Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices 57967 

Dated: September 16, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–23846 Filed 9–22–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the following meetings. 

The meetings 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. 

Name of Committee: Biology of 

Development and Aging Integrated Review 

Group; Aging Systems and Geriatrics Study 

Section. 

Date: October 4, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard by Marriot, 5520 

Wisconsin Avenue, Chevy Chase, MD 20815. 

Contact Person: James P Harwood, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5168, 

MSC 7840, Bethesda, MD 20892, 301–435– 

1256, harwoodj@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; RFA Panel: 

Scientific Models to Improve Health. 

Date: October 20, 2010. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Marriott Wardman Park 

Hotel, 2660 Woodley Road, NW., 

Washington, DC 20008. 

Contact Person: Hilary D Sigmon, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5216, 

MSC 7852, Bethesda, MD 20892, (301) 594– 

6377, sigmonh@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 16, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–23844 Filed 9–22–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Science Advisory Board to the 

National Center for Toxicological 

Research Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Science 

Advisory Board (SAB) to the National 

Center for Toxicological Research 

(NCTR). 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on October 19, 2010, from 8:15 

a.m. to 5:30 p.m. and on October 20, 

2010, from 8:30 a.m. to 1 p.m. 

Location: National Center for 

Toxicological Research, 3900 NCTR Dr., 

Jefferson, AR 72079, Conference Room 

B–12. 

Contact Person: Margaret Miller, 

NCTR, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 32, 

rm. 2208, Silver Spring, MD, 20993– 

0002, 301–796–8890, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), code 301–451– 

2559. Please call the Information Line 

for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On October 19, 2010, NCTR 

Director will provide a Center-wide 

update on scientific endeavors and 

discuss prioritization, alignment, and 

the strategic focus of NCTR. The SAB 

will be presented with updates from 

each of the NCTR divisions on their 

individual accomplishments and future 

research plans based on the major items 

identified in the last subcommittee 

review. The report of the subcommittee 

review of the Division of 

Neurotoxicology will be presented for 

discussion and adoption by the full 

Board. On October 20, 2010, the SAB 

will be presented with and discuss the 

NCTR Strategic Focus and future 

direction, and the need for research and 

potential collaborations. A discussion 

will be conducted on the organization of 

the SAB, site visits and SAB 

assignments. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: On October 19, 2010, from 

8:15 a.m. to 5:30 p.m., the meeting is 

open to the public. Interested persons 

may present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before October 18, 2010. 

Oral presentations from the public will 

be scheduled between approximately 12 

p.m. to 1 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before October 8, 2010. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 11, 2010. 

Closed Committee Deliberations: On 

October 20, 2010, from 12 p.m. to 1 

p.m., the meeting will be closed to 

permit discussion where disclosure 

would constitute a clearly unwarranted 


srobinson on DSKHWCL6B1PROD with NOTICES
57968 Federal Register / Vol. 75, No. 184 / Thursday, September 23, 2010 / Notices 

invasion of personal privacy (5 U.S.C. 

552b(c)(6)). This portion of the meeting 

will be closed to permit discussion of 

information concerning individuals 

associated with the research programs at 

NCTR. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Margaret 

Miller at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at: 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 17, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–23843 Filed 9–22–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Gastroenterology and Urology Devices 

Panel of the Medical Devices Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Gastroenterology 

and Urology Devices Panel of the 

Medical Devices Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on December 2 and 3, 2010, from 

8 a.m. to 6 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, Ballroom, 620 Perry 

Pkwy., Gaithersburg, MD. 

Contact Person: Margaret McCabeJanicki, Food and Drug Administration, 

Center for Devices and Radiological 

Health, 10903 New Hampshire Ave., 

Bldg. 66, rm. 1535, Silver Spring, MD 

20993–0002, 301–796–7029, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512523. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On December 2, 2010, the 

committee will discuss, make 

recommendations, and vote on 

information related to the premarket 

approval application (PMA) for 

SOLESTA, sponsored by Oceana 

Therapeutics, Inc. SOLESTA is 

indicated for the treatment of fecal 

incontinence in patients who have 

failed conservative therapy. On 

December 3, 2010, the committee will 

discuss, make recommendations, and 

vote on information related to the PMA 

for the LAP-BAND Adjustable Gastric 

Banding System, sponsored by Allergan. 

The sponsor is requesting an expanded 

Indication for Use for their LAP-BAND 

Adjustable Gastric Banding System to 

include weight reduction in patients 

with a Body Mass Index (BMI) of at least 

35 kg/m2 or a BMI of at least 30 kg/m2

with one or more comorbid conditions. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before November 18, 2010. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. on December 2 and 3, 

2010. Those desiring to make formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before November 10, 2010. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

November 11, 2010. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact AnnMarie 

Williams, Conference Management 

Staff, 301–796–5966, at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for 

procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 17, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–23842 Filed 9–22–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of Closed 

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 following meeting. 


srobinson on DSKHWCL6B1PROD with NOTICES