[Federal Register Volume 63, Number 161 (Thursday, August 20, 1998)]
[Notices]
[Pages 44628-44629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-22393]


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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

[[Page 44629]]

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