Federal Register / Vol. 63, No. 151 /Thursday, August 6, 1998 / Notices 42053

REGISTRATION: Send registration

information (including name, title, firm

name, address, telephone, and fax

number), via fax or e-mail to the contact

person by Friday, September 4, 1998.

If you need special accommodations

due to a disability, please contact the

contact person at least 7 days in

advance.

SUPPLEMENTARY INFORMATION:

Manufacturers in the Pacific Region,

who employ biotechnology in the

production of FDA regulated products

will be able to identify and evaluate

opportunities for implementing a

partnership approach with FDA. In the

Federal Register of April 20, 1995 (60

FR 19753), FDA announced that a series

of Grassroots Regulatory Partnerships

Meetings would be held to further the

President’s initiative. FDA’s goal at this

meeting is to ‘‘listen’’ to concerns and

ideas of the biotechnology industry, and

to identify next steps for the agency.

There is no registration fee for this

meeting. However, registration is

required. Early registration is

recommended because of space

limitations and the need to send

information about the meeting format to

each registrant. You will be asked to

identify the subject area breakout

session in which you prefer to

participate. To permit the greatest

number of firms to attend, each

company registering for this meeting

should send no more than two

representatives.

Dated: July 29, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20955 Filed 8–5–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0389]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Guidance for Industry: Notification of

a Health Claim or Nutrient Content

Claim Based on an Authoritative

Statement of a Scientific Body’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(the PRA).

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 11, 1998 (63 FR

32102), the agency announced that the

proposed information collection had

been submitted to OMB for review and

clearance under section 3507 of the PRA

(44 U.S.C. 3507). An agency may not

conduct or sponsor, and a person is not

required to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0374. The

approval expires on November 30, 1998.

Dated: July 29, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20957 Filed 8–5–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0519]

Draft Modifications To Devices Subject

To Premarket Approval—The PMA

Supplement Decision Making Process;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘Modifications To Devices

Subject To Premarket Approval—The

PMA Supplement Decision Making

Process.’’ This draft guidance is neither

final nor is it in effect at this time. The

draft guidance includes a flowchart

model that could be used by premarket

approval application (PMA) holders in

their decisionmaking to analyze

whether certain changes in a device

affect the safety or effectiveness of the

device, and therefore, require

submission of a new PMA, PMA

supplement, alternate submission to a

PMA supplement, annual report or

documentation in the PMA holders’

files on the device.

DATES: Written comments concerning

this draft guidance must be received by

November 4, 1998.

ADDRESSES: Submit written requests for

single copies of the draft guidance

document entitled ‘‘Modifications To

Devices Subject To Premarket

Approval—The PMA Supplement

Decision Making Process’’ 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 self-addressed adhesive labels

to assist that office in processing your

request, or fax your request to 301–443–

8818. Written comments concerning this

draft guidance must be submitted to the

Dockets Management Branch, (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Comments should be

identified with the docket number

found in brackets in the heading of this

document. See the SUPPLEMENTARY

INFORMATION section for information on

electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:

Kathy M. Poneleit, Center for Devices

and Radiological Health (HFZ–402),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2186.

SUPPLEMENTARY INFORMATION:

I.Background

In January 1997, FDA released a

guidance document entitled ‘‘Deciding

When to Submit a 510(k) for a Change

to an Existing Device.’’ This document

was an effort to clarify current practice

and FDA’s expectations regarding the

process used to determine whether a

change to a class I or II device or to a

class III device for which premarket

approval had not yet been required

under section 515(b) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360e(b)), required submission

of a new 510(k).

Class III devices subject to premarket

approval requirements under section

515 of the act were not addressed by

that document and the PMA regulation,

part 814 (21 CFR part 814), provides

only general criteria for determining

whether a PMA supplement is required

for a particular device change. FDA’s

process of developing specific guidance

on submission of PMA supplements

coincided with FDA reengineering

activities, including the CDRH effort to

streamline the PMA supplement process

within the context of the existing

premarket approval regulation (part

814).

The draft guidance has been

developed to aid PMA holders who