[Federal Register Volume 66, Number 6 (Tuesday, January 9, 2001)]
[Notices]
[Page 1685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-531]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Adenoviral Vector Safety; Public Meeting and Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing a public 
meeting entitled ``Adenoviral Vector Safety'' and a workshop of the 
``Adenoviral Standards Working Group.'' The purpose of the public 
meeting and workshop is to discuss the scientific and technological 
issues related to developing voluntary industry reference standards for 
adenoviral vectors used to deliver human gene therapies. The voluntary 
industry reference standards will be used to help ensure the safety of 
adenoviral vectors intendedfor use in humans.
    Date and Time: The public meeting and workshop will be held on 
February 1, 2001. The Adenoviral Vector Safety meeting will be held 
from 9:30 a.m. to 12 noon.
    The Adenoviral Standards Working Group workshop will be held from 1 
p.m. to 5 p.m.
    Location: The Adenoviral Vector Safety meeting will be held at the 
Wilson Auditorium, National Institutes of Health, Bldg. 1, 8600 
Rockville Pike, Bethesda, MD 20894.
    The Adenoviral Standards Working Group workshop will be held at the 
National Institutes of Health, Bldg. 29B, Conference Rooms A, B, and C, 
8600 Rockville Pike, Bethesda, MD 20894.
    Contact: Steven R. Bauer, Center for Biologics Evaluation and 
Research (HFM-521), Food and Drug Administration, Bldg. 29B, rm. 2NN11, 
Bethesda, MD 20894, 301-827-0684, FAX 301-827-0449, or e-mail: 
[email protected].
    Registration: Mail or fax your registration information (including 
name, title, firm name, address, telephone, fax number, and e-mail 
address) to Steven R. Bauer (address above) by Friday, January 19, 
2001. There is no registration fee for the meeting or workshop. Seating 
is limited, therefore, interested parties are encouraged to register 
early. Registration at the site will be done on a space available basis 
on the day of the meeting and workshop, beginning at 8:30 a.m. If you 
need special accommodations due to a disability, please contact Steven 
R. Bauer at least 7 days in advance.
    Agenda: The Adenoviral Vector Safety meeting will provide a forum 
for all members of the public to express their concerns about 
adenoviral vector safety and explore alternatives for enhancing the 
safety of adenoviral vectors.
    The Adenoviral Standards Working Group workshop is cosponsored by 
FDA's Center for Biologics and Research (CBER) and the Williamsburg 
BioProcessing Foundation. The workshop will be of primary interest to 
public health professionals developing new human gene therapy products 
and manufacturers contemplating the production of such products. The 
objectives of the workshop are to: (1) Select adenoviruses to use as 
voluntary reference standards for adenoviral vectors used for human 
gene therapy products; (2) describe the conditions and facilities to be 
used when producing bulk quantities of a voluntary reference standard; 
(3) establish characterization protocols for voluntary reference 
standards; and (4) address other issues related to voluntary reference 
standards for adenoviral vectors.
    Transcripts: Transcripts of the Adenoviral Vector Safety meeting 
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 will also be available on 
the Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: December 29, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-531 Filed 1-8-01; 8:45 am]
BILLING CODE 4160-01-S