[Federal Register Volume 69, Number 208 (Thursday, October 28, 2004)]
[Rules and Regulations]
[Page 62810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24065]


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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.

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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.

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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

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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.

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2. Section 14.100 is amended by revising the heading of paragraph 
(b)(2) and paragraph (b)(2)(ii) to read as follows:


Sec.  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]
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