Submission of Chemistry, Manufacturing, and Controls Information in a New Drug Application Under the New Pharmaceutical Quality Assessment System; Extension of Application and Comment Deadlines, 54925-54926 [05-18515]
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Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices
Investment Limited, and New York
Global Partners, L.P., all of New York,
New York, is revised to read as follows:
A. Federal Reserve Bank of Atlanta
(Andre Anderson, Vice President) 1000
Peachtree Street, N.E., Atlanta, Georgia
30303:
1. York Capital Management, L.P.,
York Investment Limited, York Global
Value Partners, L.P., York Global Value
Holdings, LLC, Dinan Management, LLC,
York Offshore Holdings, Limited, Dinan
Management, L.P., Dinan Management
Corporation, and James G. Dinan
(collectively, ‘‘York’’), all of New York,
New York, and York Global Value
Holdings, L.P., York Global Value
Holdings, LLC and James G. Dinan,
individually and on behalf of the York
group, to acquire up to 24.9 percent of
the voting shares of PanAmerican
Bancorp, Miami, Florida, and thereby
indirectly acquire voting shares of
PanAmerican Bank, Miami, Florida.
Comments on this application must
be received by October 4, 2005.
Board of Governors of the Federal Reserve
System, September 14, 2005.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. 05–18597 Filed 9–16–05; 8:45 am]
BILLING CODE 6210–01–S
FEDERAL RESERVE SYSTEM
Federal Open Market Committee;
Domestic Policy Directive of August 9,
2005
In accordance with § 271.25 of its
rules regarding availability of
information (12 CFR part 271), there is
set forth below the domestic policy
directive issued by the Federal Open
Market Committee at its meeting held
on August 9, 2005.1
The Federal Open Market Committee
seeks monetary and financial conditions
that will foster price stability and
promote sustainable growth in output.
To further its long-run objectives, the
Committee in the immediate future
seeks conditions in reserve markets
consistent with increasing the federal
funds rate to an average of around 31⁄2
percent.
The vote encompassed approval of the
paragraph below for inclusion in the
statement to be released shortly after the
meeting:
1 Copies of the Minutes of the Federal Open
Market Committee Meeting on August 9, 2005,
which includes the domestic policy directive issued
at the meeting, are available upon request to the
Board of Governors of the Federal Reserve System,
Washington, DC 20551. The minutes are published
in the Federal Reserve Bulletin and in the Board’s
annual report.
VerDate Aug<31>2005
15:48 Sep 16, 2005
Jkt 205001
‘‘The Committee perceives that, with
appropriate monetary policy action, the
upside and downside risks to the
attainment of both sustainable growth
and price stability should be kept
roughly equal. With underlying
inflation expected to be contained, the
Committee believes that policy
accommodation can be removed at a
pace that is likely to be measured.
Nonetheless, the Committee will
respond to changes in economic
prospects as needed to fulfill its
obligation to maintain price stability.’’
both CDC and the Agency for Toxic
Substances and Disease Registry.
By order of the Federal Open Market
Committee, September 6, 2005.
Vincent R. Reinhart,
Secretary, Federal Open Market Committee.
[FR Doc. 05–18559 Filed 9–16–05; 8:45 am]
54925
Food and Drug Administration
Dated: September 13, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–18527 Filed 9–16–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. 2005N–0262]
BILLING CODE 6210–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submission of Chemistry,
Manufacturing, and Controls
Information in a New Drug Application
Under the New Pharmaceutical Quality
Assessment System; Extension of
Application and Comment Deadlines
AGENCY:
Food and Drug Administration,
HHS.
Centers for Disease Control and
Prevention
ACTION:
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panels (SEP): Surveillance
Review, Program Announcement PAR–
04–106
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
extension in the deadlines for
submitting requests to participate in and
comment on a pilot program involving
the submission of chemistry,
manufacturing, and controls (CMC)
information consistent with the new
pharmaceutical quality assessment
system.
DATES: Submit written requests to
participate in the pilot program by
March 31, 2006. Submit eligible new
drug applications (NDAs) by March 31,
2007. Submit written or electronic
comments on the pilot program by
March 31, 2007.
ADDRESSES: Submit written requests to
participate in the pilot program and
comments on the pilot program to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit electronic requests to
participate in and comments on the
pilot program to https://www.fda.gov/
dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Michael Folkendt, Center for Drug
Evaluation and Research (HFD–800),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–827–5918, e-mail:
folkendtm@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting:
Name: Disease, Disability, and Injury
Prevention and Control Special Emphasis
Panel (SEP): Surveillance Review, Program
Announcement PAR–04–106.
Times and Dates: 8 a.m.–5 p.m., November
2, 2005 (Closed), 8 a.m.–5 p.m., November 3,
2005 (Closed).
Place: Marriott Inner Harbor at Camden
Yard, 110 South Eutaw Street, Baltimore, MD
21201, Telephone Number 410.962.0202.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the review, discussion, and
evaluation of applications received in
response to: Surveillance Review, Program
Announcement PAR–04–106.
Contact Person For More Information:
Steve Olenchock, PhD, Scientific Review
Administrator, National Institute for
Occupational Safety and Health, CDC, 1095
Willowdale Road, Morgantown, WV 26506,
Telephone 304.285.6127.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Notice to extend application
and comment deadlines.
I. Background
In the Federal Register of July 14,
2005 (70 FR 40719), FDA announced
E:\FR\FM\19SEN1.SGM
19SEN1
54926
Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices
that it is seeking pharmaceutical
companies to participate in a pilot
program involving the submission of
CMC information consistent with a new
pharmaceutical quality assessment
system. The Office of New Drug
Chemistry (ONDC) in the Office of
Pharmaceutical Science, Center for Drug
Evaluation and Research, is establishing
a modern, risk-based pharmaceutical
quality assessment system, as described
in a September 2004 White Paper,
‘‘ONDC’s New Risk-Based
Pharmaceutical Quality Assessment
System’’ (https://www.fda.gov/cder/gmp/
gmp2004/ondc_reorg.htm). The pilot
program will provide additional
information for ONDC to use in
implementing the new quality
assessment system. The pilot program
will provide participating
pharmaceutical companies an
opportunity to submit critical CMC
information that demonstrates their
understanding of quality by design,
product knowledge, and process
understanding of the drug substance
and drug product at the time of
submission of an NDA. The pilot
program will also enable the public and
regulated industry to provide feedback
that will assist FDA in developing
guidance for industry on the new
quality assessment system.
The July 14, 2005 (70 FR 40719),
notice provided deadlines related to the
submission of certain information
related to the pilot program. To ensure
inclusive and relevant results from the
pilot program, this notice extends the
deadlines as follows: Requests to
participate in the pilot program to
March 31, 2006, from October 31, 2005,
and submission of eligible New Drug
Applications (NDA) to March 31, 2007,
from December 31, 2006. This notice
also extends the comment period on the
pilot program to March 31, 2007, from
December 31, 2006. See the process
VerDate Aug<31>2005
15:48 Sep 16, 2005
Jkt 205001
section (II.B) in the July 14, 2005 (70 FR
40719) notice for instructions on
submitting requests to participate in the
pilot program. All requests to
participate in the pilot program, both
written and electronic, should be
marked confidential.
II. Comments
Interested persons may submit written
comments on this pilot program to the
Division of Dockets Management (see
ADDRESSES). Two copies of any
comments are to be submitted, except
that individuals may submit one 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.
While detailed information on
participating NDAs will not be publicly
available, names of participating
applicants will be made public.
Dated: September 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–18515 Filed 9–16–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Memorandum of Understanding
Between the Food and Drug
Administration, Center for Biologics
Evaluation and Research, and the
National Institutes of Health, National
Institute of Neurological Disorders and
Stroke
Food and Drug Administration,
HHS.
PO 00000
Frm 00035
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between the Food
and Drug Administration, Center for
Biologics Evaluation and Research
(FDA/CBER), and the National Institutes
of Health, National Institute of
Neurological Disorders and Stroke (NIH/
NINDS). The purpose of this MOU is to
provide a framework for coordination
and collaborative efforts between these
two entities, which are both
components of the Department of Health
and Human Services. This MOU also
provides the principles and procedures
by which information sharing between
FDA/CBER and NIH/NINDS units shall
take place.
The agreement became effective
February 12, 2002.
DATES:
For
FDA/CBER: Kimberly Benton, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, WOC1/rm. 209N,
Rockville, MD 20852, 301–827–5102.
For NIH/NINDS: Robert Finkelstein,
Extramural Research, Neuroscience
Center, National Institutes of Health,
6001 Executive Blvd., rm. 2143,
Bethesda, MD 20892, 301–496–9248.
FOR FURTHER INFORMATION CONTACT:
In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
SUPPLEMENTARY INFORMATION:
[FDA 225–02–1000]
AGENCY:
ACTION:
Dated: September 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–S
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19SEN1
]]>Agencies
[Federal Register Volume 70, Number 180 (Monday, September 19, 2005)]
[Notices]
[Pages 54925-54926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18515]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0262]
Submission of Chemistry, Manufacturing, and Controls Information
in a New Drug Application Under the New Pharmaceutical Quality
Assessment System; Extension of Application and Comment Deadlines
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice to extend application and comment deadlines.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
extension in the deadlines for submitting requests to participate in
and comment on a pilot program involving the submission of chemistry,
manufacturing, and controls (CMC) information consistent with the new
pharmaceutical quality assessment system.
DATES: Submit written requests to participate in the pilot program by
March 31, 2006. Submit eligible new drug applications (NDAs) by March
31, 2007. Submit written or electronic comments on the pilot program by
March 31, 2007.
ADDRESSES: Submit written requests to participate in the pilot program
and comments on the pilot program to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic requests to participate in and
comments on the pilot program to https://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Michael Folkendt, Center for Drug
Evaluation and Research (HFD-800), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-5918, e-mail:
folkendtm@cder.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 14, 2005 (70 FR 40719), FDA
announced
[[Page 54926]]
that it is seeking pharmaceutical companies to participate in a pilot
program involving the submission of CMC information consistent with a
new pharmaceutical quality assessment system. The Office of New Drug
Chemistry (ONDC) in the Office of Pharmaceutical Science, Center for
Drug Evaluation and Research, is establishing a modern, risk-based
pharmaceutical quality assessment system, as described in a September
2004 White Paper, ``ONDC's New Risk-Based Pharmaceutical Quality
Assessment System'' (https://www.fda.gov/cder/gmp/gmp2004/ondc_
reorg.htm). The pilot program will provide additional information for
ONDC to use in implementing the new quality assessment system. The
pilot program will provide participating pharmaceutical companies an
opportunity to submit critical CMC information that demonstrates their
understanding of quality by design, product knowledge, and process
understanding of the drug substance and drug product at the time of
submission of an NDA. The pilot program will also enable the public and
regulated industry to provide feedback that will assist FDA in
developing guidance for industry on the new quality assessment system.
The July 14, 2005 (70 FR 40719), notice provided deadlines related
to the submission of certain information related to the pilot program.
To ensure inclusive and relevant results from the pilot program, this
notice extends the deadlines as follows: Requests to participate in the
pilot program to March 31, 2006, from October 31, 2005, and submission
of eligible New Drug Applications (NDA) to March 31, 2007, from
December 31, 2006. This notice also extends the comment period on the
pilot program to March 31, 2007, from December 31, 2006. See the
process section (II.B) in the July 14, 2005 (70 FR 40719) notice for
instructions on submitting requests to participate in the pilot
program. All requests to participate in the pilot program, both written
and electronic, should be marked confidential.
II. Comments
Interested persons may submit written comments on this pilot
program to the Division of Dockets Management (see ADDRESSES). Two
copies of any comments are to be submitted, except that individuals may
submit one 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. While detailed information on
participating NDAs will not be publicly available, names of
participating applicants will be made public.
Dated: September 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18515 Filed 9-16-05; 8:45 am]
BILLING CODE 4160-01-S
