Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 71539 [05-23373]
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Federal Register / Vol. 70, No. 228 / Tuesday, November 29, 2005 / Notices
probability of an unavailable important
public health benefit.
Under section 610 of the Clean Air
Act (42 U.S.C. 7671(i)), MDIs that are
not the subject of an essential-use
designation cannot be legally
distributed in interstate commerce.
We particularly encourage comments
on the second criterion in § 2.125(f)(i)
regarding the public health benefit
derived from the availability of these
products in the OTC setting.
Information that may aid in the
Committee’s discussion of essential use
includes:
• Who currently uses OTC
epinephrine MDIs?
• How many of these MDIs are used
annually?
• What are the alternatives if these
products are no longer available?
• From literature sources, what is the
value of use of the product to the users,
and why do they use it?
• What established treatment
guidelines recommend the use of OTC
epinephrine?
• How many people with asthma do
not have ready access to prescription
medication through healthcare
professionals?
The background material will become
available no later than the day before
the meeting and will be posted under
the Nonprescription Drugs Advisory
Committee (NDAC) and the Pulmonary
Drugs Advisory Committee (PADAC) on
FDA’s website at https://www.fda.gov/
ohrms/dockets/ac/acmenu.htm. (Click
on the year 2006 and scroll down to
NDAC or PADAC).
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committees. Written
comments should be submitted by close
of business January 6, 2006, to the
Division of Dockets Management (see
Addresses). Oral presentations from the
public will be scheduled between
approximately 1 p.m. and 2 p.m. Time
allotted for each presentation may be
limited. Those desiring to make formal
oral presentations should notify the
contact person by close of business
January 6, 2006, and submit a brief
statement of the general nature of the
information 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
VerDate Aug<31>2005
20:13 Nov 28, 2005
Jkt 208001
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 Darrell Lyons
(see Contact Person) 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: November 17, 2005.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. 05–23372 Filed 11–28–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Vaccines and Related Biological
Products 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: Vaccines and
Related Biological Products 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 December 14, 2005, from 9 a.m.
to 4:30 p.m. and on December 15, 2005,
from 9 a.m. to 4:30 p.m.
Location: Holiday Inn Select, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: Christine Walsh or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512391. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: On December 14, 2005, the
committee will hear presentations and
make recommendations on the safety
and efficacy of a rotavirus vaccine
manufactured by Merck. On December
15, 2005, the committee will hear
presentations and make
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
71539
recommendations on the safety and
efficacy of ZOSTAVAX (zoster vaccine
live (Oka/Merck)) manufactured by
Merck.
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 December 7, 2005. Oral
presentations from the public will be
scheduled between approximately 1:15
p.m. and 1:45 p.m. on December 14,
2005, and from approximately 1:30 p.m.
and 2 p.m. on December 15, 2005. Time
allotted for each presentation may be
limited. Those desiring to make formal
oral presentations should notify the
contact person before December 7, 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 Christine
Walsh or Denise Royster 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: November 17, 2005.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. 05–23373 Filed 11–28–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Federal Emergency
Management Agency, Department of
Homeland Security.
ACTION: Notice and request for
comments.
AGENCY:
SUMMARY: The Federal Emergency
Management Agency, as part of its
E:\FR\FM\29NON1.SGM
29NON1
]]>Agencies
[Federal Register Volume 70, Number 228 (Tuesday, November 29, 2005)]
[Notices]
[Page 71539]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23373]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Vaccines and Related Biological Products 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: Vaccines and Related Biological Products
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 December 14, 2005, from
9 a.m. to 4:30 p.m. and on December 15, 2005, from 9 a.m. to 4:30 p.m.
Location: Holiday Inn Select, 8120 Wisconsin Ave., Bethesda, MD.
Contact Person: Christine Walsh or Denise Royster, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314,
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 3014512391. Please call the
Information Line for up-to-date information on this meeting.
Agenda: On December 14, 2005, the committee will hear presentations
and make recommendations on the safety and efficacy of a rotavirus
vaccine manufactured by Merck. On December 15, 2005, the committee will
hear presentations and make recommendations on the safety and efficacy
of ZOSTAVAX (zoster vaccine live (Oka/Merck)) manufactured by Merck.
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 December 7,
2005. Oral presentations from the public will be scheduled between
approximately 1:15 p.m. and 1:45 p.m. on December 14, 2005, and from
approximately 1:30 p.m. and 2 p.m. on December 15, 2005. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before December 7,
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 Christine Walsh or
Denise Royster 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: November 17, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-23373 Filed 11-28-05; 8:45 am]
BILLING CODE 4160-01-S
