The Food and Drug Administration (FDA) is providing notice of an exchange of letters between FDA and the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA). The participants concluded this exchange of letters on September 12, 2003. These letters express the intentions of FDA, the European Commission, and

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing a call for data for certain categories of ingredients in overthecounter (OTC) drug products that are eligible for the original OTC drug review but have not been reviewed by FDA to date. FDA will review the submitted data and information as part of its ongoing review of OTC drug products to

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration (FDA), Department of Health and Human Services of the United States of America and the Health Products and Food Branch, Health Canada of Canada. The purpose of this MOU is to enhance and strengthen the exchange of

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration, Department of Health and Human Services of the United States of America and Swissmedic of the Swiss Confederation. The purpose of this MOU is to further enhance and strengthen communication and existing public

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Biological Response Modifiers Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2004. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for overthecounter (OTC) pediculicide drug products to revise labeling for the statement of identity, warnings, directions, and other required statements. Pediculicide drug products are used for the treatment of head, pubic (crab), and body lice. FDA

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of acesulfame potassium (ACK) as a generalpurpose sweetener and flavor enhancer in food, not including meat and poultry. This action
[[Page 75412]]
is in response to a food additive petition filed by Nutrinova, Inc. It will simplify the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The public is invited to comment on the following applications to conduct certain activities with endangered species and/or marine mammals.

DEPARTMENT OF THE INTERIOR : Fish and Wildlife Service

This is supplement No. 5 to the Treasury Department Circular 570; 2003 Revision, published July 1, 2003 at 68 FR 39186.

DEPARTMENT OF THE TREASURY : Fiscal Service

FHWA and FTA are issuing this notice to advise the public that an environmental impact statement/Section 4(f) Evaluation will be prepared for transportation improvements in the Counties of Denver, Boulder, Broomfield, Adams, Larimer and Weld.

DEPARTMENT OF TRANSPORTATION : Federal Transit Administration

Two public meetings will be held regarding the notice submitted by Bank of America Corporation, Charlotte, North Carolina, to acquire FleetBoston Financial Corporation, Boston, Massachusetts (``FleetBoston''), and its banking and nonbanking subsidiaries pursuant to the Bank Holding Company Act (``BHC Act'') and related statutes. The purpose of the

FEDERAL RESERVE SYSTEM : Federal Reserve System

This notice corrects a notice (FR Doc. 0330951) published on page 70015 of the issue for Tuesday, December 16, 2003.

Under the Federal Reserve Bank of Richmond heading, the entry for Southern Financial Bancorp, Inc., Warrenton, Virginia, is revised to read as follows:

[[Page 75567]]

A. Federal Reserve Bank of Richmond (A. Linwood Gill,

FEDERAL RESERVE SYSTEM : Federal Reserve System

The companies listed in this notice have given notice under section 4 of the Bank Holding Company Act (12 U.S.C. 1843) (BHC Act) and Regulation Y (12 CFR Part 225) to engage de novo, or to acquire or control voting securities or assets of a company, including the companies listed below, that engages either directly or through a subsidiary or

FEDERAL RESERVE SYSTEM : Federal Reserve System

The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the

FEDERAL RESERVE SYSTEM : Federal Reserve System

The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the

FEDERAL RESERVE SYSTEM : Federal Reserve System

This notice corrects a notice (FR Doc. 0328720) published on page 65932 of the issue for Monday, November 24, 2003.

Under the Federal Reserve Bank of Richmond heading, the entry for Bank of America Corporation, Charlotte, North Carolina, is revised to read as follows:

A. Federal Reserve Bank of Richmond (A. Linwood Gill, III, Vice

FEDERAL RESERVE SYSTEM : Federal Reserve System

The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR Part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the

FEDERAL RESERVE SYSTEM : Federal Reserve System

The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and Sec. 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

The notices are

FEDERAL RESERVE SYSTEM : Federal Reserve System

The FMCSA announces its decision to exempt 24 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs). The exemptions will enable these individuals to qualify as drivers of commercial motor vehicles (CMVs) in interstate commerce without meeting the vision standard prescribed in 49 CFR 391.41(b)(10).

DEPARTMENT OF TRANSPORTATION : Federal Motor Carrier Safety Administration

FMCSA withdraws its February 17, 1999, ANPRM relating to responsibilities for the inspection, repair, and maintenance of intermodal container chassis and trailers. After reviewing the public comments received in response to the ANPRM, transcripts from three listening sessions held in November 1999, comments submitted in response to the agency's

DEPARTMENT OF TRANSPORTATION : Federal Motor Carrier Safety Administration

The Commission hereby gives notice of the filing of the following agreements under the Shipping Act of 1984. Interested parties can review or obtain copies of agreements at the Washington, DC offices of the Commission, 800 North Capitol Street, NW, Room 940. Interested parties may submit comments on an agreement to the Secretary, Federal

FEDERAL MARITIME COMMISSION : Federal Maritime Commission

The FHWA is issuing this notice to advise the public that a new supplement to a final environmental impact statement will be prepared for a proposed highway project in Chittenden County, Vermont, and that a 1984 supplement to the final environmental impact statement will not be completed.

DEPARTMENT OF TRANSPORTATION : Federal Highway Administration

December 23, 2003.

In the matter of: ER031372002, ER031372001, ER021406002, ER031207001, ER00891003, ER03287001, ER0033004, ER021084
001, ER001372002, ER022074001, ER01811001, ER972153013,
ER002677003, ER03170002, ER011302003, ER031039002, ER00
2117002, ER002118002, ER003751002, ER001828002, ER0047002, ER03725002, ER0224003, ER013103004,

DEPARTMENT OF ENERGY : Federal Energy Regulatory Commission