[Federal Register Volume 65, Number 34 (Friday, February 18, 2000)]
[Notices]
[Pages 8365-8367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-3840]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-0001]


Leveraging--Collaborating With Stakeholders; Notice of Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of Meetings.

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SUMMARY: The Food and Drug Administration (FDA) is announcing two 
public meetings entitled ``Leveraging--Collaborating with 
Stakeholders.'' The purpose of these meetings is to discuss ways in 
which FDA can better leverage its expertise and resources by working 
with outside organizations. Participants may include, but are not 
limited to, academia, consumer groups, scientific experts, industry, 
public health providers, States, and other Government agencies.

DATES: The first meeting will be held on March 23, 2000. The second 
meeting will be held on April 12, 2000. For additional information 
regarding registration and the location and time of the meetings 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: [email protected] or to the Internet 
at http://www.fda.gov.

REGISTRATION AND REQUESTS FOR ORAL PRESENTATIONS: Send registration 
information (including name, title, firm name, address, telephone, fax 
number, and e-mail address) and requests to make oral presentations, to 
the appropriate contact person listed in table 1 of section III of this 
document by March 17, 2000, for the California meeting and by April 5, 
2000, for the North Carolina meeting. Because space is limited, it is 
necessary to register in advance of the meetings and by the appropriate 
deadlines. Participants who wish to make a formal oral presentation 
should register with the appropriate contact for ``speaker 
registration'' identified by meeting in table 1 of section III of this 
document by the same deadlines listed above. Presentations will be 
limited to the questions and subject matter identified under section I 
of this document. All registration will be accepted on a first-come, 
first-served basis. Speakers will be chosen in order of registration. 
All other comments should be sent to the Dockets Management Branch 
(address above).
    If you need special accommodations due to a disability, please 
indicate such at the time of registration.
    You may register by e-mail, at http://www.fda.gov/oc/leveraging/stakeholders2000.

FOR GENERAL INFORMATION CONTACT: Virginia Cox, Office of the 
Commissioner (HF-10), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3409, FAX 301-594-6807, e-mail 
[email protected]. Local contact information is listed in table I of 
section III of this documnent.

SUPPLEMENTARY INFORMATION:   

I. Background

    FDA is exploring new opportunities to leverage its own assets by 
working with other organizations in order to carry out its public 
health mission effectively in the 21st century. These collaborations 
are intended to have a larger net public health benefit to the American 
public than would be possible if FDA worked alone. The agency is 
currently working closely with a diverse set of partners, including 
public health organizations, scientific experts, other Federal 
regulators, States, industry and consumers, to expand these benefits. 
Leveraging activities are prominent in every major area of FDA 
responsibility, including:
    (1) Safety related research,
    (2) Safety review for new products,
    (3) Monitoring safety of products on the market,
    (4) Assuring industry compliance with safety regulations, and
    (5) Patient/consumer education on the safe use of products.
    The agency would like to expand these leveraging initiatives in 
order to address the increasingly complex regulatory challenges of this 
millennium.
    In the section II. A. and B. of this document, FDA has provided 
illustrations of collaborative projects that are currently ongoing and 
those that are proposed. As you read through both sections, please 
respond to the following questions, as appropriate; these initiatives 
and questions will be discussed at the stakeholders meetings:
    1. Does your organization share an interest in any of these 
initiatives?
    2. If so, what role would your organization play in this 
initiative, and what could you contribute?
    3. Do you have suggestions for improving FDA's approach to any of 
the leveraging initiatives?
    4. Do you have suggestions for other organizations that would 
benefit from working with FDA on these types of efforts?
    5. Are there other initiatives not listed below that you would 
suggest as a possibility for collaborative efforts between FDA and your 
organization or other organizations?

A. Examples of Ongoing Initiatives

1. Safety-Related Research--National Center for Food Safety and the 
Technology (Moffett Center)
    The Moffett Center is a collaboration with industry, the Illinois 
Institute of Technology, and the University of Illinois' Food Science 
Department. The Moffett Center was established in 1987 to address food 
safety, specifically food processing and packaging technologies. The 
collaborative programs positioned the Moffett Center as a focal point 
of FDA's participation in research and technology outreach associated 
with the President's Food Safety Initiative focus on preventing and 
reducing foodborne contamination. The scope of food safety information 
and expertise achieved through this participation far outreaches the 
work any one member could accomplish to answer critical food safety 
questions. A recent expansion of

[[Page 8366]]

the Moffett Center focuses on small business needs in food safety. The 
Moffett Center research has helped in developing higher product safety 
standards and better consumer protection.
2. Safety Review for New Products--Product Quality Research Institute 
(PQRI)
    PQRI fosters scientific research to support regulatory policy in 
the areas of drug substance, drug product, biopharmaceutics, science 
management, and novel approaches for regulating pharmaceuticals. PQRI 
provides opportunities to develop science-based publicly available 
information to: (1) Facilitate the drug development process, (2) 
facilitate needed changes in the manufacture of drug substance and drug 
product, (3) enhance review consistency and efficiency, and (4) 
increase reliance on tests that are no more burdensome than necessary 
to assure product quality. Co-sponsors include the Center for Drug 
Evaluation and Research (FDA), American Association of Pharmaceutical 
Scientists, Generic Pharmaceutical Industry Association, National 
Association of Pharmaceutical Manufacturers, Nonprescription Drug 
Manufacturers Association, National Pharmaceutical Alliance, Parenteral 
Drug Association, and Pharmaceutical Research and Manufacturers of 
America.
3. Assuring Industry Compliance With Safety Regulations--Mammography
    Mammographies are provided by more than 10,000 facilities 
throughout the United States, a far greater number than FDA can 
effectively inspect for compliance with quality standards. The 
Mammography Quality Standards Act of 1992 (MQSA) requires these 
facilities to be accredited by FDA approved accrediting bodies that are 
either nonprofit organizations or State agencies and directs FDA to 
delegate site inspection tasks to States. FDA established mammography 
accreditation standards based on American College of Radiology (ACR) 
technical standards that are endorsed by other industry and government 
experts. FDA approved accreditation bodies now include ACR and several 
State agencies.
4. Patient/Consumer Education on the Safe Use of Products--Take Time to 
Care
    The Take Time to Care Outreach program brings together FDA's Office 
of Women's Health and the National Association of Chain Drug Stores, 
and other senior citizen groups, professional associations, business/
labor women's organizations and other health organizations. This 
network of organizations delivers the message about safe drug use, 
including the ``My Medicines'' brochure distributed at over 20,000 
pharmacy outlets. Through this program, FDA expects to help 6.5 million 
women safely use their medications.

B. Examples of Proposed Initiatives

1. Safety Review for New Products--Safety Assurance in Clinical Trials
    The volume of clinical trials has grown dramatically over the past 
decade, due to expanding development of new medical products. In 
addition, clinical trials are more often performed at multiple study 
sites, including multi-country studies. Extensive oversight by FDA is 
not feasible in an era of significantly scaled-back field staffing. FDA 
sees a growing need to collaborate with outside organizations in 
managing the research, compliance and educational aspects of clinical 
investigations, particularly those sponsored by academia, industry, 
other government agencies and other private institutions/corporations.
2. Assuring Industry Compliance with Safety Regulations--Gene therapy, 
Human Cellular and Tissue Based Products
    Advances in these categories of new medical products create the 
need for better science to assure product safety and strategies to 
assure industry compliance with safe manufacturing practices. FDA is 
interested in exploring collaborative strategies for research studies 
that will lead to the development of scientifically based standards 
for: Safety and toxicity of viral vectors carrying a human gene for 
replacement or reconstitution; safety of cell substrates for use in 
production of live-attenuated viral vaccines or gene therapy vectors; 
and quality control and safety of human cellular and tissue-based 
products.
3. Patient/Consumer Education on the Safe Use of Products--Risk 
Management
    FDA is interested in launching widespread educational initiatives, 
aimed at consumers, of newly approved medical products, as well as 
important products that have been on the market. The agency would like 
to target, in particular, vulnerable populations such as children, the 
elderly and those with special needs. FDA would also like to capitalize 
on the capabilities of the Internet to get its message to the right 
people. It would be very useful to join forces with other organizations 
in order to amplify and focus messages that would help consumers/
patients better manage their own health status.
4. Inspections--Internet
    The Internet is being used by a rapidly growing number of consumers 
to obtain information about drugs and to order these medical products. 
FDA is in the early stages of an initiative to monitor firms marketing 
drugs through this medium. The agency is interested in exploring ways 
to collaborate with other organizations in order to extend its ability 
to monitor the situation and to keep consumers safe and informed.
5. Safety-Related Research--NCTR Identified Opportunity
    Work on gene-chip and gene-array technology to provide high-
throughput screening of biomarkers for susceptible populations is 
already underway. This is being done in collaboration with academia, 
industry and government. However, we see a growing need to collaborate 
in the development of DNA microarray technology to better define 
biomarkers of toxic response that are more relevant and applicable to 
the human population. The FDA is interested in exploring strategies 
with its stakeholders to develop the capacity to utilize these DNA-, 
RNA-, and bioinformatic-based technologies to better understand toxin-
induced responses in in vitro and in vivo model systems to improve 
extrapolation of these systems to the human.

II. Comments

    Stakeholders are encouraged to submit their responses in advance of 
the March 23, 2000, and April 12, 2000, meetings. Written comments 
should be identified with docket number 00N-0001 and submitted to the 
Dockets Management Branch (address above).

III. Scheduled Meetings

[[Page 8367]]



                                                                                            Table I.
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         Date and Location                                    Address                                      Scheduled Time                        Attendance and Speaker Registration
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March 23, 2000,                     Stanford Law School,                                         6 p.m. to 8 p.m.                    Judy Keast,
  Stanford, CA.                       rm. 290, 559 Nathan Abbott Way,                              PST.                                Food and Drug Administration, Oakland Federal Bldg., 1301
                                      Stanford, CA.                                                                                   Clay St., suite 118ON,   Oakland, CA 94612, 510-637-3960,
                                                                                                                                      ext. 112, FAX: 510-637-3976, e-mail: [email protected].
April 12, 2000,                     Duke University Medical Center,                              1 p.m. to 3 p.m.                    Mary Lewis,
  Durham, NC.                         Searle Conference Center, Seeley Mudd Bldg., Research        EST.                                Food And Drug Administration, 310 New Bern Ave., rm. 370,
                                     Dr.,                                                                                             Raleigh, NC 27601,   919-856-4456, FAX: 919-856-4776, e-
                                      Durham, NC.                                                                                     mail: [email protected].
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IV. 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.

    Dated: February 11, 2000,
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-3840 Filed 2-17-00; 8:45 am]
BILLING CODE 4160-01-F