[Federal Register Volume 70, Number 17 (Thursday, January 27, 2005)]
[Notices]
[Pages 3935-3936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1475]


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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; Reopening of the 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
January 27, 2006, the comment period for the notice of public workshop 
and request for comments published in the Federal Register of August 
31, 2004 (69 FR 53077). FDA is reopening the comment period to allow 
interested persons additional time to submit comments and to receive 
any new information.

DATES: Submit written or electronic comments by January 27, 2006.

ADDRESSES: Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Astrid Szeto, Center for Biologics 
Evaluation and Research (HFM-17), Food and Drug Administration, 1401 
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 31, 2004 (69 FR 53077) (August 
2004 notice), FDA announced a public workshop entitled ``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.'' The public workshop was held on October 7, 2004. The goal 
of the public workshop was 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.
    Interested persons were originally given until September 23, 2004, 
to comment on the topic of the workshop.

II. Request for Comments

    Following publication of the August 2004 notice, FDA received 
several requests to allow interested persons additional time to 
comment. The requesters asserted that the time period of 23 days was 
insufficient to respond fully to FDA's specific requests for comments 
and to allow potential respondents to thoroughly evaluate and address 
pertinent issues.

III. How to Submit Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two paper 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

[[Page 3936]]

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.

    Dated: January 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-1475 Filed 1-26-05; 8:45 am]
BILLING CODE 4160-01-S >