Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices 64839

• Clinical description of the service

under discussion, with comparison to

other services within the APC;

• Description of the resource inputs

associated with the service under

discussion, with a comparison to other

services within the APC;

• Recommendations and rationale for

change; and

• Expected outcome of change and

potential consequences of no change.

Further details can be found on our

web site at http://www.hcfa.gov/fac/

apcpage.htm. Presentations submitted

without the required data and

information will not be considered.

In order to be scheduled to speak, this

information must be received no later

than 5 p.m., Tuesday, January 8, 2002 at

the above address. Alternatively, the

information may be sent electronically

to the email address specified above.

Because of staffing and resource

limitations, we cannot accept this

information by facsimile (FAX).

Presentations are limited to no more

than 5 minutes and must be on the

listed agenda topics only. The number

of presentations may be limited by the

time available.

In addition to formal presentations,

there will be an opportunity during the

meeting for public comment, limited to

1 minute for each individual or

organization. The number of speakers

may be limited by the time available.

Any persons wishing to attend this

meeting located on Federal property

must call the meeting coordinator,

Angela Mason, at (410) 786–7452 to

register at least 72 hours in advance.

Persons attending must show a

photographic identification to the

Federal Protective Service or Guard

Service personnel before they will be

allowed to enter the building. Persons

not registered in advance will not be

permitted into the building and will not

be permitted to attend the meeting.

News media representatives should

contact the CMS Press Office at (202)

690–6145.

Individuals requiring sign language

interpretation for the hearing impaired

or other special accommodations should

contact the meeting coordinator at least

10 days before the meeting.

Authority: Section 1833 of the Social

Security Act (42 U.S.C. 1395l) and section

10(a) of Public Law 92–463 (5 U.S.C. App. 2,

section 10(a)); 45 CFR part 11)

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare-Hospital

Insurance; and Program No. 93.774,

Medicare-Supplementary Medical Insurance

Program)

Dated: December 11, 2001.

Thomas A. Scully,

Administrator, Centers for Medicare &

Medicaid Services.

[FR Doc. 01–30990 Filed 12–13–01; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers For Medicare & Medicaid

Services

[CMS–4031–N]

Medicare Program; Open Public

Meeting on January 16, 2002 to

Discuss Activities Related to the

Collection of Diagnostic Data from

Medicare+Choice Organizations for

Risk Adjustment

AGENCY: Centers for Medicare &

Medicaid Services (CMS), Health and

Human Services.

ACTION: Notice of meeting.

SUMMARY: This notice announces a

public meeting to provide

Medicare+Choice Organizations

(M+COs), providers, practitioners, and

other interested parties an opportunity

to ask questions and raise issues

regarding the risk adjustment model that

will be selected for use beginning in

2004 and reporting requirements for

diagnostic information. The purpose of

the meeting is to provide information

about risk adjustment model options

and associated data collection issues

and to allow for public comment

regarding the models and data

collection.

DATES: The meeting is scheduled for

January 16, 2002 from 9 a.m. until 4

p.m., EST.

ADDRESSES: The meeting will be held in

the CMS Auditorium, 7500 Security

Boulevard, Baltimore, Maryland, 21244–

1850.

FOR FURTHER INFORMATION CONTACT:

Bobbie Knickman at (410) 786–4161. To

submit public comment no later than

February 1, 2002, email: Bobbie

Knickman at bknickman@cms.hhs.gov

or fax to (410) 786–1048.

SUPPLEMENTARY INFORMATION:

Background

The Balanced Budget Act of 1997

(BBA) (Public Law 105–33) established

the Medicare+Choice program that

significantly expanded the health care

options available to Medicare

beneficiaries. Under the BBA, the

Secretary of the Department of Health

and Human Services (the Secretary)

must implement a risk adjustment

methodology that accounts for

variations in per capita costs based on

health status and other demographic

factors for payment to Medicare+Choice

organizations (M+COs). The BBA also

gives the Secretary the authority to

collect inpatient hospital data for

discharges on or after July 1, 1997, and

additional data for other services

occurring on or after July 1, 1998. Risk

adjustment implementation began

January 1, 2000. Payments to M+COs are

made at 10 percent risk adjusted rates

and 90 percent demographically

adjusted rates for years 2000 through

2003. The Medicare, Medicaid, and

SCHIP Benefits Improvement and

Protection Act (BIPA), enacted in

December 2000, stipulates that the risk

adjustment methodology for 2004 and

succeeding years should be based on

data from inpatient hospital and

ambulatory settings. BIPA contains a

provision that phases in future risk

adjusted payments as follows: 30

percent in 2004; 50 percent in 2005; 75

percent in 2006; and 100 percent in

2007. The collection of physician

encounter data, which began on October

1, 2000, and hospital outpatient

encounter data, which began on April 1,

2001, was suspended on May 25, 2001

through July 1, 2002. The Secretary

indicated that we will be working

closely with all interested parties to

explore and implement a risk

adjustment process for M+C payments

that balances accuracy with

administrative burden. The meeting will

address the following topics:

• Risk adjustment models

incorporating ambulatory and inpatient

diagnoses;

• Collection/reporting of beneficiary

and diagnostic information for

Medicare+Choice enrollees in hospital

inpatient, outpatient, and physician

settings for use in risk adjustment

models; and

• Data issues.

The agenda will include presentations

by our staff and a question and answer

sessions. Written public comments are

preferred following the meeting and will

be accepted until February 1, 2002.

Registration

Registration for this public meeting is

required and will be on a first-come,

first-serve basis, limited to two

attendees per organization. A waiting

list will be available for additional

requests. The registration deadline will

be January 11, 2002 at 5:00 pm. EST.

Registration will be done via the

Internet at http://www.hcfa.gov/events/

events.htm. A confirmation notice will

be sent to attendees upon finalization of

registration.

64840 Federal Register / Vol. 66, No. 241 / Friday, December 14, 2001 / Notices

Persons who are not registered in

advance will not be permitted into the

Federal Building and thus not be able to

attend the meeting. Persons attending

the meeting will be required to show a

photographic identification, preferably a

valid drivers’ license before entering the

building. Please note that if the meeting

is cancelled we will post that

information on our website.

Attendees will be provided with

meeting materials at the time of the

meeting. Written meeting materials will

be posted on the CMS website before the

January 16, 2002 meeting at: http://

www.hcfa.gov and http://

www.cms.hhs.gov. We will accept

written questions about meeting

logistics or requests for meeting

materials either before the meeting or up

to 14 days after the meeting. Written

submissions must be sent to:

Aspen Systems Corporation, ATTN:

Kim Slaughter, 2275 Research

Boulevard, Mail Stop 5W, Rockville,

Maryland 20850.

You may also contact Encounter Data

Representative: Kim Slaughter,

Telephone Number: (301) 519–5388,

Fax Number: (301) 519–6360, E-mail:

encounterdata@aspensys.com.

Written public comments will be

accepted until February 1, 2002. Written

public comments should be sent to

Bobbie Knickman at

bknickman@cms.hhs.gov or fax to (410)

786–1048.

(Authority: Sections 1851 through 1859 of

the Social Security Act (42 U.S.C. 1395w–21

through 1395w–28))

(Catalog of Federal Domestic Assistance

Program No. 93.773 Medicare—Hospital

Insurance Program; and No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: December 11, 2001.

Thomas A. Scully,

Administrator, Centers for Medicare &

Medicaid Services.

[FR Doc. 01–30991 Filed 12–13–01; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0393]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Prescription Drug Product Labeling;

Medication Guide Requirements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by January 14,

2002.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attn: Stuart

Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Prescription Drug Product Labeling;

Medication Guide Requirements (OMB

Control No. 0910–0393)—Extension

FDA regulations require the

distribution of patient labeling, called

Medication Guides, for certain

prescription human drug and biological

products used primarily on an

outpatient basis that pose a serious and

significant public health concern

requiring distribution of FDA-approved

patient medication information. These

Medication Guides inform patients

about the most important information

they should know about these products

in order to use them safely and

effectively. Included are information

such as the drug’s approved uses,

contraindications, adverse drug

reactions, and cautions for specific

populations, with a focus on why the

particular product requires a Medication

Guide. These regulations are intended to

improve the public health by providing

information necessary for patients to use

certain medication safely and

effectively.

The regulations contain the following

reporting requirements that are subject

to the PRA. The estimates for the burden

hours imposed by the following

regulations are listed in table 1 of this

document:

21 CFR 208.20—Applicants must

submit draft Medication Guides for FDA

approval according to the prescribed

content and format.

21 CFR 314.70(b)(3)(ii) and

601.12(f)—Application holders must

submit changes to Medication Guides to

FDA for prior approval as supplements

to their applications.

21 CFR 208.24(e)—Each authorized

dispenser of a prescription drug product

for which a Medication Guide is

required, when dispensing the product

to a patient or to a patient’s agent, must

provide a Medication Guide directly to

each patient unless an exemption

applies under § 208.26 (21 CFR 208.26).

Section 208.26(a)—Requests may be

submitted for exemption or deferral

from particular Medication Guide

content or format requirements.

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency

per Response

Total Annual

Responses Hours per Response Total Hours

208.20 8 1 8 242 1,936

314.70(b)(3)(ii) and

601.12(f) 3 1 3 24 72

208.24(e) 55,000 8.3 460,000 .0014 644

208.26(a) 1 1 1 4 4

Total 2,656

1There are no capital costs or operating and maintenance costs associated with this collection of information.

In the Federal Register of September

25, 2001 (66 FR 49024), the agency

requested comments on the proposed

collections of information. FDA

received one comment on the

September 25, 2001, notice. The