Medical Devices; Immunology and Microbiology Devices; Classification of the Endotoxin Assay; Technical Amendment, 53069 [05-17645]
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Federal Register / Vol. 70, No. 172 / Wednesday, September 7, 2005 / Rules and Regulations
do not include tallow that contains no
more than 0.15 percent insoluble
impurities, tallow derivatives, hides and
hide-derived products, and milk and
milk products.
(2) Inspected and passed means that
the product has been inspected and
passed for human consumption by the
appropriate regulatory authority, and at
the time it was inspected and passed, it
was found to be not adulterated.
(3) Mechanically Separated
(MS)(Beef) means a meat food product
that is finely comminuted, resulting
from the mechanical separation and
removal of most of the bone from
attached skeletal muscle of cattle
carcasses and parts of carcasses that
meet the specifications contained in 9
CFR 319.5, the regulation that prescribes
the standard of identity for MS
(Species).
(4) Nonambulatory disabled cattle
means cattle that cannot rise from a
recumbent position or that cannot walk,
including, but not limited to, those with
broken appendages, severed tendons or
ligaments, nerve paralysis, fractured
vertebral column, or metabolic
conditions.
(5) Specified risk material means the
brain, skull, eyes, trigeminal ganglia,
spinal cord, vertebral column
(excluding the vertebrae of the tail, the
transverse processes of the thoracic and
lumbar vertebrae, and the wings of the
sacrum), and dorsal root ganglia of cattle
30 months and older and the tonsils and
distal ileum of the small intestine of all
cattle.
(6) Tallow means the rendered fat of
cattle obtained by pressing or by
applying any other extraction process to
tissues derived directly from discrete
adipose tissue masses or to other carcass
parts and tissues. Tallow must be
produced from tissues that are not
prohibited cattle materials or must
contain not more than 0.15 percent
insoluble impurities as determined by
the method entitled ‘‘Insoluble
Impurities’’ (AOCS Official Method Ca
3a-46), American Oil Chemists’ Society
(AOCS), 5th Edition, 1997, incorporated
by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51, or another
method equivalent in accuracy,
precision, and sensitivity to AOCS
Official Method Ca 3a-46. You may
obtain copies of the method from the
AOCS (https://www.aocs.org) 2211 W.
Bradley Ave. Champaign, IL 61821.
Copies may be examined at the Center
for Food Safety and Applied Nutrition’s
Library, 5100 Paint Branch Pkwy.,
College Park, MD 20740, or at the
National Archives and Records
VerDate Aug<18>2005
15:01 Sep 06, 2005
Jkt 205001
Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030,
or go to https://www.archives.gov/federal
_register/code_of_federal_regulations/
ibr_locations.html.
(7) Tallow derivative means any
chemical obtained through initial
hydrolysis, saponification, or transesterification of tallow; chemical
conversion of material obtained by
hydrolysis, saponification, or transesterification may be applied to obtain
the desired product.
(b) Requirements.
(1) No cosmetic shall be manufactured
from, processed with, or otherwise
contain, prohibited cattle materials.
(2) The small intestine is not
considered prohibited cattle material if
the distal ileum is removed by a
procedure that removes at least 80
inches of the uncoiled and trimmed
small intestine, as measured from the
caeco-colic junction and progressing
proximally towards the jejunum, or by
a procedure that the establishment can
demonstrate is equally effective in
ensuring complete removal of the distal
ileum.
(c) Records. Manufacturers and
processors of cosmetics that are
manufactured from, processed with, or
otherwise contain, cattle material must
make existing records relevant to
compliance with this section available
to FDA for inspection and copying.
(d) Adulteration. Failure of a
manufacturer or processor to operate in
compliance with the requirements of
paragraph (b) or (c) of this section
renders a cosmetic adulterated under
section 601(c) of the act.
Dated: August 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–17693 Filed 9–6–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUMMARY: The Food and Drug
Administration (FDA) published a final
rule in the Federal Register of October
31, 2003 (68 FR 62007). The final rule
classified the endotoxin assay into class
II (special controls). The agency
classified the device into class II
(special controls) in order to provide
reasonable assurance of safety and
effectiveness of the device. FDA is
amending the agency’s regulations to
redesignate the section number listed in
the Code of Federal Regulations (CFR)
from § 866.3610 to § 866.3210.
This rule is effective September
7, 2005.
DATES:
FOR FURTHER INFORMATION CONTACT:
Freddie M. Poole, Center for Devices
and Radiological Health (HFZ–440),
Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240–
276–0496 ext. 1111.
FDA has
found that the endotoxin assay
regulation does not reflect the correct
section number listed in the CFR.
Accordingly, FDA is amending the
regulation in § 866.3610 (21 CFR
866.3610) to correct the error by
redesignating the section number from
§ 866.3610 to 866.3210.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, Medical
devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 866 is
amended as follows:
I
PART 866—IMMUNOLOGY AND
MICROBIOLOGY DEVICES
1. The authority citation for 21 CFR
part 866 continues to read as follows:
I
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
§ 866.3610
Food and Drug Administration
21 CFR Part 866
[Docket No. 2003D–0221]
Medical Devices; Immunology and
Microbiology Devices; Classification of
the Endotoxin Assay; Technical
Amendment
AGENCY:
[Redesignated as § 866.3210 ]
2. Section 866.3610 is redesignated as
§ 866.3210.
I
Dated: August 26, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. 05–17645 Filed 9–6–05; 8:45 am]
BILLING CODE 4160–01–S
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
PO 00000
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[Federal Register Volume 70, Number 172 (Wednesday, September 7, 2005)]
[Rules and Regulations]
[Page 53069]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-17645]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. 2003D-0221]
Medical Devices; Immunology and Microbiology Devices;
Classification of the Endotoxin Assay; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) published a final rule
in the Federal Register of October 31, 2003 (68 FR 62007). The final
rule classified the endotoxin assay into class II (special controls).
The agency classified the device into class II (special controls) in
order to provide reasonable assurance of safety and effectiveness of
the device. FDA is amending the agency's regulations to redesignate the
section number listed in the Code of Federal Regulations (CFR) from
Sec. 866.3610 to Sec. 866.3210.
DATES: This rule is effective September 7, 2005.
FOR FURTHER INFORMATION CONTACT: Freddie M. Poole, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0496 ext. 1111.
SUPPLEMENTARY INFORMATION: FDA has found that the endotoxin assay
regulation does not reflect the correct section number listed in the
CFR. Accordingly, FDA is amending the regulation in Sec. 866.3610 (21
CFR 866.3610) to correct the error by redesignating the section number
from Sec. 866.3610 to 866.3210.
List of Subjects in 21 CFR Part 866
Biologics, Laboratories, Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES
0
1. The authority citation for 21 CFR part 866 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Sec. 866.3610 [Redesignated as Sec. 866.3210 ]
0
2. Section 866.3610 is redesignated as Sec. 866.3210.
Dated: August 26, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-17645 Filed 9-6-05; 8:45 am]
BILLING CODE 4160-01-S
