78466 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

IV. Oral Presentations 

Individuals or organizations wishing 

to make 5-minute oral presentations 

must contact the DFO. The DFO must 

receive hardcopy presentations by 5 

p.m. (e.s.t.), on Wednesday, January 26, 

2005, in order to be scheduled. 

The number of oral presentations may 

be limited by the time available. Oral 

presentations should not exceed 5 

minutes in length. 

The Chair may further limit time 

allowed for presentations due to the 

number of oral presentations, if 

necessary. 

V. Presenter and Presentation Criteria 

The additional criteria below must be 

supplied to the DFO by the January 26, 

2005 deadline (along with hardcopies of 

presentations). 

• Required personal information 

regarding presenter(s): 

+ Name of presenter(s); 

+ Title(s); 

+ Organizational affiliation; 

+ Address; 

+ E-mail address, and 

+ Telephone number(s). 

• All presentations must contain, at a 

minimum, the following supporting 

information and data: 

+ Financial relationship(s) of 

presenter(s), if any, with any company 

whose products, services, or procedures 

that are under consideration; 

+ Physicians’ Current Procedural 

Terminology (CPT) codes involved; 

+ APC(s) affected; 

+ Description of the issue(s); 

+ Clinical description of the service 

under discussion (with comparison to 

other services within the APC); 

+ Recommendations and rationale for 

change;

+ Expected outcome of change; and 

+ Potential consequences of not 

making the change(s). 

VI. Oral Comments 

In addition to formal oral 

presentations, there will be opportunity 

during the meeting for public oral 

comments that will be limited to 1 

minute for each individual and a total 

of 5 minutes per organization. 

VII. Meeting Attendance 

The meeting is open to the public; 

however, attendance is limited to space 

available. Attendance will be 

determined on a first-come, first-served 

basis. 

Persons wishing to attend this 

meeting, which is located on Federal 

property, must call or e-mail the Panel 

DFO to register in advance no later than 

5 p.m. (e.s.t.), Wednesday, February 9, 

2005. 

The following information must be emailed or telephoned to the DFO by the 

date and time above: 

• Name(s) of attendee(s); 

• Title(s); 

• Organization; 

• E-mail address(es); and 

• Telephone number(s). 

VIII. Security, Building, and Parking 

Guidelines 

Persons attending the meeting must 

present photographic identification to 

the Federal Protective Service or Guard 

Service personnel before they will be 

allowed to enter the building. 

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 30–45 

minutes prior to the convening of the 

meeting each day. (Please note that the 

meeting on Wednesday, February 23, 

2005 does not convene until 1 p.m.) 

All visitors must be escorted in areas 

other than the lower and first-floor 

levels in the Central Building. 

Parking permits and instructions are 

issued upon arrival by the guards at the 

main entrance. 

IX. Special Accommodations 

Individuals requiring sign-language 

interpretation or other special 

accommodations must send a request 

for these services to the DFO by 5 p.m. 

(e.s.t.), Wednesday, February 9, 2005.

Authority: Section 1833(t) of the Act (42 

U.S.C. 1395l(t), as amended by section 201(h) 

of the BBRA of 1999 (Pub. L. 106–113). The 

Panel is governed by the provisions of Pub. 

L. 92–463, as amended (5 U.S.C. Appendix 

2).

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program).

Dated: December 9, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

[FR Doc. 04–28151 Filed 12–29–04; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1292–N] 

Medicare Program; Town Hall Meeting 

on the Fiscal Year 2006 Applications 

for New Medical Services and 

Technologies Add-on Payments Under 

the Hospital Inpatient Prospective 

Payment System Scheduled for 

February 23, 2005

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS.

ACTION: Notice of meeting.

SUMMARY: This notice, in accordance 

with section 503 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA), 

announces a Town Hall meeting to 

discuss fiscal year (FY) 2006 

applications for add-on payments for 

new medical services and technologies 

under the hospital inpatient prospective 

payment system (IPPS). Applicants, 

supporters, opponents, and other 

interested parties are invited to this 

meeting to present their comments, 

recommendations, and data regarding 

whether the FY 2006 new medical 

services and technologies applications 

meet the substantial clinical 

improvement criteria.

DATES: Meeting Date: The Town Hall 

meeting announced in this notice will 

be held on Wednesday, February 23, 

2005 at 9 a.m. and check-in will begin 

at 8:30 a.m. EST. 

Registration Deadline for Presenters:

All presenters, whether attending in 

person or by phone, must register and 

submit their agenda item(s) by February 

15, 2005. 

Registration Deadline for All Other 

Participants: All other participants must 

register by February 17, 2005. 

Comment Deadline: Written 

comments for discussion at the meeting 

must be received by February 15, 2005. 

All other written comments for 

consideration before publication of the 

IPPS proposed rule must be received by 

March 15, 2005.

ADDRESSES: The Town Hall meeting will 

be held in the Auditorium in the central 

building of the Centers for Medicare & 

Medicaid Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

Agenda Items or Written Comments:

Agenda items and written comments 

regarding whether a FY 2006 

application meets the substantial 

clinical improvement criterion may be 

sent by mail, fax, or electronically. 

Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 78467

Agenda items must be received by 

February 15, 2005. We will accept 

written questions or other statements, 

not to exceed three single-spaced, typed 

pages that are received by March 15, 

2005. Send written comments, 

questions, or other statements to—

Division of Acute Care, Mail stop C4–

07–05, Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Attention: Meredith Walz or Michael 

Treitel, Fax: (410) 786–0169. E-mail: 

newtech@cms.hhs.gov

FOR FURTHER INFORMATION CONTACT:

Meredith Walz, (410) 786–9421, 

mwalz@cms.hhs.gov; Michael Treitel, 

(410) 786–4552, mtreitel@cms.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background 

Sections 1886(d)(5)(K) and (L) of the 

Social Security Act (the Act) require the 

Secretary to establish a process of 

identifying and ensuring adequate 

payments for new medical services and 

technologies under Medicare. Effective 

for discharges beginning on or after 

October 1, 2001, section 1886(d)(5)(K)(i) 

required the Secretary to establish (after 

notice and opportunity for public 

comment) a mechanism to recognize the 

costs of new services and technologies 

under the inpatient hospital prospective 

payment system (IPPS). In addition, 

section 1886(d)(5)(K)(vi) of the Act 

specifies that a medical service or 

technology will be considered ‘‘new’’ if 

it meets criteria established by the 

Secretary (after notice and opportunity 

for public comment). (See the May 4, 

2001 proposed rule (66 FR 22693) and 

the September 7, 2001 final rule (66 FR 

46912) for a more detailed discussion.) 

In the September 7, 2001 final rule (66 

FR 46914), we noted that we evaluate a 

request for special payment for a new 

medical service or technology against 

the following criteria in order to 

determine if the new technology meets 

the substantial clinical improvement 

requirement: 

• The device offers a treatment option 

for a patient population unresponsive 

to, or ineligible for, currently available 

treatments. 

• The device offers the ability to 

diagnose a medical condition in a 

patient population where that medical 

condition is currently undetectable or 

offers the ability to diagnose a medical 

condition earlier in a patient population 

than allowed by currently available 

methods. There must also be evidence 

that use of the device to make a 

diagnosis affects the management of the 

patient. 

• Use of the device significantly 

improves clinical outcomes for a patient 

population as compared to currently 

available treatments. Some examples of 

outcomes that are frequently evaluated 

in studies of medical devices are the 

following: 

++ Reduced mortality rate with use of 

the device. 

++ Reduced rate of device-related 

complications. 

++ Decreased rate of subsequent 

diagnostic or therapeutic interventions 

(for example, due to reduced rate of 

recurrence of the disease process). 

++ Decreased number of future 

hospitalizations or physician visits. 

++ More rapid beneficial resolution 

of the disease process treatment because 

of the use of the device. 

++ Decreased pain, bleeding, or other 

quantifiable symptom. 

++ Reduced recovery time. 

In addition, we indicated that the 

requester is required to submit evidence 

that the technology meets one or more 

of these criteria. 

Section 503 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) 

revised the process for evaluating new 

medical services and technology 

applications by requiring the Secretary 

to do the following: 

• Before publication of a proposed 

rule, provide for public input regarding 

whether a new service or technology 

represents an advance in medical 

technology that substantially improves 

the diagnosis or treatment of Medicare 

beneficiaries.

• Make public and periodically 

update a list of all the services and 

technologies for which an application is 

pending. 

• Accept comments, 

recommendations, and data from the 

public regarding whether the service or 

technology represents a substantial 

improvement. 

• Before publication of a proposed 

rule, provide for a meeting at which 

organizations representing hospitals, 

physicians, manufacturers and any 

other interested party may present 

comments, recommendations, and data 

to the clinical staff of CMS. 

The opinions and alternatives 

provided during this meeting will assist 

us as we evaluate the new medical 

services and technology applications for 

FY 2006. In addition, they will help us 

to evaluate our policy on the IPPS new 

technology add-on payment process 

before the publication of the FY 2006 

IPPS proposed rule. 

II. Meeting Format 

This meeting will allow for a 

discussion of the substantial clinical 

improvement criteria for each of the FY 

2006 new medical services and 

technology add-on payment 

applications. Information regarding the 

applications can be found on our Web 

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

providers/hipps/newtech.asp. In 

addition, we believe some of the issues 

raised in public comments during the 

FY 2005 rulemaking cycle warrant 

further investigation to determine 

whether our definition of ‘‘substantial 

clinical improvement’’ should be 

revised (69 FR 49001 through 49006). 

We also believe that the definition of 

‘‘substantial similarity’’ may need to be 

revisited. (See the IPPS FY 2005 final 

rule (69 FR 49011) and the September 

7, 2001 (66 FR 46915) final rule). 

Although we do not expect to have a 

general discussion of these topics 

during the timeframe of the town hall 

meeting, we are inviting comment as 

part of this town hall meeting notice. So 

that we can consider these comments in 

development of our proposed rule, we 

will accept comments through the 

deadline for other written comments 

specified in the DATES section of this 

notice. We will also solicit comments 

during the rulemaking process. 

The majority of the meeting will be 

reserved for comments, 

recommendations, and data from 

registered presenters. The time for each 

presenter’s comments will be 

approximately 10 minutes and will be 

based on the number of registered 

presenters. Presenters will be scheduled 

to speak in the order in which they 

register and grouped by new technology 

applicant. Therefore, individuals who 

want to be presenters must register and 

submit their agenda items by Tuesday, 

February 15, 2005. Once the agenda is 

completed, it will be posted on the IPPS 

Web site at http://www.cms.hhs.gov/

providers/hipps/newtech.asp.

Comments from participants will be 

heard (time permitting) after the 

completion of the presentations. 

For presenters or participants that 

cannot come to CMS for the meeting, an 

open toll-free phone line, (877) 357–

7851, has been made available. If you 

are calling in, you will be prompted to 

enter the conference identification 

number, 2940111, or the name of the 

meeting. In addition, written comments 

will also be accepted and presented at 

the meeting if they are received by 

February 15, 2005. Written comments 

may also be submitted after the meeting. 

If the comments are to be considered 

before the publication of the proposed 

rule, the comments must be received by 

March 15, 2005. 

78468 Federal Register / Vol. 69, No. 250 / Thursday, December 30, 2004 / Notices 

III. Registration Instructions 

The Division of Acute Care is 

coordinating meeting registration. While 

there is no registration fee, individuals 

must register to attend. Individuals may 

present their comments either in person 

or by phone. These individuals must 

register and submit their agenda item(s) 

by February 15, 2005. All other 

participants must register by February 

17, 2005. All registrants will receive 

confirmation with instructions for 

arrival at the CMS complex (persons 

who register on-line will receive this 

confirmation upon completion of the 

registration process and should print the 

confirmation and bring it with them to 

the meeting). Because of limited 

meeting space and our desire to 

maintain an accurate count of 

registrants that plan to come to CMS, we 

prefer that these persons register online. In addition, we would prefer that 

registrants that plan to participate by 

phone, register by phone or fax. 

On-line Registration: Registration may 

be completed on-line at the following 

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

providers/hipps/newtech.asp. Select the 

link ‘‘Register to Attend the New 

Technology Town Hall Meeting’’ and 

then select ‘‘New Technology Town 

Hall Meeting’’ from the drop down 

menu and follow the instructions. After 

completing registration, on-line 

registrants should print the 

confirmation page and bring it with 

them to the meeting. 

Registration by Phone or Fax:

Registration may be completed by 

contacting Meredith Walz at (410) 786–

9421 or Michael Treitel at (410) 786–

4552. Registration may also be 

completed by fax to the attention of 

Meredith Walz or Michael Treitel at 

(410) 786–0169. If registration is 

completed by phone or fax, please 

provide your name, address, telephone 

number, and, if available, e-mail address 

and fax number.

IV. Security Information 

Since this meeting will be held in a 

Federal government building, Federal 

security measures are applicable. In 

planning your arrival time, we 

recommend allowing additional time to 

clear security. In order to gain access to 

the building and grounds, participants 

must bring a government-issued photo 

identification and a copy of their 

confirmation of registration for the 

meeting. Access may be denied to 

persons without proper identification. 

For security reasons, no additional 

meeting registrations will be accepted 

after the close of the registration period. 

Security measures also include 

inspection of vehicles, inside and out, at 

the entrance to the grounds. In addition, 

all persons entering the building must 

pass through a metal detector. All items 

brought to CMS, whether personal or for 

the purpose of demonstration or to 

support a presentation, are subject to 

inspection. Laptops and other computer 

equipment must be registered with the 

security desk upon entry. CMS 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. Participants should e-mail 

presentations to CMS prior to the 

meeting to ensure that CMS has a backup copy in the event of computer 

problems or lack of software or memory 

card compatibility. Please note that 

CMS headquarters is a smoke-free 

facility.

Authority: Section 503 of Public Law 108–

173.

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

Dated: December 16, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services.

[FR Doc. 04–28153 Filed 12–29–04; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0545]

Nonclinical and Clinical Datasets; 

Notice of Pilot Project

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA), Center for 

Biologics Evaluation and Research 

(CBER), is seeking volunteers to 

participate in a pilot project involving 

the evaluation of various analysis tools 

to facilitate the use of electronic datasets 

for analysis of animal and human data 

submitted to FDA by applicants of 

biologics license applications (BLAs). 

These analysis tools will allow a 

reviewer to more efficiently capture and 

evaluate nonclinical and clinical 

datasets submitted in electronic format.

DATES: Submit written requests to 

participate in the pilot project by 

February 28, 2005. Comments on this 

pilot project may be submitted at any 

time.

ADDRESSES: Submit written requests to 

participate and comments regarding the 

pilot project 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:

Richard Diamond, Center for Biologics 

Evaluation and Research (HFM–6), Food 

and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–0372.

SUPPLEMENTARY INFORMATION:

I. Background

Under current FDA regulations (21 

CFR 601.2), applicants must provide 

nonclinical and clinical data in BLAs. 

CBER provided recommendations for 

the electronic submission of BLAs, as 

well as new drug applications (NDAs), 

in the ‘‘Guidance for Industry: Providing 

Regulatory Submissions to the Center 

for Biologics Evaluation and Research 

(CBER) in Electronic Format—Biologics 

Marketing Applications’’ dated 

November 1999. A joint CBER and 

Center for Drug Evaluation and Research 

(CDER) document entitled ‘‘Guidance 

for Industry: Providing Regulatory 

Submissions in Electronic Format—

General Considerations’’ dated January 

1999 provided recommendations for the 

file formats for nonclinical and clinical 

datasets.

FDA announced on July 21, 2004, a 

standard format, called the Study Data 

Tabulation Model (SDTM) developed by 

the Clinical Data Interchange Standards 

Consortium (CDISC), that sponsors of 

human drug clinical trials can use to 

submit data to the agency. It is expected 

that this step will lead to greater 

efficiencies in clinical research and FDA 

reviews of NDAs and BLAs. CDISC is an 

open, multidisciplinary, nonprofit 

organization including members from 

pharmaceutical companies, 

biotechnology companies, contract 

research organizations, and software 

vendors. CDISC committed to the 

development of industry standards to 

support the electronic acquisition, 

exchange, submission and archiving of 

clinical trials data and metadata for 

medical and biopharmaceutical product 

development. CDISC is currently 

facilitating the work on similar 

standards for nonclinical and clinical 

datasets. Where possible, the standards 

developed for clinical datasets and 

metadata should be used in the 

development of standardized