Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 3780-3781 [2012-1456]
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3780
Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices
Regarding Human Prescription Drugs
Ernest S. Voyard, Jr., Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 Hampshire
Ave., Bldg. 51, Rm. 3276, Silver Spring,
MD 20993, (301) 796–1200.
Regarding Prescription Human
Biological Products
Stephen Ripley, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448, (301) 827–6210.
Regarding Animal Prescription Drugs
Julie Garnier, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, (240) 276–9300.
SUPPLEMENTARY INFORMATION:
srobinson on DSK4SPTVN1PROD with NOTICES
I. Background
FDA is announcing the availability of
a guidance document entitled ‘‘Product
Name Placement, Size, and Prominence
in Advertising and Promotional
Labeling.’’ This guidance discusses the
requirements for product name
placement, size, prominence, and
frequency in promotional labeling and
advertising for prescription human and
animal drugs and biological products.
The disclosure of the product name in
promotional labeling and advertising for
all prescription human and animal drug
and biological products is important for
the proper identification of such
products to ensure their safe and
effective use.
The placement, size, prominence, and
frequency of the proprietary and
established names for human and
animal prescription drug products are
specified in labeling and advertising
regulations (21 CFR 201.10(g) and (h);
202.1(b), (c), and (d)). These regulations
are also applicable to biological product
labeling and advertising materials.
The recommendations in this
guidance pertain to product names in
traditional print media promotion (e.g.,
journal ads, detail aids, brochures),
audiovisual promotional labeling (e.g.,
videos shown in a health care provider’s
office), broadcast media promotion (e.g.,
television advertisements, radio
advertisements), and electronic and
computer-based promotional labeling
and advertisements, such as Internet
promotion, social media, emails, CD–
ROMs, and DVDs.
In the Federal Register of March 12,
1999 (64 FR 12341), FDA announced the
availability of the draft guidance of the
same title, dated January 1999. FDA
received six comments on the draft
guidance, five were from the
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18:09 Jan 24, 2012
Jkt 226001
pharmaceutical industry and one was
from a consumer. The majority of the
comments related to requests to provide
additional clarifications and examples
related to the individual
recommendations in the draft guidance.
These comments were considered
carefully during the finalization of the
guidance document. The guidance has
been revised in the following ways: (1)
It clarifies certain concepts previously
discussed in the draft guidance and
adds definitions for certain terms; (2) it
provides examples to illustrate the
appropriate juxtaposition and
prominence of proprietary and
established names for products with one
active ingredient and examples to
illustrate the juxtaposition of products
with two or more active ingredients; (3)
it reorganizes and renames the draft
guidance’s sections pertaining to the
frequency of the disclosure of
proprietary and established names in
various media into one section with
three subsections—traditional print
promotional labeling and
advertisements, audiovisual
promotional labeling and broadcast
advertisements, and electronic and
computer-based promotional labeling
and advertisements; and (4) it discusses
the use of proprietary and established
names in columns in traditional print
promotional labeling and
advertisements.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents 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. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments 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.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
PO 00000
Frm 00052
Fmt 4703
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GuidanceCompliance
RegulatoryInformation/default.htm, or
https://www.regulations.gov.
Dated: January 19, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–1431 Filed 1–24–12; 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). 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 February 28, 2012, from
approximately 8 a.m. to 4 p.m. and
February 29, 2012, from approximately
8 a.m. to 1 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You’’, click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
For those unable to attend in person,
the meeting will also be webcast. The
link for the webcast is available at:
https://collaboration.fda.gov/cberac.
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), and follow the
E:\FR\FM\25JAN1.SGM
25JAN1
srobinson on DSK4SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices
prompts to the desired center or product
area. 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 February 28, 2012, the
committee will meet in open session to
hear an overview of the research
program in the Laboratory of
Mycobacterial Diseases and Cellular
Immunology, Division of Bacterial,
Parasitic and Allergenic Products, Office
of Vaccines Research and Review,
Center for Biologics Evaluation and
Research, FDA. The committee will then
discuss and make recommendations on
the selection of strains to be included in
the influenza virus vaccine for the 2012
to 2013 influenza season. On February
29, 2012, the committee will discuss
licensure pathways for pandemic
influenza vaccines.
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 February 28, 2012,
between approximately 8 a.m. and 9:45
a.m. and between approximately 10:15
p.m. and 4 p.m., the meeting is open to
the public. On February 29, 2012, the
entire 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
February 21, 2012. Oral presentations
from the public will be scheduled
between approximately 2:40 p.m. and
3:10 p.m. on February 28, 2012, and
between approximately 10:45 a.m. and
11:15 a.m. on February 29, 2012. Those
individuals interested in making 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
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Jkt 226001
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before February 13, 2012. 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 14, 2012.
Closed Committee Deliberations: On
February 28, 2012, between
approximately 9:45 a.m. and 10:15 a.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 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 17, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–1456 Filed 1–24–12; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
3781
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0754]
Pediatric Medical Devices; Public
Workshop; Reopening of Comment
Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; reopening of comment
period.
The Food and Drug
Administration (FDA) is reopening until
March 5, 2012, the comment period for
the notice entitled ‘‘Pediatric Medical
Devices; Public Workshop; Request for
Comments’’ that appeared in the
Federal Register of Tuesday, November
1, 2011 (76 FR 67463). In the notice,
FDA announced a public workshop to
consider factors affecting the use of
scientific research data to support
pediatric medical device efficacy
claims. This is part of an on-going effort
to address the ways scientific research
data can be used to support pediatric
effectiveness claims for medical devices
and pediatric device approvals or
clearance; the scientific and regulatory
limitations and issues of using existing
scientific research data to support
pediatric effectiveness claims and
pediatric indication approvals for
medical devices; and methods to
overcome the pitfalls and data gaps,
including statistical approaches and
modeling. The agency is taking this
action to allow interested persons
additional time to submit comments on
the use of scientific research data,
including published scientific literature,
to support and establish pediatric
indications for medical devices.
DATES: Submit either electronic or
written comments by March 5, 2012.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Carol Krueger, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5437, Silver Spring,
MD 20993–0002, (301) 796–3241,
Carol.Krueger@fda.hhs.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
I. Background
In 2007, Congress passed the Pediatric
Medical Device Safety and Improvement
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]]>Agencies
[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3780-3781]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1456]
-----------------------------------------------------------------------
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). 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 February 28, 2012, from
approximately 8 a.m. to 4 p.m. and February 29, 2012, from
approximately 8 a.m. to 1 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), Silver Spring MD 20993-
0002. Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/default.htm; under the heading
``Resources for You'', click on ``Public Meetings at the FDA White Oak
Campus.'' Please note that visitors to the White Oak Campus must enter
through Building 1.
For those unable to attend in person, the meeting will also be
webcast. The link for the webcast is available at: https://collaboration.fda.gov/cberac.
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), and follow the
[[Page 3781]]
prompts to the desired center or product area. 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 February 28, 2012, the committee will meet in open
session to hear an overview of the research program in the Laboratory
of Mycobacterial Diseases and Cellular Immunology, Division of
Bacterial, Parasitic and Allergenic Products, Office of Vaccines
Research and Review, Center for Biologics Evaluation and Research, FDA.
The committee will then discuss and make recommendations on the
selection of strains to be included in the influenza virus vaccine for
the 2012 to 2013 influenza season. On February 29, 2012, the committee
will discuss licensure pathways for pandemic influenza vaccines.
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 February 28, 2012, between approximately 8 a.m. and
9:45 a.m. and between approximately 10:15 p.m. and 4 p.m., the meeting
is open to the public. On February 29, 2012, the entire 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
February 21, 2012. Oral presentations from the public will be scheduled
between approximately 2:40 p.m. and 3:10 p.m. on February 28, 2012, and
between approximately 10:45 a.m. and 11:15 a.m. on February 29, 2012.
Those individuals interested in making 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 13, 2012. 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 14,
2012.
Closed Committee Deliberations: On February 28, 2012, between
approximately 9:45 a.m. and 10:15 a.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 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 17, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-1456 Filed 1-24-12; 8:45 am]
BILLING CODE 4160-01-P
