[Federal Register Volume 63, Number 142 (Friday, July 24, 1998)]
[Notices]
[Pages 39877-39879]
From the Federal Register Online via the Government Printing 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                                                    
----------------------------------------------------------------------------------------------------------------
   FDA Center/Region                Meeting Address                 Date and Time            Contact Person     
----------------------------------------------------------------------------------------------------------------
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    
                                                                                        ``SHERMAN@cber.fda.gov''
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
                                                                                        ``CAREYS@cder.fda.gov'' 
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
                                                                                        ``RSJ@CDRH.FDA.GOV''    
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
                                                                                        ``LGrassie@bangate.fda.g
                                                                                        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''    
----------------------------------------------------------------------------------------------------------------

    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