25184 Federal Register / Vol. 77, No. 82 / Friday, April 27, 2012 / Notices 

area. Please call the Information Line for upto-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 June 13, 2012, the committee 

will discuss, make recommendations and 

vote on information related to the premarket 

approval application for the Edwards 

SAPIEN Transcatheter Heart Valve sponsored 

by Edwards Lifesciences. The Edwards 

SAPIEN Transcatheter Heart Valve is 

indicated for use in patients with 

symptomatic severe aortic stenosis who have 

high operative risk. 

The Edwards SAPIEN Transcatheter Heart 

Valve, model 9000TFX, sizes 23mm and 

26mm and accessories implant system 

consists of the following: 

• A heterologous (bovine) pericardium 

leaflet valve sutured within a stainless steel 

mesh frame, with a polyester skirt. It is 

offered in two sizes, a 23 mm and a 26 mm. 

• The RetroFlex 3 Delivery System is used 

to advance the bioprosthesis through the 

RetroFlex sheath over a guidewire and to 

track the bioprosthesis over the aortic arch 

and for crossing and positioning in the native 

valve. The delivery system also comes with 

a sheath, introducer, loader, dilator, balloon 

(used to pre-dilate the native annulus) and a 

crimper. 

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 meeting 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 June 

5, 2012. On June 13, 2012, oral presentations 

from the public will be scheduled between 

approximately 1 p.m. and 2 p.m. 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 or before May 

29, 2012. 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 June 1, 2012. 

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 James 

Clark, Conference Management Staff, at 

James.Clark@fda.hhs.gov or 301–796–5293 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/ 

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: April 19, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–10156 Filed 4–26–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Oncologic Drugs 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: Oncologic Drugs 

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 June 20, 2012, from 8 a.m. to 5 p.m. 

Location: FDA White Oak Campus, 

Building 31, the Great Room, White Oak 

Conference Center, (Rm. 1503), 10903 New 

Hampshire Avenue, Silver Spring, MD 

20993–0002. Information regarding special 

accommodations due to a disability, visitor 

parking, and transportation may be accessed 

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

default.htm; under the heading ‘‘Resources 

for You,’’ click on ‘‘Public Meetings at the 

FDA White Oak Campus.’’ Please note that 

visitors to the White Oak Campus must enter 

through Building 1. 

Contact Person: Caleb Briggs, Pharm.D., 

Center for Drug Evaluation and Research, 

Food and Drug Administration, 10903 New 

Hampshire Ave., WO31–2417, Silver Spring, 

MD 20993–0002, (301) 796–9001, Fax: (301) 

847–8533, email: ODAC@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 1– 

800–741–8138 (301–443–0572 in the 

Washington, DC area), to find out further 

information regarding FDA advisory 

committee information. 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 advisory committee information 

line or visit our Web site at http:// 

www.fda.gov/AdvisoryCommittees/ 

default.htm to learn about possible 

modifications before coming to the meeting. 

Agenda: On June 20, 2012, during the 

morning session, the committee will discuss 

new drug application (NDA) 203213, with 

the established name semuloparin sodium 

injection, application submitted by sanofiaventis U.S. LLC. The proposed indication 

(use) for this product is for the prophylaxis 

of venous thromboembolism (VTE) in 

patients receiving chemotherapy for locally 

advanced or metastatic pancreatic or lung 

cancer or for locally advanced or metastatic 

solid tumors with a VTE risk score ≥3. 

During the afternoon session, the 

committee will discuss NDA 202714, with 

the proposed trade name Kyprolis 

(carfilzomib) for injection, application 

submitted by Onyx Pharmaceuticals, Inc. The 

proposed indication (use) for this product is 

for the treatment of patients with relapsed 

and refractory (recurring and/or not 

responsive to other treatments) multiple 

myeloma who have received at least 2 prior 

lines of therapy that included a proteasome 

inhibitor and an immunomodulatory agent. 

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 June 

6, 2012. Oral presentations from the public 

will be scheduled between approximately 

10:30 a.m. to 11 a.m., and 3:30 p.m. to 4 p.m. 

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 or 

before May 29, 2012. 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 82 / Friday, April 27, 2012 / Notices 25185 

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 May 30, 2012. 

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 Caleb 

Briggs 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/ 

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: April 19, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–10154 Filed 4–26–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary 

and 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 a meeting of the 

National Advisory Council for 

Complementary and Alternative 

Medicine. 

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 

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: National Advisory 

Council for Complementary and Alternative 

Medicine. 

Date: June 1, 2012. 

Closed: 8:30 a.m. to 10 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 10, Bethesda, MD 20892. 

Open: 10:15 a.m. to 4 p.m. 

Agenda: A report from the Institute 

Director and other staff. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 10, Bethesda, MD 20892. 

Contact Person: Martin H. Goldrosen, 

Ph.D., Director, Division of Extramural 

Activities, National Center for 

Complementary and Alternative Medicine, 

NIH, 6707 Democracy Blvd., Ste. 401, 

Bethesda, MD 20892–5475, (301) 594–2014, 

goldrosm@mail.nih.gov. 

Any member of the public interested in 

presenting oral comments to the committee 

may notify the Contact Person listed on this 

notice at least 10 days in advance of the 

meeting. Interested individuals and 

representatives of organizations may submit 

a letter of intent, a brief description of the 

organization represented, and a short 

description of the oral presentation. Only one 

representative of an organization may be 

allowed to present oral comments and if 

accepted by the committee, presentations 

may be limited to five minutes. Both printed 

and electronic copies are requested for the 

record. In addition, any interested person 

may file written comments with the 

committee by forwarding their 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 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. 93.213, Research and Training 

in Complementary and Alternative Medicine, 

National Institutes of Health, HHS) 

Dated: April 20, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–10130 Filed 4–26–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2012–0013] 

Agency Information Collection 

Activities: Submission for Review; 

Information Collection Extension 

Request for the DHS S&T First 

Responders Community of Practice 

Program 

AGENCY: Science and Technology 

Directorate, DHS. 

ACTION: 60-day Notice and request for 

comment. 

SUMMARY: The Department of Homeland 

Security (DHS) invites the general 

public to comment on the data 

collection form for the DHS Science & 

Technology (S&T) First Responders 

Community of Practice (FRCoP): User 

Registration Page (DHS Form 10059 (9/ 

09)). The FRCoP web based tool collects 

profile information from first responders 

and select authorized non-first 

responder users to facilitate networking 

and formation of online communities. 

All users are required to authenticate 

prior to entering the site. In addition, 

the tool provides members the 

capability to create wikis, discussion 

threads, blogs, documents, etc., allowing 

them to enter and upload content in 

accordance with the site’s Rules of 

Behavior. Members are able to 

participate in threaded discussions and 

comment on other member’s content. 

The DHS S&T FRCoP Program is 

responsible for providing a collaborative 

environment for the first responder 

community to share information, best 

practices, and lessons learned. Section 

313 of the Homeland Security Act of 

2002 (Pub. L. 107–296) established this 

requirement. This notice and request for 

comments is required by the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13, 

44 U.S.C. Chapter 35). This notice and 

request for comments is required by the 

Paperwork Reduction Act of 1995 (Pub. 

Law 104–13, 44 U.S.C. chapter 35). 

DATES: Comments are encouraged and 

will be accepted until June 26, 2012. 

ADDRESSES: Interested persons are 

invited to submit comments, identified 

by docket number DHS–2012–0013, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Please follow the 

instructions for submitting comments. 

• Email: Kathy.Higgins@hq.dhs.gov. 

Please include docket number DHS– 

2012–0013 in the subject line of the 

message. 

• Fax: (202) 254–6171. (Not a toll-free 

number). 

• Mail: Science and Technology 

Directorate, Attn: Chief Information 

mstockstill on DSK4VPTVN1PROD with NOTICES