Board of Scientific Counselors, Coordinating Office for Terrorism Preparedness and Emergency Response (BSC, COTPER), 34360 [E9-16771]
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Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Notices
sroberts on DSKD5P82C1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Lawrence Yu, Center for Drug
Evaluation and Research (HFD–600),
Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240–
276–9310.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a revised guidance for industry entitled
‘‘ANDAs: Impurities in Drug
Substances.’’ The guidance provides
revised recommendations on what CMC
information to include regarding the
reporting, identification, and
qualification of impurities in drug
substances produced by chemical
synthesis when submitting: (1) Original
ANDAs; (2) DMFs, including type II
DMFs; and (3) ANDA supplements for
changes in the synthesis or processing
of a drug substance. The guidance also
provides recommendations for
establishing acceptance criteria for
impurities in drug substances.
In November 1999, FDA published
the first version of this guidance. In
2003, the International Conference on
Harmonisation made changes to
recommendations on impurities in drug
substances for new drug applications in
the guidance for industry entitled ‘‘Q3A
Impurities in New Drug Substances’’
(Revision 1) (Q3A(R)). As a result of
these changes, FDA began an effort to
revise this guidance for ANDAs. FDA
has revised the guidance to update
information on listing impurities,
setting acceptance criteria, and
qualifying impurities (thresholds and
procedures) in ANDAs to make it
consistent with Q3A(R).
On January 31, 2005 (70 FR 4857),
FDA announced the availability of the
draft revision for public comment. The
comment period closed on May 2, 2005.
A number of comments were received,
which the agency considered carefully
as it began the process of finalizing the
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 impurities in drug
substances for generic drugs. 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 an
approach satisfies the requirements of
the applicable statutes and regulations.
II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
VerDate Nov<24>2008
17:21 Jul 14, 2009
Jkt 217001
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.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 314 have been approved
under OMB Control No. 0910–0001.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm or https://
www.regulations.gov.
Dated: July 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–16868 Filed 7–14–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention (CDC)
Board of Scientific Counselors,
Coordinating Office for Terrorism
Preparedness and Emergency
Response (BSC, COTPER)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), CDC announces the
following meeting of the
aforementioned committee:
Times and Dates: 12 p.m.–5:15 p.m.,
August 13, 2009; 9 a.m.–3:30 p.m., August
14, 2009.
Place: CDC, 1600 Clifton Road, NE., Global
Communications Center, Building 19,
Auditorium B3, Atlanta, Georgia 30333.
Status: Open to the public for observation
and comment, limited only by the space
available. The meeting room accommodates
approximately 50 people. Visitors to the CDC
campus must be processed in accordance
with established Federal policies and
procedures and should pre-register for the
meeting as described in Additional
Information for visitors. Public comment
periods are planned for both meeting days.
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
Purpose: This Board is charged with
advising the Secretary of HHS and Director
of CDC concerning strategies and goals for
the programs and research within COTPER,
monitoring the strategic direction and focus
of the Divisions, and conducting peer review
of scientific programs. For additional
information about the COTPER BSC, please
visit: https://emergency.cdc.gov/cotper/
science/counselors.asp.
Matters To Be Discussed: A program
response to the Board’s recommendations
from the external peer review of the fiscal
allocation process; a briefing on the findings
of the external peer review of COTPER’s
Division of Select Agents and Toxins; status
updates on other external peer reviews of
COTPER programs; updates from COTPER
activities and programs; and a discussion of
external peer review topics for fiscal year
2010. Agenda items are subject to change as
priorities dictate.
Additional Information For Visitors: All
visitors are required to present a valid form
of picture identification issued by a State,
Federal or international government. To
expedite the security clearance process for
visitors to the CDC Roybal campus, all
visitors must pre-register by submitting the
following information by e-mail or phone
(see Contact Person for More Information) no
later than 12 noon (EDT) on Monday, July 27,
2009:
• Full Name,
• Organizational Affiliation,
• Complete Mailing Address,
• Citizenship, and
• Phone Number or E-mail Address.
For foreign nationals or non-U.S. citizens,
pre-approval is required. Please contact the
BSC Coordinator (see Contact Person for
More Information) in advance of the posted
pre-registration deadline for additional
security requirements that must be met.
Contact Person for More Information:
Matthew Jennings, BSC Coordinator,
COTPER, CDC, 1600 Clifton Rd., NE.,
Mailstop D–44, Atlanta, GA 30333,
Telephone: (404) 639–7357; Facsimile: (404)
639–7977; E-mail:
COTPER.BSC.Questions@cdc.gov.
The Director, Management Analysis and
Service Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both CDC and Agency for Toxic Substances
and Disease Registry.
Dated: July 7, 2009.
Elaine L. Baker,
Director, Management Analysis and Service
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–16771 Filed 7–14–09; 8:45 am]
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[Federal Register Volume 74, Number 134 (Wednesday, July 15, 2009)]
[Notices]
[Page 34360]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16771]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention (CDC)
Board of Scientific Counselors, Coordinating Office for Terrorism
Preparedness and Emergency Response (BSC, COTPER)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), CDC announces the following meeting of
the aforementioned committee:
Times and Dates: 12 p.m.-5:15 p.m., August 13, 2009; 9 a.m.-3:30
p.m., August 14, 2009.
Place: CDC, 1600 Clifton Road, NE., Global Communications
Center, Building 19, Auditorium B3, Atlanta, Georgia 30333.
Status: Open to the public for observation and comment, limited
only by the space available. The meeting room accommodates
approximately 50 people. Visitors to the CDC campus must be
processed in accordance with established Federal policies and
procedures and should pre-register for the meeting as described in
Additional Information for visitors. Public comment periods are
planned for both meeting days.
Purpose: This Board is charged with advising the Secretary of
HHS and Director of CDC concerning strategies and goals for the
programs and research within COTPER, monitoring the strategic
direction and focus of the Divisions, and conducting peer review of
scientific programs. For additional information about the COTPER
BSC, please visit: https://emergency.cdc.gov/cotper/science/counselors.asp.
Matters To Be Discussed: A program response to the Board's
recommendations from the external peer review of the fiscal
allocation process; a briefing on the findings of the external peer
review of COTPER's Division of Select Agents and Toxins; status
updates on other external peer reviews of COTPER programs; updates
from COTPER activities and programs; and a discussion of external
peer review topics for fiscal year 2010. Agenda items are subject to
change as priorities dictate.
Additional Information For Visitors: All visitors are required
to present a valid form of picture identification issued by a State,
Federal or international government. To expedite the security
clearance process for visitors to the CDC Roybal campus, all
visitors must pre-register by submitting the following information
by e-mail or phone (see Contact Person for More Information) no
later than 12 noon (EDT) on Monday, July 27, 2009:
Full Name,
Organizational Affiliation,
Complete Mailing Address,
Citizenship, and
Phone Number or E-mail Address.
For foreign nationals or non-U.S. citizens, pre-approval is
required. Please contact the BSC Coordinator (see Contact Person for
More Information) in advance of the posted pre-registration deadline
for additional security requirements that must be met.
Contact Person for More Information: Matthew Jennings, BSC
Coordinator, COTPER, CDC, 1600 Clifton Rd., NE., Mailstop D-44,
Atlanta, GA 30333, Telephone: (404) 639-7357; Facsimile: (404) 639-
7977; E-mail: COTPER.BSC.Questions@cdc.gov.
The Director, Management Analysis and Service Office, has been
delegated the authority to sign Federal Register notices pertaining
to announcements of meetings and other committee management
activities for both CDC and Agency for Toxic Substances and Disease
Registry.
Dated: July 7, 2009.
Elaine L. Baker,
Director, Management Analysis and Service Office, Centers for Disease
Control and Prevention.
[FR Doc. E9-16771 Filed 7-14-09; 8:45 am]
BILLING CODE 4163-18-P
