[Federal Register: January 3, 2005 (Volume 70, Number 1)]
[Notices]
[Page 91-92]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ja05-60]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0539]
Establishing a Docket for the Development of Plasma Standards
Public Workshop; Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
opening of a docket to receive information and comments on the August
31 and September 1, 2004,
[[Page 92]]
public workshop entitled ``Development of Plasma Standards'' (the
workshop). We are opening the docket to gather additional information
from interested parties on the subjects of plasma collection, freezing,
and storage, and for interested parties to provide comments on the
presentations and discussions that took place during the workshop.
DATES: Submit written or electronic comments on the workshop, related
regulatory and scientific issues, and comments on information submitted
to the docket by other interested parties by July 5, 2004.
ADDRESSES: Submit written comments and information regarding the
workshop to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852-1448.
Submit electronic comments or information to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for
electronic and other access to the slide presentations and transcripts
from the workshop.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, 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 9, 2004 (69 FR 48250), we
published a notice to announce a public workshop entitled ``Development
of Plasma Standards.'' On August 31 and September 1, 2004, we held the
workshop to address regulatory and scientific issues about currently
licensed plasma products and unlicensed recovered plasma that is
fractionated into both injectable and non-injectable products. The
workshop covered a broad range of topics. A major objective of the
workshop was to assist FDA in the development of plasma standards that
would address concerns encountered over the years with regard to the
preparation, storage, shipment, and use of plasma for both transfusion
and the manufacture of plasma derived blood products such as Factor
VIII and Immune Globulin Intravenous. Another objective was to gather
information on current industry practices that are in place for the
manufacture of plasma. At the end of the workshop, we invited written
comments from workshop participants to gather additional public
information on the subject of plasma freezing and storage.
We have established this docket to encourage interested parties to
continue to provide information about suggested plasma standards,
comments on the workshop, and comments on information submitted to the
docket by other interested parties. We also request that those who have
already submitted written comments and information to FDA resubmit the
same comments to the docket to ensure their adequate consideration
since this information was not previously submitted to the docket. This
notice will also be posted at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/minutes/workshop-min.htm
.
Comments submitted to the docket will assist us in determining the
need for and feasibility of establishing new standards for currently
licensed plasma products, including time to freezing, freezing and
storage temperatures, and shipping temperatures, among other issues. We
may also consider this information in preparing any future additional
standards for recovered plasma.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the workshop.
Submit a single copy of electronic comments 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 heading of this document. A copy of this notice, the slide
presentations and transcripts from the workshop, and received comments
are available for public examination in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the slide
presentations at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/summaries.htm and the transcripts of the workshop at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/minutes/workshop-min.htm.
Dated: December 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-28655 Filed 12-30-04; 8:45 am]
BILLING CODE 4160-01-S