[Federal Register Volume 70, Number 87 (Friday, May 6, 2005)]
[Notices]
[Page 24079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9011]



[[Page 24079]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Biological Products for Treatment of Rare Plasma Protein 
Disorders; Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) Office of Public Health 
and Science in the Department of Health and Human Services, are 
announcing a public workshop entitled ``Biological Products for 
Treatment of Rare Plasma Protein Disorders.'' The purpose of the 
workshop is to discuss the scientific and regulatory challenges 
encountered during the development of biological products used to treat 
rare plasma protein disorders. The workshop also will include a 
discussion about options that could be used to facilitate future 
product development.
    Date and Time: The 2-day public workshop will be held on June 13 
and June 14, 2005, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the National 
Institutes of Health, Lister Hill Auditorium, Building 38A, 8600 
Rockville Pike, Bethesda, MD 20894.
    Contact Person: Rhonda Dawson, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-3514, FAX: 301-827-2843, 
email: [email protected].
    Registration: There is no registration fee for the workshop. 
Registration by May 30, 2005, is recommended due to limited seating. 
There will be onsite registration, on a space available basis, the 
first day of the workshop, beginning at 7:15 a.m. If you need special 
accommodations due to a disability, please contact Rhonda Dawson at 
least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: FDA and Office of Public Health and Science 
in the Department of Health and Human Services are co-sponsoring a 2-
day public workshop entitled ``Biological Products for Treatment of 
Rare Plasma Protein Disorders.'' The opening session of the workshop 
will include presentations from national and international regulatory 
officials, patient groups, health care providers, and manufacturers 
concerning the need for therapeutic products to treat plasma protein 
disorders that may affect small patient populations, and the obstacles 
to developing these products. The second session of the workshop will 
include discussions about regulatory issues affecting industry, 
including trial designs, statistical considerations, orphan drug 
provisions, product development, and case studies. The last session of 
the workshop will include presentations and discussions on other 
relevant topics, including the availability and possible use of patient 
registries, research support, reimbursement, potentials for 
international harmonization, modifying clinical trial design, and 
facilitating future product development.
    FDA will post the agenda for this public workshop, when finalized, 
on CBER's Web sites at http://www.fda.gov/cber/scireg.htm and http://www.fda.gov/cber/minutes/workshop-min.htm.
    Transcripts: Transcripts of the meeting may be requested in writing 
from the Freedom of Information Office (FOI), (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the workshop at a cost of 10 cents 
per page. The transcript will also be placed on the FDA Web site at 
http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: April 29, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-9011 Filed 5-5-05; 8:45 am]
BILLING CODE 4160-01-S