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. 

[FR Doc. 2010–30641 Filed 12–6–10; 8:45 am] 

BILLING CODE 4140–01–P 

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. 


emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices 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 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Internal Agency Docket No. FEMA–1940– 

DR; Docket ID FEMA–2010–0002] 

Arizona; Amendment No. 1 to Notice of 

a Major Disaster Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: 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. 

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 

Agency Information Collection 

Activities: Passenger List/Crew List 

(CBP Form I–418) 

AGENCY: 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. 

SUMMARY: 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 

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 


emcdonald on DSK2BSOYB1PROD with NOTICES