[Federal Register: January 3, 2005 (Volume 70, Number 1)]
[Page 91-92]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.

electronic and other access to the slide presentations and transcripts 
from the workshop.

Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.


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]