Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 5465-5466 [2013-01561]
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Federal Register / Vol. 78, No. 17 / Friday, January 25, 2013 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR 514.80(b)(5)
Number of
recordkeepers
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
Records and reports concerning experience with approved new animal
drugs—special drug experience report .....................................................
34
1
34
2
68
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Total annual records were calculated
by multiplying the number of
recordkeepers times the number of
records per recordkeeper. Total hours
were calculated by multiplying total
annual records times the average burden
per recordkeeping.
In the Federal Register of January 17,
2012 (77 FR 2302), FDA published a 60day notice requesting public comment
on the proposed collection of
information to which three comments
were received: two from organizations
and one from a member of Congress.
The commenters generally supported
the collection of sales data, and stated
that this information would be useful in
assessing antimicrobial drugs used in
food-producing animals to better
address the problem of antimicrobial
resistance. One commenter stated that
the information supplied by drug
companies should be submitted in a
format that would allow it to be easily
merged with data from other FDA
databases.
Beyond the scope of this Federal
Register notice, all commenters
recommended collection of
antimicrobial use information in
addition to the current requirements of
ADUFA II sales reporting. All
commenters also recommended
revisions to the public reporting of the
data being collected. The commenters
requested FDA report sales of
antimicrobial drug classes by month, by
route of administration, by indication,
by over-the-counter or prescription
status, or grouped by their importance
in human medicine. It was
recommended that FDA collect and
publicly report distribution information
down to the state or regional level.
ADUFA II requires that no class with
fewer than three distinct sponsors of
approved applications shall be
independently reported; it was
recommended that FDA seek additional
authority from Congress to report sales
figures for all antimicrobial classes
regardless of the number of distinct drug
sponsors. There was also a
recommendation that all of the
information collected be made publicly
available in a searchable database.
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FDA has considered the comments,
but at this time we can only require the
submission of information on the new eform FDA 3744a that is expressly
required to be submitted by section
512(l)(3) of the FD&C Act. We are
pursuing notice and comment
rulemaking to codify these
requirements, and are currently
assessing any additional data
requirements. In this regard, FDA
published an Advance Notice of
Proposed Rulemaking on July 27, 2012,
in which FDA solicited comment on the
following: (1) Whether FDA should
require submission of an estimate of the
amount of antimicrobial ingredient sold
or distributed for use in each approved
food animal species, (2) how FDA can
best compile and present required
summary information, and (3)
alternative methods there may be for
obtaining additional data and
information about the extent of
antimicrobial drug use in foodproducing animals and are there
alternative methods the Agency can
employ within its existing authority.
Dated: January 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–01446 Filed 1–24–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
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.
PO 00000
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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 February 27, 2013 between approximately
8:30 a.m. and 2:45 p.m.
Location: National Institutes of Health
(NIH) Fishers Lane Conference Center,
Terrace Level, Rooms 508–510, 5635 Fishers
Lane, Rockville, MD, 20852. Please enter the
building through the main front entrance on
Fishers Lane and take the elevators down to
the T-Terrace Level. For those unable to
attend in person, the meeting will also be
webcast. The link for the webcast is available
at https://videocast.nih.gov.
Contact Person: Donald W. Jehn 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). 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
at https://www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting link,
or call the advisory committee information
line to learn about possible modifications
before coming to the meeting.
Agenda: On February 27, 2013, the
committee will meet in open session to
discuss and make recommendations on the
selection of strains to be included in the
influenza virus vaccine for the 2013–2014
influenza season.
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 meeting link.
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 on or before
February 20, 2013. Oral presentations from
the public will be scheduled between
approximately 12:35 p.m. and 1:35 p.m.
Those individuals interested in making
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Federal Register / Vol. 78, No. 17 / Friday, January 25, 2013 / Notices
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 February 12, 2013. 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 February
13, 2013.
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 Donald W.
Jehn 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: January 22, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–01561 Filed 1–24–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with
Center for Scientific Review; 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.
VerDate Mar<15>2010
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Name of Committee: Population Sciences
and Epidemiology Integrated Review Group,
Behavioral Genetics and Epidemiology Study
Section.
Date: February 20, 2013.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sir Francis Drake Hotel, 450 Powell
Street at Sutter, San Francisco, CA 94102.
Contact Person: George Vogler, Ph.D.,
Scientific Review Officer, PSE IRG, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3140,
Bethesda, MD 20892, 301–435–0694.
Name of Committee: Immunology
Integrated Review Group, Immunity and Host
Defense Study Section.
Date: February 21–22, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Dallas Marriott Suites Medical/
Market Center, 2493 North Stemmons
Freeway, Dallas, TX 75207.
Contact Person: Patrick K Lai, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2215,
MSC 7812, Bethesda, MD 20892, 301–435–
1052, laip@csr.nih.gov.
Name of Committee: Emerging
Technologies and Training Neurosciences
Integrated Review Group, Molecular
Neurogenetics Study Section.
Date: February 21–22, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Delfina Santa Monica
Hotel, 530 West Pico Boulevard, Santa
Monica, CA 90405.
Contact Person: Eugene Carstea, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194,
MSC 7846, Bethesda, MD 20892, (301) 408–
9756, carsteae@csr.nih.gov.
Name of Committee: Genes, Genomes, and
Genetics Integrated Review Group,
Prokaryotic Cell and Molecular Biology
Study Section.
Date: February 21, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance M Street Hotel, 1143
New Hampshire Avenue, NW., Washington,
DC 20037.
Contact Person: Dominique Lorang-Leins,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Room 5108,
MSC 7766, Bethesda, MD 20892,
301.326.9721, Lorangd@mail.nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group, Myocardial Ischemia and Metabolism
Study Section.
Date: February 21–22, 2013.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Alexandria, 1900
Diagonal Road, Alexandria, VA 22314.
PO 00000
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Contact Person: Kimm Hamann, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4118A,
MSC 7814, Bethesda, MD 20892, 301–435–
5575, hamannkj@csr.nih.gov.
Name of Committee: Genes, Genomes, and
Genetics Integrated Review Group, Molecular
Genetics A Study Section.
Date: February 21–22, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance M Street Hotel, 1143
New Hampshire Avenue NW., Washington,
DC 20037.
Contact Person: Michael M Sveda, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1114,
MSC 7890, Bethesda, MD 20892, 301–435–
3565, svedam@csr.nih.gov.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group, Neural Oxidative Metabolism
and Death Study Section.
Date: February 21–22, 2013.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Fairmont Hotel San Francisco, 950
Mason Street, San Francisco, CA 94108.
Contact Person: Carol Hamelink, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4192,
MSC 7850, Bethesda, MD 20892, (301) 213–
9887, hamelinc@csr.nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group, Gene and Drug Delivery Systems
Study Section.
Date: February 21–22, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard by Marriott, 5520
Wisconsin Avenue, Chevy Chase, MD 20815.
Contact Person: Amy L Rubinstein, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5152,
MSC 7844, Bethesda, MD 20892, 301–408–
9754, rubinsteinal@csr.nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group,
Virology–B Study Section.
Date: February 21–22, 2013.
Time: 8:30 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marina del Rey Hotel, 13534 Bali
Way, Marina del Rey, CA 90292.
Contact Person: John C Pugh, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1206,
MSC 7808, Bethesda, MD 20892, (301) 435–
2398, pughjohn@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group, Clinical Neuroimmunology and Brain
Tumors Study Section.
Date: February 21–22, 2013.
Time: 8:30 a.m. to 5:00 p.m.
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]]>Agencies
[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Notices]
[Pages 5465-5466]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01561]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
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 February 27, 2013
between approximately 8:30 a.m. and 2:45 p.m.
Location: National Institutes of Health (NIH) Fishers Lane
Conference Center, Terrace Level, Rooms 508-510, 5635 Fishers Lane,
Rockville, MD, 20852. Please enter the building through the main
front entrance on Fishers Lane and take the elevators down to the T-
Terrace Level. For those unable to attend in person, the meeting
will also be webcast. The link for the webcast is available at
https://videocast.nih.gov.
Contact Person: Donald W. Jehn 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). 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 at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming
to the meeting.
Agenda: On February 27, 2013, the committee will meet in open
session to discuss and make recommendations on the selection of
strains to be included in the influenza virus vaccine for the 2013-
2014 influenza season.
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 meeting link.
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 on or before
February 20, 2013. Oral presentations from the public will be
scheduled between approximately 12:35 p.m. and 1:35 p.m. Those
individuals interested in making
[[Page 5466]]
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 February 12, 2013. 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 February 13,
2013.
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 Donald W. Jehn 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: January 22, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-01561 Filed 1-24-13; 8:45 am]
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