Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 59983-59984 [E9-27728]
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Federal Register / Vol. 74, No. 222 / Thursday, November 19, 2009 / Notices
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transfusion and blood components
intended for further manufacture,
including recovered plasma, Source
Plasma and Source Leukocytes.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by December 3, 2009.
The abbreviated comment period is
necessary because pandemic (H1N1)
2009 virus has the potential to cause
disruptions in the blood supply and
given this possibility, the agency needs
to finalize the guidance as soon as
possible.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N,
Rockville, MD 20852–1448. Send one
self-addressed adhesive label to assist
the office in processing your requests.
The draft guidance may also be obtained
by mail by calling CBER at 1–800–835–
4709 or 301–827–1800. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
Submit written comments on the
guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Benjamin A. Chacko, 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
FDA is announcing the availability of
a draft document entitled ‘‘Guidance for
Industry: Recommendations for the
Assessment of Blood Donor Suitability,
Blood Product Safety, and Preservation
of the Blood Supply in Response to
Pandemic (H1N1) 2009 Virus’’ dated
November 2009. This draft guidance
provides recommendations for assessing
blood donor suitability and blood
product safety and maintaining blood
and blood product availability in
response to pandemic (H1N1) 2009
virus. It is intended for establishments
that manufacture Whole Blood and
blood components intended for use in
VerDate Nov<24>2008
15:22 Nov 18, 2009
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transfusion and blood components
intended for further manufacture,
including recovered plasma, Source
Plasma and Source Leukocytes. At the
present time, FDA is working with other
HHS agencies to monitor the pandemic
(H1N1) 2009 virus and its potential
impact on blood availability and blood
safety. The agency notes that the Centers
for Disease Control and Prevention
(CDC) has issued a document entitled
‘‘Interim Infection Control Guidance on
2009 H1N1 Influenza for Personnel at
Blood and Plasma Collection
Facilities.’’1 We recognize the
importance of the CDC
recommendations for infection control
in blood and plasma collection
establishments.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on this
topic. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
The draft guidance refers to
previously approved collections of
information found in FDA regulations.
The collection of information in 21 CFR
part 606 has been approved under OMB
control number 0910–0116. The
collection of information for 21 CFR
part 601 has been approved under OMB
control number 0910–0338.
III. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may, at
any time, submit to the Division of
Dockets Management (see ADDRESSES)
written or electronic comments
regarding the draft guidance. 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 the draft guidance
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.
IV. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
1 https://www.cdc.gov/h1n1flu/infectioncontrol.
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59983
https://www.fda.gov/Biologics
BloodVaccines/GuidanceCompliance
RegulatoryInformation/guidances/
default.htm or https://
www.regulations.gov.
Dated: November 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27729 Filed 11–18–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
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). At least one portion of the
meeting will be closed 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 Tuesday, December 15, 2009,
from 1:30 p.m. to approximately 5 p.m.
Location: National Institutes of
Health, Bldg. 29, conference rm. 121.
The public is welcome to attend the
meeting at the specified location where
a speakerphone will be provided. Public
participation in the meeting is limited to
the use of the speakerphone in the
conference room. Important information
about transportation and directions to
the NIH campus, parking, and security
procedures is available on the Internet
at https://www.nih.gov/about/visitor/
index.htm. Visitors must show two
forms of identification, one of which
must be a government-issued photo
identification such as a Federal
employee badge, driver’s license,
passport, green card, etc. Detailed
information about security procedures is
located at https://www.nih.gov/about/
visitorsecurity.htm. Due to the limited
available parking, visitors are
encouraged to use public transportation.
Contact Person: Christine Walsh or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
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erowe on DSK5CLS3C1PROD with NOTICES
59984
Federal Register / Vol. 74, No. 222 / Thursday, November 19, 2009 / Notices
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. A notice in the Federal
Register about last minute modifications
that impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the agency’s Web
site and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On December 15, 2009, the
committee will meet in open session to
hear updates of the research programs in
the Laboratory of Retroviruses,
Laboratory of Immunoregulation, and
Laboratory of Respiratory Viruses,
Division of Viral Products, Office of
Vaccines Research and Review, Center
for Biologics Evaluation and Research,
FDA.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: On December 15, 2009,
from 1:30 p.m. to approximately 4:15
p.m., the meeting is open to the public.
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 on or before
December 11, 2009. Oral presentations
from the public will be scheduled
between approximately 3:15 p.m. and
4:15 p.m. Those desiring to make formal
oral presentations should notify the
contact person 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 on
or before December 7, 2009. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
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FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
December 8, 2009.
Closed Committee Deliberations: On
December 15, 2009, from approximately
4:15 p.m. to approximately 5 p.m., the
meeting will be closed to permit
discussion where disclosure would
constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). The committee will discuss
the report of the intramural research
programs and make recommendations
regarding personnel staffing decisions.
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.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: November 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27728 Filed 11–18–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Program Announcement Number (PA)
PAR09–184]
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): State Based
Occupational Health and Safety
Surveillance Grants, Initial Review
Correction: This notice was published
in the Federal Register on November 5,
2009, Volume 74, Number 2123, Page
57321. The time and date should read
as follows:
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Time and Dates
8 a.m.–5 p.m., December 3, 2009
(Closed).
8 a.m.–5 p.m., December 4, 2009
(Closed).
Contact Person for More Information:
Mack Stiles, DDS, MPH, PhD, Scientific
Review Administrator, Office of
Extramural Programs, National Institute
for Occupational Safety and Health,
CDC, 1600 Clifton Road, NE., Mailstop
E–74, Atlanta, Georgia 30333;
Telephone (404) 498–2530.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both CDC
and the Agency for Toxic Substances
and Disease Registry.
Dated: November 13, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–27805 Filed 11–18–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel, Training in
Developmental Biology and Child Health
Research.
Date: December 1, 2009.
Time: 2 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Blvd., Room 5B01, Bethesda, MD
20852 (Telephone Conference Call).
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]]>Agencies
[Federal Register Volume 74, Number 222 (Thursday, November 19, 2009)]
[Notices]
[Pages 59983-59984]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27728]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
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). At least one
portion of the meeting will be closed 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 Tuesday, December 15,
2009, from 1:30 p.m. to approximately 5 p.m.
Location: National Institutes of Health, Bldg. 29, conference rm.
121. The public is welcome to attend the meeting at the specified
location where a speakerphone will be provided. Public participation in
the meeting is limited to the use of the speakerphone in the conference
room. Important information about transportation and directions to the
NIH campus, parking, and security procedures is available on the
Internet at https://www.nih.gov/about/visitor/index.htm. Visitors must
show two forms of identification, one of which must be a government-
issued photo identification such as a Federal employee badge, driver's
license, passport, green card, etc. Detailed information about security
procedures is located at https://www.nih.gov/about/visitorsecurity.htm.
Due to the limited available parking, visitors are encouraged to use
public transportation.
Contact Person: Christine Walsh or Denise Royster, Center for
Biologics Evaluation and Research (HFM-71), Food and Drug
Administration, 1401
[[Page 59984]]
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. A notice in the Federal
Register about last minute modifications that impact a previously
announced advisory committee meeting cannot always be published quickly
enough to provide timely notice. Therefore, you should always check the
agency's Web site and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the
meeting.
Agenda: On December 15, 2009, the committee will meet in open
session to hear updates of the research programs in the Laboratory of
Retroviruses, Laboratory of Immunoregulation, and Laboratory of
Respiratory Viruses, Division of Viral Products, Office of Vaccines
Research and Review, Center for Biologics Evaluation and Research, FDA.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: On December 15, 2009, from 1:30 p.m. to approximately
4:15 p.m., the meeting is open to the public. 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 on or before December 11, 2009. Oral presentations from
the public will be scheduled between approximately 3:15 p.m. and 4:15
p.m. Those desiring to make formal oral presentations should notify the
contact person 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 on or before December 7, 2009.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by December 8, 2009.
Closed Committee Deliberations: On December 15, 2009, from
approximately 4:15 p.m. to approximately 5 p.m., the meeting will be
closed to permit discussion where disclosure would constitute a clearly
unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The
committee will discuss the report of the intramural research programs
and make recommendations regarding personnel staffing decisions.
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.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27728 Filed 11-18-09; 8:45 am]
BILLING CODE 4160-01-S
