[Federal Register Volume 63, Number 142 (Friday, July 24, 1998)]
[Notices]
[Pages 39877-39879]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19816]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
[Docket No. 98N-0339]
Public Meetings on Section 406(b) of the FDA Modernization Act of
1997
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meetings.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following series of meetings 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 consumer and scientific
groups and the regulated industry in drafting FDA's developmental plan
to meet the objectives of FDAMA.
DATES: Comments may be submitted by September 11, 1998. For the dates
of each meeting, see section III of this document.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852; e-mail ``FDADockets@bangate.fda.gov'' or via the
FDA website ``http://www.fda.gov''. For the address of each meeting,
see section III of this document.
FOR FURTHER INFORMATION CONTACT: Catherine P. Beck, Office of
Management and Systems (HF-20), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-3443.
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.
[[Page 39878]]
To help focus comments, FDA requests that oral and/or written views
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 persons
listed in section III of 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 ``FDADockets@bangate.fda.gov'' or via the FDA
website ``http://www.fda.gov''.
III. Scheduled Meetings
The meetings will be held as follows:
Table 1
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FDA Center/Region Meeting Address Date and Time Contact Person
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Center for Biologics Department of Health and Human Friday, August 14, Gail H. Sherman, HFM-42,
Evaluation and Services, Hubert H. Humphrey Bldg., 1998, from 9 a.m. to Food and Drug
Research (CBER-- Penthouse Conference Room (rm. 800), 5 p.m Administration, suite
Washington, DC) 200 Independence Ave. SW., 200-N, 1401 Rockville
Washington, DC. Pike, Rockville MD
20852, 301-827-1315, FAX
301-827-3079, e-mail
``[email protected]''
Center for Drug Department of Health and Human Monday, August 17, Susan H. Carey, HFD-011,
Evaluation and Services, Hubert H. Humphrey Bldg., 1998, from 9 a.m. to Food and Drug
Research (CDER) Penthouse Conference Room (rm. 800), 5 p.m. Administration, 5600
200 Independence Ave. SW., Fishers Lane, Rockville,
Washington, DC. MD 20857, 301-827-1496,
FAX 301-827-0509, e-mail
``[email protected]''
Center for Devices and Department of Health and Human Tuesday, August 18, Ronald G. Jans, HFZ-205,
Radiological Health Services, Hubert H. Humphrey Bldg., 1998, from 9 a.m. to Food and Drug
(CDRH) Penthouse Conference Room (rm. 800), 5 p.m. Administration, 1350
200 Independence Ave. SW., Piccard Dr. Rockville,
Washington, DC. MD 20850, 301-594-3744,
FAX 301-443-8810, e-mail
``[email protected]''
Center for Veterinary Department of Health and Human Wednesday, August 19, Linda A. Grassie, HFV-12,
Medicine (CVM) Services, Hubert H. Humphrey Bldg., 1998, from 9 a.m. to Food and Drug
Penthouse Conference Room (rm. 800), 5 p.m. Administration, 7500
200 Independence Ave. SW., Standish Pl., Rockville,
Washington, DC. MD 20855, 301-827-6513,
FAX 301-594-1831, e-mail
``[email protected]
ov''
CBER--San Francisco Oakland Federal Bldg., Royball Friday, August 28, Mark S. Roh, HFR-PA17,
Auditorium, 1301 Clay St., Oakland, 1998, from 9 a.m. to Pacific Regional Office,
CA. 5 p.m. Food and Drug
Administration, 1301
Clay St., suite 1180-N,
Oakland, CA 94612, 510-
637-3980, FAX 510-637-
3977, e-mail
mroh@ora.fda.gov''
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A separate FDAMA section on the FDA website will provide current
information about these public meetings. It is highly recommended that
individuals who wish to present at these public meetings, plan to
attend the entire day. Information will be presented throughout the day
about FDA activities related to the FDA Plan.
[[Page 39879]]
Each public meeting will provide an opportunity for an open comment
session where attendees can express their views.
IV. 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 appropriate contact person
listed in section III of this document by July 31, 1998.
If you need special accommodations due to a disability, please
contact the appropriate contact person listed in section III of this
document at least 7 days in advance.
V. Additional Meetings
The public meeting for the Center for Food Safety and Applied
Nutrition (CFSAN) was held on June 24 and 25, 1998. The comment period
associated with the CFSAN meeting closed on July 15, 1998. A summary of
the views presented at the CFSAN meeting is available on the CFSAN
website ``http://www.cfsan.fda.gov''. For 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''.
An additional public meeting is being planned for September 15,
1998, to obtain stakeholder views on potential recurring themes and the
best approach for consolidating these themes agency wide. A separate
notice of this meeting will be published in the Federal Register.
VI. 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: July 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-19816 Filed 7-21-98; 3:31 pm]
BILLING CODE 4160-01-F
