[Federal Register Volume 70, Number 191 (Tuesday, October 4, 2005)]
[Notices]
[Page 57884]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-19852]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0347]


Establishing a Docket for the Biological Products for Treatment 
of Rare Plasma Protein Disorders Public Workshop; Availability

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 June 13 
and 14, 2005, public workshop entitled ``Biological Products for 
Treatment of Rare Plasma Protein Disorders'' (the workshop). We are 
opening the docket to gather additional information from interested 
persons on the challenges in the development of products to treat rare 
plasma protein disorders and on current and future opportunities to 
facilitate development of such products. Interested persons may also 
submit comments on the workshop presentations and discussions, which we 
are also making available.

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 persons by April 4, 2006.

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://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for 
electronic and other access to the slide presentations from the 
workshop.

FOR FURTHER INFORMATION CONTACT: Paula S. McKeever, 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 May 6, 2005 (70 FR 24079), we published 
a notice to announce a public workshop entitled ``Biological Products 
for Treatment of Rare Plasma Protein Disorders.'' On June 13 and 14, 
2005, we, in cosponsorship with the Office of Public Health and Science 
in the Department of Health and Human Services, held the workshop to 
facilitate the development of biological products used to treat 
patients with rare plasma protein disorders and to discuss related 
scientific and regulatory challenges. The following topics were 
discussed at the workshop:
    <bullet> Patients' and physicians' perspective on the need for 
products to treat rare plasma protein disorders;
    <bullet> The availability of registries and databases to identify 
patients for clinical trials;
    <bullet> Differences between international and FDA regulatory 
approaches to the licensure of products for treating rare plasma 
protein diseases;
    <bullet> Case studies describing the application of current FDA 
regulatory pathways to product development;
    <bullet> Issues of product reimbursement; and
    <bullet> Incentives for product development, such as the 
availability of small business and research grants, and orphan drug 
provisions.
    The meeting concluded with proposals for advancing product 
development, and suggestions for future discussions on this topic. At 
the end of the workshop, we invited written comments to provide an 
opportunity for additional information and discussion of the issues.
    We encourage interested persons to continue to provide information 
to this docket regarding:
    <bullet> How to facilitate development of products used to treat 
rare plasma protein disorders,
    <bullet> Comments on the workshop, and
    <bullet> Comments on information submitted to the docket by other 
interested persons.
    Information and comments submitted to the docket will assist us in 
determining the need for, and feasibility of, establishing new 
regulatory pathways and incentives for developing products to treat 
rare plasma protein disorders, among other issues.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the workshop 
and any additional information on the development of biological 
products for treatment of rare plasma protein disorders. 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 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://www.fda.gov/cber/summaries.htm#biother.

    Dated: September 12, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-19852 Filed 10-3-05; 8:45 am]
BILLING CODE 4160-01-S