Federal Register / Vol. 75, No. 234 / Tuesday, December 7, 2010 / Notices 76019 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0550] 

Compliance Policy Guide Sec. 390.500 

Definition of ‘‘High-Voltage Vacuum 

Switch’’—21 CFR 1002.61(a)(3) and 

(b)(2); Withdrawal of Guidance 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

withdrawal of Compliance Policy Guide 

Sec. 390.500 Definition of ‘‘High-Voltage 

Vacuum Switch’’—21 CFR 1002.61(a)(3) 

and (b)(2) (CPG Sec. 390.500). CPG Sec. 

390.500 is included in FDA’s 

Compliance Policy Guides Manual, 

which was listed in the Annual 

Comprehensive List of Guidance 

Documents that published on August 9, 

2010. 

DATES: The withdrawal is effective 

December 7, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Sean M. Boyd, Center for Devices and 

Radiological Health, Office of 

Communication, Education, and 

Radiological Programs, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 4640, Silver Spring, 

MD 20993–0002, 301–796–5895. 

SUPPLEMENTARY INFORMATION: In a notice 

containing a cumulative list of 

guidances available from the agency that 

published in the Federal Register of 

August 9, 2010 (75 FR 48180 at 48233), 

FDA included the Compliance Policy 

Guides Manual, which includes CPG 

Sec. 390.500. FDA is withdrawing CPG 

Sec. 390.500 because it is obsolete. 

Dated: November 22, 2010. 

Dara Corrigan, 

Associate Commissioner for Regulatory 

Affairs. 

[FR Doc. 2010–30677 Filed 12–6–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Council for 

Biomedical Imaging and Bioengineering. 

The meeting will be open to the 

public as indicated below, 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. 

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/or 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 grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council for Biomedical Imaging and 

Bioengineering NACBIB January 2011. 

Date: January 24, 2011. 

Open: 8:30 a.m. to 1 p.m. 

Agenda: Report from the Institute Director, 

other Institute Staff and discussion of 

strategic plan. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Independence Room 

(2nd Level), Bethesda, MD 20817. 

Closed: 1 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Independence Room 

(2nd Level), Bethesda, MD 20817. 

Contact Person: Anthony Demsey, PhD, 

Director, National Institute of Biomedical 

Imaging and Bioengineering, 6707 

Democracy Boulevard, Room 241, Bethesda, 

MD 20892. 

Any interested person may file written 

comments with the committee by forwarding 

the 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. 

Information is also available on the 

Institute’s/Center’s home page: http://

www.nibib1.nih.gov/about/NACBIB/

NACBIB.htm, where an agenda and any 

additional information for the meeting will 

be posted when available. 

Dated: December 1, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–30644 Filed 12–6–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App), notice is 

hereby given of the National Advisory 

Council for Complementary and 

Alternative Medicine (NACCAM) 

meeting. 

The meeting will be open to the 

public as indicated below, 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. 

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 USC, 

as amended. The grant applications 

and/or contract Proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable materials, and 

personal information concerning 

individuals associated with the grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Council for Complementary and Alternative 

Medicine. 

Date: February 4, 2011. 

Closed: February 4, 2011, 8:30 a.m. to 

10:30 a.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 6, Bethesda, MD 20892. 

Open: February 4, 2011, 11 a.m. to 4 p.m. 

Agenda: Opening remarks by the Director 

of the National Center for Complementary 

and Alternative Medicine, presentation of a 

new research initiative, and other business of 

the Council. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 6, Bethesda, MD 20892. 

Contact Person: Martin H. Goldrosen, PhD, 

Executive Secretary, Director, Division of 

Extramural Activities, National Center for 

Complementary and Alternative Medicine, 

National Institutes of Health, 6707 

Democracy Blvd., Suite 401, Bethesda, MD 

20892. (301) 594–2014. 

The public comments session is scheduled 

from 3:30 to 4 p.m. on February 4, 2011, but 

could change depending on the actual time 

spent on each agenda item. Each speaker will 

be permitted 5 minutes for their presentation. 

Interested individuals and representatives of 


emcdonald on DSK2BSOYB1PROD with NOTICES
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