Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 8179 

the building and grounds, participants 

must bring government-issued photo 

identification and a copy of your written 

meeting registration confirmation. 

Persons without proper identification 

will be denied access. 

Individuals who are not registered in 

advance will not be permitted to enter 

the building and will be unable to 

attend the meeting. The public may not 

enter the building earlier than 45 

minutes before the convening of the 

meeting each day. 

Security measures will also include 

inspection of vehicles, inside and 

outside, at the entrance to the grounds 

and buildings. In addition, all persons 

entering the building must pass through 

a metal detector. All items brought to 

CMS are subject to inspection. We 

cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for 

demonstration or to support a 

presentation. Special arrangements and 

approvals are required in order to bring 

pieces of equipment or medical devices 

at least two weeks prior to each public 

meeting. These arrangements need to be 

made with the appropriate public 

meeting coordinator. It is possible that 

certain requests, made in advance, of 

the public meeting could be denied 

because of unique safety, security or 

handling issues related to the 

equipment. A minimum of two weeks is 

required for approvals and security 

procedures. Any request not submitted 

at least two weeks in advance of the 

public meeting will be denied. 

Parking permits and instructions are 

issued upon arrival by the guards at the 

main entrance. 

All visitors must be escorted in areas 

other than the lower and first-floor 

levels in the Central Building. 

Authority: Section 1102 and 1871 of the 

Social Security Act (42 U.S.C. 1302 and 42 

U.S.C. 1395hh). 

Dated: January 29, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–3034 Filed 2–22–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1383–N2] 

Medicare Program; Listening Session 

on the Draft Plan for Medicare Hospital 

Value-Based Purchasing—April 12, 

2007 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces the 

second Listening Session being 

conducted as part of the development of 

a plan for Medicare hospital value-based 

purchasing, as authorized by section 

5001(b) of the Deficit Reduction Act of 

2005 (Pub. L. 109–171) (DRA). The 

purpose of the second Listening Session 

is to solicit comments on the Draft Plan 

that has been developed. Hospitals, 

hospital associations, and all interested 

parties are invited to attend and make 

comments in person. The perspectives 

expressed during this session and in 

writing will assist us in making 

revisions to the Draft Plan to create the 

final Medicare Hospital Value-Based 

Purchasing Plan to be completed by 

June 2007. The Draft Plan will be posted 

no later than March 22, 2007 on the 

CMS Web site, Hospital Center, under 

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

center/hospital.asp. 

DATES:

Meeting Date: The listening session 

will be held on Thursday, April 12, 

2007 from 10 a.m. until 5 p.m. e.d.t. 

Registration and Request for Special 

Accommodations Deadline: Registration 

will open February 26, 2007. For 

security reasons, registration must be 

completed no later than 5 p.m. e.d.t. on 

Thursday, April 9, 2007. Requests for 

special accommodations must be 

received by 5 p.m. e.d.t. on Thursday, 

April 9, 2007. See Section III. below for 

detailed instructions. 

Deadline for Submission of Written 

Comments or Statements: Written 

comments on the Draft Plan may be sent 

by mail, fax, or electronically and must 

be received by 5 p.m. e.d.t. on April 19, 

2007. 

ADDRESSES:

Meeting Location: The Listening 

Session will be held in the main 

auditorium of the central building of the 

Centers for Medicare and Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244–1850. 

Registration and Special 

Accommodations: Persons interested in 

attending the meeting or listening by 

teleconference must register by 

completing the on-line registration 

located at http:// 

registration.mshow.com/cms2/. 

Individuals who need special 

accommodations should contact Robin 

Phillips at (410) 786–3010, by e-mail to 

robin.phillips@cms.hhs.gov, or by 

regular mail to Mail Stop C4–13–07 

Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244–1850. 

Written Comments or Statements: 

Written comments on the Draft Plan 

may be mailed to Mail Stop C4–13–07 

Centers for Medicare and Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, MD 21244; e-mail to 

cmshospitalVBP@cms.hhs.gov or fax to 

410–786–0330. 

FOR FURTHER INFORMATION CONTACT: 

Robin Phillips, 410–786–3010 in the 

Medicare Feedback Group. You may 

also send inquires about this meeting 

via e-mail to 

robin.phillips@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 5001(b) of the Deficit 

Reduction Act of 2005 (Pub. L. 109–171) 

(DRA) specifies that we develop a plan 

to implement a Value-Based Purchasing 

(VBP) Program for payments under the 

Medicare program for subsection (d) 

hospitals (as defined in section 

1886(d)(1)(B) of the Social Security Act) 

beginning with FY 2009. The Congress 

specified that the ‘‘plan’’ include 

consideration of the following issues: 

• The ongoing development, 

selection, and modification process for 

measures of quality and efficiency in 

hospital inpatient settings. 

• The reporting, collection, and 

validation of quality data. 

• The structure of value-based 

payment adjustments, including the 

determination of thresholds or 

improvements in quality that would 

substantiate a payment adjustment, the 

size of such payments, and the sources 

of funding for the value-based 

payments. 

• The disclosure of information on 

hospital performance. 

In developing the plan, we must 

consult with relevant affected parties 

and consider experience with 

demonstrations that are relevant to the 

VBP program. We have created an 

internal Hospital Pay-for-Performance 

Workgroup that is charged with 

developing the VBP Plan for Medicare 

hospital services. This Workgroup is 

organized into four subgroups to 

address each of the required planning 


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8180 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 

issues: (1) Measures; (2) data collection 

and validation; (3) incentive structure; 

and (4) public reporting. It is also 

charged with preparing a set of design 

options, narrowing the set of design 

options to prepare a draft plan, and 

preparing a report on the plan for 

implementing VBP for Medicare 

hospital services, which will be 

provided to the Congress as required 

under section 5001(b)(3) of the DRA. 

In the November 24, 2006 Federal 

Register, we announced that we would 

have a listening session to consider 

design questions posed in the Issues 

Paper that we posted on our Web site 

http://www.cms.hhs.gov. This listening 

session was held on January 17, 2007. 

II. Listening Session Format and 

Agenda 

The second listening session will be 

held on April 12, 2007 to consider the 

Draft Plan. This listening session will 

begin at 10 a.m. with an overview of the 

objectives for the session and a brief 

summary of the approach to developing 

the Draft Plan. Beginning at 

approximately 10:30 a.m., the remainder 

of the meeting will be devoted to 

addressing each section of the Plan. The 

agenda will provide opportunities for 

brief 2-minute comments from on-site 

session attendees. As time allows, 

telephone participants will also have 

the opportunity to provide brief 2- 

minute comments. A lunch break will 

occur from approximately 12:30 p.m. to 

1:30 p.m. The meeting will conclude by 

5 p.m. with brief comments on ‘‘next 

steps.’’

III. Registration Instructions 

Persons interested in attending the 

meeting or listening by teleconference 

must register by completing the on-line 

registration located at http:// 

registration.mshow.com/cms2/. The online registration system will generate a 

confirmation page to indicate the 

completion of your registration. Please 

print this page as your registration 

receipt. 

Individuals may also participate in 

the listening session by teleconference. 

Registration is required. The call-in 

number will be provided upon 

confirmation of registration. 

An audio download of the listening 

session will be available through the 

CMS Hospital Center Web site within 72 

hours after completion of the listening 

session. 

IV. Security, Building, and Parking 

Guidelines 

Because this meeting will be located 

on Federal property, for security 

reasons, any persons wishing to attend 

this meeting must register by close of 

business on April 9, 2007. Individuals 

who have not registered in advance will 

not be allowed to enter the building to 

attend the meeting. Seating capacity is 

limited to the first 550 registrants. 

The on-site check-in for visitors will 

begin at 9:15 a.m. Please allow sufficient 

time to go through the security 

checkpoints at both the entrance to the 

grounds and the entrance to the 

building. It is suggested that you arrive 

at central building by 9 a.m. so that you 

will have enough time to check-in 

before the session begins. 

Security measures will include 

inspection of vehicles, inside and out, at 

the entrance to the grounds. In addition, 

all persons entering the building must 

check in by name with Security, provide 

a government-issued ID, and pass 

through a metal detector. All items 

brought to the building, whether 

personal or for the purpose of 

demonstration or to support a 

presentation, including items such as 

laptops, cell phones, and palm pilots, 

are subject to physical inspection. 

Authority: Section 5001(b) The Deficit 

Reduction Act (DRA) of 2005. 

Dated: February 15, 2007. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–3048 Filed 2–22–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0261] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; EXJADE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for EXJADE 

and is publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent that claims that 

human drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–7), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 

product becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human drug product and continues 

until FDA grants permission to market 

the product. Although only a portion of 

a regulatory review period may count 

toward the actual amount of extension 

that the Director of Patents and 

Trademarks may award (for example, 

half the testing phase must be 

subtracted, as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product EXJADE 

(deferasirox). EXJADE is indicated for 

the treatment of chronic iron overload 

due to blood transfusions (transfusional 

hemosiderosis) in patients 2 years of age 

and older. Subsequent to this approval, 

the Patent and Trademark Office 

received a patent term restoration 

application for EXJADE (U.S. Patent No. 

6,465,504) from Novartis AG, and the 

Patent and Trademark Office requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated July 24, 

2006, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 


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