Biological Products for Treatment of Rare Plasma Protein Disorders; Public Workshop, 24079 [05-9011]
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Federal Register / Vol. 70, No. 87 / Friday, May 6, 2005 / Notices
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.
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: dawsonr@cber.fda.gov.
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
VerDate jul<14>2003
18:03 May 05, 2005
Jkt 205001
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 https://www.fda.gov/
cber/scireg.htm and https://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 https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Cardiovascular and Renal Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Cardiovascular
and Renal Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 15 and 16, 2005, from 8
a.m. to 5 p.m.
Location: Holiday Inn, The Ballrooms,
Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Cathy Groupe, Center
for Drug Evaluation and Research (HFD–
PO 00000
Frm 00119
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24079
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093) Rockville,
MD 20857, 301–827–7001, e-mail:
groupec@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512533. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On June 15, 2005, the
committee will discuss class labeling of
antihypertensive drugs based on the
proximity of their data to outcome trials.
On June 16, 2005, the committee will
discuss new drug application (NDA) 20–
727, proposed trade name BIDIL
(hydralazine hydrochloride/isosorbide
dinitrate) (tablets are 37.5 milligrams
(mg) hydralazine hydrochloride/20 mg
isosorbide dinitrate), NitroMed, Inc.,
proposed for the indication of heart
failure, based on the results from the
African American Heart Failure Trial.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person by June 8, 2005. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. on both days. Time
allotted for each presentation may be
limited. Those desiring to make formal
oral presentations should notify the
contact person before June 8, 2005, and
submit a brief statement of the general
nature of the evidence or arguments
they wish to present, the names and
addresses of proposed participants and
an indication of the approximate time
requested to make their presentation.
Persons attending FDA’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Beverly
O’Neil at 301–827–7001 at least 7 days
in advance of the meeting.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 28, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External
Relations.
[FR Doc. 05–9010 Filed 5–5–05; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 70, Number 87 (Friday, May 6, 2005)]
[Notices]
[Page 24079]
From the Federal Register Online via the Government Printing 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.
-----------------------------------------------------------------------
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: dawsonr@cber.fda.gov.
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 https://www.fda.gov/cber/scireg.htm and https://
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
https://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
