Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2009 Proposed Guidance Development, 56830-56831 [E8-22911]
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ebenthall on PROD1PC60 with NOTICES
56830
Federal Register / Vol. 73, No. 190 / Tuesday, September 30, 2008 / Notices
Administration for Children and
Families, 370 L’Enfant Promenade, SW.,
Washington, DC. The meeting will be
open to the public; however, seating is
limited and pre-registration is
encouraged (see below).
FOR FURTHER INFORMATION CONTACT:
Roberta Lavin, Office of Human Services
Emergency Preparedness and Response,
e-mail roberta.lavin@acf.hhs.gov or
(202) 401–9306.
SUPPLEMENTARY INFORMATION: The
National Commission on Children and
Disasters (henceforth ‘‘the
Commission’’) is a commission that
shall independently conduct a
comprehensive study to examine and
assess the needs of children as they
relate to preparation for, response to,
and recovery from all hazards, building
upon the evaluations of other entities
and avoiding unnecessary duplication
by reviewing the findings, conclusions,
and recommendations of these entities.
The Commission shall then submit a
report to the President, the Secretary of
Health and Human Services, and the
Congress on the Commission’s
independent and specific findings,
conclusions, and recommendations to
address the needs of children as they
relate to preparation for, response to,
and recovery from all hazards, including
major disasters and emergencies. The
Commission implements the intent of
Congress as expressed in The
Consolidated Appropriations Act, 2008
(Pub. L. 110–161), Division G, Title VI,
(henceforth ‘‘the Act’’) signed into law
on December 26, 2007, authorizing
funds for a body performing the
functions here assigned to the
Commission.
The Commission will hear
presentations on and discuss: (1) The
Department of Health and Human
Services’ efforts to support the needs of
children in disaster situations; (2) the
Federal Emergency Management
Administration’s efforts to support the
needs of children in disaster situations;
(3) White House perspectives on the
Administration’s efforts to support the
needs of children in disaster situations;
and (4) plans for future work of the
Commission.
The meeting will be open to the
public; however, seating is limited and
pre-registration is encouraged. To preregister, please e-mail
carol.apelt@acf.hhs.gov with ‘‘Meeting
Registration’’ in the subject line, or call
Carol Apelt at (202) 205–4618 by 5 p.m.
EST, October 9, 2008. Registration must
include your name, affiliation, phone
number. If you require a sign language
interpreter or other special assistance,
please call Carol Apelt at (202) 205–
VerDate Aug<31>2005
15:35 Sep 29, 2008
Jkt 214001
4618 as soon as possible and no later
than October 6, 2008.
Dated: September 24, 2008.
Charles Keckler,
Deputy Assistant Secretary for Policy for
Children and Families.
[FR Doc. E8–22939 Filed 9–29–08; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–N–0270] (formerly
Docket No. 2007N–0357)
Medical Device User Fee and
Modernization Act; Notice to Public of
Web Location of 2009 Proposed
Guidance Development
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
Web location where the agency will post
a list of guidance documents the Center
for Devices and Radiological Health
(CDRH) is considering for development
in fiscal year (FY) 2009. In addition,
FDA has established a docket where
stakeholders may provide comments
and/or draft language for those topics as
well as suggestions for new or different
guidances.
DATES: Submit written or electronic
comments at any time.
ADDRESSES: Submit written comments
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. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Deborah A. Wolf, Center for Devices and
Radiological Health (HFZ–215), Food
and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850, 240–276–
2350.
SUPPLEMENTARY INFORMATION:
I. Background
During negotiations over the
reauthorization of the Medical Device
User Fee and Modernization Act
(MDUFMA), FDA agreed, in return for
additional funding from industry, to
meet a variety of quantitative and
qualitative goals intended to help get
safe and effective medical devices to
market more quickly. These
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
commitments include annually posting
a list of guidance documents that CDRH
is considering for development and
providing stakeholders an opportunity
to provide comments and/or draft
language for those topics, or suggestions
for new or different guidances. This
notice announces the Web location of
the list of guidances (see § 10.115(c)(1)
(21 CFR 10.115(c)(1))) on which CDRH
is intending to work over the next FY.
We note that the agency is not required
to issue every guidance on the list, nor
is it precluded from issuing guidance
documents that are not on the list. The
list includes topics that currently have
no guidance associated with them,
topics where updated guidance may be
helpful, and topics for which CDRH has
already issued level 1 drafts that may be
finalized following review of public
comments. We will consider
stakeholder comments as we prioritize
our guidance efforts.
FDA and CDRH priorities are subject
to change at any time. Topics on this
and past guidance priority lists may be
removed or modified based on current
priorities. We also note that CDRH’s
experience over the years has shown
that there are many reasons CDRH staff
does not complete the entire annual
agenda of guidances it undertakes. Staff
are frequently diverted from guidance
development to other activities,
including review of premarket
submissions or postmarket problems. In
addition, the Center is required each
year to issue a number of guidances that
it cannot anticipate at the time the
annual list is generated. These may
involve newly identified public health
issues as well as special control
guidance documents for de novo
classifications of devices. It will be
helpful, therefore, to receive comments
that indicate the relative priority of
different guidance topics to interested
stakeholders.
Through feedback from stakeholders,
including draft language for guidance
documents, CDRH expects to be able to
better prioritize and more efficiently
draft guidances that will be useful to
industry and other stakeholders. This
will be the second annual list CDRH has
posted. FDA intends to update the list
each year.
FDA invites interested persons to
submit comments on any or all of the
guidance documents on the list. FDA
has established a specific docket (see
docket number found in brackets in the
heading of this document) where
comments about the FY 2009 list, draft
language for guidance documents on
those topics, and suggestions for new or
different guidances may be submitted.
FDA believes this docket is an
E:\FR\FM\30SEN1.SGM
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Federal Register / Vol. 73, No. 190 / Tuesday, September 30, 2008 / Notices
important tool for receiving information
from interested parties and for sharing
this information with the public.
Similar information about planned
guidance development is included in
the annual agency-wide notice issued by
FDA under its good guidance practices
(§ 10.115(f)(5)). The CDRH list, however,
will be focused exclusively on devicerelated guidances and will be made
available on FDA’s Web site prior to the
beginning of each FY from 2008 to 2012.
To access the list of the guidance
documents CDRH is considering for
development in 2009, visit the FDA
Web Site at https://www.fda.gov/cdrh/
mdufma/guidance/agenda/fy09.html.
II. Request for Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
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. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Comments submitted to this docket may
include draft guidance documents that
stakeholders have prepared for FDA’s
consideration.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: September 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–22911 Filed 9–29–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ebenthall on PROD1PC60 with NOTICES
[Docket No. FDA–2008–N–0038]
Antiviral Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Aug<31>2005
15:35 Sep 29, 2008
Jkt 214001
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: Antiviral Drugs
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 October 30, 2008, from 9 a.m.
to 1 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 1750
Rockville Pike, Rockville, MD, 301–
468–1100.
Contact Person: Paul Tran, Center for
Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–6793, FAX: 301–
827–6776, e-mail:
paul.tran@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512531. 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: The meeting will be open to
the public from 8 a.m. to 9 a.m., unless
public participation does not last that
long, from 9 a.m. to 1 p.m., the meeting
will be closed to permit discussion of
current and future advances on antiviral
drugs which will include the review of
trade secret and/or confidential
information.
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2008 and scroll down to the
appropriate advisory committee link.
Procedure: On October 30, 2008, from
8 a.m. to 9 a.m., the meeting is open to
the public. Interested persons may
PO 00000
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Fmt 4703
Sfmt 4703
56831
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 October 16, 2008.
Oral presentations from the public will
be scheduled between approximately 8
a.m. and 9 a.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 October 7, 2008. 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 October 8, 2008.
Closed Committee Deliberations: On
October 30, 2008, from 9 a.m. to 1 p.m.,
the meeting will be closed to permit
discussion and review of trade secret
and/or confidential information (5
U.S.C. 552b(c)(4)). During this session,
the committee will be updated on
current and future advances on antiviral
drugs.
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 Paul Tran 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/oc/advisory/
default.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: September 19, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8–22912 Filed 9–29–08; 8:45 am]
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]]>Agencies
[Federal Register Volume 73, Number 190 (Tuesday, September 30, 2008)]
[Notices]
[Pages 56830-56831]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22911]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-N-0270] (formerly Docket No. 2007N-0357)
Medical Device User Fee and Modernization Act; Notice to Public
of Web Location of 2009 Proposed Guidance Development
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the Web
location where the agency will post a list of guidance documents the
Center for Devices and Radiological Health (CDRH) is considering for
development in fiscal year (FY) 2009. In addition, FDA has established
a docket where stakeholders may provide comments and/or draft language
for those topics as well as suggestions for new or different guidances.
DATES: Submit written or electronic comments at any time.
ADDRESSES: Submit written comments 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. Identify comments with the docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Deborah A. Wolf, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 240-276-2350.
SUPPLEMENTARY INFORMATION:
I. Background
During negotiations over the reauthorization of the Medical Device
User Fee and Modernization Act (MDUFMA), FDA agreed, in return for
additional funding from industry, to meet a variety of quantitative and
qualitative goals intended to help get safe and effective medical
devices to market more quickly. These commitments include annually
posting a list of guidance documents that CDRH is considering for
development and providing stakeholders an opportunity to provide
comments and/or draft language for those topics, or suggestions for new
or different guidances. This notice announces the Web location of the
list of guidances (see Sec. 10.115(c)(1) (21 CFR 10.115(c)(1))) on
which CDRH is intending to work over the next FY. We note that the
agency is not required to issue every guidance on the list, nor is it
precluded from issuing guidance documents that are not on the list. The
list includes topics that currently have no guidance associated with
them, topics where updated guidance may be helpful, and topics for
which CDRH has already issued level 1 drafts that may be finalized
following review of public comments. We will consider stakeholder
comments as we prioritize our guidance efforts.
FDA and CDRH priorities are subject to change at any time. Topics
on this and past guidance priority lists may be removed or modified
based on current priorities. We also note that CDRH's experience over
the years has shown that there are many reasons CDRH staff does not
complete the entire annual agenda of guidances it undertakes. Staff are
frequently diverted from guidance development to other activities,
including review of premarket submissions or postmarket problems. In
addition, the Center is required each year to issue a number of
guidances that it cannot anticipate at the time the annual list is
generated. These may involve newly identified public health issues as
well as special control guidance documents for de novo classifications
of devices. It will be helpful, therefore, to receive comments that
indicate the relative priority of different guidance topics to
interested stakeholders.
Through feedback from stakeholders, including draft language for
guidance documents, CDRH expects to be able to better prioritize and
more efficiently draft guidances that will be useful to industry and
other stakeholders. This will be the second annual list CDRH has
posted. FDA intends to update the list each year.
FDA invites interested persons to submit comments on any or all of
the guidance documents on the list. FDA has established a specific
docket (see docket number found in brackets in the heading of this
document) where comments about the FY 2009 list, draft language for
guidance documents on those topics, and suggestions for new or
different guidances may be submitted. FDA believes this docket is an
[[Page 56831]]
important tool for receiving information from interested parties and
for sharing this information with the public. Similar information about
planned guidance development is included in the annual agency-wide
notice issued by FDA under its good guidance practices (Sec.
10.115(f)(5)). The CDRH list, however, will be focused exclusively on
device-related guidances and will be made available on FDA's Web site
prior to the beginning of each FY from 2008 to 2012.
To access the list of the guidance documents CDRH is considering
for development in 2009, visit the FDA Web Site at https://www.fda.gov/
cdrh/mdufma/guidance/agenda/fy09.html.
II. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday. Comments submitted to this docket may include draft
guidance documents that stakeholders have prepared for FDA's
consideration.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: September 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-22911 Filed 9-29-08; 8:45 am]
BILLING CODE 4160-01-S
