39100 Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices

with access to the Web. Updated on a

regular basis, the CDRH home page

includes ‘‘New Medical Device

Development Process’’ device safety

alerts, Federal Register reprints,

information on premarket submissions

(including lists of approved applications

and manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh.

A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

1–800–222–0185 (terminal settings are

8/1/N). Once the modem answers, press

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select Medical

Devices and Radiological Health. From

there select CENTER FOR DEVICES

AND RADIOLOGICAL HEALTH for

general information, or arrow down for

specific topics.

III. Comments

Interested persons may, on or before

October 19, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

document. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The

document and received comments may

be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: July 10, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–19318 Filed 7–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0133]

Revised Guidance for Industry on

Implementation of Section 126 of the

Food and Drug Administration

Modernization Act of 1997—

Elimination of Certain Labeling

Requirements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a revised guidance for

industry entitled ‘‘Implementation of

Section 126 of the Food and Drug

Administration Modernization Act of

1997— Elimination of Certain Labeling

Requirements.’’ Section 126 of the Food

and Drug Administration Modernization

Act of 1997 (Modernization Act)

amends the Federal Food, Drug, and

Cosmetic Act (the act) to require, at a

minimum, that prior to dispensing, the

label of prescription products contain

the symbol ‘‘Rx only’’ instead of the

‘‘Caution: Federal law prohibits

dispensing without prescription’’

statement. In addition, the requirement

that the labels of certain habit-forming

drugs bear the statement ‘‘Warning-May

be habit forming’’ has been repealed.

The revised guidance changes the

implementation schedule provided in

the original guidance dated February

1998, and answers certain questions

concerning implementation of these

amendments.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Copies of this guidance for

industry can be obtained on the Internet

at http://www.fda.gov/cder/guidance/

index.htm or http://www.fda.gov/cber/

guidelines.htm. Submit written requests

for single copies of this guidance to the

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857 or to the Office of

Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Jerry Phillips, Center for Drug

Evaluation and Research (HFD–

610), Food and Drug

Administration, Office of Generic

Drugs, 7500 Standish Pl., Rockville,

MD 20855, 301–827–5846, or

Robert A. Yetter, Center for Biologics

Evaluation and Research (HFM–10),

Food and Drug Administration,

1401 Rockville Pike, Rockville, MD

20852–1448, 301–827–0373.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a revised

guidance for industry entitled

‘‘Implementation of Section 126 of the

Food and Drug Administration

Modernization Act of 1997—

Elimination of Certain Labeling

Requirements.’’ Section 126 of Title I of

the Food and Drug Administration

Modernization Act of 1997 (Pub. L. 105–

115), signed into law by President

Clinton on November 21, 1997, amends

section 503(b)(4) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 353(b)(4)) to require, at a

minimum, that prior to dispensing, the

label of prescription products contain

the symbol ‘‘Rx only’’ instead of the

‘‘Caution: Federal law prohibits

dispensing without prescription’’

statement. In addition, section 502(d) of

the act (21 U.S.C. 352(d)), that required

the labels of certain habit-forming drugs

to bear the statement ‘‘Warning–May be

habit forming’’ is repealed. The

amendments to section 503(b)(4) and

the repeal of section 502(d) of the act

became effective February 19, 1998.

FDA published a notice in the Federal

Register of March 13, 1998, announcing

the availability of the original guidance

(63 FR 12473) and soliciting comments.

Three comments on the guidance were

submitted to the docket. In response to

the comments, and to questions that

were asked concerning the

implementation of section 126 of the

Modernization Act, FDA is issuing a

revised guidance.

The revised guidance: (1) Describes

the new prescription drug labeling

requirements of the act as amended by

the Modernization Act, (2) changes the

implementation schedule previously

described in the February 1998

guidance, and (3) answers certain

frequently asked questions about the

provision. The revised guidance advises

that FDA does not intend to object if a

sponsor of a currently approved product

implements section 126 of the

Modernization Act at the time of the

next revision of its labels, or by

February 19, 2003, whichever comes

first, and reports these minor changes in

the next annual report. For pending
Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices 39101

(unapproved) full or abbreviated

applications received by the agency

prior to February 19, 1998, sponsors

have until the time of next revision of

their labels or by February 19, 2003,

whichever comes first, to comply with

the amendments and they must report

these minor changes in their next

annual report. The guidance also

advises that full or abbreviated

applications received by FDA after

February 19, 1998, should provide

labels and labeling in compliance with

the amendments.

This revised guidance document

represents the agency’s current thinking

on implementation of the elimination of

certain labeling requirements. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulations, or both.

Interested persons may, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). Two copies of

any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. The guidance and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: July 10, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–19317 7–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–R–193]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) the necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: ‘‘ An Important

Message form Medicare.’’and

Supporting Regulations 42 CFR 466.78,

489.27, .20; Form No.: HCFA–R–193,

OMB # 0938–0692; Use: Hospitals

participating in the Medicare program

have agreed to distribute ‘‘ An Important

Message from Medicare’’ to beneficiaries

during each admission. Receiving this

information will provide the beneficiary

with some ability to participate and/ or

initiate discussions concerning

discussions affecting Medicare coverage

or payment and about his or her appeal

rights in response to any hospitals

notice to the effect that Medicare will no

longer cover continued care in the

hospital. Frequency: Other, as needed;

Affected Public: Individuals or

Households, Business or other for-profit,

Not-for-profit, Federal Government,

State, Local, or Tribal Government;

Number of Respondents: 6,700; Total

Annual Responses: 11,000,000.; Total

Annual Hours: 183,000.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, E-mail

your request, including your address

and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: July 9, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 98–19386 Filed 7–20–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Privacy Act of 1974; Report of New

System

AGENCY: Department of Health and

Human Services (HHS), Health Care

Financing Administration (HCFA).

ACTION: Notice of new system of records.

SUMMARY: In accordance with the

requirements of the Privacy Act of 1974,

we are proposing to establish a new

system of records, called ‘‘End-Stage

Renal Disease (ESRD) Managed Care

Demonstration System,’’ HHS/HCFA/

OSP No. 09–70–0067. We have provided

background information about the

proposed new system in the

SUPPLEMENTARY INFORMATION section

below. Although the Privacy Act

requires only that the ‘‘routine uses’’

portion of the system be published for

comment, HCFA invites comments on

all portions of this notice.

DATES: HCFA filed a new system report

with the Chairman of the Committee on

Government Reform and Oversight of

the House of Representatives, the

Chairman of the Committee on

Governmental Affairs of the Senate, and

the Administrator, Office of Information

and Regulatory Affairs, Office of

Management and Budget (OMB), on July

9, 1998. The new system of records,

including routine uses, will become

effective 40 days from the date

submitted to OMB and the Congress,

unless HCFA receives comments which

require alteration to this notice.

ADDRESSES: The public should address

comments to the HCFA Privacy Act

Officer, Division of Freedom of

Information & Privacy, Office of

Information Services, Health Care

Financing Administration, 7500

Security Boulevard, C2–01–11,

Baltimore, Maryland 21244–1850.

Comments received will be available for

review at this location by appointment,

Monday through Friday 9 a.m.–3 p.m.,

eastern time zone.

FOR FURTHER INFORMATION CONTACT: Paul

Eggers, Office of Strategic Planning,

Health Care Financing Administration,

7500 Security Boulevard, C3–24–07,

Baltimore, Maryland 21244–1850. His

telephone number is (410) 786–6691.

SUPPLEMENTARY INFORMATION: The ESRD

Managed Care Demonstration System

data file contains information on

beneficiaries enrolled in the ESRD

Managed Care Demonstration. This

information will be used by HCFA and

its evaluation contractor to monitor and

evaluate the demonstration. The system