[Federal Register: October 28, 2004 (Volume 69, Number 208)]
[Rules and Regulations]
[Page 62810]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc04-6]
=======================================================================
-----------------------------------------------------------------------
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.
0
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
0
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.
0
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]
BILLING CODE 4160-01-S