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 the following

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

of 1997 (FDAMA). The topic to be discussed is how FDA can best meet its

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

(the act). The meeting is intended to involve participants from

consumer and patient advocacy groups, health professionals, scientific

and academic experts, and the regulated industry in drafting FDA's

developmental plan to meet the objectives of FDAMA.

Date and Time: The meeting will be held on Monday, September 14,

1998, 9 a.m. to 5 p.m.

Location: The meeting will be held at Bethesda Holiday Inn, 8120

Wisconsin Ave., Bethesda, MD 20814.

Contact: Patricia M. Kuntze, Office of External Affairs (HF-60),

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

301-827-3363, FAX 301-594-0113, or e-mail ``PK[email protected]''.

Registration and Requests for Oral Presentations: Send registration

information (including name, title, firm name, address, telephone, and

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

presentations, to the contact person by Monday, August 31, 1998.

If you need special accommodations due to a disability, please

contact Patricia M. Kuntze 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 statutory obligations.

Section 406(b) of FDAMA further requires that 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.

The agency held a series of public meetings to obtain public views

on how FDA can best meet its statutory obligations related to foods,

biologics, human drugs, medical devices, and veterinary medicine. FDA

also solicited specific suggestions on how the agency can most

effectively achieve the six FDAMA objectives outlined above. The views

received by the agency on these topics were used as a source for

identifying crosscutting issues, themes, and priorities that should be

addressed in the FDA plan.

This meeting will focus on these crosscutting issues, themes, and

priorities. Of particular interest to the agency are its stakeholder

views on FDA's consumer health protection obligations and the

approaches that should be used to fulfill them. These obligations

include: (1) Conducting the research, or taking other steps, necessary

to assess risks associated with product consumption/use; (2)

establishing standards, based on risk assessment, for products and the

processes necessary to produce them; (3) reviewing new product

applications and determining the product's acceptability for entry onto

the market; (4) assisting new product sponsors in designing and

implementing research and testing protocols that will facilitate the

progress of their applications through the FDA review process; (5)

determining ``experience'' with products once they are on the market;

(6) conducting inspections to determine the state of industry

compliance with FDA standards; (7) carrying out a variety of strategies

to ensure compliance, including education, technical assistance, and

more directed enforcement activities such as warning letters, product

seizures, and prosecutions; and (8) educating consumers and health

professionals on risks and risk-avoidance behavior.

The agency is open to all views and ideas about what methods should

be used to carry out these basic consumer protection functions, the

level of consumer protection that will be provided by different methods

and whether this level of protection is acceptable, and what will be

needed to reach the desired level of consumer protection by using the

proposed method. To help clarify stakeholder views on FDA's role and

approaches for fulfilling its consumer protection obligations, the

agency requests that oral and/or written views address the following

seven questions:

1. Should the above-listed consumer protection functions be

modified in any way? If so, what functions would you change, add, or

delete?

2. For which of the above-listed functions do you believe that it

would be acceptable for FDA to charge fees?

3. For which of the above-listed functions could, and should, FDA

rely more on the efforts of third parties, such as testing

laboratories, health professional organizations, standard setting

organizations, States, or regulated industry?

4. For which of the above-listed functions do you see the best

potential for FDA to collaborate with its external stakeholders, such

as States, industry, other regulatory agencies, international

organizations, etc. to the greater benefit of all parties?

5. Which of the above-listed functions do you believe offers the

greatest opportunities for FDA to place more emphasis on non-regulatory

approaches--such as education, technical assistance, and collaborative

problem solving--to protect and promote the public health?

6. FDA's product and process standards have long been considered as

the ``benchmark'' by which to judge the safety, quality, and efficacy

of foods, drugs, biologicals, and medical devices. Would it be

appropriate for the agency to sanction the use of an FDA seal or mark

on products that meet the `gold' standard, as a way of encouraging more

widely behavior that meets the standard? Should FDA charge user fees to

third parties and others who use the seal, as a way of financing agency

operations?

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7. Currently, the vast majority of the agency's international

resources are devoted to detecting and stopping product problems at the

border, while developing the capability to allow safe products to go

forward quickly. A smaller percentage of FDA's international resources

are dedicated to working with other countries through our participation

in international standard setting, developing mutual recognition

agreements between the United States and other nations, and offering

technical assistance to the public sector regulators and private sector

producers of other countries. Do you think that the American consumer

is adequately protected with this balance of activities?

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 21, 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''.

The FDA website provides substantive background information. It is

strongly recommended that those individuals or groups who wish to make

a presentation or submit written comments consult the FDA website

``http://www.fda.gov'' for additional information. For pertinent

information not on the website, consult with the designated contact

person listed in this document.

Individuals who wish to present at this public meeting are

encouraged to attend the entire day. Information will be presented

throughout the meeting about cross-cutting issues and themes related to

the FDA plan that will be derived from stakeholder input. This meeting

will provide an opportunity for an open comment session in which

attendees can express their views.

III. Additional Meetings

FDA held a series of public meetings to discuss the FDAMA

objectives, within the context of its statutory obligations for foods,

biologics, human drugs, medical devices, and veterinary medicine, as

described in section I of this document. The public meeting for the

Center for Food Safety and Applied Nutrition (CFSAN) was held on June

24 and 25, 1998. A summary of the views presented at the CFSAN meeting

is available on the CFSAN website ``http://www.cfsan.fda.gov''. For

more information on the CFSAN meeting, contact Tracy S. Summers, Center

for Food Safety and Applied Nutrition (HFS-1), Food and Drug

Administration, 200 C St. SW., Washington, DC 20204, 202-205-4850, FAX

202-205-5025, e-mail ``[email protected]''.

The other meetings were held in Washington, DC on August 14, 1998

(Biologics); August 17, 1998 (Human Drugs); August 18, 1998 (Medical

Devices); and August 19, 1998 (Veterinary Medicine); and in Oakland, CA

on August 28, 1998 (Biologics). For additional information about these

meetings, please refer to the Federal Register of July 24, 1998 (63 FR

39877) or the FDA website ``http://www.fda.gov''.

IV. Transcripts

The transcript of this meeting 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 11, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-22391 Filed 8-19-98; 8:45 am]

BILLING CODE 4160-01-F