Federal Register / Vol. 61, No. 127 / Monday, July 1, 1996 / Notices 33927

committee of experts. A petition is to be

in the form of a petition for

reconsideration under § 10.33(b) (21

CFR 10.33(b)). A petitioner shall

identify the form of review requested

(hearing or independent advisory

committee) and shall submit with the

petition supporting data and

information showing that there is a

genuine and substantial issue of

material fact for resolution through

administrative review. After reviewing

the petition, FDA will decide whether to

grant or deny the petition and will

publish a notice of its decision in the

Federal Register. If FDA grants the

petition, the notice will state the issue

to be reviewed, the form of the review

to be used, the persons who may

participate in the review, the time and

place where the review will occur, and

other details.

Petitioners may, at any time on or

before July 31, 1996, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: April 9, 1996.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 96–16663 Filed 6–28–96; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETING: The following advisory

committee meeting is announced:

Advisory Committee for Reproductive

Health Drugs

Date, time, and place. July 19, 1996,

9 a.m., FDA Technical Center, 16071

Industrial Dr., Gaithersburg, MD.

Attendees should allow time to proceed

through security procedures. Admission

to the facility by public participants will

be available on a first come, first serve

basis, and will be limited to

approximately 200, the number of seats

available to the public in the conference

room. There will be an overflow room

with both audio and video link to the

meeting. The overflow room is located

at the Hilton Hotel, 620 Perry Pkwy.,

Gaithersburg, MD.

Type of meeting and contact person.

Open committee discussion, 9 a.m. to

1:30 p.m.; open public hearing, 1:30

p.m. to 3:30 p.m., unless public

participation does not last that long;

open committee discussion, 3:30 p.m. to

5 p.m.; Philip A. Corfman, Center for

Drug Evaluation and Research (HFD–

580), Food and Drug Administration,

5600 Fishers Lane, rm. 14B–04,

Rockville, MD 20857, 301–443–3510,

FAX 301–443–9282, or e-mail

july19@cder.fda.gov. Information

concerning the meeting is available from

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Advisory Committee for Reproductive

Health Drugs, code 12537. Please call

the hotline for information concerning

any possible changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational human

drugs for use in the practice of

obstetrics, gynecology, and related

specialties.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person in writing by mail, email, or fax no later than 5 p.m., EDT

on July 12, 1996, with a brief statement

of the general nature of the evidence or

arguments they wish to present, the

names, telephone numbers, and

addresses of proposed participants, and

an indication of the approximate time

required to make their comments. The

time for presentations will be allotted

equitably, and will depend on how

many individuals give advance notice

within the time indicated of their

intention to speak. In the interest of

time, the agency may require persons

with common interests to make joint

presentations.

Open committee discussion. The

committee will discuss the new drug

application for mifepristone for the

interruption of early pregnancy.

FDA public advisory committee

meetings may have as many as four

separable portions: (1) An open public

hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. There are no closed portions

for the meetings announced in this

notice. The dates and times reserved for

the open portions of each committee

meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published
33928 Federal Register / Vol. 61, No. 127 / Monday, July 1, 1996 / Notices

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above in writing,

prior to the meeting.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

This notice is issued under section

10(a)(1) and (2) of the Federal Advisory

Committee Act (5 U.S.C. app. 2), and

FDA’s regulations (21 CFR part 14) on

advisory committees.

Dated: June 25, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96–16770 Filed 6–28–96; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[BPD–847–CN]

RIN 0938–AH34

Medicare Program; Changes to the

Hospital Inpatient Prospective

Payment Systems and Fiscal Year 1997

Rates; Correction

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Correction notice.

SUMMARY: On May 31, 1996, we

published a proposed rule (61 FR

27444) that would revise the Medicare

hospital inpatient prospective payment

systems for operating costs and capitalrelated costs to implement necessary

changes arising from our continuing

experience with the systems. In the

addendum to the proposed rule, we

announced the prospective payment

rates for Medicare hospital inpatient

services for operating costs and capitalrelated costs that would apply to

discharges occurring on or after October

1, 1996, and set forth the factors for

determining the rate-of-increase limits

for hospital and hospital units excluded

from the prospective payment system.

This notice corrects errors made in that

document.

FOR FURTHER INFORMATION CONTACT: Tzvi

Hefter, (410) 786–1304.

SUPPLEMENTARY INFORMATION: In the May

31, 1996 proposed rule (61 FR 27444),

we indicated that the addendum would

discuss our proposed update of the

factors for determining the rate-ofincrease limits for cost reporting periods

beginning in Federal fiscal year 1997 for

hospitals and hospital units excluded

from the prospective payment system.

This discussion was inadvertently

omitted from the published document.

In addition, there were errors in our

calculations of the Geographic

Adjustment Factors (GAFs) in tables 4a

and 4b. The tables are reprinted in their

entirety in this document. The GAFs set

forth in table 4c are correct.

The proposed rule also contained

other technical and typographical

errors. Therefore, we are making the

following corrections to the May 31,

1996 proposed rule:

1. On page 27474, in the table entitled

Initial Residency Period, after

‘‘Allopathy’’ and before

‘‘ANESTHESIOLOGY’’ insert the

following row:

ALLERGY AND IMMUNOLOGY ..................3.

2. On page 27504, in the second

column before ‘‘V. Tables’’, the

following information should be

inserted:

IV. Proposed Rate-of-Increase

Percentages for Excluded Hospitals and

Hospital Units

The inpatient operating costs of

hospitals and hospital units excluded

from the prospective payment system

are subject to rate-of-increase limits

established under the authority of

section 1886(b) of the Act, which is

implemented in § 413.40 of the

regulations. Under these limits, an

annual target amount (expressed in

terms of the inpatient operating cost per

discharge) is set for each hospital, based

on the hospital’s own historical cost

experience trended forward by the

applicable rate-of-increase percentages

(update factors). The target amount is

multiplied by the number of Medicare

discharges in a hospital’s cost reporting

period, yielding the ceiling on aggregate

Medicare inpatient operating costs for

the cost reporting period.

Effective with cost reporting periods

beginning on or after October 1, 1991, a

hospital that has Medicare inpatient

operating costs in excess of its ceiling is

paid its ceiling plus 50 percent of its

costs in excess of the ceiling. Total

payment may not exceed 110 percent of

the ceiling. A hospital that has inpatient

operating costs less than its ceiling is

paid its costs plus the lower of—

• Fifty percent of the difference

between the allowable inpatient

operating costs and the ceiling; or

• Five percent of the ceiling.

Each hospital’s target amount is

adjusted annually, at the beginning of

its cost reporting period, by an

applicable rate-of-increase percentage.

Section 1886(b)(3)(B) of the Act

provides that for cost reporting periods

beginning on or after October 1, 1993,

and before October 1, 1994, the

applicable rate-of-increase percentage is

the market basket percentage increase

minus the lesser of 1 percentage point

or the percentage point difference

between 10 percent and the hospital’s

‘‘update adjustment percentage’’ of at

least 10 percent. The rate-of-increase

percentage for hospitals in the latter

case is the market basket percentage

increase. The ‘‘update adjustment

percentage’’ is the percentage by which

a hospital’s allowable inpatient

operating costs exceeds the hospital’s

ceiling for the cost reporting period

beginning in Federal fiscal year (FY)

1990. For cost reporting periods

beginning on or after October 1, 1994,

and before October 1, 1997, the update

adjustment percentage is the update

adjustment percentage from the

previous year plus the previous year’s

applicable reduction. The applicable

reduction and applicable rate-ofincrease percentage are then determined

in the same manner as for FY 1994. The

most recent forecasted market basket

increase for FY 1997 for hospitals and

hospital units excluded from the

prospective payment system is 2.7

percent.

3. On pages 27521 to 27527, Table

4a—Wage Index and Capital Geographic

Adjustment Factor (GAF) for Urban

Areas is corrected by replacing the table

with the following table: