complying with Sections 231 and 251 of the Immigration and Nationality Act (INA). This form is filled out upon arrival of any person by water at any E:\FR\FM\07DEN1.SGM 07DEN1

Agencies

[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76020-76021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30639]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Prospective Grant of Exclusive License: Devices for Treating 
Dysphagia and Dysphonia

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 (HHS), is contemplating the 
grant of an exclusive worldwide license to practice the invention 
embodied in: HHS Ref. No. E-251-2005/0,/1,/2:

----------------------------------------------------------------------------------------------------------------
      Patent/application number                Territory                Filing date                Status
----------------------------------------------------------------------------------------------------------------
60/695,424...........................  US......................  July 1, 2005............  Expired.
60/787,215...........................  US......................  March 30, 2006..........  Expired.
PCT/US2006/025535....................  Intl....................  June 30, 2006...........  Expired.
PCT/US2007/007993....................  Intl....................  March 20, 2007..........  Expired.
PCT/US2009/57158.....................  Intl....................  September 16, 2009......  Expired.
2006265985...........................  AU......................  December 18, 2007.......  Pending.
2,614,072............................  CA......................  June 30, 2006...........  Pending.
06785933.0...........................  EP......................  June 30, 2006...........  Pending.
2008-520302..........................  JP......................  June 30, 2006...........  Pending.
11/993,094...........................  US......................  December 19, 2007.......  Pending.
08112281.5...........................  HK......................  November 5, 2008........  Pending.
12/240,398...........................  US......................  September 29, 2008......  Pending.
12/211,633...........................  US......................  September 16, 2008......  Pending.
----------------------------------------------------------------------------------------------------------------

to Passy-Muir, Inc., a company incorporated under the laws of the State 
of California having its headquarters in Irvine, California. The United 
States of America is the assignee of the rights of the above 
inventions. The contemplated exclusive license may be granted in a 
field of use limited to devices for treating dysphagia and dysphonia.

DATES: Only written comments and/or applications for a license received 
by the NIH Office of Technology Transfer on or before January 6, 2011 
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: Michael A. Shmilovich, Esq., Office of 
Technology Transfer, National Institutes of Health, 6011 Executive 
Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 435-
5019; Facsimile: (301) 402-0220; E-mail: shmilovm@mail.nih.gov. A 
signed confidentiality nondisclosure agreement will be required to 
receive copies of any patent applications that have not been published 
by the United States Patent and Trademark Office or the World 
Intellectual Property Organization.

SUPPLEMENTARY INFORMATION: The patents and patent applications intended 
for licensure disclose or cover a system, device and method for 
rehabilitating dysphagia due to stroke, ex-tubation or coronary bypass 
surgery. Swallowing recovery alleviates the risk of aspiration by 
augmenting volitional control using a simultaneous motor act (e.g., 
such as pressing a button to indicate when they are ready to swallow). 
It is believed that such motor training also initiates sensory 
stimulation, immediately preceding the motor act and that such sensory 
stimulation enhances excitation of a central pattern generator in the 
brain stem that augments the volitional control of swallowing. This 
principle is applicable to other neurological impairments; their 
associated enhancement of voluntary motor act control by the patient 
initiating immediately concurrent and related sensory stimulations. 
Neurological impairments that are contemplated include reflex actions 
involving interactions between afferent and efferent paths (at the 
spinal cord or in the brain stem) as well as higher order interactions. 
This invention includes methods for treating neurologically impaired 
humans using devices such as those that produce vibratory stimulation, 
pressure stimulation, auditory stimulation, temperature stimulation, 
visual stimulation, olfactory stimulation, taste stimulation, or a 
combination of these. Upon activation a vibrator moves and vibrates the 
larynx. Patients can initiate sensory stimulation immediately prior to 
the patient's own initiation of a swallow.

[[Page 76021]]

Specifically, the device allows the patient coordinate muscular 
movement with a button press to permit volitional swallowing.
    In one aspect of the invention, the device comprises a connector 
for attaching the device to the patient's neck, substantially over the 
patient's larynx. The device also comprises a contact section for 
contacting the patient's neck above the larynx. Additionally, the 
device also comprises a stimulator for applying at least one stimulus 
to the patient's larynx. Also, the device comprises an adjustment 
mechanism for shifting the position of the device over the patient's 
larynx.
    The device can also include a movement sensor for monitoring 
pressure on the patient's larynx and a swallowing detector. The 
swallowing detector includes a piezoelectric stretch receptor and a 
stimulator, coupled to the movement sensor, for applying pressure to a 
patient's larynx prior to swallowing. 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 exclusive license 
may be granted unless, within thirty (30) 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: December 1, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2010-30639 Filed 12-6-10; 8:45 am]
BILLING CODE 4140-01-P
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