Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater; Technical Amendment, 36993 [2011-15817]
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Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Rules and Regulations
PART 50—PROTECTION OF HUMAN
SUBJECTS
1. The authority citation for 21 CFR
part 50 continues to read as follows:
■
Authority: 21 U.S.C. 321, 343, 346, 346a,
348, 350a, 350b, 352, 353, 355, 360, 360c–
360f, 360h–360j, 371, 379e, 381; 42 U.S.C.
216, 241, 262, 263b–263n.
2. Revise § 50.23(e)(3) to read as
follows:
■
§ 50.23 Exception from general
requirements.
*
*
*
*
*
(e) * * *
(3) The investigator must submit the
written certification of the
determinations made by the investigator
and an independent physician required
in paragraph (e)(1) or (e)(2) of this
section to the IRB and FDA within 5
working days after the use of the device.
*
*
*
*
*
Dated: June 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–15816 Filed 6–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA–1997–N–0040] (formerly
Docket No. 1997N–0484P)
Medical Devices; Neurological
Devices; Clarification of Classification
for Human Dura Mater; Technical
Amendment
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
device regulations to clarify the
applicability of the device classification
for human dura mater. This action is
being taken to improve the accuracy of
the regulations.
DATES: This final rule is effective June
24, 2011.
FOR FURTHER INFORMATION CONTACT:
Melissa Reisman, Center for Biologics
Evaluation and Research (HFM–17),
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448, 301–827–6210.
SUPPLEMENTARY INFORMATION: FDA is
clarifying the regulatory authority for
human dura mater in the Agency’s
jlentini on DSK4TPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
16:28 Jun 23, 2011
Jkt 223001
codified regulations for part 882 (21
CFR part 882). In the Federal Register
of November 24, 2004 (69 FR 68612),
FDA published a final rule regarding
current good tissue practice for
establishments that manufacture human
cell, tissue, and cellular and tissuebased products (HCT/Ps). That rule
became effective on May 25, 2005. Prior
to the effective date of the final rule,
human dura mater was regulated as a
medical device under § 882.5975. As
stated in the final rule, human dura
mater is now defined under 21 CFR
1271.3(d) as a HCT/P. As such, it is
regulated under section 361 of the
Public Health Service Act (42 U.S.C.
264) and the requirements of 21 CFR
part 1271, including requirements
related to registration and listing, donor
eligibility determinations, and current
good tissue practice. Accordingly, the
device classification contained in
§ 882.5975 is only applicable for human
dura mater recovered prior to the
effective date of the final rule, May 25,
2005. The final rule omitted a
corresponding annotation to § 882.5975
to clarify that the device classification is
only applicable for human dura mater
recovered prior to the effective date of
the final rule. This document clarifies
the regulatory authority for human dura
mater. Publication of this document
constitutes final action under the
Administrative Procedure Act (5 U.S.C.
553). FDA has determined that notice
and public comment are unnecessary
because this amendment is
nonsubstantive.
List of Subjects in 21 CFR Part 882
Medical devices, Neurological
devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 882 is
amended as follows:
PART 882—NEUROLOGICAL DEVICES
1. The authority citation for 21 CFR
part 882 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
2. Section 882.5975 is amended by
adding paragraph (c) to read as follows:
■
§ 882.5975
Human dura mater.
*
*
*
*
*
(c) Scope. The classification set forth
in this section is only applicable to
human dura mater recovered prior to
May 25, 2005.
PO 00000
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36993
Dated: June 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–15817 Filed 6–23–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9530]
RIN 1545–BH56
Guidance Under Section 956 for
Determining the Basis of Property
Acquired in Certain Nonrecognition
Transactions
Internal Revenue Service (IRS),
Treasury.
ACTION: Final and temporary
regulations.
AGENCY:
This document contains final
and temporary regulations under section
956 of the Internal Revenue Code (Code)
regarding the determination of basis in
certain United States property acquired
by a controlled foreign corporation in
certain nonrecognition transactions that
are intended to repatriate earnings and
profits of the controlled foreign
corporation without U.S. income
taxation. The regulations affect United
States shareholders of a controlled
foreign corporation that acquires United
States property in certain
nonrecognition transactions.
DATES: Effective Date: These regulations
are effective on June 24, 2011.
Applicability Date: For dates of
applicability, see § 1.956–1(e)(6)(vii).
FOR FURTHER INFORMATION CONTACT:
Kristine A. Crabtree at (202) 622–3840
(not a toll-free number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background and Explanation of
Provisions
On June 24, 2008, the IRS published
final and temporary regulations under
section 956 (TD 9402) in the Federal
Register (73 FR 35580). On the same
date, the IRS published a notice of
proposed rulemaking (REG–102122–08)
(the proposed regulations) in the
Federal Register (73 FR 35606) crossreferencing the temporary regulations.
The temporary and proposed
regulations provided guidance regarding
the determination of basis in certain
United States property (as defined in
section 956(c)) acquired by a controlled
foreign corporation (as defined in
section 957(a)) in certain nonrecognition
E:\FR\FM\24JNR1.SGM
24JNR1
]]>Agencies
[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Rules and Regulations]
[Page 36993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15817]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA-1997-N-0040] (formerly Docket No. 1997N-0484P)
Medical Devices; Neurological Devices; Clarification of
Classification for Human Dura Mater; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the device
regulations to clarify the applicability of the device classification
for human dura mater. This action is being taken to improve the
accuracy of the regulations.
DATES: This final rule is effective June 24, 2011.
FOR FURTHER INFORMATION CONTACT: Melissa Reisman, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION: FDA is clarifying the regulatory authority
for human dura mater in the Agency's codified regulations for part 882
(21 CFR part 882). In the Federal Register of November 24, 2004 (69 FR
68612), FDA published a final rule regarding current good tissue
practice for establishments that manufacture human cell, tissue, and
cellular and tissue-based products (HCT/Ps). That rule became effective
on May 25, 2005. Prior to the effective date of the final rule, human
dura mater was regulated as a medical device under Sec. 882.5975. As
stated in the final rule, human dura mater is now defined under 21 CFR
1271.3(d) as a HCT/P. As such, it is regulated under section 361 of the
Public Health Service Act (42 U.S.C. 264) and the requirements of 21
CFR part 1271, including requirements related to registration and
listing, donor eligibility determinations, and current good tissue
practice. Accordingly, the device classification contained in Sec.
882.5975 is only applicable for human dura mater recovered prior to the
effective date of the final rule, May 25, 2005. The final rule omitted
a corresponding annotation to Sec. 882.5975 to clarify that the device
classification is only applicable for human dura mater recovered prior
to the effective date of the final rule. This document clarifies the
regulatory authority for human dura mater. Publication of this document
constitutes final action under the Administrative Procedure Act (5
U.S.C. 553). FDA has determined that notice and public comment are
unnecessary because this amendment is nonsubstantive.
List of Subjects in 21 CFR Part 882
Medical devices, Neurological devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
882 is amended as follows:
PART 882--NEUROLOGICAL DEVICES
0
1. The authority citation for 21 CFR part 882 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 882.5975 is amended by adding paragraph (c) to read as
follows:
Sec. 882.5975 Human dura mater.
* * * * *
(c) Scope. The classification set forth in this section is only
applicable to human dura mater recovered prior to May 25, 2005.
Dated: June 17, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15817 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-01-P
