Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 25593-25594 [E6-6509]
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Federal Register / Vol. 71, No. 83 / Monday, May 1, 2006 / Notices
based on internal pilot testing of the
survey instrument at the agency.
Dated: April 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–6461 Filed 4–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Research Review Subcommittee of the
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
cchase on PROD1PC60 with NOTICES
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 the Subcommittee: Research
Review Subcommittee of the 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 May 19, 2006, from 8 a.m. to
4:30 p.m.
Location: Hilton Hotel, Washington
DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
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 May 19, 2006, the
subcommittee will listen to
presentations about the research
program at the Office of Vaccines
Research and Review (OVRR), Center for
Biologics Evaluation and Research
(CBER). The program is intended to
provide dynamic, responsive, cutting
edge research to contribute to OVRR’s
regulatory mission and facilitate
development of safe and effective
biological products. The subcommittee
will discuss the program and make
recommendations to the Vaccines and
Related Biological Products Advisory
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Committee at a future open meeting of
the full committee. Information
regarding CBER’s scientific program is
outlined in its Strategic Plan of 2004
and is available to the public on the
Internet at: https://www.fda.gov/cber/
inside/mission.htm. Information
regarding FDA’s Critical Path to New
Medical Products is available to the
public on the Internet at: https://
www.fda.gov/oc/initiatives/
criticalpath/.
Procedure: On May 19, 2006, from 8
a.m. to 1 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 by May 12, 2006. Oral
presentations from the public will be
scheduled between approximately 12
p.m. to 1 p.m. Time allotted for each
presentation may be limited. Those
desiring to make formal oral
presentations should notify the contact
person before May 12, 2006, 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.
Closed Committee Deliberations: On
May 19, 2006, from 2 p.m. to 4:30 p.m.,
the meeting will be closed to the public.
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) and to permit discussion and
review of trade secret and/or
confidential information (5 U.S.C.
552b(c)(4). The subcommittee will
discuss internal research programs in
the Office of Vaccines Research and
Review, CBER.
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).
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25593
Dated: April 21, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–6508 Filed 4–28–06; 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 May 18, 2006, from 9 a.m. to
4:45 p.m.
Location: Hilton Hotel, Washington
DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
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: The committee will hear
presentations and make
recommendations on the safety and
efficacy of GARDASIL (Human
Papillomavirus [Types 6,11,16,18]
Recombinant Vaccine) 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 May 11, 2006. Oral
presentations from the public will be
scheduled between approximately 1:30
p.m. and 2:30 p.m. Time allotted for
each presentation may be limited. Those
desiring to make formal oral
E:\FR\FM\01MYN1.SGM
01MYN1
25594
Federal Register / Vol. 71, No. 83 / Monday, May 1, 2006 / Notices
presentations should notify the contact
person before May 11, 2006, 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: April 24, 2006.
Jason Brodsky,
Acting Associate Commissioner for External
Relations.
[FR Doc. E6–6509 Filed 4–28–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D–0401]
Guidance for Industry and Food and
Drug Administration Staff: Compliance
With the Medical Device User Fee and
Modernization Act of 2002, as
amended—Prominent and
Conspicuous Mark of Manufacturers
on Single-Use Devices; Availability
AGENCY:
Food and Drug Administration,
HHS.
cchase on PROD1PC60 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Compliance With Section 301 of the
Medical Device User Fee and
Modernization Act of 2002, as
amended—Prominent and Conspicuous
Mark of Manufacturers on Single-Use
Devices.’’ The Medical Device User Fee
and Modernization Act 2002
(MDUFMA), as amended by the Medical
Device User Fee Stabilization Act of
2005 (MDUFSA), requires that FDA
issue guidance identifying the
circumstances in which the name,
abbreviation, or symbol of the
manufacturer of an original device is not
‘‘prominent and conspicuous.’’
MDUFSA requires that FDA issue
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guidance no later than 180 days after the
date of enactment (August 1, 2005).
DATES: Submit written or electronic
comments on this guidance at any time.
General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Submit written requests for
single copies on a 3.5’’ diskette of the
guidance document entitled
‘‘Compliance With Section 301 of the
Medical Device User Fee and
Modernization Act of 2002, as
amended—Prominent and Conspicuous
Mark of Manufacturers on Single-Use
Devices’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance (HFZ–220), Center
for Devices and Radiological Health,
Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–443–
8818. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit written comments concerning
this 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.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Casper E. Uldriks, Center for Devices
and Radiological Health (HFZ–300),
Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240–
276–0106.
SUPPLEMENTARY INFORMATION:
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on ‘‘Compliance With
Section 301 of the Medical Device User
Fee and Modernization Act of 2002, as
amended—Prominent and Conspicuous
Mark of Manufacturers on Single-Use
Devices.’’ 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 statute
and regulations.
I. Background
MDUFMA (Public Law 107–250)
amended section 502 of the Federal
Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 352) to require a device, or
an attachment to the device, to bear
prominently and conspicuously the
name of the manufacturer, a generally
recognized abbreviation of such name,
or a unique and generally recognized
symbol identifying the manufacturer.
This labeling provision applied to all
devices and all device manufacturers.
On August 1, 2005, MDUFSA (Public
Law 109–43) amended section 502(u) of
the act by limiting the provision to
reprocessed single-use devices (SUDs)
and the manufacturers who reprocess
them. Therefore, section 502(u) of the
act, as amended by MDUFSA, no longer
sets forth requirements for original
equipment manufacturers, unless they
also reprocess SUDs. Under the
amended provision, if an original device
III. Electronic Access
To receive ‘‘ Compliance With Section
301 of the Medical Device User Fee and
Modernization Act of 2002, as
amended—Prominent and Conspicuous
Mark of Manufacturers on Single-Use
Devices’’ by fax, call the CDRH FactsOn-Demand system at 800–899–0381 or
301–827–0111 from a touch-tone
telephone. Press 1 to enter the system.
At the second voice prompt, press 1 to
order a document. Enter the document
number (1217) followed by the pound
sign (#). Follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy
of the guidance may also do so by using
the Internet. CDRH maintains an entry
on the Internet for easy access to
information including text, graphics,
and files that may be downloaded to a
personal computer with Internet access.
Updated on a regular basis, the CDRH
home page includes device safety alerts,
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or an attachment to it does not
prominently and conspicuously bear the
name of the manufacturer of the original
device, a generally recognized
abbreviation of such name, or a unique
and generally recognized symbol
identifying such manufacturer, the
manufacturer who reprocesses the SUD
may identify itself using a detachable
label on the packaging of the device.
Section 2(c)(2) of MDUFSA requires
that FDA issue guidance not later than
180 days after the date of its enactment
to identify the circumstances under
which the identifying mark of a
manufacturer of an original device is not
‘‘prominent and conspicuous,’’ as used
in section 502(u) of the act. On October
11, 2005, FDA issued draft guidance
describing the circumstances under
which the agency would not consider a
manufacturer’s mark to be prominent
and conspicuous. FDA received several
comments on the draft guidance, all of
which were considered in finalizing the
guidance.
E:\FR\FM\01MYN1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 83 (Monday, May 1, 2006)]
[Notices]
[Pages 25593-25594]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-6509]
-----------------------------------------------------------------------
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 May 18, 2006, from 9
a.m. to 4:45 p.m.
Location: Hilton Hotel, Washington DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20877.
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: The committee will hear presentations and make
recommendations on the safety and efficacy of GARDASIL (Human
Papillomavirus [Types 6,11,16,18] Recombinant Vaccine) 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 May 11, 2006.
Oral presentations from the public will be scheduled between
approximately 1:30 p.m. and 2:30 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
[[Page 25594]]
presentations should notify the contact person before May 11, 2006, 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: April 24, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-6509 Filed 4-28-06; 8:45 am]
BILLING CODE 4160-01-S
