[Federal Register: August 31, 2004 (Volume 69, Number 168)]
[Notices]
[Page 53077-53078]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31au04-62]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0366]
From Concept to Consumer: Center for Biologics Evaluation and
Research Working With Stakeholders on Scientific Opportunities for
Facilitating Development of Vaccines, Blood and Blood Products, and
Cellular, Tissue, and Gene Therapies; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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The Food and Drug Administration (FDA), is announcing a public
workshop entitled ``From Concept to Consumer: Center for Biologics
Evaluation and
[[Page 53078]]
Research Working With Stakeholders on Scientific Opportunities for
Facilitating Development of Vaccines, Blood and Blood Products, and
Cellular, Tissue, and Gene Therapies.'' The goal of the public workshop
is to provide a forum for stakeholders to discuss opportunities for and
potential approaches to the development of innovative scientific
knowledge and tools to facilitate the development and availability of
new biological products including vaccines, blood and blood products,
and cellular, tissue, and gene therapies.
Date and Time: The public workshop will be held on October 7, 2004,
from 8:30 a.m. to 5 p.m.
Location: The public workshop will be held at The Gaithersburg
Marriott Washingtonian Center, 9751 Washingtonian Blvd., Gaithersburg,
MD.
Contact Person: Melanie Whelan, Center for Biologics Evaluation and
Research (HFM-43), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448, 301-827-3841, FAX: 301-827-3079,
e-mail: Whelan@cber.fda.gov.
Registration: Mail, fax, or e-mail the registration information
(including name, title, affiliation, address, and telephone and fax
numbers) to Melanie Whelan (see Contact Person) by September 30, 2004.
Because seating is limited, we recommend early registration. There is
no registration fee for the workshop. If you need special
accommodations due to a disability, please contact Melanie Whelan (see
Contact Person) at least 7 days in advance.
Comments: Regardless of attendance at the public workshop,
interested persons may submit to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852 written or electronic comments by September 23,
2004. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www/fda.gov/dockets/ecomments.
Submit a single copy of electronic comments or two copies of
any mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
SUPPLEMENTARY INFORMATION: The goal of this workshop is to provide a
public forum for input and discussion concerning opportunities for the
enhancement of scientific knowledge and tools for safety, efficacy, and
product quality that can be used to more effectively and efficiently
develop and evaluate new biological products in the areas described.
On March 16, 2004, FDA released a report addressing the recent
slowdown in innovative medical therapies submitted to FDA for approval
entitled ``Innovation/Stagnation: Challenge and Opportunity on the
Critical Path to New Medical Products'' at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/initiatives/criticalpath/.
That report describes the urgent need to
create the scientific and technological ``tools'' to modernize the
medical product development process--the Critical Path--to make medical
product development more predictable and less costly.
The Center for Biologics Evaluation and Research (CBER) is seeking
input from government and nongovernment research organizations, medical
professional organizations, health care practitioners, patients,
disease interest groups, pharmaceutical and biological product
manufacturers and their industry organizations, and others with
interests in facilitating development of the biological products that
CBER regulates. The workshop will cover delineation of opportunities in
key technologies and medical science knowledge needed to contribute to
science based evaluation of the safety and efficacy of those biological
products, and innovative development processes to manufacture them. FDA
will discuss and welcomes input concerning all applicable areas of
science including, but not limited to, bench laboratory investigations,
clinical research and clinical trial design and execution, facility and
manufacturing process research, statistical and epidemiological
research, and computer science and computer modeling research. The
workshop will not cover discussions of biological product discovery and
invention or regulatory policies. The workshop will include
presentations by FDA speakers and breakout sessions with panels
composed of both FDA staff and non-FDA stakeholders, with an
opportunity for public questions and comments.
FDA will post the agenda for this public workshop, when finalized
on CBER's Web sites at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/scireg.htm and http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/minutes/workshop-min.htm.
Transcripts: Please note that transcripts of the workshop will not
be prepared.
Dated: August 24, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-19778 Filed 8-30-04; 8:45 am]
BILLING CODE 4160-01-S