Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment, 24599 [E8-9726]
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[FR Doc. E8–9762 Filed 5–2–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0257]
Draft Prescription Drug User Fee Act IV
Drug Safety Five-Year Plan; Availability
for Comment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability for public comment of the
draft drug safety 5-year plan entitled
‘‘Prescription Drug User Fee Act
(PDUFA) IV Drug Safety Five-Year
Plan.’’ This plan is intended to
communicate FDA’s strategy for meeting
the commitments for enhancing and
modernizing the drug safety system
within the context of the PDUFA IV
program.
DATES: Submit written or electronic
comments on the draft drug safety 5year plan by June 19, 2008.
ADDRESSES: Submit written requests for
single copies of the draft plan to the
Office of Executive Programs, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6100,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the draft drug safety 5-year plan 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. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the document.
FOR FURTHER INFORMATION CONTACT:
Jayne C. Ware, Food and Drug
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SUMMARY:
VerDate Aug<31>2005
15:16 May 02, 2008
Jkt 214001
Administration, Center for Drug
Evaluation and Research, Office of
Executive Programs, 10903 New
Hampshire Ave., Bldg. 51, rm. 6100,
Silver Spring, MD 20993–0002, 301–
796–3200.
SUPPLEMENTARY INFORMATION:
I. Background
On September 27, 2007, President
Bush signed into law the Food and Drug
Administration Amendments Act of
2007, which includes the
reauthorization and expansion of
PDUFA. The reauthorization of PDUFA
will significantly broaden and
modernize the agency’s drug safety
program and facilitate more efficient
development of safe and effective new
medications for the American public.
During the user fee negotiation process
leading up to the renewal of PDUFA,
FDA and the relevant regulated
industries mutually agreed to certain
commitments that the FDA will carry
out during fiscal years 2008 through
2012. Congress signaled its agreement
with the commitments by authorizing
PDUFA funds for them. Among those
commitments is the responsibility of the
FDA to develop and periodically update
a 5-year plan describing activities that
will lead to enhancing and modernizing
FDA’s drug safety system.
FDA is announcing for public
comment the availability of the draft
drug safety 5-year plan entitled
‘‘Prescription Drug User Fee Act
(PDUFA) IV Drug Safety Five-Year
Plan.’’ This plan is intended to
communicate FDA’s strategy for meeting
the commitments for enhancing and
modernizing the drug safety system
within the context of the PDUFA IV
program. The plan describes the
agency’s strategy for achieving the
commitments defined in section VIII,
Enhancement and Modernization of the
FDA Drug Safety System, and section
IX, Review of Proprietary Names to
Reduce Medication Errors, of the
PDUFA IV Performance Goals (https://
www.fda.gov/oc/pdufa4/
pdufa4goals.html). At the end of the
comment period, FDA will review the
comments, update the ‘‘PDUFA IV Drug
Safety Five-Year Plan,’’ and publish the
final version.
II. 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
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
24599
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.
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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/cder/pdufa/
PDUFA_IV_5yr_plan_draft.pdf.
Dated: April 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–9726 Filed 5–2–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
The 11th Annual Food and Drug
Administration-Orange County
Regulatory Affairs Educational
Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of meeting.
The Food and Drug Administration
(FDA) is announcing the following
conference: 11th Annual Educational
Conference co-sponsored with the
Orange County Regulatory Affairs
Discussion Group (OCRA). The
conference is intended to provide the
Drug, Device, and Biologics industries
with an opportunity to interact with
FDA reviewers and compliance officers
from the Centers and District Offices, as
well as other industry experts. The main
focus of this interactive conference will
be product approval, compliance, and
risk management in the three medical
product areas. Industry speakers,
interactive questions and answers, and
workshop sessions will also be included
to assure open exchange and dialogue
on the relevant regulatory issues.
Date and Time: The conference will
be held on June 11 and 12, 2008, from
7:30 a.m. to 5 p.m.
Location: The conference will be held
at the Irvine Marriott Hotel, 18000 Von
Karman Ave., Irvine, CA 92612.
E:\FR\FM\05MYN1.SGM
05MYN1
Agencies
[Federal Register Volume 73, Number 87 (Monday, May 5, 2008)]
[Notices]
[Page 24599]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9726]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0257]
Draft Prescription Drug User Fee Act IV Drug Safety Five-Year
Plan; Availability for Comment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for public comment of the draft drug safety 5-year plan
entitled ``Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-
Year Plan.'' This plan is intended to communicate FDA's strategy for
meeting the commitments for enhancing and modernizing the drug safety
system within the context of the PDUFA IV program.
DATES: Submit written or electronic comments on the draft drug safety
5-year plan by June 19, 2008.
ADDRESSES: Submit written requests for single copies of the draft plan
to the Office of Executive Programs, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6100, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests.
Submit written comments on the draft drug safety 5-year plan 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. See the SUPPLEMENTARY
INFORMATION section for electronic access to the document.
FOR FURTHER INFORMATION CONTACT: Jayne C. Ware, Food and Drug
Administration, Center for Drug Evaluation and Research, Office of
Executive Programs, 10903 New Hampshire Ave., Bldg. 51, rm. 6100,
Silver Spring, MD 20993-0002, 301-796-3200.
SUPPLEMENTARY INFORMATION:
I. Background
On September 27, 2007, President Bush signed into law the Food and
Drug Administration Amendments Act of 2007, which includes the
reauthorization and expansion of PDUFA. The reauthorization of PDUFA
will significantly broaden and modernize the agency's drug safety
program and facilitate more efficient development of safe and effective
new medications for the American public. During the user fee
negotiation process leading up to the renewal of PDUFA, FDA and the
relevant regulated industries mutually agreed to certain commitments
that the FDA will carry out during fiscal years 2008 through 2012.
Congress signaled its agreement with the commitments by authorizing
PDUFA funds for them. Among those commitments is the responsibility of
the FDA to develop and periodically update a 5-year plan describing
activities that will lead to enhancing and modernizing FDA's drug
safety system.
FDA is announcing for public comment the availability of the draft
drug safety 5-year plan entitled ``Prescription Drug User Fee Act
(PDUFA) IV Drug Safety Five-Year Plan.'' This plan is intended to
communicate FDA's strategy for meeting the commitments for enhancing
and modernizing the drug safety system within the context of the PDUFA
IV program. The plan describes the agency's strategy for achieving the
commitments defined in section VIII, Enhancement and Modernization of
the FDA Drug Safety System, and section IX, Review of Proprietary Names
to Reduce Medication Errors, of the PDUFA IV Performance Goals (https://www.fda.gov/oc/pdufa4/pdufa4goals.html). At the end of the comment
period, FDA will review the comments, update the ``PDUFA IV Drug Safety
Five-Year Plan,'' and publish the final version.
II. 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.
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.
III. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/cder/pdufa/PDUFA_IV_5yr_plan_draft.pdf.
Dated: April 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9726 Filed 5-2-08; 8:45 am]
BILLING CODE 4160-01-S