[Federal Register Volume 63, Number 161 (Thursday, August 20, 1998)]
[Pages 44627-44628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22391]



Food and Drug Administration
[Docket No. 98N-0339]

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

AGENCY:  Food and Drug Administration, HHS.

ACTION: Notice of meeting.


    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 ``PKuntze@bangate.fda.gov''.
    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.

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 
    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 

[[Page 44628]]

    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 ``FDADockets@bangate.fda.gov'' 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 ``tsummers@bangate.fda.gov''.
     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://

    Dated: August 11, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-22391 Filed 8-19-98; 8:45 am]