Board of Scientific Counselors, Coordinating Office for Terrorism Preparedness and Emergency Response (BSC, COTPER), 34360 [E9-16771]

Download as PDF 34360 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 http://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or http:// 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] BILLING CODE 4160–01–S 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: http://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 E:\FR\FM\15JYN1.SGM 15JYN1

Agencies

[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]


-----------------------------------------------------------------------

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: http://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