Federal Register / Vol. 77, No. 82 / Friday, April 27, 2012 / Notices 25183 

Total Annual Hours: 365,136. (For 

policy questions regarding this 

collection contact William Lehrman at 

410–786–1037. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Site 

Investigation for Durable Medical 

Equipment (DME) Suppliers ; Use: CMS 

is mandated to identify and implement 

measures to prevent fraud and abuse in 

the Medicare program. To meet this 

challenge, CMS has moved forward to 

improve the quality of the process for 

enrolling suppliers into the Medicare 

program by establishing a uniform 

application for enumerating suppliers of 

durable medical equipment, prosthetics, 

orthotics, and supplies (DMEPOS). 

Implementation of enhanced procedures 

for verifying the enrollment information 

has also improved the enrollment 

process. As part of this process, 

verification of compliance with supplier 

standards is necessary. The site 

investigation form has been used in the 

past to aid the Medicare contractor (the 

National Supplier Clearinghouse and/or 

its subcontractors) in verifying 

compliance with the required supplier 

standards found in 42 CFR 424.57(c). 

The primary function of the site 

investigation form is to provide a 

standardized, uniform tool to gather 

information from a DMEPOS supplier 

that tells us whether it meets certain 

qualifications to be a DMEPOS supplier 

(as found in 42 CFR 424.57(c)) and 

where it practices or renders its 

services. 

This site investigation form collects 

the same information as its predecessor, 

with the exception of one new yes/no 

question under the ‘‘Records and 

Telephone’’ section (question 11(a)) 

used to verify if the DMEPOS supplier 

maintains physician ordering/referring 

records for the supplies and/or services 

it renders to Medicare beneficiaries (if 

applicable). This information is required 

by section 1833(q) of the Social Security 

Act (the Act) which states that all 

physicians and non-physician 

practitioners that meet the definitions at 

section 1861(r) and 1842(b)(18)(C) of the 

Act, be uniquely identified for all claims 

for services that are ordered or referred. 

Other information collected on this site 

investigation remains unchanged, but 

has been reformatted for greater 

functionality. Form Number: CMS–R– 

263 (OCN: 0938–0749); Frequency: 

Once; Affected Public: Private Sector— 

Business or other for-profits and not-forprofit institutions; Number of 

Respondents: 30,000; Total Annual 

Responses: 30,000; Total Annual Hours: 

15,000. (For policy questions regarding 

this collection contact Kimberly 

McPhillips at 410–786–5374. For all 

other issues call 410–786–1326.) 

3. Type of Information Collection 

Request: Revision of a currently 

approved collection; 

Title of Information Collection: 

Medicare Registration Application; Use: 

The CMS 855O allows a physician to 

receive a Medicare identification 

number (without being approved for 

billing privileges) for the sole purpose of 

ordering and referring Medicare 

beneficiaries to Medicare approved 

providers and suppliers. This new 

Medicare registration application form 

allows physicians who do not provide 

services to Medicare beneficiaries to be 

given a Medicare identification number 

without having to supply all the data 

required for the submission of Medicare 

claims. It also allows the Medicare 

program to identify ordering and 

referring physicians without having to 

validate the amount of data necessary to 

determine claims payment eligibility 

(such as banking information), while 

continuing to identify the physician’s 

credentials as valid for ordering and 

referring purposes. Since the physicians 

and non-physician practitioners 

submitting this application are not 

enrolling in Medicare to submit claims 

but are only registering with Medicare 

as eligible to order and refer, CMS 

believes changing the title from 

Medicare Enrollment Application to 

Medicare Registration Application 

better captures the actual purpose of 

this form. 

Where appropriate, CMS has changed 

all references to enrollment or enrolling 

to registration and registering and 

Medicare billing number to National 

Provider Identifier. CMS also added a 

check box to allow physicians and nonphysician practitioners to withdraw 

from the ordering and referring registry. 

A section to collect information on 

professional certifications was added for 

those practitioners who are not 

professionally licensed. Editorial and 

formatting corrections were made in 

response to prior comments received 

during the approval of the current 

version of this application. Other minor 

editorial and formatting corrections 

were made to better clarify the purpose 

of this application. Form Number: 

CMS–855(O) (OCN: 0938–1135); 

Frequency: Occasionally; Affected 

Public: Individuals; Number of 

Respondents: 48,500; Total Annual 

Responses: 48,500; Total Annual Hours: 

24,125. (For policy questions regarding 

this collection contact Kimberly 

McPhillips at 410–786–5374. For all 

other issues call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on May 29, 2012. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–6974, 

Email: OIRA_submission@omb.eop.gov. 

Dated: April 24, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–10225 Filed 4–26–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–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 June 13, 2012, from 8 a.m. to 6 p.m. 

Location: Hilton Washington DC North/ 

Gaithersburg, Salons A, B, C, and D, 620 

Perry Pkwy., Gaithersburg, MD 20877. The 

hotel telephone number is 301–977–8900. 

Contact Person: Jamie Waterhouse, 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), and follow the 

prompts to the desired center or product 

mstockstill on DSK4VPTVN1PROD with NOTICES

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