62810 Federal Register / Vol. 69, No. 208 / Thursday, October 28, 2004 / Rules and Regulations 

Issued in Washington, DC on October 22, 

2004. 

Anthony F. Fazio, 

Director, Office of Rulemaking.

[FR Doc. 04–24141 Filed 10–27–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

Advisory Committee: Change of Name 

and Function; Technical Amendment

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule; technical 

amendment.

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

standing advisory committees’

regulations to change the name and 

function of the Biological Response 

Modifiers Advisory Committee. This 

action is being taken to reflect changes 

made to the charter for this advisory 

committee.

DATES: This rule is effective October 28, 

2004.

FOR FURTHER INFORMATION CONTACT:

Theresa Green, Advisory Committee 

Oversight Management Staff (HF–4), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–1220.

SUPPLEMENTARY INFORMATION: FDA is 

announcing that the name of the 

Biological Response Modifiers Advisory 

Committee, which was established on 

October 28, 1988, has been changed. 

The name ‘‘Cellular, Tissue and Gene 

Therapies Advisory Committee’’ more 

accurately describes the subject areas for 

which the committee is responsible. The 

committee reviews and evaluates 

available data relating to the safety, 

effectiveness, and appropriate use of 

human cells, human tissues, gene 

transfer therapies, and 

xenotransplantation products which are 

intended for transplantation, 

implantation, infusion, and transfer in 

the prevention and treatment of a broad 

spectrum of human diseases, and in the 

reconstruction, repair or replacement of 

tissues for various conditions. The 

Committee also considers the quality 

and relevance of FDA’s research 

program which provides scientific 

support for the regulation of these 

products, and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs.

The Biological Response Modifiers 

Advisory Committee name was changed 

and its functions expanded in the 

charter renewal dated October 28, 2004. 

FDA is revising 21 CFR 14.100(b)(2) to 

reflect these changes. In this document, 

FDA is hereby formally changing the 

name and the function of the committee 

by revising 21 CFR 14.100(b)(2).

Publication of this final rule 

constitutes a final action on this change 

under the Administrative Procedure 

Act. Under 5 U.S.C. 553(b)(B) and (d) 

and 21 CFR 10.40(d) and (e), the agency 

finds good cause to dispense with notice 

and public procedure and to proceed to 

an immediately effective regulation. 

Such notice and procedures are 

unnecessary and are not in the public 

interest, because the final rule is merely 

codifying the new name and expanded 

function of the advisory committee to 

reflect the current committee charter.

List of Subjects in 21 CFR Part 14

Administrative practice and 

procedure, Advisory committees, Color 

additives, Drugs, Radiation protection.

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 14 is 

amended as follows:

PART 14—PUBLIC HEARING BEFORE 

A PUBLIC ADVISORY COMMITTEE

■ 1. The authority citation for 21 CFR 

part 14 continues to read as follows:

Authority: 5 U.S.C. App. 2; 15 U.S.C. 

1451–1461, 21 U.S.C. 41–50, 141–149, 321–

394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 

U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; 

Pub. L. 108–155.

■ 2. Section 14.100 is amended by 

revising the heading of paragraph (b)(2) 

and paragraph (b)(2)(ii) to read as 

follows:

§ 14.100 List of standing advisory 

committees.

* * * * *

(b) * * *

(2) Cellular, Tissue and Gene 

Therapies Advisory Committee.

* * * * *

(ii) Function: Reviews and evaluates 

available data relating to the safety, 

effectiveness, and appropriate use of 

human cells, human tissues, gene 

transfer therapies and 

xenotransplantation products which are 

intended for transplantation, 

implantation, infusion, and transfer in 

the prevention and treatment of a broad 

spectrum of human diseases and in the 

reconstruction, repair or replacement of 

tissues for various conditions. The 

Committee also considers the quality 

and relevance of FDA’s research 

program which provides scientific 

support for the regulation of these 

products, and makes appropriate 

recommendations to the Commissioner 

of Food and Drugs.

* * * * *

Dated: October 21, 2004.

Sheila Dearybury Walcoff,

Associate Commissioner for External 

Relations.

[FR Doc. 04–24065 Filed 10–27–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

New Animal Drugs; Change of Sponsor

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for three new animal 

drug applications (NADAs) from 

Sweetlix LLC to Ridley U.S. Holdings, 

Inc.

DATES: This rule is effective October 28, 

2004.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.gov.

SUPPLEMENTARY INFORMATION: Sweetlix 

LLC, 175 South Main St., suite 150, Salt 

Lake City, UT 84111, has informed FDA 

that it has transferred ownership of, and 

all rights and interest in, the following 

three approved NADAs to Ridley U.S. 

Holdings, Inc., 424 North Riverfront Dr., 

P.O. Box 8500, Mankato, MN 56002–

8500:

Application Number 21 CFR Section Trade Name 

NADA 033–733 520.1840 Sweetlix Bloat Guard Block