[Federal Register: August 31, 2004 (Volume 69, Number 168)]
[Page 53077-53078]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


    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, 
    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]