[Federal Register Volume 64, Number 54 (Monday, March 22, 1999)]
[Notices]
[Pages 13804-13806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7038]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0386]


Talking With Stakeholders About FDA Modernization; Notice of 
Meetings and Teleconference

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meetings and teleconference.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing public 
meetings and an interactive satellite teleconference entitled ``Talking 
With Stakeholders About FDA Modernization.'' The purpose of the meeting 
is to discuss the agency's progress in implementing the FDA 
Modernization Act (FDAMA) and to seek additional input on specific 
FDAMA performance targets.

DATES: The meetings and teleconference will be held on April 28, 1999. 
The deadlines for speaker registration and attendance registration are 
April 9, 1999, and April 16, 1999, respectively. Stakeholders 
interested in being a member of the studio audience should indicate 
their interest by April 15, 1999. Comments may be submitted by May 14, 
1999. For additional information regarding registration, the meetings, 
and teleconference, see Table 1 in 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 ``FDAD[email protected]'', or via the 
FDA web site ``http://www.fda.gov''.

FOR FURTHER INFORMATION CONTACT: Carrie Smith Hanley, Office of 
External Affairs (HF-60), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-3365, FAX: 301-594-0113, e-mail: 
``[email protected]''.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 406(b) of FDAMA (21 U.S.C. 393(f) and (g)) requires the 
agency: To consult with its external stakeholders as it moves forward 
to modernize the agency; to develop a plan, based on input from 
stakeholders, for complying with the agency's obligations under the 
Federal Food, Drug, and Cosmetic Act (the act); and to periodically 
revisit the plan in consultation with stakeholders to make appropriate 
adjustments. As a culmination of these requirements, FDA will issue a 
performance report to Congress at the end of the 1999 calendar year.
    A summary of the agency's responses to each obligation follows.

A. Consult With External Stakeholders

    To respond to the first requirement of section 406(b) of FDAMA, the 
agency held a series of well attended public meetings last summer to 
obtain stakeholder views on how FDA can best meet its statutory 
obligations. Stakeholders offered a wealth of productive suggestions, 
many of which reflect their desire for greater involvement in FDA's 
work by contributing to the agency's future strategies and for 
receiving clear and timely information about the agency's processes and 
new regulated products.

B. Develop a Plan That Reflects Stakeholders Views

    FDA listened carefully to its stakeholders and used their 
contributions to guide the development of a plan for complying with its 
obligations under FDAMA, as well as responding to the public's 
expectations. In the Federal Register of November 24, 1998 (63 FR 
65000), the agency published the ``FDA Plan for Statutory Compliance'' 
(see FDA's web site, ``http://www.fda.gov/oc/fdama/fdamapln''). This 
plan provides a broad, agency wide strategic framework and specific 
performance goals for the current fiscal year (1999) that will allow 
FDA to act on stakeholder recommendations as well as allow the agency 
to meet its statutory obligations. The strategic framework outlines six 
broad directions: Strengthening the science base, closely collaborating 
with stakeholders, establishing risk-based priorities, adopting a 
systems approach, continuing to reengineer FDA processes, and 
capitalizing on information technology. The plan describes how the 
agency is already implementing many strategies in new and creative ways 
within each of these broad directions.

C. Periodically Revisit the Plan in Consultation with Stakeholders

    FDA is now preparing to revisit the 406(b) plan as part of a formal 
consultation with its stakeholders on April 28, 1999. The agency would 
like to receive input from stakeholders on the elements of the plan 
that have been implemented thus far and obtain additional suggestions 
on how the agency can continue to improve its modernization efforts. 
FDA specifically wants input on how to: (1) Strengthen its science base 
and (2) improve its communication processes. To help focus the 
discussion at the April 28, 1999, meeting, FDA has designed five 
questions that address these two concerns. As stakeholders respond to 
these questions, it may be useful to review the ``FDA Plan for 
Statutory Compliance'' which outlines the agency's current and proposed 
activities in these two areas. FDA requests that stakeholders address 
the five questions below in their oral and/or written views:
    1. Science based decisions are made throughout the life span of 
products from initial research, development and testing, through 
production, marketing, and consumption. These decisions require the 
best science to identify, evaluate, and balance product risks and 
benefits. It is crucial that FDA, in collaboration with product 
sponsors, develop a shared understanding of new science and 
technologies and their effect throughout a product's life span.
    What actions do you propose the agency take to expand FDA's 
capability to incorporate state-of-the-art science into its risk-based 
decisionmaking?
    2. As the agency attempts to meet its public health 
responsibilities, the speed of discovery results in an avalanche of new 
information from government, academic, and industry scientists.
    What actions do you propose to facilitate the exchange and 
integration of scientific information to better enable FDA to meet its 
public health responsibilities throughout a product's lifecycle?
    3. Most products in the American marketplace, especially medical 
ones, have two facets. On one side they benefit users and often improve 
lives. They are, however, rarely without risk, and their use can result 
in known and unknown side effects. Consumers must weigh benefits and 
risks before using these products, oftentimes with incomplete 
information.
    What actions do you propose for educating the public about the 
concept

[[Page 13805]]

of balancing risks against benefits in public health decisionmaking?
    4. The agency stated in the ``FDA Plan for Statutory Compliance'' 
that inflation has eroded real assets that can be applied to meet its 
public health mission while Congress has increased its 
responsibilities.
    Because the agency must allocate its limited resources to achieve 
the greatest impact, what actions do you propose to enable FDA and its 
product centers to focus resources on areas of greatest risk to the 
public health?
    5. FDAMA requires the agency to continue to meet with stakeholders 
on key issues. Meetings have ranged from explaining the positions of 
the agency on particular issues to working with sponsors on product 
applications. Historically, these interactions have benefited both 
stakeholders, through better knowledge of FDA, and the agency, by 
leading to positive changes in its operations.
    Because the agency wants to assure that its stakeholders are aware 
of and participate in its modernization activities, what additional 
actions do you propose for enhancing communication processes that allow 
for ongoing feedback and/or evaluation of our modernization efforts?

II. Comments

    Stakeholders are encouraged to submit their responses in advance of 
the April 28, 1999, meeting. Written comments should be identified with 
docket number 99N-0386 and submitted to the Dockets Management Branch 
(address above). In order to promote a variety of responses, 
stakeholders are encouraged to state a proposed action as a separate 
concise statement followed by a written explanation of its meaning.

III. Scheduled Meetings

    Open public meetings with stakeholders will be held in several 
locations throughout the country. These meetings will provide down-link 
interactive viewing sites for the live satellite teleconference and 
also provide an opportunity for formal presentations to FDA's senior 
managers at the local meetings. The teleconference will feature Jane E. 
Henney, Commissioner of Food and Drugs, and Linda A. Suydam, Associate 
Commissioner for Strategic Management, who will be talking with 
stakeholders during the live satellite teleconference. These meetings 
are open to all stakeholders and will be co-hosted by FDA's field 
offices and centers, and they will focus on the specific product center 
listed in the first column of Table 1 of this document. The scheduled 
time of meetings, as listed in Table 1 of this document, includes the 
time devoted to the live satellite teleconference broadcast, as well as 
a period of time for presentations and/or discussion of the questions 
listed in section I.C of this document.

                                                                         Table 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
 Center/City Registration        Location/Address        Scheduled Time Of Meeting      Speaker Registration Contact            Attendance Contact
--------------------------------------------------------------------------------------------------------------------------------------------------------
Center for Drug Evaluation  Temple University, Main     12:30 p.m. to 6 p.m.        Marcia Trenter, Phone: 301-827-      Anitra Brown-Reed, Phone: 215-
 and Research,               Campus, Ritter Hall, Kiva   Eastern Time                1492, Fax: 301-827-3056, Email:      597-4390 ext. 4202, Fax: 215-
 Philadelphia, PA            Auditorium, 130 Cecil B.                                T[email protected]                597-4660, Email:
                             Moore Ave., Philadelphia,                                                                    A[email protected]
                             PA
Center for Biologics        Boston University, School   9:30 a.m. to 3 p.m.         Lorrie Harrison, Phone: 301-827-     Lorrie Harrison, Phone: 301-827-
 Evaluation and Research,    of Medicine, 715 Albany     Eastern Time                5546, Fax: 301-827-3079, Email:      5546, Fax: 301-827-3079,
 Boston, MA                  St., Boston, MA                                         H[email protected]                Email: H[email protected]
Center for Biologics        South San Francisco         9:30 a.m. to 3 p.m.         Lorrie Harrison, Phone: 301-827-     Lorrie Harrison, Phone: 301-827-
 Evaluation and Research,    Conference Ctr., 255        Pacific Time                5546, Fax: 301-827-3079, Email:      5546, Fax: 301-827-3079,
 San Francisco, CA           South Airport Blvd.,                                    H[email protected]                Email: H[email protected]
                             South San Francisco, CA
Center for Food Safety and  Ralph Metcalfe Federal      12 Noon to 4:30 p.m.        Marquita Steadman, Phone: 301-827-   Kimberly Phillips, Phone: 312-
 Applied Nutrition,          Bldg., 77 West Jackson      Central Time                6735, Fax: 301-480-5730, Email:      353-7126 ext. 193, Fax: 312-
 Chicago, IL                 Blvd., Morrison                                         [email protected]            886-3280, Email:
                             Conference Room, Chicago,                                                                    K[email protected]
                             IL
Center for Veterinary       Johnson County Community    11:30 a.m. to 5 p.m.        Linda Grassie, Phone: 301-827-6513,  Linda Grassie, Phone: 301-827-
 Medicine, Overland Park,    College, Bldg. CE, rm.      Central Time                Fax: 301-594-1831, Email:            6513, Fax: 301-594-1831,
 KS                          211, 12345 College Blvd.,                               L[email protected]             Email:
                             (Kansas City, KS) (111th                                                                     L[email protected]
                             & Quivera), Overland
                             Park, Kansas (Kansas
                             City, KS)
Center for Devices and      Scripps Research            9:45 a.m. to 4 p.m.         Ron Jans, Phone: 301-827-0048, Fax:  Ron Jans, Phone: 301-827-0048,
 Radiological Health, San    Institute, Shepherd Great   Pacific Time                301-443-8810, Email:                 Fax: 301-443-8810, Email:
 Diego, CA                   Hall, Schaetzle Education                               R[email protected]                     R[email protected]
                             Center, Scripps Memorial
                             Hospital, 9890 Genesee
                             Ave., La Jolla, CA, (San
                             Diego)

[[Page 13806]]

 
Office of Regulatory        Food and Drug               12 noon to 5 p.m. Eastern   Joann Pittman, Phone: 404-253-1272,  Joann Pittman, Phone: 404-253-
 Affairs, Atlanta, GA        Administration, 60 Eighth   Time                        Fax: 404-253-1202, Email:            1272, Fax: 404-253-1202,
                             St., N.E. Atlanta, GA                                   [email protected]                 Email: [email protected]
FDA General, Washington,    United States Department    12:30 p.m. to 5:30 p.m.     Mary Gross, Phone: 301-827-3364,     Russell Campbell, Phone: 301-
 DC                          of Agriculture, Jefferson   Eastern Time                Fax: 301-594-0113, Email:            827-4413, Fax: 301-443-9767,
                             Auditorium (West Wing),                                 [email protected]                    Email: [email protected]
                             14th and Independence
                             Ave., SW., Washington, DC
--------------------------------------------------------------------------------------------------------------------------------------------------------

    A separate FDAMA section on the FDA web site will provide current 
information about these public meetings. It is highly recommended that 
individuals who wish to participate at these public meetings plan to 
attend the entire session. Each public meeting will include an 
opportunity for an open comment session where attendees can express 
their views.
    The interactive satellite teleconference is a C-Band broadcast with 
the following coordinates: satellite GE-2, 85 West, Transponder 3, 
frequency 3760 MHz Vertical. Test signal begins at 12 noon Eastern 
Time. The satellite teleconference will begin promptly at 1 p.m. 
Eastern Time and end no later than 3:30 p.m. Eastern Time. Limited 
seating will be available for a live studio audience at the broadcast 
studio in Gaithersburg, MD. Individuals representing broad interest 
groups are invited to participate in the studio audience. A balanced 
representation of FDA stakeholders will be selected. Stakeholders who 
are interested in participating in the broadcast as a member of the 
studio audience should indicate their interest by April 15, 1999, to 
Carrie Smith Hanley, Office of External Affairs at the phone, fax or e-
mail address listed in the section of this document entitled ``For 
Further Information Contact''.

IV. Registration and Requests for Oral Presentations

    All participants should send registration information (including 
name, title, firm name, address, telephone and fax number) to the 
appropriate ``attendance registration'' contact person listed in 
section III of this document by April 16, 1999. If you need special 
accommodations due to a disability, please indicate such at the time of 
registration.
    Participants who wish to make a formal oral presentation should 
register with the appropriate contact for ``speaker registration'' 
identified by meeting in section III of this document by April 9, 1999. 
Formal oral presentations will not be made at the studio. Stakeholders 
wishing to make presentations should make their wishes known to the 
appropriate individuals listed in section III of this document.

V. Transcripts

    Transcripts of the meetings (from each site listed in section III 
of this document) 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 web site ``http://www.fda.gov''.

    Dated: March 17, 1999.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 99-7038 Filed 3-18-99; 11:48 am]
BILLING CODE 4160-01-F