[Federal Register: January 27, 2005 (Volume 70, Number 17)]
[Notices]
[Page 3935-3936]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27ja05-59]
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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