Medical Device User Fee and Modernization Act; Notice to Public of Web Location of 2008 Proposed Guidance Development; Establishment of a Public Docket, 57587-57588 [E7-19864]
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Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Notices
Application
No.
Drug
57587
Applicant
NDA 7–518
Synthetic Vitamin A
Pfizer Laboratories, Division of Pfizer, Inc., 235 East 42nd
St., New York, NY 10017
NDA 8–837
Isoniazid Tablets
Barnes Hind, 895 Kifer Rd., Sunnyvale, CA 94806
NDA 8–851
NDK Fluoride Dentifrice (sodium monofluorophosphate)
NDK Co., c/o J.W. Emmer/Kenneth Emmer, 215 Genevieve
Dr., Lafayette, LA 70503
NDA 9–395
Paskalium (potassium aminosalicylate)
Glenwood, 111 Cedar Lane, Englewood, NJ 07631
NDA 19–518
Extra Strength Aim (sodium monofluorophosphate)
Chesebrough-Ponds USA Co., 33 Benedict Pl., P.O. Box
6000, Greenwich, CT 06836–6000
The Director, Center for Drug
Evaluation and Research, under section
505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)), and
under authority delegated by the
Commissioner, finds that the holders of
the applications listed in this document
have repeatedly failed to submit reports
required by § 314.81. In addition, under
§ 314.200, we find that the holders of
the applications have waived any
contentions concerning the legal status
of the drug products. Therefore, under
these findings, approval of the
applications listed in this document,
and all amendments and supplements
thereto, is hereby withdrawn, effective
October 10, 2007.
Dated: September 24, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E7–19865 Filed 10–9–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0357]
Medical Device User Fee and
Modernization Act; Notice to Public of
Web Location of 2008 Proposed
Guidance Development; Establishment
of a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
Web location where it will post a list of
guidance documents the Center for
Devices and Radiological Health (CDRH)
is considering for development. In
addition, FDA is establishing a docket
where stakeholders may provide
comments and/or draft language for
those topics as well as suggestions for
new or different guidances.
VerDate Aug<31>2005
17:08 Oct 09, 2007
Jkt 214001
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.fda.gov/dockets/ecomments.
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.
DATES:
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 FDA’s
Center for Devices and Radiological
Health (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 CDRH is intending to work
on over the next fiscal year. 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
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
comments. We will consider
stakeholder comments as we prioritize
our guidance efforts.
We also note that CDRH’s experience
over the years has shown that there are
many reasons CDRH staff cannot
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 it
cannot know about in advance. These
may involve newly identified public
health issues as well as special control
guidance documents that are necessary
for the classification of de novo devices.
It will be helpful, therefore, to receive
comments that indicate the relative
priority of different guidance topics to
interested stakeholders.
The Center expects that the recent
initiatives it has taken to streamline and
track guidance development will
improve its capacity to issue more
guidance documents. The posting and
the establishment of a docket
announced through this notice is one of
the ways CDRH hopes to enhance the
process. 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. 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 list, draft language
for guidance documents on those topics,
and suggestions for new or different
guidances may be submitted. FDA
hopes this docket will become an
important tool for receiving information
from interested parties and for sharing
this information with the public.
E:\FR\FM\10OCN1.SGM
10OCN1
57588
Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Notices
Similar information about planned
guidance development is included in
the annual agency-wide notice issued by
FDA under its good guidance practices
(21 CFR 10.115(f)(5)). This 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 fiscal year from
2008 to 2012.
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.
To access the list of the guidance
documents CDRH is considering for
development in 2008, visit the FDA
Web Site at https://www.fda.gov/cdrh/
mdufma/guidance/agenda/fy08.html.
Dated: October 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–19864 Filed 10–9–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of meeting of the Advisory
Committee on Organ Transplantation
Health Resources and Services
Administration, HHS.
ACTION: Notice of meeting of the
Advisory Committee on Organ
Transplantation.
rwilkins on PROD1PC63 with NOTICES
AGENCY:
SUMMARY: Pursuant to Public Law 92–
463, the Federal Advisory Committee
Act, as amended (5 U.S.C. Appendix 2),
notice is hereby given of the thirteenth
meeting of the Advisory Committee on
Organ Transplantation (ACOT),
Department of Health and Human
Services (HHS). The meeting will be
held from approximately 9 a.m. to 5:30
p.m. on November 15, 2007, and from
9 a.m. to 3 p.m. on November 16, 2007,
at the Crowne Plaza Hotel Washington,
VerDate Aug<31>2005
19:46 Oct 09, 2007
Jkt 211001
DC—Silver Spring, 8777 Georgia
Avenue, Silver Spring, MD 20910. The
meeting will be open to the public;
however, seating is limited and preregistration is encouraged (see below).
SUPPLEMENTARY INFORMATION: Under the
authority of 42 U.S.C. 217a, Section 222
of the Public Health Service Act, as
amended, and 42 CFR 121.12 (2000),
ACOT was established to assist the
Secretary in enhancing organ donation,
ensuring that the system of organ
transplantation is grounded in the best
available medical science, and assuring
the public that the system is as effective
and equitable as possible, and, thereby,
increasing public confidence in the
integrity and effectiveness of the
transplantation system. ACOT is
composed of up to 25 members,
including the Chair. Members are
serving as Special Government
Employees and have diverse
backgrounds in fields such as organ
donation, health care public policy,
transplantation medicine and surgery,
critical care medicine and other medical
specialties involved in the identification
and referral of donors, non-physician
transplant professions, nursing,
epidemiology, immunology, law and
bioethics, behavioral sciences,
economics and statistics, as well as
representatives of transplant candidates,
transplant recipients, organ donors, and
family members.
ACOT will hear presentations on
xenotransplantation; pediatric
transplantation; transplantation
economics; a description of two
National Institutes of Health long-term
living donor follow up studies; and
Organ Procurement and Transplantation
Network Long-Term Follow Up. The
ACOT work groups also will update the
full Committee on their deliberations on
transplant tourism, informed consent,
sources of funding for additional data
collection, and tissue recovery and
transplantation certification/
accreditation.
The draft meeting agenda will be
available on November 1 on the
Department’s donation Web site at
https://www.organdonor.gov/acot.html.
A registration form will be available
on October 15 on the Department’s
donation Web site at https://
www.organdonor.gov/acot.html. The
completed registration form should be
submitted by facsimile to Professional
and Scientific Associates (PSA), the
logistical support contractor for the
meeting, at fax number (703) 234–1701.
Individuals without access to the
Internet who wish to register may call
Sowjanya Kotakonda with PSA at (703)
234–1737. Registration can also be
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
completed electronically at https://
www.psava.com/dot/acot2007/.
Individuals who plan to attend the
meeting and need special assistance,
such as sign language interpretation or
other reasonable accommodations,
should notify the ACOT Executive
Secretary, Remy Aronoff, in advance of
the meeting. Mr. Aronoff may be
reached by telephone at 301–443–3264,
e-mail: Remy.Aronoff@hrsa.hhs.gov or
in writing at the address provided
below. Management and support
services for ACOT functions are
provided by the Division of
Transplantation, Healthcare Systems
Bureau, Health Resources and Services
Administration, 5600 Fishers Lane,
Parklawn Building, Room 12C–06,
Rockville, Maryland 20857; telephone
number 301–443–7577.
After the presentations and ACOT
discussions, members of the public will
have an opportunity to provide
comments. Because of the Committee’s
full agenda and the timeframe in which
to cover the agenda topics, public
comment will be limited. All public
comments will be included in the
record of the ACOT meeting.
Dated: October 2, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7–19969 Filed 10–9–07; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (DHHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
67 FR 46519, July 15, 2002; 68 FR 787–
793, January 7, 2003; 68 FR 8515–8517,
February 21, 2003; 68 FR 64357–64358,
November 13, 2003; 69 FR 56433–
56445, September 21, 2004; as last
amended at 70 FR 19962–19963, April
15, 2005). This Order of Succession
supersedes the Order of Succession for
the Administrator, HRSA, published at
FR 70 19962–19963, April 15, 2005.
This notice updates changes to
HRSA’s hierarchy affecting the Office of
the Administrator; Deputy
Administrator; Senior Advisor to the
Administrator, Chief Financial Officer;
Bureau of Primary Health Care; Office of
E:\FR\FM\10OCN1.SGM
10OCN1
]]>Agencies
[Federal Register Volume 72, Number 195 (Wednesday, October 10, 2007)]
[Notices]
[Pages 57587-57588]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19864]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0357]
Medical Device User Fee and Modernization Act; Notice to Public
of Web Location of 2008 Proposed Guidance Development; Establishment of
a Public Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the Web
location where it will post a list of guidance documents the Center for
Devices and Radiological Health (CDRH) is considering for development.
In addition, FDA is establishing 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.fda.gov/dockets/ecomments. 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 FDA's Center for Devices and
Radiological Health (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 CDRH is
intending to work on over the next fiscal year. 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.
We also note that CDRH's experience over the years has shown that
there are many reasons CDRH staff cannot 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 it cannot know about in
advance. These may involve newly identified public health issues as
well as special control guidance documents that are necessary for the
classification of de novo devices. It will be helpful, therefore, to
receive comments that indicate the relative priority of different
guidance topics to interested stakeholders.
The Center expects that the recent initiatives it has taken to
streamline and track guidance development will improve its capacity to
issue more guidance documents. The posting and the establishment of a
docket announced through this notice is one of the ways CDRH hopes to
enhance the process. 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. 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 list, draft language for guidance
documents on those topics, and suggestions for new or different
guidances may be submitted. FDA hopes this docket will become an
important tool for receiving information from interested parties and
for sharing this information with the public.
[[Page 57588]]
Similar information about planned guidance development is included in
the annual agency-wide notice issued by FDA under its good guidance
practices (21 CFR 10.115(f)(5)). This 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 fiscal year
from 2008 to 2012.
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.
To access the list of the guidance documents CDRH is considering
for development in 2008, visit the FDA Web Site at https://www.fda.gov/
cdrh/mdufma/guidance/agenda/fy08.html.
Dated: October 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-19864 Filed 10-9-07; 8:45 am]
BILLING CODE 4160-01-S
