Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 54925 

1Copies 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. 

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: 

‘‘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.’’ 

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] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panels (SEP): Surveillance 

Review, Program Announcement PAR–

04–106 

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 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

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 

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 http://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 

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’’ (http://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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[FDA 225–02–1000] 

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 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: 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. 

DATES: The agreement became effective 

February 12, 2002. 

FOR FURTHER INFORMATION CONTACT: 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. 

SUPPLEMENTARY INFORMATION: 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. 

Dated: September 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

BILLING CODE 4160–01–S