Public Meeting on Section 406(b) of the FDA Modernization Act of 1997

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0339]

Public Meeting on Section 406(b) of the FDA Modernization Act of

1997

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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The Food and Drug Administration (FDA) is announcing a meeting with

health professional organizations on section 406(b) of the FDA

Modernization Act of 1997 (FDAMA) to discuss how FDA can best meet its

statutory obligations under the Federal Food, Drug, and Cosmetic Act

(the act). The agency intends to involve participants from health

professional organizations in drafting FDA's developmental plan to meet

the objectives of FDAMA.

Date and Time: The meeting will be held on Tuesday, September 8,

1998, 1 p.m. to 4 p.m.

Location: The meeting will be held at the Hyatt Regency Hotel, One

Metro Center, Bethesda, MD.

Contact: Elizabeth B. Palsgrove, Office of Health Affairs (HFY-40),

Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,

301-827-6618, FAX 301-443-2446, or 1-800-433-3332, e-mail

``[email protected]''.

Registration and Requests for Oral Presentations: Send registration

information (including name, title, firm name, address, telephone, e-

mail, and fax number), and written material and requests to make oral

presentations, to the designated contact person listed in this

document. There is no registration fee, however, space is limited.

Persons will be registered in the order in which registration is

received.

If you need special accommodations due to a disability, please

contact Elizabeth B. Palsgrove at least 7 days in advance.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 406(b) of FDAMA, the agency is required to consult

with its external stakeholders, specifically ``appropriate scientific

and academic experts, health care professionals, representatives of

patient and consumer advocacy groups, and the regulated industry.''

Following these consultations, FDA is to develop and publish a plan for

achieving compliance with each of its obligations under the act.

Under section 406(b) of FDAMA, the plan, which must be published in

the Federal Register by November 21, 1998, should address, but may not

be confined to, the following six objectives: (1) Maximizing the

availability and clarity of information about the agency application

and submission review processes; (2) maximizing the availability and

clarity of information for consumers and patients concerning new

products; (3) implementing inspection and postmarket monitoring

provisions of the act; (4) assuring access to the scientific and

technical expertise needed to carry out FDA's obligations; (5)

establishing mechanisms, by July 1, 1999, for meeting specified time

periods for the review of applications and submissions; and (6)

eliminating backlogs in the review of applications and submissions.

To help focus comments, FDA requests that oral and/or written views

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regarding how the agency can best meet these six objectives of its

modernization plan address seven questions. An information packet,

available on the FDA webpage or from the designated contact person

listed in this document, provides substantive background information;

it is highly recommended that those individuals or groups who wish to

make a presentation or submit written comments obtain this packet.

Specific questions relate to each objective as follows:

1. What can FDA do to improve its explanation of the agency's

submission review processes, and make explanations more available to

product sponsors and other interested parties?

2. How can the agency maximize the availability and clarity of

information concerning new products?

3. How can FDA work with its partners to ensure that products--both

domestic and foreign--produced and marketed by the regulated industry

are of high quality and provide necessary consumer protection; and how

can FDA best establish and sustain an effective, timely, and science-

based postmarketing surveillance system for reporting, monitoring,

evaluating, and correcting problems associated with use/consumption of

FDA-regulated products?

4. What approach should FDA use to assure an appropriate scientific

infrastructure, with continued access to the scientific and technical

expertise needed to meet its statutory obligations and strengthen its

science-based decisionmaking process?

5. What do you believe FDA should do to adequately meet the demands

that are beginning to burden the application review process, especially

for non-user fee products, so that it can meet its statutory

obligations to achieve timely product reviews?

6. What suggestions do you have for the agency to eliminate

backlogs in the review process?

7. What other objectives related to the agency's statutory

obligations or public expectations--beyond the six objectives--should

be included in the FDA plan?

II. Comments

Written comments should be identified with the docket number found

in brackets in the heading of this document and should be submitted by

September 11, 1998, to the Dockets Management Branch (HFA-305), Food

and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD

20852. Comments can be sent to the Dockets Management Branch at the

following e-mail address ``FDAD[email protected]'' or via the FDA

website ``http://www.fda.gov''.

III. Additional Meetings

This meeting is related to a series of other public meetings held

that were announced in the Federal Register of July 24, 1998. A

separate FDAMA section on the FDA website is available for information

about these public meetings.

An additional public meeting is being planned for September 14,

1998, to obtain stakeholder views on potential recurring themes and the

best approach for consolidating these themes agencywide. A separate

notice of this meeting will be published in the Federal Register.

IV. Transcripts

Transcripts of these meetings may be requested in writing from the

Freedom of Information Office (HFI-35), Food and Drug Administration,

5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15

working days after the meeting at a cost of 10 cents per page. The

transcript of the meeting will be available for public examination at

the Dockets Management Branch (address above) between 9 a.m. and 4

p.m., Monday through Friday, as well as on the FDA website ``http://

www.fda.gov''.

Dated: August 13, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-22393 Filed 8-19-98; 8:45 am]

BILLING CODE 4160-01-F