Establishing a Docket for the Biological Products for Treatment of Rare Plasma Protein Disorders Public Workshop; Availability, 57884 [05-19852]
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57884
Federal Register / Vol. 70, No. 191 / Tuesday, October 4, 2005 / Notices
Reduction Act of 1995 (the PRA) (44
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information addressed in the guidance
document have been approved by OMB
in accordance with the PRA under the
regulations governing premarket
notification submissions (21 CFR part
807, subpart E, OMB control number
0910–0120), and the quality system
regulation (21 CFR part 820, OMB
control number 0910–0073). The
labeling provisions addressed in the
guidance have been approved by OMB
under OMB control number 0910–0485.
V. 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 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. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: September 9, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–19853 Filed 10–3–05; 8:45 am]
BILLING CODE 4160–01–S
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
VerDate Aug<31>2005
16:55 Oct 03, 2005
Jkt 205001
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 https://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:
• Patients’ and physicians’
perspective on the need for products to
treat rare plasma protein disorders;
• The availability of registries and
databases to identify patients for clinical
trials;
• Differences between international
and FDA regulatory approaches to the
licensure of products for treating rare
plasma protein diseases;
• Case studies describing the
application of current FDA regulatory
pathways to product development;
• Issues of product reimbursement;
and
• 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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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:
• How to facilitate development of
products used to treat rare plasma
protein disorders,
• Comments on the workshop, and
• 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
https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on Migrant
Health; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
E:\FR\FM\04OCN1.SGM
04OCN1
]]>Agencies
[Federal Register Volume 70, Number 191 (Tuesday, October 4, 2005)]
[Notices]
[Page 57884]
From the Federal Register Online via the Government Printing 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 https://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:
Patients' and physicians' perspective on the need for
products to treat rare plasma protein disorders;
The availability of registries and databases to identify
patients for clinical trials;
Differences between international and FDA regulatory
approaches to the licensure of products for treating rare plasma
protein diseases;
Case studies describing the application of current FDA
regulatory pathways to product development;
Issues of product reimbursement; and
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:
How to facilitate development of products used to treat
rare plasma protein disorders,
Comments on the workshop, and
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 https://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
