81282 Federal Register / Vol. 75, No. 247 / Monday, December 27, 2010 / Notices 

early childhood community, formulate 

the OHS strategic plans and long-term 

goals, provide guidance and support 

with budget planning, oversee 

development of regulations and other 

policy issuances, and serve as liaison 

with ACF and HHS legislative offices on 

all Congressional matters relating to 

Head Start. 

F. Grants and Contracts Division 

(KUG): The Grants and Contracts 

Division (GCD) (1) Oversees matters 

related to competitive funding 

opportunities; (2) manages competition, 

paneling, and selection of national 

contracts and Head Start and Early Head 

Start replacement grantees; (3) provides 

ongoing fiscal oversight of national 

contracts; (4) serves as the lead for the 

OHS Program Management and Fiscal 

Operations Center; and (5) serves as the 

liaison to the Office of Administration, 

Divisions of Grants Management and 

Division of Grants Policy. 

G. State Initiatives Division (KUH): 

The State Initiatives Division (SID) leads 

and consolidates collaboration efforts to 

new and expanding Head Start 

programs. The Division will promote 

collaborations with state pre-k 

programs, local child care providers and 

other national and state early childhood 

efforts to ensure the sustainability of 

strong collaborations. The Division 

serves as the locus for ensuring that 

mandates in the Head Start Act 

regarding collaboration are 

implemented as well as coordination 

with the U.S. Department of Education 

and state early childhood entities. The 

Division will focus on State Advisory 

Councils, Centers of Excellence, State 

Collaboration Offices, and the Training 

and Technical Assistance System. 

II. Continuation of Policy. Except as 

inconsistent with this reorganization, all 

statements of policy and interpretations 

with respect to organizational 

components affected by this notice 

within ACF, heretofore issued and in 

effect on this date of this reorganization 

are continued in full force and effect. 

III. Delegation of Authority. All 

delegations and redelegations of 

authority made to officials and 

employees of affected organizational 

components will continue in them or 

their successors pending further 

redelegations, provided they are 

consistent with this reorganization. 

IV. Funds, Personnel, and Equipment. 

Transfer of organizations and functions 

affected by this reorganization shall be 

accompanied in each instance by direct 

and support funds, positions, personnel, 

records, equipment, supplies, and other 

resources. 

This reorganization will be effective 

upon date of signature. 

Dated: December 16, 2010. 

David A. Hansell, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. 2010–32462 Filed 12–23–10; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Circulatory System 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: Circulatory 

System 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 January 25 and 26, 2011, from 

8 a.m. to 6 p.m. 

Location: Holiday Inn, Main 

Ballroom, Two Montgomery Village 

Ave., Gaithersburg, MD. Information 

regarding special accommodations due 

to a disability, visitor parking and 

transportation may be accessed at: 

http://www.fda.gov/Advisory

Committees/default.htm; under the 

heading ‘‘Resources for You,’’ click on 

‘‘White Oak Conference Center Parking 

and Transportation Information for FDA 

Advisory Committee Meetings.’’ Please 

note that visitors to the White Oak 

Campus must enter through Building 1. 

Contact Person: James Swink, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512625. 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 January 25, 2011, the 

committee will discuss and make 

recommendations regarding regulatory 

classification of Automated External 

Defibrillators to either reconfirm to class 

III (subject to premarket approval 

application (PMA)) or reclassify to class 

II (subject to premarket notification 

(510(k))), as directed by section 515(i) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C 360e(i)). 

On January 26, 2011, the committee 

will discuss, make recommendations 

and vote on information related to the 

PMA supplement for the RX Acculink 

Carotid Stent System, sponsored by 

Abbott Vascular. The RX Acculink is 

indicated for treatment of patients at 

high and standard risk for adverse 

events from carotid endarterectomy who 

require carotid revascularization and 

meet the criteria outlined as follows: 

1. Patients with neurological 

symptoms and >50 percent stenosis of 

the common or internal carotid artery or 

patients without neurological symptoms 

and >80 percent (high risk) or >70 

percent (standard risk) stenosis of the 

common or internal carotid artery and 

2. Patients must have a reference 

vessel diameter within the range of 4.0 

and 9.0 mm at the target lesion. 

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 January 18, 2011. 

Oral presentations from the public will 

be scheduled for 1 hour at 

approximately 1 p.m., immediately 

following lunch on both days. Those 

individuals interested in making 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 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 75, No. 247 / Monday, December 27, 2010 / Notices 81283 

or before January 10, 2011. 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 

January 11, 2011. 

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/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: December 20, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–32367 Filed 12–23–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Oncologic Drugs Advisory Committee; 

Cancellation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The meeting of the Oncologic 

Drugs Advisory Committee scheduled 

for February 9, 2011, is cancelled. This 

meeting was announced in the Federal 

Register of December 6, 2010 (75 FR 

75680). On February 9, 2011, the 

Oncologic Drugs Advisory Committee 

was scheduled to discuss biologics 

license application (BLA) 125377, with 

the proposed trade name YERVOY 

(ipilimumab), submitted by BristolMyers Squibb Co. The proposed 

indication (use) for this product is for 

the treatment of advanced melanoma in 

patients who have received prior 

therapy. This meeting has been 

cancelled because the issues for which 

FDA was seeking the scientific input of 

the committee have been resolved. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Vesely, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, FAX: 301–847–8533, e-mail: 

Nicole.vesely@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

Dated: December 21, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–32413 Filed 12–23–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; 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 Child Health and 

Human Development Council. 

The meeting will be open to the 

public, 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 

Child Health and Human Development 

Council. 

Date: January 20, 2011. 

Open: 8 a.m. to 12:20 p.m. 

Agenda: (1) A report of the Director, 

NICHD; (2) Select Pay Plan Presentation; (3) 

NIH Peer Review Enhancement Update, (4) 

NIH Support for Human Embryonic Stem 

Cell Research Update. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, C–Wing, 

Conference Room 6, Bethesda, MD 20892. 

Closed: 12:20 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, C–Wing, 

Conference Room 6, Bethesda, MD 20892. 

Contact Person: Yvonne T. Maddox, PhD, 

Deputy Director, National Institute of Child 

Health and Human Development, NIH, 9000 

Rockville Pike MSC 7510, Building 31, Room 

2A03, Bethesda, MD 20892. (301) 496–1848. 

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. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxis, 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: http:// 

www.nichd.nih.gov/about/nachhd.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

In order to facilitate public attendance at 

the open session of Council, reserve seating 

will be made available to the first five 

individuals reserving seats in the main 

meeting room, Conference Room 6. Please 

contact Ms. Lisa Kaeser, Program and Public 

Liaison Office, NICHD, at 301–496–0536 to 

make your reservation. Additional seating 

will be available in the meeting overflow 

rooms, Conference Rooms 7 and 8. 

Individuals will also be able to view the 

meeting via NIH Videocast. Please go to the 

following link for Videocast access 

instructions at: http:// 

wwwauthor.nichd.nih.gov/about/overview/

advisory/nachhd/virtual-meeting201005.cfm. The meeting is partially closed 

to the public. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 


erowe on DSK5CLS3C1PROD with NOTICES