Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Notices 41397

Information and Regulatory Affairs,

Attn: OMB Desk Officer for ACF, Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street N.W.,

Washington, D.C. 20503, (202) 395–

7316.

Dated: July 28, 1997.

Robert Driscoll,

Reports Clearance Officer.

[FR Doc. 97–20315 Filed 7–31–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0201]

Agency Information Collection

Activities: Proposed Collection;

Comment Request; Extension;

Reopening of Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

reopening of the comment period on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995,

Federal agencies are required to publish

notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension or reopening of an existing

collection of information, and to allow

60 days for public comment in response

to the notice. The notice is reopening

the comment period for a data collection

effort consisting of consumer surveys

regarding preferences for, and

comprehension of information

contained in different formats and

methods for communication in over-thecounter (OTC drug labels), studies C and

D.

DATES: Submit written comments on the

collection of information studies C and

D by September 30, 1997.

ADDRESSES: Submit written comments

of information for studies C and D to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, ATTN: OTC Drug

Labeling Data Collection. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1472.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 23, 1997 (62 FR

28482), FDA published a notice

soliciting comments on a data collection

effort consisting of four consumer

surveys regarding preferences for, and

comprehension of information

contained in different formats and

methods for communication in over-thecounter (OTC) drug labels. To give

interested persons additional time to

submit comments on the proposed data

collection for studies C and D. The

agency is reopening the comment period

for studies C and D only until

September 30, 1997.

Dated: July 28, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20389 Filed 7-31-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0304]

Draft Guidance on Medical Device

Labeling—Suggested Form and

Content; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

medical devices entitled ‘‘Medical

Device Labeling—Suggested Form and

Content.’’ The draft guidance is

intended to assist the device

manufacturers in designing labeling and

FDA in evaluating labeling and to

promote clarity and uniformity in

medical device labeling. The draft

guidance identifies a suggested content

for device labeling and each element of

the suggested labeling is discussed.

DATES: Written comments concerning

this draft guidance must be received by

October 30, 1997.

ADDRESSES: Written comments

concerning this draft guidance must be

submitted to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Comments should be identified with the

docket number found in brackets in the

heading of this document. Submit

written requests for single copies of

‘‘Medical Device Labeling—Suggested

Form and Content’’ to the Division of

Small Manufacturers Assistance (HFZ–

220), Center for Devices and

Radiological Health (CDRH), Food and

Drug Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. See the

SUPPLEMENTARY INFORMATION

section for electronic access to the draft

guidance.

FOR FURTHER INFORMATION CONTACT: Dan

A. Spyker, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8320, or e-mail:

dxs@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

There are labeling requirements for

medical devices in the Federal Food,

Drug, and Cosmetic Act (the act) and in

the regulations issued under the act in

Title 21 of the Code of Federal

Regulations (CFR). General labeling

requirements can be found in 21 CFR

part 801, while detailed and specific

labeling requirements for in vitro

diagnostic products appear in 21 CFR

809.10. In 1991 FDA issued a Blue Book

Memorandum #G91–1, entitled ‘‘Device

Labeling Guidance.’’ The ‘‘Device

Labeling Guidance’’ has been in use

since it was issued, but CDRH studies

and experience have demonstrated a

need for greater direction in the format

and content of device labeling.

Therefore, this updated and expanded

guidance has been drafted. Neither the

act nor the regulations provide specific

definitions or explanations of some

significant labeling terms such as

warnings, precautions,

contraindications and adverse events.

Because labeling is a key factor in the

FDA clearance of premarket

notifications (510(k)’s) and approval of

premarket approval applications

(PMA’s), it is important that

manufacturers and FDA personnel have

a common understanding of how these

terms and other elements of labeling are

defined. An alternative approach may

be used if such approach satisfies the

applicable statute and regulations.

Furthermore, this draft guidance will

not be retrospective; it is intended for

use in the preparation and review of

labeling prior to the issuance of a final

FDA decision.

This draft guidance represents the

agency’s current thinking on device

labeling. 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
41398 Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Notices

such approach satisfies the applicable

statute, regulations, or both.

II. Comments

Interested persons may, on or before

October 30, 1997, submit to the Dockets

Management Branch (address above)

written comments regarding this draft

guidance. 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 draft

guidance and received comments may

be seen in the office above between 9

a.m. and 4 p.m., Monday through

Friday.

III. Electronic Access

In order to receive the ‘‘Medical

Device Labeling—Suggested Form and

Content’’ draft guidance via your fax

machine, call the CDRH Facts-OnDemand system at 800–899–0381 or

301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number 119 followed by the

pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the draft guidance may also do so

using the World Wide Web (www).

CDRH maintains an entry on the World

Wide Web for easy access to information

including text, graphics, and files that

may be downloaded to a PC with access

to the Web. Updated on a regular basis,

the CDRH homepage includes the

‘‘Medical Device Labeling—Suggested

Form and Content’’ draft guidance,

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 homepage may be accessed

at ‘‘http://www.fda.gov/cdrh’’. The

‘‘Medical Device Labeling—Suggested

Form and Content’’ draft guidance is

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

draftgui.html’’.

A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

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. Select menu choice 1–FDA

Bulletin Board Service. At login prompt

type ‘‘bbs’’ and hit Enter, at password

prompt type ‘‘bbs’’ and hit Enter, at this

screen, hit Enter (brings you to FDA

Home Page), using tab key, select

Medical Devices/Radiological Health—

hit Enter, using

tab key, select Topic Index—hit Enter,

using tab key, select ‘‘L’’—hit Enter,

under ‘‘Labeling’’ is the title of the draft

guidance ‘‘Medical Device LabelingSuggested Form and Content’’—select

text file—hit Enter, use space bar to

move page to page, in order to view the

whole document.

Dated: July 2, 1997.

Joseph A. Levitt.

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–20313 Filed 07–31–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0312]

Medical Devices; Device Labeling

Requirements; Notice of Public

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

open public meeting to discuss the draft

guidance entitled ‘‘Medical Device

Labeling—Suggested Format and

Content,’’ which is being announced

elsewhere in the issue of the Federal

Register, and to identify other concerns

that manufacturers and others may have

regarding the medical device labeling

regulation or the labeling procedures

used by the Center for Devices and

Radiological Health (CDRH). Revision of

the labeling requirements for in vitro

diagnostic products is not being

considered at this time. Health care

practitioners and lay users of medical

devices are encouraged to participate in

the public meeting.

DATES: The public meeting will be held

on September 5, 1997, from 9 a.m. to 5

p.m. Written notices of participation

should be filed by August 22, 1997.

Submit written comments by September

24, 1997.

ADDRESSES: The public meeting will be

held at the Double Tree Hotel, 1750

Rockville Pike, Rockville, MD 20852.

Submit written notices of participation

and written comments to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Patricia A. Kingsley, Center for Devices

and Radiological Health (HFZ–230),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–2436, or via Internet at

‘‘PAK@cdrh.fda.gov’’.